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Administrative data

Endpoint:
acute toxicity: dermal
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 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

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
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
3/sex
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

No compound-related findings were observed with regard to clinical and local observations, determination of body weight and post mortem examination in all male animals and in 2 out of 3 animals. One female animal showed hair loss at the fore- and hind leg from day 15 onwards. Microscopical examination revealed no pathological alteration in the skin.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 of ethisterone > 2000 mg/kg, therefore classification is not required.
Executive summary:

The single dermal administration of ethisterone to male and female rats in the doses of 2000 mg/kg resulted in hair loss in 1/3 female rat. No other compound-related clinical or macroscopic pathological signs were observed. LD50 > 2000 mg/kg