A plea for risk assessment of endocrine disrupting chemicals.
Some recent EU Regulations have focused on the potential risks posed by the presence of endocrine disrupters (ED) into the environment. However there are conflicting opinions on how to assess the risk from exposure to these molecules that can reversibly modulate hormonal activity, endocrine active substances (EAS) rather than causing irreversible damage (ED). The present paper attempts to discuss that perturbation of normal endocrine homeostasis in itself may not be an adverse effect, since the endocrine system is naturally dynamic and responsive to various stimuli as part of its normal function and it is modulated according to the characteristic trend of the dose-response curve. EDs should be evaluated using a weight-of-evidence (WoE) approach. If a chemical meets the criteria to be defined as an ED in experimental animals, the relevance of observed effects to the human then needs to be addressed. Hazard-based risk management is therefore not justified since does not meet the criteria for a sound scientifically based assessment.
Istituto Superiore di Sanità, Department of Environment and Primary Prevention, Mechanisms of Toxicity Unit, Viale Regina Elena, 299, Rome, Italy. Electronic address: emanuela.testai@iss.it.
Emanuela
E
Testai
Corrado L
CL
Galli
Wolfgang
W
Dekant
Marina
M
Marinovich
Aldert H
AH
Piersma
Richard M
RM
Sharpe
D000818:Animals; D004305:Dose-Response Relationship, Drug; D052244:Endocrine Disruptors / Q000009:adverse effects / Q000633:toxicity*; D006801:Humans; D018570:Risk Assessment; D018675:Toxicity Tests
D052244:Endocrine Disruptors
Endocrine active substances (EASs); Endocrine disrupters (EDs); Exposure; Monotonic dose–response; Regulatory decisions; Risk assessment