Registration Dossier
Registration Dossier
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EC number: 811-711-8 | CAS number: 14952-06-8
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:
- April - July 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
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:
- (E)-methyl non-2-enoate
- EC Number:
- 811-711-8
- Cas Number:
- 14952-06-8
- Molecular formula:
- C10H18O2
- IUPAC Name:
- (E)-methyl non-2-enoate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Batch Number: 9000492664
Purity: 98.2%
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:
- 33, 100, 333, 1000, 2500 and 5000 ug/plate in Experiement I (TA 1535, TA1537, TA100, TA102 with and without S9 mix)
3, 10, 33, 100, 333 and 1000 ug/plate in Experiment I (TA 98 with and without S9 mix and TA102 with S9 mix).
In experiemnt 2 without S9 mix concentrations were : 3, 10, 33, 100, 333, 1000 and 2500 ug/plate without S9 mix and 1, 3, 10, 33, 100, 333 and 1000 ug/plate with S9 mix.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Details on test system and experimental conditions:
- For each strain and dose level, including the controls, three plates were used.
- Rationale for test conditions:
- The bacteria used in this assay do not possess the enzyme systems which, in mammals, are known to convert promutagens into active DNA damaging metabolites. In order to overcome this major drawback and exogenous metabolic system must be added in the form of mammalian microsome enzyme activation mixture (S9 mix).
- Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice or thrice the colony count of the corresponding solvent control is observed.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Executive summary:
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, Neofolione did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
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