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EC number: 814-375-0 | CAS number: 67036-09-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09.03.2018 to 26.04.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [2,2,6,6-tetramethyl-4-(trimethylazaniumyl)piperidin-1-yl]oxidanyl chloride
- EC Number:
- 814-375-0
- Cas Number:
- 67036-09-3
- Molecular formula:
- C12H26N2OCl
- IUPAC Name:
- [2,2,6,6-tetramethyl-4-(trimethylazaniumyl)piperidin-1-yl]oxidanyl chloride
- Test material form:
- solid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 2500 and 5000 μg/plate
- Vehicle / solvent:
- purified water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- purified water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- purified water
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- sodium azide
- Remarks:
- Strain TA100 (10µg/plate) and TA1535 (10µg/plate)
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- other: 4-NOPD; 4-nitro-o-phenylene-diamine
- Remarks:
- Strain TA98 (10µg/plate) and TA1537 (40µg/plate)
- Positive controls:
- yes
- Remarks:
- without metabolic activation
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Strain TA102 (1µg/plate)
- Positive controls:
- yes
- Remarks:
- with metabolic activation
- Positive control substance:
- other: 2-AA; 2-aminoanthracene
- Remarks:
- Strain TA98, TA100, TA1535, TA1537 (all 2.5µg/plate) and TA102 (10µg/plate)
- Details on test system and experimental conditions:
- The test item TMA-TEMPO was investigated for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA102.
In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. - Evaluation criteria:
- The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs
in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA98, TA100 and TA102 the number of reversions is at least twice as high
- if in tester strains TA1535 and TA1537 the number of reversions is at least three times higher
than the reversion rate of the solvent control
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA102
- 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:
- No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation).
No toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaluated with and without metabolic activation in experiment I and II.
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, TMA-TEMPO did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, TMA-TEMPO is considered to be non-mutagenic in this bacterial reverse mutation assay.
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