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EC number: 700-232-9 | CAS number: 68489-09-8
- 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
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008-05-12 to 2008-06-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP guideline study with minor deviation to the guideline without effects on results: - following the guideline, one dose level with precipitation should be tested and further dose levels should be chosen below this dose level. In this study only two dose level below the dose level causing precipitation (500 µg/plate) were chosen plus two higher dose level (1500 and 5000 µg/plate) which also causing precipitation. - SD not presented for untreated-negative control
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- please refer to the field "Rationale for reliability incl. deficiencies" above
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- , 2000
- Deviations:
- yes
- Remarks:
- please refer to the field "Rationale for reliability incl. deficiencies" above
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2007-10-15
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- TA1537: his C 3076
TA98: his D 3052
TA1535 & TA100: his G 46
TA102: his G 428 (pAQ1) - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 prepared from livers of male Sprague-Dawley rats orally receiving three consecutive daily doses of phenobarbitone/β-naphthoflavone (80/100 mg/kg/day)
- Test concentrations with justification for top dose:
- Preliminary test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate (with and without metabolic activation)
Experiment I and II: 50, 150, 500, 1500 and 5000 µg/plate (with and without metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethyl sulphoxide (DMSO)
- Justification for choice of solvent/vehicle: test material was insoluble in water, but fully soluble in DMSO at 50 mg/mL. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Positive control without metabolic activation: concentrations: 3 μg/plate (strain TA100) & 5 μg/plate (strain TA1535)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Positive control without metabolic activation: concentration: 80 μg/plate (strain TA1537)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Positive control without metabolic activation: concentration: 0.5 μg/plate (strain TA102)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Positive control without metabolic activation: concentration: 0.2 μg/plate (strain TA98)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- Positive control with metabolic activation: concentrations: 1 μg/plate (strain TA100) & 2 µg/plate (strains TA1535 & TA1537)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Positive control with metabolic activation: concentrations: 5 μg/plate (strain TA98)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1,8-Dihydroxyanthraquinone
- Remarks:
- Positive control with metabolic activation: concentrations: 10 μg/plate (strain TA102)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (direct plate incorporation method)(preliminary test and main study)
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
A preliminary test was carried out to determine the toxicity of the test material. Ten doses of the test material and a vehicle control were tested using TA100. In addition, the sterility of the test material was assessed. After approximately 48 hours incubation at 37 °C the plates were assessed for numbers of revertant colonies using a Domino colony counter and examined for effects on the growth of the bacterial background lawn.
MAIN STUDY (Experiment I and II)
- Exposure duration: approximately 48 hours incubation at 37 °C
- Number of replications: triplicate
- Number of cells evaluated: frequency of revertant colonies was assessed using a Domino colony counter. Manual counts were performed at 5000 µg/plate because of excessive test material precipitation. - Evaluation criteria:
- There are several criteria for determining a positive result, such as a dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. Biological relevance of the results will be considered first. Statistical methods, as recommended by the UKEMS can also be used as an aid to evaluation, however, statistical significance will not be the only determining factor for a positive response.
A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met. - Statistics:
- no data
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: grease-like precipitation (which appeared fibrous under a microscope) was observed at and above 500 µg/plate (did not prevent the scoring of revertant colonies).
RANGE-FINDING/SCREENING STUDIES:
- test material was non-toxic to the strain used (TA100).
MAIN STUDY
- no significant increases in the frequency of revertant colonies were recorded for any of the strains of Salmonella, at any dose level either with or without metabolic activation.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- test material formulation and the S9-mix were both shown to be sterile.
- test material caused no visible reduction in the growth of the bacterial background lawn at any dose level
Please also refer to the field "Attached background material" below. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The substance tested non-mutagenic under the conditions of the study. According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance should not be considered to have a mutagenic potential. - Executive summary:
A reliable bacterial reverse mutation assay was performed according to the OECD guideline 471 (1997). Salmonella typhimurium strains TA1535, TA1537, TA102, TA98 and TA100 were treated with the substance using the plate incorporation method at five dose levels in triplicate with and without metabolic activation. Two experiments were conducted with the following concentrations: 50, 150, 500, 1500 and 5000 µg/plate. The substance did not cause visible reduction in the growth of the bacterial background lawn at any dose level. Significant increases in the frequency of revertant colonies were not recorded for any of the bacterial strains at any dose with or without metabolic activation. Thus, the substance tested non-mutagenic under the conditions of this study.
According to Regulation (EC) No 1272/2008 and subsequent adaptations, the substance should not be considered to have a mutagenic potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Genetic toxicity in vitro
The substance was not observed to induce gene mutation in a reliable bacterial reverse mutation assay (OECD 471).
Justification for selection of genetic toxicity endpoint
GLP guideline study conducted with the test item
Justification for classification or non-classification
The substance should not be considered to have a mutagenic potential based on a bacterial reverse mutation assay (OECD 471) and does not require classification according to Regulation (EC) No 1272/2008 and subsequent adaptations.
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