Registration Dossier
Registration Dossier
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EC number: 401-990-0 | CAS number: 106990-43-6 CHIMASSORB 119; LOWILITE 19
Endpoint summary
Administrative data
Description of key information
The skin irritation potential was investigated following the EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion).
The eye irritation potential was investigated following the EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion).
Both studies were performed more than 12 years ago, under GLP conditions.
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:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Vehicle:
- other: 0.5 g of the test substance moistened with tap water and 2 to 3 drops of TWEEN 80 were applied to the intact skin and covered with a surgical gauze.
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4h
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not classified as irritating to the skin.
Reference
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
- Study period:
- 1987
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Amount / concentration applied:
- 100 MG
- Number of animals or in vitro replicates:
- 3
- Remarks on result:
- other: At one hour a score of one was seen in one animal. No inflammation was observed between 24 and 72 hours.
- Other effects:
- At one hour a score of one was seen in one animal. No inflammation was observed between 24 and 72 hours.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance is not classificed as irritating to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Only one study available
Justification for selection of eye irritation endpoint:
Only one study available
Justification for classification or non-classification
No significant signs of irritation are observed in eye and dermal irritation studies in rabbit.
The test substance does not required classification for irritation potential.
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