Registration Dossier
Registration Dossier
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EC number: 213-552-4 | CAS number: 976-70-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 25. Sep to 12. Oct 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- combined acute toxicity and local tolerance study
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-oxopregn-4-ene-21,17α-carbolactone
- EC Number:
- 213-552-4
- EC Name:
- 3-oxopregn-4-ene-21,17α-carbolactone
- Cas Number:
- 976-70-5
- Molecular formula:
- C22H30O3
- IUPAC Name:
- (1R,3aS,3bR,9aR,9bS,11aS)-9a,11a-dimethyl-2,3,3a,3b,4,5,7,8,9,9a,9b,10,11,11a-tetradecahydrospiro[cyclopenta[a]phenanthrene-1,2'-oxolane]-5',7-dione
- Details on test material:
- - Name of test material (as cited in study report): aldona (ZK 57564)
- Analytical purity: 95.5% HPLC
- Impurities (identity and concentrations):
- Lot/batch No.: 59035042
- Expiration date of the lot/batch: Aug 2002
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: 0.5% (m/v) Tylose MH 1000
- Controls:
- no
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 14 days
- Number of animals:
- 3/sex
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Score:
- ca. 0
- Other effects:
- None of the animals showed alterations of the skin at the application sites.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- not irritant, no classification required
- Executive summary:
In the acute dermal toxicity study in rats (3/sex) no signs of skin irritation could be identified; non-irritant
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