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EC number: 216-263-1 | CAS number: 1538-75-6
- 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
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- 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
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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:
- May - June 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
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:
- Trimethylacetic anhydride
- EC Number:
- 216-263-1
- EC Name:
- Trimethylacetic anhydride
- Cas Number:
- 1538-75-6
- Molecular formula:
- C10H18O3
- IUPAC Name:
- 2,2-dimethylpropanoyl 2,2-dimethylpropanoate
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- histidine gene locus
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/β-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment 1 (Plate incorporation test): 3; 10; 33; 100; 333; 1000; 2500 and 5000 μg/plate. Since only moderate toxic effects were observed 5000 μg/plate were chosen as maximal concentration.
Experiment 2 (pre-incubation test):
TA 98: 10; 33; 100; 333; 1000; 2500 and 5000 μg/plate
TA 100: 3; 10; 33; 100; 333; 1000; 2500 and 5000 μg/plate
Remaining strains: 33; 100; 333; 1000; 2500 and 5000 μg/plate - Vehicle / solvent:
- DMSO
The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene, 4-nitro-o-phenylene-diamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Experiment 1: in agar (plate incorporation);
Experiment 2: preincubation;
DURATION
- Preincubation period: 60 minutes
- Exposure duration: at least 48 hours
Each concentration and the controls were tested in triplicate. - 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 (strains TA 98, TA 100 and 102) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test results
- Key result
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, TA 102
- 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:
- The test item precipitated in the overlay agar in the test tubes from 1000 to 5000 μg/plate in the absence of S9 mix and at 5000 in the presence of S9 mix. Precipitation of the test item in the overlay agar on the incubated agar plates was observed in Experiment II in the presence of S9 mix at 5000 μg/plate. The undissolved particles had no influence on the data recording.
Reduced background growth or a reduction in the number of revertants were observed at the following concentrations:
TA1535 and TA 102 - none
TA 1537 - from 1000 µg/plate on without S9 mix in Experiment I and from 2500 µg/plate without S9 mix in experiment II; none with S9 mix
TA 98 - from 1000 µg/plate on without S9 mix in Experiment I and II; none with S9 mix
TA 100 - from 333 µg/plate on wihout S9 mix in Experiment I and II; with S9 mix only at 5000 µg/plate in experiment II
Any other information on results incl. tables
Table 1: Summary of results from the salmonella typhimurium reverse mutation assay of experiment 1 (plate incorporation assay) with the test substance (mean +/- SD of revertants per plate).
Substance | Dose (µg/plate) | Without metabolic activation | ||||
TA 1535 | TA 1537 | TA 98 | TA 100 | TA 102 | ||
DMSO | 11 ± 1 |
11 ± 3 |
28 ± 8 | 174 ± 8 | 527 ± 21 | |
Untreated | 12 ± 4 | 11 ± 5 | 35 ± 4 | 174 ± 28 | 561 ± 70 | |
Test substance | 3 | 12 ±3 | 10 ± 1 | 27 ± 7 | 176 ± 14 | 531 ± 18 |
10 | 12 ± 4 | 9 ± 3 | 27 ± 4 | 171 ± 12 | 564 ± 28 | |
33 | 13 ± 5 | 11 ± 5 | 30 ± 10 | 172 ± 15 | 564 ± 27 | |
100 | 11 ± 4 | 10 ± 5 | 37 ± 8 | 149 ± 14 | 537 ± 14 | |
333 | 13 ± 1 | 11 ± 4 | 23 ± 9 | 73 ± 9 | 552 ± 28 | |
1000 | 9 ± 2 | 9 ± 2 | 33 ± 15 | 53 ± 8 | 520 ± 17 | |
2500 | 14 ± 5 | 10 ± 1 | 28 ± 3 | 31 ± 6 | 526 ± 38 | |
5000 | 10 ± 1 | 9 ± 6 | 5 ± 2 | 6 ± 3 | 542 ± 17 | |
sodium azide | 10 | 1305 ± 124 | 2215 ± 128 | |||
4 -nitro-o-phenylene-diamine | 10 | 392 ± 17 | ||||
4 -nitro-o-pneylene-diamine | 50 | 85 ± 3 | ||||
methyl methane sulfonate | 2.0 µl | 6183 ± 412 | ||||
Substance | Dose (µg/plate) | With metabolic activation | ||||
TA 1535 | TA 1537 | TA 98 | TA 100 | TA 102 | ||
DMSO | 11 ± 4 | 15 ± 3 | 45 ± 0 | 169 ± 3 | 638 ± 7 | |
Untreated | 11 ± 5 | 17 ± 6 | 40 ± 8 | 176 ± 30 | 665 ± 13 | |
Test substance | 3 | 10 ± 1 | 10 ± 4 | 49 ± 17 | 173 ± 18 | 732 ± 9 |
10 | 14 ± 3 | 10 ± 5 | 37 ± 2 | 177 ± 9 | 735 ± 20 | |
33 | 14 ± 3 | 13 ± 4 | 33 ± 12 | 182 ± 18 | 768 ± 12 | |
100 | 12 ± 2 | 12 ± 1 | 41 ± 3 | 161 ± 23 | 764 ± 7 | |
333 | 14 ± 3 | 10 ± 3 | 41 ± 4 | 163 ± 3 | 750 ± 10 | |
1000 | 14 ± 5 | 10 ± 4 | 42 ± 7 | 187 ± 7 | 772 ± 7 | |
2500 | 10 ± 5 | 12 ± 3 | 29 ± 3 | 171 ± 13 | 726 ± 58 | |
5000 | 9 ± 5 | 15 ± 4 | 30 ± 6 | 113 ± 15 | 698 ± 53 | |
2 -aminoanthracene | 2.5 | 383 ± 34 | 235 ± 24 | 5046 ± 72 | 4825 ± 97 | |
2 -aminoanthracene | 10.0 | 1501 ± 13 |
Table 2: Summary of results from the salmonella typhimurium reverse mutation assay of experiment 2 (pre-incubation test) with the test substance (mean +/- SD of revertants per plate).
Substance | Dose (µg/plate) | Without metabolic activation | ||||
TA 1535 | TA 1537 | TA 98 | TA 100 | TA 102 | ||
DMSO | 10 ± 4 | 8 ± 2 | 30 ± 6 | 147 ± 9 | 500 ± 47 | |
Untreated | 11 ± 2 | 9 ± 2 | 29 ± 7 | 193 ± 6 | 457 ± 32 | |
test substance | 3 | 145 ± 16 | ||||
10 | 29 ± 3 | 149 ± 8 | ||||
33 | 9 ± 2 | 9 ± 2 | 29 ± 3 | 142 ± 8 | 479 ± 17 | |
100 | 8 ± 2 | 8 ± 2 | 30 ± 9 | 68 ± 13 | 495 ± 4 | |
333 | 9 ± 3 | 8 ± 3 | 19 ± 4 | 51 ± 8 | 473 ± 20 | |
1000 | 7 ± 2 | 10 ± 2 | 15 ± 6 | 34 ± 9 | 405 ± 9 | |
2500 | 9 ± 2 | 8 ± 2 | 1 ± 1 | 1 ± 1 | 333 ± 28 | |
5000 | 8 ± 3 | 1 ± 1 | 1 ± 1 | 0 ± 1 | 297 ± 13 | |
Sodium azide | 10 | 1051 ± 93 | 1958 ± 135 | |||
4 -nitro-o-phenylene-diamine | 10 | 352 ± 32 | ||||
4 -nitro-o-phenylene-diamine | 50 | 85 ± 19 | ||||
methyl methane sulfonate | 2.0 µL | 4348 ± 421 | ||||
Substance | Dose (µg/plate) | With metabolic activation | ||||
TA 1535 | TA 1537 | TA 98 | TA 100 | TA 102 | ||
DMSO | 15 ± 1 | 16 ± 5 | 45 ± 6 | 132 ± 24 | 633 ± 5 | |
Untreated | 12 ± 2 | 18 ± 6 | 38 ± 1 | 197 ± 24 | 667 ± 11 | |
Test substance | 3 | 121 ± 11 | ||||
10 | 44 ± 7 | 145 ± 4 | ||||
33 | 13 ± 5 | 16 ± 5 | 37 ± 11 | 139 ± 14 | 605 ± 27 | |
100 | 12 ± 5 | 13 ± 5 | 34 ± 11 | 151 ± 14 | 659 ± 67 | |
333 | 12 ± 6 | 15 ± 5 | 36 ± 5 | 107 ± 8 | 616 ± 5 | |
1000 | 14 ± 3 | 16 ± 5 | 40 ± 16 | 133 ± 16 | 646 ± 67 | |
2500 | 12 ± 4 | 12 ± 3 | 40 ± 2 | 89 ± 2 | 583 ± 72 | |
5000 | 11 ± 5 | 14 ± 2 | 38 ± 2 | 36 ± 8 | 534 ± 49 | |
2 -aminoanthracene | 2.5 | 385 ± 12 | 178 ± 28 | 3323 ± 333 | 3923 ± 461 | |
2 -aminoanthracene | 1575 ± 177 |
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Trimethylessigsäureanhydrid at any concentration 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. Appropriate reference mutagens were used as positive controls. They showed a distinct in-crease in induced revertant colonies.
Applicant's summary and conclusion
- Executive summary:
This study was performed to investigate the potential of the test substance to induce gene mutations (according to OECD guideline 471) according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and TA 102. The assay was performed in two independent experiments both with and without liver microsomal activation in concentrations up to 5000 µg/plate. It can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test substance is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
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