Select Projects

Toxicological Risk Assessment:  Contributed to a toxicological risk assessment of chemicals identified as migrating from the packaging of an over-the-counter drug product and extractables from a medical device.  For these projects, analyzed chemical characterization data and applied read-across for data-poor chemicals.  Provided reports on both the safety of the drug product’s packaging and in support of a safety evaluation for the medical device.

Chemical Health Hazard Identification:  Established and applied procedures for identifying chemical health hazards, determined proper analytical methods, and set appropriate detection limits for quantifying chemicals of concern in the manufacturer’s product and the product’s raw materials.  The focus was on preventing adverse health effects associated with skin contact.  The analysis assisted the manufacturer in deciding whether to move forward with the release of new products.

Chemical Compliance Support:  Managed the project by providing general chemical compliance support for imports into Thailand.  Evaluated the client’s portfolio and determined the appropriate regulatory submissions needed for import compliance, including license submission and registrations, as part of a larger effort to help the company achieve global chemical compliance.

Hazard and Risk Assessment for Personal Care Products:  Contributed to the hazard and risk assessment of ingredients in personal care products.  The overall objective of these tasks was to develop a sustainable ingredient assessment program that can later be maintained by the company.

Exposure Assessment:  Evaluated the scientific basis for class certification in the context of property damage and medical monitoring for residents near a former zinc smelter site.  Examined factors contributing to the variability in exposure to metals in residential soil among the residents, and quantified this variability to determine whether residents were sufficiently similar to be certified as a class.  Identified alternative sources of metals in the area based on metal concentration ratios, historical aerial imagery analysis of topography and land use, and flooding information in the area

Selected Publications

Mashankar, PA; Cronin, BA; Chang, RY; Cohen, JM. 2024. “Modifications to Toxtree’s Revised Cramer Module in the Context of Cramer Classification Predictions for Medical Device Extractables.” Abstract/Poster #: 3364/P489. Presented at the Society of Toxicology (SOT) 63rd Annual Meeting and ToxExpo, Salt Lake City, UT, March 10-14.

Chang, RY; Clyde, PM; Mashankar, PA; Cohen, JM. 2023. “Ranking Surrogate Suitability for Read-Across of Medical Device Extractables: A Case Study of Irganox-Related Compounds.” Abstract/ Poster #: 4428/P299. Presented at the Society of Toxicology (SOT) 62nd Annual Meeting and ToxExpo, Nashville, TN, March 19-23.

Mashankar, PA; Hadley, IG; Chang, R; Cohen, JM. 2022. “Expert Review of Cramer Classification Predictions for Medical Device Extractables.” Abstract/Poster # 3477/P855. Presented at the Society of Toxicology (SOT) 61st Annual Meeting and ToxExpo, San Diego, CA, March 27-31.