Division Aim of the testF1

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

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

• identify target organs, where relevant,

• establish the dose-response relationship,

• identify changes in toxic signs and manifestations observed, and

• establish the Noael.

Similarly, the carcinogenicity studies taken together with other relevant data and information on the active substance, must be sufficient to permit the hazards for humans, following repeated exposure to the active substance, to be assessed, and in particular must be sufficient:

• to identify carcinogenic effects resulting from exposure to the active substance,

• to establish the species and organ specificity of tumours induced,

• to establish the dose-response relationship, and

• for non-genotoxic carcinogens, to identify the maximum dose eliciting no adverse effect (threshold dose).