EpidStrategies scientists have collaborated with toxicologists from ToxStrategies’ Biopharmaceuticals/Pharmaceuticals Practice to produce a white paper that provides “Critical insights into nonclinical toxicology and real-world evidence essential for a successful rare disease product launch.” The paper summarizes how well-designed nonclinical studies, coupled with an understanding of the epidemiology and natural history of the condition, can support a clinical program in the rare disease arena.
ToxStrategies scientists published a GLP OECD designed reproductive toxicity study (Thompson et al., 2020) assessing the potential for adverse follicular effects in mice following exposure to hexavalent chromium [Cr(VI)] in drinking water. This study demonstrated that reproductive toxicity was limited to extremely high doses that are not environmentally-relevant. At Cr(VI) doses consistent with, and substantially higher than, the basis for the California Proposition 65 Maximum Allowable Dose Level (MADL), no effects are observed, supporting that the MADL should be re-evaluated.
Thompson CM, Donahue DA, Hobbs C, Costecalde Y, Franzen A, Suh M, Proctor DM, Harris MA. 2020. Exposure to environmentally-relevant concentrations of hexavalent chromium does not induce ovarian toxicity in mice. Regul Toxicol Pharmacol 116, open access:
FDA is warning consumers and health care providers that they have seen a sharp increase in hand sanitizer products labeled to contain ethanol but that have tested positive for methanol contamination. The FDA has developed a searchable list to help consumers identified whether those hand sanitizer products that are being recalled or confirmed to contain methanol contamination.
Consumers can access the searchable list here:
The Toxicology Forum will convene a series of virtual sessions in July and August 2020. The goal of these sessions is to facilitate dialogue and information exchange among presenters, panelists, and attendees. ToxStrategies scientists Drs. Candace Doepker and Susan Borghoff will present recent work related to the application of new approach methods (NAMS).
In the July 20th session, titled “Strategies to Use Non-Animal Approaches in Food Safety Assessment,” Dr. Doepker will discuss food regulations and their influence on toxicological methods for evaluating food ingredient safety.
In the August 21st session, titled “Applying New Approach Methodologies to Risk Assessment: Consideration of Exposure and Compensatory Mechanisms,” Dr. Borghoff will discuss the integration of NAM data to identify chemicals with endocrine disruptor properties under ECHA/EFSA Guidance.
An international group of experts, including ToxStrategies scientist Dr. Daniele Wikoff, has developed and published a comprehensive framework for the planning and conduct of high-quality Systematic Reviews (SRs). Derived from existing standards of Systematic Review used in biomedicine, the Conduct of Systematic Reviews in Toxicology and Environmental Health Research (COSTER) standard outlines 70 requirements spanning various research methodology considerations and establishes the first overarching code for Systematic Review in environmental health studies.
Published in Environment International, the open access article can be found here:
The FDA has released a statement advising consumers not to use hand sanitizer manufactured by Eskbiochem SA de CV in Mexico. FDA has stated that methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects.
The following products manufactured by Eskbiochem potentially contain methanol.
FDA has urged consumers to stop using these products immediately and discard them in hazardous waste containers. These products should not be flushed or poured down the drain.
Complete advisory can be found here:
A bill has been introduced that would extend for two years the FDA’s “Temporary Policy for Preparation of Alcohol-based Hand Sanitizer Products During the Public Health Emergency.”
Click here for more information.
U.S. EPA IRIS just released its Draft Systematic Review Protocol for Methylmercury (MeHg). Methylmercury is currently in Step 1 of the IRIS Assessment. The public comment period is 45 days, with comments due July 13th.
Click here to view the Federal Register Notice and the Systematic Review Protocol
