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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Toxicity to reproduction

Currently viewing:

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

Constituent 1
Chemical structure
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.