GS HBsAg EIA 3.0

Hazard statements (CLP)

H317

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

R3. HBsAg - Anti-HBsAg (mouse monoclonal): horseradish peroxidase conjugate in a buffer (pH neutral) with protein Conjugate stabilizers (murine and/or bovine),  25% glycerol [C3H8O3, CAS#: 56-81-5, EC No 200-289-5], < 3% Sodium Concentrate, chloride [NaCl, CAS# 7647-14-5, EC No 231-598-3], < 2% HEPES [(4-[2-hydroxyethyl]-1- 5 vials (1.2 mL) piperazineethanesulfonic acid), CAS# 7365-45-9; EC No 230-907-9] and green dye. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this product mixture and Catalog No. 25103 concentration. - Preserved with 0.5% ProClin 300, (0.015% active ingredient), EC Index No 613-167-00-5 with CAS# 55965- 84-9 [GHS \ US HCS \ EC CLP Classification: WARNING; GHS07; H317; P280; P302 + P352, P333 + P313; WARNING P501]. - 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. R1. Strip Plates Anti- - Microwell strips in holder, coated with antibody to HBsAg (mouse monoclonal). HBsAg - Potential residue of ProClin 150 and sodium azide used as production preservatives (aspirated prior to drying Microwell, strips). 50 plates - Tabs are labeled “CC.” - 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. C0. HBsAg Negative - Normal human serum that is nonreactive for HBsAg, anti-HBsAg, and antibodies to HIV and HCV. Control - Preserved with 0.16% ProClin 950, containing 0.016% active ingredient: 9.5-9.9% 2-methyl-4-isothiazolin-3- (Human), one (C4H5NOS); CAS # 2682-20-4, EC No 220-239-6. Not subject to GHS, US HCS, EC CLP and analogous 5 vials (12 mL) 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, Catalog No. 25108 EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C1. HBsAg Positive - Purified HBsAg (human ad and ay subtypes) in synthetic diluent / Control Buffer with protein stabilizers (bovine),  20% Glycerol [C3H8O3, CAS# 56-81-5, EC No 200-289-5] and yellow (Human), dye. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this 5 vials (8 mL) product mixture and concentration. - Preserved with 0.5% ProClin 300 (0.015% active ingredient), EC Index No 613-167-00-5 with CAS# 55965-84- Catalog No. 25109 9 [GHS \ US HCS \ EC CLP Classification: 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, US HCS, WARNING EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. C2. HBsAg Low - Purified HBsAg (human ad and ay subtypes) in synthetic diluent / Positive Control Buffer with protein stabilizers (bovine),  20% Glycerol [C3H8O3, CAS# 56-81-5, EC No 200-289-5] and yellow (Human), dye. Not subject to GHS, US HCS, EC CLP and analogous global GHS-based regulatory requirements in this 5 vials (8 mL) product mixture and concentration. - Preserved with 0.5% ProClin 300 (0.015%active ingredient), EC Index No 613-167-00-5 with CAS# 55965-84- Catalog No. 25110 9 [GHS \ US HCS \ EC CLP Classification: 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, US HCS, WARNING EC CLP and analogous global GHS-based regulatory requirements in this product mixture and concentration. R4. HBsAg - Buffer with protein stabilizers (murine and bovine), [pH neutral amber liquid] with < 3% Sodium chloride Conjugate [NaCl, CAS# 7647-14-5, EC No 231-598-3) and < 2% HEPES [(4-[2-hydroxyethyl]-1-piperazineethanesulfonic Diluent, acid), CAS# 7365-45-9; EC No 230-907-9]. Not subject to GHS, US HCS, EC CLP and analogous global GHS- based regulatory requirements in this product mixture and concentration. 5 bottles (120 mL) - Preserved with 0.5% ProClin 300 (0.015% active ingredient), EC Index No 613-167-00-5 with CAS# 55965-84- Catalog No. 25104 9 [GHS \ US HCS \ EC CLP Classification: 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 * R8. Substrate Buffer, - Dilute citric acid (C6H8O7, CAS# 79-92-9, EC No 201-069-1) / sodium acetate buffer, [pH ~ 4.0, clear liquid]. 5 bottles (120 mL) - < 5% dimethylsulfoxide [DMSO - C2H6OS], CAS# 67-68-5, EC No 200-644-3. Catalog No. 26181 - < 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, - ≤ 0.25% 3,3’,5,5’ tetramethylbenzidine dihydrochloride [TMB– C16H20N22HCl], CAS# 207738-08-7, 5 bottles (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. * 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 C1, C2, R3, and 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):

Signal word

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

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]