Registration Dossier
Registration Dossier
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EC number: 617-707-0 | CAS number: 85390-93-8
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- May 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:
- 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one
- EC Number:
- 617-707-0
- Cas Number:
- 85390-93-8
- Molecular formula:
- C19 H28 O4
- IUPAC Name:
- 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one
- Details on test material:
- - Name of test material (as cited in study report): ZK 91535
- Batch No.: EW320/98A
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Vehicle:
- physiological saline
- 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.
After administration of ZK 91535 skin discoloration was observed in all animals at the application site. This effect was reversible 48 hours after termination of treatment and was most probably caused by the intensive green color of the compound. No local intolerance reactions (reddening and/or scab formation; swelling) were observed at the application sites .
Applicant's summary and conclusion
- Executive summary:
The single dermal administration of the test substance 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one (ZK 91535) 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 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one in rats is therefore above 2000 mg/kg body weight.
ZK 91535 caused discoloration of the skin at the application site but this effect was reversible within 48 hours and most probably due to the intensive green color of the test compound. No local intolerance reactions at the application sites were observed.
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