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Diss Factsheets
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EC number: 603-450-1 | CAS number: 1310-39-0
- 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
Key value for chemical safety assessment
Effects on fertility
Description of key information
In conclusion, since the dissolved Fe, Ti and Al and concentrations from this pigment under simulated physiological conditions were below 178 µg/L, 106 µg/L and 139 µg/L (GST) , respectively even at the highest loading of 0.1g/L, corresponding to a solubility of less than 0.4 % after 24 hours, this pigment may reasonably be considered biologically inert.
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The chemical and physiological properties of the pigment Pseudobrookite are characterised by inertness because of the specific synthetic process (calcination at high temperatures, approximately 1000°C), rendering the substance to be of a unique, stable crystalline structure in which all atoms are tightly bound and not prone to dissolution in environmental and physiological media. This manufacturing process leads to a very low bioaccessibility of the elements contained in the pigment. This has been investigated experimentally in vitro by simulating dissolution under physiological conditions considered to mimic the most relevant exposure routes (oral, dermal and inhalation), as follows:
1.) Gamble’s solution (GMB, pH 7.4) which mimics the interstitial fluid within the deep lung under normal health conditions,
2.) phosphate-buffered saline (PBS, pH 7.2), which is a standard physiological solution that mimics the ionic strength of human blood serum,
3.) artificial sweat (ASW, pH 6.5) which simulates the hypoosmolar fluid, linked to hyponatraemia (loss of Na+ from blood), which is excreted from the body upon sweating,
4.) artificial lysosomal fluid (ALF, pH 4.5), which simulates intracellular conditions in lung cells occurring in conjunction with phagocytosis and represents relatively harsh conditions and
5.) artificial gastric fluid (GST, pH 1.5), which mimics the very harsh digestion milieu of high acidity in the stomach.
Solubility of Fe from the pigment Pseudobrookite in physiological media was in a range of below LOD and 25.5 µg/L (GST) after 2 hours. After 24 hours a dissolution range from below LOD - 178 µg/L (GST) was measured.
Solubility of Ti from the pigment Pseudobrookite in physiological media was in a range of below LOD and 15.7 µg/L (GST) after 2 hours. After 24 hours a dissolution range from below LOD – 105.8 µg/L (GST) was measured.
Solubility of Al from the pigment Pseudobrookite in physiological media was in a range of below LOD and 57.9 µg/L (GST) after 2 hours. After 24 hours a dissolution range from below LOD – 138.4 µg/L (GST) was determined.
In conclusion, since the dissolved Fe, Ti and Al and concentrations from this pigment under simulated physiological conditions were below 178 µg/L, 106 µg/L and 139 µg/L (GST) , respectively even at the highest loading of 0.1g/L, corresponding to a solubility of less than 0.4 % after 24 hours, this pigment may reasonably be considered biologically inert.
Effects on developmental toxicity
Description of key information
In conclusion, since the dissolved Fe, Ti and Al and concentrations from this pigment under simulated physiological conditions were below 178 µg/L, 106 µg/L and 139 µg/L (GST) , respectively even at the highest loading of 0.1g/L, corresponding to a solubility of less than 0.4 % after 24 hours, this pigment may reasonably be considered biologically inert.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The chemical and physiological properties of the pigment Pseudobrookite are characterised by inertness because of the specific synthetic process (calcination at high temperatures, approximately 1000°C), rendering the substance to be of a unique, stable crystalline structure in which all atoms are tightly bound and not prone to dissolution in environmental and physiological media. This manufacturing process leads to a very low bioaccessibility of the elements contained in the pigment. This has been investigated experimentally in vitro by simulating dissolution under physiological conditions considered to mimic the most relevant exposure routes (oral, dermal and inhalation), as follows:
1.) Gamble’s solution (GMB, pH 7.4) which mimics the interstitial fluid within the deep lung under normal health conditions,
2.) phosphate-buffered saline (PBS, pH 7.2), which is a standard physiological solution that mimics the ionic strength of human blood serum,
3.) artificial sweat (ASW, pH 6.5) which simulates the hypoosmolar fluid, linked to hyponatraemia (loss of Na+ from blood), which is excreted from the body upon sweating,
4.) artificial lysosomal fluid (ALF, pH 4.5), which simulates intracellular conditions in lung cells occurring in conjunction with phagocytosis and represents relatively harsh conditions and
5.) artificial gastric fluid (GST, pH 1.5), which mimics the very harsh digestion milieu of high acidity in the stomach.
Solubility of Fe from the pigment Pseudobrookite in physiological media was in a range of below LOD and 25.5 µg/L (GST) after 2 hours. After 24 hours a dissolution range from below LOD - 178 µg/L (GST) was measured.
Solubility of Ti from the pigment Pseudobrookite in physiological media was in a range of below LOD and 15.7 µg/L (GST) after 2 hours. After 24 hours a dissolution range from below LOD – 105.8 µg/L (GST) was measured.
Solubility of Al from the pigment Pseudobrookite in physiological media was in a range of below LOD and 57.9 µg/L (GST) after 2 hours. After 24 hours a dissolution range from below LOD – 138.4 µg/L (GST) was determined.
In conclusion, since the dissolved Fe, Ti and Al and concentrations from this pigment under simulated physiological conditions were below 178 µg/L, 106 µg/L and 139 µg/L (GST) , respectively even at the highest loading of 0.1g/L, corresponding to a solubility of less than 0.4 % after 24 hours, this pigment may reasonably be considered biologically inert.
Justification for classification or non-classification
The chemical and physiological properties of the pigment Pseudobrookite are characterised by inertness because of the specific synthetic process (calcination at high temperatures, approximately 1000°C), rendering the substance to be of a unique, stable crystalline structure in which all atoms are tightly bound and not prone to dissolution in environmental and physiological media. Bioavailability which is the basis for the oral, dermal or inhalation exposure route is negligible. In consequence, this substance may reasonably be considered inert in all media relevant for uptake into the body and also the compartment relevant for distribute within body tissues.
Hence, no toxicity to reproduction, effects on fertility and developmental toxicity effects are expected and no further testing is considered to be required. No classification for toxicity to reproduction according to EC Regulation No. 1272/2008 is anticipated.
Additional information
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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