Note: Ingredients listed on restricted chemical lists
EC/CAS
278-928-2/78491-02-8
Name of the chemical
1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea; Diazolidinylurea
Concentration
<1 928-2
General Information
Revision date
2015-02-25
Product name
Sea-Clens
CAS No.
78491-02-8
1.2.1 Relevant identified uses
Medical device
Manufacturer Name
Coloplast A/S
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
-
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.
EU Classification
Regulation (EC) No 1272/2008: The product shall not be classified as hazardous ac- cording to EU classification and labelling rules. Wording of H-statements – see section 16. Most serious harmful effects: May cause slight irritation to the skin and eyes. Persons with a known allergy to 1-[1,3-bis(hy- droxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hy- droxymethyl) urea (DIAZOLIDINYL UREA) may ex- hibit an allergic response to the product.
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. The product shall not be classified as hazardous according to EU classifica- tion and labelling rules.
Contains
1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hy- droxymethyl) urea (DIAZOLIDINYL UREA). May produce an allergic reaction. Safety data sheet available on request. According to Regulation (EC) No 1272/2008: 1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl) urea (DIAZOLIDINYL UREA). May produce an allergic reaction. Safety data sheet available on request.
2.3 Other hazards
Assessment to determine PBT and vPvB has not been made.
