Registration Dossier
Registration Dossier
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EC number: 203-441-9 | CAS number: 106-91-2
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Method and GLP are unknown.
Data source
Referenceopen allclose all
- Title:
- No information
- Author:
- Ou-Yang
- Year:
- 1 988
- Bibliographic source:
- Ou-Yang, G.S. et al., J.Hyg.Res., 17 (3), 1-5 (1988)
- Title:
- No information
- Author:
- OECD
- Year:
- 1 999
- Bibliographic source:
- OECD SIDS for glycidyl methacrylate, December 1999
Materials and methods
Test guideline
- Guideline:
- other: no data
- GLP compliance:
- not specified
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:
- Purity 92%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- Day 5 to day 15 of gestation
- Frequency of treatment:
- Daily
- Duration of test:
- 15 days
- No. of animals per sex per dose:
- 93 pregnant rats (200 - 280 g) were divided into six groups with 14 to 18 animals in each group. The animals were sacrificed on the 19th day of pregnancy.
- Control animals:
- other: There was negative control (no further data). Positive control was DIKUSHUANG (phonetic tranlation of Chinese report) at 1.0 mg/kg
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
At 108.0 mg/kg:
Significant decrease in body weight gain.
Pregnancy/litter data: At 108.0 mg/kg: A statistically significant increase in the fetal resorption rate (12.7 %, compared to 5.18 % of control group)
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 21.52 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No external, skeletal or organ abnormalities No significant difference in body weight from the control
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 108 mg/kg bw/day (nominal)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
The percentage of pups stillborn was somewhat higher than control at all dose levels (0 % for control, and 1.35 %, 7.58 %, 1.26 % and 6.03 % for treated group at 5.38, 10.76, 21.52 and 108.0 mg/kg/day, respectively). However, this change was not dose-dependent and statistically significant change was only at 10.76 mg/kg. This was not considered to be dose-related change.
Conclusions:
Developmental toxicity in rats by oral administration is not observed at the highest dose, 108 mg/kg/day which induces maternal toxicity.
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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