Registration Dossier

Administrative data

Description of key information

Skin irritation: In a rabbit skin irritation/corrosion test according to OECD Guideline 404, the test substance showed corrosive effects to the skin (Kiecza, 1986).

Eye irritation: Based on the data of this OECD Guideline 405 study and according to the criteria of the CLP Regulation, the test substance is regarded as causing serious eye damage (Reagan, 1981).

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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Well documented study performed according to a method similar to OECD TG 404. No 14 days follow-up is performed.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
no follow-up during 14 days after exposure
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): 3-methoxipropylamin, 85/455
Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main. Frg
- Age at study initiation: no data
- Weight at study initiation: 2.87 kg (males); 3.16 kg (females)
- Housing: 1 animal per cage, cage made of stainless stell with wire mesh walk floors (area 40 x 51 cm), no bedding in the cages; saw-dust in the waste trays
- Diet (e.g. ad libitum): Kliba 341.4 mm (Switzerland) - ad libitum
- Water (e.g. ad libitum): about 250 ml tab water per animal per day - ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): fully air-conditioned rooms: 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12h (06:00-18:00 light)
Type of coverage:
other: test patch is secured with a porous dressing (4 layers of absorbent gauze - porous bandage)
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.5 ml of the undiluted test substance is absorbed by the patch (2.5 x 2.5 cm)

Duration of treatment / exposure:
3 min, 1 hour
Observation period:
72 h
Number of animals:
1 male, 2 females per exposure duration
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lutrol and lutrol / water (1:1)
- Time after start of exposure: after 3 min, resp 1 h exposure
- Readings: 30 - 60 minutes after removal of the test patches and 24h, 48h, 72h after the beginning of the application

SCORING SYSTEM: Draize
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 3 min, 24h, 48h, 72h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: 3 min exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 3 min, 24h, 48h, 72h
Score:
0.6
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: 3 min exposure
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1h, 24h, 48h, 72h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: 1h exposure
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 1h, 24h, 48h, 72h
Score:
1.2
Max. score:
4
Reversibility:
not fully reversible within: 72h
Remarks on result:
other: 1h exposure
Irritant / corrosive response data:
Necrosis is observed in all animals exposed for 3 min. At 72h after exposure, full thickness necrosis is confirmed by gross pathology examination.
The mean scores for edema after 3 min exposure are resp 1.0; 0.3; 0.3.

Necrosis is observed in all animals exposed for 1 hour. At 1 and 72h edema was extended beyond the area of exposure in one animal. At 24 and 48h edema was extended in two animals. At 72h after exposure, full thickness necrosis is confirmed by gross pathology examination.
The mean scores for edema after 1h exposure are resp 2.0; 0.7; 1.0
Interpretation of results:
Category 1A (corrosive) based on GHS criteria
Conclusions:
In an in vivo acute dermal irritation test performed similar to OECD 404, rabbits are exposed to the test substance during resp 3 min and 1h. On the basis of the observations and the lack of reversibility of effects, the substance is considered to be Corrosive Cat 1A according to the CLP Regulation No 1272/2008.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
06 November 1990 - 20 November 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Well documented GLP study performed according to a method similar to OECD TG 404 with the following deviations: both intact and abraded skin was exposed under an occlusive dressing (instead of non-occlusive dressing).
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
both intact and abraded skin was tested using an occlusive dressing
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): 6398-24-1
- Substance type: clear, colorless liquid
- Physical state: liquid
- Analytical purity: responsibility of the sponsor
- Stability under test conditions: no apparent change in the physical state of the test substance during administration
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hare-Marland, Hewitt, NJ
- Age at study initiation: young adult
- Weight at study initiation: 2,739 - 3,097 - 2,927 - 2,485 - 2,874 - 3,123 kg
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Animal Resources, National Research Council.
- Diet (e.g. ad libitum): Purina Rabbit RationR HF, ad libitum,
- Water (e.g. ad libitum): fresh tap water, ad libitum
- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark


IN-LIFE DATES: From: To:
Type of coverage:
occlusive
Preparation of test site:
other: shaved (intact) and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/site, 3 sites per animal
Duration of treatment / exposure:
4h (upper dorsal site) and 24h (lower dorsal sites)
Observation period:
14 days after application of the substance
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: one site (intact) on the upper dorsal trunk and two sites ( intact and abraded), on the lower dorsal trunk (all application sites were clipped free of hair)
- Type of wrap if used: gauze patch applied, wrapped with a rubber dam and an elastic bandage to retard evaporation


REMOVAL OF TEST SUBSTANCE
- No data

SCORING SYSTEM:
Draize Evaluation of Dermal Irritation
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: at all sites of application: severe erythema and necrosis
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: at all sites of application: severe erythema and necrosis
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: at all sites of application: severe erythema and necrosis
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: at all sites of application: severe erythema and necrosis
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: at all sites of application: severe erythema and necrosis
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: at all sites of application: severe erythema and necrosis
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: at all sites of application: severe edema and necrosis
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: at all sites of application: severe edema and necrosis
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: at all sites of application: severe edema and necrosis
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: at all sites of application: severe edema and necrosis
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: at all sites of application: severe edema and necrosis
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: at all sites of application: severe edema and necrosis
Irritant / corrosive response data:
Severe erythema and severe edema remained present in all animals at all observation periods during the study (up to 14 days).
Upper dorsal site: 6/6 necrosis and 1/6 sloughing of the skin at the application sites
Lower dorsal site: 6/6 necrosis and 2/6 sloughing of the skin at the application sites
Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The substance is considered corrosive under the conditions of the test.
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:
supporting study
Study period:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Methoxypropylamine (MOPA)
- Batch: FABRICATION F 6612 r (860208)
- Purity c.a. 99%
- Supplir: Atochem, la Chambre
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River : Saint Aubin Les Elbeuf - 76410 Cléon -France
- Age at study initiation: no data
- Weight at study initiation: 2,5 ± 0,2 kg.
- Housing: individual housing, in polystyren cages, of interna! dimensions 560 x 355 x 315 mm, with a perforated floor.
- Diet: Rabbit canplete pelleted maintenance food, ad libitum
- Water: Softened and filtered drinking water
- Acclimation period: minimum of one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 to 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours, 7 and 14 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: the back and the flanks
- Surface coverage: 2.4 cm²
- Type of wrap if used: 10 cm wide perforated tape (Peloplast

SCORING SYSTEM:
- Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beetroot red) to slight eschar formation (deep lesions) 4
- Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (edges raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond the area of exposure) 4
- Description and evaluation of the cutaneous corrosion
This evaluation was carried out when severe cutaneous lesions were noted 72 hours after the application of the test article in at least one rabbit. These lesions corresponded either to a moderate to severe oedema (score = 3), or to a moderate oedema (score = 3).
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks on result:
other: Corrosive
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not reversible
Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
0.5 ml per animal of the test article applied as supplied, under semi-occlusive patch for 4 hours on intact skin was corrosive
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
10-03-1982 - 12-03-1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study was performed according to a method similar to OECD 404 guideline. The following deviations were observed: animals were only observed at 4 and 44 hours after exposure. An occlusive dressing was used instead of a non-occlusive one.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
animals only observed at 4 and 44 hours after application of the test material; occlusive dressing was used
GLP compliance:
not specified
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4236-43-15
- Lot/batch No.: J -104
- Substance type: clear liquid
- Physical state: liquid
- Other: pH approximately 8
- Purity: responsibility of the sponsor.
- Stability: there was no apparent change in the physical state of the test article during administration.
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hilltop Laboratory Animals Scottdale, Pennsylvania
- Age at study initiation: adult
- Weight at study initiation: 2-3 kilograms
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Resources, National Research Council.
- Diet (e.g. ad libitum): Wayne Rabbit Ration, ad libitum
- Water (e.g. ad libitum): fresh tap water, fit for human consumption, ad libitum, using 16 ounce glass bottles with rubber stopper and stainless steel sipper tube or an automatic watering system supplied by Edstrom Industries Inc., Waterford, Wisconsin.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml/site (covered by a one inch square patch)

Duration of treatment / exposure:
4h
Observation period:
48h
Number of animals:
Two (1male and 1 females)
Details on study design:
TEST SITE
- Area of exposure: trunk ( clipped free of fur)
- Type of wrap if used: a rubber dam and an Ace bandage to retard evaporation

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The wrappings were removed and the skin wiped to remove any remaining material.
- Time after start of exposure: At the end of the 4 hour exposure period

SCORING SYSTEM: No data
Corrosion will be considered to have resulted if the substance in contact with the rabbit skin has caused destruction or irreverisble alteration of the tissue on at least two out of each six rabbits tested. Tissue destruction does not include merely sloughing of the epidermis or erythema, edema or fissuring.
Irritation parameter:
other: observation
Basis:
animal: 2/2
Time point:
other: 4h
Remarks on result:
other: necrosis
Irritation parameter:
other: observation
Basis:
animal: 2/2
Time point:
other: 44h
Remarks on result:
other: necrosis
Irritant / corrosive response data:
Skin necrosis was visible in both rabbits at 4 and 44 hours after application of the substance.
Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
Based upon the results of the DOT Corrosivity Study in Rabbits, the substance was considered to be corrosive.
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
29 July 1981 - 01 August 1981
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
GLP study performed according to a method similar to OECD TG 404 with the following deviations: exposure to both intact and abraded skin, 24h of exposure instead of 4h, occlusive dressing instead of non-occlusive one was used, no skin readings at 48h and no 14-day observation period. As the test substance is poorly identified, the test results are poorly described and there are too many deviations from the OECD test guideline, the study is considered not reliable.
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
exposure to both intact and abraded skin, 24h of exposure instead of 4h, occlusive dressing instead of non-occlusive one was used, no skin readings at 48h and no 14-day observation period.
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4236-43-15
- Lot/batch No.: J-78
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: H.A.R.E.-Rabbits for Research, Hewitt, New Jersey
- Age at study initiation: adult
- Weight at study initiation: 2 - 4 kg
- Housing: Individually housed in wire mesh bottom cages
- Diet (e.g. ad libitum): NIH Animal Feed A, certified diet (Zeigler Bros.), ad libitum.
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: minimum 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): according to the "Guide for the Care and Use of Labolatory Animals"
- Humidity (%): according to the "Guide for the Care and Use of Labolatory Animals"
- Air changes (per hr): 12-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12hours light/12 hours dark


Type of coverage:
occlusive
Preparation of test site:
other: shaved (intact) and abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: OECD 404: untreated area of the test animal serves as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml



Duration of treatment / exposure:
24 hours
Observation period:
24 and 72h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2 sites per animal, dorsal surface (clipped free of fur)
- Type of wrap if used: occlusive binder


REMOVAL OF TEST SUBSTANCE
- Washing (if done): gently wiped using a soft clean gauze
- Time after start of exposure: 24 and 72h


SCORING SYSTEM:
Draize scoring system
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72h
Interpretation of results:
study cannot be used for classification
Conclusions:
The substance is considered to be moderately irritating (Draize scoring).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

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:
29 July 1981 - 12 August 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): 4236-43-15
- Physical state: liquid
- Analytical purity: responsibility of the Sponsor
- Stability under test conditions: responsibility of the Sponsor
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: H.A.R.E Rabbits for Research, Hewitt,New Jersey.
- Age at study initiation: adult
- Weight at study initiation: 2-4 kg
- Housing: individually housed in wire mesh bottom cages in an environment-controlled room
- Diet (e.g. ad libitum): NIH Animal Feed A (certified), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min.5d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): according to the "Guide for the Care and Use of Labolatory Animals"
- Humidity (%): according to the "Guide for the Care and Use of Labolatory Animals"
- Air changes (per hr): 12-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12h dark/12h light

Vehicle:
unchanged (no vehicle)
Controls:
other: OECD 405: untreated eye of the test animal serves as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml

Duration of treatment / exposure:
no wash-out
Observation period (in vivo):
14 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: observation: Draize scale for Scoring Ocular Lesions and Modification of the Kay and Calendra

TOOL USED TO ASSESS SCORE:
sodium fluorescein and ultraviolet lamp
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 6 animals
Time point:
24/48/72 h
Score:
1.89
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Remarks on result:
other: Chemosis scoring increased to max. score at 14 days reading
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
not reversible
Remarks:
within 14 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: All eye tissue surrounding the eyeball itself was completely necrosed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: days
Remarks on result:
other: All eye tissue surrounding the eyeball itself was completely necrosed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: All eye tissue surrounding the eyeball itself was completely necrosed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: All eye tissue surrounding the eyeball itself was completely necrosed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: All eye tissue surrounding the eyeball itself was completely necrosed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: All eye tissue surrounding the eyeball itself was completely necrosed
Irritant / corrosive response data:
Conjunctiva of the eye showed necrosis after 1 hour. All eye tissue surrounding the eyeball itself was completely necroses and colored black after 24 hours and later. One rabbit showed a hemorraged eye after 1 hour. Bloody discharge from the eye was observed in this rabbit after 7days, while the others showed no discharge.
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Based on the results of this study the test substance can be regarded as causing serious eye damage.
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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation / corrosion:

Kiecza (1986) studied acute dermal irritation/ corrosivity in 6 rabbits which were exposed to the undiluted substance during resp 3 minutes and 1 hour in a test according to the OECD 404 guideline. Necrosis is observed in all animals exposed for 3 min. At 72h after exposure, full thickness necrosis is confirmed by gross pathology examination. The mean scores for edema after 3 min exposure are resp 1.0; 0.3; 0.3. On the basis of the observations and the lack of reversibility of effects, the substance is considered to be Corrosive Category 1A according to the CLP Regulation No 1272/2008. This study was identified as key study.

This was supported by a study by Mallory (1990) who studied skin irritation/corrosion by applying the test substance on one site (intact) on the upper dorsal trunk and two sites ( intact and abraded), on the lower dorsal trunk (all application sites were clipped free of hair) of 6 New Zealand White rabbits in occlusive conditions (shaved and abraded skin), according to OECD guideline 404. Exposure lasted for 4 hours (upper dorsal site) and 24 hours (lower dorsal site) and observations were performed at 24, 48 and 72 hours and up to 14 days after application of the substance. Lesions were scored according to the Draize system: erythema and edema scores of 4 were observed. Effects were not fully reversible within 14 days. At all sites of application severe erythema and edema and necrosis were observed. The substance was observed to be corrosive under the conditions of the test.

Eye irritation:

Reagan (1981) investigated the eye irritation effects of 0.1 mL the test substance in 6 male New Zealand White rabbits. The study was performed according to a method similar to OECD guideline 405. After an observation period of 14 days (scoring at 24, 48 and 72 hours), following responses were observed: conjunctivae of the eye showed necrosis after 1 hour. All eye tissues surrounding the eyeball itself were completely necrosed and colored black after 24 hours and later. One rabbit showed a hemorraged eye after 1 hour. Bloody discharge from the eye was observed in this rabbit after 7days, while the others showed no discharge. Based on these observations the substance is regarded as causing serious eye damage.

Justification for classification or non-classification

Based on the available data and the criteria of the CLP Regulation, the substance should be classified for skin corrosion category 1A and eye damage category 1.