N,N-dimethylglycinium chloride

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation toxicity study was performed by A.J.W. Hoorn (Mutation Research, 1989) to determine the mutagenic nature of Dimethylglycine hydrochloride(2491-06-7) using Salmonella typhimurium strains. Dimethylglycine hydrochloride was 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.

Link to relevant study records

Reference

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.

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

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

Target gene:

Histidine

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.

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.

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

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.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Genotoxicity In-vitro

Various publications were reviewed to determine the mutagenic nature of Dimethylglycine hydrochloride IUPAC name 2-(dimethylamino)acetic acid hydrochloride; N,N-dimethylglycinium chloride (2491-06-7). The studies are as mentioned below:

Gene mutation toxicity study was performed by A.J.W. Hoorn (Mutation Research, 1989) to determine the mutagenic nature of Dimethylglycine hydrochloride(2491-06-7) using Salmonella typhimurium strains. Dimethylglycine hydrochloride was 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.

Supported by a experimental study conducted by U.S. National Library of Medicine (TOXLINE, 2017). Dimethylglycine hydrochloride was tested for its mutagenic potential. The test material was exposed to S. typhimurium strains TA100 and TA1535. The test substance did not induce any mutagenic effect. Therefore Dimethylglycine hydrochloride was considered to be not mutagenic in S. typhimurium strains TA100 and TA1535. Hence the substance cannot be classified as gene mutant in vitro.

It is further supported by  Experimental test‘s abstract of Dimethylglycine hydrochloride conducted by Neville Colmanet al.( PROC SOC EXP BIOL MED,1980). Dimethylglycine hydrochloride was evaluated for its mutagenic potential as formulations of the health food product variously tradenamed “B15,” vitamin B15, pangamic acid, and pangamate contain dimethylglycine hydrochloride (DMG) . Gastric lavage and saliva were collected from human and tested by Preincubation method in medium. No mutagenic effect were observed on the saliva and gastric lavage. Therefore Dimethylglycine hydrochloride was considered to be not mutagenic in human gastric lavage and saliva. Hence the substance cannot be classified as gene mutant in vitro.

Based on the data and prediction, available for the target chemical, Dimethylglycine hydrochloride IUPAC name 2-(dimethylamino)acetic acid hydrochloride; N,N-dimethylglycinium chloride (2491-06-7)does not induce gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.

Justification for classification or non-classification

Thus based on the above annotation and CLP criteria for the target chemical, Dimethylglycine hydrochloride IUPAC name 2-(dimethylamino)acetic acid hydrochloride; N,N-dimethylglycinium chloride (2491-06-7)does not induce gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.