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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
27. Jan to 23. Feb 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well reported GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethisterone
EC Number:
207-096-5
EC Name:
Ethisterone
Cas Number:
434-03-7
Molecular formula:
C21H28O2
IUPAC Name:
(1R,3aS,3bR,9aR,9bS,11aS)-1-ethynyl-1-hydroxy-9a,11a-dimethyl-1H,2H,3H,3aH,3bH,4H,5H,7H,8H,9H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-7-one
Details on test material:
- Name of test material (as cited in study report): ethisterone (ZK 4957)
- Analytical purity: 100.1%
- Lot/batch No.: 8115-13/08
- Expiration date of the lot/batch: 22 Oct 2011

Test animals

Species:
rat
Strain:
Wistar

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period:
21 days
Number of animals:
3/sex

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Other effects:
Loss of hair was noted in one out of three female animals at fore- and hind leg from day 15 onwards.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Ethisterone is not irritating to the skin, therefore classifiaction is not required.
Executive summary:

The single dermal administration of ethisterone(ZK 4957) to male and female rats in the doses of 2000 mg/kg was tolerated without any local skin irritations.