Registration Dossier
Registration Dossier
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EC number: 609-222-8 | CAS number: 3625-82-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- August 2002
- 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:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Considering the new approach to acute toxicity testing of chemicals described in OECD guideline no.423
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-Methoxy-18-methyl-1,3,5(10)-estratrien-17 beta-ol
- EC Number:
- 609-222-8
- Cas Number:
- 3625-82-9
- Molecular formula:
- C20 H28 O2
- IUPAC Name:
- 3-Methoxy-18-methyl-1,3,5(10)-estratrien-17 beta-ol
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Shoe: WIST (SPF)
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- 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 animal died in the course of the study. No clinical findings were observed after single dermal administration of 2000 mg/kg. In the first week after treatment, a decrease in body weight gain or a body weight loss was observed in both sexes, which was not fully compensated until day 14. Autopsy revealed no compound-related findings.
Applicant's summary and conclusion
- Executive summary:
The dermal administration of 2000 mg/kg caused a decrease in body weight in both, male and female rats, but no other signs of toxicity. According to OECD TG 402 taking into consideration the approach described in OECD guideline no. 423 the dermal LD50 is therefore > 2000 mg/kg body weight.
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