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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. QA statement)
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-lauroyloxyethyltrimethylammonium chloride
EC Number:
246-745-7
EC Name:
2-lauroyloxyethyltrimethylammonium chloride
Cas Number:
25234-60-0
Molecular formula:
C17H36NO2.Cl
IUPAC Name:
[2-(dodecanoyloxy)ethyl]trimethylazanium chloride

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Remarks:
and TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9-mix, rat liver
Test concentrations with justification for top dose:
0.24, 1.20, 6.00, 30.0 and 150.0 µg/plate
Vehicle / solvent:
Solvent dimethylsulfoxide (DMSO)
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
other: 2-aminoanthracene

Results and discussion

Test results
Key result
Species / strain:
other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified

Applicant's summary and conclusion

Conclusions:
The results of the Ames Salmonella plate incorporation assay indicate, that the test compound lauroyl choline chloride did not induce base pair or frame shift mutations with and without metabolic activation under the test conditions reported.
Executive summary:

Lauroyl choline chloride was assayed in a bacterial gene mutation plate incorporation assay (Ames test) using the strains TA 100, TA 1535, TA 98, TA 1537 and TA 1538 according to OECD guideline no.471. Induced his( + )revertants were determined both in the absence and presence of metabolic activation by a rat liver post-mitochondrial fraction (S9) from Aroclor 1254 induced animals.

Depending on a preliminary toxicity experiment, in two independent mutation experiments, cells were exposed to concentrations of 0.24, 1.20, 6.00, 30.0 and 150.0 μg per plate in the absence and presence of S9 (1st and 2nd experiment). In order to demonstrate the sensitivity of the assay system, positive control agents were used and marked increases in his(+)-revertants were induced in all tester-strains.

In the first and second assay, lauroyl choline chloride did not induce statistically significant increases in histidine-prototroph revertants in any tester-strains with and without metabolic activation in the tested concentration range.

It is thus concluded that lauroyl choline chloride did not induce gene mutations in the bacterial mutagenicity assay with and without metabolic activation in vitro when tested under the experimental conditions reported.