Registration Dossier
Registration Dossier
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EC number: 617-345-3 | CAS number: 82543-14-4
Acute Toxicity: dermal
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:
- 1 998
- 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
- Reference substance name:
- 5-hydroxy-15β,16β-methylene-3β-pivaloyloxy-5β-androst-6-en-17-one
- EC Number:
- 617-345-3
- Cas Number:
- 82543-14-4
- Molecular formula:
- C25H36O4
- IUPAC Name:
- 5-hydroxy-15β,16β-methylene-3β-pivaloyloxy-5β-androst-6-en-17-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 90504
- Batch No.: 21608604
Constituent 1
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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