Cetalkonium chloride

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

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 peer reviewed publication.

Data source

Reference

Reference Type:

publication

Title:

Gene mutation toxicity study of the test chemical

Author:

Inoue et al

Year:

1980

Bibliographic source:

Food and chemical toxicology

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Cetalkonium chloride

EC Number:

204-526-3

EC Name:

Cetalkonium chloride

Cas Number:

122-18-9

Molecular formula:

C25H46ClN

IUPAC Name:

cetalkonium chloride

Details on test material:

CAS no: 122-18-9
CAS name: Benzylcetyldimethylammonium Chloride Hydrate
EC no: 204-526-3
Details on test material
- Name of test material: cetyldimethylbenzylammonium chloride (CDBAC)
- Molecular formula: C25H46NCl
- Molecular weight: 396.098 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: 98.4%
- Impurities (identity and concentrations): 1.6%

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 metabolic activation system

Test concentrations with justification for top dose:

0, 0.01, 0.05, 0.1, 0.5, 1, 5 or 10 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Distilled water or DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO or distilled water

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Distilled water or DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 4-nitroquinoline-N-oxide benzo(a)pyrene other: N-Methyl-N’-nitro-N-nitrosoguanidine, 2-Acetylaminofluorene, N-Nitrosodimethylamine

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar

DURATION
- Preincubation period: No data
- 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

Rationale for test conditions:

Not specified

Evaluation criteria:

The plates were observed or a dose dependent increase in the number of revertants/plate

Statistics:

Mean value was observed.

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

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:The test compound was toxic at dose level of 5 and 10 µg/plate in the absence of S9 metabolilc activation system

Remarks on result:

other: No mutagenic potential

Any other information on results incl. tables

Table 1. Mutagenicity of the test compound and the respective control chemicals

Compound	Dose (µg/plate)	No. of His+ revertants/plate
		TA100		TA98
		-S9	+S9	-S9	+S9
Distilled water	-	145	137	19	32
DMSO	-	151	141	23	28
4-Nitroquinoline 1-oxide	0.5	1588	148	167	36
Benzo[a]pyrene	2	4152	128	27	30
2-Acetylaminofluorene	5	178	928	35	614
N-Nitrosodimethylamine	50	128	1080	18	2292
Cetyltrimethylammonium chloride	0.01	123	139	12	29
	0.05	133	108	13	22
	0.1	105	120	10	40
	0.5	100	115	17	18
	1	96	129	15	26
	5	0*	132	0*	28
	10	0*	91	0*	18

Applicant's summary and conclusion

Conclusions:

The test chemical did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence it 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 test substance. The test chemical was dissolved in distilled water or DMSO as the solvent and used at dose level of 0, 0.01, 0.05, 0.1, 0.5, 1, 5 or 10µg/plate. The exposure duration was 48 hrs at 37˚C. Concurrent solvent and negative control chemicals were also included in the study. Test chemical did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.