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EC number: 843-143-1 | CAS number: 709647-81-4
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
OECD 471 (2005) = Non-mutagenic
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 June - 05 July 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted under GLP in accordance with the international guideline.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Test concentrations with justification for top dose:
- Doses selected for the mutagenicity assay was based on data generated in preliminary study (Doses of 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg per plate) where no growth inhibition was observed in all tested strains with and without metabolic activation a. Precipitation was also not observed in all strains with and without metabolic activation. Therefore the doses for the main test were as follows;
0, 50, 150, 500, 1500 & 5000 μg per plate for all tested strains with or without metabolic activation. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Sterile water
- Justification for choice of solvent/vehicle: guideline recommended - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene (2AA), 1 μg per plate for TA100, 2 μg per plate for TA1535/37 & 10 μg per plate for WP2uvrA
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate): Triplicate
- Number of independent experiments: Three ; preliminary test and two main experiment
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): n/a
- Test substance added in medium; Direct plate incorporation was used for the assay. Measured aliquots (0.1 ml) of the bacterial cultures were dispensed into sets of test tubes followed by 2.0 ml of molten, trace histidine or tryptophan supplemented top agar, 0.1 ml of the test material formulation, vehicle or positive control and either 0.5 ml of S9-mix or phosphate buffer. The contents of each test tube were mixed and equally distributed onto the surface of Vogel-Bonner Minimal agar plates (one tube per plate). This procedure was repeated, in triplicates for each bacterial strain and for each concentration of test material both with and without S9-mix. All plates were incubated at at 37 °C for 48 hours and the frequency of revertant colonies assessed using Domino colony counter.
The second experiment was performed using dose range of 50 – 5000 ug/plate. The assay was perfomed by mixing 0.1 ml of bacterial culture, 0.1 ml of test material formulation, 0.5 ml of S9-mix or phosphate buffer and 2 ml of molten, trace histidine or tryptophan supplemented, top agar and overlaying onto sterile plates of Vogel-Bonner Minimal agar plates (30 ml/plate). In addition, 0.1 ml of the maximum concentration of test material and 2 ml of molten, trace histidine or tryptophan supplemented, top agar and overlaying onto sterile Nutrient agar plate in order to assess the sterility of the test material. After approximately 48 hours incubation at 37°C the plates were assessed for revertant colonies using Domino colony counter.
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: N/A
- Exposure duration/duration of treatment: 48 hours at 37 °C
- Harvest time after the end of treatment (sampling/recovery times): not stated - Rationale for test conditions:
- The reverse mutation was considered valid if the following criteria are met;
All tester strains cultures exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls.
The appropriate characteristics for each tester strain have been confirmed, e.g. rfa cell-wall mutation and pKM101 plasmid R-factor etc.
there should be a minimum of four non-toxic test material dose levels.
There should not be an excessive loss of plate due to contamination.
All tester strain cultures should be in the approximate range of 1 – 9.9 x109 bacteria per ml.
Each mean positive control value should be at least twice the respective vehicle control value for each strain, thus demonstrating the intrinsic sensitivity of the tester strains to mutagenic exposure and the integrity of the S9-mix. - Evaluation criteria:
- There are several criteria for determining a positive result, such as a dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. Biological relevance of the result will be considered first, statistical methods, as recommended by the UKEMS (5) can also be used as an aid to evaluation, however, statistical significant will not be the only determining factor for positive response.
A test material will be considered non-mutagenic (negative in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit a definitive judgment about the test material activity. Results of this type will be reported as equivocal. - Statistics:
- Not stated
- Key result
- 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:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- 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:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- 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:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- 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:
- valid
- True negative controls validity:
- not specified
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- MTEST-SPECIFIC CONFOUNDING FACTORS:
- Data on pH: Not specified
- Data on osmolality: Not specified
- Possibility of evaporation from medium: Not specified
- Water solubility: Not specified
- Precipitation and time of the determination: No precipitation was observed at all doses with and without metabolic activation.
- Definition of acceptable cells for analysis: All bacterial strains must have demonstrated the required characteristics as determined by their respective strain checks according to Ames et al (1975), Maron and Ames (1983) and Mortelmans and Zeiger (2000).
- Other confounding effects: no
RANGE-FINDING/SCREENING STUDIES (if applicable): Was conducted, no growth inhibition was observed in all TA strains with and without metabolic activation and Precipitation was not observed in all groups with and without metabolic activation.
STUDY RESULTS - Concurrent vehicle negative and positive control data: Both with historical control range
For all test methods and criteria for data analysis and interpretation: - Concentration-response relationship where possible: No increase in revertant were observed.
- Statistical analysis; not stated
- Any other criteria: not stated - Remarks on result:
- other: Negative for mutagenicity
- Conclusions:
- Based on the conditions of the study, the test item did not induce mutagenicity in the bacterial reverse mutation assay with or without metabolic activation.
- Executive summary:
OECD 471 ( 2005 ): The test item, was tested to evaluate its mutagenic potential using the preincubation method by measuring its ability to induce reverse mutations at selected loci of several strains of Salmonella typhimurium and at the tryptophan locus of Escherichia coli strain WP2uvrA in the presence and absence of an exogenous metabolic activation system. Distilled water was used as the vehicle.
The doses for the main test were as follows; 0, 50, 150, 500, 1500 & 5000 μg per plate for all tested strains with or without metabolic activation were selected based on the result of the preliminary study.
The test item in distilled water at, at concentrations of 50 mg/mL, was stable at room temperature under the condition of the study. No contaminant colonies were observed on the sterility plates for the vehicle control, the test substance dilutions or the S9 mixes.
Both positive and negative control gave acceptable results, confirming the validity of the test system. No visible reduction in the growth of bacterial background lawn or precipitate were observed with all tested strains under all conditions. No dose dependent increases were in all tester strain with or without metabolic activation. The test item was negative for mutagenicity in bacterial reverse mutation assay with or without metabolic activation.
Under the conditions of this study, test item did not meet the criteria for classification for mutagenicity in accordance with Globally Harmonized Classification System or the Regulation (EC) No. 1272/2008; relating to the Classification, Labelling and Packaging of Substances and Mixtures.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
The available information is insufficient to make conclusion on the mutagenic potential and mode of analysis of the substance.
Additional information
OECD 471 ( 2005 ): The test item, was tested to evaluate its mutagenic potential using the preincubation method by measuring its ability to induce reverse mutations at selected loci of several strains of Salmonella typhimurium and at the tryptophan locus of Escherichia coli strain WP2uvrA in the presence and absence of an exogenous metabolic activation system. Distilled water was used as the vehicle.
The doses for the main test were as follows; 0, 50, 150, 500, 1500 & 5000 μg per plate for all tested strains with or without metabolic activation were selected based on the result of preliminary study.
The test item in distilled water at a concentrations of 50 mg/mL, was stable at room temperature under the condition of the study. No contaminant colonies were observed on the sterility plates for the vehicle control, the test substance dilutions or the S9 mixes.
Both positive and negative control gave acceptable result, confirming the validity of the test system. No visible reduction in the growth of bacterial background lawn or precipitate were observed with all tested strains under all conditions. No dose dependent increases were in all tester strain with or without metabolic activation. The test item was negative for mutagenicity in bacterial reverse mutation assay with or without metabolic activation.
Under the conditions of this bacterial assay (OECD 471), the test item was concluded not to be mutagenic.
Justification for classification or non-classification
The test item was not mutagenic based on the OECD 471 study performed, however this information alone is not sufficient to conclude on classification for mutagenicity in accordance with Globally Harmonized Classification System or the Regulation (EC) No. 1272/2008; relating to the Classification, Labelling and Packaging of Substances and Mixtures.
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