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EC number: 287-007-4 | CAS number: 85408-46-4
- 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
The test substance is not mutagenic in bacterias as determined in two bacterial reverse mutation assays, with the latest from 2016, both according to OECD 471.
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:
- 12 Jul 2016 to 21 Jul 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:
- 21 July 1997
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- August 1998
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 001-152602
- Expiration date of the lot/batch: 01 Jul 2025
- Purity test date: 01 Jul 2015
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The homogeneity of the test substance was ensured by mixing before preparation of the test substance solutions.
- Final preparation of a solid: The test substance was weighed and topped up with the chosen vehicle to achieve the required concentration of the stock solution. The test substance was dissolved in dimethyl sulfoxide (DMSO). - Target gene:
- S. typhimurium: his
E. coli: trp - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-naphthoflavone induced rat liver S9 fraction or Uninduced hamster liver S9 fraction
- Test concentrations with justification for top dose:
- 0; 33; 100; 333; 1000; 2500 and 5000 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:DMSO;
- Justification for choice of solvent/vehicle: Due to the insolubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available. - Untreated negative controls:
- yes
- Remarks:
- Sterility control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- congo red
- other: 2-aminoanthracene (2AA) / N-methyl-N'-nitro-N-nitrosoguanidine (MNNG) / 4-nitro-o-phenylenediamine (NOPD) see section "Any other information on materials and methods incl. tables"
- Remarks:
- See 'Any other information on materials and methods incl. tables' for details on positive controls
- Details on test system and experimental conditions:
- EXPERIMENT 1, 2:
METHOD OF APPLICATION: in medium; in agar (plate incorporation)
DURATION
- Exposure duration: 48 - 72 hours at 37°C
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
Toxicity detected by a
• decrease in the number of revertants (factor ≤ 0.6)
• clearing or diminution of the background lawn (= reduced his- or trp- background growth) was recorded for all test groups both with and without S9 mix in all experiments and indicated in the tables. Single values with a factor ≤ 0.6 were not detected as toxicity in low dose groups. - Evaluation criteria:
- ACCEPTANCE CRITERIA
Generally, the experiment was considered valid if the following criteria were met:
• The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
• The sterility controls revealed no indication of bacterial contamination.
• The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above.
• Fresh bacterial culture containing approximately 10E+9 cells per mL were used.
ASSESSMENT CRITERIA
The test substance was considered positive in this assay if the following criteria were met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other. - Key result
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA1535, TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- See any other information on results
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- cytotoxicity
- Remarks:
- See any other information on results
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Solubility - Precipitation: Precipitation of the test substance was found at 5000 μg/plate with and without S9 mix.
Reference
BACTERIOTOXIC EFFECT
Decreased revertant numbers were observed at following concentrations (μg/plate):
Experiment |
S9 |
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
E. coli |
1st-SPT |
Without |
- |
1000 - 5000 |
2500 - 5000 |
- |
5000 |
With |
5000 |
- |
- |
5000 |
- |
|
2nd-Prival |
Without |
5000 |
5000 |
5000 |
5000 |
5000 |
With |
5000 |
- |
5000 |
5000 |
5000 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the latest reverse mutation assay (BASF, 2016), strains of Salmonella typhimurium and Escherichia coli were exposed to five concentrations of the test item in a Standard plate test (SPT) as well as Prival preincubation test (Prival) both with and without metabolic activation. The study is according to OECD 471 and US EPA OPPTS 870.5100, Aug 1998, performed in compliance with GLP criteria.
All strains were exposed to the concentrations of 0, 33, 100, 333, 1000, 2500 and 5000 µg test item per plate. Each experiment included negative controls in order to check for possible contaminants (sterility control) and to determine the spontaneous mutation rate (vehicle control). Additionally, positive controls were used to check the mutability of the bacteria and the activity of the S9 mix. Precipitation of the test substance was found at 5000 μg/plate with and without S9 mix. A bacteriotoxic effec (decrease in the number of his+ or trp+ revertants) was observed in the standard plate test depending on the strain and test conditions from about 1000 μg/plate onward. In the prival preincubation assay bacteriotoxicity (decrease in the number of his+ or trp+ revertants) was observed depending on the strain and test conditions at 5000 μg/plat.
A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the prival preincubation test either without S9 mix or after the addition of a metabolizing system. Based on the results of this study it is concluded that the test substance is not mutagenic in the S. typhimurium/E. coli reverse mutation assay in the absense and presence of metabolic activation.
In the other Ames study (Batelle, 1978), also performed according to OECD 471, the test substance was tested with the Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at concentrations from 0.2 to 2000 µg (or nL) per Petri dish both in the presence and absence of metabolic activation by microsomal enzymes from rat liver. The compounds to be tested were prepared fresh daily in DMSO or in sterile water. The appropriate dilutions were made from a 20 mg (or nL)/mL stock. The S-9 mix was prepared fresh daily from sterile stocks. The test substance was tested at five dose levels: 0.2, 2, 20, 200 and 2000 µg (or nL) per Petri dish. The test substance was dissolved in DMSO and every concentration was tested in triplicate. The criteria of mutagenicity used in this test are a doubling of the spontaneous reversion rate and a dose-effect relationship.
Under the experimental conditions defined in the protocol, and employing a doubling of the spontaneous reversion rate and dose-effect relationship as criteria of mutagenicity, the test substance was not mutagenic for S. typhimurium strains TA 1535, TA 1537, TA 98 and TA 100. The lack of evidence for mutagenicity existed both in the absence and presence of a liver microsomal enzyme preparation (S9-mix) from male rats pretreated with Aroclor 1254 and over a concentration range of 0.2 to 2000 µg (or nL) of product per Petri dish.
Justification for classification or non-classification
Based on the available information no classification is warranted according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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