Dimethyldioctylammonium chloride

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 August 1986 - 18 Spetember 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

Read-across

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

not specified

GLP compliance:

yes

Type of assay:

in vitro mammalian cell transformation assay

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

7173-51-5

Test material form:

liquid

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Details on mammalian cell type (if applicable):

CHO-K1B4

Metabolic activation:

with and without

Metabolic activation system:

Liver S9 from Aroclor 1254 induced rats.

Test concentrations with justification for top dose:

The concentration of the test substance employed was based on the results from a toxicity test. The levels selected were 2, 4, 8 and 16 µg/ml (with S9 mix) and 1, 2, 4 and 8 µg/ml (without S9 mix).

Vehicle / solvent:

Distilled water.

Controls

Untreated negative controls:

yes

Remarks:

Vehicle control - distilled water

Negative solvent / vehicle controls:

no

True negative controls:

yes

Remarks:

Untreated control cultuure

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

cyclophosphamide

methylmethanesulfonate

Details on test system and experimental conditions:

Mitotic inhibitor was colcemid (N-deacetyl-N-methylcolchicine)

Evaluation criteria:

All structural chromosome aberrations were assigned artifical lesion or break scores and the aberrations yield quantified as follows:
i) Chromatid and chromosome (isochromatid) gaps, breaks and acentric fragments were counted as one lesion each, indicating that a single event had generated the damage.
ii) Chromatid and chromosome complexes, such as exchanges, rings and dicentrics were designated 2 lesions each, indicating that 2 separate breaks has occurred. A cell containing a rearrangement and an associated fragment was, however, scored as having 2 and not 3 lesions, due to the likely shared origin of this damage.
iii) Metaphase with chromosomes showing multiple and extensive aberrations were awarded an arbitary value of 10 lesions per cell.

Results and discussion

Test results

Key result

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The substance was found to be negative for clastogencity in a chromosome aberration test using Chinese hamster ovary cells in the presence and absence of a metabolic activation system.

Executive summary:

The substance was tested for clastogenic potential using Chinese hamster ovary cells in vitro in the presence and absence of a metabolic activation system (liver S9 from Aroclor 1254 induced rats). There was no evidence of chromosomal aberrations and no indication of chromosomal ploidy changes following exposure to the substance at concentrations of 2, 4, 8 and 16 µg/ml (with S9 mix) and 1, 2, 4 and 8 µg/ml (without S9 mix). It was concluded that the substance was negative for clastogencity in a chromosome aberration test using Chinese hamster ovary cells in the presence and absence of a metabolic activation system.