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EC number: 806-451-7 | CAS number: 42532-60-5
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in compliance with OECD GLP regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- MTDID 28136
- IUPAC Name:
- MTDID 28136
- Test material form:
- other: Gas
- Details on test material:
- - Name of test material (as cited in study report): MTDID 28136
- Substance type: Mono-constituent
- Physical state: Gas
- Analytical purity: 99.97
- Purity test date: 26 December 2013
- Lot/batch No.: Lot 2
Constituent 1
Method
- Target gene:
- Salmonella thyphimurium strains: Histidine operon, Escherichia coli: thyptophan operon
Species / strain
- 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:
- Arclor 1254 induced rat liver S9 mix
- Test concentrations with justification for top dose:
- 0.0781, 0.156, 0.313, 0.625, 1.25, 2.50, 5.00, 10.0, 20.0, and 40.0 % v/v
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Air
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Strain Specific
- Remarks:
- TA100, TA1535, WP2 uvrA: Chloroethane, TA1537: ICR-191 acridine, TA98: 2-nitrofluorene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Incubation in a bag containing the test article at the appropriate concentration.
DURATION
- Preincubation period: None
- Exposure duration: 2 days
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): NA
- Fixation time (start of exposure up to fixation or harvest of cells): 2 days
SELECTION AGENT (mutation assays): None
NUMBER OF CELLS EVALUATED: All
DETERMINATION OF CYTOTOXICITY
- Method: A concentration was considered cytotoxic if it caused a >50% reduction in the mean number of revertants per plate as compared to the mean vehicle control accompanied by an abrupt concentration-dependent drop in the mean number of revertants or a significant reduction in the background lawn - Evaluation criteria:
- The test substance was considered positive for mutagenicity if it induced an increase of revertants per plate with increasing concentration. The increases should be at least two times the vehicle control substance background frequency for strains with high spontaneous levels (TA100) and three times for those with low spontaneous levels (TA1537, TA98, TA1535, and WP2 uvrA). Increases should be seen in at least two or more successive concentrations or the response should be repeatable at a single concentration.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: A rangefinding assay was conducted at concentrations of 0.001, 0.003, 0.01, 0.03, 0.1, 0.3, 1, 3, 10 and 30% v/v. Cytotoxicity was observed at concentrations at and above 3% in TA100 with and without metabolic activation and WP2 uvrA with metabolic activation and at 10% or greater in WP2 uvrA without metabolic activation.
COMPARISON WITH HISTORICAL CONTROL DATA: Controls were consistent with historical data. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the results of the test, the test article was not mutagenic in the Bacterial Reverse Mutation Assay in either the presence or absence of metabolic activation. - Executive summary:
The mutagenic potential of the test article was evaluated in the Bacterial Reverse Mutation Assay with S. typhimurium strains TA98, TA100, TA1535, and TA1537 and E. coli strain WP2 uvrA in the presence and absence of a metabolic activation system (S9-mix rat liver induced by Arclor 1254). The study was performed in compliance with OECD GLP. The test method was based on OECD No. 471 and ICH S2A and S2B. Plates were exposed to the test substance via incubation in a sealed bag containing the test article at the appropriate concentration. Strains TA100, TA1535 and WP2 uvrA were exposed to chloroethane as a positive control. A dose range-finding test was performed with concentration up to 30% v/v test article in the absence and presence of metabolic activation in strains TA100 and WP2uvrA. Based on the results of the dose range finding test, the test article was tested at concentrations of 0 (control) 0.0781, 0.156, 0.313, 0.625, 1.25, 2.50, 5.00 and 10.0% v/v test article in TA1537 and TA100 with metabolic activation and at 10 % v/v in TA100 and WP2 uvrA without metabolic activation and TA1535 with and without metabolic activation. A confirmatory assay was performed at 0.0781, 0.156, 0.313, 0.625, 1.25, 2.50, 5.00, 10.0, 20.0, and 40.0 % v/v in strains TA98, TA1537 and WP2 uvrA. All treatments were performed in triplicate. No increase in revertant colonies was observed in either the presence or absence of metabolic activation in any strain tested. All criteria for a valid test were met as described in the protocol. Based on the results of the test, the test article was not mutagenic in the Bacterial Reverse Mutation Assay in either the presence or absence of metabolic activation.
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