Letermovir Solid Formulation

Hazard statements (CLP)

H361d, H373

Code

Statements

H361d

Suspected of damaging the unborn child

SECTION 2: Hazards identification

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

Signal word

Warning

Hazard statements

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. P280 Wear protective gloves/ protective clothing/ eye protec- tion/ face protection.

Response

P308 + P313 IF exposed or concerned: Get medical advice/ attention.

Storage

P405 Store locked up.

Hazardous Ingredients

Letermovir

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. Dust contact with the eyes can lead to mechanical irritation. 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) Reproductive toxicity, Category 2 H361d: Suspected of damaging the unborn child. Specific target organ toxicity - repeated H373: May cause damage to organs through pro- exposure, Category 2 longed or repeated exposure.