Registration Dossier
Registration Dossier
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EC number: 943-381-7 | CAS number: 2156594-85-1
Endpoint summary
Administrative data
Description of key information
The registration substance is irritating to skin and not irritating to eye.
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:
- 1994-09-13 - 1994-11-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically well performed and well documented. Guideline study: GLP study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- 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:
- 4h
- Observation period:
- 21 days
- Number of animals:
- 3 rabbits
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- other: 24, 48, 72h
- Score:
- 2.9
- Max. score:
- 3
- Reversibility:
- fully reversible within: 21 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24,48, 72h
- Score:
- 1.2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The registration substance induced reversible irritating effects in rabbits. According to EU criteria, the registration substance should be classified as "irritating".
- Executive summary:
The registration substance was investigated for its skin irritation property according to Guideline OECD 404. Three rabbits were administered semiocclusively by the undiluted registration substance for 4 hours and the skin irritation effects were observed for up to 21 days. Erythema of scores of up to 3 and oedema of scores of up to 2 was observed within the first three days of the observation period. Two animals exhibited on observation day 14 erythema of scores of 1, which were no more present on observation day 21.
The registration substance should be classified as "irritating" according to the EU criteria.
Reference
Result:
Animal no. |
Effect |
Hour |
Days after application |
Mean score erythema (24/48/72 h) |
Mean score oedema (24/48/72 h) |
|||||
0.5 - 1 |
1 |
2 |
3 |
7 |
14 |
21 |
||||
69 |
Erythema Oedema |
3 0 |
3 2 |
3 1 |
3 1 |
2 1 |
0 0 |
|
3.0 |
1.3 |
113 |
Erythema Oedema |
2 0 |
3 2 |
3 1 |
3 1 |
1 0 |
1 0 |
0 0 |
3.0 |
1.3 |
114 |
Erythema Oedema |
2 0 |
3 2 |
3 1 |
2 0 |
1 0 |
1 0 |
0 0 |
2.7 |
1.0 |
Mean all animals |
|
|
|
|
|
|
|
|
2.9 |
1.2 |
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Scientifically well performed and well documented. Guideline study: GLP study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- a single application of 0.1 ml of test substance into the eye
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of three animals at three reading time
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of three animals at three reading time
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of three animals at three reading time
- Time point:
- other: 24, 48, 72 h
- Score:
- 1.4
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- of three animals at three reading time
- Time point:
- other: 24, 48, 72 h
- Score:
- 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The registration substance induced transient conjunctivae redness and chemosis in rabbits. According to EU criteria, no classification is warranted for the registration substance.
- Executive summary:
The registration substance was investigated for its eye irritation property according to Guideline OECD 405. Three rabbits were used. The undiluted registration substance was applied into eye. Conjuctivae redness of scores up to 2 and chemosis of scores of 1 were observed within the first three days of the observation period. The observed effects were fully reversible within 7 days of observation period.
No classificaiton is warranted for the registration substance according to the EU criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The registration substance was investigated for its skin irritation property according to Guideline OECD 404. Three rabbits were administered semiocclusively by the undiluted registration substance for 4 hours and the skin irritation effects were observed for up to 21 days. Erythema of scores of up to 3 and oedema of scores of up to 2 was observed within the first three days of the observation period. Two animals exhibited on observation day 14 erythema of scores of 1, which were no more present on observation day 21.
The registration substance should be classified as "irritating" according to the OECD GHS criteria.
The registration substance was investigated for its eye irritation property according to Guideline OECD 405. Three rabbits were used. The undiluted registration substance was applied into eye. Conjuctivae redness of scores up to 2 and chemosis of scores of 1 were observed within the first three days of the observation period. The observed effects were fully reversible within 7 days of observation period.
No classificaiton is warranted for the registration substance according to the OECD GHS criteria.
Justification for selection of skin irritation / corrosion endpoint:
Scientifically well performed and well documented Guideline study performed under GLP.
Justification for selection of eye irritation endpoint:
Scientifically well performed and well documented Guideline study performed under GLP.
Effects on skin irritation/corrosion: irritating
Justification for classification or non-classification
For the skin irritation/corrosion property the registration substance should be classified as Cat 2, H315.
For the eye irritation, no classification is warranted.
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