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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1980, 1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across to cetrimonium bromide from data on cetrimonium chloride (with data reliability value of 1). Read-across justifications are provided in the endpoint summary.

Data source

Referenceopen allclose all

Reference Type:
other: Assessment report for American Chemistry Council, Fatty Nitrogen Derivatives Panel, Cationics Task Group
Title:
Unnamed
Year:
2001
Reference Type:
other: SCCS opinion document
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Principles of method if other than guideline:
Reverse mutation assay
Study 1980 according to Ames et al 1975
GLP compliance:
yes
Remarks:
study 1983 - not stated
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): cetrimonium chloride
- Molecular formula (if other than submission substance): C19H42N.Cl
- Molecular weight (if other than submission substance): 320.0

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA98 an TA100
Test concentrations with justification for top dose:
Study 1980: 0.05, 0.1, 0.5, 1.0, 5.0 and 10.0 μg/plate

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Remarks on result:
other: strain/cell type: TA98 and TA100
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative without metabolic activation

Cetrimonium chloride showed to be negative under the test conditions with a cytotoxic concentration of 5.0 μg/plate without metabolic activation. This study is considered relevant for read-cross to cetrimonium bromide.
Executive summary:

A US National Toxicology Programme report mentions two references of 1980 and 1983

describing bacterial reverse mutation assays with cetrimonium chloride in Salmonella

typhimurium TA98 and TA100, with and without S9 activation. Cetrimonium chloride

showed to be negative under the test conditions with a cytotoxic concentration of

5.0 μg/plate without metabolic activation.

This study is considered relevant for read-cross to cetrimonium bromide.