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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Type of information:
migrated 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:
other: limited study report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: FDA requirements of Jan 1966
Principles of method if other than guideline:
Metenolone was applied orally to female rabbits on day 6 to 18 p.c. in the doses of 0, 1, 3 and 10 mg/kg. All dams and fetuses were examined macroscopically.
Study procedure and evaluation corresponds to FDA requirements of Jan. 1966
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
- Name of test material (as cited in study report): metenolone acetate (ZK 5469)

Test animals

Species:
rabbit
Strain:
New Zealand White

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Traganth 0.5%
Analytical verification of doses or concentrations:
no
Details on mating procedure:
no data
Duration of treatment / exposure:
13 days, from day 6 to 18 p.c.
Frequency of treatment:
daily
Duration of test:
not specified
Doses / concentrations
Remarks:
Doses / Concentrations:
1, 3 and 10 mg/kg
Basis:
actual ingested
No. of animals per sex per dose:
13 inseminated females/dose
Control animals:
yes, concurrent vehicle

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
LOAEL
Effect level:
>= 1 mg/kg bw/day
Based on:
test mat.
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:
>= 10 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
other: teratogenicity

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

reduced body weight gain in dams in all dose groups

Applicant's summary and conclusion

Conclusions:
No effects on fetuses
Executive summary:

There is no teratogenicity study with ZK 5466 (metenolone). Results of the study with metenolone acetate (ZK 5469) are regarded as representative as most likely ester cleavage occurs in vivo.

After oral administration of metenolone acetate to pregnant rabbits on pregnancy day 6 to 18 in the doses of 0, 1, 3 and 10 mg/kg bw no substance-related findings besides decreased body weight gain in dams (>= 10 mg/kg) was observed.