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Toxicological information

Genetic toxicity: in vivo

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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 / concentrationsopen allclose all
Dose / conc.:
0 other: % of the diet by weight
Dose / conc.:
5 other: % of the diet by weight
Dose / conc.:
10 other: % of the diet by weight
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.