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EC number: 224-339-0 | CAS number: 4316-74-9
- 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
The publication by Zeiger et al. reports that the read-across substance N-methyltaurine does not exhibit genetic toxicity in a bacterial reverse mutation assay (Ames test) using various Salmonella typhimurium strains in the presence or absence of metabolic activation with liver S-9 mixes. Concentrations of up to 10 mg of N-methyltaurine per plate were tested. N-methyltaurinate is the deprotonated form of N-methyltaurine. Both sodium N-methyltaurinate and N-methyltaurine are highly soluble in water. Therefore, it is expected that both substances behave similarly in aqueous solution. Hence, the experimental data on N-methyltaurine provide a reasonable measure for the genetic toxicity of sodium N-methyltaurinate.
This result is supported by the OECD 471 guideline study on sodium N-methyltaurinate, where no genetic toxicity has been detected up to the maximum tested concentration of 5 mg of sodium N-methyltaurinate per plate.
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:
- Read across from N-Methyltaurine
- Qualifier:
- according to guideline
- Guideline:
- other: not specified
- Principles of method if other than guideline:
- The results and data from the testing of 255 chemicals for mutagenicity in Salmonella are presented. All chemicals were tested under code using a preincubation modification of the Salmonellal microsome test in the absence of exogenous metabolic activation and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters.
The purpose of this report is to present the results and data from the testing of 255 chemicals for their ability to induce mutations in Salmonella. Because some chemicals were tested in more than one laboratory or at different times within the same laboratory, a total of 291 individual samples were tested. All testing was performed at Case Western Reserve University (CWR; Dr. W. Speck), EG&G Mason Research Institute (EGG; Dr. S. Haworth [later Microbiological Associates, Inc.; MIC]), and SRI International (SRI; Dr. K. Mortelmans). The substance N-Methyltaurine was tested at SRI. - GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Supplier: Crescent Chemical
Testing Lab: SRI International - Target gene:
- his
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Metabolic activation was performed using S-9 fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers.
- Test concentrations with justification for top dose:
- Dose: 100-10000 µg/plate
At least five doses of the chemical were tested in triplicate. Experiments were repeated at least 1 wk following the initial trial. Each chemical was tested initially at half-log doses up to a dose that elicited toxicity; subsequent trials occasionally used narrower dose increments. Chemicals that were not toxic were tested to a maximum dose of 10 mg/plate. Chemicals that were poorly soluble were tested up to a dose defined by their solubility. A maximum of 0.05 ml solvent was added to each plate. - Vehicle / solvent:
- Solvent: Distilled water
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine (Strain: TA98)
- Remarks:
- The positive control for metabolic activation was 2-aminoanthracene for all strains.
- Evaluation criteria:
- An individual trial was judged mutagenic, if a dose-related increase over the corresponding solvent control was seen. A chemical was judged to be mutagenic, if it produced a reproducible, dose-related increase in his+ revertants over the corresponding solvent controls in replicate trials.
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Method: Preincubation; Dose: 100-10000 µg/plate (test material solvent: distilled water)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Metabolic Activation: Hamster, Liver, S-9, Aroclor 1254 (10%); Method: Preincubation; Dose: 100-10000 µg/plate (test material solvent: distilled water)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Remarks:
- Metabolic Activation: Rat, Liver, S-9, Aroclor 1254 (10%); Method: Preincubation; Dose: 100-10000 µg/plate (test material solvent: distilled water)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Method: Preincubation; Dose: 100-10000 µg/plate (test material solvent: distilled water)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Metabolic Activation: Hamster, Liver, S-9, Aroclor 1254 (10%); Method: Preincubation; Dose: 100-10000 µg/plate (test material solvent: distilled water)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Remarks:
- Metabolic Activation: Rat, Liver, S-9, Aroclor 1254 (10%); Method: Preincubation; Dose: 100-10000 µg/plate (test material solvent: distilled water)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Method: Preincubation; Dose: 100-10000 µg/plate (test material solvent: distilled water)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Metabolic Activation: Hamster, Liver, S-9, Aroclor 1254 (10%); Method: Preincubation; Dose: 100-10000 µg/plate (test material solvent: distilled water)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 1537
- Remarks:
- Metabolic Activation: Rat, Liver, S-9, Aroclor 1254 (10%); Method: Preincubation; Dose: 100-10000 µg/plate (test material solvent: distilled water)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Method: Preincubation; Dose: 100-10000 µg/plate (test material solvent: distilled water)
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Metabolic Activation: Hamster, Liver, S-9, Aroclor 1254 (10%); Method: Preincubation; Dose: 100-10000 µg/plate (test material solvent: distilled water)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Metabolic Activation: Rat, Liver, S-9, Aroclor 1254 (10%); Method: Preincubation; Dose: 100-10000 µg/plate (test material solvent: distilled water)
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- The genetic toxicity of N-methyltaurine was tested in a bacterial reverse mutation assay (Ames test). Concentrations of up to 10 mg N-methyltaurine per plate were tested. N-methyltaurine does not exhibit genetic toxicity on S. typhimurium strains TA 100, TA 1535, TA 1537 and TA 98 in the presence or absence of metabolic activation using S-9 fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers.
- Executive summary:
The publication reports the results of a bacterial reverse mutation assay (Ames test) from the testing of 255 chemicals, including N-methyltaurine, for mutagenicity in various Salmonella typhimurium strains with and without metabolic activation. Metabolic activation was performed with liver S-9 mixes from Aroclor 1254-induced male Sprague-Dawley rats and Syrian hamsters, respectively. Concentrations of up to 10 mg N-methyltaurine per plate were tested. N-methyltaurine does not exhibit genetic toxicity on S. typhimurium strains TA 100, TA 1535, TA 1537 and TA 98 in the presence or absence of metabolic activation.
N-methyltaurinate is the deprotonated form of N-methyltaurine. Both sodium N-methyltaurinate and N-methyltaurine are highly soluble in water. Hence, it is expected that both substances behave similarly in aqueous solution. Therefore, the experimental data on N-methyltaurine provide a reasonable measure for the genetic toxicity of sodium N-methyltaurinate. Hence, we conclude that sodium N-methyltaurinate has no mutagenic effects.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The publication by Zeiger et al. reports the results of a bacterial reverse mutation assay (Ames test) from the testing of 255 chemicals, including N-methyltaurine, for mutagenicity in various Salmonella typhimurium strains with and without metabolic activation. Metabolic activation was performed with liver S-9 mixes from Aroclor 1254-induced male Sprague-Dawley rats and Syrian hamsters, respectively. Concentrations of up to 10 mg of N-methyltaurine per plate were tested. N-methyltaurine does not exhibit genetic toxicity on S. typhimurium strains TA 100, TA 1535, TA 1537 and TA 98 in the presence or absence of metabolic activation. N-methyltaurinate is the deprotonated form of N-methyltaurine. Both sodium N-methyltaurinate and N-methyltaurine are highly soluble in water. Therefore, it is expected that both substances behave similarly in aqueous solution. Hence, the experimental data on N-methyltaurine provide a reasonable measure for the genetic toxicity of sodium N-methyltaurinate.
This result is supported by the OECD 471 guideline study on sodium N-methyltaurinate, where no genetic toxicity has been detected up to the maximum tested concentration of 5 mg of sodium N-methyltaurinate per plate.
Conclusively, sodium N-methyltaurinate has no mutagenic effects and does not need to be classified.
Justification for classification or non-classification
According to the bacterial reverse mutation studies on N-methyltaurine and sodium N-methyltaurinate using various strains of Salmonella typhimurium and various concentrations, both test substances do not exhibit genetic toxicity. N-methyltaurinate is the deprotonated form of N-methyltaurine. Both sodium N-methyltaurinate and N-methyltaurine are highly soluble in water. Therefore, it is expected that both substances behave similarly in aqueous solution. Hence, the experimental data on N-methyltaurine provide a reasonable measure for the genetic toxicity of sodium N-methyltaurinate. Therefore, we conclude that sodium N-methyltaurinate has no mutagenic effects and does not need to be classified.
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