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EC number: 272-028-3 | CAS number: 68649-42-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Studies Of In Vitro Cell Transformation and Mutagenicity by Surfactants And Other Compounds
- Author:
- K. Inoue et.al.
- Year:
- 1 980
- Bibliographic source:
- Food and Cosmetic toxicology,1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Simialar to OECD 471; Ames, McCann & Yamasaki (1975) with some modification (Yahagi, 1975).
- Principles of method if other than guideline:
- Gene mutation toxicity study was performed to evaluate the mutagenic nature of Cetyl trimethyl ammonium chloride
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Cetrimonium chloride
- EC Number:
- 203-928-6
- EC Name:
- Cetrimonium chloride
- Cas Number:
- 112-02-7
- Molecular formula:
- C19H42N.Cl
- IUPAC Name:
- 1-Hexadecanaminium, N,N,N-trimethyl-, chloride
- Reference substance name:
- Trimethylhexadecylammonium chloride
- IUPAC Name:
- Trimethylhexadecylammonium chloride
- Details on test material:
- - Name of test material: Cetyl trimethyl ammonium chloride
- Molecular formula: C19H42N.Cl
- Molecular weight: 320.0008 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 99.3%
- Impurities (identity and concentrations): No data
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Details on test material
- Name of test material: Cetyl trimethyl ammonium chloride
- Molecular formula: C19H42N.Cl
- Molecular weight: 320.0008 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 99.3%
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98 and TA100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix was prepared from rats pretreated with polychlorinated biphenyl
- Test concentrations with justification for top dose:
- 0, 0.05, 0.1, 0.5, 1, 5 or 10 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Distilled water/ DMSO
- Justification for choice of solvent/vehicle: No data
Controlsopen allclose all
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO and Distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- TA 98
- Positive control substance:
- other: N-methyl-N’-nitroquinoline 1- oxide
- Remarks:
- Without S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO and Distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- TA100
- Positive control substance:
- other: N-methyl-N’-nitro-N-nitrosoguanidine
- Remarks:
- Without S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO and Distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- TA98
- Positive control substance:
- 2-acetylaminofluorene
- Remarks:
- With S9
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- yes
- Positive controls:
- yes
- Remarks:
- TA100
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- With S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: No data
NUMBER OF CELLS EVALUATED: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data
OTHER: No data - Evaluation criteria:
- The plates were observed for a dose dependent increase in the number of Histidine- independent (his+) colonies.
- Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA98 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At 5 and 10 µg/plate without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: No data
COMPARISON WITH HISTORICAL CONTROL DATA: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data - Remarks on result:
- other: No mutagenic effect were observed.
Applicant's summary and conclusion
- Conclusions:
- Cetyl trimethyl ammonium chloride (112-02-7) failed to induce mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
- Executive summary:
Gene mutation toxicity study was performed to determine the mutagenic nature of Cetyl trimethyl ammonium chloride. The study was performed using Salmonella typhimurium strainsTA98 and TA100 both in the presence and absence of S9 metabolic activation system. The chemical was dissolved in DMSO and used at dose levels of 0, 0.05, 0.1, 0.5, 1, 5 or 10µg/plate by the preincubation method. Cetyl trimethyl ammonium chloridefailed to induce mutation in Salmonella typhimurium strainsTA98 and TA100 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
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