Difficulties in translating in vitro hazards of local acute irritants to relevant human risk: Learnings from Captan and Folpet.


Journal

Regulatory toxicology and pharmacology : RTP
ISSN: 1096-0295
Titre abrégé: Regul Toxicol Pharmacol
Pays: Netherlands
ID NLM: 8214983

Informations de publication

Date de publication:
Sep 2023
Historique:
received: 29 03 2023
revised: 31 07 2023
accepted: 31 07 2023
medline: 1 9 2023
pubmed: 8 8 2023
entrez: 7 8 2023
Statut: ppublish

Résumé

In order to assess the regulatory value of New Approach Methodologies (NAMs), authors should provide their opinion on the physiological and exposure relevance of observed in vitro effects for correlation with predicted in vivo effects. Further, peer-reviewers should be encouraged to request such information during review. This is critical to scientifically transition to animal-free, reliable, robust and -- most importantly -- relevant regulatory toxicology and risk assessment approaches. Recently published studies using NAMs for the fungicides Captan and Folpet illustrate the difficulties and limitations of applying NAMs to adequately assess the toxicological relevance of these substances.

Identifiants

pubmed: 37549825
pii: S0273-2300(23)00135-6
doi: 10.1016/j.yrtph.2023.105467
pii:
doi:

Substances chimiques

Captan EOL5G26Q9F
folpet X5NFK36917
Irritants 0
Phthalimides 0
Fungicides, Industrial 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

105467

Informations de copyright

Copyright © 2023 Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: FMK works as a regulatory toxicologist for ADAMA, which registers, produces, and markets Captan, Folpet and their products.

Auteurs

Felix M Kluxen (FM)

ADAMA Deutschland GmbH, Cologne, Germany. Electronic address: Felix.Kluxen@adama.com.

Articles similaires

[Redispensing of expensive oral anticancer medicines: a practical application].

Lisanne N van Merendonk, Kübra Akgöl, Bastiaan Nuijen
1.00
Humans Antineoplastic Agents Administration, Oral Drug Costs Counterfeit Drugs

Smoking Cessation and Incident Cardiovascular Disease.

Jun Hwan Cho, Seung Yong Shin, Hoseob Kim et al.
1.00
Humans Male Smoking Cessation Cardiovascular Diseases Female
Humans United States Aged Cross-Sectional Studies Medicare Part C
1.00
Humans Yoga Low Back Pain Female Male

Classifications MeSH