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Registration Dossier
Diss Factsheets
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EC number: 440-560-7 | CAS number: 346709-25-9
- 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
Link to relevant study record(s)
Description of key information
Short description of key information on bioaccumulation potential result:
Based on the physico-chemical properties and the absence of systemic toxicity in acute and repeated-dose studies, absorption of the study is unlikely.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
There were no studies available in which the toxicokinetic properties of the substance were investigated.
The substance is a yellowish powder, which is poorly soluble in water and has a low measured vapour pressure of 0.42 Pa at 20°C (see chapter „vapour pressure“). The calculated log Po/w is -0.74 at 20 °C.
Experimental studies on solubility properties of the main components of the substance were performed
(Brendle, E. Solubility measurements under specific defined conditions, Reference TKP 50052; Ciba Specialty Chemicals Inc., R&P Analytics PA, CH- 4002 Basel: September 2007)
. The solubility in n-octanol was determined to be below the detection limit of 10 μg/L and 50 μg/L for any of the main components and the trihydroxy minor component, respectively.. The solubility of the main components in phosphate buffer pH 7 is inthe range of 0.2 mg/L and – due to the protonation of the amino group – increases to 20 mg/L in 3% acetic acid. Considering this, the n-octaonol/water partition coefficient is expected to be less than zero, which is in line with the calculated value of -0.74 for the main component.
No indication of a substance specific systemic toxicity can be found in acute toxicity studies in rats with oral and dermal application (see chapter „acute toxicity“) as well as in a subacute toxicity study and reproductive toxicity screening study in rats with oral application (see chapter „repeated dose toxicity“ and "reproductive toxcity"). The observation of green faeces in the acute oral study is assessed as indication of intestinal passage of the pigment. The poor water solubility makes it unlikely that the compound will be absorbed to a high extent from the gastro-intestinal tract and the epidermis (ECHA guidance document 7c, 2008).
Uptake vapour is considered as not relevant due to the low vapour pressure.
Based on the poor solubility in water and the even poorer solubility in octanol, absorption of the substance is unlikely. This is confirmed by the absence of systemic toxicity in any of the available acute or repeated dose studies.
The substance is considered to be not absorbed, and to have no potential for bioaccumulation.
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