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EC number: 209-987-4 | CAS number: 600-22-6
- 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
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- modified version of the Ames test (OECD 471), designated Ames II Assay (microtiter version).
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methyl pyruvate
- EC Number:
- 209-987-4
- EC Name:
- Methyl pyruvate
- Cas Number:
- 600-22-6
- Molecular formula:
- C4H6O3
- IUPAC Name:
- methyl 2-oxopropanoate
Constituent 1
Method
- Target gene:
- His gene
Species / strain
- Species / strain / cell type:
- other: TA 98, TA Mix (TA 7001 - TA 7006)
- Metabolic activation:
- with and without
- Metabolic activation system:
- mix from induced male Wistar rats
- Test concentrations with justification for top dose:
- O; 4; 20; 100; 500; 2500 and 5000 μg/ml
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other:
- Details on test system and experimental conditions:
- Bacteria from overnight cultures were used. 5 ml of the overnight cultures were added to tubes containing 25 ml Ames II Exposure medium and were gently mixed. After thorough
pipetting the following components were added in 24-well plates:
Without S9 mix
240 μL Bacteria suspension (tester strain + exposure medium)
10 μL Test substance or vehicle or positive control
With S9 mix
200 μL Bacteria suspension
40 μL S9 mix (liver homogenate to buffer ratio: 3:7)
10 μL Test substance or vehicle or positive control
The 24-well plates were incubated at 37°C with shaking at 250 rpm for about 90 minutes. After this incubation period, 2.8 ml Ames II Reversion indicator medium (containing bromocresol purple) was pipetted to each well of the 24-well plate. The contents of each well of the 24-well plates were distributed in 50 μL aliquots over 48 wells of a 348-well Revertant Colony Selection plate (RCSP). The plates were sealed in plastic bags and incubated at 37°C in the dark. After 48 hours incubation each 48-well section of the RCSP were scored and the number of positive wells (yellow = high number of his+ revertants) were counted.
48 wells in triplicate plates per dose or per control were used - Rationale for test conditions:
- This method shows a good accuracy concerning the prediction of the results in the regular Ames test.
- Evaluation criteria:
- An increase in the mean number of positive wells in dose groups was compared to the mean value of the concurrent negative control (Evaluation factor 1 F).
- An increase in the mean of revertant wells in dose groups was calculated on the basis of the baseline data of the actual experiment (Evaluation factor 2 F). The baseline was derived from the mean spontaneous revertant number plus the value of standard deviation (mean + SD) from the distribution of spontaneous data.
- An increase in the mean of revertant wells in dose groups was calculated on the basis of the baseline data of an experimental run (Evaluation factor 3 F). A run consists of a variable number of experiments generally testing different test substances together each using the same vehicle control. This leads to an accumulation of replicates for negative controls which was used to calculate the mean spontaneous reversion number for each run.
A test substance is considered mutagenic in this test system if more than a doubling of Evaluation factor 3 F is observed.
Results and discussion
Test results
- Species / strain:
- other: TA 98, TA Mix (TA 7001 - TA 7006)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- - TOXICITY
No bacteriotoxic effect (clearing of the background lawn, decrease in the number of yellow wells) was observed.
- MUTAGENICITY
An increase in the number of positive wells (his+ revertants) was not observed either without S9 mix or after the addition of a metabolizing system.
- Precipitation in plates: No precipitation occurred
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this study, the test substance Methyl pyruvat is not a mutagenic substance in the Ames II Assay (Salmonella typhimurium reverse mutation assay) in the absence and the presence of metabolic activation.
- Executive summary:
No bacteriotoxic effect (clearing of the background lawn, decrease in the number of yellow wells) and no increase in the number of positive wells (his+ revertants) was observed either without S9 mix or after the addition of a metabolizing system.
Thus, Methyl pyruvat is not a mutagenic substance in the Ames II Assay (Salmonella typhimurium reverse mutation assay) in the absence and the presence of metabolic activation under the experimental conditions of this study.
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