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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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

Constituent 1
Chemical structure
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).