Classification schemes for carcinogenicity based solely on hazard-identification such as the IARC monograph process and the UN system adopted in the EU have become outmoded. They are based on a concept developed in the 1970s that chemicals could be divided into two classes: carcinogens and non-carcinogens. Categorization in this way places into the same category chemicals and agents with widely differing potencies and modes of action. This is how eating processed meat can fall into the same category as sulfur mustard gas. Approaches based on hazard and risk characterization present an integrated and balanced picture of hazard, dose response and exposure and allow informed risk management decisions to be taken. Because a risk-based decision framework fully considers hazard in the context of dose, potency, and exposure the unintended downsides of a hazard only approach are avoided, e.g., health scares, unnecessary economic costs, loss of beneficial products, adoption of strategies with greater health costs, and the diversion of public funds into unnecessary research. An initiative to agree upon a standardized, internationally acceptable methodology for carcinogen assessment is needed now. The approach should incorporate principles and concepts of existing international consensus-based frameworks including the WHO IPCS mode of action framework.

Classification schemes for carcinogenicity based on hazard-identification have become outmoded and serve neither science nor society / A.R. Boobis, S.M. Cohen, V.L. Dellarco, J.E. Doe, P.A. Fenner Crisp, A. Moretto, T.P. Pastoor, R.S. Schoeny, J.G. Seed, D.C. Wolf. - In: REGULATORY TOXICOLOGY AND PHARMACOLOGY. - ISSN 0273-2300. - 82(2016 Dec), pp. 158-166. [10.1016/j.yrtph.2016.10.014]

Classification schemes for carcinogenicity based on hazard-identification have become outmoded and serve neither science nor society

A. Moretto;
2016

Abstract

Classification schemes for carcinogenicity based solely on hazard-identification such as the IARC monograph process and the UN system adopted in the EU have become outmoded. They are based on a concept developed in the 1970s that chemicals could be divided into two classes: carcinogens and non-carcinogens. Categorization in this way places into the same category chemicals and agents with widely differing potencies and modes of action. This is how eating processed meat can fall into the same category as sulfur mustard gas. Approaches based on hazard and risk characterization present an integrated and balanced picture of hazard, dose response and exposure and allow informed risk management decisions to be taken. Because a risk-based decision framework fully considers hazard in the context of dose, potency, and exposure the unintended downsides of a hazard only approach are avoided, e.g., health scares, unnecessary economic costs, loss of beneficial products, adoption of strategies with greater health costs, and the diversion of public funds into unnecessary research. An initiative to agree upon a standardized, internationally acceptable methodology for carcinogen assessment is needed now. The approach should incorporate principles and concepts of existing international consensus-based frameworks including the WHO IPCS mode of action framework.
carcinogenicity; classification; GHS; hazard characterization; IARC; risk assessment; animal testing alternatives; animals; biological assay; carcinogenicity tests; carcinogens; dose-response relationship, drug; humans; reproducibility of results; risk assessment; species specificity; terminology as topic; toxicology
Settore MED/44 - Medicina del Lavoro
dic-2016
22-ott-2016
Article (author)
File in questo prodotto:
File Dimensione Formato  
Classification_RegulatoryToxicologyPharmacology_2016.pdf

accesso aperto

Tipologia: Publisher's version/PDF
Dimensione 312.83 kB
Formato Adobe PDF
312.83 kB Adobe PDF Visualizza/Apri
Pubblicazioni consigliate

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/520934
Citazioni
  • ???jsp.display-item.citation.pmc??? 7
  • Scopus 59
  • ???jsp.display-item.citation.isi??? 53
social impact