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Opinion on solubility of Synthetic Amorphous Silica (SAS)
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Opinion on solubility of Synthetic Amorphous Silica (SAS)

Közzétételi metaadat

1. Does the SCCS consider that Synthetic Amorphous Silica (SAS) are soluble (100 mg/L or higher) or degradable/non-persistent in biological systems, in light of the nanomaterial definition of the Cosmetic Regulation? Having considered the data provided in this dossier and that available in published literature, the SCCS concludes that: i) the solubility values for hydrophilic SAS materials have been reported to range from 22 mg/L to 225 mg/L for the solubility tests performed in aqueous media following the OECD TG 105 protocol or the Enhanced OECD TG 105 protocol. The latter protocol has been noted to increase the solubility by a factor of 10 for some hydrophilic SAS materials. ii) the solubility values of hydrophobic surface-treated SAS materials have been reported to range from 0.4 to 180 mg/L for solubility tests performed in aqueous media following the OECD TG 105 or following a modified Enhanced OECD TG 105 protocol (i.e. using 10% ethanol). The latter protocol has been noted to strongly increase the solubility of some hydrophobic SAS materials (by a factor up to 173). The hydrophilic and hydrophobic SAS materials can therefore be regarded as “insoluble” (i.e. below 100 mg/L) to “very slightly soluble” (i.e. 100 mg/L to 1000 mg/L) by the SCCS based upon the terminology used in USP38 and USP 38 NF33 (Table 1 corrected by the SCCS). In regard to the nanomaterial definition in the Cosmetic Regulation, none of the SAS materials (hydrophilic or hydrophobic) included in the dossier can be regarded as soluble. In fact, the Applicant had mistakenly interpreted the SAS materials as soluble on the basis of the solubility of some of the materials being 100 mg/L or higher. The threshold for regarding a material 'soluble' is 33.3 g/L under the USP38 and USP 38 NF33 categorisation (not 100 mg/L as claimed by the Applicant). No data were provided to help establish whether the SAS materials could be regarded degradable/non-persistent in biological systems.
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ISSN 1831-4767
ISBN 978-92-76-15265-1
DOI 10.2875/776214
Katalógusszám EW-AQ-20-007-EN-N
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ISSN 1831-4767 ISBN 978-92-76-15265-1 DOI 10.2875/776214 Katalógusszám EW-AQ-20-007-EN-N
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