Registration Dossier
Registration Dossier
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EC number: 608-880-3 | CAS number: 335153-21-4
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:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Principles of method if other than guideline:
- Only TA98 and TA100 strains used.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-(2-formyl-4-nitrophenoxy)hexanoic acid
- EC Number:
- 608-880-3
- Cas Number:
- 335153-21-4
- Molecular formula:
- C13H15NO6
- IUPAC Name:
- 2-(2-formyl-4-nitrophenoxy)hexanoic acid
Constituent 1
Method
- Target gene:
- Salmonella typhimurium
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Test suggests mild 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
The substance is considerd non-mutagenic. - Executive summary:
The assay was conducted on two strains (TA98, TA100), of Salmonella typhimurium in the presence and absence of an exogenous mammalain activation system. All positive controls exhibited a statistically increase in the number of revertants as compared to the negative control and untreated groups, demonstrating the functionality of the assay. A statistically significant increase in the number of colonies was not observed with the test substance in the Reverse Mutation Assay. A slight decrese in the mean number of revertants were observed with the 5000ug/plate gropus in the TA100 strain without metabolic activation suggesting mild cytotoxicity. Based on the criteria of the study protocol, the substance is considered non-mutagenic.
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