N,N-dimethylglycinium chloride

Genetic toxicity: in vitro

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 publication.

Data source

Reference

Reference Type:

publication

Title:

Dimethylglycine and chemically related amines tested for mutagenicity under potential nitrosation conditions

Author:

A.J.W. Hoorn

Year:

1989

Bibliographic source:

Mutation Research, 222 (1989) 343-350

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Principles of method if other than guideline:

Evaluate mutagenicity of Dimethylglycine hydrochloride in Salmonella typhimurium strain TA100 by using Ames test.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethylglycinium chloride

EC Number:

219-648-2

EC Name:

N,N-dimethylglycinium chloride

Cas Number:

2491-06-7

Molecular formula:

C4H9NO2.ClH

IUPAC Name:

2-(dimethylamino)acetic acid hydrochloride

Test material form:

solid: crystalline

Details on test material:

- Name of test material : 2-(dimethylamino)acetic acid hydrochloride; N,N-dimethylglycinium chloride
- Molecular formula : C4H10ClNO2
- Molecular weight : 139.581 g/mol
- Smiles notation : OC(=O)CN(C)C.Cl
- InChl : 1S/C4H9NO2.ClH/c1-5(2)3-4(6)7;/h3H2,1-2H3,(H,6,7);1H
- Substance type: Organic
- Physical state: Solid

Specific details on test material used for the study:

- Name of test material : 2-(dimethylamino)acetic acid hydrochloride; N,N-dimethylglycinium chloride
- Molecular formula : C4H10ClNO2
- Molecular weight : 139.581 g/mol
- Smiles notation : OC(=O)CN(C)C.Cl
- InChl : 1S/C4H9NO2.ClH/c1-5(2)3-4(6)7;/h3H2,1-2H3,(H,6,7);1H
- Substance type: Organic
- Physical state: Solid

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium TA 100

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:

The microsomal S9 fraction that was used as the metabolic activation system was prepared from Sprague-Dawley adult male rat liver induced by Aroclor 1254.

Test concentrations with justification for top dose:

0,1, 10,100, 500, 1000, 2500,5000and 10000 µg/plate

Vehicle / solvent:

Not specified.

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

sodium azide

other:

Details on test system and experimental conditions:

Details on test system and conditions
METHOD OF APPLICATION: Preincubation

DURATION
- Preincubation period: 45 min at 37 °C
- Exposure duration: 60 min at 25 °C

OTHER: For Mutagenicity 3 plates per concentration wee used.

Rationale for test conditions:

Dose selection was based on toxicity range-finding studies both with and without metabolic activation.

Evaluation criteria:

A minimum increase in the number of revertants that exceeded twice the mean of the solvent control values and exhibiting a dose-effect relationship was considered to be mutagenic in strain TA100.

Statistics:

For all mutagenicity tests 3 plates per concentration were used and the means and standard deviations calculated.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 100

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

Remarks on result:

other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:

The substance Dimethylglycine hydrochloride(2491-06-7) was considered to be not mutagenic in S. typhimurium strains TA100.

Executive summary:

Dimethylglycine hydrochloride were tested for its mutagenic potential. For this purpose the bacterial reverse mutation assay was performed according to OECD 471 guideline. The test material was exposed to S. typhimurium strains TA100.The substance was tested in with and without metabolic activation at concentration of 0,1, 10,100, 500, 1000, 2500,5000and 10000µg/plate. Sodium azide and 2-anthramine used as positive control. The substance Dimethylglycine hydrochloride were not toxic or induced increases in the number of revertants of TA100 with or without metabolic activation.Therefore, the substanceDimethylglycine hydrochloride was considered to be not mutagenic in S. typhimurium strains TA100. Hence the substance cannot be classified as gene mutant in vitro.