Registration Dossier
Registration Dossier
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EC number: 304-925-3 | CAS number: 94291-97-1
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Oct 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
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
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3,3-[(2,2-dimethylpropane-1,3-diyl)bis(oxy)]-17α-hydroxyestr-5(10)-ene-17-carbonitrile
- EC Number:
- 304-925-3
- EC Name:
- 3,3-[(2,2-dimethylpropane-1,3-diyl)bis(oxy)]-17α-hydroxyestr-5(10)-ene-17-carbonitrile
- Cas Number:
- 94291-97-1
- Molecular formula:
- C24H35NO3
- IUPAC Name:
- 3,3-(2,2-Dimethyltrimethylenedioxy)-17 alpha-hydroxy-5(10)-estrene-17 beta-carbonitrile
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
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 animal died in the course of the study.
At 2000 mg/kg an encrusted, reddened nose was observed in the three male and in one of the three female animals at 3 hours after substance administration.
One female animal did not gain body weight during the entire study period. As all other animals did not show this effect, the significance of the finding remains unclear.
Autopsy revealed no compound-related findings.
Applicant's summary and conclusion
- Executive summary:
A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, effects on body weight gain and gross pathological findings. Clinical signs (encrusted, reddened nose) were observed 3 hours after administration in both genders. According to OECD TG 402 the dermal LD50 of ZK 30367 is therefore > 2000 mg/kg body weight.
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