Registration Dossier
Registration Dossier
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EC number: 273-535-2 | CAS number: 68988-63-6
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:
- 08 October 2020
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Imidazolium compounds, 2-C7-18-alkyl-1-(2-carboxyethyl)-4,5-dihydro-3-(hydroxyethyl), hydroxides, sodium salts
- EC Number:
- 273-535-2
- EC Name:
- Imidazolium compounds, 2-C7-18-alkyl-1-(2-carboxyethyl)-4,5-dihydro-3-(hydroxyethyl), hydroxides, sodium salts
- Cas Number:
- 68988-63-6
- IUPAC Name:
- Imidazolium compounds, 2-C7-18-alkyl-1-(2-carboxyethyl)-4,5-dihydro-3-(hydroxyethyl), hydroxides, sodium salts
- Test material form:
- solid - liquid: aqueous solution
Constituent 1
- Specific details on test material used for the study:
- Cola®Teric CNA-40
Batch/Lot # 2093C20
Imidazolium compounds, 2-C7-18-alkyl-1-(2-carboxyethyl)-4,5-dihydro-3(hydroxyethyl), hydroxides, sodium salts 31.5 % w/w; Water 68.5 % w/w
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with
- Test concentrations with justification for top dose:
- Experiment 2 (TA98 (+/-S9), TA100 (-S9), TA1535 (+/-S9), TA1537 (+/-S9)):
500, 250, 125, 63, 31,16; 8 μg/plate
- Experiment 2c (TA98 (-S9), TA100 (-S9)): 63, 31.5; 15.8, 7.9, 3.94, 1.97, 0.98 μg/plate
- Experiment 2d (TA100 (+S9), TA102 (+/-S9)): 1500, 750; 375, 188, 94, 47 μg/plate
- Experiment 2e (TA100 (+S9), TA102 (+/-S9)): 375, 188, 94, 47, 23, 12, 6, 3 μg/plate
Based on pre-test:
- Experiment 1: 5000, 1500, 500, 150 and 50 μg/plate
- Experiment 1b: 5000, 1500, 500, 150, 50, 15, 5, 1.5, 0.5 μg/plate
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- benzo(a)pyrene
- other:
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA98, TA100, TA102, TA1535 and TA1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: In the cytotoxicity test, the test item Cola®Teric CNA-40 shows toxicity in the highest test item concentration (5000 μg/plate) towards all tested Salmonella strains. Therefore, experi-ment 1 was repeated with additional lower concentrations.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study it is concluded that Cola®Teric CNA-40 is not mutagenic in the Salmonella typhimurium test strains TA98, TA100, TA102, TA1535 and TA1537 in the absence and presence of metabolic activation under the experimental conditions.
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