Development of Adverse Outcome Pathways relevant for the identification of substances having endocrine disruptors properties

Deadline
14 septembre 2020 - 23:59 (CEST)
  • Procedure Reference: NP/EFSA/PREV/2020/01
  • Budget: 100.000 €
  • Approximate launch date: Mid-September 2020
  • Deadline to register interest: 14/09/2020 cob

Background:

Hormone-related cancers, like breast, endometrium, ovary, prostate, testis and thyroid, share commonalities in the mechanism of carcinogenesis. Endogenous and exogenous hormones drive cell proliferation, increasing the opportunity for the accumulation of random genetic errors. Progression to a malignant phenotype depends on a series of somatic mutations that occur during cell division. Therefore, endocrine disrupter chemicals (EDCs) can act as exogenous substances promoting target tissue cell proliferation leading to neoplasms. One relatively common example is the uterine adenocarcinoma, a common human malignancy that can be induced experimentally in laboratory animals following treatment with EDCs. However, a direct link on the occurrence of rodent uterine adenocarcinoma and an endocrine mode of action relevant to human is not immediate, mostly because the hazard can only be characterized at the end of the carcinogenicity study. To investigate the link between an endocrine mode action and the uterine adenocarcinoma, and therefore identify EDCs, the Adverse Outcome Pathway (AOP) conceptual framework is considered a scientifically sound and regulatory acceptable method to be applied in order to investigate early Key Events (KEs) or Molecular Initiating Events (MIEs) that can be investigated in-vitro or in in-vivo short studies.

EFSA is therefore intended to launch a negotiated procedure to develop AOPs relevant for the identification of substances having ED properties leading to a uterine adenocarcinoma as AO, applying an evidence-based approach including a structured identification, screening for relevance and appraisal of available information.

Objectives:

  1. Based on the search Strategy and eligibility criteria provided by EFSA, retrieve and screen for relevance the evidence published in the scientific literature databases
  2. Extract relevant data based on data models developed in collaboration with EFSA
  3. Appraise the internal validity of the studies included for relevance using Critical Appraisal Tools defined by EFSA
  4. Develop evidence based AOPs for rodent uterine adenocarcinoma

Selection criteria - technical and professional capacity:

The proposed experts must have demonstrable experience in the following areas:

  • 1 toxicologist of at least 8 years of experience with experience in conducting in-vivo and in-vitro studies. Demonstrated experience with AOP development is considered an added value and;
  • 1 scientist with at least 5 years of experience in conducting Systematic Reviews in risk assessments involving different types of study designs. Demonstrated ability to use critical appraisal tools for appraising studies is considered an added value.

If you are interested in this procedure please send an email within the deadline to efsaprocurement [at] efsa.europa.eu quoting the reference of the procedure and specifying the following:

  • your name/organisation’s name and address;
  • whether you participate as a physical person or an organisation/private company.
Published
6 août 2020