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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:
2001
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

Constituent 1
Chemical structure
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

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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