Please note, this OEL/ADE monograph also applies to Sodium butyrate (CAS RN 156-54-7). Butyric acid is a saturated short-chain fatty acid (SCFA) with a 4-carbon backbone. Butyric acid is commonly found in esterified form in animal fats and plant oils. It has a role as a Mycoplasma genitalium metabolite and a human urinary metabolite. It is a straight chain saturated fatty acid and a fatty acid. It is a conjugate acid of a butyrate. Sodium butyrate is the sodium salt of butyrate with potential antineoplastic activity, Butyric acid is increasingly used as a supportive agent in the treatment and prevention of exacerbations of various diseases and disorders of the digestive tract, such as diarrhea (specific and nonspecific), inflammatory conditions (nonspecific bowel inflammation, diverticulitis, diversion colitis, radiation-induced bowel inflammation), functional disturbances (irritable bowel syndrome), dysbiosis, and postsurgery (resections, short bowel syndrome) or postchemotherapy conditions. Recently, it has been stressed that SCFA affect not only processes occurring in the lumen of the gastrointestinal tract but also other systems and organs, such as circulatory or nervous systems, through mechanisms associated with the intestinal barrier, carbohydrate metabolism, immunomodulation, and appetite control, and with an effect on obesity.
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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Affygility Solutions’ OEL Fastrac service is an user-friendly system that enables us to make confident decisions and focus on moving the compound safely through our facility. We can quickly access the database to determine if a new drug is within the OEL Fastrac library, and if so, immediately download a detailed OEL banding report. The OEL Fastrac system has been a helpful tool in our overall EH&S program.