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EC number: 401-680-5 | CAS number: 125304-04-3 TINUVIN 171; TINUVIN 571
- 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 mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30.09. - 14.01.2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- adopted July 21, 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- RCC Cytotest Cell Research GmbH
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6
- EC Number:
- 401-680-5
- EC Name:
- A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6
- Cas Number:
- 125304-04-3
- Molecular formula:
- C25 H35 N3 O and C37 H59 N3 O
- IUPAC Name:
- Reaction mass of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol, branched and 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol, branched
- Details on test material:
- - Appearance: yellow liquid
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- HPRT locus
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: MEM (minimum essential medium) supplemented with 10 % FCS (foetal calf serum).
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from phenobarbital and ß-naphthoflavone induced liver of male Wistar rats.
- Test concentrations with justification for top dose:
- Cytotoxicity test
4hrs, with metabolic activation: 3.5, 7.0, 14.1, 28.1, 56.3, 112.5, 225.0, 450 µg/mL
4hrs, without metabolic activation: 3.5, 7.0, 14.1, 28.1, 56.3, 112.5, 225.0, 450 µg/mL
24hrs, without metabolic activation: 3.5, 7.0, 14.1, 28.1, 56.3, 112.5, 225.0, 450 µg/mL
Mutagenicity test
Experiment I (with and without metabolic activation):
4hrs: 14.1, 28.1, 56.3, 112.5, 225, 450 µg/mL (14.1 µg/ml was not continued)
Experiment II (without metabolic activation):
24 hrs: 14.1, 28.1, 56.3, 112.5, 225, 450 µg/mL (14.1 µg/ml was not continued) - Vehicle / solvent:
- - Vehicle/solvent used: ethanol (0.5 % v/v)
- Justification for choice of solvent/vehicle: The solvent was chosen according to its solubility properties and its non-toxicity to the cells.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: Ethylmethane sulfonate (0.3 mg/mL); with metabolic activation: 7,12-dimethylbenz(a)anthracene (2.5 µg/mL)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 hrs (with and without metabolic activation) and 24 hrs (without metabolic activation).
- Expression time (cells in growth medium): approx. 7 days
- Selection time (if incubation with a selection agent): 7-8 days
- Fixation time (start of exposure up to fixation or harvest of cells): after 15-16 days
SELECTION AGENT (mutation assays): 6-Thioguanin (11 µg/mL)
STAIN: 10 % methylene blue in 0.01 % KOH solution
NUMBER OF INDEPENDENT EXPERIMENTS: 2
NUMBER OF REPLICATIONS:
In each assay, cultures were treated in duplicate with four test chemical concentrations, a positive and a negative (DMSO) control.
EVALUATION: Counting of colonies formed after seeding of 3 - 5x10E5 cells in selective medium
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- The test item will be considered to be mutagenic if:
1. A test item is classified as mutagenic if it reproducibly induces a mutation frequency that is three times above the spontaneous mutation frequency at least at one of the concentrations in the experiment.
2. The test item is classified as mutagenic if there is a reproducible concentration-related increase of the mutation frequency. Such evaluation may be considered also in the case that a threefold increase of the mutant frequency is not observed.
Assay evaluation criteria
The gene mutation assay is considered acceptable if it meets the following criteria:
a) the numbers of mutant colonies per 10E6 cells found in the negative and/or solvent controls fall within the laboratory historical control data range of 1996 - 1997.
b) the positive control substances must produce a significant increase in mutant colony frequencies.
c) the cloning efficiency (absolute value) of the negative and/or solvent controls must exceed 50 %.
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Solubility: The test item formed a fine emulsion in the medium at 56.3 µg/mL and above in the absence and presence of metabolic activation in the first experiment and at 14.1 µg/mL and above in the second experiment. The maximal applicable concentration was 450 µg/mL since higher concentrations led to inhomogeneous emulsions with phase separation in the medium.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No relevant toxic effects were observed up to the maximal concentration of the test item. The concentration range of the test item was limited by solubility rather than toxicity.
Any other information on results incl. tables
EXPERIMENTAL RESULT
concentration (µg/ml) | S9 Mix | relative cloning efficiency (%)* | relative cell density (% of control) | viability factor** | mutant colonies / 106 cells | relative cloning efficiency (%)* | relative cell density (% of control) | viability factor** | mutant colonies / 106 cells | |
Experiment I, 4h treatment | culture I | culture II | ||||||||
Negative control | - | 100 | 100 | 0.82 | 7.8 | 100 | 100 | 0.75 | 8.9 | |
Solvent control with Ethanol | - | 100 | 100 | 0.79 | 3.9 | 100 | 100 | 0.73 | 6.3 | |
Positive control EMS | 300 | - | 97.1 | 67.4 | 0.8 | 109.2 | 89.8 | 84.6 | 0.94 | 119.9 |
Test item | 14.1 | - | 95.2 | 92.8 | culture was not continued | 87.5 | 97.6 | culture was not continued | ||
Test item | 28.1 | - | 99.5 | 96.6 | 0.57 | 8.8 | 95 | 82.6 | 0.66 | 10.5 |
Test item | 56.3 | - | 84.9 | 90.5 | 0.63 | 2.3 | 80.2 | 79.5 | 0.78 | 4.3 |
Test item | 112.5 | - | 86.8 | 109.5 | 1.03 | 5.1 | 87.6 | 75.9 | 0.69 | 12.7 |
Test item | 225 | - | 91.1 | 81 | 0.64 | 9.8 | 76.1 | 75.2 | 0.77 | 5.6 |
Test item | 450 | - | 90.4 | 111 | 0.8 | 19.3 | 81.9 | 71.2 | 0.7 | 7 |
Negative control | + | 100 | 100 | 0.67 | 6.4 | 100 | 100 | 0.47 | 9 | |
Solvent control with DMSO | + | 100 | 100 | 0.84 | 6.7 | 100 | 100 | 0.76 | 8.8 | |
Solvent control with Ethanol | + | 100 | 100 | 0.79 | 1.3 | 100 | 100 | 0.65 | 4 | |
Positive control DMBA | 2.5 | + | 52 | 86.4 | 0.85 | 453.6 | 50.6 | 62.9 | 0.63 | 638.3 |
Test item | 14.1 | + | 112.8 | 120.3 | culture was not continued | 123.4 | 69.3 | culture was not continued | ||
Test item | 28.1 | + | 110 | 122.4 | 0.75 | 10.7 | 107.5 | 103.6 | 0.76 | 3.4 |
Test item | 56.3 | + | 107.3 | 100.9 | 0.7 | 1.5 | 115.9 | 113.5 | 0.69 | 14.4 |
Test item | 112.5 | + | 93.5 | 117.4 | 0.65 | 4 | 110.7 | 87.7 | 0.67 | 6.5 |
Test item | 225 | + | 109.8 | 147.5 | 0.93 | 1.6 | 119.2 | 91.7 | 0.68 | 5.8 |
Test item | 450 | 110.8 | 137.4 | 0.8 | 3.2 | 113.4 | 148.4 | 0.64 | 4.9 | |
Experiment II, 24 h treatment | culture I | culture II | ||||||||
Negative control | - | 100 | 100 | 0.72 | 7.5 | 100 | 100 | 0.68 | 5.2 | |
Solvent control with Ethanol | - | 100 | 100 | 0.9 | 0.6 | 100 | 100 | 0.6 | 6.9 | |
Positive control EMS | 300 | - | 35.5 | 41.8 | 0.52 | 578 | 31.1 | 83.5 | 0.26 | 606.9 |
Test item | 14.1 | - | 98.8 | 101.4 | culture was not continued | 99.5 | 101.1 | culture was not continued | ||
Test item | 28.1 | - | 82.3 | 83 | 0.67 | 7 | 82.6 | 135.5 | 0.6 | 7.7 |
Test item | 56.3 | - | 93.2 | 57.2 | 0.65 | 1.7 | 73.3 | 113.1 | 0.57 | 8.3 |
Test item | 112.5 | - | 79 | 85.8 | 0.93 | 3.2 | 77.2 | 104.8 | 0.79 | 7.9 |
Test item | 225 | - | 93.8 | 81.1 | 0.97 | 3.4 | 85.1 | 104 | 0.68 | 0 |
Test item | 450 | - | 87 | 74.8 | 0.87 | 7.3 | 84.4 | 112.2 | 0.57 | 14.3 |
* mean number of cells per flask divided by mean number of cells per flask of the negative control multiplied with 100 (from cultures seeded with 500 cells each before treatment with the test substance)
** mean number of cells per flask divided by number of cells seeded (from cultures seeded with 500 cells each after expression)
Up to the highest investigated concentrations no relevant increase in mutant colony numbers was observed in both independent experiments. An isolated increase (19.3 colonies per 106cells) exceeding the threshold of three times the corresponding solvent control and the historical range of our negative and solvent controls was observed at 450.0 µg/ml in experiment I, culture I without metabolic activation. This increase was judged as biologically irrelevant since it was not reproduced in the parallel culture (culture II) under identical conditions. This effect is probably induced by inhomogeneity of the emulsion of the test item in medium at the maximal concentration. The factor of three times the corresponding solvent control was exceeded at almost all concentrations in the first culture of the second experiment. This effect however, is based upon the very low solvent control (0.6 colonies per 106cells) and represents statistical fluctuations at such low absolute numbers. The absolute numbers of colonies remained well within our range of historical negative and solvent controls and are below the corresponding negative control.
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions reported the test item did not induce gene mutations at the HPRT locus in V79 cells and is therefore considered to be non-mutagenic in this HPRT assay.
- Executive summary:
In an HPRT study according to OECD test guideline 476 and in compliance with GLP principles, the test article’s potential to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster was investigated. The assay was performed in two independent experiments. The cells were exposed to the test item for 4 hours in the first experiment with and without metabolic activation. The second experiment was solely performed in the absence of metabolic activation with a treatment period of 24 h. In order to determine the concentration range for the mutagenicity, a pre-test was performed with eight concentrations ranging from 3.5 to 450.0 µg/ml without metabolic activation (4 h and 24 h treatment) and with metabolic activation (4 h treatment). The maximal concentration was limited by the solubility of the test item. Concentrations above 450 µg/ml formed unstable emulsions leading to phase separation. No relevant toxic effects occurred in the pre-experiment up to the maximal concentration. Therefore, the following concentrations were evaluated in the main study: 28.1; 56.3; 112.5; 225.0; and 450.0 µg/ml. In the man test, the test item formed a fine emulsion in the medium at 56.3 µg/ml and above in the absence and presence of metabolic activation in the first experiment and at 14.1 µg/ml and above in the second experiment. Appropriate reference mutagens were used as positive controls and showed a distinct increase in induced mutant colonies. Up to the highest investigated concentration no relevant increase in mutant colony numbers was obtained in both independent experiments. An isolated increase exceeding the threshold of three times the corresponding solvent control and the historical range of our negative and solvent controls was observed at 450.0 µg/ml in experiment I, culture I without metabolic activation. This increase was judged as biologically irrelevant since it was not reproduced in the parallel culture (culture II) under identical conditions and based on a very low solvent control value. In conclusion, the test item did not induce gene mutations at the HPRT locus in V79 cells and is therefore considered to be non-mutagenic in this HPRT assay.
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