Losartan / Hydrochlorothiazide Formulation

Hazard statements (CLP)

H317, H318, H360D, H362, H373

Code

Statements

H317

May cause an allergic skin reaction

SECTION 2: Hazards identification

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

Signal word

Danger

Hazard statements

H317 May cause an allergic skin reaction. H318 Causes serious eye damage. H360D May damage the unborn child. H362 May cause harm to breast-fed children. H373 May cause damage to organs through prolonged or repeated exposure.

Prevention

P201 Obtain special instructions before use. P260 Do not breathe dust. P263 Avoid contact during pregnancy and while nursing. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.

Response

P305 + P351 + P338 + P310 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rins- ing. Immediately call a POISON CENTER/ doctor. P308 + P313 IF exposed or concerned: Get medical advice/ attention.

Hazardous Ingredients

Losartan Hydrochlorothiazide

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) Serious eye damage, Category 1 H318: Causes serious eye damage. Skin sensitisation, Category 1 H317: May cause an allergic skin reaction. Reproductive toxicity, Category 1B H360D: May damage the unborn child. Effects on or via lactation H362: May cause harm to breast-fed children. Specific target organ toxicity - repeated H373: May cause damage to organs through pro- exposure, Category 2 longed or repeated exposure.