Mind the gap: Concerns using endpoints from endocrine screening assays in risk assessment

Area of Science:

• Endocrinology
• Toxicology
• Risk Assessment

Background:

• Endocrine screening assays provide mechanistic data on substance interactions with the endocrine system.
• These assays are crucial for evaluating potential human and environmental risks.
• However, limitations exist for the direct application of screening assay data in risk assessments.

Purpose of the Study:

• To discuss the limitations of endocrine screening assays for risk assessment.
• To propose an objective and transparent process for evaluating the relevance of screening data.
• To provide guidance for incorporating screening data into human and environmental risk assessments.

Main Methods:

• Literature review and critical analysis of endocrine screening assay limitations.
• Development of a decision-making framework and flowchart for data evaluation.
• Consideration of criteria for incorporating screening endpoints and identifying needs for definitive studies.

Main Results:

• Identification of key limitations in endocrine screening assays for risk assessment.
• Proposal of a structured approach to objectively assess the utility of screening data.
• A flowchart designed to assist scientists and regulators in evaluating data relevance.

Conclusions:

• Endocrine screening assay data requires careful consideration of limitations before use in risk assessment.
• A transparent process is essential for appropriate integration of screening data.
• The proposed framework aids in understanding the eco/toxicological profile of screened substances.