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EC number: 263-038-9 | CAS number: 61789-18-2
- Life Cycle description
- Uses advised against
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- Short-term toxicity to fish
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Mouse lymphoma assay
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 15 October, 2001 to 05 March, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission directive 2002/32/EC and U.K Environmental Mutagen Society
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Quaternary ammonium compounds, coco alkyltrimethyl, chlorides
- EC Number:
- 263-038-9
- EC Name:
- Quaternary ammonium compounds, coco alkyltrimethyl, chlorides
- Cas Number:
- 61789-18-2
- Molecular formula:
- C(n+3) H(2n+10) N Cl (n=8-18)
- IUPAC Name:
- Quaternary ammonium compounds, cocoalkyl trimethyl, chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- water
- Test material form:
- liquid
- Details on test material:
- - Chemical name: Quaternary ammonium compounds, coco alkyltrimethyl, chlorides
- EC number: 263-038-9
To the best of knowledge, the sample used is representative to the boundary composition of the substance registered
Constituent 1
Constituent 2
Method
- Target gene:
- Thymidine kinase gene
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- For Experiment 1: 0.625, 1.25, 2.5, 5, 10 and 20 µg/mL for both with and without S9-mix
For Experiment 2: 0.313, 0.625, 0.938, 1.25, 2.5 and 5 µg/mL (without S9 mix) and 2.5, 5, 10, 15, 20 and 30 µg/mL (with S9-mix) - Vehicle / solvent:
- RPMI 1640 without serum
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- in the absence of S9-mix
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- in the presence of S9-mix
- Details on test system and experimental conditions:
- After a preliminary toxicity test, 0.625, 1.25, 2.5, 5, 10 and 20 µg/L was selected for the first experiment. The entire experiment was repeated to confirm the results of the first experiment. 3 h exposure were used both with and without S9 mix while for the second experiment, the exposure time was increased to 24 h. For the second experiment, the dose range was 2.5 to 30 µg/L with S9 mix and 0.313 to 5 µg/L without S9 mix.
- Evaluation criteria:
- For a test substance to give a significant result then two or more of the following criteria should be met:
a) A greater than three-fold increase in the mutant frequency/survivor over the negative control value.
b) A dose-related increase in the mutant frequency per survivor.
c) An increase in the absolute number of mutants.
Results and discussion
Test results
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: Yes
- Remarks on result:
- other: not mutagenic
Any other information on results incl. tables
There was evidence of toxicity with the test substance in both the presence and absence of S9-mix as indicated by relative suspension growth (RSG), this was confirmed by the decrease in relative total growth (RTG). There was no evidence of a reduction in Day 2 viability, therefore indicating that no residual toxicity occurred, in either the presence or absence of S9-mix. Optimum level of toxicity was achieved, in both the presence and absence of S9-mix. The toxicity observed at 30 µg/mL in the presence of metabolic activation exceeded the upper acceptable limit of 90%; therefore it was excluded from the statistical analysis.
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, the test substance was not found to show mutagenic activity in mouse lymphoma assay.
- Executive summary:
A study was conducted to determine the potential of the test substance, Coco TMAC (35.5% active in water), to induce mutations at the TK (thymidine kinase) locus in L5178Y mouse lymphoma cells. Study was performed accoding to OECD 476 Guideline, EU Method B.17 and Commission directive 2002/32/EC and U.K Environmental Mutagen Society, in compliance with GLP. After a preliminary toxicity test, 0.625, 1.25, 2.5, 5, 10 and 20 µg/L was selected as the test concentrations for the first experiment. The experiment was repeated to confirm the results of the first experiment. Three hour exposures were used both with and without S9-mix while for the second experiment, the exposure time was increased to 24 h. For the second experiment, the concentration range was 2.5 to 30 µg/L with S9-mix and 0.313 to 5 µg/L without S9-mix. The test substance did not induce a statistically significant or concentration-related increase in the mutant frequency at any concentration level, either with or without metabolic activation. Adequate levels of toxicity were achieved in all exposure groups. Under the study conditions, the test substance was not found to show mutagenic activity in mouse lymphoma assay (Nolan, 2002).
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