Under REACH, chemical substances added to the candidate list of substances of very high concern (SVHC) require additional information on the safety and use of the compound. SVHC classifications include carcinogens, mutagens and/or reproductive toxicants (CMRs), persistent, bio-accumulative and toxic chemicals (PBT) and chemicals of equivalent concern. Chemicals of equivalent concern includes substances for which there is evidence of effects to human health or the environment. Additionally, the Classification, Labelling and Packaging of chemicals (CLP) regulation was recently updated to incorporate endocrine disruption as a new hazard class.
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
Thyroid evaluation
Smithers endocrine testing also supports regulatory submissions for agrochemicals, biocides, and pharmaceuticals.
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