GS HIV-1/HIV-2 PLUS O EIA

Hazard statements (CLP)

H314, H317

Code

Statements

H314

Causes severe skin burns and eye damage

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

R1. HIV-1/HIV-2 - Microwell plate with adsorbed purified HIV-1 and HIV-2 antigens (Recombinant and Synthetic Peptide). PLUS O Microwell - Potential residue of ProClin 150 used as a production preservative (aspirated prior to drying strips). Strip Plate - Tabs are labeled “BB” 5 or 10 plates - Contains sealed pelletized desiccant packet(s): There are no health hazards associated with intact desiccant container; however, health hazards could result from dusts generated if the packet is cut, split or otherwise compromised and is crushed. R2. Wash Solution - Sodium chloride (NaCl) [CAS# 7647-14-5, EC No 231-598-3] aqueous solution with < 2% Tween 20 Concentrate (C58H114O26) [CAS# 9005-64-5, EC No 585-580-06-X] (clear liquid). Not subject to GHS, US HCS, (30X), 2 or 3 bottles EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. (120 mL) Catalog No. 25261 R3. Specimen Diluent - Buffer (pH neutral) with protein stabilizers, bovine proteins and sample indicator dye (< 0.1%, dark purple). 1 bottle (100 mL) - Preserved with 0.1% ProClin 300 (0.003% active ingredient), EC Index No 613-167-00-5 with Catalog No. 25123 CAS# 55965-84-9. GHS \ US HCS \ EC CLP R5. Conjugate Diluent, - Buffer with protein stabilizers (bovine) and glycerol (CAS#: 56-81-5, EC No 200-289-5) [pH neutral, clear 1 bottle (120 mL) liquid]. Catalog No. 25121 - Preserved with 0.1% ProClin 300 (0.003% active ingredient), EC Index No 613-167-00-5 with CAS# 55965-84-9. GHS \ US HCS \ EC CLP

2.1 Classification of the substance or mixture

WARNING; GHS07; H317; P280; P302 + P352, P333 + P313; P501 WARNING C0. Negative Control - Heat-treated human serum/plasma containing HIV-2 antibody, non-reactive for HBsAg and antibody to HCV. 1 vial (8 mL) - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient: 9.5-9.9% 2-methyl-4-isothiazolin- Catalog No. 25117 3-one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C1. HIV-1 Positive - Heat-treated human serum/plasma containing HIV-1 antibody, non-reactive for HBsAg and antibody to HCV. Control - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient: 9.5-9.9% 2-methyl-4-isothiazolin- 1 or 2 vial(s) 3-one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and (1.4 mL) analogous global GHS-based regulatory requirements in this product mixture and concentration. Catalog No. 25118 - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C2. HIV-2 Positive - Heat-treated human serum/plasma containing HIV-2 antibody, non-reactive for HBsAg and antibody to HCV. Control - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient: 9.5-9.9% 2-methyl-4-isothiazolin- 1 or 2 vial(s) 3-one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and (1.4 mL) analogous global GHS-based regulatory requirements in this product mixture and concentration. Catalog No. 25119 - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C3. HIV-1 Group O - Rabbit serum containing HIV-1 Group O antibody diluted in normal human serum/plasma; negative for HIV Positive Control and HCV antibodies and HBsAg. 1 or 2 vial(s) - Preserved with 0.16% ProClin 950 containing 0.016% active ingredient: 9.5-9.9% 2-methyl-4-isothiazolin- (1.4 mL) 3-one (C4H5NOS); CAS# 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and Catalog No. 25120 analogous global GHS-based regulatory requirements in this product mixture and concentration. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. R4. Conjugate - Purified HIV-1 and HIV-2 antigens labeled with peroxidase in a buffer with protein stabilizers (bovine and Concentrate (11X) caprine) and green dye (food grade). 1 vial (12 mL) Preserved with 0.5% ProClin 300 (0.015% active ingredient), EC Index No 613-167-00-5 with CAS# 55965- Catalog No. 25122 84-9 [GHS \ US HCS \ EC CLP WARNING; GHS07; H317; P280; P302 + P352, P333 + P313; P501.]. - Preserved with 0.005% gentamicin sulfate, CAS# 1405-41-0, EC No 215-778-9. Not subject to GHS, WARNING US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. * Component WARNING; GHS07; H317; P280; P302 + P352, P333 + P313; P501. WARNING R8. Substrate Buffer, - Dilute citric acid (C6H8O7, CAS# 79-92-9, EC No 201-069-1) / sodium acetate buffer, [pH ~ 4.0, clear 1 bottle (120 mL) liquid]. Catalog No. 26181 - < 5% dimethylsulfoxide [DMSO - C2H6OS], CAS# 67-68-5, EC No 200-644-3. - < 0.1% hydrogen peroxide [H2O2], CAS# 7722-84-1, EC No 231-765-0. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. R9. Chromogen (11X) - ≤ 0.25% 3,3’,5,5’ tetramethylbenzidine dihydrochloride [TMB– C16H20N22HCl], CAS# 207738-08-7, 1 bottle (12 mL) EC No 264-769-6. Catalog No. 26182 - ≤ 0.04 N hydrochloric acid [~ 0.3% HCl, CAS# 7647-01-0, EC No 231-595-7] solution (pH ~ 1.5, clear liquid). Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. R10. EIA Stopping - 1N Sulfuric Acid (4.4% w/w H2SO4), CAS# 7664-93-9, EC No 231-639-5[pH < 2, clear liquid]. Severely Solution irritating to skin, corrosive to eyes. GHS \ US HCS \ EC CLP: DANGER! GHS05; H314; P280; P301 + P330 + P331, P305 + P351 + P338; P501. 1 bottle (120 mL) Catalog No. 25260 DANGER! * Replacement, component Catalog numbers are provided in this column where available. Markings according to the United Nations (UN) Globally Harmonized System (GHS), United States Hazard Communication Standard (US HCS), European Community (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 Community (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): Component R10 - 1N H2SO4 [4.4% w/w Sulfuric acid], CAS# 7664-93-9, EC No 231-639-5 (pH  2); severely irritating to skin, corrosive to eyes. [This STOP solution has been evaluated with the CORROSITEX test method to determine its corrosive potential and classification. The results of this testing classified this STOP solution as Class: 8, Packing group II (UN2796)] Comprehensive GHS Based Classification: Skin Corrosive Category 1B Serious eye damage (Category 1) Label(s):

Signal word

DANGER! Label Hazard Statements: H314 Causes severe skin burns and eye damage. Precautionary Statements (statements for product intended use and as codified on the product label): P280 Wear protective gloves / protective clothing / eye protection / face protection. P301 + P330 + P331 IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. P305 + P351 + P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P303 + P361 + P353 IF ON SKIN (or hair): Remove/Take off immediately all contaminated clothing. Rinse skin with water/shower. P501 This material and its container must be disposed of as hazardous waste. WARNING Label Hazard Statements: H317 May cause an allergic skin reaction. Precautionary Statements (statements for product intended use and as codified on the product label): 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

Statements (additional precautions to consider relative to specific customer use) P308 + P313 If exposed or concerned: Get medical advice/ attention. P405 Store locked up. [Source: Raw Material vendor SDS, CCOHS databases and regulatory research] Component R3, and R5 - 0.1% ProClin 300 or Component R4 - 0.5% ProClin 300 [ 0.015%. 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): Statements (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]