Registration Dossier
Registration Dossier
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EC number: 235-878-6 | CAS number: 13019-22-2
Endpoint summary
Administrative data
Description of key information
Skin Irritation in vivo:
Under the test conditions, the test substance is classified Category 2 according to the GHS classification.
Eye Irritation in vivo:
Under the test conditions, the test substance is classified Category 2 according to the GHS classification.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 February 1982 - 02 March 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 163.81-5 Primary dermal irritation study
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: between 2.3 to 3.0 kg
- Housing: caged individually in stainless steel cages
- Diet (e.g. ad libitum): standard rabbit maintenance feed, ad libitum
- Water (e.g. ad libitum): automatic drinking supply
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hours/day - Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Remarks:
- and slightly scarified
- Vehicle:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 21 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- TEST SITE
- Area of exposure: entire back and the flank
- Type of wrap if used: surgical gauze, aluminium foil (approximately 2.5 x 2.5cm) and occlusive bandage of elastic adhesive dressing
OBSERVATION TIME POINTS
1, 24, 48 and 72 hours, 7, 14 and 21 days - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3.33
- Max. score:
- 3.33
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- >= 0 - <= 3
- Max. score:
- 3
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- intact skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 5
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- primary irritation index
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.6
- Max. score:
- 3.6
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Remarks:
- abraded skin
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 3.8
- Reversibility:
- not specified
- Remarks on result:
- probability of moderate irritation
- Irritant / corrosive response data:
- Assessment of irritation:
0 to 0.5: none
0.6 to 3.0: slight
3.1 to 5.0: moderate
5.1 to 8.0: marked
see Table 1 - Other effects:
- In the area of application no discoloration of the skin was observed.
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the conditions of this experiment the test material was found to cause moderate irritation when applied to intact and abraded rabbit skin.
In the area of application no discoloration of the skin was observed.
Within 72 hours after starting the application 2 out of 6 rabbits showed necrosis of the skin at the application site. There was a clear tendency of healing during the following observation period.
The calculated primary irritation index was found to be:
- intact skin: 4.0
- abraded skin: 3.3
Mean irritation index for intact and abraded skin: 3.6
Reference
Table 1: results
| erythema | oedema | |||||||||||
| rabbit# | score 24h | score 48h | score 72 h | mean 24 / 48 / 72 | 7 days | 14 days | score 24h | score 48h | score 72 h | mean 24 / 48 / 72 | 7 days | 14 days |
| 835 | 2 | 2 | 3 | 2,333333333 | 2 | 0 | 1 | 1 | 2 | 1,333333333 | 1 | 0 |
| 836 | 2 | 2 | 2 | 2 | 0 | 0 | 1 | 1 | 1 | 1 | 0 | 0 |
| 837 | 2 | 3 | 4 | 3 | 0 | 0 | 2 | 2 | 2 | 2 | 1 | 0 |
| 838 | 2 | 3 | 3 | 2,666666667 | 2 | 0 | 1 | 1 | 1 | 1 | 1 | 0 |
| 839 | 2 | 3 | 4 | 3 | 1 | 0 | 2 | 2 | 2 | 2 | 1 | 0 |
| 840 | 3 | 3 | 4 | 3,333333333 | 3 | 0 | 1 | 1 | 2 | 1,333333333 | 2 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 March 1982 - 9 March 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: recommended guideline for 'Acute Eye Irritation Testing', Interagency regulatory liaison group, CPSC, EPA, FDA, OSHA, January 1981
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.3 to 3.0 kg
- Housing: caged individually in stainless steel cages
- Diet (e.g. ad libitum): standard rabbit maintenance feed, ad libitum
- Water (e.g. ad libitum): automatic drinking water supply
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 55 ± 10 %
- Photoperiod (hrs dark / hrs light): 12 hours/ day - Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- Amount: 0.1 mL
- Duration of treatment / exposure:
- Single application, a few seconds
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): In 3 out of 6 rabbits, the treated eye was flushed with physiological saline for about one minute.
- Time after start of exposure: approximately 30 seconds - Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 7.6
- Max. score:
- 7.6
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- rinced
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- overall irritation score
- Remarks:
- not rinced
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 14.7
- Max. score:
- 24.3
- Reversibility:
- not specified
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 2
- Max. score:
- 2
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Remarks on result:
- positive indication of irritation
- Irritant / corrosive response data:
- Assessment of irritation:
0 to 10: none
11 to 25: slight
26 to 56: moderate
57 to 110: marked - Other effects:
- Rinsing the eyes following substance instillation practically abolished the action of the compound.
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the conditions of this experiment the test material was classified as Category 2.
Reference
Effect of rinsing: 29.4
Scaling:
Less than 1 : rinsing increased the effect of the compound
1 : no effect
1.1 to 1.5 : practically no effect
1.6 to 2.0 : little but assessable effect
2.1 to 4.0 : good effect
4.1 to 10 : very good effect
Above 10 : action of the compound practically abolished
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
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