Mirtazapine Solid Formulation

Hazard statements (CLP)

H361fd, H373, H412

Code

Statements

H361fd

Suspected of damaging fertility; 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

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child. H373 May cause damage to organs through prolonged or repeated exposure. H412 Harmful to aquatic life with long lasting effects.

Prevention

P201 Obtain special instructions before use. P260 Do not breathe dust. P273 Avoid release to the environment. P280 Wear protective gloves/ protective clothing/ eye protection/ face protection.

Response

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

Storage

P405 Store locked up.

Hazardous Ingredients

(+/-)-1,2,3,4,10,14b-Hexahydro-2-methylpyrazino[2,1-a]pyrido[2,3-c][2]benzazepine

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. 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) as amended by GB-CLP Regulation, UK SI 2019/720, and UK SI 2020/1567) Reproductive toxicity, Category 2 H361fd: Suspected of damaging fertility. 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. Long-term (chronic) aquatic hazard, Cat- H412: Harmful to aquatic life with long lasting ef- egory 3 fects.