Registration Dossier
Registration Dossier
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EC number: 680-602-3 | CAS number: 98133-47-2
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- September 1978
- Reliability:
- 4 (not assignable)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Bandmann's method
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3-(acetyloxy)-1-{[3-(acetyloxy)propyl]carbamoyl}-2,2-dimethylpropyl acetate
- Cas Number:
- 98133-47-2
- Molecular formula:
- C15H25NO7
- IUPAC Name:
- 3-(acetyloxy)-1-{[3-(acetyloxy)propyl]carbamoyl}-2,2-dimethylpropyl acetate
- Reference substance name:
- Reference substance 001
- Cas Number:
- 25322-68-3
- Test material form:
- liquid
Constituent 1
Constituent 2
Test animals
- Species:
- other: human
- Strain:
- other: human
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact skin
- Vehicle:
- other: Polyglycol P-4000
- Controls:
- not required
- Amount / concentration applied:
- 10%
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 48 hours
- Number of animals:
- 50 subjects
- Details on study design:
- Patch test on 50 subjects. 0.1g of preparation was applied via a chamber and occluded with a plaster to human skin for 24 hours. Observations were made after 2 and 48 hours
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- other: overall evaluation
- Time point:
- 24/48 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- other: overall evaluation
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- other: overall evaluation
- Time point:
- 24/48/72 h
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No reaction observed under the given test conditions
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 10% test substance in Polyglycol 4000 showed no irritation in a human patch test. The preparation has an excellent skin tolerance.
- Executive summary:
10% test substance in Polyglycol 4000 showed no irritation in a human patch test. The preparation has an excellent skin tolerance.
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