Raltegravir Formulation

Hazard statements (CLP)

H318, H335, H361d

Code

Statements

H318

Causes serious eye damage

SECTION 2: Hazards identification

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

Signal word

Danger

Hazard statements

H318 Causes serious eye damage. H335 May cause respiratory irritation. H361d Suspected of damaging the unborn child.

Prevention

P201 Obtain special instructions before use. P261 Avoid breathing dust. P280 Wear protective gloves/ protective clothing/ eye protec- tion/ face protection.

Response

P304 + P340 + P312 IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER/ doctor if you feel unwell. P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if pre- sent and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor. P308 + P313 IF exposed or concerned: Get medical advice/ attention.

Hazardous Ingredients

Raltegravir

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) Serious eye damage, Category 1 H318: Causes serious eye damage. Reproductive toxicity, Category 2 H361d: Suspected of damaging the unborn child. Specific target organ toxicity - single ex- H335: May cause respiratory irritation. posure, Category 3