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EC number: 203-317-4 | CAS number: 105-64-6
- 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
- Study period:
- 13 March 2017 - 16 May 2017
- 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:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bisisopropyl peroxydicarbonate
- EC Number:
- 203-317-4
- EC Name:
- Bisisopropyl peroxydicarbonate
- Cas Number:
- 105-64-6
- Molecular formula:
- C8H14O6
- IUPAC Name:
- 2-[({[(propan-2-yloxy)carbonyl]peroxy}carbonyl)oxy]propane
- Reference substance name:
- Ethyl acetate
- EC Number:
- 205-500-4
- EC Name:
- Ethyl acetate
- Cas Number:
- 141-78-6
- Molecular formula:
- C4H8O2
- IUPAC Name:
- ethyl acetate
- Test material form:
- liquid
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- n/a
- Additional strain / cell type characteristics:
- not applicable
- Cytokinesis block (if used):
- n/a
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix
- Test concentrations with justification for top dose:
- Since the test item was found freely soluble but toxic in the preliminary test, the selection of the highest dose level to be used in the main experiments was based on the level of toxicity, according to the criteria specified in the international guidelines.
Without S9 mix:
- 156.3, 312.5, 625, 1250, 2500 and 3750 µg/plate for the TA 98 strain in the 1st experiment,
- 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate for the TA 1535 and TA 1537 strains in the 1st experiment,
- 156.3, 312.5, 625, 1250, 2500, 3750 and 5000 µg/plate for the TA 98 strain in the 2nd experiment,
- 312.5, 625, 1250, 2500, 3750 and 5000 µg/plate for the TA 100 and TA 102 strains in the first experiment, and for the TA 98 strain in the 3rd experiment,
- 312.5, 625, 1250, 2500 and 5000 µg/plate for the TA 1535, TA 1537, TA 100 and TA 102 strains in the 2nd experiment.
With S9 mix:
- 312.5, 625, 1250, 2500, 3750 and 5000 µg/plate for the 5 strains in the 1st experiment, for the TA 1535 strain in the third experiment using the direct plate incorporation method, and for the TA 102 strain in the 3rd experiment,
- 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate for the 5 strains in the 2nd experiment and for the TA 98 strain in the 3rd experiment,
- 312.5, 500, 625, 937.5, 1250 and 2500 µg/plate for the TA 1535 strain in the 3rd experiment using the pre-incubation method,
- 250, 312.5, 500, 625, 1250 and 2500 µg/plate for the TA 100 strain in the 3rd experiment. - Vehicle / solvent:
- - Vehicle used: dimethylsulfoxide
- Justification for choice: test item was found soluble in the vehicle at a concentration of 100 mg/mL. Using a treatment volume of 50 µL/plate, the highest recommended dose level was avhievable.
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
- mitomycin C
- other: 2-Anthramine (2AM) Benzo(a)pyrene (BAP)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation);
- The direct plate incorporation method was used for all the experiments without S9 mix and for the first main test with S9 mix, as well as for the third experiment in the TA 1535 strain.
- The pre-incubation method was used for the second experiment with S9 mix, as well as for the third experiment with S9 mix conducted with the TA 1535, TA 98, TA 100 and TA 102 strains.
DURATION
- Preincubation period: 60 minutes
- Exposure duration: 48 to 72 hours.
DETERMINATION OF CYTOTOXICITY
- Method: decrease in number of revertant colonies and/or thinning of the bacterial lawn
NUMBER OF REPLICATIONS:
Three plates/dose-level. - Evaluation criteria:
- In all cases, biological relevance (such as reproducibility and reference to historical data) was taken into consideration when evaluating the results.
The test item is considered to have shown mutagenic activity in this study if:
- a reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the mean number of revertants compared with the vehicle controls is observed, in any strain, at any dose level,
- and/or a reproducible dose-response relationship is evidenced.
The test item is considered to have shown no mutagenic activity in this study if:
- neither an increase in the mean number of revertants, reaching 2-fold (for the TA 98, TA 100 and TA 102 strains) or 3-fold (for the TA 1535 and TA 1537 strains) the vehicle controls value, is observed at any of the tested dose levels,
- nor any evidence of a dose-response relationship is noted. - Statistics:
- no
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- Pre-incubation method
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- moderate to strong toxicity at the highest dose levels
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- Pre-incubation method
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- moderate to strong toxicity at the highest dose levels
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- moderate to strong toxicity at the highest dose levels
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- pre-incubation method
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- moderate to strong toxicity at the highest dose levels
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Moderate to strong toxicity at the highest dose levels
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Moderate to strong toxicity at the highest dose levels
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Moderate to strong toxicity at the highest dose levels
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Moderate to strong toxicity at the highest dose levels
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- Pre-incubation method
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- moderate to strong toxicity at the highest dose levels
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
Neither precipitate nor emulsion was observed in the Petri plates when scoring the revertants at any of the tested dose levels, either with or without S9 mix
RANGE-FINDING STUDY: In the absence of S9 mix, a moderate to strong toxicity (decrease in the number of revertants and/or of thinning of the bacterial lawn) was noted at dose levels = 2500 µg/plate in the TA 98 strain, and at the highest tested dose level of 5000 µg/plate in the TA 100 strain.
No noteworthy toxicity was noted in the presence of S9 mix.
RESULTS OF CYTOTOXICITY and GENOTOXICITY:
Without S9 mix
A moderate to strong toxicity (decrease in the number of revertants and/or thinning of the bacterial lawn) was noted at dose levels = 2500 µg/plate in the TA 1537 strain, = 3750 µg/plate in the TA 98 strain (except for the first experiment), and at 5000 µg/plate in the TA 1535 strain (second experiment only) and TA 100 strain (both experiments).
The test item did not induce any noteworthy increase in the number of revertants, in any of the five tested strains.
With S9 mix
Using the direct plate incorporation method, a moderate to strong toxicity (decrease in the number of revertants and/or thinning of the bacterial lawn) was noted at dose levels = 2500 µg/plate in the TA 1537 strain and at 5000 µg/plate in the TA 98 strain.
Using the pre-incubation method, a moderate to strong toxicity (decrease in the number of revertants and/or thinning of the bacterial lawn) was noted at dose levels = 937.5 µg/plate in the TA 1535 strain, = 1250 µg/plate in the TA 1537 and TA 100 strains, = 2500 µg/plate in the TA 98 strain and at 5000 µg/plate in the TA 102 strain (third experiment only).
Dose-related increases in the number of revertants were noted in the second main experiment when using the pre-incubation method, in all strains (except TA 1537 strain) and exceeded the thresholds of positivity. Since the first main experiment with S9 mix was conducted according to the direct plate incorporation method, the reproducibility of these increases was evaluated in a third independent experiment. In this third assay, the reproducibility of the increases was demonstrated in the same bacterial strains.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%): see attached
Applicant's summary and conclusion
- Conclusions:
- Diisopropyl peroxydicarbonate showed a mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium strains in the presence of a rat liver metabolizing system. No mutagenic activity was evidenced in the absence of metabolic activation.
- Executive summary:
The potential of diisopropyl peroxydicarbonate to induce reverse mutations was evaluated in Salmonella typhimurium. The study was performed according to the OECD guideline No. 471 and in compliance with the principles of Good Laboratory Practice. A preliminary toxicity test was performed to define the dose levels of the test item, dissolved in dimethylsulfoxide (DMSO), to be used for the mutagenicity experiments. The test item was then tested in three independent experiments, with or without a metabolic activation system, the S9 mix, prepared from a liver post-mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254. The direct plate incorporation method was used for all the experiments without S9 mix and for the first main test with S9 mix, as well as for the third experiment in the TA 1535 strain.
The pre-incubation method was used for the second experiment with S9 mix, as well as for the third experiment with S9 mix conducted with the TA 1535, TA 98, TA 100 and TA 102 strains. Five strains of bacteria Salmonella typhimurium were used: TA 1535, TA 1537, TA 98, TA 100 and TA 102. Each strain was exposed to at least five dose levels of the test item (three plates/dose level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored. The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
The mean number of revertants for the vehicle and positive controls met the acceptance criteria. Also, there were at least five analysable dose levels for each strain and test condition. The study was therefore considered to be valid. Since the test item was found freely soluble but toxic in the preliminary test, the selection of the highest dose level to be used in the main experiments was based on the level of toxicity, according to the criteria specified in the international guidelines. Neither precipitate nor emulsion was observed in the Petri plates when scoring the revertants at any of the tested dose levels, either with or without S9 mix.
Experiments without S9 mix
The selected dose levels were:
. 156.3, 312.5, 625, 1250, 2500 and 3750 µg/plate for the TA 98 strain in the first experiment,
. 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate for the TA 1535 and TA 1537 strains in the first experiment,
. 156.3, 312.5, 625, 1250, 2500, 3750 and 5000 µg/plate for the TA 98 strain in the second experiment,
. 312.5, 625, 1250, 2500, 3750 and 5000 µg/plate for the TA 100 and TA 102 strains in the first experiment, and for the TA 98 strain in the third experiment,
. 312.5, 625, 1250, 2500 and 5000 µg/plate for the TA 1535, TA 1537, TA 100 and TA 102 strains in the second experiment.
A moderate to strong toxicity (decrease in the number of revertants and/or thinning of the bacterial lawn) was noted in all the tested strains (except for the TA 102 strain) at the highest tested dose levels.
The test item did not induce any noteworthy increase in the number of revertants, in any of the five tested strains.
Experiments with S9 mix
The selected dose levels were:
. 312.5, 625, 1250, 2500, 3750 and 5000 µg/plate for the five strains in the first experiment, for the TA 1535 strain in the third experiment using the direct plate incorporation method, and for the TA 102 strain in the third experiment (pre-incubation method),
. 156.3, 312.5, 625, 1250, 2500 and 5000 µg/plate for the five strains in the second experiment and for the TA 98 strain in the third experiment,
. 312.5, 500, 625, 937.5, 1250 and 2500 µg/plate for the TA 1535 strain in the third experiment using the pre-incubation method,
. 250, 312.5, 500, 625, 1250 and 2500 µg/plate for the TA 100 strain in the third experiment.
A moderate to strong toxicity (decrease in the number of revertants and/or thinning of the bacterial lawn) was noted in all the tested strains at the highest dose levels.
Dose-related and/or reproducible increases in the number of revertants, exceeding the thresholds of positivity, were observed in the TA 1535, TA 98, TA 100 and TA 102 strains when using the pre-incubation method.
These results met the criteria for a positive response.
Diisopropyl peroxydicarbonate showed a mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium strains in the presence of a rat liver metabolizing system. No mutagenic activity was evidenced in the absence of metabolic activation.
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