Example Regulations Include:
US EPA’s Endocrine Disruptor Screening Program (EDSP), and European regulations for plant protection products, biocides, and pharmaceuticals, such as Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Classification, Labelling and Packaging (CLP). Gradient has been at the scientific forefront of this issue and we have been assisting chemical companies, energy companies, personal care product companies, pharmaceutical companies, and trade associations related to this topic for nearly 20 years.
Our Services Include:
Links:
News + Events
European Union Finalizes CLP Guidance for Endocrine Disruptors, November 21, 2024.
Representative Projects:
Portfolio Screening of Endocrine Disruption Properties. Gradient compiled information regarding the endocrine disruption potential for a large portfolio of hydrocarbons and petroleum substances following the 2018 ECHA/EFSA guidance. Using a heat map approach, the compiled information was used to prioritize substances and identify critical data gaps.
Summary of Endocrine Disruption Programs in Asia. Gradient summarized the landscape of existing testing programs, criteria for establishing endocrine disruption potential, and regulatory restrictions or obligations for a substance/product with endocrine-disrupting properties.
Estrogen Receptor Binding Assay Development. For a large pharmaceutical company, Gradient developed a targeted in vitro screening assay to evaluate the potential estrogenicity of its products.
Bisphenol A Weight-of-Evidence Review. Gradient conducted a comprehensive critical weight-of-evidence review of studies bearing on the ability of very low bisphenol A (BPA) exposures to affect reproduction and development in mammals via endocrine disruption.
Integrated Summary Report (ISR) Endocrine Disruptor Screening Program. Author and lead technical expert on the ISR of the Invertebrate (Mysid) Two-Generation Toxicity Test being proposed as a Tier 2 testing assay under US EPA’s Endocrine Disruptor Screening Program (EDSP).
Pharmaceutical Endocrine Disruption Evaluation. For major pharmaceutical companies, Gradient evaluated the environmental risk associated with the societal use of their products (including endocrine disruption effects), in compliance with either EU or US risk assessment guidelines.
Example Publications/Presentations:
Lewis, AS. 2024. “Screening, Testing, and Assessing Ingredient Portfolios for Endocrine Disruption.” Presented at the 2024 Society for Chemical Hazard Communication (SCHC) Annual Meeting, Charlotte, NC, September 24. 30p.
Verslycke, T; Lewis, AS; Manidis, T; Lyon, D; Synhaeve, N; Hinkal, G; Saunders, L; Villalobos, SA; Colvin, K. 2023. “Screening Assessment of Endocrine Disruption Properties of a Large Portfolio of Petroleum-Related UVCB Substances.” Poster # 4.05.P-We301. Presented at the SETAC Europe 33rd Annual Meeting, Dublin, Ireland, April 30-May 4.
Verslycke, T; Reid, K. 2015. “Hazard versus Risk Assessment of Endocrine Disruptors: A Communications Challenge.” Presented at the SETAC Europe 25th Annual Meeting, Barcelona, Spain, May 3-7.
Verslycke, T. 2014. “Regulatory Multi-Generational Testing: The Endocrine Disruptor Screening Program Experience.” Presented at the SETAC North America 35th Annual Meeting, Vancouver, British Columbia, November 13.
Verslycke, T; Mayfield, DB; Brown, V; Houchens, D; Browne, P; Touart, L. 2013. “Validation of the Mysid Two-Generation and Copepod Lifecycle Assays for the Regulatory Testing of Endocrine Active Compounds.” Presented at the SETAC North America 34th Annual Meeting, Nashville, TN, November 17-21.
