2-chloroethanol

Toxicity to reproduction

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

Test material information

Constituent 1

Reference substance name:

2-chloroethanol

EC Number:

203-459-7

EC Name:

2-chloroethanol

Cas Number:

107-07-3

Molecular formula:

C2H5ClO

IUPAC Name:

2-chloroethan-1-ol

Details on test material:

no details

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system 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).