Registration Dossier
Registration Dossier
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EC number: 203-441-9 | CAS number: 106-91-2
Genetic toxicity: in vivo
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:
- 1 997
- Bibliographic source:
- Ministery of Health and Welfare, Japan, Toxicity Testing Reports of Environmental Chemicals 5, 359-385 (1997)
- Title:
- No information
- Author:
- OECD
- Year:
- 1 999
- 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
- 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%
Constituent 1
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
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