European regulators are moving toward a Category 1 repeated dose toxicity classification for all forms of synthetic amorphous silica via inhalation, a designation that carries significant compliance implications.
Animal studies consistently showed lung inflammation and tissue damage at concentrations well below the threshold that normally triggers a Category 1 classification.
The proposal covers all SAS types regardless of how they are manufactured, meaning pyrogenic, precipitated, colloidal, and gel forms are all in scope.
Human workplace studies were too compromised by confounding factors to be used either way, leaving animal data to drive the classification outcome.
NIA Report on the RAC-72 CLH WG
Dr. Blanca Suarez-Merino
1 min read
Summary
Focusing on item Silica, amorphous, fumed, cryst.-free; Pyrogenic, synthetic amorphous silica, nano, Silica gel, pptd., cryst.-free; Precipitated silica, silica gel, colloidal silica, amorphous, nano
By Blanca Suarez Merino Director of Regulatory Affairs
NOTE: This document and all appended documents are confidential to registered NIA Members.
