Registration Dossier
Registration Dossier
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EC number: 810-760-2 | CAS number: 149855-64-1
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study, Guideline study, GLP, carried out by Nihon Bioresearch Inc. Hashima Laboratory.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 422
- Principles of method if other than guideline:
- OECD Combined Repeated Dose and Reproductive/Developmental Toxicity Screening Test
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-ethylhexyl methacrylate
- EC Number:
- 211-708-6
- EC Name:
- 2-ethylhexyl methacrylate
- Cas Number:
- 688-84-6
- IUPAC Name:
- 2-ethylhexyl methacrylate
- Details on test material:
- 2-ethylhexyl methacrylate
Purity: 99.4 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- Males, 49 days
Female, from 14 days before mating to day 3 of lactation - Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0 (vehicle), 30, 100, 300, 1000 mg/kg/day
Basis:
- No. of animals per sex per dose:
- 12 (males) and 12 (females)/group
- Control animals:
- yes
- Details on study design:
- Terminal sacrifice: Males: 50 days; Females, day 4 of lactation
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 300 mg/kg bw/day
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Decreased birth, live birth and viability indices, and decreased body weights of both sexes on day 0 and day 4 after birth were seen in the 1000 mg/kg group.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a valid guideline study, decreased birth, live birth and viability indices, and decreased body weights of both sexes on day 0 and day 4 after birth were seen in the 1000 mg/kg group.
- Executive summary:
In a valid guideline study, decreased birth, live birth and viability indices, and decreased body weights of both sexes on day 0 and day 4 after birth were seen in the 1000 mg/kg group.
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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