Prontosan Wound Irrigation Solution

B. Braun Melsungen AG

Revision date : 2020-05-27

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

Note: Ingredients listed on restricted chemical lists

EC/CAS

27083-27-8

Name of the chemical

Polyhexamethylene biguanide hydrochloride with a mean number-average molecular weight (Mn) of 1600 and a mean polydispersity (PDI) of 1.8

Concentration

0,1-<0,25% 616-207-

General Information

Revision date

2020-05-27

Product name

Prontosan Wound Irrigation Solution

CAS No.

27083-27-8

supplier name

B. Braun Melsungen AG

Manufacturer Name

B. Braun Medical AG

Emergency telephone

INTERNATIONAL: +49 - (0) 6132 - 84463, GBK GmbH (24h - 7d/w - 365d/a

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Company Information

company name

B. Braun Melsungen AG

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

info.bbmch@bbraun.com, logistics.service@bbraun.com

Hazard Codes

Hazard statements (CLP)

H412

Hazard statements

Code

Statements

H412

Harmful to aquatic life with long lasting effects

Section 2

2.1 Classification of the substance or mixture

Regulation (EC) No. 1272/2008

Hazard categories

Hazardous to the aquatic environment: Aquatic Chronic 3

Hazard statements

Harmful to aquatic life with long lasting effects. H412 Harmful to aquatic life with long lasting effects. H412

2.2 Label elements

Regulation (EC) No. 1272/2008

Precautionary statements

P273 Avoid release to the environment. P501 Dispose of contents/container to an approved waste disposal plant. .

Special rules for supplemental label elements for certain mixtures

EUH208

Contains

Polyhexamethylene biguanide hydrochloride. May produce an allergic reaction

Supplemental label elements

This product is not subject to labeling obligation according to art. 1 (5) d) of Regulation (EC) no. 1272/2008 under the form of a medical product because it is used under body contact. Labelling of packages where the contents do not exceed 125 ml

2.3 Other hazards

According to Regulation (EC) No 1907/2006 (REACH) none of the substances, contained in this product are a

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