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EC number: 229-313-2 | CAS number: 6471-49-4
- 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 gene mutation study in mammalian cells was conducted by NTP (NATIONAL TOXICOLOGY PROGRAM. Technical Report Series. No.411, 1992) to evaluate the mutagenic potential of target chemical 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide; Other name:C.I. Pigment Red 23 ( 6471-49-4) in mammalian cell line by chromosome aberration test. The chromosome aberration is a confirmatory test for genetic mutation.The genetic toxicity of C.I. Pigment Red 23 was assessed by testing the ability of the chemical to induce chromosome aberration in Chinese hamster ovary cells. In the Abs test without S9, cells were incubated in McCoy's 5A medium with 30, 50, 100 µg/ml concentration of C.1. Pigment Red 23 for 10-h Colcemid was added and incubation continued for 2 to 3 hours. The cells were then harvested by mitotic shake-off, fixed, and stained with Giemsa.For the Abs test with S9, cells were treated with 30, 50, 100 µg/ml concentration of C.1. Pigment Red 23 and S9 for 2 hours, after which the treatment medium was removed and the cells incubated for 11 hours in fresh medium, with Colcemid present for the final 2 hours. No induction of chromosome aberration was observed in Chinese hamster ovary cell in presence and absence of metabolic activation. Hence the substance can be classified as non mutagenic in vitro.
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- The genetic toxicity of C.I. Pigment Red 23 was assessed by testing the ability of the chemical to induce chromosome aberration in Chinese hamster ovary cells.
- GLP compliance:
- not specified
- Type of assay:
- other: chromosome aberration test
- Specific details on test material used for the study:
- - Name of test material : 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- Common name : 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide, C.I. Pigment Red 23
- Molecular formula : C24H17N5O7
- Molecular weight : 487.4263 g/mol
- Smiles notation : c12c(c(c(cc1cccc2)C(=O)Nc1cc(ccc1)[N+](=O)[O-])O)/N=N/c1c(ccc(c1)[N+](=O)[O-])OC
- InChl : 1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
- Substance type : Organic
- Physical state : Solid
-Purity->96 % - Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- Not specified
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced male Sprague-Dawley rats
- Test concentrations with justification for top dose:
- 0,30, 50, 100 µg/ml
- Vehicle / solvent:
- Vehicle
- Vehicle(s)/solvent(s) used: DMSO - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: No data available
- Exposure duration:
Without metabolic activation- 15 hour
With metabolic activation- 2 hour
- Expression time (cells in growth medium): Without metabolic activation- 15 hour
With metabolic activation- 13 hour
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays):stained with Giemsa
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: - Evaluation criteria:
- Classes of aberrations included simple (breaks and terminal deletions), complex (rearrangements and translocations), and other (pulverized cells, despiralized chromosomes, and cells containing 10 or more aberrations). were observed .
- Statistics:
- Not applicable.
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- 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
- Remarks on result:
- other: No mutagenic effect were observed
- Conclusions:
- The pigment C.I. Pigment Red 23 was negative for the induction of chromosomal aberrations in Chinese hamster ovary cells both in the presence and absence of S9.
- Executive summary:
The genetic toxicity of C.I. Pigment Red 23 was assessed by testing the ability of the chemical to induce chromosome aberration in Chinese hamster ovary cells.In the Abs test without S9, cells were incubated in McCoy's 5A medium with 30, 50, 100 µg/ml concentration of C.1. Pigment Red 23 for 10-h Colcemid was added and incubation continued for 2 to 3 hours. The cells were then harvested by mitotic shake-off, fixed, and stained with Giemsa.For the Abs test with S9, cells were treated with 30, 50, 100 µg/ml concentration of C.1. Pigment Red 23 and S9 for 2 hours, after which the treatment medium was removed and the cells incubated for 11 hours in fresh medium, with Colcemid present for the final 2 hours. No induction of chromosome aberration was observed in Chinese hamster ovary cell in presence and absence of metabolic activation.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In different studies, 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide; Other name:C.I. Pigment Red 23 ( 6471-49-4) has been investigated for potential of mutagenic response with and without metabolic activation. The studies are based on in vitro gene mutation study in mammalian cells and bacteria for target chemical C.I. Pigment Red 23. Different studies based on these experiments are concluded below
In vitro gene mutation study in mammalian cells was conducted by NTP (NATIONAL TOXICOLOGY PROGRAM. Technical Report Series. No.411, 1992) to evaluate the mutagenic potential of target chemical 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide; Other name:C.I. Pigment Red 23 ( 6471-49-4) in mammalian cell line by chromosome aberration test. The chromosome aberration is a confirmatory test for genetic mutation.The genetic toxicity of C.I. Pigment Red 23 was assessed by testing the ability of the chemical to induce chromosome aberration in Chinese hamster ovary cells. In the Abs test without S9, cells were incubated in McCoy's 5A medium with 30, 50, 100 µg/ml concentration of C.1. Pigment Red 23 for 10-h Colcemid was added and incubation continued for 2 to 3 hours. The cells were then harvested by mitotic shake-off, fixed, and stained with Giemsa.For the Abs test with S9, cells were treated with 30, 50, 100 µg/ml concentration of C.1. Pigment Red 23 and S9 for 2 hours, after which the treatment medium was removed and the cells incubated for 11 hours in fresh medium, with Colcemid present for the final 2 hours. No induction of chromosome aberration was observed in Chinese hamster ovary cell in presence and absence of metabolic activation. Hence the substance can be classified as non mutagenic in vitro.
Supported by In vitro gene mutation study in mammalian cells conducted by NTP (NATIONAL TOXICOLOGY PROGRAM. Technical Report Series. No.411, 1992) to evaluate the mutagenic potential of target chemical 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide; Other name:C.I. Pigment Red 23 ( 6471-49-4)in mammalian cell line by sister chromatid exchange assay.C.I. Pigment Red 23were tested for mutagenicity with the Chinese hamster ovary cell with and without metabolic activation(Aroclor 1254-induced male Sprague-Dawley rats).In the SCE test without S9,CHO cells were incubated for 26 hours with C.1. Pigment Red 23 of 5, 10, 16 and 30 µg/ml concentration in McCoy's 5A medium supplemented with 10% fetal bovine serum, I-glutamine (2mM), and antibiotics.In the SCE test with S9, cells were incubated with C.I. Pigment Red 23 of 10, 16, 30 and 50 µg/ml concentration, serum-free medium, and S9 for 2 hours. In results,C.I. Pigment Red 23 induced SCE over a concentration range of 5 to50 µg/mL in the absence of S9 in an initial trial; the second trial performed without S9 also demonstrated an increase in SCEs, but only at a higher dose than was evaluated in the first trial. At higher dose a delayed harvest protocol was employed to offset the toxic effect of the pigment on cell cycle progression. There was no induction of SCEs was observed in CHO cells in the presence of liver S9 from Aroclor 1254-induced male Sprague-Dawley rats. Hence,the substance C.I. Pigment Red 23 is considered to be mutagenic in Chinese hamster ovary cell without metabolic activation and non-mutagenic with activation.
Further supported by in vitro gene mutation study in bacteria conducted by Kristien Mortelmans et.al (Environmental Mutagenesis,1986) to evaluate the mutagenic potential of target chemical 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide; Other name:C.I. Pigment Red 23 ( 6471-49-4)in bacterial strain. The genetic toxicity of C.I. Pigment Red 23 was assessed by screening test in Salmonella typhemurium strain TA1537, TA100 and TA98. The stains were exposed to 10, 33, 100, 333, 1000 and 3333µg/plate concentration of C.I. Pigment Red 23 in the presence and absence of metabolic activation (Hamster and rat liver). Reproducible dose-related increases in the number of revertant was observed. Under this condition the study gives positive mutagenic result. Therefore as per this study, the pigment C.I. Pigment Red 23 was considered to be mutagenic in Salmonella typhemurium strain TA1537, TA100 and TA98.
Bacterial reverse mutation assay is a screening test for mutagenic response, while mammalian cell gene mutation assay is a confirmatory test for mutagenic response. As per the above studies the target chemical 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide; Other name:C.I. Pigment Red 23 ( 6471-49-4) is considered to be non mutagenic according to In vitro gene mutation study in mammalian cells. While according to in vitro gene mutation study in bacteria the target chemical is mutagenic. On the basis of the confirmatory tests, the test substance was observed to be non mutagenic with and without metabolic activator in mammalian cell by chromosome aberration test. Even in the sister chromatid exchange assay the test chemical was non mutagenic in the presence of S9 metabolic activation.This confirmatory test concludes that the test substance shows negative result for mutagenic potential. Thusbased on the available data for the target chemical,3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide; Other name:C.I. Pigment Red 23 does notexhibits gene mutation toxicity in vitro. Hence, the chemical isnot likely to classify as a gene mutant in vitro.
Justification for classification or non-classification
Thus based on the above annotation Bacterial reverse mutation assay is a screening test for mutagenic response, while mammalian cell gene mutation assay is a confirmatory test for mutagenic response. As per the above studies the target chemical 3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl) naphthalene-2-carboxamide; Other name:C.I. Pigment Red 23 ( 6471-49-4) is considered to be non mutagenic according to In vitro gene mutation study in mammalian cells. While according to in vitro gene mutation study in bacteria the target chemical is mutagenic. On the basis of the confirmatory tests, the test substance was observed to be non mutagenic with and without metabolic activator in mammalian cell by chromosome aberration test. Even in the sister chromatid exchange assay the test chemical was non mutagenic in the presence of S9 metabolic activation.This confirmatory test concludes that the test substance shows negative result for mutagenic potential. Thusbased on the available data for the target chemical,3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide; Other name:C.I. Pigment Red 23 does notexhibits gene mutation toxicity in vitro. Hence, the chemical isnot likely to classify as a gene mutant in vitro.
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