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EC number: 219-746-5 | CAS number: 2519-30-4
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Skin sensitisation of Brilliant Black BN is reported
- GLP compliance:
- not specified
- Type of study:
- not specified
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- no data
- Route:
- other: no data
- Vehicle:
- no data
- Concentration / amount:
- no data
- No. of animals per dose:
- no data
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- Clinical observations:
- Not sensitizing
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Clinical observations: Not sensitizing.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Non sensitising effects were known in skin sensitisation test of chemical Black PN exposed to skin of guinea pig.
- Executive summary:
Skin sensitisation test was conducted on guinea pig to evaluate skin sensitising potency of chemical Black PN.
Non sensitising effects were known in skin sensitisation test of chemical Black PN exposed to skin of guinea pig(Bar & Griepentrog, 1960).
Reference
not known
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin Sensitisation
Several studies for the target chemical Brilliant Black PN and Read across Acid Red 1 were reviewed to determine the skin sensitization of the test compound (CAS no 2519-30-4). The studies are summarized as below:
Skin sensitisation test (EFSA, 2010 and FAO/WHO Expert Committee on Food Additives, 2016 ) was conducted on guinea pig to evaluate skin sensitising potency of chemical Black PN. In vivo, non sensitising effects were known in skin sensitisation test of chemical Black PN exposed to skin of guinea pig.
From ranking of hair dye substances according to Predicted sensitization potency: quantitative structure–activity relationships Predicted skin sensitization,2004, the potency of chemical Brilliant Black 1was determined by quantitative structure–activity relationships. Prediction of sensitization potency Structures identified were then imported into a molecular spreadsheet TSAR (Version 3.3, Accelrys Ltd., Cambridge, UK). Simplified Molecular Input Line Entry Specifications (SMILES,www.daylight. com), which are 1-dimensional representations of chemical structures, were generated. This list was filtered in order to remove any further duplicate structures, such as salt-containing ingredients (HCl and SO4), leaving 229 hair dye substances. Moderate sensitising effect was predicted for chemical Brilliant Black 1 determined by quantitative structure–activity relationships.
From Read across RED 2G (RA CAS 3734-67-6) study report (1988) indicates a sensitization test was carried out in guinea pigs to estimate the sensitizing potential of RED 2G. Guinea pigs were given two times 4 intradermal injections of 0.1 ml of a 7.5% solution in saline during the induction phase.14 days after second injection, a challenge exposure was conducted. In the challenge exposure, single intradermal injection of a 3% solution in saline was administered to the guinea pigs. Signs of sensitization were not observed RED 2G was found to be non sensitizing after challenge exposure.
From the above mentioned studies indicate that the substance is not expected to exhibit skin sensitization, though one of the study indicates the moderate skin sensitization but on the basis of majority and study performed data. It has been concluded that the substance is not expected to exhibit skin sensitization as per the CLP criteria.
Migrated from Short description of key information:
Non sensitising effects were known in skin sensitisation test of chemical Black PN exposed to skin of guinea pig
Justification for selection of skin sensitisation endpoint:
Data is from peer review publication.
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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