Note: Ingredients listed on restricted chemical lists
EC/CAS
247-500-7/26172-55-4
Name of the chemical
5-chloro-2-methyl-4-thiazoline-3-ketone
Concentration
≥0.00055
EC/CAS
220-239-6/2682-20-4
Name of the chemical
2-Methyl-2H-isothiazol-3-one
Concentration
≥0.00015
EC/CAS
217-699-5/1934-21-0
Name of the chemical
Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate and aluminium lake (17); (CI 19140)
Concentration
N/A
EC/CAS
231-639-5/7664-93-9
Name of the chemical
sulphuric acid
Concentration
N/A
General Information
Revision date
2024-03-11
Product name
M65 ELISA
1.2.1 Relevant identified uses
OF THE The ELISA kits are medical devices and are not covered by the CLP- SUBSTANCE OR MIXTURE AND regulation; EU 1272/2008 (Classification & Labelling of Chemical Products)
1.2.2. Uses advised against
However, relevant information of the products is provided in this safety data sheet
supplier name
VLVbio AB
Emergency telephone
(01) 809 2166
Icons in SDS
Company Information
company name
VLVbio AB
e-mail address of the competent person responsible for the Safety Data Sheet
info@vlvbio.com, info@vlvbio.com
GHS Information
Signal word
WARNING
Hazard Codes
Hazard statements (CLP)
H319
Hazard statements
Code
Statements
H319
Causes serious eye irritation
Section 2
SECTION 2: Hazards identification
1272/2008 CLASSIFICATION OF THE SUBSTANCE OR MIXTURE
Environmental hazards
None of the components in M65 ELISA kit are classified as hazardous to the environment
Physical hazards
None of the components in M65 ELISA kit are classified for physical hazards 2.2 LABEL ELEMENTS (only applies to the component 6 - Stop solution)
Signal word
WARNING
Contains
Sulphuric acid
Hazard statements
H315 Causes skin irritation. H319 Causes serious eye irritation.
Precautionary statements
P280 Wear protective gloves/eye protection. P302+P352 IF ON SKIN: Wash with plenty of water. P305 +P351 + IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy P338 to do. Continue rinsing. Other labelling EUH208 - Contains Methyl-4-isothiazolin-3-one. May produce an allergic reaction. The labelling is recommended on the following kits: M65 HRP Conjugate, M65 Conjugate Dilution Buffer, Standard A-H and M65 Control Low and M65 Control High. Other regulations -
Further information
The product does not contain any SVHC-substances (= Substance of Very High Concern) ≥ 0,1% from the candidate list of EU. The components do not contain any substances which fulfills the criteria for PBT and vPvB according to annex XIII to
2.3 Other hazards
No other hazards are related to the product. M65®ELISA
2.1 Classification of the substance or mixture
Health hazards: The component 6 (Stop solution) is classified as hazardous to health according to Regulation (EC) No 1272/2008. Causes skin irritation (Skin Irrit. 2; H315). Causes serious eye irritation (Eye Irrit. 2; H319). The components 1-5 (M65 HRP Conjugate, M65 Conjugate Dilution Buffer, Standard solutions A-G, M65 Control Low and M65 Control High and TMB Substrate) are not classified as hazardous to health according to Regulation (EC) No 1272/2008. Environmental hazards None of the components in M65 ELISA kit are classified as hazardous to the environment. Physical hazards None of the components in M65 ELISA kit are classified for physical hazards.
