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EC number: 215-119-5 | CAS number: 1303-36-2
- 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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16/06/2015 - 13/07/2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Japanese Regulatory Authorities including METI, MHLW and MAFF
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- analysis for concentration, homogeneity and stability f the test item is not a requirement of the test guidelines and is not determined.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Diarsenic triselenide
- EC Number:
- 215-119-5
- EC Name:
- Diarsenic triselenide
- Cas Number:
- 1303-36-2
- Molecular formula:
- As2Se3
- IUPAC Name:
- diarsenic triselenide
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: E15-01025
- Expiration date of the lot/batch: Not supplied
- Source: University of California, Berkeley, on culture discs on 4 August 1995 + British Industrial Biological Research Association on nutrient agar plate on 17 august 1987.
- Storage conditions: -196 °C in Statebourne loquid nitrogen freezer, model SXR34
- Purity test date: 100%
- Physical state/appearance: black powder
- Storage conditions: room temperature in the dark
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Remarks:
- frame shift mutations + base pair substitutions
- Additional strain / cell type characteristics:
- other: rfa-, uvrB-. for TA98 and TA100: R-factor
- Species / strain / cell type:
- E. coli WP2 uvr A
- Remarks:
- base-pair substitutions
- Additional strain / cell type characteristics:
- other: trp-, uvrA-
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Experiment 1: 8 concentrations between 1,5 - 5000 µg/plate: 1,5 - 5 - 15 - 50 - 150 - 500 - 1500 - 5000 µg/plate
Experiment 2: 6 concentrations between 1,5 - 5000 µg/plate: 15 - 50 - 150 - 500 - 1500 - 5000 µg/plate
5000 µg/plate is the maximum recommended dose level. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethyl formamide at max concentration of 50 mg/ml
- half-log dilutions of the test item are prepared in the vehicle by mixing on a vortex mixer and sonication for 5 minutes at room temperature on the day of each experiment.
- All formulations are used within 4 hours of preparation and were assumed to be stable for this period.
- The test item and the bacteria are also incubated in the presence of a liver microsomal preparation (S9-mix) prepared from rats pre-treated with a mixture known to induce an elevated level of these enzymes.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- series without S9-mix
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Remarks:
- series with S9-mix
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS: 3
METHODS :
- Experiment 1: direct plate incorporation method (test for mutagenicity) with + without metabolic activation
- Experiment 2: pre incubation method with + without metabolic activation
- The S9 mix was prepared before use using sterilized co-factors and maintained on ice for the duration of the test. - Evaluation criteria:
- - Sensitivity of the assay and the efficacy of the S9-mix are validated in the (positive) controls
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - There was no visible reduction in the growth of the bacterial background lwan at any dose level, either in the presence or absence of metabolic activation S9 mix, in the first mutation test and in the second mutation test.
- Small, statistically significant increases in TA100 reveratnt colony frequency observed in the absence of S9-mix at 15 and 150 µg/plate in the first mutation test. These increases were considered to be of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the indidivudal revertant colony counts at 15 and 150 µg/plate were within the control range
- Acceptance criteria are met
Applicant's summary and conclusion
- Conclusions:
- GASIR 5 was considered to be non-mutagenic under te conditions of this test.
- Executive summary:
Introduction
The test method was designed to be compatible with the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF,the OECD Guidelines for TestingofChemicals No.471’’Bacterial Reverse Mutation Test,’,Method B13/14ofCommission Regulation (EC) number440/2008of30 May 2008 and the USA, EPA OCSPP harmonized guideline-Bacterial Reverse MutationTest.
Methods
Salmonella typhimurium strains TA1535,Ta 1^j7?TA98 and TA100 and Escherichia coli strain WFluvr Awere treated with suspensions of the test item using both the Ames plate incorporation and pre-incubation methods at up to eight dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolizing system (10% liver S9 in standardco-factors).The dose range for Experiment1 was predetermined and was 1.5to 5000トig/plate. The experiment was repeated on a separate day (pre-incubation method) using fresh culturesofthe bacterial strains and fresh test item formulations. The dose range was amended following the results of Experiment1 and was15to 5000jug/plate.
Six test item concentrations were selected in Experiment2 in order to achieve both four non-toxic dose levels and the potential toxic limit of the testitem following the change in test methodology.
Results
The vehicle (dimethyl formamide) control plates gave counts of revertant colonies within the normal range. All ofthe positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The maximum dose level of the test item in the first experiment was selected as the maximum recommended dose level of 5000jug/plate.There was no visible reduction in the growth of the bacterial background lawn at any dose level,either in the presence or absence of metabolic activation (S9-mix),in the first mutationtest(plate incorporation method) and consequently the same maximum dose level was used m the second mutationtest.Similarly, there was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation (S9-mix),in the second mutationtest(pre-incubation method).A test item precipitate (black and powdery in appearance) was initially observed under an inverted microscope at 1500|iig/plate and by eye at 5000|ug/plate?this observation did not prevent the scoring of revertant colonies.
There were no toxicologically significant increases in the frequencyofrevertant colonies recorded for anyofthe bacterial strains,with any doseofthetestitem, either with or without metabolic activation (S9-mix) in Experiment1(plate incorporation method). Similarly, no significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item,either with or without metabolic activation (S9-mix) in Experiment 2 (pre-incubation method). Small, statistically significant increases in TA100 revertant colony frequency were observed in the absence of S9-mix at15and150 |iig/plate in the first mutation test.These increases were considered to be of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the individual revertant colony counts at 15and150 |ng/plate were within the in-house historical untreated/vehicle control range for the tester strain and the maximum fold increase was only1.2 times the concurrent vehicle control.
Conclusion
GASIR5was considered to be non-mutagenic under the conditionsofthistest.
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