RelyX Unicem 2 Automix Catalyst

Solventum International Ireland Limited

Revision date : 2026-02-18

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GHS07 GHS09
Health risk rating 4
Safety risk rating 1
Environmental risk rating 4

Note: Ingredients listed on restricted chemical lists

EC/CAS

215-137-3/1305-62-0

Name of the chemical

Calcium dihydroxide

Concentration

< 2

EC/CAS

236-675-5

Name of the chemical

Titandioxid; [in Pulverform mit mindestens 1 % Partikel mit aerodynamischem Durchmesser ≤ 10 μm] (2020/217)

Concentration

<2 71-1

General Information

Version

2.00

Revision date

2026-02-18

Product name

RelyX Unicem 2 Automix Catalyst

1.2.1 Relevant identified uses

Medical device; refer to Instructions for Use

1.2.2. Uses advised against

For use only by dental professionals

Emergency telephone

1-800-424-9300, 1-703-527-3887

Icons in SDS

GHS07 GHS09 M004

Company Information

company name

Solventum International Ireland Limited

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

psops_supportteam@solventum.com

GHS Information

Signal word

WARNING

Hazard Codes

Hazard statements (CLP)

H317, H319, H400, H411

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

Signal word

WARNING.

Hazard pictograms

GHS07 (Exclamation mark) |GHS09 (Environment) | Ingredients: Ingredient CAS Nbr EC No. % by Wt Aliphatic dimethacrylate 72829-09-5 276-900-4 < 5 Methacrylated amine 93962-71-1 300-709-8 < 2

Hazard statements

H319 Causes serious eye irritation. H317 May cause an allergic skin reaction. H400 Very toxic to aquatic life. H411 Toxic to aquatic life with long lasting effects.

Prevention

P273 Avoid release to the environment. P280E Wear protective gloves.

Response

P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P333 + P313 If skin irritation or rash occurs: Get medical advice/attention. P391 Collect spillage.

2.3 Other hazards

For information on hazards and safe use, please consider the corresponding sections of this document. This material does not contain any substances that are assessed to be a PBT or vPvB

2.1 Classification of the substance or mixture

CLP REGULATION (EC) No 1272/2008 The health and environmental classifications of this material have been derived using the calculation method, except in cases where test data are available or the physical form impacts classification. Classification(s) based on test data or physical form are noted below, if applicable. This product is a medical device as defined in Directive 93/42/EEC (MDD) respectively Regulation (EU) 2017/745 (MDR), which is invasive or used in direct physical contact with the human body, and therefore is exempt from the requirements of classification and labelling according to Regulation (EC) No. 1272/2008 (CLP; Article 1, paragraph 5). Although not required, the classification and label information, as applicable, is provided below. CLASSIFICATION: Serious Eye Damage/Eye Irritation, Category 2 - Eye Irrit. 2; H319 Skin Sensitization, Category 1 - Skin Sens. 1; H317 Hazardous to the Aquatic Environment (Acute), Category 1 - Aquatic Acute 1; H400 Hazardous to the Aquatic Environment (Chronic), Category 2 - Aquatic Chronic 2; H411 For full text of H phrases, see Section 16. 2.2. Label elements CLP REGULATION (EC) No 1272/2008 SIGNAL WORD WARNING. Symbols GHS07 (Exclamation mark) |GHS09 (Environment) | Pictograms Ingredients: Ingredient CAS Nbr EC No. % by Wt Aliphatic dimethacrylate 72829-09-5 276-900-4 < 5 Methacrylated amine 93962-71-1 300-709-8 < 2 HAZARD STATEMENTS: H319 Causes serious eye irritation. H317 May cause an allergic skin reaction. H400 Very toxic to aquatic life. H411 Toxic to aquatic life with long lasting effects. PRECAUTIONARY STATEMENTS Prevention: P273 Avoid release to the environment. P280E Wear protective gloves. Response: P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P333 + P313 If skin irritation or rash occurs: Get medical advice/attention. P391 Collect spillage. 2.3. Other hazards For information on hazards and safe use, please consider the corresponding sections of this document.

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