SETAC Europe Poster: Inter-laboratory Xenopus laevis developmental stage-matched control data in AMA
Joseph Marini, Senior Research Biologist, presents results from inter-laboratory stage-matched historical control data.
Under the EU Biocidal Products Regulation (BPR), biocides that exhibit endocrine disruptor properties require that compound poses minimal risk via exposure or that it has essential uses that overcome the requirement for human and environmental protection, for approval.
Smithers is a leading laboratory for in vivo testing to evaluate endocrine disruption. As a premier provider first for the EDSP Tier 1 program, and subsequently for EFSA endocrine disruptor 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 (ED) 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). All tests can be conducted to EU regulations under OECD and / or US EPA requirements (OCSPP/OPPTS).
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
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 also supports regulatory submissions for agrochemicals, chemicals, and pharmaceuticals.
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