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EC number: 264-859-5 | CAS number: 64381-99-3
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test: The test chemical did not induce gene mutation in Salmonella typhimurium TA98, TA100, TA1538 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
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 is summarized based on the available information from various read across test chemicals.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- WoE report is based on 2 gene mutation studies as - WoE 2 and WoE 3
Gene mutation test was carried out to study the effects of the test chemical. - GLP compliance:
- not specified
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA 100 and TA 1538
- Remarks:
- 2
- Species / strain / cell type:
- S. typhimurium, other: TA 100, TA 1535, TA 97, TA 98
- Remarks:
- 3
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- 2.S9 protein was obtained from the liver of Aroclor-induced male Sprague-Dawley rats.
3.The S-9 fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers were prepared - Test concentrations with justification for top dose:
- 2.100µg/plate or 1 mg/plate
3. 0, 33, 100, 333, 1000, 2000, 3333, 5000 or 10000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data available - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- 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:
- 9-aminoacridine
- sodium azide
- other: 2-Aminoanthracene (All strains + S9); 4-Nitro-o-phenylenediamine (TA98; -S9)
- Remarks:
- 3
- Details on test system and experimental conditions:
- 2.METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: No data available
- Exposure duration: 2 days (48 hrs)
- Expression time (cells in growth medium): 2 days (48 hrs)
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: Duplicate
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available
OTHER EXAMINATIONS: No data available
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available
OTHER: No data available
3.METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: Triplicate
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other:
OTHER: No data available - Rationale for test conditions:
- No data
- Evaluation criteria:
- 2.A sample was judged mutagenic if it produced greater than twice the spontaneous background colonies at more than one dose or at the highest dose tested.
3.An individual trial was judged mutagenic (+) if a dose-related increase over the corresponding solvent control was seen, and it was judged weakly mutagenic C+W) if a low-level dose response was seen. A trial was considered questionable (?) if a dose-related increase was judged insufficiently high to justify a call of "+W," if only a single dose was elevated over the control, or if a non-dose-related increase was seen.
The chemical was judged to be mutagenic (+), or weakly mutagenic (+W), if it produced a reproducible, dose-related increase in his+ revertants over the corresponding solvent controls in replicate trials.
It chemical was considered to be questionable (?) if a reproducible increase of his+ revertants did not meet the criteria for either a " + " or " + W," or if only single doses produced an increase in his+ revertants in repeat trials. - Statistics:
- 2.To estimate mutagenic potency (revertant /µg) from linear dose-response curves, the method of Moore and Felton was used
3.No data - Species / strain:
- S. typhimurium, other: TA 100 and TA 1538
- Remarks:
- 2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium, other: TA100, TA1535, TA97, TA98
- 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
- Positive controls validity:
- valid
- Additional information on results:
- 2.TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data available
- Effects of osmolality: No data available
- Evaporation from medium: No data available
- Water solubility: No data available
- Precipitation: No data available
- Other confounding effects: No data available
RANGE-FINDING/SCREENING STUDIES: Spot test was performed with and without activation using the Salmonella typhimurium strains TA1538, TA98 and TA100. The spot test results were inconclusive. The dyes were then screened at 0.1 mg/plate and 1 mg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: No data available
ADDITIONAL INFORMATION ON CYTOTOXICITY: No data available
3.No data - Remarks on result:
- other: No mutagenic potential observed
- Conclusions:
- The test chemical does not induce gene toxicity in the Salmonella typhimurium strains in the presence and absence of metabolic activation and hence it is negative for gene mutation.
- Executive summary:
Data available for the test chemical was reviewed to determine the mutagenic nature of test chemical, The studies are as mentioned below:
Gene mutation study was performed to evaluate the mutagenic nature of test chemical using Salmonella typhimurium strain TA1538 and TA100. Bacteria were grown overnight in Oxoid nutrient broth, then refrigerated at 4-5OC for a few hours before use. 0.1 ml of bacterial culture was added to 2 ml of 45°C molten top agar containing 0.01 mg histidine HCI and 0.012 mg biotin/ml, followed by the test sample in ≤0.2 ml DMSO. Finally, 0.5 ml of sodium phosphate buffer, pH 7.4 (no activation), or 0.5 ml of Aroclor-induced rat S9 mixture was added, and the mixture was poured on minimal glucose agar plates. Histidine revertant colonies were counted on a Biotran II automated colony counter after 2-day incubation at 37°C. 100µg/plate or 1 mg/plate of test chemical was used in the study. A sample was judged mutagenic if it produced greater than twice the spontaneous background colonies at more than one dose or at the highest dose tested. In the above mentioned study, test chemical failed to induce gene mutation in theSalmonella typhimuriumstrains TA1538 and TA100 with and without metabolic activation. Hence, the test chemical, is not likely to be a gene mutant in vitro.
In another study, Gene mutation toxicity study was performed to determine the mutagenic nature of test chemical using Salmonella typhimurium strains TA100, TA1535, TA97and TA98. Salmonella/microsome test was performed both in the absence and presence of liver S-9 obtained from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters. Preincubation assay was performed at dose levels of 0, 33, 100, 333, 1000, 2000, 3333, 5000, 10000 µg/plate. The plates were preincubated for 20 mins and incubated futher for 48 hrs chemical exposure. Concurrent solvent and positive controls were also included in the study. The test chemical did not induce gene mutation in Salmonella typhimurium strains TA98, TA100, TA1535 and TA 97 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
Based on the observations made, the test chemical does not exibit gene mutation in vitro . Hence it is not likely to classify as a gene mutant in vitro as per the criteria mentioned in CLP regulation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Ames test:
Data available for the test chemical was reviewed to determine the mutagenic nature of test chemical, The studies are as mentioned below:
Gene mutation study was performed to evaluate the mutagenic nature of test chemical using Salmonella typhimurium strain TA1538 and TA100. Bacteria were grown overnight in Oxoid nutrient broth, then refrigerated at 4-5OC for a few hours before use. 0.1 ml of bacterial culture was added to 2 ml of 45°C molten top agar containing 0.01 mg histidine HCI and 0.012 mg biotin/ml, followed by the test sample in ≤0.2 ml DMSO. Finally, 0.5 ml of sodium phosphate buffer, pH 7.4 (no activation), or 0.5 ml of Aroclor-induced rat S9 mixture was added, and the mixture was poured on minimal glucose agar plates. Histidine revertant colonies were counted on a Biotran II automated colony counter after 2-day incubation at 37°C. 100µg/plate or 1 mg/plate of test chemical was used in the study. A sample was judged mutagenic if it produced greater than twice the spontaneous background colonies at more than one dose or at the highest dose tested. In the above mentioned study, test chemical failed to induce gene mutation in theSalmonella typhimuriumstrains TA1538 and TA100 with and without metabolic activation. Hence, the test chemical, is not likely to be a gene mutant in vitro.
In another study, Gene mutation toxicity study was performed to determine the mutagenic nature of test chemical using Salmonella typhimurium strains TA100, TA1535, TA97and TA98. Salmonella/microsome test was performed both in the absence and presence of liver S-9 obtained from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters. Preincubation assay was performed at dose levels of 0, 33, 100, 333, 1000, 2000, 3333, 5000, 10000 µg/plate. The plates were preincubated for 20 mins and incubated futher for 48 hrs chemical exposure. Concurrent solvent and positive controls were also included in the study. The test chemical did not induce gene mutation in Salmonella typhimurium strains TA98, TA100, TA1535 and TA 97 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
Based on the observations made, the test chemical does not exibit gene mutation in vitro . Hence it is not likely to classify as a gene mutant in vitro as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the observations made, the test chemical does not exibit gene mutation in vitro. Hence it is not likely to classify as a gene mutant in vitro 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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