Note: Ingredients listed on restricted chemical lists
EC/CAS
27083-27-8
Name of the chemical
Poly(hexamethylenebicyanoguanide-hexamethylenediamine) Hydrochloride
Concentration
0,1-<0
General Information
Version
2.1
Revision date
2023-01-24
Product name
ProntOral Mouth Rinse
1.2.1 Relevant identified uses
For oral cavity and pharynx decolonization including MDRO by physical cleansing [MDRO: Multi-Drug-Resistant-Organisms]
supplier name
B. Braun Medical AG
Manufacturer Name
B. Braun Medical AG
Emergency telephone
+49 - (0) 6132 - 84463
Icons in SDS
Company Information
company name
B. Braun Medical AG
e-mail address of the competent person responsible for the Safety Data Sheet
info.bbmch@bbraun.com, logistics.service@bbraun.com
GHS Information
Signal word
-
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
No. 1272/2008 Classification of the substance or mixture
Adverse physicochemical, human health and environmental effects
Harmful to aquatic life with long lasting effects
Signal word
-
Hazard statements
H412 - Harmful to aquatic life with long lasting effects. H412 - Harmful to aquatic life with long lasting effects.
Precautionary statements
P273 - Avoid release to the environment. P501 - Dispose of contents and container to an approved waste disposal plant.
Supplemental label elements
EUH208 - Contains polyhexamethylene biguanide hydrochloride; PHMB. May produce an allergic reaction. EUH208 - Contains polyhexamethylene biguanide hydrochloride; PHMB. May produce an allergic reaction.
Additional information
This product is not subject to labeling obligation according to art. 1 (5) d) of Regulation (EC) This product is not subject to labeling obligation according to art. 1 (5) d) of Regulation (EC)
2.3 Other hazards
This substance/mixture does not meet the PBT criteria of REACH regulation, annex XIII This substance/mixture does not meet the vPvB criteria of REACH regulation, annex XIII Contains no PBT/vPvB substances ≥ 0.1% assessed in accordance with REACH Annex XIII The substance is not included in the list established in accordance with Article 59(1) of REACH for having endocrine disrupting properties, or is not identified 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
2.1 Classification of the substance or mixture
Classification according to Regulation (EC) No. 1272/2008 [CLP] Hazardous to the aquatic environment – Chronic Hazard, Category 3 H412 Full text of H- and EUH-statements: see section 16 Adverse physicochemical, human health and environmental effects Harmful to aquatic life with long lasting effects.
