Registration Dossier
Registration Dossier
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EC number: 222-048-3 | CAS number: 3327-22-8
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Rapporteur for the EU risk assessment of (3-chloro-2-hydroxypropyl)trimethylammonium chloride is the National Product Control Agency for Welfare and Health, Finland. The report is the result of in-depth work performed by experts in one Member State, working with counterparts in other Member States, Industry and public interest groups. The information reported is considered reliable.
Data source
Reference
- Reference Type:
- other: Published secondary source
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- (3-chloro-2-hydroxypropyl)trimethylammonium chloride
- EC Number:
- 222-048-3
- EC Name:
- (3-chloro-2-hydroxypropyl)trimethylammonium chloride
- Cas Number:
- 3327-22-8
- Molecular formula:
- C6H15ClNO.Cl
- IUPAC Name:
- 3-chloro-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride
- Details on test material:
- 60% aqueous solution of 99.92% purity (3-chloro-2-hydroxypropyl)trimethylammonium chloride.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: BOR:NMRI
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Frequency of treatment:
- Single administration
- Post exposure period:
- Observation period : 72 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
147 mg/kg bw
Basis:
other: intraperitoneal injection
- No. of animals per sex per dose:
- 21 male ; 24 female
- Control animals:
- yes
- Positive control(s):
- Positive control : Cyclophosphamide
Route of administration : Oral gavage
Doses/concentrations : 51 mg/kg bw administered once
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
(3-Chloro-2-hydroxypropyl)trimethylammonium chloride was considered to be non-mutagenic in this micronucleus assay.
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