Loratadine / Montelukast Formulation

Hazard statements (CLP)

H361f, H411

Code

Statements

H361f

Suspected of damaging fertility

SECTION 2: Hazards identification

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

Signal word

Warning

Hazard statements

H361f Suspected of damaging fertility. H411 Toxic to aquatic life with long lasting effects.

Prevention

P201 Obtain special instructions before use. 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. P391 Collect spillage.

Storage

P405 Store locked up.

Hazardous Ingredients

Loratadine

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 combustible dust concentrations in air during processing, handling or other means.

2.1 Classification of the substance or mixture

Classification (REGULATION (EC) No 1272/2008) Reproductive toxicity, Category 2 H361f: Suspected of damaging fertility. Long-term (chronic) aquatic hazard, Cat- H411: Toxic to aquatic life with long lasting effects. egory 2