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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
24. Jun to 13. Jul 1998
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): adrostanolone acetate (5180)
- Lot/batch No.: 11630702

Test animals

Species:
rat
Strain:
Wistar

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
24 hours
Observation period:
14 days
Number of animals:
3/sex

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1, 24, 48, 75 hours
Score:
0
Reversibility:
other: not appropriate
Other effects:
no

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Androstanolone acetate is not skin irritating
Executive summary:

After single dermal administration of androstanolone acetate (ZK 5180) to 3 male and 3 female rats at a dose of 570 -594 mg/male rat and 436 -448 mg/female rat of the original compound, no compound related local findings were observed after removing of the bandages at the time points 1, 24, 48 and 72 hours.