Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Column 2 of Annex VIII criteria for skin irritation testing of styrene provide the following adaptations to required testing data:

The study does not need to be conducted if:

·                   the substance is classified as corrosive to the skin or as a skin irritant, or

·                   the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or

·                   the substance is flammable in air at room temperature, or

·                   the substance is classified as very toxic in contact with skin, 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).

Column 2 criteria of Annex VIII for eye irritation testing of styrene provide the following adaptations to required testing data:

The study does not need to be conducted if:

·                   the substance is classified as irritating to eyes with risk of serious damage to eyes, or

·                   the substance is classified as corrosive to the skin and provided that the registrant classified the substance as eye irritant, or

·                   the substance is a strong acid (pH ≤ 2,0) or base (pH ≥ 11,5), or

·                   the substance is flammable in air at room temperature.

Styrene is a flammable (R10/ Flam. Liq. 3) liquid substance.

Styrene has harmonized at EU level classifications and it is classified as Xi; R36/38 – Irritating to eyes and skin, in accordance with Directive 67/548/EEC, and Skin and Eye Irritant, Hazard Category 2, H315: Causes skin irritation and H319: Causes serious eye irritation, in accordance with the GHS criteria of Regulation (EC) No 1272/2008. Therefore, no further testing for skin and eye irritation properties is required for styrene.

Because of the data on respiratory irritation effects in animal studies and in humans, styrene iss elf-classified as STOT Single Exposure Category 3 substance; H335: May cause respiratory irritation.

From the data available for styrene, it is likely that liquid styrene or high concentrations of styrene vapour in the air may cause irritation of skin, eye or respiratory tract. Moreover, accidental skin and/or eye contact with liquid styrene may take place. However, this scenario could be relevant for occupational settings.

In general, appropriate engineering controls and work practices to reduce employee exposure to the lowest level achievable must be in place with additional suitable skin, eye, face and respiratory protection in work areas and operations with high risks of exposure to styrene.

Justification for classification or non-classification