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EC number: 201-932-2 | CAS number: 89-71-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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
- Study period:
- 2015-06-19 till 2015-10-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD 471 guideline study in compliance with GLP, available as unpublished report, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: US Food and Drug Administration, Center for Food Safety & Applied Nutrition, Redbook 2000 Toxicological Principles for the safety of Food Ingredients. IV.C.1.a. Bacterial Reverse Mutation Test, July 2000
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- TNO Triskelion, Utrechtseweg 48, 3704 HE Zeist, The Netherlands
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methyl o-toluate
- EC Number:
- 201-932-2
- EC Name:
- Methyl o-toluate
- Cas Number:
- 89-71-4
- Molecular formula:
- C9H10O2
- IUPAC Name:
- methyl o-toluate
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): Ylanganate
- Storage condition of test material: ambient temperature (15-25°C)
- Appearance: clear, colourless liquid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver homogenate (S9-mix)
- Test concentrations with justification for top dose:
- First bacterial reverse mutation test:
Experiment 1: 0, 21, 62, 185, 556, 1667, 5000 µg/plate (all strains)
Experiment 2: 0, 21, 62, 185, 556, 1667, 5000 µg/plate (strain TA1535 and TA100 without S9-mix)
Experiment 3: 0, 21, 62, 185, 556, 1667, 5000 µg/plate (strain TA 1535 without S9-mix)
Second bacterial reverse mutation test
Experiment 1: 51, 128, 320, 800, 2000, 3500, 5000 µg/plate (all strains)
Experiment 2: 51, 128, 320, 800, 2000, 3500, 5000 µg/plate (strain TA1535, E. coli WP2 uvr A without S9-mix) - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- ethylnitrosurea
- other: 2-aminoanthracene, N-ethyl-N-nitrosourea
- Remarks:
- In the absence of S9-mix: sodium azide: TA 1535 and TA 100; 9-aminoacridine: TA 1537; 2-nitrofluorene: TA 98; N-ethyl-N-nitrosourea: WP2uvrA. In the presence of S9-mix: 2-aminoanthracene: TA 1535, TA 98, TA 100, WP2uvrA; benzo(a)pyrene: TA 1537
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48-72 hours at ca. 37 °C
NUMBER OF REPLICATIONS: All determinations were made in triplicate.
DETERMINATION OF CYTOTOXICITY
- Toxicity was defined as a reduction (by at least 50%) in the number of revertant colonies and/or a clearing of the background lawn of bacterial growth as compared to the negative (solvent) control and/or the occurrence of pinpoint colonies. - Evaluation criteria:
- The study was considered valid if the mean colony counts of the vehicle control values of the strains were within the acceptable ranges, if the results of the positive controls met the criteria for a positive response, if no more than 5 % of the plates was lost through contamination or other unforeseen events and if at least three concentrations were non-toxic.
A test substance was considered to be positive in the bacterial gene mutation test if the mean number of revertant colonies on the test plates was increased in a dose-related manner or if a two-fold or greater increase was observed compared to the negative control plates. A clear positive response did not need to be verified. Marginally or weakly positive results should be verified by additional testing.
A test substance was considered to be negative in the bacterial gene mutation test if it showed neither a dose-related increase in the mean number of revertant colonies nor a reproducible positive response at any of the concentrations tested.
Positive results from the bacterial reverse mutation test indicate that a test substance induces point mutations by base pair substitutions or frameshifts in the genome of either Salmonella typhimurium and/or Escherichia coli. Negative results indicate that, under the test conditions used, the test substance is not mutagenic in the tested strains. Although most studies give clearly positive or negative results, in rare cases the data set may preclude making a definite judgement about the mutagenic potential of the test substance. Results may remain equivocal in this case.
Both numerical significance and biological relevance were considered together in the evaluation. - Statistics:
- No statistical analysis was performed.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The first test included three experiments. In the first experiment, for strain TA 1535 and TA 100, both in the absence of S9-mix, the negative control was outside the acceptable range. Therefore, the experiment was repeated for these strains. In the second experiment for strain TA 1535 (-S9-mix), the negative control was outside the historical range. Therefore the experiment was repeated for this strain The second test included two experiments. In the first experiment, for strains TA 1535 and WP2 uvrA, both in the absence of S9-mix, the negative control was outside the acceptable range. Therefore, the experiment was repeated for these strains.
In both the first and second test, negative controls (vehicle) and positive controls were run simultaneously with the test substance. In some of the experiments, the mean numbers of his+ and trp+ revertant colonies of the negative control in some of the strains appeared to be outside the acceptable range. Therefore, the experiments were repeated until the acceptance criteria were met. Finally, both tests of this study were considered valid.
In both the first and second test, the test substance was found toxic to all strains tested, both in the absence and presence of S9-mix. In the first test, toxicity was observed at and above 1667 μg/plate and at 5000 μg/plate for the Salmonella strains and WP2 uvrA, respectively. In the second test, toxicity was observed at and above 800 μg/plate for TA 1537, in the absence of S9-mix and at and above 2000 μg/plate for all other strains tested. In all experiments, toxicity was evidenced by a decrease in the mean number of revertants and/or a clearing of the background lawn of bacterial growth compared to the negative controls and/or pinpoint colonies.
In all experiments, a dose related precipitation of the test substance in the final treatment mix (top agar) was observed. Precipitation was observed in all mixtures at and above 1667 μg/plate (first test) and 2000 μg/plate (second test) with the unaided eye.
In both tests, in all strains tested, in both the absence and presence of S9-mix, the test substance did not induce a more than 2-fold and/or dose related increase in the mean number of revertant colonies compared to the background spontaneous reversion rate observed with the negative control. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions (OECD 471, GLP) the results obtained in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and in the Escherichia coli strain WP2 uvrA, in the absence and presence of the S9-mix, indicate that the test substance is not mutagenic.
- Executive summary:
According to OECD guideline 471 and GLP, the test substance, dissolved in DMSO, was examined for its possible mutagenic activity in the bacterial reverse mutation test using Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and the Escherichia coli strain WP2uvrA, in the absence and presence of a liver fraction of Aroclor 1254-induced rats for metabolic activation (S9-mix). Two independent bacterial reverse mutation tests were performed. In the first test, three independent experiments were performed where six concentrations of the test substance ranging from 21 to 5000 μg/plate were tested. In the second test, two independent experiments were performed where seven concentrations of the test substance ranging from 51 to 5000 μg/plate were tested. In both the first and second test, negative controls (vehicle) and positive controls were run simultaneously with the test substance. In some of the experiments, the mean numbers of his+ and trp+ revertant colonies of the negative control in some of the strains appeared to be outside the acceptable range. Therefore, the experiments were repeated until the acceptance criteria were met. Finally, both tests of this study were considered valid. In both the first and second test, the test substance was found toxic to all strains tested, both in the absence and presence of S9-mix. In the first test toxicity was observed at and above 1667 μg/plate and at 5000 μg/plate for the Salmonella strains and WP2 uvrA, respectively. In the second test, toxicity was observed at and above 800 μg/plate for TA 1537, in the absence of S9-mix and at and above 2000 μg/plate for all other strains tested. In all experiments toxicity was evidenced by a decrease in the mean number of revertants and/or a clearing of the background lawn of bacterial growth compared to the negative controls and/or pinpoint colonies. In both tests, in all strains tested, in both the absence and presence of S9-mix, the test substance did not induce a more than 2-fold and/or dose related increase in the mean number of revertant colonies compared to the background spontaneous reversion rate observed with the negative control. It is concluded that the results obtained in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100, and in the Escherichia coli strain WP2 uvrA, in both the absence and presence of the S9 mix, indicate that the test substance is not mutagenic under the conditions used in this study.
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