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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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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:
Read across from N-Methyltaurine

Data source

Reference
Reference Type:
publication
Title:
Salmonella Mutagenicity tests: III. Results from the testing of 255 chemicals
Author:
Zeiger, E. , Anderson, B. , Haworth, S. , Lawlor, T. , Mortelmans, K. and Speck, W.
Year:
1987
Bibliographic source:
Environ. mutagen, 9: 1-60. doi:10.1002/em.2860090602

Materials and methods

Test guideline
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

Test material

Constituent 1
Reference substance name:
N-methyltaurine
EC Number:
203-510-3
EC Name:
N-methyltaurine
Cas Number:
107-68-6
Molecular formula:
C3H9NO3S
Specific details on test material used for the study:
Supplier: Crescent Chemical
Testing Lab: SRI International

Method

Target gene:
his
Species / strain
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
Controls
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.

Results and discussion

Test resultsopen allclose all
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

Applicant's summary and conclusion

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.