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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study design not sufficient for examination of effects on fertility in male rats, e.g. short exposure period, one dose, only 3 rats treated (result section only 2 rats), no controls, limited documentation

Data source

Reference
Reference Type:
publication
Title:
Male antifertility compounds: structure and activity relationships of U-5897, U-15,646 and related substances
Author:
Ericsson RJ and Youngdale GA
Year:
1970
Bibliographic source:
J Reprod Fert 21: 263-266

Materials and methods

Principles of method if other than guideline:
Fertility of male rats after repeated oral exposure.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no details

Test animals

Species:
rat
Strain:
not specified
Sex:
male
Details on test animals and environmental conditions:
Source: Spartan or Upjohn; body weight 300+-25g.
No further data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 0.25% methylcellulose in sterile water
Details on exposure:
Only successfully mated rats were used; rats received once daily 30 mg/rat for 8 days; test substance in 0.5 ml vehicle.
Details on mating procedure:
Oestrous females caged overnight (Day 8) with test males and then checked for evidence of mating (spermatozoa in vagina and/or vaginal plugs) . Males which did not mate were given another opportunity the following night.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Premating exposure period (males): 8 days
premating exposure period (females): no exposure
Frequency of treatment:
once daily
Details on study schedule:
Antifertility activity was assessed in terms of implantation sites found in mated females on Day 9 or 10 of gestation.
Doses / concentrations
Remarks:
Doses / Concentrations:
30 mg/rat corresponding to 100 mg/kg bw
Basis:

No. of animals per sex per dose:
3 males
Control animals:
not specified
Details on study design:
no data
Positive control:
Active substances in parallel trials but also only 3 rats per substance.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
not specified

Overall reproductive toxicity

Reproductive effects observed:
not specified

Any other information on results incl. tables

One treated male rat produced 13 implants in the female, no successful mating was observed in a 2nd; no data were given on the 3rd treated male. Authors comment: the test substance is inactive.

No further data were given.

Applicant's summary and conclusion

Conclusions:
In an invalid study in male rats no effects were observed on fertility at a dose of 30 mg/rat for 8 days (ca. 100 mg/kg bw/day).
Executive summary:

The study design is not sufficient for examination of effects on fertility in male rats.

Three male rats received via gavage 30 mg/rat once daily for 8 days. The males were then mated with oestrus females. Antifertility activity was assessed in terms of implantation sites found in mated females on Day 9 or 10 of gestation. One treated male rat produced 13 implants in the female, no successful mating was observed in a 2nd; no data were given on the 3rd treated male. Authors comment: the test substance is inactive. No further data were given.

Conclusion: In an invalid study in male rats no effects were observed on fertility at a dose of 30 mg/rat for 8 days (ca. 100 mg/kg bw/day).