Registration Dossier
Registration Dossier
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EC number: 607-988-8 | CAS number: 2668-75-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
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)
- Principles of method if other than guideline:
- combined acute dermal toxicity and local irritation study
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 17-Acetoxy-1,4,6-pregnatriene-3,20-dione
- EC Number:
- 607-988-8
- Cas Number:
- 2668-75-9
- Molecular formula:
- C23 H28 O4
- IUPAC Name:
- 17-Acetoxy-1,4,6-pregnatriene-3,20-dione
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- 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
- Key result
- 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 animal died in the course of the study. A single dermal application of the limit dose was tolerated without compound-related findings. The body weight gain on days 7 and 14 was within the normal range for rats of this age and strain. On day 14 all surviving animals were sacrificed without showing any compound-related clinical findings. Autopsy also revealed no compound-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test item is of low acute dermal toxicity
- Executive summary:
A single dermal administration of the test substance (ZK 5560) to male and female rats at the limit-dose (2000 mg/kg) was tolerated without mortalities and moreover, without compound-related findings. The body weight gain on days 7 and 14 was within the normal range for rats of this age and strain. On day 14 all surviving animals were sacrificed without showing any compound-related clinical findings. Autopsy also revealed no compound-related findings. The acute dermal toxicity of the substance in rats is therefore above 2000 mg/kg body weight.
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