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EC number: -
CAS number: -
chemical and physiological properties of the pigmentsilicic
acid, zirconium salt, cadmium pigment encapsulatedare
inertness because of the specific synthetic process (calcination at high
approximately1000°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:
Gamble’s solution (GMB, pH 7.4) which mimics the interstitial fluid
within the deep lung under normal health conditions,
phosphate-buffered saline (PBS, pH 7.2), which is a standard
physiological solution that mimics the ionic strength of human blood
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,
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
artificial gastric fluid (GST, pH 1.5), which mimics the very harsh
digestion milieu of high acidity in the stomach.
dissolution of Cd of the test item is between 0.07 µg/L /0.07 µg/L (GMB)
and 2.58 µg/L/ 6.13 µg/L (GST) at a loading of 0.1g/L after 2 and 24
dissolution of Zr of the test item is in a range of below LoD (0.017
µg/L, GST) and 0.52 µg/L/ 1.25 µg/L (ALF) at a loading of 0.1g/L after 2
and 24 hours.
dissolution of Se of the test item is in a range 0.12 µg/L/ 0.20 µg/L
(GST) and 0.74 µg/L/ 0.82 µg/L (PBS) at a loading of 0.1g/L after 2 and
pHdependent dissolution can be observed.In conclusion, since the
dissolvedCd, Zr, and Se concentrations were below 6.13 µg/L even at the
highest loading of 0.1g/L, referring to a solubility of 0.0061 %, this
pigment may reasonably be considered biologically inert.
Short description of key information:
In conclusion, since the dissolved Cd, Zr and Se concentrations from this pigment (silicic acid, zirconium salt, cadmium pigment encapsulated) under simulated physiological conditions were below 6.13 µg/L even at the highest loading of 0.1 g/L, corresponding to a solubility of less than 0.0061 %, this pigment may reasonably be considered biologically inert.
chemical and physiological properties of the pigment silicic
acid, zirconium salt, cadmium pigment encapsulated
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