Registration Dossier
Registration Dossier
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EC number: 200-164-5 | CAS number: 53-16-7
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: FDA recommendations of 66
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Estradiol
- EC Number:
- 200-023-8
- EC Name:
- Estradiol
- Cas Number:
- 50-28-2
- Molecular formula:
- C18H24O2
- IUPAC Name:
- estra-1,3,5(10)-triene-3,17-diol
- Details on test material:
- - Name of test material (as cited in study report): estradiol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
Administration / exposure
- Route of administration:
- subcutaneous
- Vehicle:
- castor oil
- Analytical verification of doses or concentrations:
- no
- Details on mating procedure:
- - M/F ratio per cage: 1/4 ratio
- Proof of pregnancy: vaginal plug and sperm referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 20 days
- Frequency of treatment:
- daily from day 6 to day 15 post coitum
- Duration of test:
- ca. 3 weeks
- No. of animals per sex per dose:
- 20 females/group
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOEL
- Effect level:
- > 0.001 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOEL
- Effect level:
- > 0.001 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No teratogenicity and maternal toxicity up to the highest dose level observed. No classification required.
- Executive summary:
Pregnant rats were treated subcutaneously with estradiol from day 6 to day 15 p.c. On day 19 the animals were sacrificed and dams and fetuses examined. No teratogenicity and maternal toxicity up to the highest dose level of 0.001 mg/kg observed. Classification of estradiol is not required.
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