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EC number: 212-603-8 | CAS number: 831-52-7
- 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
In vitro Mammalian gene mutation assay
Under the experimental conditions reported, the test item did not induce mutations in the mouse lymphoma thymidine kinase locus assay using the cell line L5178Y in the absence and presence of metabolic activation.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary literature.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Principles of method if other than guideline:
- To evaluate the mutagenic potential of test chemical in mouse lymphoma L5178Y cells by In mammalian cell gene mutation assay.
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Additional strain / cell type characteristics:
- other: tk+/-
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- experiment 1: 112.5, 225, 450, 900, 1350 and 1800 μg/ml with and without S9-mix
experiment 2: 28.1, 56.3, 112.5, 225, 337.5 and 450 μg/ml without S9-mix
112.5, 225, 450, 750, 900, 1050 and 1200 μg/ml with S9-mix - Vehicle / solvent:
- de-ionised water
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Details on test system and experimental conditions:
- Treatment experiment 1: 4h treatment with and without S9-mix
experiment 2: 4h treatment with and 24h without S9-mix - Evaluation criteria:
- The cells were evaluated for mutagenic potential.
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Remarks on result:
- other: No mutagenic effect were observed
- Conclusions:
- Under the experimental conditions reported, the test item did not induce mutations in the mouse lymphoma thymidine kinase locus assay using the cell line L5178Y in the absence and presence of metabolic activation.
- Executive summary:
Test substance was assessed for its possible mutagenic potential. For this purpose In vitro Mammalian cell gene mutation assay was performed as per OECD 476 in Mouse Lymphoma cell line L5178Y. The test material was exposed at the concentration mention below.
experiment 1: 112.5, 225, 450, 900, 1350 and 1800 μg/ml with and without S9-mix
experiment 2: 28.1, 56.3, 112.5, 225, 337.5 and 450 μg/ml without S9-mix
112.5, 225, 450, 750, 900, 1050 and 1200 μg/ml with S9-mix
No substantial and reproducible concentration-dependent increase in mutant colony numbers was observed in both main experiments. No relevant shift of the ratio of small versus large colonies was observed up to the maximal concentration of the test item. Appropriate reference mutagens were used as positive controls and showed a distinct increase in induced mutant colonies, indicating that the tests were sensitive and valid. The concentration range of the main experiments was adjusted to toxicity data and the occurrence of precipitation. Therefore test substance was considered to be non-mutagenic in Mouse Lymphoma cell line L5178Y by In vitro Mammalian cell gene mutation assay. Hence the substance cannot be classified as gene mutant in vitro.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
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 sodium 2-amino-4,6-dinitrophenolate ( 831-52-7). The studies are as mentioned below:
AMES test
This study was performed to assess the mutagenic potential of test substance to induce gene mutations in comparison to negative control according to the plate incorporation method (Trial-I) 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 negative and positive controls was tested in triplicates. The test item was tested at the following concentrations i.e., 0.0 (NC),0.050, 0.158, 0.501, 1.582 and 5 mg/plate, both in presence (+S9) and in absence (-S9) of metabolic activation. A significant increase in revertant colony numbers were observed in the tester strains (TA 98 and TA 1537) following treatment with test substance both in the presence and absence of metabolic activation (S9 mix) except TA 1535, TA 100 and TA 102. High mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance were observed. The spontaneous reversion rates in the negative and positive controls were within the range of our historical data.Reference mutagens showed a distinct increase in induced revertant colonies in TA98 and TA1537 strains both in the presence (+S9) as well as in the absence (-S9) of metabolic activation, without showing any signs of cytotoxicity.The positive controls used for various strains showed a distinct increase in induced revertant colonies in the Plate incorporation method.
Conclusion
It is concluded that the test substance did not induce gene mutations by frame shifts in the genome of the Salmonella typhimurium strains TA 1535, TA 100 and TA 102 in the presence and absence of S9 metabolic activation system while there were mutagenic effects were observed in TA 98 and TA 1537 both in the presence and absence of metabolic activation.
In vitro Mammalian gene mutation assay
Test substance was assessed for its possible mutagenic potential. For this purpose In vitro Mammalian cell gene mutation assay was performed as per OECD 476 in Mouse Lymphoma cell line L5178Y. The test material was exposed at the concentration mention below.
experiment 1: 112.5, 225, 450, 900, 1350 and 1800 μg/ml with and without S9-mix
experiment 2: 28.1, 56.3, 112.5, 225, 337.5 and 450 μg/ml without S9-mix
112.5, 225, 450, 750, 900, 1050 and 1200 μg/ml with S9-mix
No substantial and reproducible concentration-dependent increase in mutant colony numbers was observed in both main experiments. No relevant shift of the ratio of small versus large colonies was observed up to the maximal concentration of the test item. Appropriate reference mutagens were used as positive controls and showed a distinct increase in induced mutant colonies, indicating that the tests were sensitive and valid. The concentration range of the main experiments was adjusted to toxicity data and the occurrence of precipitation. Therefore test substance was considered to be non-mutagenic in Mouse Lymphoma cell line L5178Y by In vitro Mammalian cell gene mutation assay. Hence the substance cannot be classified as gene mutant in vitro.
Based on the data summarized, sodium 2-amino-4,6-dinitrophenolate ( 831-52-7) was mutagenic in two strain of Salmonella typhimurium TA 98 and TA 1537 both in the presence and absence of metabolic activation. While the test substance exhibit a negative result in confirmatory test i.e. inIn vitro Mammalian gene mutation assay. The test substance was considered to be non-mutagenic in Mouse Lymphoma cell line L5178Y both in the presence and absence of metabolic activation. Hence the substance cannot be classified as gene mutant in vitro. .Hence it is not likely to be mutagenic in vitro.
Justification for classification or non-classification
Thus based on the above annotation and CLP criteria the test chemical sodium sodium 2-amino-4,6-dinitrophenolate ( 831-52-7) did not induce gene mutation in confirmatory test i.e. in In vitro Mammalian gene mutation assay and 3 strains of Salmonella typhimurium .Hence it is not likely to be classified as mutagenic in vitro.
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