Registration Dossier
Registration Dossier
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EC number: 203-441-9 | CAS number: 106-91-2
Toxicity to reproduction
Administrative data
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Referenceopen allclose all
- Title:
- No information
- Author:
- Ministery 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 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- no
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%
Kept at cold and closed dark place untiluse.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age at study initiation was 10 weeks old (males: 382-414 g, females: 245-282 g)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- 40-47 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10, 30, 100 mg/kg/day
Basis:
nominal in diet
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
Examinations
- Statistics:
- Multi-comparison analysis for continuous data and Chai square test for quantal data.
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOEL
- Generation:
- F1
- Effect level:
- 100 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: Toxicity to offspring: No abnormalities were noted in the body weights of live pups or on necropsy of pups of any treated group.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Decrease of fertility index at 100 mg/kg was reproducible. There was a tendency for decrease in the number of corpora lutea, implants, pups born and live pups born, implantation index and delivery index at 100 mg/kg. However, these changes were not statistically significant.
Conclusions
Reproductive toxicity in rats by oral administration is a decrease of fertility index and NOAEL is 30 mg/kg/day.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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