Registration Dossier
Registration Dossier
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EC number: 942-330-6 | CAS number: -
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only summary in EU risk assessment available, but judged to be reliable by the authors.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- European Union Risk Assessment Report - Primary Alkyl Amines
- Author:
- Germany
- Year:
- 2 008
- Bibliographic source:
- Published Draft, page 166
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- Test performed in 1989
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- (Z)-octadec-9-enylamine
- EC Number:
- 204-015-5
- EC Name:
- (Z)-octadec-9-enylamine
- Cas Number:
- 112-90-3
- Molecular formula:
- C18H37N
- IUPAC Name:
- octadec-9-en-1-amine
- Reference substance name:
- Reference substance 001
- Details on test material:
- name: Oleylamine
purity: 90%
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
volume: 10ml/kg - Frequency of treatment:
- single dose
- Post exposure period:
- Cells were collected 6, 12, 24h after treatment
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 2500, 5000 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
Examinations
- Tissues and cell types examined:
- bone marrow cells
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Additional information on results:
- One female in the 2500 mg/kg bw group died prematurely.
No significant reduction in the rate of body weight gain was observed.
Clinical signs of toxicity were observed in test substance-treated mice indicating that the test substance was systemically available after oral application.
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.
