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EC number: 243-424-3 | CAS number: 19910-65-7
- 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:
- 17 January 2018 - 07 March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis-sec-butyl peroxydicarbonate
- EC Number:
- 243-424-3
- EC Name:
- Bis-sec-butyl peroxydicarbonate
- Cas Number:
- 19910-65-7
- Molecular formula:
- C10H18O6
- IUPAC Name:
- 2-[({[(butan-2-yloxy)carbonyl]peroxy}carbonyl)oxy]butane
- Test material form:
- not specified
- Details on test material:
- - Storage conditions: frozen at -60°C to -80°C, protected from light
Constituent 1
- Specific details on test material used for the study:
- - Density: 1.06 g/mL at 5°C
- No correction factor was applied
Method
- Target gene:
- Salmonella typhimurium: histidine gene
Escherichia coli: tryptophan gene
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor™ 1254-induced rat liver S9 fraction.
- Test concentrations with justification for top dose:
- Dose range finding experiment (all strains, with and without S9): 25, 50, 100, 250, 500, 1000, 2500, and 5000 μg/plate
First experiment (TA1537, TA98, TA100 and TA1535 without S9): 0.1, 0.25, 0.5, 1.0, 2.5, 5.0, 10, 25, 50, and 100 μg/plate
First experiment (TA1537, TA 98, TA100 and TA1535 with S9 and WP2uvrA with and without S9): 0.5, 1.0, 2.5, 5.0, 10, 25, 50, 100, 250, and 500 μg/plate
Second experiment (TA1537, TA98, TA100 and TA1535 without S9): 0.5, 1.0, 2.5, 5.0, 10, 25, 50, and 100 μg/plate
Second experiment (TA1537, TA 98, TA100 and TA1535 with S9 and WP2uvrA with and without S9): 2.5, 5.0, 10, 25, 50, 100, 250, and 500 μg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: according to OECD test guideline
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- other: ICR-191; 2-aminoanthracene
- Remarks:
- For more details on the positive control substances, see table 1
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3
PERFORMANCE OF THE ASSAY: Sterile 12 × 75 mm test tubes were placed in heating blocks at 45°C to 47°C and the following items were added in a stepwise manner for each concentration of test or control substance: 2.00 mL of top agar, supplemented with 10% of a 0.5 mM histidine/biotin/tryptophan solution, 0.10 mL of indicator organisms (overnight culture), 0.10 mL of vehicle control or test substance, or 0.05 mL of positive control substance and 0.50 mL of metabolic activation mixture or PBS, for tests with or without S9, respectively. The tube contents were mixed gently and then poured onto minimal glucose plates. The top agar was allowed to set and the plates were incubated at 36°C to 38°C for 2 days.
CYTOTOXICITY:
- Cytotoxicity was examined by the reduction of the bacterial background lawn
COLONY COUNTING:
The number of revertant colonies were counted by hand or with an automatic colony counter and then recorded. Plates that had a cytotoxic reduction in background lawn growth (> 50% reduction in the background lawn) were counted. - Evaluation criteria:
- POSITIVE RESPONSE:
The test substance was considered positive for mutagenicity if it induced an increase of revertants per plate with increasing concentration. The increases should be at least 2 times the vehicle control background frequency for strains with high spontaneous levels (i.e., TA100) and three times for those with low spontaneous levels (TA1537, TA98, TA1535, and WP2 uvrA).
These increases should be seen in at least 2 or more successive concentrations or the response should be repeatable at a single concentration.
NEGATIVE RESPONSE:
The test substance was considered to be negative for inducing mutagenicity if it did not induce a response which fulfills the criteria for a positive response.
EQUIVOCAL RESPONSE:
Cases which did not clearly fit into the positive or negative criteria may be judged equivocal. In these cases the Study Director, based on sound scientific judgment, may take additional factors into consideration in evaluating the test results.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 250 μg/plate and ≥ 50 μg/plate (DRF study, with and without S9, resp.); ≥ 100 μg/plate and ≥ 50 μg/plate (first experiment, with and without S9, resp.); ≥ 250 μg/plate and ≥ 100 μg/plate (second experiment, with and without S9, resp.)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 100 μg/plate and ≥ 50 μg/plate (DRF study, with and without S9, resp.); ≥ 100 μg/plate and ≥ 25 μg/plate (first experiment, with and without S9, resp.); ≥ 100 μg/plate and ≥ 50 μg/plate (second experiment, with and without S9, resp.)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Remarks:
- ≥ 250 μg/plate and ≥ 50 μg/plate (DRF study, with and without S9, resp.); ≥100 μg/plate (first experiment, with and without S9); ≥ 100 μg/plate (second experiment, with and without S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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
- Remarks:
- ≥ 250 μg/plate and ≥ 25 μg/plate (DRF study, with and without S9, resp.); ≥ 100 μg/plate and ≥ 25 μg/plate (first experiment, with and without S9, resp.); ≥ 100 μg/plate and ≥ 25 μg/plate (second experiment, with and without S9, resp.)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- ≥ 250 μg/plate and ≥ 500 μg/plate (DRF study, with and without S9, resp.); ≥ 250 μg/plate (first and second experiment, with and without S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- - No precipitation was observed in any of the experiments.
- There were no increases in the number of revertant colonies indicating a positive repsonse for inducing mutagenicity. Therefore, the test item is considered to be not mutagenic.
- The means of all positive control data were at least 3-fold greater than the means of the vehicle control data and comparable to the historical data.
- In both the first and second assay, criteria for a negative response were met for all tester strains with and without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of an Ames test, performed according to OECD guideline 471 and GLP principles, Di-sec-butyl peroxydicarbonate is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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