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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
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

Constituent 1
Chemical structure
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.