Embutramide / Mebezonium / Tetracaine Formulation

Hazard statements (CLP)

H302, H302+H312+H332, H312, H319, H332, H336, H360D

Code

Statements

H302

Harmful if swallowed

SECTION 2: Hazards identification

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

Signal word

Danger

Hazard statements

H302 + H312 + H332 Harmful if swallowed, in contact with skin or if inhaled. H319 Causes serious eye irritation. H336 May cause drowsiness or dizziness. H360D May damage the unborn child.

Prevention

P201 Obtain special instructions before use. P280 Wear protective gloves/ protective clothing/ eye protec- tion/ face protection.

Response

P302 + P352 + P312 IF ON SKIN: Wash with plenty of wa- ter. Call a POISON CENTER/ doctor if you feel unwell. P304 + P340 + P312 IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER/ doctor if you feel unwell. P308 + P313 IF exposed or concerned: Get medical advice/ attention. P337 + P313 If eye irritation persists: Get medical advice/ attention.

Hazardous Ingredients

N,N-Dimethylformamide Embutramide Mebezonium iodide EUH208 Contains tetracaine hydrochloride. May produce an allergic reaction. Restricted to professional users.

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. Vapours may form explosive mixture with air.

2.1 Classification of the substance or mixture

Classification (REGULATION (EC) No 1272/2008) Acute toxicity, Category 4 H302: Harmful if swallowed. Acute toxicity, Category 4 H332: Harmful if inhaled. Acute toxicity, Category 4 H312: Harmful in contact with skin. Eye irritation, Category 2 H319: Causes serious eye irritation. Reproductive toxicity, Category 1B H360D: May damage the unborn child. Specific target organ toxicity - single ex- H336: May cause drowsiness or dizziness. posure, Category 3