Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
not specified
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
castor oil
Remarks:
with benzyl benzoat
Analytical verification of doses or concentrations:
no
Details on mating procedure:
no data
Duration of treatment / exposure:
treatment on day 0 and 4 of pregnancy
Frequency of treatment:
once/day
Duration of test:
no data
No. of animals per sex per dose:
Groups of 21, 20 or 19 pregnant rats
(21 animals for control)
Control animals:
yes, concurrent vehicle

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
NOEL
Effect level:
> 200 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:
> 200 mg/kg bw/day
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Gestonorone caproate was not teratogenic in rats
Executive summary:

No developmental toxicity studies were conducted with ZK 5624 (gestonorone acetate). Results of studies conducted with a different ester of gestonorone (ZK 5623, gestonorone caproate) are regarded as representative as most likely ester cleavage occurs in vivo after administration.

The effect of gestonorone caproate (ZK 5623) on early embryonic development was studied in rats after subcutaneous administration of doses of 0/ 2/ 20/ 200 mg/kg on Days 0 and 4 p.c. No effects on pregnancy and embryo-fetal development were seen in this study.