Registration Dossier
Registration Dossier
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EC number: 269-047-4 | CAS number: 68186-85-6 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77377.
Specific investigations: other studies
Administrative data
Link to relevant study record(s)
Description of key information
In leaching studies according to EN1811 with C.I. Pigment Yellow 53 and EN1811 with C.I. Pigment Yellow 50, the latter designed to show tolerable leaching levels of Nickel ions from costume jewellery and other articles of daily use which are not anticipated to lead to an increase in human nickel allergy. These pigments showed leaching concentrations significantly below the prescribed threshold level for EN 1811 (0.5 μg/cm2/week). In contrast to EN 1811, the pH test conditions were expanded to cover also potential release under strongly acidic conditions as e.g. in gastric juice and lung endosomal environments as well as under the moderately alkaline conditions of the rat gut and therefore were pH 1 and pH 8.5 in addition to pH 6.5 in artificial sweat.
Additional information
Since the test covers the pH extrema in the human organism and for dermal contact, the leachable fraction of metals can be regarded as of no concern for all exposure pathways. Also, ions only become available in significant amounts under pH conditions which are not relevant to exposure routes for pigments, i.e. the oral route (pH 1). These results parallel in vivo studies that have failed to reveal bioavailability of ions from these types of pigments.
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