BioPlex 2200 System Anti-CCP System 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 Cyclic Citrullinated Peptide, plus Internal Standard beads (ISB), Serum Verification beads (SVB), BioPlex 2200 and Reagent Blank beads (RBB) in buffer with glycerol and protein stabilizers (bovine CAS# 9048-46-8) (pH 7.4). Anti-CCP - 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 10 mL global GHS-based regulatory requirements in this product mixture and concentration. (Faint brown - < 20% Glycerol [C3H8O3], CAS# 56-81-5, EC No 200-289-5. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. liquid) - < 2% 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 requirements in this product mixture and concentration. - < 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. WARNING - 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 [NaN3], CAS# 26628-22-8 and EC No 247-852-1. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. Conjugate - Phycoerythrin conjugated murine monoclonal anti-human IgG antibody and phycoerythrin conjugated murine monoclonal BioPlex 2200 anti-human FXIII antibody, in buffer with protein stabilizers (bovine CAS# 9048-46-8) (pH 7.4). Anti-CCP - 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 - < 2% 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 requirements aqueous in this product mixture and concentration. liquid) - < 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. - 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 [NaN3], CAS# 26628-22-8 and EC No 247-852-1. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. Sample - Buffer with protein stabilizers (bovine CAS# 9048-46-8 and murine) (pH 7.4). Diluent - 50-100% water [H20] CAS# 7732-18-5, EC No 231-791-2 [Not subject to GHS and EU 2008/1272/EC regulatory BioPlex requirements.] 2200 Anti- - < 2% Magnesium Chloride Hexahydrate [MgCl2•6H2O], CAS# 7791-18-6; EC No 232-094-6. Not subject to UN GHS, CCP US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. 1 x 10 mL al - < 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. (Yellow aqueous - < 1% Triethanolamine hydrochloride [C6H15NO3HCl] CAS 637-39-8, EC No 211-284-2. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. liquid) - 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. WARNING - Preserved with < 0.1% sodium azide [NaN3], CAS# 26628-22-8 and EC No 247-852-1. Not subject to UN GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. SDSen-665-3250 Revision E (February 2020) 2 of 16 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 applicable 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]