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EC number: 800-036-4 | CAS number: 1422423-64-0
- 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:
- weight of evidence
- Study period:
- From April 21st to May 05th, 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Set Retard Plus
- IUPAC Name:
- Set Retard Plus
- Test material form:
- solid: particulate/powder
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 97a, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- Tester strains of Salmonella typhimurium containing a different type of mutation in the histidine operon were employed for this study.
The strains are tested routinely for other genotypic characters such as:
- Histidine requirement – The His - character of all tester strains was confirmed by demonstrating the histidine requirement for growth on selective agar plates
- rfa mutation, i.e. cell membrane permeability was checked through sensitivity to crystalviolet
- uvrB mutation was checked through sensitivity to ultra-violet light (TA1535, TA98, TA100and TA97a)
- R- factor plasmid (pKM101)
- presence or absence of R- factor plasmid was checked through ampicillin resistance (TA98, TA100 and TA97a), and-pAQ1 plasmid
- the pAQ1 strain (TA102) was tested for both ampicillin and tetracycline resistance (TA102).
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 fraction
- Test concentrations with justification for top dose:
- 5000, 1500, 500, 150 and 50 µg/plate
- Vehicle / solvent:
- - Vehicle: distilled water.
Controls
- Untreated negative controls:
- yes
- Remarks:
- Plates containing the reaction mixture, but not the test article formulation, and overlay agar supplemented with histidine, served as a negative control to check spontaneous revertants.
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Since distilled water was the vehicle employed, plates containing the reaction mixture comprising of distilled water but not test item, and overlay agar supplemented with histidine, served as a control to check spontaneous revertants.
- Positive controls:
- yes
- Remarks:
- with and without S9 Mix
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- cumene hydroperoxide
- other: 2-Aminoanthracene, 2- Aminofluorene, Danthron, ICR 191
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation).
DURATION
- Preincubation period: 12 to 16 hs at 37 °C to achieve cell density of about 1 x 10^9 cells/ml.
- Exposure duration: 48 hs.
NUMBER OF REPLICATIONS: triplicate plating was performed at each dose level.
DETERMINATION OF CYTOTOXICITY IN A PRELIMINARY TEST ON STRAIN TA100: relative total growth, in order to select test concentrations for main study.
PREPARATION OF MAMMALIAN LIVER FRACTION (S9)
Preparation of S9, using liver of Sprague Dawley rats and phenobarbitone with beta-naphthoflavone as inducing agents was carried out at INTOX laboratories following the method of Westphal et.al (2000).The S9 fraction was tested for protein content as well as sterility before preserving in cryocans at about -196 °C. For every experiment, fresh vials were removed from the cryocan, thawed and used in the preparation of S9 mix.
PREPARATION OF S9 MIX
The S9 mix was prepared in cold condition at ~ 4 °C, immediately prior to its use in the experiment.
The microsomal enzyme reaction mixture contained following components for 10 ml.
1) Rat liver S9 fraction1.00 ml
2) 0.4 M MgCl2, 1.65 M - KCl salt solution 0.20 ml
3) 1.0 M G-6-P0.05 ml
4) 0.1 M NADP0.40 ml
5) 0.2 M Phosphate buffer pH 7.4 5.00 ml
6) Distilled water3.35 ml - Evaluation criteria:
- The mutagenic activity of the test article was assessed by applying the following criteria:
1. a test article is considered as mutagenic if it produces a concentration related increase over the range tested and /or a reproducible increase at one or more concentrations in the number of revertant colonies per plate in at least one strain with or without metabolic activation system.The biologically significant increase would be assumed if the average colony counts are: at least twice as compared to those in vehicle control group for strain TA97a, TA98, TA100 and TA102 and at least thrice as compared to those in vehicle control group for strain TA1535.
2.a test article is considered as non-mutagenic, if it does not induce any increase in the number of revertants and does not show any dose response relationship, in two separate experiments, with any bacterial strain, either with or without metabolic activation.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA1535, TA97a, TA98, TA100 and TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- REVERTANT FREQUENCIES IN TREATMENT GROUPS
Test item was not found to be cytotoxic to strain TA100 as was observed during the preliminary cytotoxicity study. Frequencies of histidine revertant colonies observed at all concentrations of test item in tester strains TA1535, TA97a, TA98, TA100 and TA102, with and without the presence of a metabolic activation system, were comparable to those observed in the vehicle control groups, as per the criteria employed for evaluation of mutagenic potential, and this observation was confirmed by repetition of the experiments.
REVERTANT FREQUENCIES IN VEHICLE CONTROL GROUPS
Plate counts for the spontaneous histidine revertant colonies in the vehicle control groups were found to be within the frequency ranges expected from the laboratory historical control data at testing laboratory. They also compared well with the range reported in the published literature.
REVERTANT FREQUENCIES IN POSITIVE CONTROL GROUPS
Concurrent positive controls demonstrated sensitivity of the assay with and without metabolic activation.
Applicant's summary and conclusion
- Conclusions:
- Test item is non-mutagenic in Salmonella typhimurium strains TA1535, TA97a, TA98, TA100 and TA102, with and without metabolic activation.
- Executive summary:
Method
Salmonella typhimurium Reverse Mutation Assay was carried out in compliance with the OECD Guidelines for Testing of Chemicals (No. 471, Section 4: Health Effects) on conduct of "Bacterial Reverse Mutation Test", adopted 21 July 1997 and as per mutually agreed protocol. The test item was evaluated in the / Salmonella Plate Incorporation Assay to determine its ability to induce reverse mutation at selected histidine loci in five tester strains of Salmonella typhimurium viz. TA1535, TA97a, TA98, TA100 and TA102 in the presence and absence of metabolic activation system (S9). Based upon the preliminary tests conducted to assess the solubility / precipitation and cytotoxicity of test item, the tester strains were exposed to the test article in triplicate cultures at the doses of 5000, 1500, 500, 150 and 50 µg/plate, both with and without metabolic activation system (S9). Liver S9, induced in Sprague Dawley rats by phenobarbitone with β-naphthoflavone, was used for this purpose. Distilled water was used as a vehicle. The exposed bacteria were plated onto minimal glucose agar medium supplemented with L-histidine. The plates were incubated at 37 °C for 48 hours after which the histidine revertant colonies were counted and their frequency was compared with that in the vehicle control group. Concurrent negative control group and positive control groups were also included in the experiment, as specified by the test guideline.
Observations
Results of this test indicated that the frequencies of histidine revertant colonies at all concentrations of test item in strains TA1535, TA97a, TA98, TA100 and TA102, with and without the presence of a metabolic activation system, were comparable to those observed in the vehicle control group, as per the criteria employed for evaluation of mutagenic potential, and this observation was confirmed by repetition of the experiments. Plate counts for the spontaneous histidine revertant colonies in the vehicle control groups were found to be within the frequency ranges expected from the laboratory historical control data at INTOX. They also compared well with the range reported in the literature. Concurrent positive controls demonstrated sensitivity of the assay with and without metabolic activation.
Conclusions
Under the conditions of this study, the test item is non-mutagenic in Salmonella typhimurium strains TA1535, TA97a, TA98, TA100 and TA102.
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