Note: Ingredients listed on restricted chemical lists
EC/CAS
254-372-6/39236-46-9
Name of the chemical
N,N″-methylenebis[N′-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]
Concentration
>=10,0-<
General Information
Revision date
2023-06-30
Product name
F1L CDx GLOBAL IVDR KIT
Emergency telephone
+49(0)621-759-2203, +49(0)6131-19240
Icons in SDS
Company Information
company name
Roche Diagnostics Deutschland GmbH
e-mail address of the competent person responsible for the Safety Data Sheet
info.dia-sds@roche.com
GHS Information
Signal word
Warning
Hazard Codes
Hazard statements (CLP)
H317, H319, H373
Hazard statements
Code
Statements
H317
May cause an allergic skin reaction
Section 2
SECTION 2: Hazards identification
Regulation (EC) No. 1272/2008 Classification of the substance or mixture
Signal word
Warning
Hazard statements
H317 May cause an allergic skin reaction. H319 Causes serious eye irritation. H373 May cause damage to organs through prolonged or repeated exposure.
Prevention
P260 Do not breathe mist or vapours. P280 Wear protective gloves/ eye protection/ face protection.
Response
P314 Get medical advice/ attention if you feel unwell. P333 + P313 If skin irritation or rash occurs: Get medical advice/ attention. P337 + P313 If eye irritation persists: Get medical advice/ attention. P362 + P364 Take off contaminated clothing and wash it before reuse.
Hazardous Ingredients
65501-24-8 Tripotassium hydrogen ethylenediaminetetraacetate 39236-46-9 N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4- yl]urea]
Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumula- tive and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher
ECOLOGICAL INFORMATION
The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regu- lation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
TOXICOLOGICAL INFORMATION
The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
2.1 Classification of the substance or mixture
Classification (REGULATION (EC) No 1272/2008) Eye irritation, Category 2 H319: Causes serious eye irritation. Skin sensitisation, Category 1 H317: May cause an allergic skin reaction. Specific target organ toxicity - repeated H373: May cause damage to organs through pro- exposure, Category 2 longed or repeated exposure.
