File: SDB_E-107_Cdiff-GDH_EN_v01.docx

Seramun Diagnostica GmbH

Revision date : 2019-03-26

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GHS05 GHS07 GHS08
Health risk rating 5
Safety risk rating 5
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

7664-93-9

Name of the chemical

sulphuric acid

Concentration

N/A

EC/CAS

212-828-1

Name of the chemical

N-Methyl-2-pyrrolidon (2016/1179)

Concentration

N/A

General Information

Revision date

2019-03-26

Product name

File: SDB_E-107_Cdiff-GDH_EN_v01.docx

1.2.1 Relevant identified uses

Reserved for industrial and professional use

Icons in SDS

Company Information

company name

Seramun Diagnostica GmbH

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

info@seramun.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H290, H319, H360D

Hazard statements

Code

Statements

H290

May be corrosive to metals

Section 2

2.1 Classification of the substance or mixture

Classification in accordance with Regulation (EG) No 1272/2008 [CLP], as amended by Commission Regulation (EU) 2018/1480 Part of the Test Kit

Hazard statements

HRP-conjugate Reproductive toxicity Category 1B (Repr. 1B) H360D Substrate Serious eye damage/irritation Category 2 (Eye Irrit. 2) H319 Stop solution Corrosive to metals Category 1 (Met. Corr. 1) H290 H360D May damage the unborn child. H319 Causes serious eye irritation. H290 May be corrosive to metals.

2.2 Label elements

INFORMATION: According to EU Regulation (EC) 1272/2008, Article 1 (5) d), in vitro diagnostic medical devices (IVD) within the meaning of Directive 98/79/EC are exempt from the labelling requirement. Labels according European regulation (EC) 1272/2008 [CLP], as amended by Commission Regulation (EU) 2018/1480: HRP-Conjugate:

Signal word

Danger Warning Danger

Precautionary statements

P201 Obtain special instructions before use. P280 Wear protective gloves/protective clothing/eye protection/face protection. P501 Dispose of contents/container in accordance with the applicable local regulations and laws. P308 + P313 If exposed: Call a doctor. Substrate: P264 Wash hands thoroughly after handling. P280 Wear protective gloves/protective clothing/eye protection/face protection. P337 + P313 IF eye irritation persists: Get medical advice/attention. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses if present and easy to do – continue rinsing. Stop Solution: P234 Keep only in original container. P390 Absorb spillage to prevent material damage. Safety data sheet available for industrial and professional users on request.

2.3 Other hazards

None of the components is listed as PBT or vPvB relevant.

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