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EC number: 253-649-9 | CAS number: 37743-18-3
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: gene mutation
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data to 1987-04-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Study conducted with methods similar to OECD Guideline 471 (Bacterial Reverse Mutation Assay) with acceptable deviations (only two tester strains were used, only brief information was on the test substance, and only a protocol with results were provided without a final report). The study was conducted in the presence and absence of metabolic activation with positive and vehicle controls. Since the results are positive, no further testing is considered relevant to cover this endpoint.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only two tester strains were used, only brief information was on the test substance, and only a protocol with results were provided without a final report
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Storage: at room temperature in closed containers
- Target gene:
- histidine locus
- Species / strain / cell type:
- S. typhimurium, other: TA98 and TA100
- Details on mammalian cell type (if applicable):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9 (20 and 50 µL)
- Test concentrations with justification for top dose:
- - Preliminary dose range finding assay (TA100 only): 50, 100, 250, 500, 1000, 2500 and 5000 µg/plate
- Experiment 1 (without metabolic activation): 50, 100, 250, 500, 1000, 2500 and 5000 µg/plate
- Experiment 1 (with metabolic activation): 25, 100, 250, 500, 1000, 2500 and 5000 µg/plate
- Experiment 2 (with and without metabolic activation): 25, 100, 250, 500, 1000, 2500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: In a preliminary solubility assay, the test substance (100 mg) was introduced in a test tube, with 2 mL distilled water and mixed vigorously. Since the test substance was still not soluble upon warming up to 45°C, a new solution was prepared in absolute ethanol following the same procedure. Based on the findings of this solubility test, ethanol was chosen as solvent. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without S9; at 0.5 µg/plate for TA98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9; at 0.1 µg/plate for TA100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9; at 1.0 µg/plate for TA98 and TA100
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
For each test, 0.1 mL of an overnight culture in nutrient broth (Oxoid) was introduced into test tubes. This corresponds to an average of 1 -6 x 10^8 viable bacteria per tube. The histidine-biotin (0.05 mM) supplemented top agar (2 mL) was then added, followed by the substrate dilution (0.1 mL). When specified S9 -mix was then added (0.5 mL) and the content of the test tube well mixed. This mixture was then layered on minimal glucose agar (Vogel Bonner E medium) containing petri dishes following the method of Ames. After incubation of the plates for 48 hours at 37°C in the dark, the number of revertant colonies were counted manually.
DURATION:
- Exposure duration: 48 hours
- Selection time: 48 hours, simultaneously with exposure
SELECTION AGENT: histidine
NUMBER OF REPLICATIONS: triplicates
DETERMINATION OF CYTOTOXICITY
- Method: The background lawn of bacterial growth was checked as an indicator of the possible toxic effect of the test substance towards the strains. - Evaluation criteria:
- - The test substance was considered positive if:
1) there was a significant increase in the number of revertant colonies (at least two-fold the spontaneous reversion of the corresponding solvent controls, when their spontaneous reversion was below 10);
2) a dose effect relationship was observed; and
3) these effects could be reproduced.
- The above mentioned criteria can be applied in most cases. When equivocal results are obtained more assays may be required, in order to evaluate the mutagenic potential of the test substance. - Statistics:
- No statistical analyses were required for the given evaluation criteria.
- 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:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Evaporation from medium: no data
- Water solubility: not soluble at 50 mg/mL
- Precipitation: none
RANGE-FINDING/SCREENING STUDIES:
- The results of the preliminary dose range finding study indicated that the test substance was non-toxic to TA100 at concentrations up to 5000 µg/plate as the number of revertant colonies was not found to be reduced.
- Toxic action of the test substance was also not detected by a thinning of the bacterial lawn at 5000 µg/plate or a significant reduction of the number of colonies. Considering the reversion rate of TA100 to prototrophy with the test substance, a significant increase in the number of revertant colonies could be evidenced at one dose level (2500 µg/plate) in the presence of metabolic activation.
COMPARISON WITH HISTORICAL CONTROL DATA:
- All positive and vehicle control mean values were within the range of historical data except for the vehicle control of TA100 in Experiment 2, which was only slightly above the max value in the historical data (176 versus 175).
- As expected, the appropriate positive control chemicals induced marked increases in revertant colony numbers with all strains.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- In Experiments 1 and 2 without S9 mix, and Experiment 2 with S9 mix, low toxic effects were observed at 5000 µg/plate in TA98. - Conclusions:
- Interpretation of results:
positive in TA100 with and without metabolic activation
The test substance was evaluated for mutagenic potential in the Ames reversion mutation test using S. typhimurium tester strains TA98 and TA100 in the presence and absence of metabolic activation. Based on the results of the study, it was concluded that the test substance was mutagenic to TA100 in the absence and presence of metabolic activation.
TA100 showed increased reversion to prototrophy at dose levels of 2500 and 5000 µg/plate both in the absence or presence of metabolic activation. These findings were confirmed by the repeated test.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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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