17-hydroxy-19-norpregn-4-ene-3,20-dione 17-acetate

Toxicity to reproduction

Administrative data

Endpoint:

two-generation reproductive toxicity

Remarks:

based on test type (migrated information)

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:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 416 (Two-Generation Reproduction Toxicity Study)

Deviations:

not specified

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Gestonorone caproate

EC Number:

215-010-2

EC Name:

Gestonorone caproate

Cas Number:

1253-28-7

Molecular formula:

C26H38O4

IUPAC Name:

17-acetyl-3-oxoestr-4-en-17-yl hexanoate

Test animals

Species:

mouse

Strain:

NMRI

Sex:

female

Administration / exposure

Route of administration:

subcutaneous

Vehicle:

not specified

Details on mating procedure:

no data

Analytical verification of doses or concentrations:

no

Duration of treatment / exposure:

14 days

Frequency of treatment:

1, 7 and 14 day of pregnancy

Details on study schedule:

Age at mating of the mated F1 animals in the study: 60 -80 days

Doses / concentrations

Remarks:

Doses / Concentrations:
0.3 mg/animal (ca. 12 mg/kg)
Basis:
no data

No. of animals per sex per dose:

20 /sex/group

Control animals:

yes, concurrent vehicle

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Dose descriptor:

NOEL

Effect level:

> 12 mg/kg bw/day

Sex:

female

Overall reproductive toxicity

Reproductive effects observed:

not specified

Any other information on results incl. tables

There were no compound-related findings in this study.

Applicant's summary and conclusion

Conclusions:

no substance related effect on reproduction

Executive summary:

No reproductive 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.

In this study in mice, the effect of gestonorone caproate (ZK 5623) on embryofetal development including peri/ postnatal development of F1 generation and embryonic develoment of F2 generation was studied after subcutaneous administraton on Days 1, 7 and 14 p.c. at a dose of 0.3 mg/animal (appr. 12 mg/kg). There were no compound-related findings in this study. ZK 5623 was not teratogenic.