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EC number: 402-400-4 | CAS number: 54660-00-3
- 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
Key value for chemical safety assessment
Additional information
EC 401-540-3 was investigated for absorption, distribution and excretion after a single gavage application in rats (RCC 1992). This read-across substance differs by an additional chlorine in para-position of both phenyl rings. Therefore, the molecular diameter is slightly larger and the solubility in organic solvents expected to be slightly better. The dominant structural element is the 2,5 -dihydro-pyrrolo(3,4 -c)pyrrole-1,4 dione core. It is the chromophore that is is both poorly soluble in organic and in inorganic solvents. The additional chlorines of the read-across substance may render it slightly better soluble in organic solvents. This is acceptable for the use as read-across substance as better solubility in organic solvents is related to better systemic availability.
As indicated from the discolored feces and from the subacute oral toxicity studies with both pigments, the core is neither metabolised by bacteria nor hydrolysed by gastrointestinal fluids during passage of the gastro-intestinal tract.
The toxicokinetic study was performed under GLP and followed the principles outlined in OECD testing guideline 417.
14C-labelled test compound was administered at two target dose levels of 100 mg/kg (low dose) and 1000 mg/kg (high dose) to male rats and radioactivity appearing in urine, feces, blood/plasma and organs/tissues was measured for various intervals up to 168 hours. In plasma, values which exceeded the limit of quantitation by less than 1.5fold were found around 2h after dosing. This is considered to related to the 0.2% extractable radioactive impurity in the test material and not to indicate uptake of the pigment.
At both dose levels minimal amounts (<0.6% of the total dose) were excreted via the urine. This was considered to be caused by contamination with feces, but it may also be related to the radioactive impurity in the test material. Excretion of 14C-labelled pigment proceeded exclusively via the feces and amounted after 168 hours, on average, to 119.7 % and 96.0 % at the low and high dose level, respectively.
EC no. 401-540-3 is not bioavailable after single oral administration to rats and the same is predicted for CAS no. 54660 -00 -3.
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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