Fingolimod for system suitability

Hazard statements (CLP)

H302, H315, H361d, H373, H400, H410

Code

Statements

H302

Harmful if swallowed

SECTION 2: Hazards identification

Regulation (EC) No. 1272/2008 Classification of the substance or mixture Acute toxicity, (Category 4) H302: Harmful if swallowed Skin irritation, (Category 2) H315: Causes skin irritation Reproductive toxicity, (Category H361d: 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 Immune system 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

Signal word

Warning Warning

Hazard statements

H302 Harmful if swallowed. H315 Causes skin irritation. H361d Suspected of damaging the unborn child. H373 May cause damage to organs (Immune system) through prolonged or repeated exposure. H410 Very toxic to aquatic life with long lasting effects. Reduced Labeling (<= 125 ml) H361d 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. P301 + P312 IF SWALLOWED: Call a POISON CENTER/ doctor if you feel unwell. P302 + P352 IF ON SKIN: Wash with plenty of water. P308 + P313 IF exposed or concerned: Get medical advice/ attention. P202 Do not handle until all safety precautions have been read and understood. 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.

2.1 Classification of the substance or mixture

Acute toxicity, (Category 4) H302: Harmful if swallowed. Skin irritation, (Category 2) H315: Causes skin irritation. Reproductive toxicity, (Category H361d: Suspected of damaging the unborn 2) child. Specific target organ toxicity - H373: May cause damage to organs repeated exposure, (Category 2), through prolonged or repeated exposure. Immune system 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.