Council Directive of 15 July 1991 concerning the placing of plant protection products on the market (91/414/EEC) (repealed)

[F1 7.1. Basic acute toxicity studies U.K.

The studies, data and information to be provided and evaluated, must be sufficient to permit the identification of effects following a single exposure to the plant protection product, and in particular to establish, or indicate:

• the toxicity of the plant protection product,

• toxicity of the plant protection product relative to the micro-organism,

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

• where possible the mode of toxic action, and

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

While the emphasis must be on estimating the toxicity ranges involved, the information generated must also permit the plant protection product to be classified in accordance with Directive 78/631/EEC. The information generated through acute toxicity testing is of particular value in assessing hazards likely to arise in accident situations.

7.1.1. Acute oral toxicity U.K.

Circumstances in which required U.K.

An acute oral test should always be carried out unless the applicant can justify to the satisfaction of the competent authority that Article 3(2) of Directive 78/631/EEC can be invoked.

Test guideline U.K.

The test must be carried out in accordance with Method B.1 or B.1 bis of Commission Directive 92/69/EEC (1) .

7.1.2. Acute inhalation toxicity U.K.

Aim of the test U.K.

The test will provide the inhalation toxicity to rats of the plant protection product.

Circumstances in which required U.K.

The test must be carried out where the plant protection product:

• is used with fogging equipment,

• is an aerosol,

• is a powder containing a significant proportion of particles of diameter < 50 micrometre (> 1 % on a weight basis),

• is to be applied from aircraft in cases where inhalation exposure is relevant,

• is to be applied in a manner which generates a significant proportion of particles or droplets of diameter < 50 micrometre (> 1 % on a weight basis),

• contains a volatile component at greater than 10 %.

Test guideline U.K.

The test must be carried out in accordance with Method B.2 of Directive 92/69/EEC.

7.1.3. Acute percutaneous toxicity U.K.

Circumstances in which required U.K.

An acute percutaneous test should always be carried out unless the applicant can justify to the satisfaction of the competent authority that Article 3(2) of Directive 78/631/EEC can be invoked.

Test guideline U.K.

The test must be carried out in accordance with Method B.3 of Directive 92/69/EEC.]

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).

(1)

[F1 OJ L 383, 29.12.1992, p. 113 .]

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).