Division 8 TOXICOLOGICAL INFORMATIONX1

Skin corrosion/irritation

• the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as skin corrosion (Category 1), or

• the substance is spontaneously flammable in air or in contact with water or moisture at room temperature, or

• the substance is classified as acute toxicity by the dermal route (Category 1), or

• an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level ( 2 000 mg/kg body weight).

If results from one of the two studies under point 8.1.1 or 8.1.2 already allow a conclusive decision on the classification of a substance or on the absence of skin irritation potential, the second study need not be conducted.

Skin corrosion, in vitro

Skin irritation, in vitro

Serious eye damage/eye irritation

• the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1), or

• the substance is classified as skin irritation and the available information indicates that it should be classified as eye irritation (Category 2), or

• the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5) and the available information indicates that it should be classified as serious eye damage (Category 1), or

• the substance is spontaneously flammable in air or in contact with water or moisture at room temperature.

Serious eye damage/eye irritation, in vitro

If results from a first in vitro study do not allow a conclusive decision on the classification of a substance or on the absence of eye irritation potential, (an)other in vitro study/ies) for this endpoint shall be considered.

Information allowing:

• a conclusion whether the substance is a skin sensitiser and whether it can be presumed to have the potential to produce significant sensitisation in humans (Cat. 1A), and

• risk assessment, where required.

Information from in vitro/in chemico test method(s) recognised according to Article 13(3), addressing each of the following key events of skin sensitisation:

1. (a)

   molecular interaction with skin proteins;

2. (b)

   inflammatory response in keratinocytes;

3. (c)

   activation of dendritic cells.

Mutagenicity

Further mutagenicity studies shall be considered in case of a positive result.

In vitro gene mutation study in bacteria

The study does not need to be conducted for nanoforms where it is not appropriate. In this case other studies involving one or more in vitro mutagenicity study(ies) in mammalian cells (Annex VIII, sections 8.4.2. and 8.4.3 or other internationally recognised in vitro methods) shall be provided.

Acute toxicity

• the substance is classified as corrosive to the skin.

By oral route

a study on acute toxicity by the inhalation route (8.5.2) is available.

For nanoforms, a study by the oral route shall be replaced by a study by the inhalation route (8.5.2), unless exposure of humans via inhalation is unlikely, taking into account the possibility of exposure to aerosols, particles or droplets of an inhalable size.