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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
other information
Study period:
Jul 1998
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:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
3 instead of 5 animals/sex used according to acute-toxic-class-method (OECD 423)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5-Hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androst-6-en-17-one
EC Number:
617-345-3
Cas Number:
82543-14-4
Molecular formula:
C25 H36 O4
IUPAC Name:
5-Hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androst-6-en-17-one
Details on test material:
- Name of test material (as cited in study report): ZK 90504
- Batch No.: 21608604

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Vehicle:
water
Remarks:
bidest. water
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
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 mortalities occurred. Shortly after dermal administration of ZK 90504 hyperactivity, vocalization and disturbances in gait were observed in female animals, whereas the male animals were without findings over the whole study period. All animals were without

compound-related findings from 3 hours after administration onwards. No compound-related findings were observed in body weight gain or autopsy.

No local intolerance reactions at the application sites were observed.

Applicant's summary and conclusion

Executive summary:

The single dermal administration of the test substance (ZK 90504) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality or macroscopic pathological signs. Shortly after administration females showed some clinical signs such as hyperactivity, vocalization and spastic gait. No compound-related clinical signs were observed in females from 3 hours after administration onwards, males were without findings over the whole study period. The acute dermal toxicity of Enpivalat in rats is therefore above 2000 mg/kg body weight.

No local intolerance reactions at the application sites were observed.

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