Registration Dossier
Registration Dossier
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EC number: 270-185-2 | CAS number: 68412-38-4 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77899.
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The chemical and physiological properties of the pigment manganese antimony titanium buff rutile 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 has been shown in in-vitro bioaccessibility testing, in which dissolved Mn, Sb and Ti concentrations were below 465 ug/L, 15µg/L and 37µg/L, respectively even at the highest loading of 0.1g/L, thus implying a solubility of < 0.5%, < 0.02 and <0.04%, respectively.
Thus, the rate and extent to which manganese antimony titanium buff rutile produces soluble (bio)available ionic and other metal-bearing species is limited. Further, the poor solubility of manganese antimony titanium buff rutile is expected to determine its systemic toxicity, or the lack thereof.
Key value for chemical safety assessment
Additional information
Manganese antimony titanium buff rutile
The bioaccessibility of “Manganese antimony titanium buff rutile” 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 serum,
- artificial sweat (ASW, pH 6.5) which simulates the hypo osmolar 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.
In five different artificial physiological media, up to 37µg/L titanium, (i.e., GST; pH 1.5), 465µg/L manganese (ALF; pH 4.5) and 15µg/L antimony (i.e., GST; pH 1.5) of “Manganese antimony titanium buff rutile” was dissolved depending on solution parameters and test duration.
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