The assessment and communication of genotoxicity test results: moving beyond binary.
Mutat Res Genet Toxicol Environ Mutagen
; 893: 503722, 2024 Jan.
Article
de En
| MEDLINE
| ID: mdl-38272631
ABSTRACT
Potential genotoxicity is one of the essential considerations in the safety assessment of chemicals to which humans may be exposed. Several endpoints are used to evaluate genotoxicity, but, in each case, a binary assessment (negative/positive) is demanded by regulators. The use of binary assessment has rarely been questioned, although we have pointed out some questions and difficulties with regard to the statistical methods used and the evaluation of biological significance, both of which inform the calls of negative/ positive. Here, we discuss these issues further, focusing on ambiguity and uncertainty in the binary paradigm, and we seek a new direction for genotoxicity assessment. To this end, we need to understand, acknowledge, and accept these ambiguities and study-related uncertainties and then to consider new strategies for safety assessment. We also discuss the communication of ambiguity and uncertainty in risk communication.
Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Altération de l'ADN
Type d'étude:
Etiology_studies
/
Risk_factors_studies
Limites:
Humans
Langue:
En
Journal:
Mutat Res Genet Toxicol Environ Mutagen
Année:
2024
Type de document:
Article
Pays d'affiliation:
Japon