BIODENTINE LIQUID aero+bak

Hazard statements (CLP)

H319

Code

Statements

H319

Causes serious eye irritation

SECTION 2: Hazards identification

NFPA Rating Classification of the substance or mixture GHS07 Eye Irritation 2A H319 Causes serious eye irritation Additional information This Regulation shall not apply to substances and mixtures in the following forms, in their finished state, intended for the end user medicinal products, as defined in Directive 2001/83/EC medical devices, as defined in Directives 90/385/EEC and 93/42/EEC, which are invasive or used in direct physical contact with the human body, and in Directive 98/79/EC;

2.2 Label elements

The product is classified and labeled according to the Globally Harmonized System (GHS).

Hazard pictograms

GHS07

Signal word

(Contd. of page 1)

Hazard statements

H319 Causes serious eye irritation.

Precautionary statements

P264 Wash thoroughly after handling. P280 Wear eye protection / face protection. P305+P351+P338 If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P337+P313 If eye irritation persists: Get medical advice/attention.

Classification system

· NFPA ratings (scale 0 - 4) Health = 2 0 Fire = 0 2 0 Reactivity = 0 · HMIS-ratings (scale 0 - 4) HEALTH 2 Health = 2 FIRE 0 Fire = 0 REACTIVITY 0 Reactivity = 0

2.3 Other hazards

The mixture does not contain substances listed in accordance with Article 59(1) of REACH as having endocrine disrupting properties, or is not known to have endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at a concentration equal to or greater than 0.1% .

PBT Substances

Not applicable

vPvB Substances

Not applicable

2.1 Classification of the substance or mixture

GHS07 Eye Irritation 2A H319 Causes serious eye irritation. · Additional information: This Regulation shall not apply to substances and mixtures in the following forms, in their finished state, intended for the end user (a) medicinal products, as defined in Directive 2001/83/EC (b) medical devices, as defined in Directives 90/385/EEC and 93/42/EEC, which are invasive or used in direct physical contact with the human body, and in Directive 98/79/EC;