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Registration Dossier
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EC number: 200-164-5 | CAS number: 53-16-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29. Sep to 02. Nov 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-methoxyoestra-1,3,5(10)-trien-17-one
- EC Number:
- 216-613-3
- EC Name:
- 3-methoxyoestra-1,3,5(10)-trien-17-one
- Cas Number:
- 24508-10-9
- Molecular formula:
- C19 H24 O2
- IUPAC Name:
- 3-methoxy-1,3,5(10)-estratriene-17β-ol
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Solubility and stability of the test substance in the solvent/vehicle: The mycrorystalline suspensions were prepared fresh on application day for immediate application and administrations were carried out within approximately 2 hours after preparation. The stability of the test item was verified analytically. In addition all samples are considered prepared correctly with regard to the results of analysis.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Miglyol 812
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3/sex
- 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.
- Mortality:
- no mortality
- Clinical signs:
- other: Transient clinical signs (apathy and atactic gait). All animals were without treatment-related findings from day 2 onwards.
- Gross pathology:
- no effects observed
Applicant's summary and conclusion
- Interpretation of results:
- other: no substance related mortality observed
- Conclusions:
- The acute oral toxicity of estrone-methylether in rats is above 2000 mg/kg body weight.
- Executive summary:
The single oral administration of estrone-methylether to male and female Wistar rats at the dose of 2000 mg/kg resulted in transient clinical signs (apathy and atactic gait). All animals were without treatment-related findings from Day 2 onwards. No compound-related macroscopic findings were seen. The acute oral toxicity of estrone-methylether in rats is above 2000 mg/kg body weight.
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