Commission Regulation (EU) No 544/2011 (repealed)Show full title

5.2. Acute toxicity

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 active substance, and in particular to establish, or indicate:

• the toxicity of the active substance,

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

• where possible 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 active substance to be classified in accordance with Regulation (EC) No 1272/2008. The information generated through acute toxicity testing is of particular value in assessing hazards likely to arise in accident situations.

5.2.1. Oral

Circumstances in which required

The acute oral toxicity of the active substance must always be reported.

Test guideline

The test must be carried out in accordance with the Annex to Regulation (EC) No 440/2008, Method B 1 bis or B 1 ter.

5.2.2. Percutaneous

Circumstances in which required

The acute percutaneous toxicity of the active substance must always be reported.

Test guideline

Both local and systemic effects must be investigated. The test must be carried out in accordance with the Annex to Regulation (EC) No 440/2008, method B 3.

5.2.3. Inhalation

Circumstances in which required

The inhalation toxicity of the active substance must be reported where the active substance is:

• a gas or liquified gas,

• is to be used as a fumigant,

• is to be included in a smoke generating, aerosol or vapour releasing preparation,

• is to be used with fogging equipment,

• has a vapour pressure > 1 × 10^–2 Pa and is to be included in preparations to be used in enclosed spaces such as warehouses or glasshouses,

• is to be included in preparations which are powders containing a significant proportion of particles of diameter < 50 μm (> 1 % on a weight basis), or

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

Test guideline

The test must be carried out in accordance with the Annex to Regulation (EC) No 440/2008, Method B 2.

5.2.4. Skin irritation

Aim of the test

The test will provide the potential of skin irritancy of the active substance including the potential reversibility of the effects observed.

Circumstances in which required

The skin irritancy of the active substance must be determined except where it is likely, as indicated in the test guideline, that severe skin effects may be produced or that effects can be excluded.

Test guideline

The acute skin irritation must be carried out in accordance with the Annex to Regulation (EC) No 440/2008, Method B 4.

5.2.5. Eye irritation

Aim of test

The test will provide the potential of eye irritancy of the active substance including the potential reversibility of the effects observed.

Circumstances in which required

Eye irritation tests must be conducted except where it is likely, as indicated in the test guideline, that severe effects on the eyes may be produced.

Test guidelines

The acute eye irritation must be determined in accordance with the Annex to Regulation (EC) No 440/2008, Method B 5.

5.2.6. Skin sensitisation

Aim of test

The test will provide sufficient information to assess the potential of the active substance to provoke skin sensitisation reactions.

Circumstances in which required

The test must always be carried out except where the substance is a known sensitiser.

Test guideline

The test must be carried out in accordance with the Annex to Regulation (EC) No 440/2008, Method B 6.