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EC number: 264-561-5 | CAS number: 63910-74-7
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames assay:
The test chemical did not induce mutation in the Salmonella typhimurium and E. coli strains both in the presence and absence of S9 metabolic activation system and hence is not likely to be mutagenic under the conditions of this study.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Experimental data from various test chemicals
- Justification for type of information:
- Data for the target chemical is summarized based on the various test chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- as per prival modification
- Principles of method if other than guideline:
- WoE for the target CAS is summarized based on data from various test chemicals.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- 2. Histidine
3. Histidine for S. typhimurium and Tryptophan for E. coli - Species / strain / cell type:
- S. typhimurium, other: TA98 and TA100
- Remarks:
- 2
- Details on mammalian cell type (if applicable):
- not specified
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Remarks:
- 3
- Details on mammalian cell type (if applicable):
- not specified
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Remarks:
- 3
- Details on mammalian cell type (if applicable):
- not specified
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- 2. Type and composition of metabolic activation system: cofactors (FMN, NADH, glucose-6-phosphate dehydrogenase, and glucose-6-phosphate), and test chemical were added, mixed, and incubated at 30 °C for 30 min without shaking.
- source of S9: uninduced hamster liver S9
- method of preparation of S9 mix: No data
- concentration or volume of S9 mix and S9 in the final culture medium: 30% v/v
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability) - Nitrogen was blown over the preincubation tube to keep the atmosphere reduced.
3. S9 mix - Test concentrations with justification for top dose:
- 2. 0, 333, 1000, 3333, 6666, 10000 ug/plate
3. 0, 156*, 31*, 625*, 1250*, 2500*, 5000* microg/plate (*: precipitation of sediment) - Vehicle / solvent:
- 2. - Vehicle(s)/solvent(s) used: Water
- Justification for choice of solvent/vehicle: Test chemical was soluble in water.
3. - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Test chemical was soluble in DMSO. - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- congo red
- Remarks:
- 2
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: S9mix(-); AF-2 (TA98, TA100, WP2uvrA), ICR-191 (TA1537); S9mix(+): 2-AA (TA1535, WP2uvrA)
- Remarks:
- 3
- Details on test system and experimental conditions:
- 2. METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): (1-2) x10^9 cells/mL
- Test substance added - preincubation
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable:30 min
- Exposure duration/duration of treatment: 48 h
- Harvest time after the end of treatment (sampling/recovery times): No data
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method.: Preincubation Method - All plates were counted with an Artek automated colony counter (Artek 880, DynaTech, Chantilly, VA) or Minicount colony counter (Imaging Products International, Inc., Chantilly, VA), which was calibrated prior to use.
3. NUMBER OF REPLICATIONS:
- Number of cultures per concentration - duplicate
- Number of independent experiments - 3
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): No data
- Test substance added - in agar (plate incorporation) - Evaluation criteria:
- 2. All plates were observed for increase in mutant frequencies.
3. No. of revertants per plates were evaluated. - Statistics:
- No data
- Species / strain:
- S. typhimurium, other: TA98 and TA100
- Remarks:
- 2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Remarks:
- 3
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Remarks:
- 3
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- 2. RANGE-FINDING/SCREENING STUDIES (if applicable): The doses that were tested in the mutagenicity assay were selected based on the levels of cytotoxicity observed in a preliminary dose range-finding study using strain TA100. Ten dose levels of the chemical, one plate per dose, were tested in both the presence and the absence of induced hamster S9. If no toxicity was observed, a total maximum dose of 10 mg of test chemical per plate was used.
3. No data - Remarks on result:
- other: No mutagenic potential
- Conclusions:
- The test chemical did not induce mutation in the Salmonella typhimurium and E. coli strains both in the presence and absence of S9 metabolic activation system and hence is not likely to be mutagenic under the conditions of this study.
- Executive summary:
In different studies, the given test chemical has been investigated for the mutagenic nature. The studies are as mentioned below:
Bacterial Reverse Mutation Assay was conducted by using the given test chemical as per OECD Guideline 471 (Bacterial Reverse Mutation Assay) and Prival modification by Prival and Mitchell (1982). For tests using the FMN-modified assay, strains TA98 and TA100 were used at doses 0, 333, 1000, 3333, 6666, 10000 ug/plate dissolved in water. The bacteria, uninduced hamster liver S9 (30% v/v), cofactors (FMN, NADH, glucose-6-phosphate dehydrogenase, and glucose-6-phosphate), and test chemical was added, mixed, and incubated at 30 °C for 30 min without shaking. Nitrogen was blown over the preincubation tube to keep the atmosphere reduced. At the end of the incubation period, 2 mL of molten top agar was added to each sample tube and the mixture was poured on a minimal agar plate containing 0.5% glucose rather than the 2% glucose specified by Ames et al. The plates were then incubated at 37 °C for 48 h. The positive control in FMN experiment was Congo red. All plates were counted with an Artek automated colony counter or Minicount Colony counter, which was calibrated prior to use. The given test chemical failed to induce mutation in Salmonella typhimurium TA98 and TA100 in the presence and absence of S9 metabolic activation and hence it is not likely to be mutagenic by in-vitro test.
Another gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical as per OECD Guideline 471 (Bacterial Reverse Mutation Assay) on S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A at doses 0, 156*, 31*, 625*, 1250*, 2500*, 5000* microg/plate (*: precipitation of sediment). DMSO was used as a solvent. Positive controls used were S9mix(-); AF-2 (TA98, TA100, WP2uvrA), SA (TA1535), ICR-191 (TA1537) / S9mix(+); B[a]P (TA98, TA100, TA1537), 2-AA (TA1535, WP2uvrA). The study was performed in duplicate with 3 plates per test by plate incorporation method. No. of revertants per plates were evaluated. The given test chemical failed to induce mutation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A in the presence and absence of S9 metabolic activation system and hence it is not likely to be mutagenic by in-vitro test.
Thus, based on the above summarized studies on test chemical, it can be concluded that the given test chemical did not induce mutation in the Salmonella typhimurium and E. coli strains both in the presence and absence of S9 metabolic activation system and hence is not likely to be mutagenic under the conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Ames assay:
In different studies, the given test chemical has been investigated for the mutagenic nature. The studies are as mentioned below:
Bacterial Reverse Mutation Assay was conducted by using the given test chemical as per OECD Guideline 471 (Bacterial Reverse Mutation Assay) and Prival modification by Prival and Mitchell (1982). For tests using the FMN-modified assay, strains TA98 and TA100 were used at doses 0, 333, 1000, 3333, 6666, 10000 ug/plate dissolved in water. The bacteria, uninduced hamster liver S9 (30% v/v), cofactors (FMN, NADH, glucose-6-phosphate dehydrogenase, and glucose-6-phosphate), and test chemical was added, mixed, and incubated at 30 °C for 30 min without shaking. Nitrogen was blown over the preincubation tube to keep the atmosphere reduced. At the end of the incubation period, 2 mL of molten top agar was added to each sample tube and the mixture was poured on a minimal agar plate containing 0.5% glucose rather than the 2% glucose specified by Ames et al. The plates were then incubated at 37 °C for 48 h. The positive control in FMN experiment was Congo red. All plates were counted with an Artek automated colony counter or Minicount Colony counter, which was calibrated prior to use. The given test chemical failed to induce mutation in Salmonella typhimurium TA98 and TA100 in the presence and absence of S9 metabolic activation and hence it is not likely to be mutagenic by in-vitro test.
Another gene mutation toxicity study was performed to determine the mutagenic nature of the test chemical as per OECD Guideline 471 (Bacterial Reverse Mutation Assay) on S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A at doses 0, 156*, 31*, 625*, 1250*, 2500*, 5000* microg/plate (*: precipitation of sediment). DMSO was used as a solvent. Positive controls used were S9mix(-); AF-2 (TA98, TA100, WP2uvrA), SA (TA1535), ICR-191 (TA1537) / S9mix(+); B[a]P (TA98, TA100, TA1537), 2-AA (TA1535, WP2uvrA). The study was performed in duplicate with 3 plates per test by plate incorporation method. No. of revertants per plates were evaluated. The given test chemical failed to induce mutation in S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 uvr A in the presence and absence of S9 metabolic activation system and hence it is not likely to be mutagenic by in-vitro test.
Thus, based on the above summarized studies on test chemical, it can be concluded that the given test chemical did not induce mutation in the Salmonella typhimurium and E. coli strains both in the presence and absence of S9 metabolic activation system and hence is not likely to be mutagenic under the conditions of this study.
Justification for classification or non-classification
Based on the data available and applying weight of evidence approach, the given test chemical does not exhibit gene mutation in vitro by Ames assay. Hence, the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.
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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