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Diss Factsheets
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EC number: 939-382-7 | CAS number: -
- 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
Description of key information
Oral toxicity: LD50 > 2000 mg/kg bw
Dermal toxicity: LD50 > 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Direct Black 22 (DBk22) is not toxic by oral, dermal and inhalation route under short-term exposure. All the available studies confirm that DBk22 is not toxic up to the highest tested dose.
Acute oral
DBk22 was tested on rats for oral acute toxicity according to Directive 67/548/EEC at a singular dose of 2000 mg/kg; no mortality was observed and no abnormalities were recorded during the test period (Castells, 2000). The result does not permit to establish the LD50 for the substance, nevertheless all other reported studies in read across confirm that DBk2 is not toxic at limits fixed for classification according to CLP regulation.
Acute inhalation
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) in addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure.
Particle size distribution study (Nebuloni, 2012) reported that DBk22 is characterized by particles that are expected to remain in the upper respiratory tract, that is characterized by efficacious defence mechanisms able to remove them. From this point of view inhalation route is expected to be an unlikely route of absorption of the substance.
Acute dermal
The study was performed on a structural analogue of DBk22, and reported an LD50 > 2000 mg/kg. The dye is non-toxic and this conclusion can also be read acroos to DBk22, considering the similar overall toxicological behaviour.
Justification for selection of acute toxicity – oral endpoint
Study well conducted, according to scientifically recognized method; the substance was tested at an adequate concentration to evaluate the acute oral toxicity.
Justification for selection of acute toxicity – inhalation endpoint
Based on REACH regulation annex VIII column 2 (specific rules for adaptation from column 1) in addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure.
Particle size distribution (R&C, 2012) showed that DB22 is characterized by particle that are expected to remain in the upper respiratory tract, that is characterized by efficacious defence mechanisms able to remove them. From this point of view inhalation route is expected to be an unlikely route of absorption of the substance.
Justification for selection of acute toxicity – dermal endpoint
Study well conducted, reliable and developed according to the official guidelines. Proper read-across from supporting substance.
Justification for classification or non-classification
Direct Black 22 (DBk22) does not meet the criteria to be considered an acutely toxic substance.
According to CLP regulation (EC1272/2008) DBk22 is not classified for oral/inhalation/dermal Acute 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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