Registration Dossier
Registration Dossier
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EC number: 617-708-6 | CAS number: 85390-94-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Jun to 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:
- equivalent or similar 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:
- 7 beta-Hydroxy-3 beta,15 alpha-dipivaloyloxy-5-androsten-17-one
- EC Number:
- 617-708-6
- Cas Number:
- 85390-94-9
- Molecular formula:
- C29 H44 O6
- IUPAC Name:
- 7 beta-Hydroxy-3 beta,15 alpha-dipivaloyloxy-5-androsten-17-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 92136
- Batch No.: 21604812
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- paraffin oil
- 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 compound-related findings were observed in neither clinical observation nor body weight gain nor 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 92136) to male and female rats at a dose of 2000 mg/kg was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The acute dermal toxicity of Dipivalat in rats is therefore above 2000 mg/kg body weight.
No local intolerance reactions at the application sites were observed.
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