SAS solubility: CSSC makes a corrigendum to its Opinion
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The SCCS has just published a corrected version, dated December 6, 2019, of its Final Opinion on the solubility of SAS (Synthetic Amorphous Silica). The objective is to clarify the description of the solubility testing, which slightly modifies the final conclusion.
The SCCS Opinion on the solubility of SAS was finalized at the SCCS plenary meeting on June 20-21, 2019.
This Corrigendum serves to clarify the description of solubility testing. An “Enhanced OECD TG 105” protocol was used for testing solubility of all the SAS materials, however, addition of ethanol to the test media was only made for surface-modified hydrophobic materials, whereas hydrophilic materials were tested without the addition of ethanol.
The new conclusion
in bold, the parts that have been corrected
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 ...