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EC number: 252-029-5 | CAS number: 34443-12-4
- 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:
- 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study but without raw data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1983
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate
- EC Number:
- 252-029-5
- EC Name:
- OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate
- Cas Number:
- 34443-12-4
- Molecular formula:
- C13H26O4
- IUPAC Name:
- 3-({[(tert-butylperoxy)carbonyl]oxy}methyl)heptane
- Test material form:
- other: liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: TA 1535, 1537, 1538, 98 and 100
- Details on mammalian cell type (if applicable):
- strains regularly checked for their histidine requirement, ampicillin resistance (TA98 and TA100) and the frequency of spontaneous revertants
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 (following intraperitoneal injection of adult male Wistar rats of Aroclor 1524 (500 mg/kg bw) in corn oil, rats were killed by decapitation, livers were removed and the supernactant was extracted.)
- Test concentrations with justification for top dose:
- 0, 100, 333, 1000, 3333, 5000 µg/plate
- Vehicle / solvent:
- DMSO excepting for positive controls: DMS for TA100, TA98 and TA1538 without activation, and for all strains with activation.
Water for TA1535 and TA1537.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: TA 1535: sodium azide; TA 100: methylmethanesulfonate; TA 98 and TA 1538: 4-nitro-o-phenylene-diamine; TA1537: 9-aminoacridine /with metabolic activation: 2-aminoanthracene for all strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
EXPOSURE DURATION: 48 hours at 37 °C
NUMBER OF REPLICATIONS: 3
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: all strains
- 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:
- other: TA1535, TA1537, TA1538
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- from 1000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- other: TA98 and TA100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- other: yes, but only for TA98 and from 3333 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Mean number of revertant (His+), colonies /3 replicate plates WITHOUT S9 | |||||
Dose (µg/plate) | TA1535 | TA1537 | TA1538 | TA98 | TA100 |
100 | 7+-3 | 7+-4 | 5+-1 | 30+-5 | 125+-13 |
333 | 9+-3 | 5+-1 | 4+-1 | 25+-5 | 99+-25 |
1000 | 9+-2 | 6+-3 | 7+-3 | 25+-4 | 85+-25 |
3333 | 9+-1 | 9+-4 | 7+-3 | 29+-2 | 92+-10 |
5000 | 11+-7 | 10+-2 | 7+-3 | 33+-7 | 87+-15 |
Solvent control | 7+-3 | 8+-3 | 7+-2 | 17+-2 | 85+-26 |
Positive control | 320+-22 | 1282+-138 | 1163+-32 | 860+-141 | 775+-33 |
Mean number of revertant (His+), colonies /3 replicate plates WITH S9 | |||||
Dose (µg/plate) | TA1535 | TA1537 | TA1538 | TA98 | TA100 |
100 | 10+-0 | 14+-2 | 16+-3 | 54+-7 | 168+-10 |
333 | 8+-1 (b) | 20+-7(b) | 17+-1(b) | 90+-10 | 223+-23(b) |
1000 | 0(d) | 0(d) | 0(d) | 26+-3 | 334+-30(b) |
3333** | 0(d) | 0(d) | 0(d) | 9*(d) | 354+-211(c ) |
5000** | 0(d) | 0(d) | 0(d) | 14*(d) | 316+-23(d) |
Solvent control | 8+-1 | 10+-1 | 16+-2 | 32+-4 | 91+-2 |
Positive control | 170+-17 | 71+-7 | 1106+-22 | 992+-80 | 1787+-140 |
b) | slightly reduced background bacterial lawn | ||||
c) | moderately reduced background bacterial lawn | ||||
d) | background bacterial lawn extremely reduced or absent | ||||
* | 2 plates with no bacterial growth |
Applicant's summary and conclusion
- Conclusions:
- TBEC shown mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.
- Executive summary:
The potential of TBEC to induce reverse mutation in Salmonella typhimurium (strains: TA 1535, TA 1537, TA1538, TA 98, TA 100) was evaluated in accordance with the international guidelines (OECD 471, 1986) and in compliance with the Principles of Good Laboratory Practice.
TBEC was tested in two independent experiments, with and without a metabolic activation system, according to direct plate incorporation method, without and with S9.
Bacterias were exposed to TBEC at six dose-levels (three plates/dose-level) selected from a preliminary toxicity test: 0, 100, 333, 1000, 3333, 5000 µg/plate. After 48 hours of incubation at 37°C, the revertant colonies were scored.
No cytotoxicity and no noteworth increase in the number of revertants was noted without S9.
With S9, Cytotoxicity was clearly observed from 1000 µg/plate for strains TA1535, TA1537, TA1538.
TBEC produced dose-related increases in the number of revertants of testers strains TA98 and TA100 in the presence of S9.
In conclusion, under these experimental conditions, TBEC shown mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.
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