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EC number: 219-759-6 | CAS number: 2524-64-3
- 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
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:
- 05 June 2008 to 25 June 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine requirement in the Salmonella typhimurium strains, tryptophan requirement in the Escherichia coli strain.
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- - Preliminary toxicity assay: 6.7, 10, 33, 67, 100, 333, 667, 1000, 3333 and 5000 µg/plate
- Mutagenicity assay: 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethylformamide (DMF)
- Justification for choice of solvent/vehicle: The test material formed a soluble and clear solution in DMF at 500 mg/mL, the maximum concentration tested. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
Minimal top agar containing 0.8 % (w/v) agar and 0.5 % (w/v) NaCl was melted and supplemented with L-histidine, D-biotin and L-tryptophan solution to a final concentration of 50 µM each. Top agar not used with S9 or Sham mix was supplemented with 25 mL of water per 100 mL. Bottom agar (Vogel-Bonner minimal medium E) contained 1.5 % (w/v) agar supplemented with 2.5 % (w/v) Oxoid nutrient Broth No. 2
0.5 mL of S9 or Sham mix, 100 µL of tester strain (10⁹ cells/mL) and 50 µL of vehicle, test material dilution or positive control were added to 2.0 mL of selective top agar at 45 ± 2 °C.
The mixture was vortexed and overlaid onto 25 mL minimal bottom agar. After setting, the plates were inverted and incubated at 37 ± 2 °C.
DURATION
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS: 3 in the mutagenicity assay
DETERMINATION OF CYTOTOXICITY
- Method: Condition of the background lawn - Evaluation criteria:
- Positive response: A dose-related increase in the mean number of revertants per plate of at least one tester strain over a minimum of two increasing test concentrations. TA 1535 and TA 1537 were considered positive if a three-fold increase was observed at the peak of the dose-response. For all other tester strains, the required increase was two-fold.
Equivocal response: A biologically relevant increase in revertant count that partially meets only one of the conditions for a positive response (a dose response relationship or an increase above the stated thresholds for the tester strains).
Negative response: A response that meets neither the criteria for a positive response nor an equivocal response. - 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation occurred during the study
- Other confounding effects: Due to contaminants in the bottom agar in the mutagenicity assay for the TA 100 plates with S9 and also the positive control plates for strain TA 1535 with S9, revertant colonies were counted by hand rather than using an automated colony counter. Acceptable vehicle and positive control values showed that the test system was functioning correctly despite this observation.
RANGE-FINDING/SCREENING STUDIES: No cytotoxicity was observed in the screening test.
COMPARISON WITH HISTORICAL CONTROL DATA: The control data were comparable to the historical control data for the performing laboratory. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative in the presence and absence of exogenous metabolic activation
Under the conditions of the study, the test material was found to be non-mutagenic in the bacterial reverse mutation assay (Ames test) in the presence and absence of exogenous metabolic activation in the tester strains S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvrA. - Executive summary:
The mutagenicity of the test material was evaluated in a bacterial reverse mutation assay (Ames test) conducted in accordance with the standardised guideline OECD 471 under GLP conditions.
The test material was evaluated using the plate incorporation method using tester strains S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvrA in the presence and absence of an exogenous metabolic activation system (S9 mix). The assay was performed in two phases; firstly, a preliminary toxicity assay was conducted to establish the dose range and in the second phase the mutagenicity assay was conducted.
The dose levels tested in the preliminary assay were 6.7, 10, 33, 67, 100, 33, 667, 1000, 333 and 5000 µg/plate. On the basis of this, the dose levels selected for the mutagenicity assay were 50, 150, 500, 1500 and 5000 µg/plate.
No cytotoxicity was observed at any dose level with any tester strain both in the cytotoxicity test and the mutagenicity test. The test material formed a clear solution in the chosen vehicle (DMF); no precipitation was observed in any of the tester plates.
No positive or equivocal responses were recorded in any of the tester strains used in the mutagenicity assay.
Under the conditions of the study, the test material was found to be non-mutagenic in the presence and absence of exogenous metabolic activation in the tester strains S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvrA.
Reference
Table 1: Summary of the Mutagenicity Assay Results in the Absence of Exogenous Metabolic Activation (S9)
Dose (µg/plate) |
Average Number of Revertants Per Plate ± Standard Deviation |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|
Vehicle control |
11 ± 4 |
132 ± 24 |
6 ± 1 |
10 ± 3 |
26 ± 4 |
50 |
10 ± 6 |
119 ± 4 |
6 ± 3 |
10 ± 1 |
19 ± 5 |
150 |
9 ± 2 |
121 ± 5 |
8 ± 1 |
7 ± 4 |
15 ± 3 |
500 |
7 ± 5 |
115 ± 14 |
9 ± 4 |
7 ± 3 |
20 ± 5 |
1500 |
8 ± 4 |
106 ± 8 |
8 ± 2 |
7 ± 1 |
20 ± 3 |
5000 |
9 ± 2 |
119 ± 13 |
12 ± 3 |
8 ± 2 |
26 ± 8 |
Positive control* |
107 ± 10 |
469 ± 38 |
271 ± 37 |
1304 ± 80 |
160 ± 22 |
*Positive controls: TA 98 2-nitrofluorene at 1.0 µg/plate; TA 100 and TA 1535 sodium azide 1.0 µg/plate; TA 1537 9-aminoacridine75 µg/plate; and WP2 uvrA methyl methanesulfonate 1000 µg/plate.
Table 2: Summary of the Mutagenicity Assay Results in the presence of exogenous metabolic activation (S9)
Dose (µg/plate) |
Average Number of Revertants Per Plate ± Standard Deviation |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|
Vehicle control |
16 ± 2 |
93 ± 7 |
6 ± 1 |
7 ± 3 |
19 ± 4 |
50 |
15 ± 7 |
91 ± 7 |
11 ± 2 |
5 ± 3 |
17 ± 7 |
150 |
17 ± 5 |
89 ± 18 |
9 ± 2 |
5 ± 3 |
20 ± 6 |
500 |
19 ± 2 |
98 ± 6 |
9 ± 2 |
5 ± 3 |
25 ± 10 |
1500 |
15 ± 3 |
86 ± 12 |
12 ± 3 |
6 ± 2 |
21 ± 8 |
5000 |
15 ± 6 |
102 ± 13 |
6 ± 2 |
6 ± 2 |
22 ± 2 |
Positive control* |
453 ± 126 |
481 ± 46 |
61 ± 21 |
97 ± 6 |
273 ± 76 |
*Positive controls: TA 98, TA 100, TA 1535 and TA 1537 2-aminoanthracene at 1.0 µg/plate; and WP2 uvrA 2-aminoanthracene at 10 µg/plate.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The mutagenicity of the test material was evaluated the key study Wagner & Hines (2008) using a bacterial reverse mutation assay (Ames test) conducted in accordance with the standardised guideline OECD 471 under GLP conditions. The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality described in Klimisch et al. (1997).
The test material was evaluated using the plate incorporation method using tester strains S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvrA in the presence and absence of an exogenous metabolic activation system (S9 mix). The assay was performed in two phases; firstly, a preliminary toxicity assay was conducted to establish the dose range and in the second phase the mutagenicity assay was conducted.
The dose levels tested in the preliminary assay were 6.7, 10, 33, 67, 100, 33, 667, 1000, 333 and 5000 µg/plate. On the basis of this, the dose levels selected for the mutagenicity assay were 50, 150, 500, 1500 and 5000 µg/plate.
No cytotoxicity was observed at any dose level with any tester strain both in the cytotoxicity test and the mutagenicity test. The test material formed a clear solution in the chosen vehicle (DMF); no precipitation was observed in any of the tester plates.
No positive or equivocal responses were recorded in any of the tester strains used in the mutagenicity assay.
Under the conditions of the study, the test material was found to be non-mutagenic in the presence and absence of exogenous metabolic activation in the tester strains S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2 uvrA.
Justification for selection of genetic toxicity endpoint
A single good quality study was available for evaluation.
Justification for classification or non-classification
The available information is not sufficient to draw conclusion on the germ-cell mutagenicity potential of the substance in accordance with Annex I of the regulation EC 1272/2008 (CLP).
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