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EC number: 219-648-2 | CAS number: 2491-06-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
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
- 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.
Reference
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.
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