PLATELIA TOXOPLASMA IgM MICROPLATE TMB EIA

SECTION 2: Hazards identification

HAZARDOUS COMPONENTS (2) 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. Component

Contains

R1 T. gondii Coated Microplate, - Microwell plate consisting of 12 strips with 8 break-away wells, coated with antibodies to human 1 plate IgM. R2 Concentrated Washing - TRIS-NaCl (sodium chloride) buffer, pH 7.4 with 1% Tween® 20[C58H114O26], EINECS/ELINCS Solution (10X), No 585-580-06-X, CAS# 9005-64-5. 1 vial (100 mL) - Preserved with 0.01% thimerosal [C9H9HgNaO2S], EINECS/ELINCS No: 200-210-4, CAS# 54- 64-8; R43-61; S24/25-28-36-53-60-61 (1999/45/EC – dilution < 0.05%). R3 Non-Reactive Control, - TRIS-NaCl (sodium chloride) buffer, pH 8 with bovine serum albumin, glycerol, E102 and E122. 1 vial (1 mL) Preserved with < 0.5% ProClin® 300, per 2001/59/EC Index No 613-167-00-5 with CAS# 55965-84-9; (0.015% active ingredient), Xi: Irritant; R43; S24-35-37. R4a Cut-off Control, - Human serum IgM low reactive for anti-T. gondii antigen and non-reactive for HBsAg and 1 vial (1 mL) antibodies to HIV-1, HIV-2 and HCV. - Preserved with < 0.01% thimerosal [C9H9HgNaO2S], EINECS/ELINCS No: 200-210-4, CAS# 54- 64-8; R43-61; S24/25-28-36-53-60-61 (1999/45/EC – dilution < 0.05%). R4b Positive Control, - Human serum IgM reactive for anti-T. gondii antigen and non-reactive for HBsAg and antibodies 1 vial (1 mL) to HIV-1, HIV-2 and HCV. - TRIS-NaCl (sodium chloride) buffer, pH ~8 with bovine serum albumin, glycerol, E102 and E122. - Preserved with < 0.01% thimerosal [C9H9HgNaO2S], EINECS/ELINCS No: 200-210-4, CAS# 54- 64-8; R43-61; S24/25-28-36-53-60-61 (1999/45/EC – dilution < 0.05%). Preserved with < 0.5% ProClin® 300, per 2001/59/EC Index No 613-167-00-5 with CAS# 55965-84-9; (0.015% active ingredient), Xi: Irritant; R43; S24-35-37. R6a T. gondii Antigen, - Inactivated T. gondii antigen (RH strain); lyophilized. 2 vials (7 mL each) R6b Concentrated Conjugate - Murine monoclonal antibody T. gondii (P30) conjugated with horseradish peroxidase (50X). (50X), 1 vial (0.4 mL) - Preserved with 0.01% thimerosal [C9H9HgNaO2S], EINECS/ELINCS No: 200-210-4, CAS# 54- 64-8; R43-61; S24/25-28-36-53-60-61 (1999/45/EC – dilution < 0.05%). R7 Diluent, - TRIS-NaCl (sodium chloride) buffer (pH 7.7), with bovine serum albumin, 0.1% Tween® 20 2 vials (80 mL each) [(C58H114O26), EINECS/ELINCS No 585-580-06-X, CAS# 9005-64-5] and phenol red. - Preserved with 0.01% thimerosal [C9H9HgNaO2S], EINECS/ELINCS No: 200-210-4, CAS# 54- 64-8; R43-61; S24/25-28-36-53-60-61 (1999/45/EC – dilution < 0.05%). R8 Substrate Buffer, - Solution of citric acid and sodium acetate containing 0.015% hydrogen peroxide (H2O2) and 4% 1 vial (60 mL) dimethyl sulfoxide [DMSO -C2H6OS], EINECS/ELINCS No: 200-644-3, CAS# 67-68-5-4 [< 20% dilution not subject to EU labeling according to EU Directives], pH ~4. R9 Chromogen – TMB Solution, - Solution containing 0.25% 3,3’,5,5’-tetramethylbenzidine (TMB). 1 vial (5 mL) R10 Stopping Solution, - 1N sulfuric acid solution (~4.8% v/v; pH ≤ 2), EINECS/ELINCS No: 231-639-5, CAS# 7664-93-9; 1 vial (28 mL) Corrosive (C); R34-41; S24/25-26-36/39-60 [Note: Per Directive 1999/45/EC, 4% H2SO4 is rated an Irritant (Xi), but was upgraded to Corrosive (C) with the conservative application of 2001/60/EC]. HAZARDOUS COMPONENTS (3) The following information is furnished for those kit hazardous constituents that require regulatory control or disclosure at the concentration found in the kit. Note that the information here is often based on data from the chemical raw material (LD50, exposure limits, etc.). The kit contains a significantly diluted concentration in an aqueous solution; thus, the assessment below has taken hazard reduction processing into consideration when possible. The EU classification was made according to the latest editions of the EU lists and expanded upon from company and literature data. Chemical Chemical Data / Information Ingredient CAS# 54-64-8 (thimerosal powder, 100%) + EINECS/ELINCS No: 200-210-4 (100%) + Thimerosal [Merthiolate RTECS# OV8400000 (100%) + Flash Point: NE Sodium, LD50 (oral-rat): 75 mg/kg (100%) + LC50: NE PEL/TLV: 0.01 mg Hg/m3 TWA (skin) (100%) + IATA/DOT ID: UN2025 (100%) + C9H9HgNaO2S 0.01% in R2, CA Proposition 65: Chemical known to the State of California to cause reproductive toxicity ++ HMIS Codes: H=2, F=0, R=0 ++ RCRA Code: D009 (to 0.2 mg/L - USA) ++ R3, R4a, R4b, EU Classification: Dilution below 1999/45/EC labeling requirement (< 0.05%); R43-61; S24/25-28-36-53-60-61 ++ R4c, R6 and R7] Thimerosal (merthiolate sodium) is an organo-mercury biocidal preservative which may be detrimental if enough is ingested, targets the central nervous system (CNS) and is a significant sensitizer; prolonged or repeated exposure may cause allergic reaction in certain sensitive individuals. There are ample cases of sensitization resulting from exposure to dilute thimerosal solutions. The chemical, physical and toxicological properties have not been thoroughly investigated. Thimerosal, classified under the generic class of mercury compounds, is known to the State of California to cause developmental toxicity. Avoid exposure. After contact with skin, wash immediately with plenty of water. Mercury compounds are considered reproductive toxicants and environmental pollutants by many government agencies at certain concentrations/quantities. Danger of cumulative effects. Avoid release to the environment. Spent mercury-containing solutions with a concentration greater than 0.2 ppm are considered RCRA hazardous waste (D009). This material and its container must be disposed of as hazardous waste and in accordance with local, regional and national regulations. Handle appropriately with the requisite Good Laboratory Practices and Universal Precautions. (Note: Mercury (Hg) makes up 49.55% of the thimerosal molecule; thus, a component with 0.01% thimerosal contains ~0.005% (50 ppm) mercury w/v). Hazardous ingredient concentration in raw material: According to the manufacturer, Supelco, the concentrated ProClin® 300 preservative is a mixture of 4 ingredients: 2.1-2.9% 5-chlor-2-methyl-4-isothiazolin-3-one (C4H4ClNOS; CAS# 26172- [0.5% in R4a, 55-4), 0.6-1.1% 2-methyl-4-isothiazolin-3-one (C4H5NOS; CAS# 2682-20-4), 91-94% glycol and 2.1-2.9% modified R4b, R4c] alkyl carboxylate (no CAS# or formula given for last two). Note that this ratio of active ingredients is listed in 2001/59/EC under Index No: 613-167-00-5 with the CAS# 55965-84-9. RTECS#: NE Flash Point: 121°F / 49.4°C (100%) + LD50 (oral-rat): 3600 mg/kg (100%) + LC50: NE PEL/TLV: NE IATA/DOT ID: UN1760 (undiluted, 100%) + HMIS Codes: H=2, F=0, R=0 ++ RCRA Code: NE (for dilution) ++ EU Classification: Irritant (Xi), R43; S24-35-37 (≤ 0.06% and > 0.0015 % active ingredient per 2001/59/EC) ++ The chemical, physical and toxicological properties have not been thoroughly investigated. At this concentration, this biocidal preservative is irritating to eyes and skin, and may be detrimental if enough is ingested (quantities above those found in the kit). ProClin® 300 is a skin sensitizer; prolonged or repeated exposure may cause allergic reaction in certain sensitive individuals. This material and its container must be disposed of in a safe way and in accordance with local, regional and national regulations. The potential for these adverse health effects is unknown for the highly diluted, small volume of ProClin® in this kit, but unlikely if handled appropriately with the requisite Good Laboratory Practices and Universal Precautions. CAS#: 64285-73-0 (TMB dihydrochloride, 100%)+ CAS#: 54827-17-7 (TMB free base, 100%) + 3,3’,5,5’- RTECS#: DV2300000 (100%) + Flash Point: NE Tetramethyl- LD50 (ipr-mouse): 135 mg/kg (100%) + LC50: NE benzidine TLV and PEL: NE RCRA Code: NE [TMB, HMIS Codes: H=1, F=0, R=0 ++ IATA/DOT ID: NE C16H2ON2 EINECS/ELINCS No: 264-769-6 (TMB dihydrochloride, 100%), 259-364-6 (TMB base, 100%) + in R9] EU Classification: None (due to dilution, < 20%); S36 ++ The chemical, physical and toxicological properties have not been thoroughly investigated. TMB is considered a non- carcinogenic and non-mutagenic analog of benzidine suitable as an EIA chromogen for peroxidase. The raw material supplier indicates that it may cause slight irritation by all routes of entry, but this potential is unlikely if handled with the requisite Good Laboratory Practices and Universal Precautions. Dispose of this material in accordance with local, regional and national regulations. CAS# 7664-93-9 (Conc. sulfuric acid 100%)+ RTECS# WS5600000 + Sulfuric Acid LD50 (oral-rat): 2,140 mg/kg (100%) + LC50 (inhalation-rat): 510 mg/m3/2H (100%) + [1N (~4.8% PEL/TLV: 1 mg/m3 (100%)+ STEL (100%) 3 mg/m3 (100%) + Flash point: NE w/w) H2SO4 in IATA/DOT ID: 2796 (< 51% sulfuric acid solutions)+ RCRA Code: D002 (if not neutralized) ++ R10] HMIS Codes: H=2, F=0, R=1 ++ EINECS No: 231-639-5 (100%) + EU Classification Corrosive (C); R34 (eyes) R41; S24/25-26-36/39-60 [Note Per Directive 1999/45/EC, < 5% H2SO4 is rated an Irritant (Xi), but was upgraded to Corrosive (C) with the conservative application of 2001/60/EC.] ++ 1.0N sulfuric acid (H2SO4) solutions are irritating to skin and severely irritating or corrosive to eyes, depending on the amount and length of exposure; greater exposures can cause eye damage, including permanent impairment of vision or blindness. May be harmful if swallowed or in contact with skin or eyes. In case of contact with eyes, immediately rinse with copious water and seek medical attention. Keep away from strong bases and reducing agents. This material and/or its container must be disposed of as hazardous acidic waste. It may be neutralized to pH 5-8 for disposal if trained and equipped to do so; however, always dispose of acidic solutions as required by local, regional and national regulations. Handle appropriately with the requisite Good Laboratory Practices. Toxoplasma Toxoplasma gondii antigens (RH strain) have been inactivated and are not considered infectious. Handle in a Biosafety gondii Level 2 lab, applying the guidelines from the current CDC/NIH Biosafety in Microbiological and Biomedical antigen Laboratories. Employ decontamination procedures with appropriate decon agent or disinfectant before discarding any [R6a] materials utilized or returning equipment used to general use. Dispose of this material in accordance with local, regional and national regulations. Handle appropriately with the requisite Good Laboratory Practices and Universal Precautions. Human Serum The human sera in the components of this product were tested and found non-reactive for hepatitis B surface antigen (reactive and (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus (HIV-1 and HIV-2) by non-reactive) French approved methods. No known test method can offer complete assurance that HIV, hepatitis B or C virus or [R3, R4a, R4b, other infectious agents are absent. Employ Universal Precautions when handling these reagents and all human blood, R4c] specimens or patient samples, which represent an unknown, heightened hazard. Handle as if capable of transmitting infectious disease, in a Biosafety Level 2 lab, applying the guidelines from the current CDC/NIH Biosafety in Microbiological and Biomedical Laboratories. Avoid splashing, spills and the generation of aerosols. Secure in secondary containment with proper biohazard labeling. Do not inhale mists or aerosols; avoid contact with skin, eyes, mucous membranes and clothing. In case of contact with eyes, immediately rinse with copious water and seek medical attention. Employ decontamination procedures with appropriate decon agent or disinfectant (typically a 1:10 dilution of household bleach, 70-80% ethanol or isopropanol, an iodophor like 0.5% Wescodyne Plus (EPA Reg.# 4959-16), an o-phenylphenol/amyphenol such as 0.8% Vesphene (EPA Reg.# 1043-87), or equiv.) before discarding any materials utilized or returning equipment used to general use. Dispose of this material in accordance with local, regional and national regulations. Handle appropriately with the requisite Good Laboratory Practices and Universal Precautions. Persons handling blood samples should have the option of receiving hepatitis B vaccination. + The Kit Concentration was not tested; the values refer to the solution concentration as tested, designated by percentage within parentheses. ++ The Kit Concentration was tested or the values given were estimated for the general diagnostic laboratory usage of the kit reagent dilution. NE: Not Established or Unknown (unable to locate data). Abbreviations for component HMIS hazard ratings are as follows: H=Health, F=Flammability, R=Reactivity General Kit Composite Health Hazards ♦ No significant adverse health effects are expected by any route for the following chemical constituents in the kit volumes and concentrations present [dilution not subject to EU Directive labeling]: Chemical Constituent Details Component Diluted (≤ 1%) Tween® 20 [C58H114O26], EINECS/ELINCS No 585-580-06-X, CAS# 9005-64-5. R2, R7 Diluted (≤ 4%) dimethyl sulfoxide [DMSO -C2H6OS], EINECS/ELINCS No: 200-644-3, CAS# 67-68-5- 4 [< 20% R8 dilution not subject to EU labeling according to EU Directives]. Diluted (≤ 0.015%) hydrogen peroxide [H2O2], EINECS/ELINCS No: 231-765-0, CAS# 7722-84-1 < 1% dilution R8 not subject to EU labeling according to EU Directives]. ♦ No significant adverse health effects are expected by any route for TRIS-NaCl, glycerol, citrate acid and sodium acetate, or bovine serum albumin containing solutions in the kit volumes and concentrations present [dilution not subject to EU Directive labeling]. ♦ According to the concept of Universal Precautions (29 CFR 1910.1030), all human blood and certain human body fluids must be treated as if known to be infectious for HIV, HBV and other bloodborne pathogens. No known test method can offer complete assurance that products derived from human blood will not transmit infection; thus, they should be handled as though they contain infectious agents. Furthermore, individual patient samples being tested represent a heightened, unknown hazard. Aerosolization/inhalation, contact and mucous membrane exposure should be avoided during sample and kit handling. Consider equipment that potentially comes in contact with human source material as contaminated until appropriately decontaminated. EMERGENCY FIRST AID MEASURES (4)