Alendronate Solid Formulation

Hazard statements (CLP)

H315, H318, H335, H361d, H373

Code

Statements

H315

Causes skin irritation

SECTION 2: Hazards identification

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

Signal word

Danger

Hazard statements

H315 Causes skin irritation. H318 Causes serious eye damage. H335 May cause respiratory irritation. H361d Suspected of damaging the unborn child. H373 May cause damage to organs through prolonged or repeated exposure.

Prevention

P201 Obtain special instructions before use. P260 Do not breathe dust. P264 Wash skin thoroughly after handling. P280 Wear protective gloves/ protective clothing/ eye protection/ 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 present and easy to do. Continue rins- ing. Immediately call a POISON CENTER/ doctor.

Hazardous Ingredients

Alendronate

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. 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) Skin irritation, Category 2 H315: Causes skin irritation. 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 Specific target organ toxicity - repeated H373: May cause damage to organs through pro- exposure, Category 2 longed or repeated exposure.