Regorafenib

Hazard statements (CLP)

H361fd, H373, H400, H410

Code

Statements

H361fd

Suspected of damaging fertility; Suspected of damaging the unborn child

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture

Reproductive toxicity, (Category H361fd: Suspected of damaging fertility. 2) Suspected of damaging the unborn child. Specific target organ toxicity - H373: May cause damage to organs repeated exposure, (Category 2), through prolonged or repeated exposure. Liver Short-term (acute) aquatic H400: Very toxic to aquatic life. hazard, (Category 1) Long-term (chronic) aquatic H410: Very toxic to aquatic life with long hazard, (Category 1) lasting effects.

2.2 Label elements

Labelling

Signal word

Warning Warning

Hazard statements

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child. H373 May cause damage to organs (Liver) through prolonged or repeated exposure. H410 Very toxic to aquatic life with long lasting effects. Reduced Labeling (<= 125 ml) H361fd Suspected of damaging fertility. Suspected of damaging the unborn child.

Precautionary statements

P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe dust. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection. P308 + P313 IF exposed or concerned: Get medical advice/ attention. P391 Collect spillage. P202 Do not handle until all safety precautions have been read and understood. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection. P308 + P313 IF exposed or concerned: Get medical advice/ attention.

Supplemental label elements

none none

2.3 Other hazards

This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher.

ECOLOGICAL INFORMATION

The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.

TOXICOLOGICAL INFORMATION

The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.