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EC number: 207-803-7 | CAS number: 495-54-5
- 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
Genetic
toxicity in vitro:
The
given test material Chrysoidin shows positive gene toxicity in vitro
result in the presence of S9 metabolic activation system and negative
result in the absence of S9 metabolic activation system.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from peer reviewed journal
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Gene toxicity in vitro study was performed on the Salmonella typhimurium TA 1538 strain to evaluate the mutagenic effect of the test material Chrysoidin
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
- Target gene:
- AMES assay
Salmonella typhimurium TA 1538 strain - Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- 50, 100 µg/plate
- Vehicle / solvent:
- Vehicle:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data available - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Acetylaminofluorene (5 and 10 µg/plate)
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period:
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other:
OTHER: No data available - Evaluation criteria:
- Numbers of revertants on test plates greater than 30 are classified as being significantly mutagenic
- Statistics:
- No data available
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- 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:
- Genotoxicity: Positive
Concentration His+ revertants/plate
Crude Purified
50 931 867
100 1260 1312
Negative
Concentration His+ revertants/plate
Crude Purified
50 11 -
100 11 - - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: Bacterial strain used
- Conclusions:
- The given test material Chrysoidin shows positive gene toxicity in vitro result in the presence of S9 metabolic activation system and negative result in the absence of S9 metabolic activation system.
- Executive summary:
Gene toxicity in vitro study was performed on theSalmonella typhimurium TA 1538 strain to evaluate the mutagenic effect of the test material Chrysoidin.
Chrysoidin was used at a concentration of 50 and 100 µg/ plate. The test material was purified and retested for mutagenicity again.
Crude chrysoidin induced 931 his+ revertants at 50 µg and 1260 his+ at 100 µg per plate while the purified material induced 867 and 1312 his+ revertants respectively. It was noticed on plates containing dye and the liver enzyme preparation that the colour remaining after 48 h incubation was less than on plates without the liver enzyme. Since reduction of the azo group leads to loss of dye colouration it was presumed that the liver enzyme catalysed this reaction probably through liver azo-reductase, an NADPH2 requiring enzyme. Chrysoidin shows positive gene toxicity in vitro result in the presence of S9 metabolic activation system and negative result in the absence of S9 metabolic activation system.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic
toxicity in vitro:
Different
experimental studies from peer reviewed journals were reviewed for
Genetic toxicity in vitro endpoint for the test substance
4-(phenyldiazenyl)benzene-1,3-diamine and are presented below as key and
supporting studies:
Gene toxicity in vitro study was performed on the Salmonella typhimurium TA 1538 strain (Mutation Research, 44 (1977) 9-19) to evaluate the mutagenic effect of the test material Chrysoidin. Chrysoidin was used at a concentration of 50 and 100 µg/ plate. The test material was purified and retested for mutagenicity again. Crude chrysoidin induced 931 his+ revertants at 50 µg and 1260 his+ at 100 µg per plate while the purified material induced 867 and 1312 his+ revertants respectively. It was noticed on plates containing dye and the liver enzyme preparation that the colour remaining after 48 h incubation was less than on plates without the liver enzyme. Since reduction of the azo group leads to loss of dye colouration it was presumed that the liver enzyme catalysed this reaction probably through liver azo-reductase, an NADPH2 requiring enzyme. Chrysoidin shows positive gene toxicity in vitro result in the presence of S9 metabolic activation system and negative result in the absence of S9 metabolic activation system.
Supporting S. typhimurium/mammalian microsomal pre-incubation mutagenicity assay was performed on the S. typhimuriumtester strains TA100 and TA98 to detect the mutagenic potential of the test material Chrysoidine Y (Carcinogenesis vol.7 no. 11 pp.1921-1923, 1986). The test was performed in the presence of three types of metabolic activation system including- phenobarbitone – induced rat liver S9 metabolic activation system, phenobarbitone – uninduced rat liver S9 metabolic activation system, With uninduced human liver S9 metabolic activation system. Positive results were noted for all the test systems in the presence of the metabolic activation system specified. The ratio of mutagenic potency is greater in the phenobarbital-induced system than in either of the uninduced systems suggesting that a phenobarbital-inducible form of cytochrome P450 is involved in the activation of the dye. Chrysoidine Y is positive to induce mutation in theS. typhimurium/mammalian microsomal pre-incubation mutagenicity assay performed on the S. typhimurium tester strains TA100 and TA98 specifically in the phenobarbitone – induced rat liver S9 metabolic activation system.
Further, Salmonella/mammalian-microsome mutagenicity test was performed for the test compound 2, 4-diamino-azobenzene in different labs A-H with and without S9 metabolic activation system (Mutation Research, 97 (1982) 429-435). The doses were chosen according to toxicity or solubility of the compound but were not higher than 2500 µg/plate. 5 consecutive doses were used each generated by a 5-fold dilution of higher dose. Five different solvents were used by different labs including water, acetone, methanol, ethanol, and DMSO. Positive control 9, 10-dimethylanthracene and negative control anthracene were also incorporated in the test. As per the results obtained,the test material2, 4-diamino-azobenzene is Positive (With metabolic activation system S9) and Negative (Without metabolic activation system S9) in the Salmonella/mammalian-microsome mutagenicity test performed in the labs A-H.
Further supporting, AMES assay was performed to evaluate the mutagenic nature of the test compound 2, 4 Diaminoazobenzene (Mutat Res 85:260, 1981). The test compound 2,4 Diaminoazobenzene has the ability to cause reversion in theSalmonella typhimuriumstrains TA98, TA 100 and TA 1537 and hence is found to be mutagenic in vitro.
In support of all the above data, the Salmonella/S9 mutagenicity assay was performed (Toxicology Letters, 58 (1991) 43-50) to evaluate the mutagenic nature of the test compound chrysoidine R with or without the addition of β-glucuronidase (βG). Chrysoidine R was dissolved in dimethyl sulphoxide (DMSO) and added (20 µL) at a concentration of 5-80 µg/plate. The test compound was found to increase the number of revertant colonies per plate and hence is mutagenic in vitro.
Thus, considering the key and various supporting studies for the substance 4-(phenylazo)benzene-1,3-diamine (CAS No. 495-54-5), it was concluded that the substance is genetically toxic and hence it can be classified under Mutagenic category 2 as per the criteria of CLP regulation.
Justification for classification or non-classification
Considering the key and various supporting studies for the substance 4-(phenylazo)benzene-1,3-diamine (CAS No. 495-54-5), it was concluded that the substance is genetically toxic and hence it can be classified under Mutagenic category 2 as per the criteria of CLP regulation.
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