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Assessment of phthalates/phthalate alternatives in children’s toys and childcare articles: Review of the report including conclusions and recommendation of the Chronic Hazard Advisory Panel of the Consumer Product Safety Commission

Abstract

The Consumer Product Safety Commission (CPSC) convened a Chronic Hazard Advisory Panel (CHAP) on Phthalates found in children’s toys, and childcare products, and in products used by women of childbearing age. The CHAP conducted a risk assessment on phthalates and phthalate substitutes, and made recommendations to either ban, impose an interim ban, or allow the continued use of phthalates and phthalate substitutes in the above products. After a review of the literature, the evaluation included toxic end points of primary concern, biomonitoring results, extant exposure reconstruction, and epidemiological results. The health end points chosen were associated with the rat phthalate syndrome, which is characterized by malformations of the epididymis, vas deferens, seminal vesicles, prostate, external genitalia (hypospadias), and by cryptorchidism (undescended testes), retention of nipples/areolae, and demasculinization (~incomplete masculinization) of the perineum, resulting in reduced anogenital distance. Risk assessment demonstrated that some phthalates should be permanently banned, removed from the banned list, or remain interim banned. Biomonitoring and toxicology data provided the strongest basis for a mixture risk assessment. In contrast, external exposure data were the weakest and need to be upgraded for epidemiological studies and risk assessments. Such studies would focus on routes and sources. The review presents recommendations and uncertainties.

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Acknowledgements

We owe a major debt of gratitude to the staff at the CPSC who sheparded us through the CHAP process, and kept us focused on our final goal, a thorough risk assessment for phthalates and phthalate substitutes. We are especially appreciative of Michael Babich of CPSC who was a taskmaster and at the same time was a wizard when it came to finding data and/or reports; and Kent Carlson of CPSC who assisted in the exposure characterization. Finally, we started with an excellent Chair, Phil Mirkes but, owing to family issues, he could not guide us across the finish line. We regret the loss of his leadership during the final report development and submission. We also acknowledge Dr. Shanna Swan, Mount Sinai School of Medicine, NY for sharing her raw data with the team.

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Lioy, P., Hauser, R., Gennings, C. et al. Assessment of phthalates/phthalate alternatives in children’s toys and childcare articles: Review of the report including conclusions and recommendation of the Chronic Hazard Advisory Panel of the Consumer Product Safety Commission. J Expo Sci Environ Epidemiol 25, 343–353 (2015). https://doi.org/10.1038/jes.2015.33

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