Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

[F1 Aim of the test U.K.

Short-term toxicity studies must be designed to provide information as to the amount of the micro-organism that can be tolerated without toxic effects under the conditions of the study. Such studies provide useful data on the risks for those handling and using preparations containing the micro-organism. In particular, short-term studies provide an essential insight into possible cumulative actions of the micro-organism, and the risks to workers who may be intensively exposed. In addition short-term studies provide information useful in the design of chronic toxicity studies.

The studies, data and information to be provided and evaluated, must be sufficient to permit the identification of effects following repeated exposure to the micro-organism, and in particular to further establish, or indicate:

• the relationship between dose and adverse effects,

• toxicity of the micro-organism including where necessary the NOAEL for toxins,

• target organs, where relevant,

• the time course and characteristics of the effects with full details of behavioural changes and possible gross pathological findings at post-mortem,

• specific toxic effects and pathological changes produced,

• where relevant the persistence and reversibility of certain toxic effects observed, following discontinuation of dosing,

• where possible, the mode of toxic action, and

• the relative hazard associated with the different routes of exposure.

During the short-term toxicity study, an estimation of the micro-organism clearance in the main organs must be performed.

Investigations should be included for pathogenicity and infectiveness end points.]

Textual Amendments

F1 Substituted by Commission Directive 2001/36/EC of 16 May 2001 amending Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance).