Imipenem / Cilastatin Formulation

Hazard statements (CLP)

H319, H334, H361d, H400, H410

Code

Statements

H319

Causes serious eye irritation

SECTION 2: Hazards identification

Regulation (EC) No. 1272/2008 Classification of the substance or mixture

Signal word

Danger

Hazard statements

H319 Causes serious eye irritation. H334 May cause allergy or asthma symptoms or breath- ing difficulties if inhaled. H361d Suspected of damaging the unborn child. H410 Very toxic to aquatic life with long lasting effects.

Prevention

P261 Avoid breathing dust. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.

Response

P304 + P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing. P342 + P311 If experiencing respiratory symptoms: Call a POISON CENTER/ doctor. P391 Collect spillage.

Hazardous Ingredients

Imipenem

2.3 Other hazards

This substance/mixture contains no components considered to be either persistent, bioaccumula- tive 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 regu- lation (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. Contact with dust can cause mechanical irritation or drying of the skin. May form explosive dust-air mixture during processing, handling or other means.

2.1 Classification of the substance or mixture

Classification (REGULATION (EC) No 1272/2008) Eye irritation, Category 2 H319: Causes serious eye irritation. Respiratory sensitisation, Category 1 H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled. Reproductive toxicity, Category 2 H361d: Suspected of damaging the unborn child. Short-term (acute) aquatic hazard, Cate- H400: Very toxic to aquatic life. gory 1 Long-term (chronic) aquatic hazard, Cat- H410: Very toxic to aquatic life with long lasting egory 1 effects.