Note: Ingredients listed on restricted chemical lists
EC/CAS
426-020-3
Name of the chemical
cis-1-(3-Chlorallyl)-3,5,7-triaza-1-azoniaadamantanchlorid (790/2009)
Concentration
N/A
General Information
Revision date
2015-03-16
Product name
Coloplast Prep
CAS No.
67-63-0
1.2.1 Relevant identified uses
Medical devices Telephone: +45 49 11 11 11
Manufacturer Name
Coloplast A/S
Emergency telephone
(DK) +45 82 12 12 12
Icons in SDS
Company Information
company name
Coloplast A/S
e-mail address of the competent person responsible for the Safety Data Sheet
msds@coloplast.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H302, H315, H317, H319, H336, H361d, H411
Hazard statements
Code
Statements
H302
Harmful if swallowed
Section 2
SECTION 2: Hazards identification
1272/2008 This product is regulated as a medical device in the European Economic Area (EEA). In other regions it may be regulated as a medical device, a cosmetic or not regulated. The product is assessed and supplied with a safety data sheet in accordance with Regulation (EC) no 1272/2008. Labelling of the product is prepared in accordance with Directive 93/42/EEC on medical de- vices and local legislation. Coloplast Prep
EU Classification
Regulation (EC) No 1272/2008: Acute tox. 4;H302 Skin irrit. 2;H315 Skin Sens. 1; H317 Eye Irrit. 2; H319 STOT SE 3; H336 Repr. 2; H361d Aquatic Chronic 2; H411 Wording of H-statements – see section 16. Most serious harmful effects: The product is a medical device and therefore not covered by the classification and labelling rules that apply to chemical products. Highly flammable. Harmful by inhalation, in contact with skin and if swallowed. Irritating to eyes. Irritating to skin. May cause sensisation by skin contact. Toxic to aquatic organisms, may cause long- term adverse effects in the aquatic environment. Possible risk of harm to the unborn child. Va- pours may cause drowsiness and dizziness.
2.2 Label elements
The product is a medical device in EAA and therefore the labelling elements from the CLP regulations do not apply, according to Regulation (EC) No 1272/2008, Title I, Article 1, Section 5.
Hazard statements
H302: Harmful if swallowed. H315: Cause skin irritation. H317: May cause an allergic skin reaction. H319: Causes serious eye irritation. H336: May cause drowsiness or dizziness. H361d: Suspected of damaging the unborn child. H411: Toxic to aquatic life with long lasting effects.
Precautionary statements
P280-h: Wear protective gloves.
2.3 Other hazards
Assessment to determine PBT and vPvB has not been made. Coloplast Prep
