Please note, this OEL/ADE monograph also applies to sodium inositol hexaphosphate (CAS RN 14306-25-3). Phytic acid, also known as inositol hexaphosphate (Ip-6), and myo-inositol hexaphosphate is a naturally occurring compound first identified in 1855. Phytic acid is found in substantial amounts in whole grains, cereals, legumes, nuts, and seeds, and is the primary energy source for the germinating plant. Phytic acid and its lower phosphorylated forms are also found in most mammalian cells, where they assist in regulating a variety of important cellular functions. In vitro studies with colon, liver, and rhabdomyosarcoma cell lines, and animal models of mammary, colon, intestinal, and liver cancer, as well as rhabdomyosarcoma, have all demonstrated phytic acid anticancer properties. Currently, human clinical trials in cancer are lacking. Other properties of phytic acid include an antiplatelet aggregating and lipidlowering effect, suggesting a potential role in cardiovascular disease, inhibition of human immunodeficiency virus (HIV)-1 virus replication, modulation of insulin secretion in pancreatic beta cells, and inhibition of urinary calcium oxalate crystallization, thereby preventing renal stone development.
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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