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EC number: 473-160-6 | 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:
- June 14, 2000 - June 29, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Directive 92/69/EEC, B.14
- Version / remarks:
- 1992
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
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
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : liver microsomal fraction
- method of preparation of S9 mix : Livers of 8-12 weeks old male rats, strain Wistar which received three applications of 80 mg/kg bw Phenobarbital i.p. dissolved in aqua deionised and beta-naphthoflavone orally dissolved in corn oil. The livers were prepared 24 h after the last treatment.
S9 liver microsomal fraction was also obtained and used from hamsters. The livers of 7-8 weeks old male Syrian golden hamsters.
- concentration or volume of S9 mix and S9 in the final culture medium : 15% final concentration (rat S9) or 30% (hamster S9) - Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 33 - 5000 µg/plate
Concentration range in the main test (without metabolic activation): 33 - 5000 µg/plate - Vehicle / solvent:
- Solvent: Bidistilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 mix, TA1535, TA100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenylene-diamine
- Remarks:
- without S9 mix, TA1537, TA98
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: methyl methane sulfonate
- Remarks:
- without S9 mix, TA 102
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with S9 mix, TA1535, TA100, TA1537, TA98, TA102
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- congo red
- Remarks:
- with hamster S9 mix only, TA 98
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- Test substance adde in agar (plate incorporation, experiment I), pre-incubation (experiment II)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period: 30 min at 30°C
- Exposure duration/duration of treatment: 48 h at 37°C
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: reduction in number of revertants - Evaluation criteria:
- A test item is considered positive if either a dose related increase in the number of revertants or a biologically relevant and reproducible increase for at least one test concentration is induced. A test item producing neither a dose related increase in the number of revertants nor a biologically relevant and reproducible positive response at any one of the test points is considered non-mutagenic in this system. A biologically relevant response is described as follows: A test item is considered mutagenic if in strains TA 98, TA 100, and TA 102 the number of reversions is at least twice as high and in strains TA 1535 and TA 1537 at least three times higher as compared to the spontaneous reversion rate. Also, a dose-dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test item regardless whether the highest dose induced the above described enhancement factors or not.
- Statistics:
- No statistical evaluation
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- STUDY RESULTS
- see attachement
Slight toxic effects, evident as a reduction in the number of revertants, were observed without metabolic activation in strains TA 1535 (33 µg/plate) and TA 98 (10 µg/plate) and with metabolic activation in strain 1537 (333 and 1000 µg/plate) in experiment I, and at 5000 µg/plate with metabolic activation in strain TA 1537 in experiment II. The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
HISTORICAL CONTROL DATA
- see attachment
Applicant's summary and conclusion
- Conclusions:
- BLUE MGi 1037 is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
- Executive summary:
A study according OECD TG 471 was performed to investigate the potential of BLUE MGi 1037 to induce gene mutations according to the plate incorporation test (experiment I) 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 two independent experiments, both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
33; 100; 333; 1000; 2500; and 5000 µg/plate.
Slight toxic effects, evident as a reduction in the number of revertants, were observed without metabolic activation in strains TA 1535 (33 µg/plate) and TA 98 (10 µg/plate) and with metabolic activation in strain 1537 (333 and 1000 µg/plate) in experiment I, and at 5000µg/plate with metabolic activation in strain TA 1537 in experiment II.
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with BLUE MGi 1037 at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, BLUE MGi 1037 is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
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