[No public or meaningful name is available]

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Ames test

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 18 April, 1989 to 08 May, 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

S. Typhimurium TA102 and/or E.coli WP2 strains not included; conducted according to old version of Guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

the version of the OECD guideline should be specified: OECD 471 (1983).

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

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

Constituent 2

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

Dihydrogen oxide

Test material form:

liquid

Specific details on test material used for the study:

- Batch: 01263LA
- Description: Clear, colourless liquid, contained in a glass screw-capped bottle. It was stored at room temperature and protected from light until required. The test substance was identified as a 33% aqueous solution.

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

1, 3, 10, 32 and 100 µg/plate for both with and without S9-mix

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Water

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

Solvent control

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

Tested with TA 1535, TA 100 in the absence of S-9 mix

Controls 2

Untreated negative controls:

yes

Remarks:

Solvent control

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

Tested for TA 1535 in the presence and absence of S9 mix

Controls 3

Untreated negative controls:

yes

Remarks:

Solvent control

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Tested for TA 1537 in the absence of S9-mix

Controls 4

Untreated negative controls:

yes

Remarks:

Solvent control

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

Tested for TA 98 in the absence of S9-mix

Controls 5

Untreated negative controls:

yes

Remarks:

Solvent control

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

Tested for TA 1537, TA 100 and TA 98 in the presence and absence of S9 mix

Details on test system and experimental conditions:

METHOD OF APPLICATION: In agar (pour-plate method)

DURATION
- Incubation period: 48 h at approximately 37°C

NUMBER OF REPLICATIONS: Three

DETERMINATION OF CYTOTOXICITY
- Method: Number of revertant colonies were counted, either manually or with a Biotran II automatic colony counter. Total colonies on nutrient plates were counted in the same way. Growth of the background lawn of non-revertant cells on minimal plates were verified.

Evaluation criteria:

The number of the revertants per plate of the tester strain is compared to the control.

Results and discussion

Test results

Key result

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Preliminary toxicity test: Yes

Remarks on result:

other: all strains/cell types tested

Applicant's summary and conclusion

Conclusions:

Under the test conditions, the test substance is not considered to be mutagenic in the presence and absence of exogenous metabolic activation.

Executive summary:

A study was conducted to determine the mutagenic potential of test substance, Coco TMAC (active ingredient 33%), according to OECD 471 and EPA OPPTS 870.5265 Guidelines, in compliance with GLP. Using pour-plate assays, the test substance was examined for mutagenic activity in four strains of Salmonella typhimurium: TA 100, TA 1535, TA 1537 and TA 98 in the absence and in the presence of S9-mix. The test concentrations included 0, 1, 3, 10, 32 and 100 µg/plate (i.e., equivalent to 0, 0.33, 0.99, 3.3, 10.56 and 33 µg/plate). No increase in reversion to prototrophy was obtained with any of the bacterial strain at any concentration level either in the presence or absence of S9-mix. Further, inhibition of growth, observed as thinning of the background lawn of non-revertant cells, occurred in all strains following exposure to the test substance at 100 µg/plate.Appropriate positive control chemicals (with S-9 mix where required) induced marked increases in revertant colony numbers with all strains, confirming sensitivity of the cultures and activity of the S-9 mix. Under the test conditions, the test substance was not mutagenic with and without metabolic activation (May, 1989).