Modernizing persistence–bioaccumulation–toxicity (PBT) assessment with high throughput animal-free methods
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In: Archives of Toxicology, Vol. 97, No. 5, 01.05.2023, p. 1267-1283.
Research output: Journal contributions › Journal articles › Research › peer-review
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TY - JOUR
T1 - Modernizing persistence–bioaccumulation–toxicity (PBT) assessment with high throughput animal-free methods
AU - Escher, Beate I.
AU - Altenburger, Rolf
AU - Blüher, Matthias
AU - Colbourne, John K.
AU - Ebinghaus, Ralf
AU - Fantke, Peter
AU - Hein, Michaela
AU - Köck, Wolfgang
AU - Kümmerer, Klaus
AU - Leipold, Sina
AU - Li, Xiaojing
AU - Scheringer, Martin
AU - Scholz, Stefan
AU - Schloter, Michael
AU - Schweizer, Pia Johanna
AU - Tal, Tamara
AU - Tetko, Igor
AU - Traidl-Hoffmann, Claudia
AU - Wick, Lukas Y.
AU - Fenner, Kathrin
N1 - Publisher Copyright: © 2023, The Author(s).
PY - 2023/5/1
Y1 - 2023/5/1
N2 - The assessment of persistence (P), bioaccumulation (B), and toxicity (T) of a chemical is a crucial first step at ensuring chemical safety and is a cornerstone of the European Union’s chemicals regulation REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals). Existing methods for PBT assessment are overly complex and cumbersome, have produced incorrect conclusions, and rely heavily on animal-intensive testing. We explore how new-approach methodologies (NAMs) can overcome the limitations of current PBT assessment. We propose two innovative hazard indicators, termed cumulative toxicity equivalents (CTE) and persistent toxicity equivalents (PTE). Together they are intended to replace existing PBT indicators and can also accommodate the emerging concept of PMT (where M stands for mobility). The proposed “toxicity equivalents” can be measured with high throughput in vitro bioassays. CTE refers to the toxic effects measured directly in any given sample, including single chemicals, substitution products, or mixtures. PTE is the equivalent measure of cumulative toxicity equivalents measured after simulated environmental degradation of the sample. With an appropriate panel of animal-free or alternative in vitro bioassays, CTE and PTE comprise key environmental and human health hazard indicators. CTE and PTE do not require analytical identification of transformation products and mixture components but instead prompt two key questions: is the chemical or mixture toxic, and is this toxicity persistent or can it be attenuated by environmental degradation? Taken together, the proposed hazard indicators CTE and PTE have the potential to integrate P, B/M and T assessment into one high-throughput experimental workflow that sidesteps the need for analytical measurements and will support the Chemicals Strategy for Sustainability of the European Union.
AB - The assessment of persistence (P), bioaccumulation (B), and toxicity (T) of a chemical is a crucial first step at ensuring chemical safety and is a cornerstone of the European Union’s chemicals regulation REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals). Existing methods for PBT assessment are overly complex and cumbersome, have produced incorrect conclusions, and rely heavily on animal-intensive testing. We explore how new-approach methodologies (NAMs) can overcome the limitations of current PBT assessment. We propose two innovative hazard indicators, termed cumulative toxicity equivalents (CTE) and persistent toxicity equivalents (PTE). Together they are intended to replace existing PBT indicators and can also accommodate the emerging concept of PMT (where M stands for mobility). The proposed “toxicity equivalents” can be measured with high throughput in vitro bioassays. CTE refers to the toxic effects measured directly in any given sample, including single chemicals, substitution products, or mixtures. PTE is the equivalent measure of cumulative toxicity equivalents measured after simulated environmental degradation of the sample. With an appropriate panel of animal-free or alternative in vitro bioassays, CTE and PTE comprise key environmental and human health hazard indicators. CTE and PTE do not require analytical identification of transformation products and mixture components but instead prompt two key questions: is the chemical or mixture toxic, and is this toxicity persistent or can it be attenuated by environmental degradation? Taken together, the proposed hazard indicators CTE and PTE have the potential to integrate P, B/M and T assessment into one high-throughput experimental workflow that sidesteps the need for analytical measurements and will support the Chemicals Strategy for Sustainability of the European Union.
KW - Biodegradation
KW - Hazard assessment
KW - In vitro bioassay
KW - Mobility
KW - New approach methodologies (NAMs)
KW - Persistence
KW - Toxicity
KW - Chemistry
UR - http://www.scopus.com/inward/record.url?scp=85150653906&partnerID=8YFLogxK
U2 - 10.1007/s00204-023-03485-5
DO - 10.1007/s00204-023-03485-5
M3 - Journal articles
C2 - 36952002
AN - SCOPUS:85150653906
VL - 97
SP - 1267
EP - 1283
JO - Archives of Toxicology
JF - Archives of Toxicology
SN - 0340-5761
IS - 5
ER -