Registration Dossier
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EC number: 229-440-3 | CAS number: 6535-46-2
- 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
Repeated oral toxicity:
The toxicity of Pigment Red 112 when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent signs of systemic toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No-Observed-Adverse-Effect Level (NOAEL) for Pigment Red 112.
Repeated dermal toxicicty:
The dermal route was waived; substance is not classified for this endpoint. The substance is considered not to exert any local or systemic adverse effects.
Repeated inhalation toxicicty:
The inhalation route was waived; substance is not classified for this endpoint. When aerosolized in respirable form; when aerosolized in respirable form, the substance is considered likely to behave like an inert dust.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Justification for classification or non-classification
Pigment Red 112 does not have to be classified regarding systemic and target organ toxicity after repeated oral exposure according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC), because
- Pigment Red 112 caused no relevant systemic effects and revealed a NOAEL of 1000 mg/kg/day in a 28 -day oral gavage study in rats and due to the virtual absence of bioavailability and toxic effects of Pigment Red 112, the performing of a 90-day repeated dose toxicity study was considered scientifically unnecessary.
It can reasonably be deduced that Pigment Red 112 does not exert systemic toxic effects after repeated dermal application and thus does not have to be classified according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) and that testing is not scientifically necessary, because
- Pigment Red 112 caused no relevant systemic effects and revealed a NOAEL of 1000 mg/kg/day in a 28-day oral gavage study in rats and due to the virtual absence of bioavailability and toxic effects of Pigment Red 112, the performing of a 90-day repeated dose toxicity study was considered scientifically unnecessary,
- it is unlikely that Pigment Red 112 becomes systemically bioavailable after skin contact due to its extremely low solubility in water and n-octanol,
- Pigment Red 112 does not have to be classified as skin sensitizing (refering to the pigment as such notwithstanding effects of impurities) or as skin or eye irritating, indicating that its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues.
It can reasonably be deduced that Pigment Red 112 does not have to be classified regarding systemic and target organ toxicity after repeated inhalation exposure according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC) and that testing is not scientifically necessary, because
- Pigment Red 112 caused no relevant systemic effects and revealed a NOAEL of 1000 mg/kg/day in a 28-day oral gavage study in rats;
- due to the virtual absence of bioavailability and toxic effects of Pigment Red 112, performance of a 90-day repeated dose toxicity study was considered scientifically unnecessary,
- it is unlikely that Pigment Red 112 becomes systemically bioavailable to a relevant extend after inhalation due to its extremely low solubility in water and n-octanol,
- Pigment Red 122 does not have to be classified as skin sensitizing (refering to the pigment as such notwithstanding effects of impurities) or
as skin or eye irritating, indicating that its chemical inertness and extremely low solubility in water and n-octanol largely prevent interaction with living cells and tissues,- and although Pigment Red 112, when aerosolized in respirable form, is likely to behave like an inert dust which may cause a mild form of inflammatory lung reaction upon high long-term, repeated inhalation exposure mediated by the activation of alveolar macrophages by deposited non-biodegradable particles.
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