Division 5.9.2 Direct observation, e.g. clinical cases and poisoning incidentsF1

Available reports from the open literature, relating to clinical cases and poisoning incidents, where they are from refereed journals or official reports, must be submitted together with reports of any follow-up studies undertaken. Such reports shall contain complete descriptions of the nature, level and duration of exposure, as well as the clinical symptoms observed, first aid and therapeutic measures applied and measurements and observations made. Summary and abstract information is not of value.

Where supported with the necessary level of detail, such documentation can be of particular value in confirming the validity of extrapolations from animal data to man and in identifying unexpected adverse effects which are specific to humans.