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Diss Factsheets

Toxicological information

Developmental toxicity / teratogenicity

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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:
1988
Bibliographic source:
Ou-Yang, G.S. et al., J.Hyg.Res., 17 (3), 1-5 (1988)
Title:
No information
Author:
OECD
Year:
1999
Bibliographic source:
OECD SIDS for glycidyl methacrylate, December 1999

Materials and methods

Test guideline
Guideline:
other: no data
GLP compliance:
not specified

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:
Purity 92%

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