Registration Dossier

Administrative data

Description of key information

The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. No skin reactions occured except a very slight erythema in 1/3 animals one hour after the end of exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008

The test material was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. No corneal effects were observed. Iridial responses were observed 24 h after application, fully reversible by 48 h after application. Conjunctival redness and Chemosis were observed in 3/3 animals up to 48 hours after application, fully reversible by 72 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.

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:
From 10 OCT 1989 to 13 OCT 1989.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 404).
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.4-3.5 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay ca. 15 g per day
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 0.4 ml 0.9% NaCl solution
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of a surgical plaster (Beiersdorf)
- Type of wrap if used: semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: with lukewarm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h.
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h.
Score:
0
Max. score:
4
Irritant / corrosive response data:
1/3 animals showed erythema score 1 one hour after exposure. No other skin reactions were observed at any other time points.
Other effects:
Large yellow discolouration of 3/3 skin sites, which was no longer observable on day two.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. No skin reactions occured except a very slight erythema in 1/3 animals one hour after the end of exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008

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:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 15 NOV 1988 to 18 NOV 1988.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 404).
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.2-3.1 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage), ad libitum, plus hay ca. 15 g per day
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs
Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 500 mg pasted with 1.2 ml physiol. saline

VEHICLE
- Concentration: 0.9% NaCl solution
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm² cellulose patch of an adhesive tape in contact with skin
- Type of wrap: semiocclusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing: lukewarm tap water
- Time after start of exposure: 4 h

SCORING SYSTEM: according to OECD TG 404
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No erythema or oedema were observed in 3/3 animals at any time point.
Other effects:
Yellow discolouration of treated skin sites.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
The test material is not irritating to skin under these test conditions.
Executive summary:

The test material was subject to an Acute Dermal Irritation/Corrosion Test in the rabbit according to OECD TG 404. Neither erythema nor edema were observed in any animal at any time point. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No 1272/2008.

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 14 MAR 1978 to 17 MAR 1978.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
other: FDA-guidelines
Deviations:
not specified
Remarks:
no further information
GLP compliance:
not specified
Species:
rabbit
Strain:
Himalayan
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Housing: individually
- Diet: mixed feed ERKA 8300 (Robert Koch, Hamm), ad libitum
- Water: tap water, ad libitum
Type of coverage:
occlusive
Preparation of test site:
other: clipped, partially scarified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 ml
Duration of treatment / exposure:
24 h
Observation period:
48 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5x2.5 cm² gauze patch
- Type of wrap if used: PVC foil, elastic bandage

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

SCORING SYSTEM: described in § 1500.41 in Fed. Reg. 38, No. 187, 27.09.1973, p.27019, in accordance with OECD TG 404.
Scores were assessed 24, 48 and 72 h after start of exposure, which lasted for 24 h. For classification, the readings are stated here as immediately, 24 and 48 h after end of exposure.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 h.
Score:
0
Max. score:
4
Remarks on result:
other: intact skin sites
Irritation parameter:
erythema score
Basis:
animal: #1, #4, #6
Time point:
other: 24, 48 h.
Score:
0
Max. score:
4
Remarks on result:
other: intact skin sites
Irritation parameter:
erythema score
Basis:
animal: #3, #5
Time point:
other: 24, 48 h.
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks:
48 h after exposure.
Remarks on result:
other: intact skin sites
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48 h.
Score:
1
Max. score:
4
Reversibility:
not reversible
Remarks:
48 h after exposure
Remarks on result:
other: intact skin site
Irritant / corrosive response data:
Immediately after exposure erythema score 1 was noted in 4/6 intact skin sites and in 5/6 scarified skin sites. Erythema score 1 persisted in animal #2 until 48 h after exposure. Every other skin response was fully reversible by 48 h. Edema score 1 was noted immediately after exposure in 5/6 intact skin sites and in 4/6 scarified skin sites, fully reversible by 48 h after exposure.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to skin under these test conditions. This conclusion is legitimate even though the applied testing regime differs from today's standard methods, as the observed skin responses were fully reversible in 5/6 animals 48 h after after exposure, which lasted 20 h longer than required by OECD TG 404. The test material contains relevant amounts of Permanent-Gelb G, which is identical to the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

The test material was tested for skin irritancy according to FDA guidelines. Both intact and scarified skin sites of six rabbits were exposed to 0.5 ml test substance for 24 h under occlusive conditions and the skin responses were watched for 48 hours after end of exposure. Very slight erythema were noted in 5/6 animals immediately after end of exposure, fully reversible in 4/6 animals by 48 h after end of exposure. Very slight edema were noted in 5/6 animals immediately after end of exposure, fully reversible by 48 h after end of exposure. Therefore, the test item has not to be classified for skin irritation according to Regulation (EC) No. 1272/2008.

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
Study period:
From 22 NOV 1988 to 25 NOV 1988.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 405).
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.8-3.2 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage), ad libitum, plus hay ca. 15 g per day
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 ml, ca. 20 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiol. saline, ca. 37 °C warm
- Time after start of exposure: 24h

SCORING SYSTEM: according to OECD TG 405

TOOL USED TO ASSESS SCORE: fluorescein, UV light
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #3
Time point:
other: 24, 48, 72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible
Remarks:
48 h after application
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible
Remarks:
48 h after application
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study. Conjunctival redness was observed in every animal 1 h and 24 h after application (max. score 2), fully reversible by 48 h after application. Chemosis was observed only in animal #3 (score 1) one hour after application, fully reversible by 24 h after application. 48 h and 72 h after application no ocular effects were observed.
Other effects:
Transparent discharge with yellow discolouration from test substance one hour after application.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions.
Executive summary:

The test material was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. No corneal or iridial effects were noted during the study. Slight conjunctival effects were observed in every animal, fully reversible by 48 hours after application. Chemosis was observed only in animal #3 one hour after application, fully reversible by 24 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 24 OCT 1989 to 27 OCT 1989.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 405).
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.9-3.7 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay ca. 15 g per day
- Water: deionised, chlorinated water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with ca. 37 °C warm physiol. saline
- Time after start of exposure: 24 h

SCORING SYSTEM: according to OECD TG 405

TOOL USED TO ASSESS SCORE: fluorescein, UV light
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h.
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 h.
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal: #2, #3
Time point:
other: 24, 48, 72 h.
Score:
0.33
Max. score:
2
Reversibility:
fully reversible
Remarks:
48 h after application.
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 h.
Score:
1
Max. score:
3
Reversibility:
fully reversible
Remarks:
72 h after application.
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 h.
Score:
1.33
Max. score:
3
Reversibility:
fully reversible
Remarks:
72 h after application.
Remarks on result:
other: redness
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 h.
Score:
1.67
Max. score:
3
Reversibility:
fully reversible
Remarks:
72 h after application.
Remarks on result:
other: redness
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 h.
Score:
0.33
Max. score:
4
Reversibility:
fully reversible
Remarks:
48 h after application.
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 h.
Score:
0.67
Max. score:
4
Reversibility:
fully reversible
Remarks:
72 h after application.
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 h.
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks:
72 h after application.
Irritant / corrosive response data:
No corneal opacity was observed during the study. Iris score 1 was observed in 2/3 animals 24 h after application. No other iridial responses were observed. Conjunctival redness was observed in every animal one, 24 and 48 h after application (max. score 3). Chemosis was observed in every animal one and 24 h after application and in 2/3 animals 48 h after aplication. No effects were noted 72 h after application.
Other effects:
Transparent discharge, yellow coloured from test substance, was observed in every animal one hour after application and in one animal 24 h after application.
Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions. Test material Permanent-Gelb P-GRL neu contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

The test material was subject to an Acute Eye Irritation/Corrosion Test in the rabbit according to OECD TG 405. No corneal effects were observed. Iridial responses were observed 24 h after application, fully reversible by 48 h after application. Conjunctival redness and Chemosis were observed in 3/3 animals up to 48 hours after application, fully reversible by 72 hours after application. As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.
Qualifier:
according to guideline
Guideline:
other: described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
Deviations:
not specified
GLP compliance:
not specified
Species:
rabbit
Strain:
other: Russian breed
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.1 g
Duration of treatment / exposure:
No rinsing of eyes in group 1 (3 animals); rinsing of eyes 30 seconds after application in group 2 (3 animals)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO (basically in accordance with OECD TG 405)
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Remarks on result:
other: group 1 + group 2
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Remarks on result:
other: group 1 + group 2
Irritation parameter:
conjunctivae score
Remarks:
( no differentiation between redness and chemosis)
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Remarks on result:
other: group 1 + group 2
Irritant / corrosive response data:
No eye responses were noted in any animal at any time point.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
The test material is not irritating to eyes under these test conditions. This conclusion is legitimate as three animals (group 1) were tested basically in accordance with today's standard methods regarding dosing, exposure duration, scoring system, reading time points and no eye responses were noted in any animal at any time point.
Executive summary:

The test material was tested for eye irritancy according to a procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). 0.1 g neat test substance was applied to the conjunctival sac of one eye each of 6 animals (no washing in 3 animals, group 1, washing after 30 seconds in 3 animals, group 2) and eye responses were watched for seven days. No eye responses were noted in any animal at any time point. The test item is not irritating to eyes and has not to be classified as irritating to eyes according to the criteria of Regulation (EC) No 1272/2008.

Endpoint:
eye irritation: in vivo
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Please see read across document in chpter 13
Reason / purpose for cross-reference:
read-across source
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
4
Remarks on result:
other: group 1 + group 2
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
2
Remarks on result:
other: group 1 + group 2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
ca. 0
Max. score:
3
Remarks on result:
other: group 1 + group 2
Irritant / corrosive response data:
No eye responses were noted in any animal at any time point.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
The test material is not irritating to eyes under these test conditions. This conclusion is legitimate as three animals (group 1) were tested basically in accordance with today's standard methods regarding dosing, exposure duration, scoring system, reading time points and no eye responses were noted in any animal at any time point.
Executive summary:

The test material was tested for eye irritancy according to a procedure described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). 0.1 g neat test substance was applied to the conjunctival sac of one eye each of 6 animals (no washing in 3 animals, group 1, washing after 30 seconds in 3 animals, group 2) and eye responses were watched for seven days. No eye responses were noted in any animal at any time point. The test item is not irritating to eyes and has not to be classified as irritating to eyes according to the criteria of Regulation (EC) No 1272/2008.

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

No classification

The test item did not cause irritant effects on skin and eyes in two in vivo studies in rabbits.