Registration Dossier
Registration Dossier
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EC number: 270-109-8 | CAS number: 68411-20-1
Endpoint summary
Administrative data
Description of key information
A valid skin irritation/corrosion and eye irritation study is available.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and sufficient documented
- Principles of method if other than guideline:
- 2 white New-Zealand rabbits were treated onto the inside of the ear with ca. 500 µl of the test substance. The test item remained under semiocclusion for 24 hours. After exposition the test substance was removed with water and soap/oliveoil. Treated animals were inspected for skin effects (erythema, oedema) after removal of plaster and after 2 days.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 2 days
- Number of animals:
- 2 animals (1 male + 1 female)
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 0 hr (after removal of plaster)
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- other: no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 0 hr (after removal of plaster)
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- other: no data
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 4
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 4
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- no data
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at 0 h (removal of plaster) and 48 h
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Remarks on result:
- not measured/tested
- Other effects:
- no data
- Interpretation of results:
- GHS criteria not met
- Executive summary:
Two white New-Zealand rabbits were treated onto the inside of the ear with ca. 500 µl of the test substance. The test item remained under semiocclusion for 24 hours. After exposition the test substance was removed with water and soap/oliveoil. Treated animals were inspected for skin effects (erythma, oedema) after removal of plaster and after 2 days.
Erythema score after removal of the test substance by washing and after 48 hours was 1.5 of 4. No edema was seen.
Therefore a classification is not justified.
Reference
No edema was seen at 0 h (removal of test substance) and 48 hours
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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:
- other: scientifically acceptable and sufficient documented
- Principles of method if other than guideline:
- One male and one female New Zealand white rabbit, 50 mg of the test substance/rabbit was applied into the conjunctival sac of one eye of each rabbit. The observation time was 7 days. Evaluation of effects according to Draize.
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2 animals (1 male + 1 female)
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: score = 0 at any time point
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
- Other effects:
- no data
- Interpretation of results:
- GHS criteria not met
- Executive summary:
One male and one female New Zealand white rabbit, 50 mg of the test substance/rabbit was applied into the conjunctival sac of one eye of each rabbit. The observation time was 7 days. Evaluation erythema and edma according to Draize.
The cornea and iris score was 0 at any time point. The conjunctiva and chemosis score was 0.2 out of 3 and 4, respectively.
Therefore a classification is not justified.
Reference
no data
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the skin irritation/corrosion study 2 white New-Zealand rabbits were treated onto the inside of the ear with ca. 500 µl of the test substance. The test item remained under semiocclusion for 24 hours. After exposition the test substance was removed with water and soap/oliveoil. Treated animals were inspected for skin effects (erythma, oedema) after removal of plaster and after 2 days.
Erythema score after removal of the test substance and after 48 hours was 1.5 of 4. No edema was seen.
In the eye irritation study one male and one female New Zealand white rabbit, 50 mg of the test substance/rabbit was applied into the conjunctival sac of one eye of each rabbit. The observation time was 7 days. Evaluation of effects according to Draize.
The cornea and iris score was 0 at any time point. The conjunctiva and chemosis score was 0.2 out of 3 and 4, respectively.
Justification for selection of skin irritation / corrosion
endpoint:
key study is used
Justification for selection of eye irritation endpoint:
key study is used
Justification for classification or non-classification
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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