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EC number: 249-655-6 | CAS number: 29463-06-7
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline compliant study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tris(2-hydroxyethyl)methylammonium methyl sulphate
- EC Number:
- 249-655-6
- EC Name:
- Tris(2-hydroxyethyl)methylammonium methyl sulphate
- Cas Number:
- 29463-06-7
- Molecular formula:
- C7H18NO3.CH3O4S
- IUPAC Name:
- 1,5-dihydroxy-3-(2-hydroxyethyl)pentan-3-aminium methyl sulfate
- Details on test material:
- - Name of test material (as cited in study report): Tris(2-hydroxyethyl)methylammonium methyl sulphate- Substance type: organic
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (phenobarbital and beta-naphthoflavone induced rat liver)
- Test concentrations with justification for top dose:
- 0, 33, 100, 333, 1000, 2500, 5000 µg/plate with and without S9 mix
- Vehicle / solvent:
- - Vehicle used: water- Justification for choice of vehicle: Due to the good solubility of the test substance in ultrapure water, ultrapure water was used.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2-AA
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with S9 mix (TA1535, TA100, TA1537, TA98, WP2 uvr A)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- MNNG
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- without S9 mix (TA1535, TA100)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- NOPD
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Remarks:
- without S9 mix (TA98)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- AAC
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix (TA1537)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 4-NQO
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9 mix (WP2 uvr A)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubationDURATION- Preincubation period: 20 min- Exposure duration: 48 - 72 hoursNUMBER OF REPLICATIONS: 3 DETERMINATION OF CYTOTOXICITY- Method: other: decrease in the number of revertants and reduced background lawn
- Evaluation criteria:
- Generally, the experiment was considered valid if the following criteria were met:- The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.- The sterility controls revealed no indication of bacterial contamination.- The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above.- Fresh bacterial culture containing approximately 109 cells per mL were used.The test substance was considered positive in this assay if the following criteria were met:- A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.A test substance was generally considered non-mutagenic in this test if:- The number of revertants for all tester strains were within the historical negative control data range under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORSNone.COMPARISON WITH HISTORICAL CONTROL DATA: In this study with and without S9 mix, the number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain. In addition, the positive control substances both with and without S9 mix induced a significant increase in the number of revertant colonies within the range of the historical positive control data.ADDITIONAL INFORMATION ON CYTOTOXICITY: No bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants) was observed in the standard plate and in the preincubation test up to the highest required concentration.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1 Standard plate test
| Dose (µg/plate) | Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E.coli | ||||
| TA1535 | TA1537 | TA98 | TA100 | WP2 uvr A | |
| Results with S9 | |||||
| Spontaneous Reversion | 8.3 | 10.0 | 36.7 | 49.3 | 61.0 |
Positive control |
365.7 | 198.0 | 2178.7 | 2171.0 | 266.7 |
| 33 | 6.0 | 11.0 | 37.0 | 72.3 | 80.3 |
| 100 | 7.7 | 7.7 | 36.0 | 52.3 | 69.7 |
| 333 | 12.0 | 10.7 | 49.0 | 58.0 | 67.0 |
| 1000 | 9.7 | 10.0 | 41.0 | 61.0 | 64.7 |
| 2500 | 11.7 | 8.3 | 33.3 | 58.3 | 75.0 |
| 5000 | 11.0 | 14.0 | 25.0 | 57.7 | 80.3 |
| Results without S9 | |||||
Spontaneous Reversion |
8.3 | 6.7 | 25.0 | 40.0 | 63.0 |
Positive control |
6320.7 | 2391.3 | 325.0 | 5669.7 | 893.3 |
| 33 | 9.7 | 5.0 | 23.7 | 35.0 | 60.3 |
| 100 | 9.7 | 7.3 | 25.3 | 37.7 | 70.3 |
| 333 | 7.0 | 7.7 | 28.0 | 42.7 | 58.3 |
| 1000 | 9.0 | 6.3 | 18.7 | 41.3 | 64.0 |
| 2500 | 8.7 | 5.0 | 26.3 | 33.3 | 62.0 |
| 5000 | 14.3 | 7.7 | 29.0 | 42.0 | 68.7 |
Table 2 Preincubation test
| Dose (µg/plate) | Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and E.coli | ||||
| TA1535 | TA1537 | TA98 | TA100 | WP2 uvr A | |
| Results with S9 | |||||
| Spontaneous Reversion | 13.3 | 9.3 | 34.7 | 71.3 | 80.3 |
Positive control |
240.3 | 90.3 | 645.0 | 2056.3 | 326.7 |
| 33 | 13.0 | 9.7 | 36.3 | 48.7 | 71.3 |
| 100 | 11.7 | 7.7 | 34.3 | 60.0 | 68.3 |
| 333 | 12.0 | 8.7 | 37.0 | 63.0 | 69.7 |
| 1000 | 11.0 | 10.0 | 30.7 | 61.3 | 68.3 |
| 2500 | 11.0 | 9.3 | 36.0 | 62.7 | 67.7 |
| 5000 | 10.3 | 8.7 | 38.3 | 54.7 | 67.0 |
| Results without S9 | |||||
| Spontaneous Reversion | 10.3 | 8.3 | 23.0 | 44.7 | 60.0 |
Positive control |
2329.0 | 1014.0 | 393.3 | 2797.3 | 368.7 |
| 33 | 9.3 | 8.0 | 25.7 | 44.3 | 68.3 |
| 100 | 8.7 | 7.3 | 25.3 | 44.3 | 66.7 |
| 333 | 9.3 | 6.7 | 25.7 | 49.0 | 57.7 |
| 1000 | 9.7 | 8.0 | 23.7 | 46.7 | 64.3 |
| 2500 | 8.3 | 8.0 | 26.3 | 44.3 | 57.0 |
| 5000 | 8.7 | 6.3 | 23.3 | 37.7 | 55.7 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:negative
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