Division 5.9.3 Direct observations

Available reports from the open literature, relating to clinical cases and poisoning incidents, where they are from refereed journals or official reports, shall be submitted together with reports of any follow-up studies undertaken. Such reports shall, where available, 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.

Where supported with the necessary level of detail, such documentation shall be used to confirm the validity of extrapolations from animal data to man and to identify unexpected adverse effects which are specific to humans.