Registration Dossier

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:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
60% aqueous solution of 99.92% purity (3-chloro-2-hydroxypropyl)trimethylammonium chloride.

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.