Evaluation of the sensory irritation test (Alarie test) for the assessment of respiratory tract irritation.
Within the framework of risk assessment of existing substances in the EC the irritating properties on the respiratory tract should be considered. Since no standardized test is available it was studied whether the Alarie test could be used for this purpose, as proposed by the Technical Guidance Document for new and existing substances. The available literature on respiratory tract irritation, seen as a local inflammatory response and/or tissue damage, after single and repeated (few-day) exposure was evaluated and compared with data on sensory irritation. No relation was found between the sensory irritation potential (as measured by the Alarie test) and local tissue damage (histopathological changes) in the respiratory tract after single or repeated exposure. It was concluded that the Alarie test is inappropriate to evaluate respiratory tract irritation. In addition, the available data do not support a quantitative potency ranking for man based on the RD50 obtained with experimental animals.
Bos
Peter M J
PM
TNO Nutrition and Food Research, P.O. Box 360, 3700 AJ Zeist, The Netherlands.
Busschers
Marloes
M
Arts
Josje H E
JH
D000280:Administration, Inhalation; D000393:Air Pollutants / Q000009:adverse effects*; D000818:Animals; D016535:Bronchial Hyperreactivity / Q000175:diagnosis* / Q000276:immunology; D004305:Dose-Response Relationship, Drug; D007509:Irritants / Q000009:adverse effects / Q000494:pharmacology*; D051379:Mice; D023421:Models, Animal; D009297:Nasal Mucosa / Q000187:drug effects / Q000294:innervation*; D051381:Rats; D017208:Rats, Wistar; D015203:Reproducibility of Results; D012140:Respiratory Tract Diseases / Q000175:diagnosis* / Q000276:immunology; D012677:Sensation / Q000502:physiology*; D012680:Sensitivity and Specificity; D013045:Species Specificity
D000393:Air Pollutants; D007509:Irritants