Abstract

A refined risk assessment was conducted to evaluate the efficacy of different glove materials in reducing the potential hazards associated with using paint strippers containing N-methylpyrrolidone (NMP) under the scenarios defined by USEPA’s TSCA risk assessment. Three categories of gloves were identified based on measured permeation rates for NMP: (1) minimal protection; (2) moderate protection; and (3) maximal protection. Simulations for eight acute and chronic occupational exposure scenarios identified by USEPA as having a potential hazard (i.e., margins of exposure, MOE, <30) were reassessed for each glove category using PBPK modeling to predict peak (Cmax) and cumulative (AUC) internal doses of NMP. For the acute assessment, the refined MOE values were ≥30 for half of the scenarios for gloves from the moderate protection group category, and all of the scenarios for gloves from the maximal protection category. For the chronic assessment, the refined MOE values were ≥30 for all scenarios except one for gloves from the maximal protection category. The results of this assessment indicate that: (1) the degree of protection provided by gloves from NMP permeation can vary widely depending upon the glove material, NMP formulation, and internal dose measure (with calculated glove protection factors ranging from 1.1 to 1900); and (2) NMP-containing paint strippers can be used safely when appropriate PPE are used. As such, these results can be used to support risk-reduction methods (e.g., product labeling, MSDS instructions on use of appropriate glove materials) as alternatives to banning NMP use under TSCA.

Highlights

  • The Toxic Substances Control Act (TSCA), originally passed in 1976 and amended in 2016, provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures

  • USEPA’s toxicity assessment was adopted unchanged for this assessment, so that the focus remains on the impact glove materials on potential hazards

  • margins of exposures (MOEs) values calculated for the moderate and maximum protection glove categories exhibit substantial improvement over the no-glove scenario values calculated by USEPA, while those calculated for minimum protection glove categories were minimally changed

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Summary

Introduction

The Toxic Substances Control Act (TSCA), originally passed in 1976 and amended in 2016, provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. In March of 2015, USEPA released its final risk assessment for N-methylpyrrolidone (NMP) used in paint strippers under TSCA [1]. In this assessment, USEPA evaluated acute and chronic exposure scenarios to workers and consumers using NMP-containing paint strippers. USEPA evaluated acute and chronic exposure scenarios to workers and consumers using NMP-containing paint strippers To support their assessment, USEPA relied upon several state-of-the-science tools/models, including physiologically based pharmacokinetic (PBPK) modeling, benchmark dose modeling, as well as a consideration of personal protective equipment (PPE) to reduce potential exposures. USEPA did not evaluate glove efficacy, California DOH recommends the use of gloves made of butyl rubber or laminated polyethylene/EVOH2.”

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