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Do metals in tampons pose a health risk? A toxicological risk assessment study
Ying Jin1, Michael Eppihimer1, Md Shah Alam1
1Division of Biology, Chemistry, and Material Science (DBCMS), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration, Silver Spring, MD 20993, United States.
Abstract:
Recently concern has been raised over metal content in tampons and the possibility of toxicological risk to women. As a result, researchers at the United States Food and Drug Administration (FDA) investigated metals present in tampons and estimated the maximum exposure and toxicological risk associated with tampon use. The levels of metals contained in, and released from 11 tampon products, which are legally marketed in the United States, were analyzed by inductively coupled plasma mass spectrometry (ICP-MS). Levels of metals released were determined under exaggerated test conditions (50°C for 24 h in acidified water) considering the recommended use of tampons. The potential for metals to be released from the tampons was used to conduct a toxicological risk assessment (TRA) based on ISO 10993 and FDA guidance. In this investigation, 19 metals were detected including ICH Class I metals-arsenic (As), cadmium (Cd), and lead (Pb) were found at trace levels. Based on the in-depth TRA, all detected metals had margins of safety (MoS) indicating that there is negligible toxicological concern from the presence of metals in tampon materials. This study expands on prior investigations of metal content in tampons.
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