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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
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:
other: Ames (Pre-incubation method)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 1535, TA 100
Metabolic activation:
with and without
Test concentrations with justification for top dose:
500, 1500, 5000, 15000 ug/plate.
Vehicle / solvent:
Water buffered to pH 4.0 or 5.5.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 1535, TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

(3-chloro-2-hydroxypropyl)trimethylammonium chloride is not mutagenic.