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EC number: 907-728-6 | CAS number: -
- 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
Ames test (OECD TG 471): negative
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:
- 9 November - 8 December 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- - S. typhimurium: Histidine gene
- 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:
- Rat liver S9-mix induced by a combination of phenobarbital and ß-naphthoflavone
- Test concentrations with justification for top dose:
- - Experiment 1:
TA 1535, TA 1537, TA 98, TA 100 and E.coli WP2uvrA (without and with S9): doses of 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
- Experiment 2:
Salmonella strains TA1535 (presence of S9) and TA1537 (absence and presence of S9): 0.5, 1.5, 5, 15, 50, 150, 500 and 1500 µg/plate.
Salmonella strain TA1535 (absence of S9) and Salmonella strains TA100 and TA98 (absence and presence of S9): 0.15, 0.5, 1.5, 5, 15, 50, 150, 500 µg/plate.
E.coli strain WP2uvrA (absence and presence of S9): 15, 50, 150, 500, 1500 and 5000 µg/plate.
However, results from the second mutation test (pre-incubation method) showed that the toxicity of the test item yielded results that differed significantly from Experiment 1 and consequently an insufficient number of non-toxic dose levels were initially attained for WP2uvrA in the absence of S9-mix. Therefore, this strain was repeated employing an amended test item dose range as follows:
WP2uvrA (absence of S9): 0.15, 0.5, 1.5, 5, 15, 50, 150, 500 µg/plate. - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: the test substance was found to be soluble in DMSO up to 5000 µg/plate - Untreated negative controls:
- yes
- Remarks:
- (untreated plates)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (50 or 100 µL/plate DMSO)
- Positive controls:
- yes
- Positive control substance:
- other: see section "Any other information on materials and methods incl. tables"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- Experiment 1: plate incorporation method (0.1 mL of the appropriate concentration of test item, solvent vehicle or appropriate positive control was added to 2 mL of molten, trace amino-acid supplemented media containing 0.1 mL of one of the bacterial strain cultures and 0.5 mL of phosphate buffer. These were then mixed and overlayed onto a Vogel Bonner agar plate. In case of treatment with metabolic activation, 0.5 mL of S9 mix was added to the molten instead of phosphate buffer.)
- Experiment 2: pre-incubation method (0.1 mL of the appropriate bacterial strain culture, 0.5 mL of phosphate buffer and 0.1 mL of the test item formulation, solvent vehicle or 0.1 mL of appropriate positive control were incubated at 37 ± 3°C for 20 minutes (with shaking) prior to addition of 2 mL of molten, trace amino-acid supplemented media and subsequent plating onto Vogel Bonner plates. In case of treatment with metabolic activation, 0.5 mL of S9 mix was added to the tube instead of phosphate buffer.)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain, in all experiments
DETERMINATION OF CYTOTOXICITY
- Method: on the basis of a decline in the number of spontaneous revertants, a thinning of the background lawn or a microcolony formation - Evaluation criteria:
- For the test substance to be considered mutagenic:
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out of historical range response (Cariello and Piegorsch, 1996)).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met. - Key result
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100 and E.coli WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test item precipitation was observed on the plates up to and including the top dose of 5000 µg/plate
EXPERIMENTS 1 AND 2:
- In the first mutation test, the test item caused a visible reduction in the growth of the bacterial background lawns of all of the tester strains (except WP2uvrA dosed in the presence of S9-mix), initially from 150 µg/plate in both the absence and presence of S9-mix.
- In the second mutation test, the test item again induced a toxic response with weakened bacterial background lawns noted in the absence of S9-mix from 50 µg/plate (TA100, TA1535, WP2uvrA and TA98) and 150 µg/plate (TA1537). In the presence of S9-mix, weakened bacterial background lawns were noted from 500 µg/plate (TA100, TA1535, TA98 and TA1537) and 1500 µg/plate (WP2uvrA).
COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
There were no toxicologically significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in Experiment 1 (plate incorporation method). Similarly, no toxicologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in Experiment 2 (pre incubation method). Statistically significant increases in TA1535 revertant colony frequency were observed in the first mutation test from 150 to 5000 µg/plate in the absence of S9-mix and from 500 to 5000 µg/plate in the presence of S9-mix. Statistically significant increases in TA1535 revertant colony frequency were again observed in the second mutation test at one dose only (500 µg/plate) in the absence and presence of S9-mix. These increases were considered to have no biological relevance because weakened bacterial background lawns were also noted at the same test item dose levels. Therefore the ‘response’ observed would be due to additional histidine being available to His- bacteria allowing these cells to undergo several additional cell divisions and present as non-revertant colonies. - Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay (Ames test) performed according to OECD 471.
- Executive summary:
The mutagenic activity of the substance was evaluated in accordance with OECD 471 and according to GLP principles, in the Ames test. The test was performed in two independent experiments, at first a direct plate assay was performed and secondly a pre-incubation assay, both in the absence and presence of S9-mix. The dose levels were selected based on the dose finder study, up to the maximum recommended dose level of 5000 µg/plate. Adequate negative and positive controls were included. There were no toxicologically significant increases in the frequency of revertant colonies recorded for any of the bacterial strains (TA1535, TA1537, TA98, TA100 and E.coli WP2uvrA), with any dose of the test item, either with or without metabolic activation. Based on the results of this study, it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The mutagenic activity of the substance was evaluated in accordance with OECD 471 and according to GLP principles, in the Ames test. The test was performed in two independent experiments, at first a direct plate assay was performed and secondly a pre-incubation assay, both in the absence and presence of S9-mix. The dose levels were selected based on the dose finder study, up to the maximum recommended dose level of 5000 µg/plate. Adequate negative and positive controls were included. There were no toxicologically significant increases in the frequency of revertant colonies recorded for any of the bacterial strains (TA1535, TA1537, TA98, TA100 and E.coli WP2uvrA), with any dose of the test item, either with or without metabolic activation. Based on the results of this study, it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay.
Justification for classification or non-classification
Based on the results of the Ames test, the substance does not have to be classified for mutagenicity in accordance with EU CLP and its amendments ( EC/1272/2008).
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