Registration Dossier
Registration Dossier
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EC number: 617-345-3 | CAS number: 82543-14-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Aug to Sep 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 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class 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
- Route of administration:
- oral: gavage
- Vehicle:
- other: physiol. saline + Myrj 53
- Doses:
- 2000 mg/kg
- 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. No compound-related findings were observed in neither clinical observation nor body weight gain nor autopsy.
One male showed thinning of the fur on the back from day 7 to 12, but this was not considered to be compound-related because this is a known spontaneous finding in rats.
Applicant's summary and conclusion
- Executive summary:
The single oral 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 compound-related clinical or macroscopic pathological signs. The acute oral toxicity of Enpivalat in rats is therefore above 2000 mg/kg body weight.
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