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Diss Factsheets
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EC number: 944-549-2 | 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
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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Methd B14 specified in the Annex to 92/69/EEC
- Qualifier:
- according to guideline
- Guideline:
- other: UKEMS Guidelines (1990)
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Harmonised Tripartite Guideline (1997)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- other: Cream powder (84% w/w)
Constituent 1
- Specific details on test material used for the study:
- MI3, solid, purity of 98.4%
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: Histidine dependent
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian liver post-mitochondrial fraction (S-9) prepared from Sprague Dawley rats induced with Arochlor 1254
- Test concentrations with justification for top dose:
- Two experiments were carried out:
Range finder experiment and mutation experiment 1:
Test concentrations: 1.6, 8, 40,200,1000 and 5000 ug/mL
Mutation experment 2:
Test concentrations: 156.25, 312.5, 625, 1250, 2500 and 5000 ug/mL - Vehicle / solvent:
- Due to the proteineous nature of the test substance, sterile water was considered to be the most appropriate solvent for this study.
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- other: 2-aminoanthracene and glutaraldehyde
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
Range-finder experiment:
S. typhimurium TA100 were exposed in triplicates to the above mentioned concentrations with and without S-9 (4 solvent controls and triplicate positive controls) for 3 days. Plates were investigated for toxicity and where possible revertant colonies were counted.
Mutation experiments:
All five strains were tested in triplicates with and without S-9.
Preincubation period: 1 hour in experiment 2 - Evaluation criteria:
- The test article was considered to be mutagenic if:
1. the assay was valid
2. Dunnett's test gave a significant response (p ≤ 0.01) and the data ste(s) showed a significant dose correlation
3. the positive responses described above were reproducible - Statistics:
- The m-statistic was calculated to check that the data were Poisson-distributed and Dunnett's test was used to compare the counts of each dose with the control. The presence or otherwise of a dose response was chekced by linear regression analysis.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
An initial toxicity range-finder experiment was carried out in strain TA100 only, using final concentrations of MI3 at 1.6, 8, 40, 200, 1000 and 5000µg/plate plus solvent and positive controls. Following these treatments and those of the remaining strains in experiment 1, no evidence of toxicity was observed.
In experiment 1, maximum test dose treatments of strain TA1537 (with and without S-9) resulted in several microcolonies in addition to the characteristic larger colonies normally observed with this strain. Streaks of bith types of colony types on to minimal agar (with biotin) plates and on to nutrient agar plates confirmed that only the larger bacterial colonies were true revertants. The plates were therefore scored manually to only count the larger colonies. The presence of microcolonies were not considered to have affected the integrity of this assay and the manual counts were accepted as valid.
Experiment 2 treatments retained 5000 µg/plate as the maximum test done but employed a narrowed dose range in order to investigate those doses of MI3 considered most likely to induce mutagenic response. In addition, treatments with S-9 were modified by the inclusion of a pre-incubation step. In this way it was hoped to increase the range of mutagenic chemicals that would be detected in the assay system. No signs of toxicity was observed in any test strains.
Negative (solvent) controls and positive controls were included for all strains in both experiments. The mean number of revertant colonies on negative control plates all fell within acceptable ranges and were significantly elevated by positive control treatments
Applicant's summary and conclusion
- Conclusions:
- MI3 did not induce mutation in five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537 and TA102), when tested under conditions employed in this study. The conditions included treatments at concentrations up to 5000 ug/plate, both in the absence and in the presence of a rat liver metabolic activation system (S-9)
- Executive summary:
MI3 was assayed for mutation in five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of salmonella typhimurium, both in the absence and presence of metabolic activation by an Aroclor 1254 induced rat liver post-mitochondrial fraction (S-9) in two separate experiments.
An initial toxicity range-finder experiment was carried out in strain TA100 only, using final concentrations of MI3 at 1.6, 8, 40, 200, 1000 and 5000µg/plate plus solvent and positive controls. Following these treatments and those of the remaining strains in experiment 1 and 2, no evidence of toxicity was observed.
MI3 did not induce mutation in five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537 and TA102), when tested under conditions employed in this study. The conditions included treatments at concentrations up to 5000 ug/plate, both in the absence and in the presence of a rat liver metabolic activation system (S-9)
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