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EC number: 218-507-2 | CAS number: 2167-23-9
- 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:
- The study was conducted between May 1978 and August 1979
- 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:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The procedures followed in the present protocol mimic as closely as possible those described by Ames and coworkers, in Mutation Research 31 (1975), 347-365.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Di-tert-butyl sec-butylidene diperoxide
- EC Number:
- 218-507-2
- EC Name:
- Di-tert-butyl sec-butylidene diperoxide
- Cas Number:
- 2167-23-9
- Molecular formula:
- C12H26O4
- IUPAC Name:
- 2,2-bis(tert-butylperoxy)butane
- Reference substance name:
- Dibutyl phthalate
- EC Number:
- 201-557-4
- EC Name:
- Dibutyl phthalate
- Cas Number:
- 84-74-2
- Molecular formula:
- C16H22O4
- IUPAC Name:
- dibutyl phthalate
- Reference substance name:
- Butanone
- EC Number:
- 201-159-0
- EC Name:
- Butanone
- Cas Number:
- 78-93-3
- Molecular formula:
- C4H8O
- IUPAC Name:
- butan-2-one
- Test material form:
- liquid
Constituent 1
additive 1
Constituent 2
- Specific details on test material used for the study:
- The study report covers multiple substances. In this report the substance is referred to as Trigonox D-B50.
Method
- Target gene:
- the histidine locus
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix using liver homogenate of Aroclor-induced rats
- Test concentrations with justification for top dose:
- 0.08, 0.4, 2 and 10 µl test liquid/0.1ml acetone/plate
All dilutions/solutions were prepared immediately before use. - Vehicle / solvent:
- acetone
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 0.1, 0.25, 0.5 and 1.0 µg/0.1ml DMSO/plate for all strains
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with and without S9-mix
- Details on test system and experimental conditions:
- Bacterial strains
Origin
The Salmonella typhimurium mutants used viz. s. typh. TA 1535, TA 1537, TA 1538, TA 98 and TA 100 were provided by Dr. B.N. Ames, Berkeley, California, USA. They are stored as frozen cultures at -80ºC.
Cultures for testing
To obtain cultures for mutagenesis testing, nutrient broth is inoculated with a thawed aliquot of the appropriate bacterial culture (0.1 ml per 10 ml nutrient bouillon) and grown up overnight with shaking at 37°C for 16 hours. The optical density is used as a measure for the total number of bacteria per ml. The bacterial cultures are stored in a refrigerator at 5ºC for up to four days.
MUTAGENESIS ASSAYS
Plate incorporation assay - Solids and non-volatile liiquids
The procedure used in this assay has been described in detail by Ames et al. (1975). Briefly the procedure is as follows: to 2 ml molten top agar (56°C) are added in this sequence 0.1 ml of a fully grown culture of one of the tester strains containing about 10^9 cells/ml , 0.1 ml of the appropriate dilution/suspension of the test product and 0.5 ml of the S-9 mix if indicated. The ingredients are thoroughly mixed and immediately poured onto minimal glucose agar plates.
After the top agar has been allowed to harden, the plates are incubated at 37°C for three days. Then the colonies (revertants which are histidine independent) are counted and the background lawn of bacterial growth is examined microscopically. Routinely, four to five different doses and a solvent control are tested with 5 different strains, viz. Salmonella typhimurium TA 1535, TA 1537, TA 1538, TA 99 and TA 100 with and without the liver microsome activation system. All determinations are made in triplicate.
S-9 mix and test product are checked for sterility. The dose range used in the mutagenesis assay is based on a preliminary test performed to assess the toxicity of the compound for the bacteria. If possible, the lowest toxic dose is taken as the highest dose for mutagenesis assay. In the case of questionable results the plate incorporation assay is partly repeated and/or, a number of revertant colonies is checked for histidine requirement and for other strain characteristics if appropriate.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and 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 1537
- Metabolic activation:
- with and 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 98
- Metabolic activation:
- with and 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:
- with and 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 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The results obtained with the various peroxides did not provide evidence of a dose-related, reproducible increase in the numbers of his+ revertants with any of the five tester strains, either in the presence or in the absence of S-9 mix.
Incorporation of 1 µl Triqonox 48 and of 0.01 µl Trigonox HM per plate appeared slightly toxic to the bacteria as revealed by a less dense background lawn of bacterial growth. Incorporation of the other four peroxides did not reveal any indication of an interference of chemical toxicity with mutagenicity testing.
From the present results it can be concluded that none of the six peroxides examined revealed mutagenic activity in the plate incorporation assay with s. typhimurium TA 1535, TA 1537, TA 1538, TA 98 or TA 100 in the presence or absence of the liver microsome activation system under the test conditions employed in this evaluation.
Applicant's summary and conclusion
- Conclusions:
- From the present results it can be concluded that none of the six peroxides examined revealed mutagenic activity in the plate incorporation assay with s. typhimurium TA 1535, TA 1537, TA 1538, TA 98 or TA 100 in the presence or absence of the liver microsome activation system under the test conditions employed in this evaluation.
- Executive summary:
1. The mutagenic activity of six organic peroxides: Trigonox B, Laurox, Trigonox 48, Trigonox HM, Trigonox D-B50 and Perkadox SE 10 was examined in the Salmonella/microsome mutagenicity test, using a set of five histidine requiring mutants of S. typhimurium (TA 1535, TA 1537, TA 1538, TA 98 and TA 100) and liver homogenate of Aroclor-induced rats.
2. Incorporation of the peroxides up to non-inhibitory levels did not increase the number of his+ revertants in any of the five tester strains, either in the presence or in the absence of the liver microsome activation system.
3. It was concluded that the present results did not reveal mutagenic activity with any of the test products in the Salmonella/microsome mutagenicity test.
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