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Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test substance lauryl chloride did not induce a mutagenic effect in Salmonella typhimurium (study no. 96 -0304 -DGM) in an Ames test. It is therefore not considered to be a bacterial mutagen.

However, there is publicly available, but proprietary data on genetic toxicity of lauryl chloride, which has been submitted to the US EPA under the Toxic Substances Control Act (TSCA). In an in vitro chromosomal aberration test in Chinese hamster ovary (CHO) cells conducted with and without metabolic activation, lauryl chloride was concluded to be positive for the induction of structural chromosome aberrations in the metabolically activated test system.

Link to relevant study records
Reference
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14-March-1996 to 13-May-1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
S9
Test concentrations with justification for top dose:
50-5000 µg/plate
Vehicle / solvent:
acetone
Negative solvent / vehicle controls:
yes
Remarks:
acetone
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
other: 2-Aminoanthracene
Details on test system and experimental conditions:
Five dose levels of LAURYLCHLORID ranging from 50 to 5000 μg/plate in the absence and in the presence of metabolic activation were spaced at half-log intervals. The plate incorporation method and the preincubation methods were used.
Key result
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Key result
Species / strain:
S. typhimurium TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Conclusions:
Lauryl chloride did not induce a mutagenic effect in S. typhimurium. It is therefore not considered to be a bacterial mutagen, and according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.

Additional information

Justification for classification or non-classification

There is information on two endpoints of genetic toxicity available for lauryl chloride: bacterial mutagenicity and chromosome mutagenicity. Whereas, an Ames test revealed no hints for bacterial mutagenicity, an in vitro

chromosomal aberration test in CHO cells was positive for structural chromosome aberrations with metabolic activation.

Thus, there are hints for potential genotoxic action of lauryl chloride, but in total there are not enough meanigful data for classification of the substance for germ cell mutagenicity according to Regulation (EC) 1272/2008.