Please note, this OEL/ADE monograph also applies to Tris(2,4-ditertbutylphenyl) phosphate (CAS RN 95906-11-9). Tris(2,4-di-tert-butylphenyl) phosphite (also known as phosphorous acid, tris (2,4-di-tertbutylphenyl) ester) is a hydrolytically stable organo-phosphite processing stabilizer. As a secondary antioxidant, it reacts during processing with hydroperoxides formed by auto-oxidation of polymers preventing process induced degradation and extending the performance of primary antioxidants. Tris(2,4-di-tert-butylphenyl) phosphite is approved for polymeric indirect food contact applications (FCA). It is also recommended for applications such as solvent-based coatings, hot-melt and construction adhesives and coatings (4). The application range of tris(2,4-di-tert-butylphenyl) phosphite, synergistically combined with other antioxidants, comprises polyolefins and olefin copolymers such as polyethylene, polypropylene, polybutene and ethylene vinyl acetate copolymers as well as polycarbonates and polyamides.
Affygility Solutions has an occupational exposure limit (OEL) and control band assignment for this active pharmaceutical ingredient (API). This monograph also contains the acceptable daily exposure (ADE) value.
OEL Fastrac monographs are a cost-effective and convenient way to meet the requirements for PDEs (ADEs) contained in the EMA Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (EMA/CHMP/CVMP/SWP/169430/2012), as well as PIC/S and ANVISA requirements, and to obtain the following information:
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