Robert J.Kavlock
September 26, 2016
Publication after first APCRA Workshop in Washington DC
Title:
Practitioner Insights: Bringing New Methods for Chemical Safety into the Regulatory Toolbox; It is Time to Get Serious
Marc A Beal
Marc Audebert
,
Tara Barton-Maclaren
,
Hannah Battaion
,
Jeffrey C Bemis
,
Xuefei Cao
,
Connie Chen
,
Stephen D Dertinger
,
Roland Froetschl
,
Xiaoqing Guo
,
George Johnson
,
Giel Hendriks
,
Francesco Cubadda
,
Laure Khoury
,
Alexandra S Long
,
Stefan Pfuhler
,
Raja S Settivari
,
Shamika Wickramasuriya
,
Paul White
,
Quantitative in vitro to in vivo extrapolation of genotoxicity data provides protective estimates of in vivo dose
Environ Mol Mutagen. 2023 Feb;64(2):105-122. doi: 10.1002/em.22521. Epub 2022 Dec 22. Abstract: Genotoxicity assessment is a critical component in the development and evaluation of chemicals. Traditional genotoxicity assays (i.e., mutagenicity, clastogenicity, and aneugenicity) have been limited to dichotomous hazard classification, while other toxicity endpoints are assessed through quantitative determination of points-of-departures (PODs) for setting exposure limits. The more…
Olimpia Vincentini
Anne-Louise Blier
,
Alessia Bogni
,
Morgane Brun
,
Serena Cecchetti
,
Francesca De Battistis
,
Sylvain Denis
,
Lucie Etienne-Mesmin
,
Francesca Ferraris
,
Francesco Sirio Fumagalli
,
Kevin Hogeveen
,
Francesca Iacoponi
,
Andrea Raggi
,
Lisa Siciliani
,
Deborah Stanco
,
Eveline Verleysen
,
Valerie Fessard
,
Jan Mast
,
Stephanie Blanquet-Diot
,
Susanne Bremer-Hoffmann
,
Francesco Cubadda
,
EFSA Project on the use of New Approach Methodologies (NAMs) for the hazard assessment of nanofibres. Lot 1, nanocellulose oral exposure: gastrointestinal digestion, nanofibres uptake and local effects
EFSA Journal, Published 20 September 2023; https://doi.org/10.2903/sp.efsa.2023.EN-8258 Abstract: Nanocellulose (NC) is an emerging material in the food sector with several prospective application areas. Three main types of NC exist, i.e. bacterial NC (BNC), nanofibrillated cellulose (NFC), and cellulose nanocrystals (CNC). The biological sources and processing conditions affect several physicochemical parameters of NC. In the present project,…
Daniel L Villeneuve
Michelle Le
,
Monique Hazemi
,
Adam Biales
,
David C Bencic
,
Kendra Bush
,
Robert Flick
,
John Martinson
,
Mackenzie Morshead
,
Kelvin Santana Rodriguez
,
Kelsey Vitense
,
Kevin Flynn
,
Pilot testing and optimization of a larval fathead minnow high throughput transcriptomics assay
Current Research in Toxicology; https://pubmed.ncbi.nlm.nih.gov/36619288/ Abstract: Concentrations at which global gene expression profiles in cells or animals exposed to a test substance start to differ significantly from those of controls have been proposed as an alternative point of departure for use in screening level hazard assessment. The present study describes pilot testing of a high throughput…
Kristin K. Isaacs
Peter Egeghy
,
Kathie L. Dionisio
,
Katherine A. Phillips
,
Angelika Zidek
,
Caroline Ring
,
Jon R. Sobus
,
Elin M. Ulrich
,
Barbara A. Wetmore
,
Antony J. Williams
,
John F. Wambaugh
,
The chemical landscape of high-throughput new approach methodologies for exposure
Journal of Exposure Science & Environmental Epidemiology; https://doi.org/10.1038/s41370-022-00496-9 Abstract: The rapid characterization of risk to humans and ecosystems from exogenous chemicals requires information on both hazard and exposure. The U.S. Environmental Protection Agency’s ToxCast program and the interagency Tox21 initiative have screened thousands of chemicals in various high-throughput (HT) assay systems for in vitro bioactivity. EPA’s…
Yadvinder Bhuller
Deborah Ramsingh
,
Marc Beal
,
Sunil Kulkarni
,
Matthew Gagne
,
Tara S Barton-Maclaren
,
Canadian Regulatory Perspective on Next Generation Risk Assessments for Pest Control Products and Industrial Chemicals
Front. Toxicol., 04 November 2021 | https://doi.org/10.3389/ftox.2021.748406 Abstract: In 2012, the Council of Canadian Academies published the expert panel on integrated testing of pesticide’s report titled: Integrating emerging technologies into chemical safety assessment. This report was prepared for the Government of Canada in response to a request from the Minister of Health and on behalf…
Andrea Rowan-Carroll
Anthony Reardon
,
Karen Leingartner
,
Remi Gagné
,
Andrew Williams
,
Matthew J Meier
,
Byron Kuo
,
Julie Bourdon-Lacombe
,
Ivy Moffat
,
Richard Carrier
,
Andy Nong
,
Luigi Lorusso
,
Stephen S Ferguson
,
Ella Atlas
,
Carole Yauk
,
High-Throughput Transcriptomic Analysis of Human Primary Hepatocyte Spheroids Exposed to Per- and Polyfluoroalkyl Substances as a Platform for Relative Potency Characterization
Toxicological Sciences, Volume 181, Issue 2, June 2021, Pages 199–214 Abstract: Per- and poly-fluoroalkyl substances (PFAS) are widely found in the environment because of their extensive use and persistence. Although several PFAS are well studied, most lack toxicity data to inform human health hazard and risk assessment. This study focused on 4 model PFAS: perfluorooctanoic…
Background paper: Evolution of the Existing Substances Risk Assessment Program under the Canadian Environmental Protection Act, 1999
Official title: Chemicals Management Plan Science Committee background paper: Evolution of the Existing Substances Risk Assessment Program under the Canadian Environmental Protection Act, 1999 and considerations looking forward Chemicals Management Plan (CMP) Science Committee meeting: February 17 to 18, 2021
John C
Achenbach
,
Cindy Leggiadro
,
Sandra A. Sperker
,
Cindy Woodland
,
Lee D. Ellis
,
Comparison of the Zebrafish Embryo Toxicity Assay and the General and Behavioral Embryo Toxicity Assay as New Approach Methods for Chemical Screening
Toxics 2020, 8(4), 126; https://doi.org/10.3390/toxics8040126 Absract: The movement away from mammalian testing of potential toxicants and new chemical entities has primarily led to cell line testing and protein-based assays. However, these assays may not yet be sufficient to properly characterize the toxic potential of a chemical. The zebrafish embryo model is widely recognized as a…
A.J.F. Reardon
A. Rowan-Carroll
,
S.S. Ferguson
,
K. Leingartner
,
R. Gagne
,
B. Kuo
,
A. Williams
,
L. Lorusso
,
J.A. Bourdon-Lacombe
,
R. Carrier
,
I. Moffat
,
C.L. Yauk
,
E. Atlas
,
High-throughput transcriptomics and benchmark concentration modeling for potency ranking of per- and polyfluoroalkyl substances (PFAS) in exposed human liver cell spheroids
Abstract: Per- and polyfluoroalkyl substances (PFAS) are some of the most prominent organic contaminants in human blood. Although the toxicological implications from human exposure to perfluorooctane sulfonate (PFOS) and perfluorooctanoate (PFOA) are well established, data on lesser-understood PFAS are limited. New approach methodologies (NAMs) that apply bioinformatic tools to high-throughput data are being increasingly considered…
Katie Paul Friedman
Matthew Gagne
,
Lit-Hsin Loo
,
Panagiotis Karamertzanis
,
Tatiana Netzeva
,
Tomasz Sobanski
,
Jill A Franzosa
,
Ann M Richard
,
Ryan R Lougee
,
Andrea Gissi
,
Jia-Ying Joey Lee
,
Michelle Angrish
,
Jean Lou Dorne
,
Stiven Foster
,
Kathleen Raffaele
,
Tina Bahadori
,
Maureen R Gwinn
,
Jason Lambert
,
Maurice Whelan
,
Mike Rasenberg
,
Tara Barton-Maclaren
,
Russell S Thomas
,
Utility of In Vitro Bioactivity as a Lower Bound Estimate of In Vivo Adverse Effect Levels and in Risk-Based Prioritization
Toxicological Sciences, Volume 173, Issue 1, January 2020, Pages 202–225, https://doi.org/10.1093/toxsci/kfz201 Abstract: Use of high-throughput, in vitro bioactivity data in setting a point-of-departure (POD) has the potential to accelerate the pace of human health safety evaluation by informing screening-level assessments. The primary objective of this work was to compare PODs based on high-throughput predictions of…