BioPlex 2200 System ToRC IgM Reagent Pack

Hazard statements (CLP)

H317, H412

Code

Statements

H317

May cause an allergic skin reaction

SECTION 2: Hazards identification

HAZARDOUS COMPONENTS This test kit should be handled only by qualified personnel trained in laboratory procedures and familiar with their potential hazards. Specific warnings are given in the instructions for use. The absence of a specific warning should not be interpreted as an indication of safety. The following information is furnished for those product hazardous constituents that require regulatory control or disclosure at the concentration found in the product. Refer to Section 16 for the full text of any solely abbreviated or coded hazard statements provided below and for the key / legend to abbreviations and acronyms. Component

Contains

Bead Set - Dyed beads coated with lysates of T. gondii, Rubella and CMV plus an Internal Standard bead (ISB) and a Serum Verification bead (SVB) in buffer with Glycerol and protein stabilizers (bovine CAS# 9048-46-8) (pH neutral). BioPlex 2200 - 50-100% water [H20] CAS# 7732-18-5, EC No 231-791-2. Not subject to UN GHS, US HCS, EC CLP and analogous ToRC IgM global GHS-based regulatory requirements in this product mixture and concentration. 1 x 10 mL - < 20% Glycerol [C3H8O3], CAS# 56-81-5, EC No 200-289-5. Not subject to UN GHS, US HCS, EC CLP and (Faint brown analogous global GHS-based regulatory requirements in this product mixture and concentration. liquid) - < 2% Sodium chloride [NaCl], CAS# 7647-14-5, EC No 231-598-3. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - < 1% MOPS free acid buffer (3-[N-Morpholino]propanesulfonic acid - C4H8ON(CH3)3SO3H], CAS# 1132-61-2, EC No 214-478-5. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory WARNING requirements in this product mixture and concentration. - Preserved with  0.3% ProClin 300 ( 0.009% active ingredient), EC Index No 613-167-00-5 with CAS# 55965-84-9. GHS \ US HCS \ EC CLP Classification: WARNING; GHS07; H317, H412; P273, P280; P302 + P352, P333 + P313; P501. - Preserved with  0.1% sodium benzoate [C7H5O2Na], CAS# 532-32-1, EC No 208-534-8. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with < 0.1% sodium azide. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - phycoerythrin-conjugated murine monoclonal anti-human IgM antibody and phycoerythrin-conjugated murine Conjugate monoclonal anti-human FXIII antibody, in phosphate buffer with protein stabilizers (bovine CAS# 9048-46-8 and BioPlex 2200 murine) (pH neutral). ToRC IgM - 50-100% water [H20] CAS# 7732-18-5, EC No 231-791-2. Not subject to UN GHS, US HCS, EC CLP and analogous 1 x 5 mL global GHS-based regulatory requirements in this product mixture and concentration. (Pink aqueous - < 1% Sodium chloride [NaCl], CAS# 7647-14-5, EC No 231-598-3. Not subject to UN GHS, US HCS, EC CLP and liquid) analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with  0.3% ProClin 300 ( 0.009% active ingredient), EC Index No 613-167-00-5 with CAS# 55965-84-9. GHS \ US HCS \ EC CLP Classification: WARNING; GHS07; H317, H412; P273, P280; P302 + P352, P333 + P313; P501. WARNING - Preserved with  0.1% sodium benzoate [C7H5O2Na], CAS# 532-32-1, EC No 208-534-8. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with < 0.1% sodium azide. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. SDSen12000670 Revision D ( February 2020) 2 of 17 Component - Goat anti-human IgG antibody and protein stabilizers (bovine CAS# 9048-46-8 and murine) in buffer (pH neutral). Sample Diluent - 50-100% water [H20] CAS# 7732-18-5, EC No 231-791-2. Not subject to UN GHS, US HCS, EC CLP and analogous BioPlex 2200 global GHS-based regulatory requirements in this product mixture and concentration. ToRC IgM - < 5% L-Arginine [C6H14N4O2] CAS 74-79-3, EC No 200-811-1. Not subject to UN GHS, US HCS, EC CLP and 1 x 10 mL analogous global GHS-based regulatory requirements in this product mixture and concentration. (Yellow - < 2% Magnesium Chloride Hexahydrate [MgCl2•6H2O], CAS# 7791-18-6; EC No 232-094-6. Not subject to aqueous liquid) UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - < 1% Sodium chloride [NaCl], CAS# 7647-14-5, EC No 231-598-3. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. WARNING - < 1% Triethanolamine hydrochloride [C6H15NO3HCl] CAS 637-39-8, EC No 211-284-2. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with  0.3% ProClin 300 ( 0.009% active ingredient), EC Index No 613-167-00-5 with CAS# 55965-84-9. GHS \ US HCS \ EC CLP Classification: WARNING; GHS07; H317, H412; P273, P280; P302 + P352, P333 + P313; P501. - Preserved with  0.1% sodium benzoate [C7H5O2Na], CAS# 532-32-1, EC No 208-534-8. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with < 0.1% sodium azide. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. Markings according to the United Nations (UN) Globally Harmonized System (GHS), United States Hazard Communication Standard (US HCS), European Commission (EC) 2008/1272/EC (EC CLP) guidelines and analogous GHS-based global regulations: This product has been conservatively classified and labeled in accordance with United Nations (UN) GHS, United States Hazard Communication Standard (US HCS), related European Commission (EC) 2008/1272/EC (EC CLP) guidelines and applicable analogous GHS-based global regulations. The following regulated hazardous chemical concentrations are found in product component(s): 0.3% ProClin 300 [ 0.009%. active ingredients – reaction mass of: 5-chloro-2-methyl-4-isothiazolin-3-one (C4H4ClNOS; CAS# 26172-55-4, EC No 247-500-7) and 2-methyl-2H -isothiazol-3-one (C4H5NOS; CAS# 2682-20-4, EC No 220-239-6) (3:1)], EC Index No 613-167-00-5 with CAS# 55965-84-9. Comprehensive GHS Based Classification: Skin Sensitizer Category 1 Label(s):

Signal word

WARNING Label Hazard Statements: H317 May cause an allergic skin reaction. H412 Harmful to aquatic life with long lasting effects.

Precautionary statements

statements for product intended use and as codified on the product label) P273 Avoid release to the environment. P280 Wear protective gloves / protective clothing / eye protection / face protection. P302 + P352 IF ON SKIN: Wash with plenty of soap and water. P333 + P313 If skin irritation or rash occurs: Get medical advice/ attention. P501 Dispose of contents and container in accordance to local, regional, national and international regulations.

Supplemental label elements

additional precautions to consider relative to specific customer use) P261 Avoid breathing mist / vapors/vapours / spray. P272 Contaminated work clothing should not be allowed out of the workplace. [Source: Raw Material vendor SDS, CCOHS databases and regulatory research] SDSen12000670 Revision D ( February 2020) 3 of 17