Registration Dossier
Registration Dossier
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EC number: 203-441-9 | CAS number: 106-91-2
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- 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:
- Mininstry of Health and Wefare, 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 until use.
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:
- Duration of test:
Males: 46 days
Females: 40-47 days
Post exposure observation period: 1 day
Duration of exposure:
Males: 45 days
Females: from 14 days before mating to day 3 of lactation - 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
- Details on study design:
- Statistical analysis: multi-comparison analysis for continuous data and Fisher's exact test for quantal data
Results and discussion
Results of examinations
- Details on results:
- Male:
At 30 mg/kg: Salivation at day 25 to day 40 of administration in 5 of 12 animals (This symptom disappeared within 10 minutes after the appearance).
Squamous hyperplasia in forestomach (0: 1/12, 10 mg/kg: 1/11, 30 mg/kg: 11/12, 100 mg/kg: 11/11).
At 100 mg/kg: Salivation continuously after 19 days of administration in all animals (This symptom were observed immediately after administration and almost disappeared within 30 minutes).
Increase in absolute and relative kidney and adrenal weights.
Increase in total protein and albumin.
Squamous hyperplasia in forestomach.
Female:
At 100 mg/kg: Cellular infiltration in forestomach (0: 0/12, 10 mg/kg: 2/12, 30 mg/kg: 3/12, 100 mg/kg: 4/12).
Remarks:
Two males died at 10 mg/kg on day 21 of administration and at 100 mg/kg on day 26 of administration, respectively. Although the reason of two males’ death was not clear, authors concluded it might be no chemical-related.
Salivation and increased serum protein in males was not considered as adverse effects.
Histological change observed in forestomach was considered to be due to irritation of this chemical.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 10 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: local adverse effect: squamous hyperplasia in forestomach
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: local adverse effect: squamous hyperplasia in forestomach
- Dose descriptor:
- LOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: local adverse effect: squamous hyperplasia in forestomach
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: local advers effect: squamous hyperplasia in forestomach
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: systemic adverse effect: increase in absolute and relative kidney and adrenal weights; increase in total protein and albumin
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: systemic adverse effect: increase in absolute and relative kidney and adrenal weights; increase in total protein and albumin
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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