Dimethylammonium chloride

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: acceptable, well-documented publication, which meets basic scientific principles

Data source

Reference

Reference Type:

publication

Title:

CHROMOSOME TESTS WITH 134 COMPOUNDS ON CHINESE HAMSTER CELLS IN VITRO -- A SCREENING FOR CHEMICAL CARCINOGENS

Author:

Motoi ishidate and Shigeyoshi Odashima

Year:

1977

Bibliographic source:

Mutation Research, 48 (1977) 337--354

Materials and methods

Principles of method if other than guideline:

Chromosomal aberration tests in vitro were carried out on Chinese hamster cells grown in culture with various chemicals.
This report presents our screening data on 134 chemicals, concerning the induction of chromosomal aberrations in Chinese hamster cells grown in culture, and data obtained from mutation assays in bacteria, which were carried our at the Dept. of Microbiol. of our institute using the same compounds.

GLP compliance:

not specified

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Dimethylammonium chloride

EC Number:

208-046-5

EC Name:

Dimethylammonium chloride

Cas Number:

506-59-2

Molecular formula:

C2H7N.ClH

IUPAC Name:

dimethylazanium chloride

Details on test material:

- Name of test material (as cited in study report): dimethylamine hydrochloride
- Substance type:
- Physical state: solid
- Analytical purity: purity of most of these chemicals was checked at the Dept. of Drugs og our institute
- Stability under test conditions:
- Storage condition of test material: kept dark in a refrigerator
- Other: solvent: physiological saline

Method

Species / strain

Species / strain / cell type:

Chinese hamster Ovary (CHO)

Details on mammalian cell type (if applicable):

- Type and identity of media: Eagle's MEM (GIbco F-11) with 10 % calf serum
- Properly maintained: yes
- Periodically checked for karyotype stability: yes (25 chromosomes

Additional strain / cell type characteristics:

not specified

Metabolic activation:

without

Metabolic activation system:

not applicable

Test concentrations with justification for top dose:

max effective dose 0.12 mg/ml / 14.7 (10 -4 M)

Vehicle / solvent:

physiological saline

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

no

Positive control substance:

no

Evaluation criteria:

CHL cells commonly have less than 3.0% cells with chromosomal aberrations. Therefore, the final judgement given to all experimental groups was as follows. Negative (--) if less than 4.9% of the aberration was detected even when doses of the agent were elevated to sub-lethal amounts, where almost no mitosis was observed; suspicious (+) if between 5.0 and 9.9%, and positive if between 10.0 and 19.9% (+), 20.0 and 49.9% (++) or more than 50.0% (+++). When no reasonable dose response was obtained, additional experiments with different doses were carried out to confirm its reproducibility.

Results and discussion

Test results

Species / strain:

Chinese hamster Ovary (CHO)

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not valid

Positive controls validity:

not examined

Additional information on results:

Carcinogenicity ???, no chromosomal aberrations, no Mutation

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

DMA hydrochloride is judged as not mutagenic or genotoxic.

Executive summary:

A in vitro mammalian chromosome aberration test with CHO cells testing among various other chemicalsDMA-HCl showed no chromosomal aberrations and no mutations [in concentrations up to 0.12 mg/ml (Ishidate et al., 1977)].