Registration Dossier
Registration Dossier
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EC number: 201-163-2 | CAS number: 78-97-7
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- 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
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- 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, commercial
Purity: 92.3 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 43 days for males, approx. 53 days for females (14 days before mating to day 3 of lactation)
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.2, 6, 30 mg/kg/day
Basis:
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOEL
- Effect level:
- 6 other: mg/kg
- Sex:
- male/female
- Dose descriptor:
- LOEL
- Effect level:
- 30 other: mg/kg
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
RS-Freetext:
Male and female rats given 30 mg/kg showed a transient hypolocomotion, hypopnea and salivation. On gross observation, swelling of the liver was noted in 9/10 males given 30 mg/kg.
Histopathologically, centrilobular hypertrophy (swelling) and fatty acid changes of hepatocytes were observed in males given 30 mg/kg.
Blood chemical analyses for 30 mg/kg males revealed a significant decrease in GOT (glutamic oxalacetic transaminase), a significant increase in total protein, albumin and calcium. All values obtainted by hematological analysis were normal. No changes were detected in body weight or food consumption in either sex.
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.
