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Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Referenceopen allclose all

Title:
No information
Author:
Ministry of Health and Welfare, Japan
Year:
1997
Bibliographic source:
Ministery of Health and Welfare, Japan, Toxicity Testing Reports of Environmental Chemicals 5, 359-385 (1997)
Title:
No information
Author:
OECD
Year:
1999
Bibliographic source:
OECD SIDS for glycidyl methacrylate, December 1999

Materials and methods

Test guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-epoxypropyl methacrylate
EC Number:
203-441-9
EC Name:
2,3-epoxypropyl methacrylate
Cas Number:
106-91-2
Molecular formula:
C7H10O3
IUPAC Name:
oxiran-2-ylmethyl methacrylate
Details on test material:
Produced by Japan Oil Ltd, Lot No. 50905Y
Purity 99.93%

Test animals

Species:
mouse
Strain:
DBF1
Sex:
male/female
Details on test animals or test system and environmental conditions:
Age at study initiation was 9 weeks old.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Duration of treatment / exposure:
48 hours
Frequency of treatment:
one single dose
Doses / concentrations
Remarks:
Doses / Concentrations:
Male: 188, 375 and 750 mg/kg. Female 250, 500 and 1000 mg/kg
Basis:
nominal in diet
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle
Positive control(s):
yes, cyclophosphamide (50 mg/kg)

Examinations

Statistics:
Fisher's exact test with a Bonferroni correction for multiple comparisons

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
positive
Toxicity:
not specified
Additional information on results:
The frequency of micronucleated polychromatic erythrocytes was significantly increased in both sexes at the highest doses (750 mg/kg for male and 1,000 mg/kg for female), compared to control. In addition, it showed a significant tendency to increase with dose-dependency. Inhibition of bone marrow cell proliferation was observed at the highest doses in both sexes under the test conditions.
Conclusion: Micronucleus test in mice by oral administration is positive but only at the highest doses.

Applicant's summary and conclusion