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EC number: 212-096-3 | CAS number: 762-26-5
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation in bacteria (OECD TG 471): negative
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:
- 14 April 2016 - 28 April 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:
- July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 31, 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- - S. typhimurium: Histidine gene
- E. coli: Tryptophan gene - 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:
- Rat liver S9-mix induced with Aroclor 1254 (500 mg/kg bw/day)
- Test concentrations with justification for top dose:
- - Dose range finding test:
TA 100 and WP2uvrA:
Absence and presence of S9-mix: 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate.
- First experiment: direct plate assay
TA1535, TA1537 and TA98:
Absence of S9-mix: 0.55, 1.7, 5.4, 17, 52 and 164 μg/plate.
Presence of S9-mix: 1.7, 5.4, 17, 52, 164 and 512 μg/plate.
- Second experiment: Pre-incubation assay
TA1535, TA1537, TA98 and TA100:
Absence of S9-mix: 0.55, 1.7, 5.4, 17, 52 and 164 μg/plate.
Presence of S9-mix: 1.7, 5.4, 17, 52, 164 and 512 μg/plate.
WP2uvrA:
Absence and presence of S9-mix: 17, 52, 164, 512, 1600 and 5000 μg/plate - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent: the test substance was found to be miscible in DMSO. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- other: other: see section "Any other information on materials and methods incl. tables"
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION:
- Exposure duration: incubation 37.0 ± 1.0°C for 48 ± 4 hours
NUMBER OF REPLICATIONS:
- Doses of the test substance were tested in triplicate in each strain (in all experiments).
NUMBER OF CELLS EVALUATED:
- 10^8 cells were evaluated
DETERMINATION OF CYTOTOXICITY
- Method: on the basis of a decline in the number of spontaneous revertants, a thinning of the background
lawn or a microcolony formation. - Evaluation criteria:
- A test item is considered negative (not mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is not greater than two (2) times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 or TA98 is not greater than three (3) times the concurrent control.
b) The negative response should be reproducible in at least one follow up experiment.
A test item is considered positive (mutagenic) in the test if:
a) The total number of revertants in tester strain TA100 or WP2uvrA is greater than two (2) times the concurrent control, or the total number of revertants in tester strains TA1535, TA1537 or TA98 is greater than three (3) times the concurrent control.
b) In case a repeat experiment is performed when a positive response is observed in one of the tester strains, the positive response should be reproducible in at least one follow up experiment. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation:
Dose range finding: Precipitation was observed at the start of the incubation period at and above 1600 μg/plate. No precipitation was observed at the end of the incubation period.
Direct plate experiment: Precipitation was observed at the start of the incubation period at concentrations of 52 and 164 μg/plate plate in the absence of S9-mix and at 164 and 512 μg/plate in the presence of S9-mix. No precipitation was observed at the end of the incubation period.
Pre-incubatiuon experiment: Precipitation was observed at the start of the incubation period at and above 1600 μg/plate. No precipitation was observed at the end of the incubation period.
RANGE-FINDING/SCREENING STUDIES: The test material was toxic at and above 52 μg/plate (without S9) and at and above 164 μg/plate (with S9) to strain TA100 and at 5000 μg/plate to WP2 uvrA.
COMPARISON WITH HISTORICAL CONTROL DATA:
- The negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
The test material was toxic to all of the Salmonella strains at the highest dose level (164 μg/plate without S9 and 512 μg/plate with S9) in the direct plate assay. In the pre-incubation experiment the test material was toxic to all of the Salmonella strains at and above 17 μg/plate without S9 and at and above 52 μg/plate with S9, except for TA98 where cytotoxicity was observed at and above 164 μg/plate with S9. The test material was toxic to E.coli strain WP2 uvrA at and above 164 μg/plate without S9 and not toxic with S9. - Conclusions:
- The substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and Escherichia coli reverse mutation assay performed according to OECD 471 guideline and GLP principles.
- Executive summary:
The mutagenic activity of the substance was evaluated in accordance with OECD 471 guideline and according to GLP principles. The test was performed in two independent experiments. The direct plate experiment was performed up to and including 5000 μg/plate in TA100 and WP2uvrA, and up to and including 164 μg/plate and 512 μg/plate in TA1535, TA1537 and TA98 in the absence and presence of S9 -mix, respectively. In the pre-incubation experiment the same dose ranges were used except for TA100 which was tested up to and including 164 μg/plate and 512 μg/plate, in the absence and presence of S9-mix, respectively. The dose levels were selected based on observed cytotoxicity in the dose range finding test (TA100 >= 164 μg/plate without S9 and 512 μg/plate with S9, WP2uvrA =5000 μg/plate). Adequate negative and positive controls were included. The substance did not induce a significant dose related increase in the number of revertant (His+) colonies in each of the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Tryp+) colonies in E.coli WP2uvrA, both in the absence and presence of S9-metabolic activation. These results were confirmed in independently repeated experiment. Based on the results of this study it is concluded that the substance is not mutagenic in the Salmonella typhimurium reverse mutation assay and not mutagenic in the Escherichia coli reverse mutation assay.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Ames test: The mutagenic activity of the substance was evaluated in
accordance with OECD 471 guideline and according to GLP principles. The
test was performed in two independent experiments. The direct plate
experiment was performed up to and including 5000 μg/plate in TA100 and
WP2uvrA, and up to and including 164 μg/plate and 512 μg/plate in
TA1535, TA1537 and TA98 in the absence and presence of S9 -mix,
respectively. In the pre-incubation experiment the same dose ranges were
used except for TA100 which was tested up to and including 164 μg/plate
and 512 μg/plate, in the absence and presence of S9-mix, respectively.
The dose levels were selected based on observed cytotoxicity in the dose
range finding test (TA100 >= 164 μg/plate without S9 and 512 μg/plate
with S9, WP2uvrA =5000 μg/plate). Adequate negative and positive
controls were included. The substance did not induce a significant dose
related increase in the number of revertant (His+) colonies in each of
the four S. typhimurium tester strains (TA1535, TA1537, TA98 and TA100)
and in the number of revertant (Tryp+) colonies in E.coli WP2uvrA, both
in the absence and presence of S9-metabolic activation. These results
were confirmed in independently repeated experiment. Based on the
results of this study it is concluded that the substance is not
mutagenic in the Salmonella typhimurium reverse mutation assay and not
mutagenic in the Escherichia coli reverse mutation assay.
Justification for classification or non-classification
Based on the results of the Ames test, the substance does not have to be classified for genotoxicity in accordance with Regulation (EC) No 1272/2008 and its amendments.
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