Registration Dossier
Registration Dossier
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EC number: 807-692-0 | CAS number: 54234-73-0
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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Potassium 2-hydroxy-5-nitrobenzoate
- EC Number:
- 807-692-0
- Cas Number:
- 54234-73-0
- Molecular formula:
- C7 H4 O5 N K
- IUPAC Name:
- Potassium 2-hydroxy-5-nitrobenzoate
- Details on test material:
- - Purity test date: > 99.5 %
- Lot/batch No.: LO126/13
- Expiration date of the lot/batch: 07/06/2016
- Storage condition of test material: 5+/- 3 °C
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:
- The test substance was prepared as solution in methanol with a concentration equivalent to 50 mg/ml and 4 different concentrations of semi-log intervals between them were prepared, at a concentration equivalent to 5, 1.5, 0.45, 0.123 and 0.041 mg/plate.
- Vehicle / solvent:
- Methanol
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:
- no cytotoxicity
- 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
Neither reproducible increase in the number of revertants colonies per plate in any strain with or without metabolic activation system was detected. Besides, the statistical test applied showed no significant difference between the number of revertants colonies for assy sample vs. negative control.
The verification of the genetic characteristics showed that the test strain maintained the required genetic prperties in both the assay repetitions.
The test substance did not show toxic effets either in the presence or absence of the enzymatic system for metabolism activation.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance proved to be not mutagenic for all the test strains, either in the presence or absence of metabolic activation.
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