Registration Dossier
Registration Dossier
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EC number: 201-163-2 | CAS number: 78-97-7
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- 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
- Principles of method if other than guideline:
- Method: other: OECD combined repeat dose and reproductive(developmental toxicity screening test (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:
- other: Crj:CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- Exposure period: males 43 days, females approx. 53 days ( from 14 days before mating to day 3 of lactation
)
Premating exposure period (males): 14 days
Premating exposure period (females): 14 days
Duration of test: male 43 days, female day 4 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: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day
- Sex:
- not specified
Results: F1 generation
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 30 mg/kg bw/day
- Sex:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext:
There were no significant differences in offspring parameters including number of offspring, live offspring,
sex ratio, survival index and body weight. The macroscopic and microscopic findings did not show any changes due to the test substance.
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.
