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MATERIAL SAFETY DATA SHEET
Creatinine Start Reagent (R1)
1. PRODUCT AND COMPANY IDENTIFICATION
Product Name: Creatinine Start Reagent (R1)
Product Number: 265-80-91R1
Kit Number: 265-30; 265-50; 265-OP
Synonym(s): Enzymatic Creatinine Reagent (R1)
Product Use: Component of Enzymatic Creatinine Assay. For the IN VITRO quantitative determination of
creatinine in serum, plasma and urine.
Description: Dilute, buffered aqueous solution containing small to trace amounts of enzyme (protein),
salt, antibiotic, surfactant and preservative.
Corporate Headquarters
Distributor
Emergency Telephone Numbers
Genzyme Corporation
Genzyme Diagnostics P.E.I. Inc.
Genzyme (U.S.): 617-562-4555
CHEMTREC (U.S.): 800-424-9300
CHEMTREC (Outside U.S.): +1 703-527-3887
Phone: 617-252-7500
Phone: 800-332-1042
Distributor
Distributor
Distributor
Genzyme Diagnostics
Genzyme Diagnostics
Genzyme Diagnostics
Phone: 800-332-1042
Phone: 800-999-6578
Phone: 44 (0) 1732 220022
2. HAZARDS IDENTIFICATION
Precautionary Statements:
CAUTION! The chemical, physical and toxicological properties of this preparation have not been thoroughlycharacterized. This preparation contains a small concentration of chloramphenicol which may cause cancer. Avoidcontact with eyes and skin. Do not ingest or inhale. Preparation appearance: light yellow liquid.
Routes of Exposure:
Occupational exposure routes may include eye contact, skin contact, skin absorption and inhalation.
Potential Health Effects:
Inhalation
Although there is no evidence that the enzyme(s) in this preparation induces specific respiratoryhypersensitivity, all proteins are potential respiratory allergens and may result in respiratorysensitization in certain individuals after repeated and/or prolonged inhalation exposure, producingmild to severe symptoms similar to pollen allergy or asthma, including mucous membrane or eyeirritation, itching of the skin or eyes, sneezing, nasal or sinus congestion, coughing, and tightnessin the chest. These symptoms may develop as late as 12 hours after exposure.
Eye exposure may cause irritation, redness and watering. Eye contact may cause systemiceffects.
Ingestion
Effects of ingestion are unknown, but may include digestive system irritation, nausea, vomiting ordiarrhea.
MATERIAL SAFETY DATA SHEET
Creatinine Start Reagent (R1)
Potential Health Effects:
Chronic Effects
Exposure to chloramphenicol may cause leukemia, a cancer of the blood or bone marrow. It maydisrupt the bone marrow's production of blood cells (aplastic anemia). Repeated exposure tochloramphenicol may damage the liver.
Target Organs
Chloramphenicol: blood, immune system (skin) and liver.
Regulatory Status:
This preparation is not classified as hazardous under E.C. Directive 1999/45/EC; Canadian R.S. 1985, c. H-3; U.K.
CHIPS 2009 No. 716 or U.N. GHS ST/SG/AC 10/30. This preparation is classified as hazardous under U.S. OSHA 29CFR 1910.1200.
This preparation contains chloramphenicol, which is classified by IARC as 2A, probably carcinogenic to humans.
Potential Environmental Effects:
3. COMPOSITION / INFORMATION ON INGREDIENTS
Ingredient Name
% (wt/wt)
EC R-Phrases: R43, R45, R63, R68
EC Hazard Class: T
4. FIRST AID MEASURES
Inhalation:
If inhaled, move from exposure area to fresh air. Seek medical attention if breathing becomes difficult or if cough orother symptoms develop.
Eye Contact:
Immediately flush eyes with plenty of tepid water while separating eyelids with fingers, removing contact lenses ifworn. Continue to flush for at least 15 minutes. Obtain medical attention if needed or if symptoms, such as redness orirritation persist.
Skin Contact:
In case of contact, immediately flush skin with copious amounts of cool water and remove contaminated clothing.
Obtain medical attention if needed or if irritation or other symptoms develop.
Ingestion:
In case of ingestion, contact a poison control center or physician for instructions.
5. FIRE FIGHTING MEASURES
Flammable Properties:
Dilute aqueous solution not considered a fire hazard.
Suitable Extinguishing Media:
Use extinguishing media suitable for surrounding fire, such as carbon dioxide, chemical foam, dry chemical or waterspray.
Unsuitable Extinguishing Media:
MATERIAL SAFETY DATA SHEET
Creatinine Start Reagent (R1)
Specific Hazards Arising from the Chemical:
Irritating and/or toxic gases may be emitted upon the product's decomposition.
Standard Protective Equipment and Precautions for Firefighters:
Firefighters should wear NIOSH-approved or equivalent Self-Contained Breathing Apparatus and full protective gear.
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions:
Wear Personal Protective Equipment (PPE) as indicated in Section 8. Avoid physical contact with material and avoidvapor inhalation. After handling, immediately wash any areas of the body that may have been exposed, whether ornot known skin contact has occurred.
Environmental Precautions:
Methods and Materials for Containment and Clean-Up:
Decontaminate the spill site following standard procedures. Dispose of materials in accordance with all applicablefederal, state, local and provincial environmental regulations, per Section 13.
7. HANDLING AND STORAGE
Handling:
Follow good laboratory hygiene practices. See Section 8, Engineering Controls. Minimize contact and contaminationof personal clothing and skin. Wash hands thoroughly after handling.
Storage:
Store at 2 - 8°C (36 - 46°F). Do not store with incompatible substances; see Section 10.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure Guidelines:
There are no ACGIH, NIOSH, OSHA or country-specific occupational exposure limits currently established forcomponents present in this preparation at concentrations equal to or greater than 1% (0.1% if carcinogen).
Engineering Controls:
Minimize potential for aerosolization. Handle within a containment system, with local exhaust ventilation, or withdilution ventilation at a minimum. Facilities storing or using this preparation should be equipped with an eyewashfountain.
Personal Protective Equipment (PPE):
Respiratory
A respiratory protection program that meets U.S. Federal OSHA 29 CFR 1910.134 and ANSIZ99.2, European Standard CR 529, or other applicable regulatory standards should be followedwhenever exposure limits may be exceeded (if applicable) and engineering controls are notfeasible, or if insufficient ventilation or workplace conditions warrant the use of respiratoryprotection. In such cases, a full-facepiece respirator with formaldehyde vapor cartridges selectedto provide a filtration efficiency appropriate to your workplace is recommended.
Eye/Face
Wear appropriate protective chemical safety goggles.
Wear appropriate protective clothing, such as a lab coat or other long-sleeved garment overclothing to minimize contact and contamination of clothing.
Wear chemical resistant protective gloves.
Follow company-specific safety procedures.
MATERIAL SAFETY DATA SHEET
Creatinine Start Reagent (R1)
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:
Solubility:
Specific Gravity:
Vapor Pressure:
Boiling Point:
Partition Coefficient
Melting Point:
(n-octanol/water):
Freezing Point:
Vapor Density:
Flammability/Explosivity Limits in Air, Lower:
Flammability/Explosivity Limits in Air, Upper:
Auto-Ignition Temperature: Not applicable
Flash Point:
10. STABILITY AND REACTIVITY
Chemical Stability:
Stable under ordinary conditions of use and storage. See Section 7.
Conditions to Avoid:
There are no physical conditions known to result in a hazardous situation.
Incompatible Materials:
Hazardous Decomposition Products:
Thermal decomposition can lead to release of irritating gases and vapors.
Possibility of Hazardous Reactions:
Hazardous polymerization will not occur.
11. TOXICOLOGICAL INFORMATION
Acute Effects:
Toxicology Data - Selected LD50s and LC50s
Chloramphenicol
Chronic Effects:
Chloramphenicol may induce aplastic anemia, and this condition is related to the occurrence of leukemia (HSDB).
Carcinogenicity:
IARC - Group 2A (Probably Carcinogenic to Humans)
Chloramphenicol
Monograph 50 [1990] (overall evaluation upgraded from 2B to2A with supporting evidence from other data relevant to theevaluation of carcinogenicity and its mechanisms),Supplement 7 [1987] NTP (National Toxicology Program) - Report on Carcinogens - Reasonably Anticipated to be Human Carcinogens
Chloramphenicol
Reasonably Anticipated To Be A Carcinogen U.S. - California - Proposition 65 - Carcinogens List
Chloramphenicol
U.S. - OSHA - Hazard Communication Carcinogens
Chloramphenicol
MATERIAL SAFETY DATA SHEET
Creatinine Start Reagent (R1)
Mutagenicity:
Chloramphenicol produced positive results in in vitro mutagenicity assays (EMEA).
Teratogenicity:
In teratogenicity studies in the rat and the rabbit chloramphenicol did not show teratogenic effects but caused a highincidence of fetal deaths (EMEA).
Reproductive Effects:
Sensitization:
Chloramphenicol induced allergic contact dermatitis has been reported in medical literature.
12. ECOLOGICAL INFORMATION
Ecotoxicity:
Persistance and Degradability:
Bioaccumulative Potential:
Mobility in Environmental Media:
13. DISPOSAL CONSIDERATIONS
Methods of Disposal:
Dispose of unused product, spilled material and waste in accordance with all applicable federal, state, local andprovincial environmental and hazardous waste regulations.
14. TRANSPORT INFORMATION
Basic Shipping Description:
Not classified as dangerous goods. Not regulated per IATA and DOT regulations.
15. REGULATORY INFORMATION
US Federal Regulations:
This preparation is a component of an FDA-regulated in vitro diagnostic device.
Inventory - United States - Section 8(b) Inventory (TSCA)
Chloramphenicol
US State Regulations:
U.S. - California - 8 CCR Section 339 - Director's List of Hazardous Substances
Chloramphenicol
MATERIAL SAFETY DATA SHEET
Creatinine Start Reagent (R1)
International Regulations:
If approved for European Communities use, this product is regulated under the In Vitro Diagnostic Medical Devices Directive(98/79/EC).
Canada - WHMIS - Classifications of Substances
Chloramphenicol
Inventory - Australia - Inventory of Chemical Substances (AICS)
Chloramphenicol
Inventory - Canada - Domestic Substances List (DSL)
Chloramphenicol
Inventory - China
Chloramphenicol
Inventory - European Union - European Inventory of Existing Commercial Chemical Substances (EINECS)
Chloramphenicol
Inventory - Korea - Existing and Evaluated Chemical Substances
Chloramphenicol
Canadian Hazardous Products:
WHMIS Status
European Communities Dangerous Substances/Preparations:
EC Hazard Class None
Risk Phrases None
Safety Phrases None
16. OTHER INFORMATION
Further Information:
This MSDS has been prepared in accordance with the ANSI Z400.1 format. Every effort has been made to adhere to the hazard criteriaand content requirements of the U.S. OSHA Hazard Communication Standard, Canadian Controlled Products Regulation (CPR), UKChemical Hazard Information and Packaging Regulations, European Communities REACH Regulation, and UN Globally HarmonizedSystem of Classification and Labelling of Chemicals (GHS).
MSDS Origination Date: July 01, 2009
Version #: 2
Revision Date: July 06, 2009
MATERIAL SAFETY DATA SHEET
Creatinine Start Reagent (R1)
Disclaimer:
The information above is provided in good faith. It is believed to be accurate and represents the best information currently available tous. HOWEVER, WE MAKE NO WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANYOTHER TYPE, EXPRESSED OR IMPLIED, WITH RESPECT TO PRODUCTS DESCRIBED OR DATA OR INFORMATIONPROVIDED, AND WE ASSUME NO LIABILITY RESULTING FROM THE USE OF SUCH PRODUCTS, DATA OR INFORMATION.
Users should make their own investigations to determine the suitability of the information for their particular purposes, and the userassumes all risk arising from their use of the material. The user is required to comply with all laws and regulations relating to thepurchase, use, storage and disposal of the material, and must be familiar with and follow generally accepted safe handling procedures.
In no event shall Genzyme be liable for any claims, losses, or damages of any individual or for lost profits or any special, indirect,incidental, consequential or exemplary damages, howsoever arising, even if Genzyme has been advised of the possibility of suchdamages.
MATERIAL SAFETY DATA SHEET
Creatinine Enzyme Reagent (R2)
1. PRODUCT AND COMPANY IDENTIFICATION
Product Name: Creatinine Enzyme Reagent (R2)
Product Number: 265-80-91R2
Kit Number: 265-30; 265-50; 265-OP
Synonym(s): Enzymatic Creatinine Reagent (R2)
Product Use: Component of Enzymatic Creatinine Assay. For the IN VITRO quantitative determination of
creatinine in serum, plasma and urine.
Description: Dilute, buffered aqueous solution containing small to trace amounts of enzyme (protein),
Corporate Headquarters
Distributor
Emergency Telephone Numbers
Genzyme Corporation
Genzyme Diagnostics P.E.I. Inc.
Genzyme (U.S.): 617-562-4555
CHEMTREC (U.S.): 800-424-9300
CHEMTREC (Outside U.S.): +1 703-527-3887
Phone: 617-252-7500
Phone: 800-332-1042
Distributor
Distributor
Distributor
Genzyme Diagnostics
Genzyme Diagnostics
Genzyme Diagnostics
Phone: 800-332-1042
Phone: 800-999-6578
Phone: 44 (0) 1732 220022
2. HAZARDS IDENTIFICATION
Precautionary Statements:
The chemical, physical and toxicological properties of this preparation have not been thoroughly characterized. Avoidcontact with eyes and skin. Do not ingest or inhale. Preparation appearance: light brown liquid.
Routes of Exposure:
Occupational exposure routes may include eye and skin contact.
Potential Health Effects:
Inhalation
Although there is no evidence that the enzyme(s) in this preparation induces specific respiratoryhypersensitivity, all proteins are potential respiratory allergens and may result in respiratorysensitization in certain individuals after repeated and/or prolonged inhalation exposure, producingmild to severe symptoms similar to pollen allergy or asthma, including mucous membrane or eyeirritation, itching of the skin or eyes, sneezing, nasal or sinus congestion, coughing, and tightnessin the chest. These symptoms may develop as late as 12 hours after exposure.
No data available. Eye exposure may cause irritation, redness and itching.
No data available. Skin contact may cause irritation, redness and discomfort.
Ingestion
Chronic Effects
Target Organs
MATERIAL SAFETY DATA SHEET
Creatinine Enzyme Reagent (R2)
Regulatory Status:
This preparation is not classified as hazardous under E.C. Directive 1999/45/EC; Canadian R.S. 1985, c. H-3; U.K.
CHIPS 2009 No. 716 or U.N. GHS ST/SG/AC 10/30. This preparation is classified as hazardous under U.S. OSHA 29CFR 1910.1200.
None of the components present in this preparation at concentrations equal to or greater than 0.1% are listed byIARC, NTP, OSHA or ACGIH as a carcinogen.
Potential Environmental Effects:
3. COMPOSITION / INFORMATION ON INGREDIENTS
No hazardous ingredients are present at or above the minimum concentration limits requiring disclosure per U.S. and internationalMSDS regulations.
4. FIRST AID MEASURES
Inhalation:
If inhaled, move from exposure area to fresh air. Seek medical attention if breathing becomes difficult or if cough orother symptoms develop.
Eye Contact:
Immediately flush eyes with plenty of tepid water for 15 minutes while separating eyelids with fingers. Remove contactlenses if worn. Obtain medical attention if needed or if symptoms, such as redness or irritation persist.
Skin Contact:
In case of contact, flush skin with copious amounts of cool water and remove contaminated clothing. Obtain medicalattention if needed or if irritation or other symptoms develop.
Ingestion:
In case of ingestion, contact a poison control center or physician for instructions.
5. FIRE FIGHTING MEASURES
Flammable Properties:
Dilute aqueous solution not considered a fire hazard.
Suitable Extinguishing Media:
Use extinguishing media suitable for surrounding fire, such as carbon dioxide, chemical foam, dry chemical or waterspray.
Unsuitable Extinguishing Media:
Specific Hazards Arising from the Chemical:
Standard Protective Equipment and Precautions for Firefighters:
Firefighters should wear NIOSH-approved or equivalent Self-Contained Breathing Apparatus and full protective gear.
MATERIAL SAFETY DATA SHEET
Creatinine Enzyme Reagent (R2)
6. ACCIDENTAL RELEASE MEASURES
Personal Precautions:
Wear Personal Protective Equipment (PPE) as indicated in Section 8. Avoid physical contact with material. Washhands thoroughly after handling.
Environmental Precautions:
Methods and Materials for Containment and Clean-Up:
Absorb spill with inert material/sorbent. Decontaminate the spill site following standard procedures. Dispose ofmaterials in accordance with all applicable federal, state, local and provincial environmental regulations, per Section13.
7. HANDLING AND STORAGE
Handling:
Follow good laboratory hygiene practices. See Section 8, Engineering Controls. Minimize contact and contaminationof personal clothing and skin. Wash hands thoroughly after handling.
Storage:
Store at 2 to 8°C (36 to 46°F). Do not store with incompatible substances. See Section 10.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
Exposure Guidelines:
There are no ACGIH, NIOSH, OSHA or country-specific occupational exposure limits currently established forcomponents present in this preparation at concentrations equal to or greater than 1% (0.1% if carcinogen).
Engineering Controls:
This preparation is not expected to require special ventilation measures. Facilities storing or using this preparationshould be equipped with an eyewash fountain.
Personal Protective Equipment (PPE):
Respiratory
A respirator is not required under normal conditions of use.
Eye/Face
Wear appropriate protective chemical safety glasses.
Wear lab coat or other protective garments. Remove contaminated clothing promptly.
Wear chemical resistant protective gloves.
Follow company-specific safety procedures.
9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance:
Solubility:
Boiling Point:
Evaporation Rate:
Melting Point:
Vapor Pressure:
Freezing Point:
Partition Coefficient
(n-octanol/water):
Viscosity:
Vapor Density:
MATERIAL SAFETY DATA SHEET
Creatinine Enzyme Reagent (R2)
Flammability/Explosivity Limits in Air, Lower:
Flammability/Explosivity Limits in Air, Upper:
Auto-Ignition Temperature: Not applicable
Flash Point:
10. STABILITY AND REACTIVITY
Chemical Stability:
Stable under ordinary conditions of use and storage. See Section 7.
Conditions to Avoid:
There are no physical conditions known to result in a hazardous situation.
Incompatible Materials:
Hazardous Decomposition Products:
None expected under normal conditions of use.
Possibility of Hazardous Reactions:
Hazardous polymerization will not occur.
11. TOXICOLOGICAL INFORMATION
Acute Effects:
Chronic Effects:
Carcinogenicity:
Mutagenicity:
Teratogenicity:
Reproductive Effects:
Sensitization:
12. ECOLOGICAL INFORMATION
Ecotoxicity:
Persistance and Degradability:
Bioaccumulative Potential:
MATERIAL SAFETY DATA SHEET
Creatinine Enzyme Reagent (R2)
Mobility in Environmental Media:
13. DISPOSAL CONSIDERATIONS
Methods of Disposal:
Do not pour this preparation down the drain. Dispose of unused product, spilled material and waste in accordance withall applicable federal, state, local and provincial environmental and hazardous waste regulations.
14. TRANSPORT INFORMATION
Basic Shipping Description:
Not classified as dangerous goods. Not regulated per IATA and DOT regulations.
15. REGULATORY INFORMATION
US Federal Regulations:
This preparation is a component of an FDA-regulated in vitro diagnostic device.
International Regulations:
If approved for European Communities use, this product is regulated under the In Vitro Diagnostic Medical Devices Directive(98/79/EC).
Canadian Hazardous Products:
WHMIS Status
European Communities Dangerous Substances/Preparations:
EC Hazard Class None
Risk Phrases None
Safety Phrases None
16. OTHER INFORMATION
Further Information:
This MSDS has been prepared in accordance with the ANSI Z400.1 format. Every effort has been made to adhere to the hazard criteriaand content requirements of the U.S. OSHA Hazard Communication Standard, Canadian Controlled Products Regulation (CPR), UKChemical Hazard Information and Packaging Regulations, European Communities REACH Regulation, and UN Globally HarmonizedSystem of Classification and Labelling of Chemicals (GHS).
MSDS Origination Date: July 01, 2009
Version #: 2
Revision Date: July 06, 2009
MATERIAL SAFETY DATA SHEET
Creatinine Enzyme Reagent (R2)
Disclaimer:
The information above is provided in good faith. It is believed to be accurate and represents the best information currently available tous. HOWEVER, WE MAKE NO WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANYOTHER TYPE, EXPRESSED OR IMPLIED, WITH RESPECT TO PRODUCTS DESCRIBED OR DATA OR INFORMATIONPROVIDED, AND WE ASSUME NO LIABILITY RESULTING FROM THE USE OF SUCH PRODUCTS, DATA OR INFORMATION.
Users should make their own investigations to determine the suitability of the information for their particular purposes, and the userassumes all risk arising from their use of the material. The user is required to comply with all laws and regulations relating to thepurchase, use, storage and disposal of the material, and must be familiar with and follow generally accepted safe handling procedures.
In no event shall Genzyme be liable for any claims, losses, or damages of any individual or for lost profits or any special, indirect,incidental, consequential or exemplary damages, howsoever arising, even if Genzyme has been advised of the possibility of suchdamages.

Source: http://www.biopacific.net/MSDS/Genzyme_CREAT-ENZYM_265_MSDS.pdf