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EC number: 210-279-2 | CAS number: 611-74-5
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:
- 11. Jul. 2017 - 29. Aug. 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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)
- Remarks:
- certificated by Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht RLP, Kaiser-Freidrich-Str. 2, D-55116 Mainz, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N-dimethylbenzamide
- EC Number:
- 210-279-2
- EC Name:
- N,N-dimethylbenzamide
- Cas Number:
- 611-74-5
- Molecular formula:
- C9H11NO
- IUPAC Name:
- N,N-dimethylbenzamide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- N,N-Dimethylbezamide, CAS-Nr. 611-74-5, batch No. 02124BI
Composition >99% mono-constituent N,N-Dimethylbenzamide
Purity >99%
Homogeneity homogeneous
Expiry date Aug. 2020
Method
- Target gene:
- hisD6610 (frame shift), hisD3052 (frame shift), hisG46 (base pair substitution), hisG428 (base pair substitution) causing histidine deficiency
uvrB (deletion) causing UV sensitivity and biotin deficiency
rfa (deletion) causing lipopolysaccharide side chain deficiency
pKM101 (plasmid) causing ampillicillin resistance
pAQ1 (plasmid) causing tetracycline resistance
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: histidine deficiency, UV sensitivity, lipopolysaccharide side chain deficiency
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: histidine deficiency, UV sensitivity, lipopolysaccharide side chain deficiency, ampillicin resistance
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: histidine deficiency, UV sensitivity, lipopolysaccharide side chain deficiency, ampillicin resistance
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: histidine deficiency, lipopolysaccharide side chain deficiency, ampillicin resistance, teracycline resistance
- Species / strain / cell type:
- S. typhimurium, other: TA97a
- Additional strain / cell type characteristics:
- other: histidine deficiency, UV sensitivity, lipopolysaccharide side chain deficiency, ampicillin resistance
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix (rat-liver)
- Test concentrations with justification for top dose:
- 1. experiment (plate incorporation method): 5000/1500/500/150/50µg/plate
2. experiment (pre-incubation method): 5000/1500/500/150/50µg/plate - Vehicle / solvent:
- demineralized water
Controls
- Untreated negative controls:
- other: toxicity control (maximum dose of test substance on maximal-soft agar)
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other:
- Remarks:
- 4-Nitro-1,2-phenylene Diamine, Sodium Azide, 2-Amino-Anthracene, Benzo-a-Pyrene
- Details on test system and experimental conditions:
- Two experiments were performed: 1. experiment: plate incorporation method, 2. experiment: pre-incubation method, both at 37+/-1°C, incubation time for 48h, 5 doses with and without S9-Mix, 3 replicates per dose, positive controls, solvent control, toxicity control and sterility control.
- Rationale for test conditions:
- according to Guideline
- Statistics:
- mean of 3 replicates
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA97a, TA98, TA100, TA102, TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No cytotoxicity at highest dose. Sterility o.k.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that N,N-Dimethylbenzamide is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in this study.
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