Abstract
Objectives: In response to increased interest in the safety of children's products, a risk management system is being prepared through exposure assessment of hazardous chemicals. To estimate exposure levels, risk assessors are using deterministic and probabilistic approaches to statistical methodology and a commercialized Monte Carlo simulation based on tools (MCTool) to efficiently support calculation of the probability density functions. This study was conducted to analyze and discuss the usage patterns and problems associated with the results of these two approaches and MCTools used in the case of probabilistic approaches by reviewing research reports related to exposure assessment for children's products. Methods: We collected six research reports on exposure and risk assessment of children's products and summarized the deterministic results and corresponding underlying distributions for exposure dose and concentration results estimated through deterministic and probabilistic approaches. We focused on mechanisms and differences in the MCTools used for decision making with probabilistic distributions to validate the simulation adequacy in detail. Results: The estimation results of exposure dose and concentration from the deterministic approaches were 0.19-3.98 times higher than the results from the probabilistic approach. For the probabilistic approach, the use of lognormal, Student's T, and Weibull distributions had the highest frequency as underlying distributions of the input parameters. However, we could not examine the reasons for the selection of each distribution because of the absence of test-statistics. In addition, there were some cases estimating the discrete probability distribution model as the underlying distribution for continuous variables, such as weight. To find the cause of abnormal simulations, we applied two MCTools used for all reports and described the improper usage routes of MCTools. Conclusions: For transparent and realistic exposure assessment, it is necessary to 1) establish standardized guidelines for the proper use of the two statistical approaches, including notes by MCTool and 2) consider the development of a new software tool with proper configurations and features specialized for risk assessment. Such guidelines and software will make exposure assessment more user-friendly, consistent, and rapid in the future.
