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EC number: 943-269-8 | CAS number: 6598-63-6
- 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
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- other: experimental result from similar substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as unpublished report, minor restrictions in design (E. coli WP2 uvrA or S. typhimurium TA 102 missing) and/or reporting but otherwise adequate for assessment
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- ; E.coli WP2 uvrA or S.typhimurium TA 102 missing
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His-locus
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 8, 40, 200, 1000, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: Aqua bidest.- Justification for choice of solvent/vehicle: The solvent was chosen for its solubility properties and its non-toxicity to the bacteria.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene
- Remarks:
- With metabolic activation: 2-AA (all strains); Without metabolic activation: 2-nitrofluorene (TA 98, TA 1538), sodium azide (TA 100, TA 1535), 9-aminoacridine (TA 1537)
- Details on test system and experimental conditions:
- - METHOD OF APPLICATION: in agar (plate incorporation)- DURATION: Exposure duration: 3 days- NUMBER OF REPLICATIONS: The assay was performed in two independent experiments, using identical procedures, both with and without metabolic activation. Each concentration was tested in triplicate. Negative and positive controls were tested in quintuplicate with and without metabolic activation.- DETERMINATION OF CYTOTOXICITY: Toxicity of the test article was determined by clearing of the bacterial background lawn.
- Evaluation criteria:
- The assay was considered valid if the following criteria were met:- the mean negative control counts fell within the normal range- the positive control chemicals induced clear increases in revertant numbers confirming discrimination between different strains, and an active S-9 preparation- no more than 5% of the plates were lost through contamination or some other unforseen eventA test compound was considered to be mutagenic if:- the assay was valid- two or three-fold increases (dependent on strain; two-fold in TA 98 or TA 100, three-fold in TA 1535, TA 1537, or TA 1538) in revertant numbers, were accompanied by significant F-statistics and dose-response correlations- the positive responses were reproducible
- Statistics:
- If the two or three-fold levels were exceeded, analysis of variance (F-test) and regression analysis were also performed.
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:The test article was tested for toxicity in strain TA 100, at the concentrations of 8, 40, 200, 1000 and 5000 µg/plate. Triplicate plates without and with S-9 mix were used. Negative (solvent) and positive controls were included in quintuplicate without and with S-9 mix. On examination these plates showed no evidence of toxicity to the background lawn. This dose range was therefore retained for experiment 1 treatments, and also for treatments in the second mutation experiment, at the sponsor's request. Revertant colonies were counted and these results comprise the TA 100 experiment 1 mutagenicity data.ADDITIONAL INFORMATION ON CYTOTOXICITY: No toxicity was seen in either of the mutation experiments.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- The test substance is not mutagenic under these experimental conditions.
- Executive summary:
The substance to be registered was tested at a concentration of 75% for its mutagenic potential, in an OECD 471 guideline study, based on the ability to induce point mutation in selected loci of several bacterial strains of Salmonella typhimurium (TA 1535, TA 1537, TA 1538 TA98, TA100) in a reverse mutation assay. No cytotoxicity was observed. An increase in the number of his+ revertants was not observed in the standard plate test either without S9 mix or after the addition of a metabolizing system. It was therefore concluded that the test substance is not mutagenic under these experimental conditions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Based on the available test on similar substance, Direct Orange 102 could be considered as not mutagen.
Justification for classification or non-classification
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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