Abstract
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.
Published Version
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