MATERIAL SAFETY DATA SHEET
IDENTIFICATION OF PRODUCT (SUBSTANCE) AND SUPPLIER (1):
Product Name: PLATELIATM LYME IgM
Product Number: Catalog 25296 (96 tests)
The PlateliaTM Lyme IgM Test is a qualitative test intended for use in the presumptive detection of
Intended Use:
human IgM antibodies to Borrelia burgdorferi in human serum or plasma (K3 EDTA, sodium
heparin or sodium citrate). The EIA system should be used to test serum or plasma from patients
with a history and symptoms of infection with Borrelia burgdorferi. The diagnosis of Lyme
disease should be made based on history and symptoms (such as erythema migrans), and other
laboratory data, in addition to the presence of antibodies to Borrelia burgdorferi.
Supplier's Name: Bio-Rad Laboratories, Inc.
6565 185th Avenue NE
Address:
Redmond, WA 98052-5039
1-800-2-BIORAD (1-800-224-6723); or (425) 881-8300 (daytime PST)
Phone Number:
This MSDS is listed with CHEMTREC (800) 424-9300. Use only in the event of a CHEMICAL
Emergency Phone Number:
EMERGENCY involving a SPILL, LEAK, FIRE, EXPLOSION or ACCIDENT with this product.
COMPOSITION/INFORMATION ON INGREDIENTS -- 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.
Content
Component
12 Microwell strips, with 8 wells, in holder, coated with goat anti-human ?chains
R1 Microplate (1)
- Tabs are labeled "68"
- Tris buffered aqueous solution with sodium chloride [(NaCl) CAS# 7647-14-5, EINECS/ELINCS
R2 Concentrated
No: 231-598-3] and 1% Tween?20 [C58H114O26], CAS# 9005-64-5 [pH 7.4 clear liquid].
Washing Solution
- Preserved with 0.01% ProClin?300, per 2001/59/EC: Index No: 613-167-00-5 with CAS# 55965-84-9
(10x),
( 0.001% active ingredient), dilution below EU regulated labeling levels.
2 x 100 mL
Negative Control, - Human serum, negative for IgM antibodies to Borrelia burgdorferi, and non-reactive for detectable hepatitis B
R3
surface antigen (HBsAg) and antibodies to hepatitis C Virus (HCV) and human immunodeficiency virus
1 x 1 mL
(HIV-1 and HIV-2) [pH neutral orange-pink liquid].
- Preserved with 0.15% ProClin?300, per 2001/59/EC: Index No: 613-167-00-5 with CAS# 55965-84-9; (0.003%
active ingredient), Xi: Irritant; R 43; S 24-35-37.
- Human serum reactive for IgM antibodies to Borrelia burgdorferi, and non-reactive for detectable hepatitis B
R4 Cut-off
surface antigen (HBsAg) and antibodies to hepatitis C Virus (HCV) and human immunodeficiency virus
Calibrator,
(HIV-1 and HIV-2) [pH neutral orange-pink liquid].
1 x 1 mL
- Preserved with 0.15% ProClin?300, per 2001/59/EC: Index No: 613-167-00-5 with CAS# 55965-84-9; (0.003%
active ingredient), Xi: Irritant; R 43; S 24-35-37.
- Human serum reactive for IgM antibodies to Borrelia burgdorferi, and non-reactive for detectable hepatitis B
R5 Positive Control,
surface antigen (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus (HIV-1
1 x 1 mL
and HIV-2) [pH neutral yellow liquid].
- Preserved with 0.15% ProClin?300, per 2001/59/EC: Index No: 613-167-00-5 with CAS# 55965-84-9; (0.003%
active ingredient), Xi: Irritant; R 43; S 24-35-37.
- Inactivated Borrelia burgdorferi Antigen [white powder].
R6a Antigen
(lyophilized),
2 x q.s. 8.0 mL
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PLATELIATM LYME IgM [Catalog 25296]
- Murine monoclonal anti-Borrelia burgdorferi antibody coupled with horseradish peroxidase [pH neutral dark
R6b Conjugate (51x),
purple solution].
1 x 0.4 mL
- Preserved with 0.16% ProClin?300, per 2001/59/EC: Index No: 613-167-00-5 with CAS# 55965-84-9; (0.003%
active ingredient), Xi: Irritant; R 43; S 24-35-37.
- Trace amount of production process preservative, < 0.0005% thimerosal [C9H9HgNaO2S], EINECS/ELINCS
No: 200-210-4, CAS# 54-64-8; R 43-61; S 24/25-36-60-61 (1999/45/EC ?dilution < 0.05%). Requires US
RCRA D009 disposal.
- Tris buffered saline solution with fetal calf serum, 0.1% Tween?20 [C58H114O26], CAS# 9005-64-5 and red
R7 Diluent
sample indicator dye (phenol red) [pH 7.7 red-orange liquid].
(for samples and
- Preserved with 0.15% ProClin?300, per 2001/59/EC: Index No: 613-167-00-5 with CAS# 55965-84-9; (0.003%
conjugate),
active ingredient), Xi: Irritant; R 43; S 24-35-37.
2 x 65 mL
- < 0.1% 3.3'.5.5' tetramethylbenzidine [TMB ?C16H2ON2].
R9 Chromogen
- < 1% hydrogen peroxide [H2O2], CAS# 7722-84-1 [pH 5.8 clear liquid].
TMB,
1 x 28 mL
- 1N H2SO4 (4.8% w/w sulfuric acid), EINECS/ELINCS No: 231-639-5, CAS# 7664-93-9; severely irritating to
R10 Stopping
skin, corrosive to eyes, R 34 (eye)-36/38-41; S 24/25-26-36/37/39-60 (1999/45/EC, 2001/60/EC) [pH 2 clear
Solution,
liquid].
1 x 28 mL
- Clear plastic sealers.
Plate Sealers (4)
HAZARDS IDENTIFICATION -- 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
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;
[0.15% in R3, R4, CAS# 26172-55-4), 0.6-1.1% 2-methyl-4-isothiazolin-3-one (C4H5NOS; CAS# 2682-20-4), 91-94% glycol and 2.1-
R5 and R7; 0.16% 2.9% modified alkyl carboxylate (no CAS# or formula given for last two). Note that this ratio of active ingredients is
in R6b] listed in 2001/59/EC under Index No: 613-167-00-5 with the CAS# 55965-84-9.
RTECS#: NE Flash Point: 121癋 / 49.4癈 (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), R 43; S 24-35-37 ( 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
?br>
diluted, small volume of ProClin in this kit, but unlikely if handled appropriately with the requisite Good Laboratory
Practices and Universal Precautions.
ProClin?300 ?br>
Note: The dilute 0.01% ProClin 300 in R2 no longer requires EU labeling due to dilution (< 0.0015% active
[0.01% in R2]
ingredient); however, the sensitization threshold is unknown (R 43; S 36), so apply the above precautions accordingly.
MSDS25296 Revision B (July 2008) 2 of 10
PLATELIATM LYME IgM [Catalog 25296]
Chemical
Chemical Data / Information
Ingredient
CAS#: 7722-84-1 (Concentrate 30%) + RTECS#: MX0899000 (Concentrate 30%) +
Hydrogen peroxide
LD50 (oral-rat): 1518 mg/kg (Concentrate 30%) + LC50: NE
[< 1% H2O2 in R9] TLV and PEL: 1 ppm (Concentrate 30%) + Flash Point: NE
RCRA Code: D001, D002 (Concentrate 30%) + IATA/DOT ID: UN2014 (Concentrate 30%) +
HMIS Codes: H=1, F=0, R=1 ++ EINECS/ELINCS No: 231-765-0 (Concentrate 30%) +
EU Classification: None (due to dilution, < 5% and 1% hydrogen peroxide); S 25-36 ++
Dilute (3%) hydrogen peroxide solutions can break down to provide oxygen to feed a fire; thus, keep away from
flames. 3% hydrogen peroxide may cause slight irritation by all routes of entry, but this potential is unlikely if
handled appropriately with the requisite Good Laboratory Practices and Universal Precautions. Dispose of this
material in accordance with local, regional and national regulations.
CAS#: 54-64-8 (thimerosal powder, 100%) + EINECS/ELINCS No: 200-210-4 (100%) +
Thimerosal
RTECS#: OV8400000 (100%) + Flash Point: NE
[< 0.0005% LD50 (oral-rat): 75 mg/kg (100%) + LC50: NE
Merthiolate PEL/TLV: 0.01 mg Hg/m3 TWA (skin) (100%) + IATA/DOT ID: UN2025 (100%) +
Sodium, CA Proposition 65: Chemical known to the State of California to cause reproductive toxicity ++
C9H9HgNaO2S in HMIS Codes: H=2, F=0, R=0 ++ RCRA Code: D009 (to 0.2 mg/L - USA) ++
R6b] EU Classification: Dilution below 1999/45/EC labeling requirement (< 0.05%); R 43-61; S 24/25-36-60-61 ++
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. 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 0.0005% thimerosal contains ~0.00025% (2.5 ppm) mercury w/v).
CAS#: 7664-93-9 (Conc. sulfuric acid 100%) + RTECS#: WS5600000 (100%) +
1N Sulfuric acid 3
LD50 (oral-rat): 2,140 mg/kg (100%) + LC50 (inhalation-rat): 510 mg/m /2H (100%) +
[4.8% w/w H2SO4 3 3
PEL/TLV: 1 mg/m (100%); STEL: 3 mg/m (100%) + Flash Point: NE
in water in R10]
IATA/DOT ID: UN2796 (< 51% sulfuric acid solutions) + RCRA Code: D002 (if not neutralized) ++
HMIS Codes: H=2, F=0, R=1 ++ EINECS/ELINCS No: 231-639-5 (100%) +
EU Classification: Corrosive (C); R 34 (eye)-36/38-41; S 24/25-26-36/37/39-60 [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 6-8 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.
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
[< 0.1% TMB, HMIS Codes: H=1, F=0, R=0 ++ IATA/DOT ID: NE
C16H2ON2 in R9] EINECS/ELINCS No: 264-769-6 (TMB Dihydrochloride, 100%), 259-364-6 (TMB Base, 100%) +
EU Classification: None (due to dilution, < 20%); S 36 ++
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.
MSDS25296 Revision B (July 2008) 3 of 10
PLATELIATM LYME IgM [Catalog 25296]
Chemical
Chemical Data / Information
Ingredient
The Borrelia burgdorferi antigen has been inactivated and is not considered infectious. According to the vendor,
Borrelia burgdorferi
the human antibody positive Borrelia burgdorferi Positive and Cut-off Controls have been filtered (0.22 祄) to
Antigen remove Borrelia antigen, if present in the sera. However, Universal Precautions should be followed when handling
[R6a] this biological. 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. Employ
Borrelia burgdorferi decontamination procedures with appropriate decon agent or disinfectant before discarding any materials utilized or
Antibody Positive returning equipment used to general use. Dispose of this material in accordance with local, regional and national
Controls regulations. Handle appropriately with the requisite Good Laboratory Practices and Universal Precautions.
[R4 and R5]
This material is of animal origin [bovine and murine] and may be a potential contact irritant. Hazard Unknown.
Animal proteins
Handle as potentially infectious. The chemical, physical and toxicological properties have not been thoroughly
[R1, R6b and R7] investigated. Handle appropriately with the requisite Good Laboratory Practices and Universal Precautions. Dispose
of this material in accordance with local, regional and national regulations.
The human sera in the components of this product were tested and found non-reactive for hepatitis B surface antigen
Human Serum
(HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus (HIV-1 and HIV-2) by
[reactive in R4 and FDA approved methods. No known test method can offer complete assurance that HIV, hepatitis B or C virus or
R5 and non- other infectious agents are absent. Employ Universal Precautions when handling these reagents and all human
reactive in R3] blood, 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 [< 20% dilution not subject to EU Directive labeling]:
Component
Chemical Constituent Details
R2, R7
Diluted Tris (TRIZMA) Buffer solution; 2-amino-2-(hydroxy-methly)-1, 3-propanediol [C4H11NO3],
EINECS/ELINCS No 214-684-5, 201-064-4, CAS# 1185-53-1, 77-86-1, 25149-07-9; 108195-86-4.
Dilute 1% Tween?20 [C58H114O26], EINECS/ELINCS No 585-580-06-X, CAS# 9005-64-5. R2, R7
Diluted Phenol red, monosodium salt [C19H13O5S ?Na], EINECS/ELINCS No:205-609-7, CAS# 34487-61-1. R7
No significant adverse health effects are expected by any route for the miscellaneous salts, buffers, water, antibodies and
other chemicals found in the peroxidase conjugate, buffers with protein stabilizers, TRIS-NaCl solutions, dyes, catalytic or
other non-reactive ingredients, in the kit volumes and/or concentrations present.
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
MSDS25296 Revision B (July 2008) 4 of 10
PLATELIATM LYME IgM [Catalog 25296]
EMERGENCY FIRST AID MEASURES (4):
Health Effects: Symptoms of overexposure may include headache, dizziness, congestion and breathing difficulty. Severely
irritating or corrosive to eyes; greater exposures can cause eye damage, including permanent impairment of
vision. Risk of serious damage to eyes. May cause ingestion corrosive effects, including burning throat,
mouth and stomach. May cause allergic skin reaction upon repeated exposure. The thimerosal-containing
components may be toxic to developing fetus, generally at concentrations and volumes greatly exceeding
that of this kit.
Eye Contact: Flush eyes with copious water for at least 15 minutes. Ensure adequate flushing by separating the eyelids
with fingers while flushing with water. OBTAIN MEDICAL ATTENTION.
Skin Contact: Remove contaminated clothing. Flush skin with copious water and wash affected area with soap and water.
If blood-to-blood contact occurs or if more severe symptoms develop, consult a physician.
Inhalation: Remove person from exposure area to fresh air. If breathing becomes difficult, immediately call for
emergency medical assistance. Treat symptomatically and supportively. Generally, this aqueous product is
not a significant inhalation hazard in the kit volumes and concentrations present.
If Swallowed: If ingested, rinse out mouth thoroughly with water, provided the person is conscious, and OBTAIN
MEDICAL ATTENTION. Call a physician or the local poison control center. Treat symptomatically and
supportively. If vomiting occurs, keep head lower than hips to prevent aspiration.
Notes to According to the OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030), Universal Precautions
Physician apply. Persons handling human blood source samples should be offered hepatitis B vaccination prior to
working with human source material.
FIREFIGHTING MEASURES (5):
Extinguishing Media: Use extinguishing media appropriate for the surrounding fire.
Special Conventional firefighting full protective equipment (with NIOSH-approved self-contained breathing
Firefighting apparatus) and procedures appropriate for the surrounding fire should be sufficient.
Procedures
ACCIDENTAL RELEASE MEASURES (6):
Avoid direct contact with skin, eyes, mucous membranes and clothing by wearing appropriate lab personal protective equipment
(PPE) including gloves, lab coat and eye/face protection.
In the event of a hazardous material spill, contain the spill if it is safe to do so and immediately move to a safe area, free from
potential aerosols, to decontaminate and/or safely remove any contaminated clothing, as necessary. Isolate the hazard area and
ventilate if appropriate. Ensure that appropriate spill cleanup materials and PPE are available and used.
Follow established laboratory policy and applicable CDC/NIH biosafety and/or OSHA/WISHA hazardous material spill and/or
NFPA/Fire Code guidelines for appropriate hazardous chemical and/or biological material spill response and cleanup.
Wear appropriate PPE. Immediately, and on-site if possible:
Decontaminate Biohazard/Human Source Material spills, which should always be treated as potentially infectious, including
the area, spill materials and any contaminated surfaces or equipment. Utilize an appropriate chemical decon agent or
disinfectant that is effective for the known or potential pathogens relative to the samples involved (commonly a 1:10 dilution
of bleach, 70-80% ethanol or isopropanol, an iodophor (such as Wescodyne Plus) or a phenolic, etc.).
Neutralize corrosive acidic spills with the appropriate acid adsorbent product.
Absorb thimerosal-containing reagents, handle and dispose of as RCRA hazardous waste.
Clean the spill area with water and wipe dry. Spills can also be absorbed with an appropriate inert material (e.g. spill pillows,
acid absorbent pads, etc.), which are secured in an appropriate, labeled, sealed container. Material used to absorb the spill may
require hazardous material waste disposal. Infectious, chemical and laboratory wastes must be handled and discarded in
accordance with all local, regional and national regulations.
MSDS25296 Revision B (July 2008) 5 of 10
PLATELIATM LYME IgM [Catalog 25296]
HANDLING AND STORAGE INFORMATION (7):
Handling: This test kit should be handled only by qualified personnel trained in laboratory procedures and familiar
with their potential hazards. Follow proper Good Laboratory Practices and safety guidelines for handling
chemical, biological and laboratory hazards. Wear appropriate personal protective equipment (PPE)
including gloves, lab coat or equivalent and eye/face protection. Keep containers tightly closed; avoid
splashing, spills and the generation of aerosols. Handle all specimens, materials and equipment used to
perform the operations as though they were capable of transmitting infectious disease, as per Universal
Precautions. Refer to Section 8 for more specifics. Consult with your Environmental Health & Safety
Office for assistance.
Storage: Store the kit components as specified in the product instructions/package insert provided with the test kit
or in the instrument operation manual.
Read and follow all the Precautions and Warnings in the kit product instructions (e.g. PREPARATION AND STORAGE OF
REAGENTS, WARNINGS FOR USERS, PRECAUTIONS FOR USERS).
EXPOSURE CONTROL / PERSONAL PROTECTION MEASURES (8):
The following personal protective equipment (PPE) is recommended to prevent blood or other potentially infectious or hazardous
materials from reaching the user's work or street clothes, skin, mouth, mucous membranes and eyes, under normal conditions of use
and for the time during which the protective equipment is utilized:
Ventilation: Adequate lab ventilation is required. It is recommended that users handle potentially infectious human
source material/patient samples in a biological safety cabinet (BSC), expressly if aerosols might be
generated.
Eye Protection: Wear ANSI approved safety glasses, goggles or face shield with safety glasses or goggles. Contact lenses
should not be worn when handling lab hazards.
Protective Gloves: Suitable gloves must be worn at all times when handling kit reagents or patient samples to provide skin
protection from splash and intermittent contact. Synthetic gloves such as nitrile, neoprene and vinyl are
recommended because they are sturdy, effective and contain no natural latex ingredients associated with
latex glove allergic reactions. Disposable (single use) gloves should be changed often and never reused.
Wash hands thoroughly after removing gloves.
Protective Clothing: Wear a lab coat, clinic jacket, gown, apron and/or smock. Disposable clothing is strongly recommended
when handling biohazardous material. If reusable clothing is used, procedures for handling potentially
infectious laundry under the OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030) are required.
Other: All personal protective equipment should be removed before leaving the work area and placed in an
appropriately designated area or container for storage, processing, decontamination or disposal. Protective
coverings such as plastic wrap, aluminum foil or imperviously backed absorbent pads used to cover
equipment and/or surfaces must be removed and replaced if they become overtly contaminated.
Note: Exposure limit values and health hazard data were given in Section 3. Environmental controls are included
in the following sections.
PHYSICAL AND CHEMICAL PROPERTIES (9):
Appearance: Variable, generally aqueous liquids. Exceptions are the solid microtiter plate, lyophilized Antigen and
related materials.
Fire Hazard: Although the components have not been tested for fire hazard and explosion data, being water-based, they
are not expected to be fire hazards, but some of the kit packaging materials may burn under fire conditions.
Flash Point: Not applicable.
Auto Igniting: Product is not known to be self-igniting.
Danger of Explosion: Product is not known to present an explosion hazard.
MSDS25296 Revision B (July 2008) 6 of 10
PLATELIATM LYME IgM [Catalog 25296]
Boiling Point: Not established.
Melting Point: Not established.
Solubility: The liquid chemical components and lyophilized Antigen are soluble in water. The acidic solutions may
release heat.
pH: The liquid chemical reagents are between pH 5.5 and 8, with the exception of the acidic Stopping
Solution (R10) at pH 2.
Specific Gravity: Not established.
No other standard characteristics are known to be applicable to the identification or hazards of the kit components.
STABILITY AND REACTIVITY INFORMATION (10):
Stability: Stable under ordinary conditions of use and storage
Materials to Avoid: Do not allow the acidic solutions to come in contact with strong bases, oxidizing agents and
metals.
Conditions to Avoid: None known when used as intended.
Hazardous Decomposition Products: May release toxic oxides of carbon, nitrogen and sulfur or mercury.
Hazardous Polymerization: Has not been reported to occur.
TOXICOLOGICAL INFORMATION -- GENERAL COMPOSITE (11):
Refer to Section 3 for the kit component concentrations. The composite toxicological information for this product is:
Acute Health Effects
Toxicity: May be detrimental in contact with skin, if swallowed, and to eyes upon contact; in case of contact with eyes,
immediately rinse with copious water and seek medical attention.
Primary Irritant Effect: Most of the kit components may be irritating to eyes and skin (note: the Stopping Solution is also listed
under corrosivity below).
Corrosivity: The Stopping Solution (R10) is severely irritating or corrosive to eyes and, with greater exposure, can cause eye
damage, including permanent impairment of vision or blindness; can cause burns to the eyes and skin and is harmful if
swallowed.
Other Acute Health Effects: The Stopping Solution (R10) poses a risk of serious damage to eyes. Mercury containing
compounds (thimerosal preserved Conjugate (R6b) target the central nervous system (CNS), lungs, gastrointestinal tract,
liver, kidneys and blood (large or prolonged dosages).
Biohazard Potential:
The Borrelia burgdorferi antigen (R6a) has been inactivated and is not considered infectious. According to the vendor, the
human antibody positive Borrelia burgdorferi Positive and Cut-off Controls (R5, R4) have been filtered (0.22 祄) to remove
Borrelia antigen, if present in the sera. No known test method can offer complete assurance that HIV, hepatitis B or C virus
or other infectious agents are absent. Moreover, patient blood samples tested with this kit represent an unknown, heightened
hazard. Employ Universal Precautions; handle these reagents, all human blood and specimens as if capable of transmitting
infectious disease, in a Biosafety Level 2 laboratory, applying the guidelines from the current CDC/NIH Biosafety in
Microbiological and Biomedical Laboratories or equivalent. Persons handling blood samples should have the option of
receiving hepatitis B vaccination.
Chronic Toxicity
Sensitization: The Controls (R3, R4, R5), Conjugate (R6b), Diluent (R7) and Washing Solution (R2) contain very dilute,
potentially skin-contact sensitizing preservative ProClin?300 and the Conjugate (R6b) contains sensitizing thimerosal
(organo-mercury compound); prolonged or repeated exposure may cause allergic reaction in certain sensitive individuals.
Though the potential for an allergic response is greatly reduced by the dilution, sensitization threshold is unknown; thus,
handle accordingly.
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PLATELIATM LYME IgM [Catalog 25296]
Carcinogenicity: No carcinogenic effect known. No component, mixture or constituent has been classified as a carcinogen by
NTP, IARC or OSHA.
Reproductive Hazard: Thimerosal (merthiolate sodium), an organo-mercury biocidal preservative found in the Conjugate
(R6b), is a known reproductive toxin, listed by the State of California to cause developmental toxicity.
Additional Toxicological Information: Mercury compounds, such as thimerosal (merthiolate sodium), an organo-mercury
biocidal preservative, are considered reproductive toxicants and environmental pollutants by many government agencies at
certain concentrations/quantities. Danger of cumulative effects; avoid release to the environment. To the best of our
knowledge, the chemical, physical and toxicological properties have NOT been thoroughly investigated for some of the
component chemicals and/or mixtures.
ECOLOGICAL INFORMATION (12):
The ecological information for the dilute organo-mercury preservative, thimerosal has not been thoroughly investigated; however,
mercury and its compounds are expected to significantly bioaccumulate. United States regulation considers mercury hazardous to
the environment to 0.2 ppm mercury (the < 0.0005% thimerosal in the Conjugate (R6b) contains ~2 ppm mercury, which makes up
~50% of the molecule); at or above this 0.2 ppm level, any waste must be handled as dangerous waste.
The corrosive Stopping Solution (R10) component is hazardous for drinking water and toxic to aquatic organisms by pH
modification if not neutralized.
DISPOSAL CONSIDERATIONS (13):
Disposal of hazardous and/or laboratory wastes, product or packaging must be conducted in accordance with all applicable local,
regional and national regulations. This section specifies the general and United States RCRA requirements. Processing, use or
contamination of the kit components may change waste management requirements and options. Contact your Environmental Health &
Safety Office for your specific disposal procedures.
Recommended Product Disposal:
? All human source and other potentially infectious material must be appropriately decontaminated or disposed of as
infectious material; check your national, regional and local ordinances accordingly.
? Waste containing thimerosal, an organo-mercury compound, is a regulated hazardous waste if the final concentration is
0.2 mg/L (0.2 ppm). The Conjugate (R6b) component in this kit contains < 0.0005% thimerosal or approximately
0.0002% = 2 mg/L (2 ppm) mercury w/v. If the thimerosal-containing waste has a final concentration that is 0.2 mg/L
( 0.2 ppm) mercury, it requires disposal as a toxic environmental pollutant material in an RCRA approved hazardous
waste facility (or equivalent). The US RCRA waste disposal code for this waste is D009; check your national, regional and
local ordinances accordingly.
? If the final pH of the Acidic Stopping Solution (R10) waste measures 2, it requires disposal as a corrosive material in an
RCRA approved hazardous waste facility (or equivalent); the US RCRA disposal code for this waste is D002, check your
national and regional ordinances accordingly. It may be neutralized to pH 6-8 for disposal if trained and equipped to do so;
however, always dispose of acidic solutions as required by local, regional and national regulations.
Recommended Unclean Packaging Disposal: Dispose of in accordance with all applicable local, regional and national
regulations.
TRANSPORT INFORMATION (14):
Shipping and disposal of product, packaging and waste must be conducted in accordance with all applicable local, regional and
national regulations. Processing, use or contamination of the kit components may change shipping requirements and options. Contact
your Environmental Health & Safety Office for your specific shipping procedures.
MSDS25296 Revision B (July 2008) 8 of 10
PLATELIATM LYME IgM [Catalog 25296]
Recommended Unused Product Multi-Modal Transportation:
Acidic Component Stopping Solution (R10) in this kit contains 1N sulfuric acid; thus, any un-neutralized discarded kit
component or waste generated from its use resulting in a corrosive liquid (pH 2 or an pH 12.5 per Method 9040 [USEPA
Publication SW-846] or Corrodes Steel [NACE Standard TM-01-69]) must be transported as follows:
Proper Shipping Name: Sulphuric acid [with not more than 51% acid]
DOT Class: 8 Packing group II DOT ID Number: UN 2796
Recommended Used Product (Waste) Disposal Transportation: Potential air and land transportation information for
discarded kit components and waste from this product when used as intended is:
The acidic 1N sulfuric acid Stopping Solution (R10) is at pH 2; thus, any un-neutralized discarded kit component or waste
generated from its use resulting in a corrosive liquid (pH 2 per Method 9040 [USEPA Publication SW-846] or Corrodes
Steel [NACE Standard TM-01-69]), must be transported as follows:
Proper Shipping Name: Corrosive Liquid n.o.s.
DOT Class: 8 Packing group III DOT ID Number: UN 1760
The Conjugate (R6b) in this kit contains approximately 2 mg/L = 2 ppm mercury (w/v) from the < 0.0005% thimerosal
preservative. Therefore, any discarded kit components and waste generated from their use, which result in a final
concentration that is greater than or equal to 0.2 mg/L (0.2 ppm) must be transported as follows:
Proper Shipping Name: Hazardous Waste Liquid n.o.s.
DOT Class: 9 Packing group: III DOT ID Number: UN 3082
REGULATORY INFORMATION (15):
Composite HMIS Rating: Health: 2 Flammability: 0 Reactivity: 1
California Proposition 65: WARNING: THIS PRODUCT CONTAINS A CHEMICAL(S) KNOWN TO THE STATE OF
CALIFORNIA TO CAUSE REPRODUCTIVE TOXICITY.
Chemicals known to cause reproductive toxicity: Thimerosal (merthiolate sodium), CAS# 54-64-8; classified under the generic
class of mercury compounds.
Chemical(s) Known to cause cancer: The product does not contain listed substances.
Carcinogenicity Categories: No component, mixture or constituent has been classified as a carcinogen by NTP (National
Toxicity Program), IARC (International Agency for Research on Cancer), TLV-CAR (Threshold
Limit Value established by ACGIH) or OSHA.
WHMIS Classification: This MSDS contains the required information in accordance with the WHMIS hazard classification
criteria for this product.
Composite WHMIS Hazard Class: Class D2B (Material Causing Other Toxic Effects)
Class D3 (Biohazardous Infection Material)
Class E (Corrosive Material)
Markings According to European Guidelines: This product has been classified and labeled in accordance with applicable
European Community (EC) Directives (refer to 1999/45/EC, 2001/59/EC and 2001/60/EC).
Hazard Designation of Composite Product: C: CORROSIVE Xi: IRRITANT
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PLATELIATM LYME IgM [Catalog 25296]
Hazard Determining Substance(s) of Labeling: (rated under 1999/45/EC unless otherwise specified):
0.15% or 0.16% ProClin?300, per 2001/59/EC: Index No: 613-167-00-5 with CAS# 55965-84-9
[Xi: Irritant; R 43; S 24-35-37 ( 0.06% and > 0.0015% active ingredient)].
0.01% ProClin?300, per 2001/59/EC: Index No: 613-167-00-5 with CAS# 55965-84-9
[R 43; S 36 (< 0.0015% active ingredient)].
< 0.0005% Thimerosal, EINECS/ELINCS No: 200-210-4, CAS# 54-64-8 [R 43-61; S 24/25-36-60-61]
1N Sulfuric acid (H2SO4) [pH 2], CAS# 7664-93-9, EINECS/ELINCS No: 231-639-5;
[C: Corrosive; R 34 (eyes) 36/38-41; S 24/25-26-36/37/39-60 (1999/45/EC, 2001/60/EC)].
Risk Phrases:
R 34 Causes burns.
R 36/38 Irritating to eyes and skin.
R 41 Risk of serious damage to eyes.
R 43 May cause sensitization by skin contact.
R 61 May cause harm to unborn child. (Designation is for concentrated thimerosal (organo-mercury compound),
which is diluted to < 0.0005% in kit components).
Caution Contains inactivated pathogen and human source material. Handle as if capable of transmitting infectious agents
(Universal Precautions).
Safety Phrases:
S 24 Avoid contact with skin.
S 24/25 Avoid contact with skin and eyes.
S 25 Avoid contact with eyes.
S 26 In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
S 35 This material and its container must be disposed of in a safe way.
S 36 Wear suitable protective clothing.
S 37 Wear suitable gloves.
S 36/37/39 Wear suitable protective clothing, gloves and eye/face protection.
S 60 This material and/or its container must be disposed of as hazardous waste.
S 61 Avoid release to the environment. Refer to special instructions/safety data sheet.
OTHER INFORMATION (16):
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.
This Revision: Added component volumes and tab branding.
Contact for general information: Bio-Rad Laboratories, Redmond Operations
Environmental Health & Safety
6565 185th Ave. NE
Redmond, WA 98052
Phone: 425-881-8300 (8 am to 5 pm PST)
bio-rad.com
This document was developed from information obtained from reputable sources, but does not purport to be all-inclusive. The data contained
herein, which is based on our present knowledge and is intended for information purposes only, shall not constitute a guarantee for any specific
product features and shall not establish a legally valid contractual relationship. Regulatory requirements are subject to change and vary from one
location to another; thus, it is the buyer's responsibility to ensure that its activities comply with national, regional and local laws and regulations.
Bio-Rad Laboratories makes no warranty, expressed or implied, regarding the accuracy or completeness of these data or the results to be obtained
from the use thereof. Since the use of this information and the conditions of use of the product are not within the control of Bio-Rad Laboratories,
it is the user's obligation to determine the suitability of the information for the intended application and use appropriate safety procedures.
MSDS25296 Revision B (July 2008) 10 of 10
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