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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jun to Jul 1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well reported GLP study with acceptable restrictions

Data source

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

Materials and methods

Principles of method if other than guideline:
combined acute dermal toxicity and local irritation study; single dermal application of test substance (application volume 0.55 - 0.8 ml) to male and female rats; exposure for 24 hours; values for reddening, scab formation and swelling of the skin obtained 1 h after removal of the bandage and the substance and 24, 48 and 72 h after the end of administration.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
7α-bromo-5,6β-epoxy-15β,16β-methylene-3β-pivaloyloxy-5β-androstan-17-one
EC Number:
617-834-1
Cas Number:
863329-69-5
Molecular formula:
C25H35BrO4
IUPAC Name:
7α-bromo-5,6β-epoxy-15β,16β-methylene-3β-pivaloyloxy-5β-androstan-17-one
Details on test material:
- Name of test material (as cited in study report): ZK 137314
- Batch No.: 21608213

Test animals

Species:
rat
Strain:
Wistar

Test system

Preparation of test site:
not specified
Vehicle:
physiological saline
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: 24, 48 and 72 hours
Score:
0
Max. score:
0
Other effects:
No compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.

Applicant's summary and conclusion

Executive summary:

The single dermal administration of Bromepoxid to male and female rats at the dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The test substance was tolerated without any local skin irritations.