Division 13.4 Toxicity and other safety testing (including safety evaluation of products and devices for human medicine and dentistry and veterinary medicine)

This covers studies carried out on any product or substance to determine its potential to cause any dangerous or undesirable effects in humans or animals as a result of its intended or abnormal use, manufacture or as a potential or actual contaminant in the environment.

Where studies involve both mother and offspring, the mother shall be reported if she has been subject to a procedure above the threshold of minimum pain, suffering, distress and lasting harm. Offspring shall be reported if they are an integral part of the procedure such as in the case of end-points for reproduction.