Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
A Study of Micronucleus Induction with Methyl Formate and 2-Methylbutane in Bone Marrow Cells of Male ICR Mice
Author:
Soo-Jin KIM, Kyung-Taek RIM, Min-Gu KANG, Jong-Kyu KIM, Yong-Hyun CHUNG and Jeong-Sun YANG
Year:
2010
Bibliographic source:
Safety and Health at Work

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
not specified
Type of assay:
mammalian erythrocyte micronucleus test

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl formate
EC Number:
203-481-7
EC Name:
Methyl formate
Cas Number:
107-31-3
Molecular formula:
C₂H₄O₂
IUPAC Name:
methyl formate
Test material form:
liquid

Test animals

Species:
mouse
Strain:
ICR
Sex:
male

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
Olive oil
Duration of treatment / exposure:
24 hours
Doses / concentrationsopen allclose all
Dose / conc.:
250 mg/kg bw/day (nominal)
Dose / conc.:
500 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
6
Control animals:
yes, concurrent vehicle
Positive control(s):
Mitomycin C (0,5 mg/kg bw)

Examinations

Tissues and cell types examined:
2,000 polychromatic erythrocytes of bone marrow (PCEs, reticulocytes; immature erythrocytes) were scored per animal for the frequency of micronucleated cells in each of the 6 animals per dosage group
Details of tissue and slide preparation:
Bone marrow cells were obtained from the femurs immediately following sacrifice.
Evaluation criteria:
Cells were considered to be micronucleated when they neatly contained defined chromatin corpuscles with a diameter of less than one-third the diameter of the cell nucleus and stained equal or lighter than the nucleus of the cell from which the micronucleated cell was developed with a DNA specific fluorescence dye.
Statistics:
The experimental and control micronucleus frequency within and between the different dose groups were compared with the One Way ANOVA test and the Kruskal-Wallis tests (α=0.05).

Results and discussion

Test results
Key result
Sex:
male
Genotoxicity:
negative
Toxicity:
no effects
Vehicle controls validity:
not specified
Negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative