Registration Dossier
Registration Dossier
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EC number: 201-163-2 | CAS number: 78-97-7
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: Guideline study (GLP), detailed documentation not available
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 422
- GLP compliance:
- yes
Test material
- Reference substance name:
- Lactonitrile
- EC Number:
- 201-163-2
- EC Name:
- Lactonitrile
- Cas Number:
- 78-97-7
- Molecular formula:
- C3H5NO
- IUPAC Name:
- 2-hydroxypropanenitrile
- Details on test material:
- 2-Hydroxypropanenitrile
Purity: 92.3 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- females approx. 53 days ( from 14 days before mating to day 3 of lactation)
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.2, 6, 30 mg/kg
Basis:
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day
- 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
RS-Freetext:
There were no effects on mating, fertility and oestrus cycle or on dams during the pregnancy and lactation period. External examination of pups revealed no increase in appearance of abnormal pups. Body weight gain of pups was normal. Pups killed at postnatal day 4 showed no abnormal gross findings.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
