Ezetimibe / Rosuvastatin Formulation

Hazard statements (CLP)

H316, H350, H360D, H360F, H360FD, H371, H373, H411

Code

Statements

H316

Causes mild skin irritation

SECTION 2: Hazards identification

Emergency Overview Appearance : powder Colour : white to off-white Odour : No data available Causes mild skin irritation. May cause cancer. May damage fertility. May damage the unborn child. May cause damage to organs. May cause damage to organs through prolonged or repeat- ed exposure. Toxic to aquatic life with long lasting effects. GHS Classification Skin corrosion/irritation Category 3 Carcinogenicity Category 1B Reproductive toxicity Category 1B Specific target organ toxicity - Category 2 single exposure Specific target organ toxicity - Category 2 repeated exposure Long-term (chronic) aquatic Category 2 hazard

Signal word

Danger

Hazard statements

H316 Causes mild skin irritation. H350 May cause cancer. H360FD May damage fertility. May damage the unborn child. H371 May cause damage to organs. H373 May cause damage to organs through prolonged or re- peated exposure. H411 Toxic to aquatic life with long lasting effects.

Prevention

P201 Obtain special instructions before use. P202 Do not handle until all safety precautions have been read and understood. P260 Do not breathe dust. P264 Wash skin thoroughly after handling. P270 Do not eat, drink or smoke when using this product. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protec- tion/ face protection.

Response

P308 + P311 IF exposed or concerned: Call a POISON CENTER/ doctor. P332 + P313 If skin irritation occurs: Get medical advice/ atten- tion. P391 Collect spillage.

Storage

P405 Store locked up.

Disposal

P501 Dispose of contents/ container to an approved waste disposal plant.

Other physicochemical hazards

Not classified based on available information.

Health hazards

Causes mild skin irritation. May cause cancer. May damage fertility. May damage the unborn child. May cause damage to organs. May cause damage to organs through prolonged or repeat- ed exposure.

Environmental hazards

Toxic to aquatic life with long lasting effects

Other hazards which do not result in classification

Dust contact with the eyes can lead to mechanical irritation. May form explosive dust-air mixture during processing, handling or other means.

2.1 Classification of the substance or mixture

Skin corrosion/irritation : Category 3 Carcinogenicity : Category 1B Reproductive toxicity : Category 1B Specific target organ toxicity - : Category 2 single exposure Specific target organ toxicity - : Category 2 repeated exposure Long-term (chronic) aquatic : Category 2 hazard