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EC number: 202-815-9 | CAS number: 100-06-1
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-05-02 to 2017-06-14
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 30, 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4'-methoxyacetophenone
- EC Number:
- 202-815-9
- EC Name:
- 4'-methoxyacetophenone
- Cas Number:
- 100-06-1
- Molecular formula:
- C9H10O2
- IUPAC Name:
- 1-(4-methoxyphenyl)ethanone
Constituent 1
Method
- Target gene:
- Salmonella typhimurium: histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver homogenate (S9) from Phenobarbital/ß-naphtoflavone pretreated rats
- Test concentrations with justification for top dose:
- In a pre-experiment the concentration range of the test item was 3 – 5000 μg/plate. Since toxic effects were observed six or seven concentrations were tested in the main experiment. 5000 μg/plate, respectively 2500 μg/plate were chosen as maximal concentration. The following concentrations were tested in the final test:
Strain WP2 uvrA: 3; 10; 33; 100; 333; 1000; and 2500 μg/plate
The remaining strains: 33; 100; 333; 1000; 2500; and 5000 μg/plate - Vehicle / solvent:
- With and without (vehicle control) DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-mainoanthracene (2-AA) and 4-nitro-o-phenylene-diamine, 4-NOPD
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Pre-experiment for toxicity: In agar (plate incorporation)
- Experiment I: In agar (plate incorporation)
- Experiment II: Preincubation
- Selective Agar: Plates with selective agar (without histidine/tryptophan) were used
DURATION
- Preincubation period: Mix of 100 μL test solution (solvent or reference mutagen solution (positive control)), 500 μL S9 mix / S9 mix substitution buffer and 100 μL bacterial suspension incubated at 37 °C for 60 minutes
- Exposure duration: 48 hours at 37 °C in the dark after solidification of the plates
NUMBER OF REPLICATIONS:
- two independent experiments with three replications
DETERMINATION OF CYTOTOXICITY
- Method: Number of revertant colonies - Evaluation criteria:
- A test item was considered as a mutagen if a biologically relevant increase in the number of revertants exceeded the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control was observed. A dose dependent increase was considered biologically relevant if the threshold was exceeded at more than one concentration. An increase exceeding the threshold at only one concentration was judged as biologically relevant if reproduced in an independent second experiment. A dose dependent increase in the number of revertant colonies below the threshold was regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remained within the historical range of negative and solvent controls such an increase was not considered biologically relevant.
- Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory. Therefore, no statistics were performed.
Results and discussion
Test results
- Key result
- Species / strain:
- other: Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
No precipitation of the test item occurred up to the highest investigated dose.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Experiment I: Bacteriotoxic towards the strain TA 100 at 5000 µg/plate without S9 mix and towards WP2 uvrA at 2500 - 5000 µg/plate both with and without S9 mix.
- Experiment II: Bacteriotoxic towards the strains TA 1537 (without S9 mix), TA 100 (without S9 mix) and TA 98 (with S9 mix) at 5000 µg/plate.Bacteriotoxic towards the strain WP2 uvrA (with and without S9 mix) at 2500 µg/plate and towards the strain T100 at 2500-5000 with S9 mix.
Any other information on results incl. tables
Table 1: Summary of Experiment I
Metabolic Activation | Test Group | Dose Level (per plate) | Revertant Colony Counts (Mean ±SD) | ||||
TA 1535 | TA1537 | TA 98 | TA 100 | WP2 uvrA | |||
Without Activation | DMSO | 8 ± 3 | 13 ± 2 | 28 ± 7 | 156 ± 7 | 44 ± 2 | |
Untreated | 13 ± 2 | 12 ± 2 | 28 ± 8 | 170 ± 22 | 36 ± 8 | ||
Test Item | 3 µg | 7 ± 1 | 9 ± 3 | 20 ± 6 | 159 ± 29 | 37 ± 2 | |
10 µg | 6 ± 1 | 11 ± 2 | 24 ± 9 | 165 ± 13 | 40 ± 11 | ||
33 µg | 10 ± 1 | 13 ± 3 | 24 ± 5 | 171 ± 12 | 46 ± 10 | ||
100 µg | 17 ± 3 | 13 ± 3 | 28 ± 8 | 167 ± 15 | 44 ± 7 | ||
333 µg | 7 ± 3 | 11 ± 4 | 24 ± 8 | 166 ± 22 | 35 ± 9 | ||
1000 µg | 8 ± 1 | 15 ± 4 | 18 ± 3 | 171 ± 14 | 27 ± 3 | ||
2500 µg | 8 ± 2 | 15 ± 1 | 22 ± 4 | 129 ± 13 | 11 ± 1 | ||
5000 µg | 9 ± 3 | 8 ± 2 | 13 ± 4 | 57 ± 16 | 3 ± 1 | ||
NaN3 | 10 µg | 1120 ± 231 | 1993 ± 36 | ||||
4-NOPD | 10 µg | 300 ± 32 | |||||
4-NOPD | 50 µg | 65 ± 9 | |||||
MMS | 2.0 µL | 996 ± 11 | |||||
With Activation | DMSO | 10 ± 2 | 16 ± 6 | 28 ± 9 | 158 ± 24 | 49 ± 18 | |
Untreated | 9 ± 2 | 16 ± 7 | 41 ± 5 | 148 ± 10 | 53 ± 10 | ||
Test Item | 3 µg | 10 ± 4 | 15 ± 1 | 38 ± 3 | 149 ± 7 | 51 ± 12 | |
10 µg | 13 ± 3 | 15 ± 1 | 29 ± 8 | 142 ± 11 | 62 ± 8 | ||
33 µg | 8 ± 2 | 16 ± 4 | 22 ± 2 | 137 ± 6 | 40 ± 2 | ||
100 µg | 9 ± 2 | 16 ± 4 | 29 ± 3 | 144 ± 19 | 54 ± 8 | ||
333 µg | 10 ± 3 | 15 ± 6 | 34 ± 10 | 134 ± 15 | 41 ± 8 | ||
1000 µg | 12 ± 0 | 27 ± 2 | 28 ± 8 | 147 ± 3 | 31 ± 9 | ||
2500 µg | 11 ± 1 | 20 ± 6 | 27 ± 9 | 130 ± 15 | 17 ± 4 | ||
5000 µg | 7 ± 4 | 12 ± 3 | 21 ± 1 | 75 ± 7 | 8 ± 3 | ||
2-AA | 2.5 µg | 441 ± 19 | 212 ± 36 | 3255 ± 284 | 4212 ± 229 | ||
2-AA | 10 µg | 296 ± 14 |
Key to Positive Controls:
NaN3: sodium azide
2-AA: 2 -aminoanthracene
4-NOPD: 4-nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
Table 2: Summary of Experiment II
Metabolic Activation | Test Group | Dose Level (per plate) | Revertant Colony Counts (Mean ±SD) | ||||
TA 1535 | TA1537 | TA 98 | TA 100 | WP2 uvrA | |||
Without Activation | DMSO | 10 ± 3 | 10 ± 1 | 27 ± 10 | 120 ± 10 | 41 ± 7 | |
Untreated | 11 ± 2 | 9 ± 09 ± 0 | 37 ± 8 | 213 ± 3 | 31 ± 10 | ||
Test Item | 3 µg | 38 ± 8 | |||||
10 µg | 38 ± 8 | ||||||
33 µg | 11 ± 5 | 8 ± 2 | 29 ± 8 | 106 ± 14 | 36 ± 9 | ||
100 µg | 13 ± 4 | 8 ± 2 | 23 ± 4 | 139 ± 3 | 32 ± 4 | ||
333 µg | 11 ± 4 | 9 ± 4 | 33 ± 12 | 119 ± 3 | 31 ± 5 | ||
1000 µg | 12 ± 3 | 10 ± 4 | 24 ± 3 | 96 ± 4 | 22 ± 3 | ||
2500 µg | 13 ± 3 | 6 ± 1 | 24 ± 4 | 67 ± 12 | 17 ± 6 | ||
5000 µg | 9 ± 3 | 4 ± 0 | 18 ± 5 | 0 ± 1 | |||
NaN3 | 10 µg | 1413 ± 31 | 2123 ± 55 | ||||
4-NOPD | 10 µg | 354 ± 7 | |||||
4-NOPD | 50 µg | 115 ± 21 | |||||
MMS | 2.0 µL | 636 ± 43 | |||||
With Activation | DMSO | 14 ± 1 | 11 ± 2 | 30 ± 5 | 125 ± 11 | 45 ± 9 | |
Untreated | 12 ± 1 | 16 ± 7 | 48 ± 5 | 174 ± 11 | 50 ± 17 | ||
Test Item | 3 µg | 55 ± 5 | |||||
10 µg | 46 ± 2 | ||||||
33 µg | 12 ± 2 | 10 ± 2 | 36 ± 10 | 113 ± 12 | 54 ± 8 | ||
100 µg | 13 ± 2 | 10 ± 4 | 36 ± 12 | 131 ± 7 | 48 ± 13 | ||
333 µg | 13 ± 5 | 11 ± 3 | 32 ± 2 | 139 ± 15 | 37 ± 6 | ||
1000 µg | 11 ± 1 | 16 ± 1 | 38 ± 11 | 83 ± 8 | 35 ± 4 | ||
2500 µg | 10 ± 1 | 15 ± 3 | 31 ± 9 | 37 ± 5 | 19 ± 2 | ||
5000 µg | 7 ± 0 | 7 ± 1 | 6 ± 0 | 3 ± 1 | |||
2-AA | 2.5 µg | 424 ± 18 | 110 ± 14 | 4237 ± 917 | 3262 ± 234 | ||
2-AA | 10 µg | 453 ± 29 |
Key to Positive Controls:
NaN3: sodium azide
2-AA: 2 -aminoanthracene
4-NOPD: 4-nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
Applicant's summary and conclusion
- Conclusions:
- The test substance was not mutagenic to Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA in the presence and absence of a metabolizing system.
- Executive summary:
An in vitro reverse mutation assay study (Ames) was conducted under GLP-conditions according to OECD Guideline 471 and EU Method B13/B14 in Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA. Two separate Experiments were performed, one as a plate incorporation assay (Experiment I) and a second one as a preincubation assay (Experiment II). All tests were conducted in triplicate and concentrations between 3μg/plate and 5000μg/plate were tested. Strains were exposed to the test substance with and without metabolic activation with rat liver S9 mix. Cytotoxicity was observed in Experiment I towards the strain TA 100 at 5000 µg/plate without S9 mix and towards WP2 uvrA at 2500 - 5000 µg/plate both with and without S9 mix. In Experiment II: the test substance showed bacteriotoxic effects towards the strains TA 1537 (without S9 mix), TA 100 (without S9 mix) and TA 98 (with S9 mix) at 5000 µg/plate as well as towards the strain WP2 uvrA (with and without S9 mix) at 2500 µg/plate and towards the strain T100 at 2500-5000 with S9 mix. No substantial increase in revertant colony numbers of any of the tester strains was detected following treatment with the test substance at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Therefore it was concluded that the test substance did not induce gene mutations and it was considered to be non-mutagenic.
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