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Division Circumstances in which required

United Kingdom

Original text. Later amendments are not shown.

The study shall be carried out where the plant protection product:

  1. (a)

    is a gas or liquified gas;

  2. (b)

    is a smoke generating plant protection product or fumigant;

  3. (c)

    is used with fogging/misting equipment;

  4. (d)

    is a vapour releasing plant protection product;

  5. (e)

    is supplied in an aerosol dispenser;

  6. (f)

    is in a form of a powder or granules containing a significant proportion of particles of diameter < 50 μm (> 1 % on a weight basis);

  7. (g)

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

  8. (h)

    contains an active substance with a vapour pressure > 1 × 10–2 Pa and is to be used in enclosed spaces such as warehouses or glasshouses;

  9. (i)

    is to be applied by spraying.

A study shall not be required if the applicant can justify an alternative approach under Regulation (EC) No 1272/2008, where applicable. For this purpose, acute inhalation toxicity of all components shall be provided or reliably predicted with a validated method. Consideration shall be given to the possible effects of components on the toxic potential of the total mixture.

The head/nose only exposure shall be used, unless whole body exposure can be justified.