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EC number: 204-933-6 | CAS number: 129-16-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
AMES assay
The test substance substance did not showed any mutagenic activity at concentrations up to 100 μg/plate in S.typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 in the presence and absence of S9 metabolic activation system and hence, it can be concluded that the test substance is non mutagenic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Weight of evidence prepared from various publication mention below.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538,TA98
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538,TA98
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver-microsome preparation from rats injected with Aroclor 1254, 0.25 ml "S-9 mix"-plate with 0.2 ml S9/ml 'S9 mix'.
- Test concentrations with justification for top dose:
- 1,10,50 and 100 µg/plate
2,33 .0µg/plate,100 .0µg/plate,333.0 µg/plate,1000.0µg/plate,3333.0µg/plate - Vehicle / solvent:
- DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- ethylmethanesulphonate
- methylmethanesulfonate
- other: Anthragallol (For strains TA-1538 and TA98 without S9); 2-Anthramine (For all strains with S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
DURATION
- Preincubation period: No data available
- Exposure duration:3 days - Evaluation criteria:
- Mutations in Salmonella typhimurium i.e. Number of His + Revertants/plate
- Statistics:
- Rounded mean ± standard deviation
- Species / strain:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538 and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: Slight toxicity was noted
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538 and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA: Yes, historical negative control were used.
- Remarks on result:
- other: no mutagenic potential
- Conclusions:
- The test substance substance did not showed any mutagenic activity at concentrations up to 100 μg/plate in S.typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 in the presence and absence of S9 metabolic activation system and hence, it can be concluded that the test substance is non mutagenic.
- Executive summary:
The Ames Salmonella/mammalian-microsome assay was used to evaluate the bacterial mutagenicity of test substance . The test substance did not showed any mutagenic activity at concentrations up to 100 μg/plate in S.typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 in the presence and absence of S9 metabolic activation system and hence test substance is not likly to be classified as mutagen.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data for the various test chemicals was reviewed to determine the mutagenic nature of Merbromin (129-16-8). The studies are as mentioned below:
AMES test
The Ames Salmonella/mammalian-microsome assay was used to evaluate the bacterial mutagenicity of test substance. The test substance did not showed any mutagenic activity at concentrations up to 100 μg/plate in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538 and TA98 in the presence and absence of S9 metabolic activation system and hence the test substance is non genotoxic.
Bacterial gene mutation assay was performed for the test material in Salmonella typhimuriumTA1535, TA1537, TA1538, TA100 and TA98 strains at a dose range of 33.0, 100.0, 333.0, 1000.0and3333.0µg/plate by Plate-incorporation method.Chemical was tested without metabolic activation and with S9 mix from Aroclor 1254-induced male Fischer 344 rats and Syrian golden hamsters. Appropriate positive and solvent controls were also incorporated in the study.Test substance failed to induce gene mutation in the bacterial strains TA1535, TA1537, TA1538, TA100 and TA98.
Based on the data summarized, test substance did not induce gene mutation .Hence it is not likely to be mutagenic in vitro.Thus based on the above annotation and CLP criteria the test chemical did not induce gene mutation .Hence it is not likely to be classified as mutagenic in vitro.
Justification for classification or non-classification
Thus based on the above annotation and CLP criteria the test chemical did not induce gene mutation .Hence it is not likely to be classified as mutagenic in vitro.
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