Registration Dossier
Registration Dossier
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EC number: 201-070-7 | CAS number: 77-93-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study not under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. Department of Transportation, 49 CFR 173.136-137
- Principles of method if other than guideline:
- U.S. Department of Transportation skin irritation method, 49 CFR 173: up to 4 hour occlusive exposure, observation to 48 hours or through 14 days., if needed.
- GLP compliance:
- no
Test material
- Reference substance name:
- Triethyl citrate
- EC Number:
- 201-070-7
- EC Name:
- Triethyl citrate
- Cas Number:
- 77-93-0
- Molecular formula:
- C12H20O7
- IUPAC Name:
- triethyl citrate
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- 0.5ml per test site was applied.
- Duration of treatment / exposure:
- 3 minutes, 60 minutes, and 4 hours.
- Observation period:
- 30 to 60 minutes, and 48 hours.
- Number of animals:
- 6
- Details on study design:
- The test substance (0.5mL/site) was applied to 3 intact skin sites then covered with gauze patches. The test material was kept in contact with the skin for 3 minutes, 60 minutes and 4 hours. The sites were washed with sterile water for injection following the exposure period to prevent further contact with the test article. The test sites were scored for erythema, edema, and/or corrosion at 30 to 60 minutes and 48 hours post exposure.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: qualitative summary of results
- Basis:
- mean
- Time point:
- other: all time points
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- other: No corrosion seen at any test site.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: U.S. Department of Transportation
- Conclusions:
- Irreversible alteration or destruction of the tissue did not occur at any of the test sites. The test article is not corrosive to the skin of albino rabbits according to the DOT guidelines.
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