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EC number: 280-622-9 | CAS number: 83732-72-3
- 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:
- 13.04. - 19.05.2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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:
- Reference substance 002
- Cas Number:
- 90817-34-8
- Test material form:
- solid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- In the pre-experiment the concentration range of the test item was 3 - 5000 µg/plate. The pre-experiment is reported as part of experiment I since the criteria mentioned above were met. Based on the toxic effects observed in the pre-experiment, seven concentrations were tested in experiment I and II. The confirmatory experiment I A was performed with six concentrations.
The concentration range included two logarithmic decades. The following concentrations were tested:
Experiment 1: 3; 10; 33; 100; 333; 1000; and 2500 µg/plate
Experiment I A: 25; 50; 100; 150; 200; and 300 µg/plate
Experiment II (without S9 mix): Experiment II (with S9 mix): 3; 10; 33; 100; 333; 1000; and 2500 µg/plate
Experiment II (with S9 mix): 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- deionised water
Controls
- Untreated negative controls:
- yes
- Remarks:
- concurrent untreated
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
Results and discussion
Test results
- Key result
- Species / strain:
- other: S. typhimurium TA 1537, TA 98
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- other: yes, obeersered in all strains used
- Remarks:
- strong toxic effects, evident as a reduction in the number of revertants
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item induced gene mutations by frameshifts in the genome of the strains TA 1537 and TA 98 in the absence of metabolic activation.
Therefore, A 130 is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay. - Executive summary:
This study was performed to investigate the potential of A 130 to induce gene mutations according to the plate incorporation test (experiment I and I A) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and TA 102.
The assay was performed in three independent experiments. Experiments I and II were performed with and without metabolic activation. Due to a questionable increase in revertant colonies in strain TA 100 in experiment I a confirmatory experiment was performed without metabolic activation. This confirmatory experiment is reported as experiment I A. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
Experiment 1: 3; 10; 33; 100; 333; 1000; and 2500 µg/plate
Experiment I A: 25; 50; 100; 150; 200; and 300 µg/plate
Experiment II (without S9 mix): Experiment II (with S9 mix): 3; 10; 33; 100; 333; 1000; and 2500 µg/plate
Experiment II (with S9 mix): 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Reduced background growth was observed in experiment I in strains TA 98 and TA 100 at 333 µg/plate and above and in strains TA 1535 and TA 102 at 1000 µg/plate and above in the absence of metabolic activation. In experiment I A reduced background growth was observed at 200 µg/plate and above. In experiment II in all strains reduced background growth was observed at 333 µg/plate and above without S9 mix and at 1000 µg/plate and above with S9 mix.
Strong toxic effects, evident as a reduction in the number of revertants, were observed in all strains used.
Substantial and dose dependent increases in revertant colony were observed following treatment with A 130 in strains TA 1537 (experiment I and II, without S9 mix) and TA 98 (experiment II, without S9 mix). The number of colonies exceeded the threshold of twice (strain TA 98) at 100 µg/plate and thrice (strain TA 1537) at 33 and 100 µg/plate the number of the corresponding solvent control. At higher concentrations the number of colonies was reduced due to overlapping toxic effects.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
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