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EC number: 687-691-8 | CAS number: 709031-43-6
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Batch number ZD48725 LOT002
Method
- Target gene:
- four histidine-requiring strains and one tryptophan-requiring strain
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Obtained from the UK NCTC
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Obtained from the UK NCTC
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver post-mitochondrial fraction (S-9)
- Test concentrations with justification for top dose:
- An initial range finding experiment was carried out in strain TA100 only, using final concentrations of BMS 528235-01 at 1.6, 8, 40, 200, 1000 and 5000 ug/plate, plus negative (solvent) adn positive contols. Experiment 1 treatments of the remained tester strains retained teh same dose series. Experiment 2 treatments of all the tester strains retained 5000 ug/plate as the max test dose. A narrowed dsoe range was employed for treatment of all strains (78.125 to 5000 ug/plate), in order to more closely examine the highest concentration considered most likely to provide evidence of any mutagenic activity.
- Vehicle / solvent:
- Sterile anhydrous analytical grade dimethyl solphoxide (DMSO)
Controls
- Untreated negative controls:
- yes
- Remarks:
- (see solvent controls)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- in DMSO
- Positive controls:
- yes
- Remarks:
- Treatments with the appropriate stock positive control solution
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- A preliminary range finding experiment was conducted with strain TA100 at 5 concentrations from 1.6 to 5000 ug/plate plus negative (solvent) controls. No evidence of toxicity was observed following this treatment. These data were considered acceptable for mutation assessment and were used to comprise the TA100 mutagenticity data for Experiment 1. Experiment 1 treatments fo the remaining tester strains retained the same dose series as used in teh Range-finder experiment. No evidence of toxicty was observed following any Experiment 1 treatments.
Experiment 2 treatments of all teh teser strains retained 5000 ug/plate as the max test dose. A narrowed dsoe range was employed for treatment of all strains (78.125 to 5000 ug/plate), in order to more closely examine the highest concentration considered most likely to provide evidence of any mutagenic activity. In addition all treatments in teh presence of S-9 were further modified by teh inclusion of a pre-incubation step. In this way it was hoped to increase the range of mutagenic chemicals that cold be detected using this assy system. Evidence of toxicisty was observed following the top dose treatments of some of the strains in teh presnced ofn S-9 only. Preciipitation of the test article was observed followign teh top dose treatment of S. tryphimurium strains in teh presenced of S-9 only.
Negative (solvent) and poistive control treatments were included fora ll strains in both experiments. Teh mean numbers of revertant colonies on negative control plates all fell within acceptable ranges, and were significantly evelvated by postive control treatments - Evaluation criteria:
- The assay was considered valid if the following crieteria were met:
1. The mean negative control counts fell within the normal ranges
2. The positive control chemicals induced clear increases in revertant numbers confirming discrimination between different strains, and an active S-9 preparation.
3. No more than 5% of the plates were lost through contamination or some other unforseen event.
The test article was considered to be mutagenic if:
1. The assay was valid (see above)
2. Dunnett's test gave a significant response (p< 0.01) and the data set(s) showed a significant dose correlation
3. The positive responses described above were reproducible.
Results and discussion
Test resultsopen allclose all
- 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
- Remarks:
- up to 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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
- Remarks:
- u ot 5000 ug/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- No statistically significant, dose-related and reproducible increases in revertant numbers were observed following any strain treatments in the absenced or presence of metabolic activation, and therefore this study was considered to have provided no evidence of any BMS 528235-01 mutagenic activity.
It was concluded that BMS 528235-01 did not induce mutation in four histidine-requiring strains of S. typhimurium (TA98, TA1000, TA1535 adn tA1537), adn one tryptophan-requiring strain of Escherichia coli (WP2 uvrA) when tested under the conditions of this study. These conditions included treatments at concentrations up to 5000 ug/plate in teh absence and in the prsence of a rat liver metabolic activation sysatem (S-9)
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