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Toxicological information

Developmental toxicity / teratogenicity

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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:
1975
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

Constituent 1
Chemical structure
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

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.