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EC number: 700-954-4 | CAS number: 1338-23-4
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-11-27 to 2009-11-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-[(2-hydroperoxybutan-2-yl)peroxy]butane-2-peroxol; butane-2,2-diperoxol
- EC Number:
- 700-954-4
- Cas Number:
- 1338-23-4
- Molecular formula:
- Mixture of C4H10O4 and C8H18O6
- IUPAC Name:
- 2-[(2-hydroperoxybutan-2-yl)peroxy]butane-2-peroxol; butane-2,2-diperoxol
Constituent 1
Method
- Target gene:
- Bacterial strains of Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 were used.
His-mutations D6610 (TA97a) and D3052 (TA98) are frameshift mutations, reversion can occur by addition or deletion of base-pairs. His-mutation G46 (TA100) is a base pair mutation, reversion occurs by the substitution of a single base. In G428 (his-mutation of TA102) th codon CAA, coding for gutamine is mutated to the stop-codon TAA. The functionality of the wild type can be restored by base pair mutation as well as by deletion of 3 or 6 bases.
The rfa mutation leads to a reduced lipopolysaccharide barrier in the cell wall and allows larger molecules to pass the cell wall. Bacteria with this mutation are sensitive to crystal violet.
UvrB results in a loss of DNA-excision repair system. This increases the sensitivity to mutagenic influences. Bacteria with this mutation are sensitive to UV light.
The plasmid pkM101 also disturbs the ability of the bacteria to repair genetic damage and therefore increases their sensitivity to mutagens. Bacteria with this plasmid are resistant against ampicillin. TA102 is also resistant against tetracycline.
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA97a, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix
- Test concentrations with justification for top dose:
- In preliminary toxicity test, the following concentrations of test substance solutions are used: 5000, 1667, 556, 185, 62 and 21 µg/plate.
Main test: 556 µg/plate was chosen as highest concentration which could be in the toxic range, and a total of 6 concentrations was tested. - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- 2-nitrofluorene
- sodium azide
- other: 4-Nitro-o-phenylenediamine (TA97, without S9); t-Butyl-hydroperoxide (TA102, without S9); 2-aminoanthracene (TA98, TA100, TA1535, with S9); 1,8-dihydroxy-anthraquinone (TA102, with S9)
- Details on test system and experimental conditions:
- One day before the Ames test was performed, a small amount from each of the frozen bacterial cultures was transferred to nutrient. The liquid cultures were incubated in a shaker overnight at 37 °C and then used for the exposure. The mean number of viable cells in the overnight-cltures is 2 to 3 x10e9 cells per mL, based on historical data.
- Evaluation criteria:
- Calculations, criteria for a positive result:
Means and standard deviations were calculated for the number of mutants in every concentration group.
The criteria for a positive result are:
A reproducible increase of the number of revertants to more than the following threshold values for at least one of the concentrations:
- For the strains with a low spontaneous revertant rate i.e. TA98 and TA1535: The 2 1/2 fold of the amount of the spontaneous revertants.
- For the strains with a high spontaneous revertant rate i.e. TA97a, TA100 and TA102: The 1 2/3 fold of the amount of the spontaneous revertants.
These threshold values were derived from the variations in the control samples of historic data of the Ames test. - Statistics:
- Means and standard deviations were calculated for the number of mutants in every concentration group.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- In the main test, the test substance was again toxic to bacteria at 556 µg/plate and some of the 185 µg/plate samples. At 62 µg/plate and beneath the bacterial background was normal. Only strain TA102 was not affected.
There was no such increase in the number of mutants in any of the tested bacterial strains at any of tested concentrations. The addition of an external metabolising system did not change these results.
Applicant's summary and conclusion
- Conclusions:
- According to these results, methyl-ethylketone peroxide in TXIB/diacetone alcohol is not mutagenic in the Ames test with the strains of Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 with and without an external metabolising system up to 556 µg/plate, which is the limit of toxicity.
- Executive summary:
Methyl-ethylketone peroxide in TXIB/diacetone alcohol was tested in the Salmonella typhimurium reverse mutation test (Ames test) according to OECD guideline 471 and EU method B.13/14. Five bacterial strains, Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 were used to investigate the mutagenic potential of methyl-ethylketone peroxide in two independent experiments. These experiments were carried out with and without metabolic activation (S9 mix). Triplicate repetitions were run for each dose group in each of two seperate experiments that were conducted, for the control groups six-fold repetitions were run. The exposure for the first experiment was performed according to the Plate Incorporation Assay. The exposure for the second experiment was performed according to the Preincubation Assay. All positive and negative (solvent) control groups were in the range of the historical control range and demonstrated the sensitivity and validity of the test. There was no biologically relevant increase in the number of mutants in any of the tested bacterial strains at any of the tested concentrations. The addition of an external metabolising system did not change the results.
Methyl-ethylketone peroxide is not mutagenic in the Ames test with the strains of Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 with and without an external metabolising system up to 556 ug/plate, which is the limit of toxicity.
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