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EC number: 224-924-0 | CAS number: 4553-89-3
- 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:
Chocolate
Brown HT ( Disodium
4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate)
is considered to be not genotoxic in the bacteria Salmonella typhimurium
TA 1538 and Escherichia coli WP2 uvrA since no detectable effects were
observed in the Modified liquid Fluctuation test.
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:
- data from handbook or collection of data
- Justification for type of information:
- Data is from a peer reviewed publication
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- Modified liquid Fluctuation test
- GLP compliance:
- not specified
- Type of assay:
- bacterial gene mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9
- Test concentrations with justification for top dose:
- 5000 mg/L
- Vehicle / solvent:
- Deionised water
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period: No data available
- Exposure duration: 72- 96 hrs
- Expression time (cells in growth medium): 72- 96 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: No data available
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: No data available
OTHER: The food colour was made up in deionized water and membrane-sterilized prior to use. The test material was tested at its maximum sublethal concentration. - Evaluation criteria:
- The test material was considered positive only if it resulted in significant more turbid tubes in a treated series when compared with an untreated set of tubes
- Statistics:
- Chi square test
- Key result
- Species / strain:
- S. typhimurium TA 1538
- 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:
- not specified
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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:
- not specified
- Remarks on result:
- other: allno mutagenic potential
- Conclusions:
- Chocolate Brown HT ( Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate) is considered to be not genotoxic in the bacteria Salmonella typhimurium TA 1538 and Escherichia coli WP2 uvrA since no detectable effects were observed in the Modified liquid Fluctuation test.
- Executive summary:
Bacterial gene mutation was studied using Modified liquid Fluctuation test. Chocolate Brown HT ( Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate) was used at a concentration of 5000 mg/kg and its genotoxic effect was studied in the bacteria Salmonella typhimurium TA 1538 and Escherichia coli WP2 uvrA. Te fluctuation assay in the liquid medium was conducted for 72-96 hrs at 25°C. The assay was performed for each bacterium in three separate experiments. The given test material is negative for inducing genotoxicity in the bacteria Salmonella typhimurium TA 1538 and Escherichia coli WP2 uvrA indicating that the substance is non-genotoxic.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Genetic
toxicity in vitro:
Based
on the available data for In vitro genetic toxicity of the target
substance disodium
4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate
the following results are summarized:
In key study, Bacterial gene mutation was studied using Modified liquid Fluctuation test. Chocolate Brown HT ( Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate) was used at a concentration of 5000 mg/kg and its genotoxic effect was studied in the bacteria Salmonella typhimurium TA 1538 and Escherichia coli WP2 uvrA. Te fluctuation assay in the liquid medium was conducted for 72-96 hrs at 25°C. The assay was performed for each bacterium in three separate experiments. The given test material is negative for inducing genotoxicity in the bacteria Salmonella typhimurium TA 1538 and Escherichia coli WP2 uvrA indicating that the substance is non-genotoxic.
While in supporting study, Chocolate Brown HT ( Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate) was used at a concentration of 5000 mg/kg and its genotoxic effect was studied in the bacteria E. coli strains WP2 trp uvrA and WP100 trp uvrA recA by rec plate assay in the agar medium. The plates were incubated overnight at 37°C. The given test material is negative for genotoxicity in the bacteria E. coli strains WP2 trp uvrA and WP100 trp uvrA recA indicating that the substance is non-genotoxic.
Based on the studies summarized above it can be observed that the substance Chocolate Brown HT ( Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate) failed to induce mutation in Salmonella typhimurium and E.coli bacterium species. Hence it is concluded that the target substance is not classified under In vitro genetic toxic category.
Justification for classification or non-classification
Based on the available information from reliable sources, the substance is likely to be non-genotoxic.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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