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EC number: 285-413-6 | CAS number: 85098-62-0
- 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
Under the conditions of this study, the test material was considered to be non-mutagenic.
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:
- 13 April 2017 to 24 April 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Salmonella typhimurium
TA1537 (frame shift mutations)
TA98 (frame shift mutations)
TA1535 (base-pair mutations)
TA100 (base-pair mutations)
Escherichia coli
WP2 uvrA (base-pair substitution) - 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:
- S9 microsomal fraction from rats induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- Preliminary test
1.2, 4.9, 20, 78, 313, 1250, 5000 µg/plate (with and without S9-mix)
Main test (1 and 2)
313, 625, 1250, 2500, 5000 µg/plate (with and without S9-mix) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water for injection
- Untreated negative controls:
- yes
- Remarks:
- (solvent control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- 0.01 µg/plate for TA100 and WP2uvrA, 0.1 µg/plate for TA98; without S9-mix
- Untreated negative controls:
- yes
- Remarks:
- (solvent control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- 0.5 µg/plate for TA1535; without S9-mix
- Untreated negative controls:
- yes
- Remarks:
- (solvent control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-methoxy-6-chloro-9-[3-(2-chloroethyl)aminopropylamino]acridine.2HCl
- Remarks:
- 1.0 µg/plate for TA1537; without S9-mix
- Untreated negative controls:
- yes
- Remarks:
- (solvent control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- 5.0 µg/plate for TA100, TA98 and TA1537; with S9-mix
- Untreated negative controls:
- yes
- Remarks:
- (solvent control)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- 2.0 µg/plate for TA1535 and 10.0 µg/plate for WP2uvrA; with S9-mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 minutes at 37°C
- Exposure duration: 48 hours at 37°C
- Selection time (if incubation with a selection agent): simultaneous with exposure
SELECTION AGENT (mutation assays): trace histidine or tryptophan supplemented
NUMBER OF REPLICATIONS: triplicate
DETERMINATION OF CYTOTOXICITY
- Method: reduction in number of revertant colonies and reduction of bacterial background lawn
The test was performed by mixing 0.1 mL of bacterial culture, 2 mL of molten, trace histidine or tryptophan supplemented, top agar, 0.1 mL of test material formulation and 0.5 mL of S9-mix or phosphate buffer. Five concentrations of the test material formulation and a vehicle control (sterile distilled water) were tested together with the positive controls (0.1 mL). In addition, three minimal agar plates were used for each dose level in the main tests which were performed at the same doses. For the sterility test, 0.1 mL of the test solution of the maximum concentration and 0.5 mL of the S9-mix wre put in each tube, 2.0 mL of top agar were then added to the tube, and the contents of the tube were poured over the surface of the minimal agar plate.
The operations were conducted under lamps with UV absorbent filter.
After approximately 48 hours incubation at 37°C the plates were assessed for numbers of revertant colonies using a colony counter and examined for effects on the growth of the bacterial background lawn with a stereomicroscope. - Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Preliminary toxicity test:
Growth inhibition was not observed in any strain either with or without metabolic activation.
Mutation test:
In the two main tests, neither an increase in the number of revertant colonies (more tha twice as many as that of the negative control) nor a dose-related response was observed at any doses in any strains of base-pair substitution type of frame-shit type, with or without metabolic activation.
The revertant colonies of the positive controls showed increases of more than twice that of the negative controls and they were within the limit of controls (mean ± 3SD) in historical data, indicating the study was performed correctly.
In the sterility test on the test solution and the S9-mix, no growth of bacteria was observed. - Conclusions:
- The test material was considered to be non-mutagenic under the conditions of this test.
- Executive summary:
The genetic toxicity of the test material was investigated in accordance with the standardised guidelines OECD 471 and in accordance with the Japanese Guidelines for Screening Mutagenicity Testing Of Chemicals, under GLP conditions.
The test material was tested on the following strains of bacteria: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A both in the presence and absence of metabolic activation in the form of S9-mix.
In the two main tests, neither an increase in the number of revertant colonies (more than twice as many as that of the negative control) nor a dose-related response was observed at any doses in any strains of base-pair substitution type of frame-shift type, with or without metabolic activation.
The revertant colonies of the positive controls showed increases of more than twice that of the negative controls and they were within the limit of controls (mean ± 3SD) in historical data, indicating the study was performed correctly.
In the sterility test on the test solution and the S9-mix, no growth of bacteria was observed.
Under the conditions of the study, the test material was considered to be non-mutagenic.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Ames Test
The genetic toxicity of the test material was investigated in accordance with the standardised guidelines OECD 471 and in accordance with the Japanese Guidelines for Screening Mutagenicity Testing Of Chemicals, under GLP conditions.
The test material was tested on the following strains of bacteria: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvr A both in the presence and absence of metabolic activation in the form of S9-mix.
In the two main tests, neither an increase in the number of revertant colonies (more than twice as many as that of the negative control) nor a dose-related response was observed at any doses in any strains of base-pair substitution type of frame-shift type, with or without metabolic activation.
The revertant colonies of the positive controls showed increases of more than twice that of the negative controls and they were within the limit of controls (mean ± 3SD) in historical data, indicating the study was performed correctly.
In the sterility test on the test solution and the S9-mix, no growth of bacteria was observed.
Under the conditions of the study, the test material was considered to be non-mutagenic.
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to genetic toxicity.
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