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Toxicological information

Toxicity to reproduction

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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:
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 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
GLP compliance:
no

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%
Kept at cold and closed dark place untiluse.

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