ALVEOGYL

SEPTODONT

Revision date : 2023-06-05

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GHS07
Health risk rating 4
Safety risk rating 1
Environmental risk rating 3

Note: Ingredients listed on restricted chemical lists

EC/CAS

202-589-1/97-53-0

Name of the chemical

eugenol

Concentration

10-25%

EC/CAS

229-352-5/6485-40-1

Name of the chemical

2-methyl-5-(prop-1-en-2-yl)cyclohex-2-en-1-one;(5R)-2-Methyl-5-prop-1-en-2-ylcyclohex-2-en-1-one;(5S)-2-Methyl-5-prop-1-en-2-ylcyclohex-2-en-1-one (40)

Concentration

5-10%

EC/CAS

227-815-6/5989-54-8

Name of the chemical

(S)-p-mentha-1,8-diene; (l-limonene) (37)

Concentration

≤2.5%

General Information

Version

4 (replaces version 3

Revision date

2023-06-05

Product name

ALVEOGYL

1.2.1 Relevant identified uses

Medical device for dental use

1.2.2. Uses advised against

No further relevant information available

Emergency telephone

+33 (0)1 45 42 59 59, 00 353 1 8092568, 00 353 1 8379964, +32 070/245 245, 0845 4647, +41 44 251 51 51

Icons in SDS

GHS07 M004 M009

Company Information

company name

SEPTODONT

e-mail address of the competent person responsible for the Safety Data Sheet

msds@septodont.com

GHS Information

Signal word

Warning

Hazard Codes

Hazard statements (CLP)

H317, H319, H412

Hazard statements

Code

Statements

H317

May cause an allergic skin reaction

Section 2

SECTION 2: Hazards identification

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

Hazard pictograms

GHS07

Hazardous Ingredients

Eugenol l-carvone (S)-p-mentha-1,8-diene trans-p-Menthan-3-one

Hazard statements

H319 Causes serious eye irritation. H317 May cause an allergic skin reaction. H412 Harmful to aquatic life with long lasting effects.

Precautionary statements

P264 Wash thoroughly after handling. 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. P501 Dispose of contents/container in accordance with local/regional/national/international regulations.

2.3 Other hazards

The mixture shall not contain substances listed in accordance with Article 59(1) of UK REACH as having endocrine disrupting properties, or be recognised as having endocrine disrupting properties in accordance with the criteria set out in Commission Delegated Regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 in 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

· Classification according to Regulation (EC) No 1272/2008 : GHS07 Eye Irrit. 2 H319 Causes serious eye irritation. Skin Sens. 1 H317 May cause an allergic skin reaction. Aquatic Chronic 3 H412 Harmful to aquatic life with long lasting effects. · Additional information: This Regulation shall not apply to substances and mixtures in the following finished forms 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; (Contd. of page 1)

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