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Diss Factsheets

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
publication
Title:
In Vivo Micronucleus Test of Methylcyclopentane and 1,4-Dichlorobutane
Author:
Kyung-Taek Rim
Year:
2011
Bibliographic source:
J. of the Korea Society for Environmental Analysis, 2:89-93

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Version / remarks:
1997
GLP compliance:
not specified
Type of assay:
other: Mouse bone marrow micronucleus test

Test material

Constituent 1
Test material form:
liquid
Details on test material:
Provider: Sigma, St Louis MO, USA, Lot No. 1323541

Test animals

Species:
mouse
Strain:
ICR
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS:
- Strain: Mouse / ICR
- Number and sex: 24 males (6 per group)
- Breeder: Japan SLC Inc., Shizuoka, Japan
- Age: 7 weeks

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Duration of treatment / exposure:
single oral administration, test was condcuted 24 h after treatment
Frequency of treatment:
once
Post exposure period:
24 h
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
500 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
Dose / conc.:
2 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
6
Control animals:
yes
Positive control(s):
yes, Mitomycin C

Examinations

Tissues and cell types examined:
bone marrow cells
Details of tissue and slide preparation:
The femur was used for the preparation of bone marrow cells. Therefore, bone marrow was flushed from the femurs and spread onto slides. The slides were air-dried, fixed with ethanol, and stained with a fluorescent DNA specific stain.
Statistics:
One way Analysis of Variance (ANOVA, P<0.001) test and Dunnett's Method (P<0.05) using SigmaStat v. 3.11.

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Under the conditions tested, 1,4-dichlorobutane does not have mutagenic potential on bone marrow cells of mice.