Since November 2018 all new active ingredients and actives due for renewal must have endocrine activity evaluated for registration in Europe. 
Smithers is a leading laboratory for in vivo testing for non-target organisms to evaluate endocrine activity. As a premier provider for the United States Environmental Protection Agency’s Endocrine Disruptor Screening Program (EDSP) Tier 1 program, and subsequently for EFSA (plant protection products) endocrine disruptor (ED) requirements and biocide ED evaluation under ECHA BPR, Smithers has developed a significant historical control database of studies to help guide interpretation of data in these critical hazard and risk assessments. Our experts have acquired extensive experience with the guidelines since their inception.   
Endocrine disruptor criteria are addressed by effects caused by estrogenic, androgenic, thyroidal and steroidogenic (EATS) modalities.  For estrogenic, androgenic, and steroidogenic endpoints (EAS), the FSTRA (OECD 229) and 21-Day Fish Assay (OECD 230) are available for evaluating potential activity. MEOGRT (OECD 240) and FSDT (OECD 234) are available for evaluating potential activity and adversity. Thyroid activity (T) can be assessed with the AMA and extended AMA (OECD 231 / modified), and LAGDA (OECD 241) for evaluating potential adversity. All tests can be conducted to EU regulations under OECD and / or US EPA requirements (OCSPP/OPPTS), according to applicable Good Laboratory Practices (GLP). Smithers can also offer non-GLP evaluations with tailored scopes to evaluate specific needs. 
The Harrogate and Wareham facilities have performed these studies as standalone designs or as combinations of the established test guidelines to meet specific requirements. Smithers understands that each compound is unique, and endocrine disruptor testing is tailored to generate the endpoints relevant for the customized risk assessment. 

Estrogen, androgen, and steroidogenesis evaluation 

  • Androgenized Female Stickleback Screen - OECD 140 
  • Fish Short-Term Reproductive Screening Assay - OECD 229 
  • 21-day Fish Assay - OECD 230 
  • Fish Sexual Development Test (FSDT) - OECD 234 
  • Medaka Extended One-Generation Reproduction Test (MEOGRT) - OECD 240 
  • Fish full life cycle - OECD 240 / OCSPP 850.1500 with endocrine endpoints included 

Thyroid evaluation 

  • Amphibian Metamorphosis Assay (AMA) - OECD 231 / OPPTS 890.1100 
  • Extended AMA - OECD 231 / OPPTS 890.1100 (modified) 
  • Larval Amphibian Growth & Development Assay - OECD 241 

Smithers endocrine testing supports regulatory submissions for biocides, chemicals, and pharmaceuticals

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