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EC number: 220-020-5 | CAS number: 2605-79-0
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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:
- 2011-11-03 to 2012-01-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N-dimethyldecylamine N-oxide
- EC Number:
- 220-020-5
- EC Name:
- N,N-dimethyldecylamine N-oxide
- Cas Number:
- 2605-79-0
- Molecular formula:
- C12H27NO
- IUPAC Name:
- decyl(dimethyl)amine oxide
- Test material form:
- other: aqueous solution
- Details on test material:
- - Name of test material (as cited in study report): N,N-dimethyldecylamine-N-oxide (solution)
- Substance type: colourless to yellowish liquid
- Analytical purity: 40.5% active
- Impurities (identity and concentrations): peroxide: 0.01%, free amine: < 0.5%
- Purity test date: 2011-11-14
- Lot/batch No.: 1108042301
- Expiration date of the lot/batch:2 years in original closed packaging
- Storage condition of test material: 10 - 25°C
Constituent 1
Method
- Target gene:
- his- → his+ reversion
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:
- Arochlor 1254 induced rat liver S9
- Test concentrations with justification for top dose:
- 3.16, 10.0, 31.6, 100, 316 and 1000 µg per plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: completely soluble in water and represents a standard solvent in the testing facility.
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO (vehicle)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- -S9: TA 98, TA 102, TA 1537 - 2-amino-anthracene in DMSO (2 µg/plate); TA 100, TA 1535 - cyclophosphamide in aqua ad iniectabilia (1500 µg/plate)
- Positive control substance:
- other: +S9: TA 1535 and TA 100 - sodium azide in aqua ad iniectabilia (10 µg/plate); TA 98 - 2-nitro-fluorene in DMSO (10 µg/plate); TA 1537 - 9-amino-acridine in ethanol, abs. (100 µg/plate); TA 102 - methyl methane sulfonate (MMS) in DMSO (1300 µg/pl
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 2nd test only: 20 minutes
- Exposure duration: 48 - 72 hours
- Expression time (cells in growth medium): 10 hours
NUMBER OF REPLICATIONS: 3
NUMBER OF CELLS EVALUATED: 10E08
DETERMINATION OF CYTOTOXICITY
- Method: 50% reduction in colony number and scarce background lawn growth - Evaluation criteria:
- The AMES test data are evaluated using the statistical method described below. A response is considered positive if
- the number of revertants is significantly increased (p =< 0.05, U-test according to MANN and WHITNEY) compared with the solvent control to at least 2-fold of the solvent control for TA 98, TA 100 and TA 102 and 3-fold of the solvent control for TA 1535 and TA 1537 in both independent experiments;
- in addition, a significant (p =< 0.05) concentration (log value)-related effect (Spearman’s rank correlation coefficient) is observed;
- positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on histidine-free agar plates.
The range of spontaneous reversion frequencies in our laboratory is generally:
TA 98: 20 - 60
TA 100: 100 - 200
TA 102: 240 - 320
TA 1535: 10 - 35
TA 1537: 3 - 20
The numbers may be slightly different on plates with S9 and may vary slightly from experiment to experiment.
Cytotoxicity is defined as a reduction in the number of colonies by more than 50% compared with the solvent control and/or a scarce background lawn. - Statistics:
- See above.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 1000 µg/plate all test strains, with/without activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
See attached tables
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
No mutagenic effect (no significant increase in revertant colony numbers as compared with control counts) was observed for N,N-dimethyldecylamine-N-oxide (solution), tested up to a cytotoxic dose level of 1000 µg N, N-dimethyl-decylamine-N-oxide/plate, in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation and preincubation test). - Executive summary:
In an in vitro reverse gene mutation (Ames) study performed in accordance with OECD Guideline 471 and EC Method B.13/14,
N,N-dimethyldecylamine-N-oxide (solution) was examined in the 5 Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254-induced rat liver). The first experiment was carried out as a plate incorporation test and the second as a preincubation test.
N,N-dimethyldecylamine-N-oxide (solution) was completely dissolved in dimethyl-sulfoxide (DMSO). A correction factor of 2.47 was used to correct for the content of active matter in the supplied solution (40.5%).
Ten concentrations ranging from 0.316 to 5000 µg N,N-dimethyldecylamine-N-oxide/plate were tested in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA 100. Pronounced cytotoxicity (scarce background lawn and reduction of the number of revertants by more than 50%) was noted in the plate incorporation test without and with metabolic activation at concentrations of 1000 µg/plate and higher.
Hence, 1000 µg N,N-dimethyldecylamine-N-oxide/plate was chosen as the maximum dose level for the main study in the plate incorporation test and in the preincubation test. Six concentrations ranging from 3.16 to 1000 µg N,N-dimethyldecylamine-N-oxide per plate were employed in two independent experiments each carried out without and with metabolic activation.
In two independent plate incorporation and preincubation tests, each carried out without and with metabolic activation, cytotoxicity (scarce background lawn and reduction of the number of revertants) was noted at the maximum dose level of 1000 µg/plate in all test strains
No mutagenic effect (no increase in revertant colony numbers as compared with control counts) was observed for the test material, tested up to the cytotoxic dose level of 1000 µg in any of the 5 test strains.
Under the present test conditions the test material tested up to a cytotoxic dose level of 1000 µg N,N-dimethyldecylamine-N-oxide/plate, caused no mutagenic effect in the Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
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