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By: LD Burgoon, CJ Borgert
Resource Summary:The Consensus Key Characteristics Approach (CKCA) applied to carcinogens or endocrine disruptors is either: 1. Unscientific: as it cannot be falsified (all endogenous and biologically relevant chemicals are carcinogens and endocrine disruptors). OR 2. False: CKCA rewards confirmation bias. Evidence of meeting 1 single criterion is sufficient to be labeled a Carcinogen or Endocrine Disruptor. Proponents specifically state the following question should be answered: “Does exposure to the agent induce end points associated with one or more specific key characteristic properties of carcinogens?
By: CJ Borgert
Resource Summary:Hazard is qualitative and depends on: . . . the Chemical and the Conditions of encounter. There may be NO HAZARD under some conditions. Risk is quantitative and depends on: . . . the Amount of the Chemical under the Conditions of encounter.
By: LD Burgoon, CJ Borgert, C Fuentes, JE Klaunig
Resource Summary:The kinetically-derived maximal dose (KMD) is defined as the maximal external dose at which kinetics are unchanged relative to lower doses, e.g., doses at which kinetic processes are not saturated. Toxicity produced at doses above the KMD can be qualitatively different from toxicity produced at lower doses. Here, we test the hypothesis that neoplastic lesions reported in the National Toxicology Program’s (NTP) rodent cancer bioassay with ethylbenzene are a high-dose phenomenon secondary to saturation of elimination kinetics.
By: D Farmer, CJ Borgert, D Saltmiras, JE Klaunig
Resource Summary:Regulatory WoE assessments are clear that GLY does not show EATS modalities. • The methodological deficiencies of KCs explain the incorrect classification of glyphosate’s potential as an ED using this novel approach compared to the application of wellestablished WoE approaches developed by regulatory agencies over the past decade. • ED KCs like other KCs have not been validated against negative controls and the GLY data is an ideal example of a negative control and demonstrates how the KC approach lacks a means to get to a negative conclusion about a chemical’s ED properties.
By: CJ Borgert
Resource Summary: For more than a decade, weight of evidence (WoE) evaluations have been the standard method for determining whether a chemical meets the definition of an endocrine disrupting chemical (EDC). WoE methods consider all data pertinent to satisfying the EDC definition and evaluating those data with respect to relevance, reliability, strength, and coherence with established endocrine physiology and pharmacology. A new approach for identifying EDC hazards has been proposed that organizes and evaluates data according to ten so-called “Key Characteristics (KCs) of EDCs”.
By: KC Coady, RC Biever, ND Denslow, M Gross et al.
Resource Summary: In the present study, existing regulatory frameworks and test systems for assessing potential endocrine active chemicals are described, and associated challenges are discussed, along with proposed approaches to address these challenges.
By: KK Coady, CM Lehman, RJ Currie, TA Marino
Resource Summary: The amphibian metamorphosis assay (AMA) and the fish short-term reproduction assay (FSTRA) are screening assays designed to detect potential endocrine activity of a test substance. These assays are included in a battery of assays in Tier 1 of U.S. Environmental Protection Agency's Endocrine Disruptor Screening Program. Based on our laboratory's experience with these two assays, we have noted several challenges in the conduct and interpretation of the AMA and FSTRA, including, but not limited to, diseased/parasitized test organisms, failure to meet some guideline performance criteria, and issues selecting and maintaining test concentrations.
By: Corresponding Author: GB Gori
Resource Summary:We, scientists and signatories of this appeal assert our concern for the erosion of scientific principles in the purported validation of experimental evidence, which is manifest in arguments disguised as true science. Such arguments are used to simulate and exaggerate hazards and risks that justify official intervention policies in health, safety and environmental issues.
By: CJ Borgert, JC Matthews, SP Baker
Resource Summary: We propose an HRPT for ERα agonism of 1E-04 relative to the potency of the endogenous estrogenic hormone 17β-estradiol or the pharmaceutical estrogen, 17α-ethinylestradiol. This approach provides a practical way to address Hazard Identification according to the draft criteria for identification of EDCs recently proposed by the European Commission
By: Cosmetic Ingredient Review (2017)
Resource Summary: The CIR Expert Panel considers ingredients that have demonstrated endocrine activity in such tests as potential endocrine disrupting chemicals (EDCs), depending on the relevance, quality and concordance of the available studies, the doses and concentrations tested and the dose- or concentration-response relationships observed in such studies, the affinities of the ingredients for endocrine receptors or other components of the endocrine system, the potency of endocrine-active ingredients compared with endogenous hormones, and other important factors that contribute to an assessment of the overall weight-of-the-evidence (WoE).