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EC number: 222-838-8 | CAS number: 3626-36-6
- 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
Not mutagenic
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- other: read across from similar substance
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study well documented, test procedure in accordance with OECD 471 methods, meets generally accepted scientific principles, acceptable for assessment. GLP guideline study with acceptable restrictions (E. coli WP2 uvrA or S. typhimurium TA 102 missing).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98, TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor-induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 10.0; 100.0; 333.3; 1000.0; and 5000.0 µg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: A. dest.- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- W/o S-9: 10 µg/plate sodium azide (TA 1535, Ta 100), 50 µg/plate 4-NOPD (TA 1537, TA 1538, TA 98); w/ S-9: 10 µg/plate 2-AA (all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)NUMBER OF REPLICATIONS: The assay was performed in two independent experiments, using identical procedures, both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate.DETERMINATION OF CYTOTOXICITY: Toxicity of the test article may be evidenced by a reduction in the number of spontaneous revertants, a clearing of the bacterial background lawn, or by degree of survival of treated cultures.
- Evaluation criteria:
- The generally accepted conditions for the evaluation of the results are:- corresponding background growth on both negative control and test plates- normal range of spontaneous reversion rates.A test article is considered as positive if either a significant dose-related increase in the number of revertants or a significant and reproducible increase for at least one test concentration is induced.A test article producing neither a significant dose-related increase in the number of revertants nor a significant and reproducible positive response at any one of the test points is considered non-mutagenic in this system.A test article is considered as mutagen if in strain TA 100 the number of reversions is at least twice as high and in strains TA 1535, TA 1537, TA 1538, and TA 98 it is at least three times higher as compared to the spontaneous reversion rate.Also, a dose-dependent increase in the number of revertants is regarded as an indication of possibly existing mutagenic potential of the test article regardless whether the highest dose induced the above described enhancement factors or not.
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:To evaluate the toxicity of the test article a pre-study was performed with strains TA 98 and TA 100. The plates with the test article showed normal background growth up to 5000.0 µg/plate in strain TA 98 and TA 100, respectively. According to the dose selection criteria, the test article was tested at the following concentrations: 10.0; 100.0; 333.3; 1000.0; and 5000.0 µg/plate.ADDITIONAL INFORMATION ON CYTOTOXICITY:In both experiments no toxic effects, normally evidenced by a reduction in the number of revertants, occurred in the test groups with and without metabolic activation in all strains used. The plates incubated with the test article showed normal background growth up to 5000.0 µg/plate with and without S9 mix in all strains used.
- Conclusions:
- Interpretation of results (migrated information):negativeUnder the experimental conditions reported, the test article did not induce point mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test article is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
- Executive summary:
The study followed OECD guideline 471 (1981) and the principles of GLP. In the presence and absence of rat liver S-9 microsomal activation system and at doses of up to 5000 μg/plate, S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 did not show an increased number of revertant colonies. In addition, there was no indication of toxicity to bacteria. Therefore, no evidence of a mutagenic potential was associated with the test substance. The purity of the test item was 94.6%. A. dest. was used as a vehicle.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Not mutagenic
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- other: read across from similar substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Route of administration:
- oral: unspecified
- Vehicle:
- in 1 % carboxymethylcellulose
- Remarks:
- Doses / Concentrations:
5000 mg/kg
Basis:
nominal conc. - No. of animals per sex per dose:
- 5/sex/group
- Positive control(s):
- Cyclophosphamide
- Tissues and cell types examined:
- Bone marrow samples were scored for polychromatic erythrocytes containing micronuclei at 24, 48 and 72 hours post-dosing.
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- some cytotoxicity
- Negative controls validity:
- not valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of results (migrated information): negative
Under experimental conditions substance did not appear to induce micronuclei. - Executive summary:
Substance was investigated for its potential to induce micronuclei in polychromatic erythrocytes in mouse bone marrow. NMRI mice (5/sex/group) were given the test substance (in 1% carboxymethylcellulose) as a single oral dose at 5000 mg/kg. Bone marrow samples were scored for polychromatic erythrocytes containing micronuclei at 24, 48 and 72 hours post-dosing. The ratio of polychromatic to normochromatic erythrocytes indicated some cytotoxicity at the dose level used. However, the number of cells with micronuclei in the tested animals was similar that in control animals. Cyclophosphamide was used as a positive control.
Reference
Additional information
On the base of results of the tests performed on similar substances both on in vitro and on in vivo, Direct Orange 26 can be considered not mutagen.
Justification for classification or non-classification
According to CLP regulation (EC1272/2008) Direct Orange 26 is not classified for genetic toxicity.
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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