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EC number: 216-971-0 | CAS number: 1709-70-2
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study in compliance with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.5375 (In Vitro Mammalian Chromosome Aberration)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- EC Number:
- 248-597-9
- EC Name:
- 1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
- Cas Number:
- 27676-62-6
- IUPAC Name:
- 1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazinane-2,4,6-trione
- Reference substance name:
- 1,3,5-tris(3,5-di-tert-butyl-4- hydroxybenzyl)-1,3,5-triazine- 2,4,6(1H,3H,5H)-trione
- IUPAC Name:
- 1,3,5-tris(3,5-di-tert-butyl-4- hydroxybenzyl)-1,3,5-triazine- 2,4,6(1H,3H,5H)-trione
- Details on test material:
- - Physical state: solid
- Analytical purity: 98.2%
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Nutrient Mixture F-12 supplemented with 10% fetal calf serum + Penicillin/Streptomycin
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Concentration range in cytotoxicity/genotoxicity test: 0.22 - 28.0 µg/ml
Concentration range in chromosome analysis test: 7.0 - 28.0 µg/ml - Vehicle / solvent:
- Solvent used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without microsomal activation
Migrated to IUCLID6: 0.2 µg/ml
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with microsomal activation
Migrated to IUCLID6: 40.0 µg/ml
- Details on test system and experimental conditions:
- The cytotoxicity test was performed as an integral part of the mutagenicity test. A series of Falcon flasks was seeded with Chinese hamster ovary cells. The preincubation time before treatment was 29 hours. The substance in DMSO was added (1:100) to the cells in culture medium. In the experiments in which the substance was metabolically activated, 1.0 ml of an activation mixture was added to 9.0 ml of culture medium.
In all four experiments, the cells were exposed to eight concentrations of the test substance ranging from 0.22 to 28.0 µg/ml.
Experiment 1: 7.0 - 28.0 µg/ml, test without activation, duration of treatment: 18 hours, recovery: 0 hours
Experiment 2: 7.0 - 28.0 µg/ml, test with activation, duration of treatment: 3 hours, recovery: 15 hours
Experiment 3: 7.0 - 28.0 µg/ml, test without activation, duration of treatment: 42 hours, recovery: 0 hours
Experiment 4: 7.0 - 28.0 µg/ml, test with activation, duration of treatment: 3 hours, recovery: 39 hours
Two hours prior to harvesting, the cultures were treated with Colcemide 0.4 µg/ml. The experiment was terminated by hypotonic treatment (0.075 M KCl solution) of the cells, followed by fixation (methanol:acetic acid, 3:1). Drop preparations were made by the air-drying technique.
The percentages of mitotic suppression in comparison with the controls were evaluated by counting at least 2000 cells per concentration . The deteirmination of the mitotic coefficient was performed for all four experiments separately.
One hundred metaphase figures with 19 to 21 chromosomes from cultures of two falcon flasks in the vehicle control, in the treated groups and at least fifty metaphases in the positive controls were examined. - Evaluation criteria:
- Criteria for a positive response:
- A test substance is considered to be active in this test system if in comparison to the negative control a marked increase in the number of specific chromosomal aberrations appears or if an increased number of exchange figures appears together with a high number of other specific chromosomal aberrations such as breaks and fragments.
- A concentration-related response in the number of aberrations should be demonstrable.
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- reduced mitotic index in all experiments at the highest concentration (28 µg/ml)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The number of chromosome aberrations was within the historical control range at all doses assessed.
The highest concentration of 28.0 µg/ml available for analysis in the first experiment caused 21.1% suppression of mitotic activity. The highest concentration of 28.0 µg/ml available for analysis in the second experiment caused 12.1% suppression of mitotic activity. In the third experiment with a 42 hours treatment period the concentration of 28.0 µg/ml available for analysis caused 29% suppression of mitotic activity. In the fourth experiment (3 hours treatment / 39 hours recovery) the highest concentration of 28.0 µg/ml available for analysis caused 19% suppression of mitotic activity. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
EXPERIMENTAL RESULT
percent of metaphases with aberrations | ||||||
Exposure Time | Sampling Time | Dose (µg/ml) | S9-Mix | number of metaphases | specific | unspecific |
18 h | 18 h | Vehicle | - | 100 | 1 | 2 |
18 h | 18 h | 7 | - | 100 | 1 | 2 |
18 h | 18 h | 14 | - | 100 | 1 | 2 |
18 h | 18 h | 28 | - | 100 | 0 | 3 |
18 h | 18 h | Mito-C; 0.2 | - | 100 | 50 | 18 |
3 h | 18 h | Vehicle | + | 100 | 0 | 1 |
3 h | 18 h | 7 | + | 100 | 2 | 2 |
3 h | 18 h | 14 | + | 100 | 1 | 0 |
3 h | 18 h | 28 | + | 100 | 1 | 2 |
3 h | 18 h | CPA; 40 | + | 100 | 36 | 18 |
42 h | 42 h | Vehicle | - | 100 | 1 | 5 |
42 h | 42 h | 7 | - | 100 | 0 | 2 |
42 h | 42 h | 14 | - | 100 | 1 | 2 |
42 h | 42 h | 28 | - | 100 | 0 | 1 |
3 h | 42 h | Vehicle | + | 100 | 3 | 1 |
3 h | 42 h | 7 | + | 100 | 1 | 0 |
3 h | 42 h | 14 | + | 100 | 3 | 2 |
3 h | 42 h | 28 | + | 100 | 1 | 5 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the given experimental conditions no evidence of clastogenic effects was obtained in Chinese hamster ovary cells in vitro treated with the test substance. - Executive summary:
The clastogenic activity of the test substance was assessed in experiments without metabolic activation at concentrations between 7.0 and 28.0 µg/ml with 18 hours incubation time and with 42 hours incubation time. In the experiments with a metabolic activating system the concentrations between 7.0 and 28.0 µg/ml with 3 hours incubation followed by 15 hours recovery period and with 3 hours incubation followed by 39 hours recovery period were assessed. One hundred metaphases were examined from the vehicle control and from the cultures treated with the various concentrations of the test substance. At least fifty metaphases each from the appropriate positive controls were analyzed. Neither with nor without metabolic activation a significant increase in the number of chromosome aberrations were observed. The number of chromosome aberrations was within the historical control range at all doses assessed. It is concluded that under the given experimental conditions no evidence of clastogenic effects was obtained in Chinese hamster ovary cells in vitro treated with the test substance.
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