{"title":"Accurate regulatory classification of chemical respiratory allergens: The case for robust characterisation of causation","authors":"Mark A. Pemberton , Ian Kimber","doi":"10.1016/j.yrtph.2025.105785","DOIUrl":null,"url":null,"abstract":"<div><div>Occupational health standards, worker safety and effective regulatory classification relies upon characterisation of occupational asthma and discrimination between allergic asthma, irritant-induced asthma, and work-exacerbated asthma, and the accurate identification of chemical allergens of the respiratory tract.</div><div>No <em>in silico, in vitro or in vivo</em> experimental method can, either alone or in combination, accurately identify chemical respiratory allergens and provide a sound basis for regulatory classification. Measurement of IgE antibody and skin prick testing can characterise allergy to proteins, but not to chemical respiratory allergens.</div><div>Therefore, characterisation of causation and accurate regulatory classification of work-related asthma relies upon characterisation of clinical and workplace histories and specific inhalation challenge tests conforming to current guidelines and best practice.</div><div>This manuscript reviews the important of accurate characterisation of causation in cases of work-related asthma to ensure accurate classification and robust regulation, and to promote a sound basis for clinical and experimental research. Commentaries on selected clinical case studies are provided that highlight key issues that confound attribution of causation. Specific recommendations are made regarding the design, conduct and interpretation of clinical investigations of work-related asthma that could provide a basis of more robust regulatory practice, and the more reliable identification of chemical respiratory allergens.</div></div>","PeriodicalId":20852,"journal":{"name":"Regulatory Toxicology and Pharmacology","volume":"157 ","pages":"Article 105785"},"PeriodicalIF":3.0000,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Regulatory Toxicology and Pharmacology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0273230025000157","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICINE, LEGAL","Score":null,"Total":0}
引用次数: 0
Abstract
Occupational health standards, worker safety and effective regulatory classification relies upon characterisation of occupational asthma and discrimination between allergic asthma, irritant-induced asthma, and work-exacerbated asthma, and the accurate identification of chemical allergens of the respiratory tract.
No in silico, in vitro or in vivo experimental method can, either alone or in combination, accurately identify chemical respiratory allergens and provide a sound basis for regulatory classification. Measurement of IgE antibody and skin prick testing can characterise allergy to proteins, but not to chemical respiratory allergens.
Therefore, characterisation of causation and accurate regulatory classification of work-related asthma relies upon characterisation of clinical and workplace histories and specific inhalation challenge tests conforming to current guidelines and best practice.
This manuscript reviews the important of accurate characterisation of causation in cases of work-related asthma to ensure accurate classification and robust regulation, and to promote a sound basis for clinical and experimental research. Commentaries on selected clinical case studies are provided that highlight key issues that confound attribution of causation. Specific recommendations are made regarding the design, conduct and interpretation of clinical investigations of work-related asthma that could provide a basis of more robust regulatory practice, and the more reliable identification of chemical respiratory allergens.
期刊介绍:
Regulatory Toxicology and Pharmacology publishes peer reviewed articles that involve the generation, evaluation, and interpretation of experimental animal and human data that are of direct importance and relevance for regulatory authorities with respect to toxicological and pharmacological regulations in society. All peer-reviewed articles that are published should be devoted to improve the protection of human health and environment. Reviews and discussions are welcomed that address legal and/or regulatory decisions with respect to risk assessment and management of toxicological and pharmacological compounds on a scientific basis. It addresses an international readership of scientists, risk assessors and managers, and other professionals active in the field of human and environmental health.
Types of peer-reviewed articles published:
-Original research articles of relevance for regulatory aspects covering aspects including, but not limited to:
1.Factors influencing human sensitivity
2.Exposure science related to risk assessment
3.Alternative toxicological test methods
4.Frameworks for evaluation and integration of data in regulatory evaluations
5.Harmonization across regulatory agencies
6.Read-across methods and evaluations
-Contemporary Reviews on policy related Research issues
-Letters to the Editor
-Guest Editorials (by Invitation)