Tri-alkyl Quat

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study conducted according to OECD Guideline and in compliance with GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)

Version / remarks:

1997

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)

Version / remarks:

2000

Deviations:

no

GLP compliance:

yes

Type of assay:

mammalian cell gene mutation assay

Test material

Test material information

Constituent 1

Test material form:

other: liquid

Method

Target gene:

thymidine kinase

Species / strain

Species / strain / cell type:

mouse lymphoma L5178Y cells

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9-mix, Phenobarbital/ß-naphthoflavone induced

Test concentrations with justification for top dose:

Cytotoxicity test concentrations:
1.22, 4.88, 19.53, 78.13, 312.5, 1250 and 5000 µg/mL (3-hour treatment period with and without S9)
0.3125, 0.625, 1.25, 2.5, 5, 10 and 20 µg/mL (24-hour treatment period without S9)

Genotoxicity test concentrations:
1st experiment: 0, 0.625, 1.25, 2.5, 5, 10 and 20 µg/mL (3-hour treatment period, with and without S9)
2nd experiment: 0, 0.313, 0.625, 0.938, 1.25, 2.5 and 5 µg/mL (24-hour treatment period, without S9),
0, 2.5, 5, 10, 15, 20 and 30 µg/mL (3-hour treatment period, with S9)

Vehicle / solvent:

- Vehicle/solvent used: R0 medium

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: with S9-mix: Cyclophosphamide, without S9-mix: Ethylmethanesulphonate

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Exposure duration: 24 hours and 3 hours

NUMBER OF REPLICATIONS: 2

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

Treated cultures were examined for a significant increase in mutant frequency.

Statistics:

UKEMS statistical package

Results and discussion

Test results

Species / strain:

mouse lymphoma L5178Y cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

treatment period / test concentration / decrease in relative suspension growth: without S9-mix: 3 h / 20 µg/mL / 98 %; with S9-mix: 3 h / 20 µg/mL / 70 and 73 %; without S9-mix: 24 h / 5 µg/mL / 91 %

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytotoxicity was observed at 20 µg/mL with and without S9-mix (3 hour treatment period) and at 5 µg/mL without S9 (24-hour treatment period)

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.