Ranitidine for impurity A identification

SECTION 2: Hazards identification

2.2 Label elements

Labelling

Signal word

Danger Danger

Hazard statements

H315 Causes skin irritation. H317 May cause an allergic skin reaction. H319 Causes serious eye irritation. H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled. H335 May cause respiratory irritation. Reduced Labeling (<= 125 ml) H334 May cause allergy or asthma symptoms or breathing difficulties if inhaled. H317 May cause an allergic skin reaction.

Precautionary statements

P261 Avoid breathing dust. P264 Wash skin thoroughly after handling. P271 Use only outdoors or in a well-ventilated area. P280 Wear protective gloves/ eye protection/ face protection. P302 + P352 IF ON SKIN: Wash with plenty of water. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P261 Avoid breathing dust. P302 + P352 IF ON SKIN: Wash with plenty of water.

Supplemental label elements

none none

2.3 Other hazards

This substance/mixture contains no components considered to be either persistent, bioaccumulative 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 regulation (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. SECTION 3: Composition/information on ingredients 3.1 Substances Formula C13H22N4O3S · HCl Molecular weight 350.9 g/mol CAS-No. 66357-59-3 EC-No. 266-333-0 Component

2.1 Classification of the substance or mixture

Concentration N-[2-[[5-[(Dimethylamino)methyl]furfuryl]thio]ethyl]-n'-methyl-2- nitrovinylidenediamine hydrochloride CAS-No. 66357-59-3 Skin Irrit. 2; Eye Irrit. 2; <= 100 % EC-No. 266-333-0 Resp. Sens. 1; Skin Sens. 1; STOT SE 3; H315, H319, H334, H317, H335 For the full text of the H-Statements mentioned in this Section, see Section 16.