3-methoxybutyl acetate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Remarks:

Dominant Lethal Assay

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

to support read across

Data source

Reference

Reference Type:

publication

Title:

Reproductive and teratology study of 1,3-butanediol in rats

Author:

Frederick G. Hess Jr, George E. Cox, David E. Bailey, Richard A. Parent and Peter J. Becci

Year:

1981

Bibliographic source:

Journal of Applied Toxicology, Vol 1, No 4

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Method of Epstein and Shafner

GLP compliance:

not specified

Type of assay:

rodent dominant lethal assay

Test material

Specific details on test material used for the study:

1,3-butanediol was obtained from Celanese Chemical Company

Test animals

Species:

rat

Strain:

Wistar

Details on species / strain selection:

FDRL-stock

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 14-15 weeks
- Housing: Individually except during mating
- Diet: Semi-purified diet ad libitum (20% casein, 8% refined corn oil, 4% salt mix, 1% vitamin mix, 33.5% corn starch, 33.5% dextrose)
- Water: tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 22±2°C
- Photoperiod: 12 hrs dark / 12 hrs light

Administration / exposure

Route of administration:

oral: feed

Details on exposure:

Males were fed with 0, 5, 10, 24% of 1,3-butanediol in the diet. 1,3-butanediol was substituted in the diet for equal amounts by weight of corn starch and dextrose.

Duration of treatment / exposure:

8 consecutive weeks

Frequency of treatment:

daily

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 other: % of the diet by weight

Doses / concentrations 2

Dose / conc.:

5 other: % of the diet by weight

Doses / concentrations 3

Dose / conc.:

10 other: % of the diet by weight

Doses / concentrations 4

Dose / conc.:

24 other: % of the diet by weight

No. of animals per sex per dose:

ten males per group and two females per male or 40 females per group

Positive control(s):

Not available

Examinations

Tissues and cell types examined:

examination of the reproductive tract

Evaluation criteria:

Mutabenic index according to the methid of Epstein and Shafner

Results and discussion

Test results

Sex:

female

Genotoxicity:

negative

Toxicity:

no effects

Additional information on results:

The mutagenic index (resoption as a percentage of implant sites) showed not dose-response.

Applicant's summary and conclusion

Conclusions:

Not Mutagenic In Vivo.

Executive summary:

1,3 -butanwdiol was evaluated in a dominant lethal assay in Wistar rats. 10 males per group from the second series of litters were reared to sexual maduration. Males were housed individually in a mating cage. Two virgin 100-day old females were left in the cage for 7 days. Then females were housed for an additional 7 days and sacrificed for examination of the reproductive tract. The number of implants and/or resoprtion sites and viable and dead fetuses were recorded. The mutagenic index was calculated. No mutagenic effects were determined.