Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (repealed) (c. 8)

ANNEX IIIA U.K. ADDITIONAL DATA SET FOR ACTIVE SUBSTANCESCHEMICAL SUBSTANCES

VI. TOXICOLOGICAL AND METABOLIC STUDIES U.K.

1. Neurotoxicity study U.K.

If the active substance is an organophosphorus compound or if there are any other indications that the active substance may have neurotoxic properties then neurotoxicity studies will be required. The test species is the adult hen unless another test species is justified to be more appropriate. If appropriate, delayed neurotoxicity tests will be required. If anticholine esterase activity is detected a test for response to reactivating agents should be considered

2. Toxic effects on livestock and pets U.K.

3. Studies related to the exposure of the active substance to humans U.K.

4. Food and feedingstuffs U.K.

If the active substance is to be used in preparations for use where food for human consumption is prepared, consumed or stored, or where feedingstuff for livestock is prepared, consumed or stored the tests referred to in Section XI, part 1 shall be required

5. If any other tests related to the exposure of the active substance to humans, in its proposed biocidal products, are considered necessary, then the test(s) referred to in Section XI, part 2 shall be required U.K.

6. If the active substance is to be used in products for action against plants then tests to assess toxic effects of metabolites from treated plants, if any, where different from those identified in animals shall be required U.K.

7. Mechanistic study — any studies necessary to clarify effects reported in toxicity studies U.K.