Division 5.5 Long-term toxicity and carcinogenicity

The results of the long-term studies conducted and reported, taken together with other relevant data and information on the active substance, shall be sufficient to permit the identification of effects, following repeated exposure to the active substance, and in particular shall be sufficient to:

• identify adverse effects resulting from long-term exposure to the active substance,

• identify target organs, where relevant,

• establish the dose-response relationship,

• establish the NOAEL and, if necessary, other appropriate reference points.

Correspondingly, the results of the carcinogenicity studies taken together with other relevant data and information on the active substance, shall be sufficient to permit the evaluation of hazards for humans, following repeated exposure to the active substance, and in particular shall be sufficient:

1. (a)

   to identify carcinogenic effects resulting from long-term exposure to the active substance;

2. (b)

   to establish the species, sex, and organ specificity of tumours induced;

3. (c)

   to establish the dose-response relationship;

4. (d)

   where possible, to identify the maximum dose eliciting no carcinogenic effect;

5. (e)

   where possible, to determine the mode of action and human relevance of any identified carcinogenic response.