Registration Dossier
Registration Dossier
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EC number: 280-518-3 | CAS number: 83682-78-4
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Two doses over 24 hour period
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data taken from US EPA review. Source of primary data not know, but accepted as reliable by EPA.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- mammalian germ cell cytogenetic assay
Test material
- Reference substance name:
- 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
- EC Number:
- 263-058-8
- EC Name:
- 1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts
- Cas Number:
- 61789-40-0
- Molecular formula:
- C19H38N2O3
- IUPAC Name:
- {[3-(Dodecanoylamino)propyl](dimethyl)ammonio}acetate
Constituent 1
- Specific details on test material used for the study:
- Material covered by review is the non-phosphated organic part of the registered substance. There is evidence to suggest that the phosphate ester in teh registered substance will metabolise quickly to the non-phosphated form
Test animals
- Species:
- mouse
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Distilled water
- Duration of treatment / exposure:
- Two administration ponits over 24 hour period
- Frequency of treatment:
- 24 hours
- Post exposure period:
- Animals killed 6 hours after second treatment.
Doses / concentrations
- Dose / conc.:
- 2 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- five
- Control animals:
- yes, historical
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Considered by EPA to be 'valid without restrictions'
Primary source of data is unknown.
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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