Protemp 4 Catalyst Paste

Solventum International Ireland Limited

Revision date : 2025-11-19

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

General Information

Version

2.00

Revision date

2025-11-19

Product name

Protemp 4 Catalyst Paste

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

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

Hazard Codes

Hazard statements (CLP)

H412

Hazard statements

Code

Statements

H412

Harmful to aquatic life with long lasting effects

Section 2

SECTION 2: Hazards identification

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

Hazard statements

H412 Harmful to aquatic life with long lasting effects.

Supplemental label elements

EUH208

Contains

Perester. May produce an allergic reaction

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: Hazardous to the Aquatic Environment (Chronic), Category 3 - Aquatic Chronic 3; H412 For full text of H phrases, see Section 16. 2.2. Label elements CLP REGULATION (EC) No 1272/2008 HAZARD STATEMENTS: H412 Harmful to aquatic life with long lasting effects. SUPPLEMENTAL INFORMATION: Supplemental Hazard Statements: EUH208 Contains Perester. May produce an allergic reaction. 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 SECTION 3: Composition/information on ingredients 3.1. Substances Not applicable 3.2. Mixtures Ingredient Identifier(s) % Classification according to Regulation (EC) No. 1272/2008 [CLP] Diacetate (CAS-No.) 19224- 70 - Substance not classified as hazardous 29-4 80 (EC-No.) 242-895-2 Barbituric acid derivative (CAS-No.) 72846- 5 - 15 Acute Tox. 4, H302 00-5 Eye Irrit. 2, H319 (EC-No.) 276-940-2 Silane treated silica (CAS-No.) 68909- 5 - 15 EUH066 20-6 STOT RE 2, H373 (EC-No.) 272-697-1 Perester (CAS-No.) 13122- < 0.4 Org. Perox. CD, H242 18-4 Skin Sens. 1B, H317 (EC-No.) 236-050-7 Aquatic Acute 1, H400,M=1 Aquatic Chronic 3, H412 Please see section 16 for the full text of any H statements referred to in this section For information on ingredient occupational exposure limits or PBT or vPvB status, see sections 8 and 12 of this SIS SECTION 4: First aid measures 4.1. Description of first aid measures

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