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Toxicological information

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Administrative data

Description of key information

Skin corrosion/irritation

The assessment of skin irritation toxicity for Set 1 compiles the review of 19 studies performed between 1970 and 2004. Different forms of synthetic amorphous silica with specific surface area (BET) ranging from 45-700 m2/g were used as test materials. 7 of these studies meet the criteria for Klimisch score 1 and 12 of them meet the Klimisch score 2. These studies were performed according to OECD test guideline 404 or similar in vivo methods. Test material was applied once to intact and abraded skin of rabbit up to 24h. Non-irritating to slightly irritating (with 0.5 g) properties were observed. There was no indication of any systemic effect due to the treatment. Signs of significant, not fully reversible skin damage or irritation were absent in all studies. The slight irritation observed in some studies is caused by hygroscopic properties and a mechanical effect of the test substance. Body weight changes were not remarkable. Untreated SAS is therefore not considered a skin irritant.

Eye irritation

The assessment of eye irritation toxicity for Set 1 compiles the review of 24 studies performed between 1973 and 2004. Different forms of synthetic amorphous silica with specific surface area (BET) ranging from 45-700 m2/g were used as test materials.

4 of these studies meet the criteria of Klimisch score 1 and 15 studies meet the criteria of Klimisch score 2. These studies were performed in vivo according to OECD test guideline 405 or similar test methods. The results vary from no irritation up to a conjunctivitis that completely recovered within 48 hours. Signs of significant eye damage or incompletely reversible irritation were absent in all studies. The slight irritation observed in some studies is caused by hygroscopic properties of the test substance and the physical presence of a foreign body in the eye of the animal. After washing, no irritation was observed. Untreated SAS is therefore not considered an eye irritant.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov. 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24-h exposure + including abraded skin
Qualifier:
according to guideline
Guideline:
other: Patch-Test; Hazardous Substances, Part 191, Section 11, FDA, Washington, 1965
Deviations:
yes
Remarks:
Exposure time 24 hours
Principles of method if other than guideline:
1 dose level, 24-hour application on intact and abraded skin, 14-day post observation period
GLP compliance:
no
Specific details on test material used for the study:
amorphous silicon dioxide Aerosil 200
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: V2A steel cages
- Diet: Altomin 2023, ad libitum except treatment day
- Water: tap water, ad libitum except treatment day
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +-2 °C
- Humidity (%): 60 +- 3
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hrs

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
other: 12-% suspension/gel in 1-% methyl-hydroxyethyl cellulose 300 P
Controls:
no
Amount / concentration applied:
Dose: 0.5 g
Duration of treatment / exposure:
24 hour(s)
Observation period:
14 days
Number of animals:
6 (intact skin)
6 (abraded skin)
Details on study design:
TEST SITE
- Area of exposure: approx. 2.5 cm x 2.5 cm
- Type of wrap if used: plasic foil


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h


SCORING SYSTEM:
Draize scoring scheme for grading skin effects (erythema and oedema)
Time: 24 and 72 h (0 and 48 h after termination of exposure)
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Remarks:
intact skin
Time point:
other: 24, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Remarks:
intact skin
Time point:
other: 24, 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: #7 - #12
Remarks:
abraded skin
Time point:
other: 24, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #7 - #12
Remarks:
abraded skin
Time point:
other: 24, 72 h
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
intact & abraded skin
Time point:
other: 24, 72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no signs of irritation.
Other effects:
There were no clinical signs observed. Behaviour, grooming, food intake and body weight were normal.
Interpretation of results:
GHS criteria not met
Conclusions:
There was no dermal irritation observed with amorphous silicon dioxide Aerosil 200
Executive summary:

The skin irritation potential of amorphous silicon dioxide Aerosil 200 was evaluated in rabbits.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Act
Version / remarks:
1973
Qualifier:
according to guideline
Guideline:
other: Title 49 - Transportation Section 173.240
GLP compliance:
not specified
Specific details on test material used for the study:
amorphous silicon dioxide C-500
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 ml on an area app. 1 inch square
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6
Details on study design:
applied on intact skin
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Time point:
other: 4, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Time point:
other: 4, 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
There was no erythema or edema recognized on no animal neither at 4- nor 72-hour observation.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide C-500 was not irritating to skin
Executive summary:

The skin irritation / corrosion potential of amorphous silicon dioxide C-500 was evaluated in rabbits.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Principles of method if other than guideline:
single dose level, 4 sites per animal (2 on intact & 2 on abraded skin), single administration, 24 h administration, 72 post observation
GLP compliance:
no
Specific details on test material used for the study:
amorhous silicon dioxide Cab-O-Sil M-5
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or test system and environmental conditions:
6 males, individually caged, Purina Certified Rabbit Chow 5322, filtered tap water ad libitum, 12 h light/dark, 67-76 °F, 63-91 % humidity
Type of coverage:
semiocclusive
Preparation of test site:
other: all clipped, 2/4 on each animal also abraded
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
4 x 0.5 g (0.5 g applied to each of 4 test sites on each rabbit)
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
cf. Table 2 for details
Other effects:
no mortality or abnormal clinical signs observed
Interpretation of results:
GHS criteria not met
Conclusions:
At the 24-hour evaluation, very slight erythema was observed at one intact site of one animal, very slight or well defined erythema was observed at all abraded sites of all six animals, and very slight or slight edema was observed at abraded sites of four animals. No other dermal reactions were observed at the 24-hour evaluation and no dermal reactions were observed at the 72-hour evaluation. The Primary Irritation Index was calculated to amount 0.44.
Executive summary:

The skin irritation potential of amorhous silicon dioxide Cab-O-Sil M-5 was examined in rabbits.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan. 12-15, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Specific details on test material used for the study:
experimental fumed silica (batch no. SP 12-7033)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
obtained from: Buckmasters, Henham, England; c. 2.1-2.6 kg, c. 9-11 wk. old, individually caged, c. 19 °C, 30-70% humidity
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
destilled, 0.5 ml
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
3 days
Number of animals:
3
Details on study design:
treatment sites washed after 4-hour treatment; one application site per rabbit
Irritation parameter:
erythema score
Basis:
animal: #1 - #3
Time point:
other: 30 min
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: #1 - #3
Time point:
other: 1 d
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: #1 - #3
Time point:
other: 2 d
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: #1 - #3
Time point:
other: 3 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #3
Time point:
other: 30 min
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #3
Time point:
other: 1 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #3
Time point:
other: 2 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #3
Time point:
other: 3 d
Score:
0
Max. score:
0
Irritant / corrosive response data:
All three animals showed no response to treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide was not irritating to skin
Executive summary:

The dermal irritation potential of fumed amorphous silicon dioxide was assessed in rabbits.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sep. 25 - Oct. 19, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
amorphous silicon dioxide Sident 9
Species:
rabbit
Strain:
other: White Russian, albino
Details on test animals or test system and environmental conditions:
from: Asta Pharma AG, Bielefeld, Germany; 3 females: 10 months, 2.76-2.90 kg, individually caged, feed: "ssniff K", municipal tape water ad libitum, 19.5-24 °C, 40-70% humidity, 12 h light/dark
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
demineralized
Controls:
yes, concurrent vehicle
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
applied to the dorsal skin area
Irritation parameter:
erythema score
Basis:
animal: #1 - #3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
During the observation period neither erythema nor edema could be detected.
Control sites showed no reactions.
Other effects:
Systemic toxic effects did not occur. The general condition of the test animals was not affected.
Interpretation of results:
GHS criteria not met
Conclusions:
Synthetic amorphous silicon dioxide Sident 9 was not irritant to the skin
Executive summary:

The skin irritation potential of amorphous silicon dioxide Sident 9 was evaluated in rabbits.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09 - 19 Oct. 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
no certificate of the laboratory attached
Specific details on test material used for the study:
amorphous silicon dioxide Sident 9
Species:
rabbit
Strain:
other: White Russian (Albino)
Details on test animals or test system and environmental conditions:
3 females, 10 months old, 2.76 -2.90 kg body weight
Husbandary: 1 rabbit per cage, stainless steel cages with grating floor, regularly cleaned with commercial antisepts, feed with standard diet, drinking water provided ad libitum
Room temperature: 19.5-24.0°C
Relative humidity: 40-70% 8for a short period up to 75%)
Room lighting: artificial lighting in a 12h light-dark-rhythm animals identified by tatooed ear numbers
Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
other: The opposite area of the dorsal skin was treated the same way but without test substance.
Amount / concentration applied:
Dose: 0.5 g, moistened with 0.507 ml demineralized water
Duration of treatment / exposure:
4 hours (occlusive patch)
Observation period:
Observation times: 1, 24, 48 and 72 hours after the removal of the patches
Duration of the observation period: 3 days after application
Number of animals:
3
Details on study design:
The substance (0.5 g) was moistened with 0.5 ml water and placed on a skin area of approx 6.25 cm² with an occlusive patch.
The opposite area of the dorsal skin was treated in the same way but without test substance (control site).
After the end of the exposition time remaining test substance was washed off.
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Remarks:
ID-Nr. 2330
Time point:
other: 1h after exposure
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #2
Remarks:
ID Nr. 2332
Time point:
other: 1 h after exposure
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #3
Remarks:
ID Nr. 2344
Time point:
other: 1h after exposure
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Remarks:
ID Nr. 2330
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #2
Remarks:
ID Nr. 2332
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #3
Remarks:
ID Nr. 2344
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no irritating effects found in this experiment.

The single application (4hours, occlusive patch) of 0.5g Sident 9 to the intact skin of three rabbits each caused no changes. During the observation period neither erythema nor endema could be detected. The irritation index is 0.0. Sident 9 therefore is classified as non-irritant in this test system.

Interpretation of results:
GHS criteria not met
Conclusions:
Synthetic amorphous silicon dioxide Sident 9 was not irritating to skin
Executive summary:

The skin irritation potential of synthetic amorphous silicon dioxide Sident 9 was evaluated in rabbits in a 4-hour occlusive patch test.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Nov. 1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
24-h exposure + including abraded skin
Qualifier:
according to guideline
Guideline:
other: Patch-Test; Hazardous Substances, Part 191, Section 11, FDA, Washington, 1965
Deviations:
yes
Remarks:
Exposure time 24 hours
Principles of method if other than guideline:
1 dose level, 24-hour application on intact and abraded skin, 72-hour post observation period
GLP compliance:
no
Specific details on test material used for the study:
amorphous silicon dioxide Sipernat 22
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: V2A steel cages
- Diet: Altromin 2023, ad libitum except treatment day
- Water: tap water, ad libitum except treatment day
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +-2 °C
- Humidity (%): 60 +- 3
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hrs

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
other: 23-% suspension/gel in 1-% methyl-hydroxyethyl cellulose 300 P
Controls:
no
Amount / concentration applied:
Concentration: 0.5 g
Duration of treatment / exposure:
24 hour(s)
Observation period:
72 h
Number of animals:
6 (intact skin)
6 (abraded skin)
Details on study design:
TEST SITE
- Area of exposure: approx. 2.5 cm x 2.5 cm
- % coverage:
- Type of wrap if used: plasic foil


REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 h


SCORING SYSTEM:
Draize scoring scheme for grading skin effects (erythema and oedema)
Time: 24 and 72 h (0 and 48 h after termination of exposure)
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Remarks:
intact skin
Time point:
other: 24, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Remarks:
intact skin
Time point:
other: 24, 72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: #7 - #12
Remarks:
abraded skin
Time point:
other: 24, 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #7 - #12
Remarks:
abraded skin
Time point:
other: 24, 72 h
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
intact & abraded skin
Time point:
other: 24, 72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no signs of irritation.
Other effects:
There were no clinical signs observed. Behaviour, grooming, food intake and body weight were normal.
Interpretation of results:
GHS criteria not met
Conclusions:
There was no dermal irritation observed. The total score according to Draize was 0.0.
Executive summary:

The skin irritation potential of amorphous silicon dioxide Sipernat 22 was assessed in rabbits.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline followed
Principles of method if other than guideline:
single dose level, 24-hour administration, on intact and abraded skin, 72-hour post observation
GLP compliance:
not specified
Specific details on test material used for the study:
amorphous silicon dioxide Syloid 378
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Type of coverage:
occlusive
Preparation of test site:
other:
Remarks:
cliiped and abraded
Vehicle:
water
Remarks:
distilled, 1.0 ml
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6 (3 with intact (clipped) and 3 with abraded skin)
Details on study design:
applied to the back of rabbits under 1-inch square gauze patches
Irritation parameter:
erythema score
Remarks:
also edema score
Basis:
animal #1
Remarks:
abraded skin
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
also edema score
Basis:
animal #2
Remarks:
abraded skin
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
also edema score
Basis:
animal #3
Remarks:
abraded skin
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
also edema score
Basis:
animal #4
Remarks:
intact skin
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
also edema score
Basis:
animal #5
Remarks:
intact skin
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Remarks:
also edema score
Basis:
animal #6
Remarks:
intact skin
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of dermal irritation were observed.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide Syloid 378 was not irritating to skin
Executive summary:

The skin irritation potential of amorphous silicon dioxide Syloid 378 was evaluated in rabbits.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jun. 15 - Oct. 19, 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods
Qualifier:
according to guideline
Guideline:
other: protocole publié au J.O.R.F.
Version / remarks:
1982-02-21
Principles of method if other than guideline:
single dose level, 24-hour administration on intact and abraded skin, 72-hour post observation period
protocole n° IPC/05-92
GLP compliance:
yes
Specific details on test material used for the study:
amorphous silicon dioxide Tixosil 375
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
from: Charles River France, Sain-Aubin-Les-Elbeuf, France; males only, ca. 3 months old, ca. 2.3-2.7 kg, individually caged, feed: aliment reference 112 C, filtered municipal water ad libitum, 18 +/- 3 °C, min. 50 % humidity, 12 h light/dark
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
water
Remarks:
purified
Controls:
not required
Amount / concentration applied:
Concentration: 33 mg
Volume: 0.5 ml (2 times per animal: on intact and abraded skin)
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
The substance was applied on intact and abraded skin on each animal.
Animals were examined 24 and 72 hours after end of exposure.
Irritation parameter:
erythema score
Basis:
animal: #1 - #4, #6
Remarks:
intact skin
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
intact skin
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Remarks:
intact skin
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: #1 - #3, #5
Remarks:
abraded skin
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
erythema score
Basis:
animal: #4, #6
Remarks:
abraded skin
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: #1 - #6
Remarks:
abraded skin
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal: #1 - #6
Remarks:
intact & abraded skin
Time point:
other: 24, 72 h
Score:
0
Max. score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24, 72 h
Score:
0.38
Irritant / corrosive response data:
Only slight eryrthema was observed in 5 of 6 animals after a 24-hour observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide Tixosil 375 was not irritating to skin
Executive summary:

The skin irritation potential of amorphous silicon dioxide Tixosil 375 was assessed in rabbits.

Endpoint:
skin irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
EPA OTS 798.4500 (Acute Eye Irritation)
Version / remarks:
Federal Hazardous Substance Act, 1973
Principles of method if other than guideline:
single administration, not rinsed, 72-hour post observation
GLP compliance:
not specified
Specific details on test material used for the study:
amorphous silicon dioxide Zeo 49
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or tissues and environmental conditions:
Purina Rabbit Chow (feed) and tap water ad libitum
Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg (= 0.1 ml)
Duration of treatment / exposure:
once, not rinsed
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
applied into the conjunctival sac of the right eye of each animal
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24/48 h
Score:
0.3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Irritant / corrosive response data:
Only one animal showed mild redness after 24 and 48 hours, but fully reversible at 72 hours. The total irritation score was 0.3 at 24 and 48 hours, and 0.0 at 72 hours.
Interpretation of results:
GHS criteria not met
Conclusions:
According to the Federal Hazardous Substances Act amorphous silicon dioxide Zeo 49 was not irritating to rabbit eye
Executive summary:

The eye irritation potential of amorphous silicon dioxide Zeo 49 was evaluated in rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act
Version / remarks:
1973
Principles of method if other than guideline:
1 dose level, single administration, rinsed after 4 seconds, 72-hour post observation period
GLP compliance:
not specified
Specific details on test material used for the study:
amorphous silicon dioxide Zeo 49
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or tissues and environmental conditions:
Prurina Rabbit Chow (feed) and tap water ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml (= 100 mg)
Duration of treatment / exposure:
once, rinsed after 4 seconds
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
into the conjunctival sac of the right eye; all treated yes were rinsed 4 seconds after application
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no signs of ocular irritation.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide Zeo 49 was not irritating to eye
Executive summary:

The eye irritation potential of amorphous silicon dioxide Zeo 49 was assessed in rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Draize-Test; Hazardous Substances, Part 191, Section 12, Federal Register, Vol. 37, No. 83, FDA, Washington
Principles of method if other than guideline:
1 dose level, single administration, rinsing after 5 min. or 24 h., 7-day post observation period
GLP compliance:
no
Specific details on test material used for the study:
amorphous silicon dioxide Aerosil 200
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: V2A steel cages
- Diet: Altomin 2023, ad libitum except treatment day
- Water: tap water, ad libitum except treatment day
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +-2 °C
- Humidity (%): 60 +- 3
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hrs
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
dose: 100 mg
Duration of treatment / exposure:
group I: 5 minutes (rinsed thereafter)
group II: 24 hours (rinsed thereafter)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
group I: 5 animals
group II: 3 animals
Details on study design:
The substance was applied into the conjunctival sac of the left eye, while the right eye remained untreated serving as control.
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #5
Remarks:
eyes rinsed after 5 min.
Time point:
other: 1, 24, 48, 72 h, 1d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #5
Remarks:
eyes rinsed after 5 min.
Time point:
other: 1, 24, 48, 72 h, 7d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #5
Remarks:
eyes rinsed after 5 min.
Time point:
other: 1, 24, 48, 72 h, 7d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal: #1 - #5
Remarks:
eyes rinsed after 5 min.
Time point:
other: eyes rinsed after 5 min.
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: #6 - #8
Remarks:
eyes rinsed after 24 h.
Time point:
other: 24, 48, 72 h, 7d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #6 - #8
Remarks:
eyes rinsed after 24 h.
Time point:
other: 24, 48, 72 h, 7d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #6 - #8
Remarks:
eyes rinsed after 24 h.
Time point:
other: 24, 48, 72 h, 7d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal: #6 - #8
Remarks:
eyes rinsed after 24 h.
Time point:
other: 24, 48, 72 h, 7d
Score:
0
Max. score:
0
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Remarks:
eyes rinsed after 5 min. or after 24 h.
Time point:
other: 1, 24, 48, 72 h, 7d
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritating response at any time after exposure (1 h - 7 d).
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide Aerosil 200 was not irritating to rabbit eye
Executive summary:

The eye irritation potential of amorphous silicon dioxide Aerosil 200 was assessed in rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Principles of method if other than guideline:
single dose l., single admin., w & w/o rinsing, 7d post obs.
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
amorphous silicon dioxide CAB-O-SIL M5
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or tissues and environmental conditions:
9 females, individually caged, Purina Certified Rabbit Chow 5322, filtered tap water ad libitum, 12 h light/dark, 67-76 °F, 63-91 % humidity
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
once
washed: rinsing ca. 30 seconds after application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
9 (6 with unwashed eyes & 3 with washed eyes)
Details on study design:
test article was instilled onto the everted lower lid of the right eye
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Grade 1 redness was observed for one unwashed eye group animal at the 24-hour evaluation. Another unwashed eye group animal exhibited grade 1 redness at the 24- and 48-hour evaluations and grade 1 chemosis at the 24-hour evaluation. No other ocular reactions were observed for animals of the unwashed eye group and no ocular reactions were observed for animals of the washed eye group during the 7-day duration of the study. The Primary Eye Irritation Score for the unwashed group was 1.0 and 0.3 at 24 and 48 hours, respectively.
Other effects:
no mortality observed
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide CAB-O-SIL M5 was not irritating to rabbit eye
Executive summary:

The eye irritation potential of amorphous silicon dioxide CAB-O-SIL M5 was tested in rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jan. 18-25, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Specific details on test material used for the study:
amorphous silicon dioxide
batch no. SP 12-7033
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or tissues and environmental conditions:
obtained from: Buckmasters, Henham, England; c. 2.8-3.0 kg, c. 12-13 wk. old, individually caged, c. 19 °C, 30-70% humidity, SDS Standart Rabbit Dieat and tap water ad libitum, 12 h light/dark
Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
1 ml (= 35 mg)
Duration of treatment / exposure:
once, not rinsed
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
applied into the lower everted lid of one eye
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h; 1, 2, 3, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h; 1, 2, 3, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 1 d
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1, 2, 3, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 1 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1, 2, 3, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 h; 1, 2, 3, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1 h; 1, 2, 3, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h, 1d
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 2 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 2, 3, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 h; 1, 2, 3, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 h; 1, 2, 3, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 h; 1, 2, 3, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 1 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1, 2, 3, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 h; 1, 2, 3, 4, 7 d
Score:
0
Max. score:
0
Irritant / corrosive response data:
No corneal damage or iridial inflammation was observed in any animal. Mild conjunctival irritation was seen one hour after instillation in all 3 animals. These reactions had resolved one or two days after treatment.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide was not irritating to rabbit eye
Executive summary:

The eye irritation potential of amorphous silicon dioxide was evaluated in rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Oct. 12 - Nov. 5, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
amorphous silicon dioxide Sident 9
Species:
rabbit
Strain:
other: White Russian, albino
Details on test animals or tissues and environmental conditions:
from: Asta Pharma AG, Bielefeld, Germany; 2 males: 10 and 11 months, 2.44 and 2.73 kg, 1 female: 8 months, 2.86, individually caged, feed: "ssniff K", municipal tape water ad libitum, 21-23 °C, 40-65% humidity, 12 h light/dark
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.04 g or 0,10 g
It is not specified what rabbit received which dose.
Duration of treatment / exposure:
once, not rinsed
Observation period (in vivo):
72 h
One animal was observed for 7 days, since irritation was still detected after 72 hours.
Number of animals or in vitro replicates:
3
Details on study design:
applied into the conjunctival sacs of the left eyes
Eyes were not rinsed.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h, 4, 7 d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h, 4 d
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
7 d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 72 h
Score:
3
Irritant / corrosive response data:
- No alterations were observed in the cornea and iris.
- The conjunctiva reacted with different redness (grade 2) in all 3 animals 1 hour after application. The findings had completely disappeared after 72 hours or on day 7. Only at the day of application the conjunctiva was swollen (grade 1) and slight discharge (grade 1) was observed in all 3 animals.
- Untreated controls did not show any changes.
As the primary irritation index was 3, Sident 9 was classified as non-irritant to the eye of the rabbit.
Other effects:
There were no systemic toxic effects and the general condition of the animals was undisturbed.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide Sident 9 was not irritating to rabbit eye
Executive summary:

The eye irritation potential of amorphous silicon dioxide Sident 9 was assessed in rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Oct. - 05 Nov 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
no certtification of the laboratory attached
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
According to the guideline the test should be done under anesthesia for the animals. There was no link found, that this was done in the report.
GLP compliance:
no
Remarks:
no link that the test animals were anesthetized in the report found, no data about control eyes
Specific details on test material used for the study:
amorphous silicon dioxid Sident 9
Species:
rabbit
Strain:
other: White Russian (Albino)
Details on test animals or tissues and environmental conditions:
2 males, 10/11 months old, 2.44/2.73 kg body weight, 1 female, 8 months old, 2.86 kg body weight, individually with ear number tattoo
Husbandary: 1 animal per cage, stainless steel cages with grating floor, cleaned regularly with commercial antisepts,
standard diet, drinking water ad libitum, room temperature: 21-23°C, humidity: 40-65% (for shorter periods 35-70%), artificial lightening in a 12h dark-light period
Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye of the animal remained untreated to serve as control. No link in the report, that this was done.
Amount / concentration applied:
dose: 0.04 g (representing a volume of 0.1ml)
Duration of treatment / exposure:
1, 24, 48 and 72h after application, thereafter once daily
Observation period (in vivo):
2 animals for 3 days, 1 animal for 7 days after application
Number of animals or in vitro replicates:
3
Details on study design:




The test substance was applied to the conjunctival sac of one eye and not rinsed. The other eye remained untreated and served as control.
The treated eye was examined with a cliptrix pencil light. Signs of irritation on the cornea, iris and conjunctiva were assed using the Draize scale.Attention was payed on further reactions of the eye and to clinical signs.


Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: redness, chemosis, discharge
Basis:
animal #1
Remarks:
ID Nr. 2303
Time point:
other: 1 h after application
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: Redness, Chemosis, Discharge
Basis:
animal #2
Remarks:
ID Nr. 2331
Time point:
other: 1 h after application
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 4 days
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: Redness, chemosis, discharge
Basis:
animal #3
Remarks:
ID Nr. 2374
Time point:
other: 1 h after application
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: Redness, chemosis, discharge
Basis:
animal #1
Remarks:
ID Nr. 2303
Time point:
24/48/72 h
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: Redness, chemosis, discharge
Basis:
animal #2
Remarks:
Id Nr. 2313
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize Grades
Remarks:
Conjunctiva: Redness, chemosis, discharge
Basis:
animal #3
Remarks:
ID Nr. 2374
Time point:
24/48/72 h
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize grade
Remarks:
Conjunctiva: Redness, chemosis, discharge
Basis:
animal #2
Remarks:
ID Nr. 2313
Time point:
other: 4 days
Score:
ca. 1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Irritation parameter:
other: Draize grade
Remarks:
Conjunctiva: Redness, chemosis, discharge
Basis:
animal #2
Remarks:
ID Nr. 2313
Time point:
7 d
Score:
ca. 0
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
no indication of irritation
Remarks:
induced by physical property of the test substance
Irritant / corrosive response data:
In the cornea and the iris no alterations were observed during the observation period.
The conjuctiva reacted with diffuse redness (grade 2) in all 3 animals 1h after application. The findings had completely disappeared after 72 h to 7 days. Only at the day of application the conjuctivas were swollen (Grade 1). In addition, a slight discharge (grade 1) was observed in all 3 animals at the day of application. All effects were reversible after 48h, 72h or 7 days respectively.
It is considered that all effects were induced by the physical property (dust) of the test substance. Therefore the test substance was considered to be not irritant.

There were weakly irritating effects on the conjunctivae only: redness score 2 in all 3 animals after 1 h, score 2 and 1 after 24 h and reversible at 7 days. Chemosis and discharge was very slight only 1 h after application (score 1).

The findings were considered to be induced by the physicalproperty of the test substance (dust) and therefore the test substance can be declared as non-irritant. No alterations on the cornea or iris were observed. The primary irritation index was 3.

Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxid Sident 9 was not irritating to eyes
Executive summary:

The acute eye irritation potential of amorphous silicon dioxid Sident 9 was evaluated in rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Draize-Test; Hazardous Substances, Part 191, Section 12, Federal Register, Vol. 37, No. 83, FDA, Washington 1972
Principles of method if other than guideline:
1 dose level, single administration, rinsing after 5 min. or 24 h., 7-day post observation period
GLP compliance:
no
Specific details on test material used for the study:
amorphous silicon dioxide Sipernat 22
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.3 - 2.8 kg
- Housing: V2A steel cages
- Diet: Altromin 2023, ad libitum except treatment day
- Water: tap water, ad libitum except treatment day
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +-2 °C
- Humidity (%): 60 +- 3
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hrs
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
group I: 5 minutes (rinsed thereafter)
group II: 24 hours (rinsed thereafter)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
group I: 5 animals
group II: 3 animals
Details on study design:
The substance was applied into the conjunctival sac of the left eye, while the right eye remained untreated serving as control.
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #5
Remarks:
eyes rinsed after 5 min.
Time point:
other: 1, 24, 48, 72 h, 7d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #5
Remarks:
eyes rinsed after 5 min.
Time point:
other: 1, 24, 48, 72 h, 7 d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #5
Remarks:
eyes rinsed after 5 min.
Time point:
other: 1, 24, 48, 72 h, 7 d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal: #1 - #5
Remarks:
eyes rinsed after 5 min.
Time point:
other: 1, 24 ,48, 72 h, 7d
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: #6 - #8
Remarks:
eyes rinsed after 24 h.
Time point:
other: 24, 48, 72 h, 7 d
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #6 - #8
Remarks:
eyes rinsed after 24 h.
Time point:
other: 24, 48, 72 h, 7 d
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #6 - #8
Remarks:
eyes rinsed after 24 h.
Time point:
other: 24, 48, 72 h, 7 d
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal: #6 - #8
Remarks:
eyes rinsed after 24 h.
Time point:
other: 24, 48, 72 h, 7 d
Score:
0
Max. score:
0
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Remarks:
eyes rinsed after 5 min. or 24 h.
Time point:
other: 1, 24, 48, 72 h, 7 d
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritating response at any time after exposure (1 h - 7 d).
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide Sipernat 22 was not irritating to rabbit eye
Executive summary:

The eye irritation potential of amorphous silicon dioxide Sipernat 22 was assessed in rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Guidelines of the Department of Transportation
Principles of method if other than guideline:
1 dose level, single administration, w/o rinsing, 72h post observation
GLP compliance:
no
Specific details on test material used for the study:
amorphous silicon dioxid Syloid 244
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or tissues and environmental conditions:
obtained from: Skippack Breeding Farm; app. 3 kg
Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml (= 100 mg powder)
Duration of treatment / exposure:
once, without rinsing
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
instilled into the conjunctival sac of one eye of each rabbit
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #5, #6
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal: #3, #4
Time point:
24/48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
The only conjunctival irritation was redness.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxid Syloid 244 was not irritating to eye
Executive summary:

The eye irritation potential of amorphous silicon dioxid Syloid 244 was evaluated in rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act
Version / remarks:
1973
Principles of method if other than guideline:
single administration, one dose level, with and without rinsing
GLP compliance:
not specified
Specific details on test material used for the study:
amorphous silicon dioxide Zeofree 153
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or tissues and environmental conditions:
Purina Rabbit Chow and tap water ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml (100 mg)
Duration of treatment / exposure:
once, without rinsing
once, rinsed after 4 seconds
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
9: 6 without rinsing, 3 with eyes rinsed
Details on study design:
applied into the conjunctival sac of the right eye
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #6
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #6
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #6
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #7 - #9
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #7 - #9
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #7 - #9
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
There were no signs for irritation either with unwashed or rinsed eyes. The total score with rinsed and unrinsed eyes was 0.0 after 24, 48 and 72 hours.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide Zeofree 153 was not irritating to rabbit eye
Executive summary:

amorphous silicon dioxide Zeofree 153 was evaluated for ocular irritation in the rabbit according to the guidelines established by the Federal Hazardous Substance Act (1973).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act
Version / remarks:
1973
Principles of method if other than guideline:
single administration, one dose level, with and without rinsing
GLP compliance:
not specified
Specific details on test material used for the study:
amorphous silicon dioxide Zeosyl 113
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or tissues and environmental conditions:
Purina Rabbit Chow and tap water ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml (100 mg)
Duration of treatment / exposure:
once, without rinsing
once, rinsed after 4 seconds
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
9: 6 without rinsing, 3 with eyes rinsed
Details on study design:
applied into the conjunctival sac of the right eye
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #6
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #6
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3, #5, #6
Remarks:
unrinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #4
Remarks:
unrinsed eyes
Time point:
24/48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Remarks:
unrinsed eyes
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
unrinsed eyes
Time point:
24/48 h
Score:
0.3
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
unrinsed
Time point:
72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: #7 - #9
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #7 - #9
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #7 - #9
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
rinsed eyes
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
unwashed eyes: Only one animal showed slight effects (redness), reversibly within 72 h
washed eyes: no effects detected
The total score was 0.3 after 24 and 48 hours, and 0.0 after 72 hours, when the eyes were not washed. With rinsed eyes, the total score was 0.0 after 24, 48 and 72 hours.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide Zeosyl 113 was not irritating to rabbit eye
Executive summary:

amorphous silicon dioxide Zeosyl 113 was evaluated for ocular irritation in the rabbit according to the guidelines established by the Federal Hazardous Substance Act (1973).

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act
Version / remarks:
1973
Principles of method if other than guideline:
1 dose level, single administration, not rinsed, 72-hour post observation period
GLP compliance:
not specified
Specific details on test material used for the study:
amorphous silicon dioxide Zeosyl 200
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or tissues and environmental conditions:
Condition of Eyes: Judged free of irritation and corneal damage as confirmed by sodium fluorescein examination prior to study.
Diet: Purina Rabbit Chow and tap water were available ad libitum.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
once, unwashed
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
A single application of the test sample (0.1ml of a liquid or 100 mg of a solid) full strength was made into the conjunctival sac of the right eye of six rabbits. The eyelids were held closed for one second.

The eyes were examined and the grade of ocular reaction recorded at 24, 48 and 72 hours following application. Reading of reactions was facilitated by the use of a hand-held ophthalmoscope. After the recording of observations, the eyes were stained with sodium fluorescein and examined with an ultra-violet lamp to detect possible corneal damage. The reactions were based on the "llustrated Guide for Grading Eye Irritation by Hazardous Substances," Federal Hazardous Substances Act Regulations.
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #4 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0.3
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48, 72 h
Score:
0
Irritant / corrosive response data:
Only light redness occured in the eye of one animal on day 1. The total score was 0.3 after 24 hours, and 0.0 on days 2 and 3.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide Zeosyl 200 was not irritating to rabbit eye



Executive summary:

The eye irritation potential of amorphous silicon dioxide Zeosyl 200 was evaluated in rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substance Act
Version / remarks:
1973
Principles of method if other than guideline:
1 dose level, single administration, rinsed after 4 seconds, 72-hour post observation period
GLP compliance:
not specified
Specific details on test material used for the study:
amorphous silicon dioxide Zeosyl 200
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or tissues and environmental conditions:
Purina Rabbit Chow and tap water were provided ad libitum.
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
single application, rinsed after 4 seconds
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
applied into the conjunctival sacs of the right eyes
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No animal showed any signs of ocular irritation.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide Zeosyl 200 was not irritating to rabbit eye
Executive summary:

The eye irritation potential of amorphous silicon dioxide Zeosyl 200 was evaluated in rabbits.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Aug. 19 - Sep. 3, 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
1998
Deviations:
no
Principles of method if other than guideline:
AMENDMENT TO PROTOCOL
Animal number 12429 died spontaneously prior to the 24-hour scoring interval and was replaced with animal number 12480. To fulfill the requirement of the protocol for three animals, a new animal was placed on study. Animal number 12429’s death does not appear to be related to exposure to the test substance.
GLP compliance:
yes
Specific details on test material used for the study:
Gel, non-surface treated Synthetic Amorphous Silica (SAS)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
from: Robinson Services, Inc. Clemmons, NC, USA; singly housed in suspended stainless steel caging with mesh floors, 17-22 °C, 12-hour light/dark, food: Purina Rabbit Chow #5326, filtered tap water ad-libitum
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml (0.04 g)
Duration of treatment / exposure:
once (unrinsed)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 (2 males, 1 female); but 1 animal was replaced due to death, so actually 4 animals participated in this study
Details on study design:
Prior to instillation, both eyes of a number of animals were examined using a fluorescein dye procedure. One drop of 2% ophthalmic fluorescein sodium was instilled into both eyes of each rabbit. The eyes were rinsed with physiological saline (0.9% NaCl) approximately 30 seconds after instillation of the fluorescein.
Prior to use, the test substance was ground with a mortar and pestle. One-tenth of a milliliter (0.04 grams) of the ground test substance was instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The other eye of each rabbit remained untreated with the test substance and served as a control. The rabbits were then returned to their designated cages.
Ocular irritation was evaluated using a high-intensity white light (Mag Lite) in accordance with Draize et al.' at 1, 24, 48, and 72 hours post-instillation. The fluorescein dye evaluation procedure described above was used at 24 hours to verify the absence of corneal damage. Individual scores were recorded for each animal. In addition to observations of the cornea, iris and conjunctivae, any other observed lesions were noted. The average score for all rabbits at each scoring period was calculated to aid in data interpretation.
The time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra.
The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
0
Remarks on result:
other: rabbit #12429 (died within 24 h)
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
other: 1 h
Score:
0
Max. score:
0
Remarks on result:
other: rabbit #12480 (replacement)
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: rabbit #12480 (replacement)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
0
Remarks on result:
other: rabbit #12429 (died within 24 h)
Irritation parameter:
iris score
Basis:
animal #4
Time point:
other: 1 h
Score:
0
Max. score:
0
Remarks on result:
other: rabbit #12480 (replacement)
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: rabbit #12480 (replacement)
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
other: not determinable due to death
Remarks on result:
other: rabbit #12429 (died within 24 h)
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: rabbit #12480 (replacement)
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: rabbit #12480 (replacement)
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
72 h
Score:
0
Max. score:
0
Remarks on result:
other: rabbit #12480 (replacement)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
0
Remarks on result:
other: rabbit #12429 (died within 24 h)
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
other: 1, 24, 48, 72 h
Score:
0
Max. score:
0
Remarks on result:
other: rabbit #12480 (replacement)
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 h
Score:
5.7
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Score:
3.7
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
48 h
Score:
0.7
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
72 h
Score:
0
Irritant / corrosive response data:
There was no corneal opacity observed in any treated eye during the study. One hour following test substance instillation, all three treated eyes exhibited conjunctivitis, and one treated eye had iritis. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation by 72 hours.
Other effects:
One of the test animals was found dead within 24 hours of test substance instillation. Gross necropsy of the decedent revealed ano-genital staining and liquid in the abdominal cavity. This animal was replaced to continue the study. The replacement animal exhibited soft feces on Days 2 and 3 of the study. The remaining two animals appeared active and healthy during the study.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test substance is not classified as irritating to the eye.
Executive summary:

A primary eye irritation test was conducted with rabbits to determine the potential for Britesorb A100 to produce irritation from a single instillation via the ocular route.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Sep. 20 - Sep. 23, 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Gel, non-surface treated Synthetic Amorphous Silica (SAS)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
from: Robinson Services, Inc. Clemmons, NC, USA; singly housed in suspended stainless steel caging with mesh floors, 17-22 °C, 12-hour light/dark, food: Purina Rabbit Chow #5326, filtered tap water ad-libitum
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml (0.02 g)
Duration of treatment / exposure:
once (unrinsed)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 (2 males, 1 female)
Details on study design:
Prior to instillation, both eyes of a number of animals were examined using a fluorescein dye procedure. One drop of 2% ophthalmic fluorescein sodium was instilled into both eyes of each rabbit. The eyes were rinsed with physiological saline (0.9% NaCl) approximately 30 seconds after instillation of the fluorescein.
Prior to use, the test substance was ground with a mortar and pestle. One-tenth of a milliliter (0.02 grams) of the test substance was instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The other eye of each rabbit remained untreated with the test substance and served as a control. The rabbits were then returned to their designated cages.
Ocular irritation was evaluated using a high-intensity white light (Mag Lite) in accordance with Draize et al.' at 1, 24, 48, and 72 hours post-instillation. The fluorescein dye evaluation procedure described above was used at 24 hours to verify the absence of corneal damage. Individual scores were recorded for each animal. In addition to observations of the cornea, iris and conjunctivae, any other observed lesions were noted. The average score for all rabbits at each scoring period was calculated to aid in data interpretation.
The time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra.
The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
48 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 h
Score:
13.7
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Score:
10.3
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
48 h
Score:
2
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
72 h
Score:
0
Irritant / corrosive response data:
There was no corneal opacity observed in any treated eye during this study. One hour after test substance instillation, all three treated eyes exhibited iritis and conjunctivitis. The overall incidence and severity of irritation decreased with time. All animals were free of ocular irritation by 72 hours.
Other effects:
All animals appeared active and healthy. Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test substance is not classified as irritating to the eye.
Executive summary:

A primary eye irritation test was conducted with rabbits to determine the potential for Britesorb D-300CE to produce irritation from a single instillation via the ocular route.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
no guideline available
GLP compliance:
no
Specific details on test material used for the study:
amorphous silicon dioxide Cab-O-Sil
Species:
rabbit
Strain:
other: albino
Details on test animals or tissues and environmental conditions:
approx. 2.0 kg, housed individually, food and water ad libitum
Controls:
yes
Amount / concentration applied:
3.0 mg
Duration of treatment / exposure:
single administration
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
without rinsing
Irritation parameter:
other: erythema
Reversibility:
fully reversible within: 48h
Remarks on result:
no indication of irritation

immediatly after application, after 1 and 4 hrs: mild erythema, vascularyzation of the scelera and nictitating membrane

after 24 hrs: very mild erythema and vascularyzation of the lower scelera and nictitating membrane

after 48 hrs: effects subsided completely

Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxide Cab-O-Sil was not irritating to eye

Executive summary:

The eye irritating potential of amorphous silicon dioxide Cab-O-Sil was examined.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Principles of method if other than guideline:
data / pages lacking; only information: with & without rinsing
GLP compliance:
not specified
Specific details on test material used for the study:
surface treated amorphous silicon dioxide Cab-O-Sil ST-22
Species:
rabbit
Strain:
not specified
Remarks:
albino
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
6 mg (0.1 ml by volume of powder)
Number of animals or in vitro replicates:
9
Details on study design:
substance applied into the conjunctival sac of the left eye
Irritation parameter:
overall irritation score
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
no signs of irritation observed, neither in the washed nor unwashed eyes
Interpretation of results:
GHS criteria not met
Conclusions:
surface treated amorphous silicon dioxide Cab-O-Sil ST-22 is not irritating to rabbit eye
Executive summary:

This is only a fragment of an eye irritation study of surface treated amorphous silicon dioxide Cab-O-Sil ST-22 in rabbits. Several pages of the study report are lacking.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Nov. 3-13, 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Oct. 2, 2012
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
commission regulation #440/2008
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
surface treated amorphous silicon dioxide
purity >99%, batch #3340998
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
from: Harlan Laboratories UK, Leicestershire; 2.22 and 2.92 kg, 12-20 wks old, 5 d of acclimatization
individually housed, drinking water and food (Teklad Global Rabbit diet #2930C) ad libitum, 17-23 °C, 30-70% humidity, 12 h light/dark
Vehicle:
unchanged (no vehicle)
Remarks:
but see "Details on study design"
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
once
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
2
Details on study design:
0.01 mg/kg buprenorphine admimistered 60 min prior and 8 h after application
two drops of 0.5% tetracaine hydrochloride administered 5 min prior application
0.5 mg/kg meloxicam administered 8 hrs after application
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 h
Score:
9.5
Max. score:
13
Reversibility:
fully reversible within: 72 h
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Score:
3
Max. score:
6
Reversibility:
fully reversible within: 72 h
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
48 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0

cf. Table 1 for more detail

Interpretation of results:
GHS criteria not met
Conclusions:
surface treated amorphous silicon dioxide was not irritating to rabbit eye
Executive summary:

The eye irritation potential of surface treated amorphous silicon dioxide was examined in this study.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Aug. 19 - Sep. 9, 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
2002
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
1998
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Gel, non-surface treated Synthetic Amorphous Silica (SAS)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
from: Robinson Services, Inc. Clemmons, NC, USA; singly housed in suspended stainless steel caging with mesh floors, 17-22 °C, 12-hour light/dark, food: Purina Rabbit Chow #5326, filtered tap water ad-libitum
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml (0.04 g)
Duration of treatment / exposure:
once (unrinsed)
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3 (1 males, 2 females)
Details on study design:
Prior to instillation, both eyes of a number of animals were examined using a fluorescein dye procedure. One drop of 2% ophthalmic fluorescein sodium was instilled into both eyes of each rabbit. The eyes were rinsed with physiological saline (0.9% NaCl) approximately 30 seconds after instillation of the fluorescein.
Prior to use, the test substance was ground with a mortar and pestle. One-tenth of a milliliter (0.04 grams) of the ground test substance was instilled into the conjunctival sac of the right eye of each rabbit by pulling the lower lid away from the eyeball. The upper and lower lids were then gently held together for about one second before releasing to minimize loss of the test substance. The other eye of each rabbit remained untreated with the test substance and served as a control. The rabbits were then returned to their designated cages.
Ocular irritation was evaluated using a high-intensity white light (Mag Lite) in accordance with Draize et al.' at 1, 24, 48, and 72 hours post-instillation. The fluorescein dye evaluation procedure described above was used at 24 hours to verify the absence of corneal damage. Individual scores were recorded for each animal. In addition to observations of the cornea, iris and conjunctivae, any other observed lesions were noted. The average score for all rabbits at each scoring period was calculated to aid in data interpretation.
The time interval with the highest mean score (Maximum Mean Total Score - MMTS) for all rabbits was used to classify the test substance by the system of Kay and Calandra.
The animals were observed for signs of gross toxicity and behavioral changes at least once daily during the test period. Observations included gross evaluation of skin and fur, eyes and mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity and behavior pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhea and coma.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 1h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 1 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 1 h
Score:
4
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
24 h
Score:
0
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
48 h
Score:
0
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
72 h
Score:
0
Irritant / corrosive response data:
There was no corneal opacity or iritis observed in any treated eye during this study. One hour after test substance instillation, all three treated eyes exhibited conjunctivitis. All animals were free of ocular irritation by 24 hours.
Other effects:
All animals appeared active and healthy. Apart from the eye irritation noted below, there were no other signs of gross toxicity, adverse pharmacologic effects or abnormal behavior.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this study, the test substance is not classified as irritating to the eye.
Executive summary:

A primary eye irritation test was conducted with rabbits to determine the potential for H-3040 MS to produce irritation from a single instillation via the ocular route.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
single dose level, single administration, with & without rinsing, 72-hour post observation
GLP compliance:
no
Specific details on test material used for the study:
amorphous silicon dioxid Ludox HS-40
Species:
rabbit
Strain:
not specified
Remarks:
albino
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
2 x 0.1 ml (0.1 ml per eye)
Duration of treatment / exposure:
once
one eye washed after 20 seconds
Observation period (in vivo):
72 h (oberservations: 1, 4 hrs., 1, 2, 3 days)
Number of animals or in vitro replicates:
2
Details on study design:
applied into the conjunctival sacs of each animal, after 20 sec. one eye was washed for 1 min., the other one was left unrinsed
Irritation parameter:
cornea opacity score
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
unrinsed: no ocular effects (cornea, iris & conjunctiva)
rinsed eyes: no ocular effects (cornea, iris & conjunctiva)
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxid Ludox HS-40 was not irritating to eye
Executive summary:

The eye irritation potential of amorphous silicon dioxid Ludox HS-40, with and without rinsing, was assessed in rabbits. Only the study's summary page was available.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Act regulations 16 CFR 1500.42
Version / remarks:
1973-09-27
Principles of method if other than guideline:
single dose level, single administration, 72-hour post observation
GLP compliance:
no
Specific details on test material used for the study:
amorphous silicon dioxid Ludox HS-40
Species:
rabbit
Strain:
not specified
Remarks:
albino
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
once
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Interpretation of results:
GHS criteria not met
Conclusions:
According to the definition of the eye test in the regulations of the Federal Hazardous Substances Act amorphous silicon dioxid Ludox HS-40 was not an eye irritant.
Executive summary:

The eye irritation potential of amorphous silicon dioxid Ludox HS-40 was assessed in rabbits. Only the study's summary pages were available.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Act regulations 16 CFR 1500.42
Version / remarks:
1973-09-27
Principles of method if other than guideline:
single dose level, single administration, 72-hour post observation
GLP compliance:
no
Specific details on test material used for the study:
amorphous silicon dioxid Ludox SM-30
Species:
rabbit
Strain:
not specified
Remarks:
albino
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
once
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Irritation parameter:
cornea opacity score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Interpretation of results:
GHS criteria not met
Conclusions:
According to the definition of the eye test in the regulations of the Federal Hazardous Substances Act amorphous silicon dioxid Ludox SM-30 was not irritating to rabbit eye.
Executive summary:

The eye irritation potential of amorphous silicon dioxid Ludox SM-30 was assessed in rabbits. Only the study's summary pages were available.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
single dose level, single administration, with & without rinsing, 72-hour post observation
GLP compliance:
no
Specific details on test material used for the study:
amorphous silicon dioxid Ludox SM-30
Species:
rabbit
Strain:
not specified
Remarks:
albino
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
2 x 0.1 ml (0.1 ml per eye)
Duration of treatment / exposure:
once
one eye washed after 20 seconds
Observation period (in vivo):
72 h (oberservations: 1, 4 hrs., 1, 2, 3 days)
Number of animals or in vitro replicates:
2
Details on study design:
applied into the conjunctival sacs of each animal, after 20 sec. one eye was washed for 1 min., the other one was left unrinsed
Irritation parameter:
overall irritation score
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
not rinsed: no effects to cornea and iris, but slight ones to conjunctiva (minimal redness and swelling at 1 h., minimal discharge at 1-4 hrs.)
rinsed eyes: no ocular effects (cornea, iris & conjunctiva)
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxid Ludox SM-30 was not irritating to rabbit eye
Executive summary:

The eye irritation potential of amorphous silicon dioxid Ludox SM-30, with and without rinsing, was assessed in rabbits. Only the study's summary page was available.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Principles of method if other than guideline:
single dose level, single administration, with & without rinsing, 72-hour post observation
GLP compliance:
not specified
Specific details on test material used for the study:
amorphous silicon dioxid Ludox TM
Species:
rabbit
Strain:
not specified
Remarks:
albino
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
2 x 0.1 ml (0.1 ml per eye)
Duration of treatment / exposure:
once
one eye washed after 20 seconds
Observation period (in vivo):
72 h (oberservations: 1, 4 hrs., 1, 2, 3 days)
Number of animals or in vitro replicates:
2
Details on study design:
applied into the conjunctival sacs of each animal, after 20 sec. one eye was washed for 1 min., the other one was left unrinsed
Irritation parameter:
overall irritation score
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
unrinsed: no ocular effects (cornea, iris & conjunctiva)
rinsed eyes: no ocular effects (cornea, iris & conjunctiva)
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxid Ludox TM was not irritaing to rabbit eye.
Executive summary:

The eye irritation potential of amorphous silicon dioxid Ludox TM, with and without rinsing, was assessed in rabbits. Only the study's summary page was available.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: Federal Hazardous Substances Act regulations 16 CFR 1500.42
Version / remarks:
1973-09-27
Principles of method if other than guideline:
single dose level, single administration, 72-hour post observation
GLP compliance:
no
Specific details on test material used for the study:
amorphous silicon dioxid Ludox TM
Species:
rabbit
Strain:
not specified
Remarks:
albino
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
once
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 48, 72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal: #2 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal: #1 - #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Interpretation of results:
GHS criteria not met
Conclusions:
According to the definition of the eye test in the regulations of the Federal Hazardous Substances Act amorphous silicon dioxid Ludox TM was not an eye irritant.
Executive summary:

The eye irritation potential of amorphous silicon dioxid Ludox TM was assessed in rabbits. Only the study's summary pages were available.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Qualifier:
no guideline followed
Principles of method if other than guideline:
single dose level, single admininstration, w/o rinsing, 72-hour post observation
GLP compliance:
not specified
Specific details on test material used for the study:
amorphous silicon dioxid Syloid 378
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino
Details on test animals or tissues and environmental conditions:
1.8 - 2.6 kg
Vehicle:
not specified
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
once, unwashed
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
applied into the conjunctival sac of the left eye
Irritation parameter:
overall irritation score
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Slight conjunctival redness in five eyes, moderate conjunctival redness in one eye, slight chemosis in six eyes and slight discharge in two eyes were observed at 24 hours. Conjunctival redness persisited in three eyes through 48 hours. Fluorescein staining at 72 hours confirmed the absence of corneal damage in all eyes.
Interpretation of results:
GHS criteria not met
Conclusions:
amorphous silicon dioxid Syloid 378 was not considered a primary irritant as defined by the Federal Hazardous Substances Act.
Executive summary:

The eye irritation potential of amorphous silicon dioxid Syloid 378 was evaluated in rabbits. The page with the detailed results for each individual animal was not available.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Jul. 12 - Oct 31, 1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
other: Fed. Haz. Sub. Act, CFR, subchapter C, part 1500.42
Principles of method if other than guideline:
single dose l., single admin., w/o rinsing, 7d post obs.
GLP compliance:
not specified
Specific details on test material used for the study:
Synthetic amorphous silica (Cab-O-Sil M5)
Species:
rabbit
Strain:
New Zealand White
Remarks:
albino, male
Details on test animals or tissues and environmental conditions:
2.5 - 3 kg, singly caged, 12 hrs. light/dark cycle, fed with Purina Rabbit Chow, water ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
once
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
without washing
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 4, 24, 48, 72h, 7d
Score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 4, 24 , 48 ,72h, 7d
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 4h
Score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48, 72h, 7d
Score:
0

At 24 hr, the animals displayed slightly greater conjunctival erythema. Four animials showed vessels difinitely injected above normal, one animal exhibited a deep crimson-red conjunctivae with the individual vessels not easily discernible, and one animal appeared normal. At 48 and 72 hrs, the serverity of conjunctival erythema had decreased with only 2 animals at each observation time demonstrating conjunctival vessels injected above normal.

Interpretation of results:
GHS criteria not met
Conclusions:
Synthetic amorphous silicon dioxide Cab-O-Sil M5 was not considered eye irritant under the Fed. Hazardous Sub. Act.
Executive summary:

The eye irritation potential of synthetic amorphous silicon dioxide Cab-O-Sil M5 was examined in rabbits.

Endpoint:
eye irritation: in vitro / ex vivo
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Acute skin irritation:

According to Annex I of the Regulation (EC) 1272/2008 and GHS (Globally Harmonized Classification System), the test substance requires no classification and has no mandatory label requirement.

Acute eye damage/ irritation:

According to Annex I of the Regulation (EC) 1272/2008 and GHS (Globally Harmonized Classification System), the test substance requires no classification and has no mandatory label requirement.