Division II.6.4.1.2

Factors to be taken into account when considering the need for such data include:

1. (a)

   the structure of the substance and its similarity to substances with known toxicological effects;

2. (b)

   the class of the substance and known toxicological properties of other substances in the class;

3. (c)

   the mode of action of the substance;

4. (d)

   any effects seen in the standard toxicity studies that warrant further investigation (e.g. immunotoxicity, neurotoxicity or endocrine dysfunction);

5. (e)

   the existence of published literature highlighting relevant findings, including literature relating to effects seen in humans exposed to the substance.