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EC number: 950-968-1 | CAS number: -
- 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
- Ames Test (OECD 471, GLP, K, rel. 1): The registered
substance is non mutagenic up to cytotoxic or limit concentration in S.
typhimurium TA 1535, TA 1537, TA 98, TA 100 & E.coli WP2uvrA.
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:
- From June 11 to August 15, 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study conducted according to OECD test Guideline No. 471 without any deviation.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- July 21, 1997
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine and tryptophan for S. typhimurium and E. coli, respectively.
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9: purchased from Molecular Toxicology, Inc. (Lot No. 3234, containing 37.5 mg/mL protein). The homogenate was prepared from male Sprague-Dawley rats that had been injected (intraperitoneally) with Aroclor 1254 (200 mg/mL in corn oil) at 500 mg/kg, 5 days before sacrifice.
- method of preparation of S9 mix: S9 mix was prepared on the day of use, maintained on ice, and contained (in 1 mL):
H2O 0.70 mL
1M NaH2PO4/Na2HPO4, pH 7.4 0.10 mL
0.25M Glucose-6-phosphate 0.02 mL
0.10M NADP 0.04 mL
0.825M KCl/0.2M MgCl2 0.04 mL
Liver Homogenate (S9) 0.10 mL
- volume of S9 mix in the final culture medium: 500 µL added to 2 mL of undiluted molten selective top agar
- quality controls of S9: The most concentrated test article dilution and the S9 mix (100 and 500 µL, respectively; the same volumes used in the assay) were checked for sterility by plating on selective agar. - Test concentrations with justification for top dose:
- Initial assay: 5.00, 16.0, 50.0, 160, 500, 1600, and 5000 µg/plate with and without S9.
Confirmatory assay: 5.00, 16.0, 50.0, 160, 500, 1600, and 5000 µg/plate with S9 and 1.60, 5.00, 16.0, 50.0, 160, 500, and 1600 µg/plate without S9. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Based on solubility assessment.
- Justification for percentage of solvent in the final culture medium: Not reported. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other:
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate)
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in medium; in agar (plate incorporation)
TREATMENT SCHEDULE:
- Exposure duration/duration of treatment: 52 +/- 4 hours at 37 +/- 2°C
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: background growth inhibition - Evaluation criteria:
- - Criteria for a Negative Response:
A test article is considered to have produced a negative response if no dose-dependent, ≥ 2.0-fold or ≥3.0-fold increases are observed in tester strains TA98, TA100, and WP2uvrA, or TA1535 and TA1537, respectively
- Criteria for an Equivocal Response
Even after repeated trials, a test article may produce results that are neither clearly positive nor clearly negative (e.g., responses that do not meet the dose-dependency or fold increase requirements but are reproducible). In those rare instances, the test article may be considered to have produced an equivocal response. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory
- Key result
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA98 & TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True 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 examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Possibility of evaporation from medium: low volatility based on vapor pressure of constituents
- Precipitation and time of the determination:
Initial assay: Precipitate was observed at ≥1600 μg/plate in all tester strains with and without S9 except WP2uvrA, where precipitate was observed at 5000 μg/plate with S9.
Confirmatory assay: Precipitate was observed at 5000 μg/plate in all tester strains with and without S9
STUDY RESULTS
- Sign of toxicity
Initial assay: Toxicity, as evident by the absence or reduction in the mean number of revertant colonies and/or reduction in the background bacterial lawn, was observed at ≥1600 μg/plate in all tester strains with S9 except TA98 and WP2uvrA, where toxicity was observed at 5000 μg/plate. Toxicity, as evident by the absence or reduction in the mean number of revertant colonies and/or absence or reduction in the background bacterial lawn, was observed at ≥160 μg/plate in all tester strains without S9 except WP2uvrA, where toxicity was observed at ≥1600 μg/plate.
Confirmatory assay: Toxicity, as evident by the absence or reduction in the mean number of revertant colonies and/or reduction in the background bacterial lawn, was observed at ≥1600 μg/plate in all tester strains with S9 except TA98 and WP2uvrA, where toxicity was observed at 500 and 5000 μg/plate, respectively. Toxicity, as evident by the absence or reduction in the mean number of revertant colonies and/or absence or reduction in the background bacterial lawn, was observed at ≥160 μg/plate in all tester strains without S9 except TA1537 and WP2uvrA, where toxicity was observed at ≥50.0 μg/plate in TA1537 and no toxicity was observed in WP2uvrA.
- Individual plate counts & Mean number of revertant colonies per plate and standard deviation are in the attached document.
HISTORICAL CONTROL DATA
- Positive historical control data: inside (cf attached document)
- Negative (solvent/vehicle) historical control data: inside (cf attached document) - Conclusions:
- Under the test condition, test material was not mutagenic to S. typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and E.coli WP2 uvrA- in the presence and absence of metabolic activation.
- Executive summary:
In a reverse gene mutation assay performed according to the OECD test guideline No. 471 and in compliance with GLP, S. typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and E. coli strain WP2 uvrA- were exposed to the test material both in the presence and absence of metabolic activation system (liver S9 in standard co-factors) using the plate incorporation method.
In the first experiment the dose levels ranged from 5 to 5000 µg/plate with and without S9. Precipitate was observed at ≥1600 μg/plate in all tester strains with and without S9 except WP2uvrA with S9, where precipitate was observed at 5000 μg/plate. Toxicity was observed in all tester strains at ≥1600 μg/plate with S9 except TA98 and WP2uvrA, where toxicity was observed at 5000 μg/plate. Toxicity was observed at ≥160 μg/plate in all tester strains without S9 except WP2uvrA, where toxicity was observed at ≥1600 μg/plate.
Based on the results of the first, a second confirmatory mutagenicity assay was conducted in all five tester strains at dose levels of 5 to 5000 µg/plate with S9 and from 1.60 to 1600 µg/plate without S9. Precipitate was observed at 5000 μg/plate in all tester strains with and without S9. Toxicity was observed in all tester strains at ≥1600 μg/plate with S9 except TA98 and WP2uvrA, where toxicity was observed at ≥500 and 5000 μg/plate, respectively. Without S9, toxicity was observed at ≥160 μg/plate in all tester strains except TA1537 and WP2uvrA, where toxicity was observed at ≥50.0 μg/plate in TA1537 and no toxicity was observed in WP2uvrA.
No increase in the mean number of revertant colonies was observed at any tested dose level in any tester strain with and without S9 in the initial or the confirmatory assay. All positive and vehicle control values were within the acceptable ranges, and all criteria for a valid study were met.
Under the test condition, test material was not mutagenic to S. typhimurium strains TA 98, TA 100, TA 1535 and TA 1537 and E.coli WP2 uvrA- in the presence and absence of metabolic activation.
This study is considered as acceptable and satisfies the requirement for reverse gene mutation endpoint.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Table 7.6/1: Summary of genotoxicity tests
Test n° |
Test / Guideline Reliability |
Focus |
Strains tested |
Metabolic activation |
Test concentration |
Statement |
1
RIFM, 2008 |
Ames Test (OECD 471) K, rel. 1 |
Gene mutation |
TA 1535, TA 1537, TA 98, TA 100 E. coli WP2uvrA |
-S9 +S9 |
Up to cytotoxic or limit concentration |
-S9 : non mutagenic +S9 : non mutagenic |
Gene mutation Assays (Tests n° 1):
A Bacterial Reverse mutation Assay (Ames test) was performed according to OECD guideline No. 471 on the registered substance (Test n°1, see Table 7.6/1). No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains under the test condition, with any dose of the substance, either in the presence or absence of metabolic activation. The substance does not induce gene mutations in bacteria whereas all positive control chemicals (with and without metabolic activation) induced significant increase of colonies. The substance is therefore considered as non-mutagenic according to the Ames test.
Justification for classification or non-classification
Harmonised classification:
The test material has no harmonised classification for human health according to the Regulation (EC) No. 1272/2008 (CLP).
Self-classification:
Based on the available data, no classification is proposed for the registered substance regarding germ cell mutagenicity according to the CLP and the GHS.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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