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EC number: 940-422-0 | CAS number: -
Genetic toxicity: in vitro
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
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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:
- Glucamide CC
- IUPAC Name:
- Glucamide CC
- Reference substance name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.
- EC Number:
- 940-422-0
- Cas Number:
- 1591783-13-9
- Molecular formula:
- C15H31NO6 (C8 derivative) C17H35NO6 (C10 derivative) C19H39NO6 (C12 derivative) C21H43NO6 (C14 derivative) C23H47NO6 (C16 derivative) C25H51NO6 (C18 derivative) C25H49NO6 (C18 unsatd. derivative)
- IUPAC Name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-[C8-16 (even numbered) and C18 unsaturated acyl] derivs.
- Test material form:
- other: solid
- Details on test material:
- Chemical Name: N-Cocoyl-N-methyl-glucamin
Physical state: solid
pH: 8-10
Constituent 1
Constituent 2
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix from induced rat liver
- Test concentrations with justification for top dose:
- Experiment I: 3.16, 10.0, 31.6, 100, 1000, 2500 and 5000 µg/plate without S9-Mix (TA 98, TA 1537, TA 102)
3.16, 10.0, 31.6, 100, 316 and 1000 µg/plate without S9-Mix (TA 100, TA 1535)
Experiment II: 0.316, 1.00, 3.16, 10.0, 31.6, 100, 1000 and 2500 µg/plate without S9-Mix (TA 98, TA 100, TA 1535, TA 1537)
1.00, 3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate with S9-Mix (TA 98, TA 100, TA 1535, TA 1337)
31.6, 100, 316, 1000, 2500 and 5000 µg/plate with S9-Mix (TA 102)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility reasons
Controls
- Untreated negative controls:
- yes
- Remarks:
- A. dest.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Preincubation period: 60 minutes
- Exposure duration: at least 48 hours
NUMBER OF REPLICATIONS: Three plates for each strain and dose level including controls
DETERMINATION OF CYTOTOXICITY
- Method: clearing or rather diminution of background lawn or reduction in number of revertants down to a mutation facot < 0.5 in relation to solvent control - Evaluation criteria:
- -A minimum of 3 dose levels were required to evaluate the mutagenic potential of test substance. For a test substance to be evaluated as positive, it must cause a dose dependant increase in the mean revertants per plate of at least one tester strain with a minimum of 2 increasing concentrations of test substance.
-Data sets for Strains TA 1535, TA 1537 and TA 1538 were judged as positive if the increase in mean revertants at the peak of the dose response is equal to or greater than three times the mean vehicle control values.
-Equal to or greater than two fold increase in the number of revertants over the spontaneous number for the strain TA 98, TA100 and E.coli WP2 uvrA was considered as minimal criteria for a positive response. The positive response should not be obtained only at concentrations near to toxic dose levels. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data was not required.The mean values with standard deviation of revertant colonies were calculated for all strains at each dose level.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- 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'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
ambiguous without metabolic activation
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Glucamide CC did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.Therefore, Glucamide CC is considered to be non-mutagenic in this bacterial reverse mutation assay. - Executive summary:
Glucamide CC was tested in a reverse gene mutation assay in bacteria, strains TA98, TA100, TA1535, TA1537 and TA102 of S. typhimurium up to the limit concentration of 5000 μg/plate with and without metabolic activation. The positive controls induced the appropriate responses in the corresponding strains.There was no evidence of induced mutant colonies over background. Based on the study results it can be stated that Glucamide CC did not cause gen mutations by base pair changes or frameshifts in the genome of the test strains used and is therefore considered to be non-mutagenic in this test system. The study is classified as acceptable and satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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