Material Safety Data Sheet
Gen-Probe Incorporated Phone: 858-410-8000
10210 Genetic Center Drive Prepared: 4/14/06
San Diego, CA 92121-4362 Updated: 6/7/06
Page 1 of 6
Product Name: Aptima HCV - Proficiency Panels
Product Description: HCV Proficiency Panels A, C, D
Used in: 400474, 400476, 400477
MSDS Number: 0003
I. Product and Company Description
Gen-Probe Incorporated.
10210 Genetic Center Drive
San Diego, CA 92121-4362
For Product Information/Emergency Phone Number:
(800) 424-9300 (CHEMTREC US)
(703) 527-3887 (CHEMTREC International)
(858) 410-8000 (Gen-Probe Corporate Office)
For product use see insert
Chemical Name or Synonym:
N/A
II. Chemical Composition
Component CAS # EC # %Composition
Human Serum NA NA >99
Sodium Azide 26628-22-8 247-852-1 <1
Gentamycin Sulfate 1405-41-0 215-778-9 <0.1
III. Hazards Identification
A. Emergency Overview:
Information Pertaining To Particular Dangers For Man And Environment:
This product is a human derived material. The human source material used to manufacture the
positive Hepatitis C Virus (HCV) control material was tested at collection for those infectious
agents which are currently screened in donated human plasma in the U.S., and was found to be
negative for all agents screened except HCV. The positive Hepatitis C Virus control material in
the products listed on this MSDS has undergone a heat inactivation process to achieve a
minimum of 10E6 kill of HCV. No known test method can offer complete assurance that products
derived from human blood will not transmit infectious agents. Handle all biological materials as
though capable of transmitting infection. Follow the recommendations of the Centers for Disease
Control (CDC) guidelines, Occupational Safety and Health Administration (OSHA), and
established Good Laboratory Practices (GLP) or the applicable country equivalent
regulations/recommendations when handling this material.
Material Safety Data Sheet
Gen-Probe Incorporated Phone: 858-410-8000
10210 Genetic Center Drive Prepared: 4/14/06
San Diego, CA 92121-4362 Updated: 6/7/06
Page 2 of 6
Physical Appearance:
Amber-colored frozen liquid
B. Potential Health Effects:
Acute Eye:
May cause irritation.
Acute Skin:
May cause irritation.
Acute Inhalation:
May be harmful if inhaled.
Acute ingestion:
May be harmful if swallowed.
Medical Conditions Generally Aggravated by Exposure:
ND
IV. First Aid Measures
First Aid Measures for Accidental:
Eye Exposure:
Immediately flush eyes with copious amounts of water for at least 15 minutes. If irritation
develops, SEEK MEDICAL ATTENTION.
Skin Exposure:
Wash affected areas with soap and water. If irritation develops, SEEK MEDICAL ATTENTION.
Inhalation:
Move to fresh air. If not breathing, administer artificial respiration. If breathing is difficult, give
oxygen. SEEK MEDICAL ATTENTION.
Ingestion:
If swallowed, rinse mouth out with water. Never give fluids or induce vomiting if the victim is
unconscious or having convulsions. SEEK MEDICAL ATTENTION.
V. Fire Fighting Measures
Fire Hazard Data:
Autoignition: NA
Flash Point: NA
Flammability Limits (vol/vol%): Lower: Upper:
NA NA
Material Safety Data Sheet
Gen-Probe Incorporated Phone: 858-410-8000
10210 Genetic Center Drive Prepared: 4/14/06
San Diego, CA 92121-4362 Updated: 6/7/06
Page 3 of 6
Extinguishing Media:
Use extinguishing media appropriate for surrounding fire
Special Fire Fighting Procedures:
None
Unusual Fire and Explosion Hazards:
None
VI. Accidental Release Measures
Cleanup and Disposal of Spill:
Use Universal Precautions as recommended by CDC/NIH or other biosafety guidelines for handling blood
and blood products of human origin. Discard any product, residue, disposable container or liner in full
compliance with national regulations.
VII. Handling and Storage
Handling/Storage:
Use Universal Precautions as recommended by CDC/NIH or other biosafety guidelines for handling blood
and blood products of human origin.
VIII. Exposure Controls / Personal Protection
Exposure Guidelines:
Component ACGIH NIOSH OSHA-PELs
Human plasma NA NA NA
0.1 ppm ceiling
Ceiling 0.29 (skin) as HN3, 0.3
Sodium Azide ND
mg/m3 mg/m3 ceiling (skin)
as NaN3
Gentamycin Sulfate ND ND ND
Engineering Controls:
Ventilation must be adequate to maintain the ambient workplace atmosphere below the exposure limit(s)
outlined in the MSDS. General room ventilation is satisfactory under anticipated use conditions.
Respiratory Protection:
Not required under anticipated use conditions.
Eye / Face Protection:
Wear appropriate safety glasses with side shields or chemical goggles as described by OSHA鈥檚 eye and
face protection regulations in 29CFR 1910.133 or European Standard EN166.
Skin Protection:
Wear chemical resistant gloves (such as latex or neoprene) and protective clothing to minimize skin
contact.
Material Safety Data Sheet
Gen-Probe Incorporated Phone: 858-410-8000
10210 Genetic Center Drive Prepared: 4/14/06
San Diego, CA 92121-4362 Updated: 6/7/06
Page 4 of 6
IX. Physical and Chemical Properties
Physical Appearance: Amber-colored frozen solid
Odor: None
pH: N/A
Specific Gravity: Slightly greater than 1
Water Solubility: ND
Melting Point: ND
Freezing Point ND
Boiling Point: ND
Vapor Pressure: ND
Vapor Density: ND
Percent Volatiles by Volume: ND
Viscosity: ND
Molecular Weight: ND
X. Stability and Reactivity
Chemical Stability:
Stable
Conditions to Avoid:
None
Materials / Chemicals to Be Avoided:
Strong oxidizing agents and acids.
Hazardous Decomposition Products:
Azide reacts with metal halides to give a range of metal azide halides, many of which are explosive.
Hazardous Polymerization:
Will not occur.
XI. Toxicological Information
Carcinogenicity:
NTP: NO
IARC: NO
Material Safety Data Sheet
Gen-Probe Incorporated Phone: 858-410-8000
10210 Genetic Center Drive Prepared: 4/14/06
San Diego, CA 92121-4362 Updated: 6/7/06
Page 5 of 6
OSHA: NO
Acute Dermal Toxicity:
For Sodium Azide: Skin rabbit LD50: 20 mg/kg
Acute Oral Toxicity:
For Sodium Azide: Oral rat LD50: 27 mg/kg
Acute Inhalation Toxicity:
ND
Chronic Toxicity:
Mutagenicity: Sodium azide may alter genetic material.
Reproductive effects: ND
XII. Ecological Information
Ecotoxicological Information:
Not Determined
XIII. Disposal Considerations
Waste Disposal Method:
Discard any product, residue, disposable container or liner in full compliance with national regulations.
Container Handling and Disposal:
Dispose of container and unused contents in accordance with national regulations.
XIV. Transportation Information
Shipping Name:
Not Regulated
Proper Shipping Name
Not Regulated
Hazard Class
ADR/RID/IMO/ICAO
/US DOT Not Regulated
ID Number
Not Regulated
Packaging Group
Not Regulated
Label Statement
XV. Regulatory Information
U.S. Federal Regulations:
SARA Title III Hazard Classes:
Fire Hazard: No
Reactive Hazard: No
Release of Pressure: No
Acute Health Hazard: No
Material Safety Data Sheet
Gen-Probe Incorporated Phone: 858-410-8000
10210 Genetic Center Drive Prepared: 4/14/06
San Diego, CA 92121-4362 Updated: 6/7/06
Page 6 of 6
Chronic Health Hazard: No
TSCA
All components of this product are on the TSCA inventory or are not required to be listed.
Other Regulations:
U.S. State
None
European/International Regulations
Risk Phrases:
None
Safety Phrases:
None
Hazard Symbol:
Xn: Harmful
XVI. Other Information
National Paint & Coating Hazardous Materials Identification System 鈥? HMIS(R):
Health Hazard: 1
Flammability: 0
Reactivity: 0
Key Legend Information:
N/A 鈥? Not Applicable
ND 鈥? Not Determined
ACGIH 鈥? American Conference of Governmental Industrial Hygienists
OSHA 鈥? Occupational Safety and Health Administration
TLV 鈥? Threshold Limit Value
PEL 鈥? Permissible Exposure Limit
TWA 鈥? Time Weighted Average
STEL 鈥? Short Term Exposure Limit
NTP 鈥? National Toxicology Program
IARC 鈥? International Agency for Research on Cancer
The information contained herein is based on the data available to us and is believed to be
correct. However Gen Probe Incorporated makes no warranty, expressed or implied regarding the
accuracy of this data or the results to be obtained from the use thereof.
Material Safety Data Sheet
Gen-Probe Incorporated Phone: 858-410-8000
10210 Genetic Center Drive Prepared: 4/14/06
San Diego, CA 92121-4362 Updated: 6/7/06
Page 1 of 6
Product Name: Aptima HCV - Proficiency Panel
Product Description: HCV Proficiency Panel B
Used in: 400475
MSDS Number: 0004
I. Product and Company Description
Gen-Probe Incorporated.
10210 Genetic Center Drive
San Diego, CA 92121-4362
For Product Information/Emergency Phone Number:
(800) 424-9300 (CHEMTREC US)
(703) 527-3887 (CHEMTREC International)
(858) 410-8000 (Gen-Probe Corporate Office)
For product use see insert
Chemical Name or Synonym:
N/A
II. Chemical Composition
Component CAS # EC # %Composition
Human Serum NA NA >99
Sodium Azide 26628-22-8 247-852-1 <1
Gentamycin Sulfate 1405-41-0 215-778-9 <0.1
III. Hazards Identification
A. Emergency Overview:
Information Pertaining To Particular Dangers For Man And Environment:
This product is a human derived material. The human source material used to manufacture the
negative Hepatitis C Virus (HCV) control material was tested at collection for those infectious
agents which are currently screened in donated human plasma in the U.S., and was found to be
negative for all agents screened. No known test method can offer complete assurance that
products derived from human blood will not transmit infectious agents.
Handle all biological materials as though capable of transmitting infection. Follow the
recommendations of the Centers for Disease Control (CDC) guidelines, Occupational Safety and
Health Administration (OSHA), and established Good Laboratory Practices (GLP) or the
applicable country equivalent regulations/recommendations when handling this material.
Physical Appearance:
Amber-colored frozen liquid
Material Safety Data Sheet
Gen-Probe Incorporated Phone: 858-410-8000
10210 Genetic Center Drive Prepared: 4/14/06
San Diego, CA 92121-4362 Updated: 6/7/06
Page 2 of 6
B. Potential Health Effects:
Acute Eye:
May cause irritation.
Acute Skin:
May cause irritation.
Acute Inhalation:
May be harmful if inhaled.
Acute ingestion:
May be harmful if swallowed.
Medical Conditions Generally Aggravated by Exposure:
ND
IV. First Aid Measures
First Aid Measures for Accidental:
Eye Exposure:
Immediately flush eyes with copious amounts of water for at least 15 minutes. If irritation
develops, SEEK MEDICAL ATTENTION.
Skin Exposure:
Wash affected areas with soap and water. If irritation develops, SEEK MEDICAL ATTENTION.
Inhalation:
Move to fresh air. If not breathing, administer artificial respiration. If breathing is difficult, give
oxygen. SEEK MEDICAL ATTENTION.
Ingestion:
If swallowed, rinse mouth out with water. Never give fluids or induce vomiting if the victim is
unconscious or having convulsions. SEEK MEDICAL ATTENTION.
V. Fire Fighting Measures
Fire Hazard Data:
Autoignition: NA
Flash Point: NA
Flammability Limits (vol/vol%): Lower: Upper:
NA NA
Extinguishing Media:
Use extinguishing media appropriate for surrounding fire
Material Safety Data Sheet
Gen-Probe Incorporated Phone: 858-410-8000
10210 Genetic Center Drive Prepared: 4/14/06
San Diego, CA 92121-4362 Updated: 6/7/06
Page 3 of 6
Special Fire Fighting Procedures:
None
Unusual Fire and Explosion Hazards:
None
VI. Accidental Release Measures
Cleanup and Disposal of Spill:
Use Universal Precautions as recommended by CDC/NIH or other biosafety guidelines for handling blood
and blood products of human origin. Discard any product, residue, disposable container or liner in full
compliance with national regulations.
VII. Handling and Storage
Handling/Storage:
Use Universal Precautions as recommended by CDC/NIH or other biosafety guidelines for handling blood
and blood products of human origin.
VIII. Exposure Controls / Personal Protection
Exposure Guidelines:
Component ACGIH NIOSH OSHA-PELs
Human plasma NA NA NA
0.1 ppm ceiling
Ceiling 0.29 (skin) as HN3, 0.3
Sodium Azide ND
mg/m3 mg/m3 ceiling (skin)
as NaN3
Gentamycin Sulfate ND ND ND
Engineering Controls:
Ventilation must be adequate to maintain the ambient workplace atmosphere below the exposure limit(s)
outlined in the MSDS. General room ventilation is satisfactory under anticipated use conditions.
Respiratory Protection:
Not required under anticipated use conditions.
Eye / Face Protection:
Wear appropriate safety glasses with side shields or chemical goggles as described by OSHA鈥檚 eye and
face protection regulations in 29CFR 1910.133 or European Standard EN166.
Skin Protection:
Wear chemical resistant gloves (such as latex or neoprene) and protective clothing to minimize skin
contact.
Material Safety Data Sheet
Gen-Probe Incorporated Phone: 858-410-8000
10210 Genetic Center Drive Prepared: 4/14/06
San Diego, CA 92121-4362 Updated: 6/7/06
Page 4 of 6
IX. Physical and Chemical Properties
Physical Appearance: Amber-colored frozen solid
Odor: None
pH: N/A
Specific Gravity: Slightly greater than 1
Water Solubility: ND
Melting Point: ND
Freezing Point ND
Boiling Point: ND
Vapor Pressure: ND
Vapor Density: ND
Percent Volatiles by Volume: ND
Viscosity: ND
Molecular Weight: ND
X. Stability and Reactivity
Chemical Stability:
Stable
Conditions to Avoid:
None
Materials / Chemicals to Be Avoided:
Strong oxidizing agents and acids.
Hazardous Decomposition Products:
Azide reacts with metal halides to give a range of metal azide halides, many of which are explosive.
Hazardous Polymerization:
Will not occur.
XI. Toxicological Information
Carcinogenicity:
NTP: NO
IARC: NO
Material Safety Data Sheet
Gen-Probe Incorporated Phone: 858-410-8000
10210 Genetic Center Drive Prepared: 4/14/06
San Diego, CA 92121-4362 Updated: 6/7/06
Page 5 of 6
OSHA: NO
Acute Dermal Toxicity:
For Sodium Azide: Skin rabbit LD50: 20 mg/kg
Acute Oral Toxicity:
For Sodium Azide: Oral rat LD50: 27 mg/kg
Acute Inhalation Toxicity:
ND
Chronic Toxicity:
Mutagenicity: Sodium azide may alter genetic material.
Reproductive effects: ND
XII. Ecological Information
Ecotoxicological Information:
Not Determined
XIII. Disposal Considerations
Waste Disposal Method:
Discard any product, residue, disposable container or liner in full compliance with national regulations.
Container Handling and Disposal:
Dispose of container and unused contents in accordance with national regulations.
XIV. Transportation Information
Shipping Name:
Not Regulated
Proper Shipping Name
Not Regulated
Hazard Class
ADR/RID/IMO/ICAO
/US DOT Not Regulated
ID Number
Not Regulated
Packaging Group
Not Regulated
Label Statement
XV. Regulatory Information
U.S. Federal Regulations:
SARA Title III Hazard Classes:
Fire Hazard: No
Reactive Hazard: No
Release of Pressure: No
Acute Health Hazard: No
Material Safety Data Sheet
Gen-Probe Incorporated Phone: 858-410-8000
10210 Genetic Center Drive Prepared: 4/14/06
San Diego, CA 92121-4362 Updated: 6/7/06
Page 6 of 6
Chronic Health Hazard: No
TSCA
All components of this product are on the TSCA inventory or are not required to be listed.
Other Regulations:
U.S. State
None
European/International Regulations
Risk Phrases:
None
Safety Phrases:
None
Hazard Symbol:
Xn: Harmful
XVI. Other Information
National Paint & Coating Hazardous Materials Identification System 鈥? HMIS(R):
Health Hazard: 1
Flammability: 0
Reactivity: 0
Key Legend Information:
N/A 鈥? Not Applicable
ND 鈥? Not Determined
ACGIH 鈥? American Conference of Governmental Industrial Hygienists
OSHA 鈥? Occupational Safety and Health Administration
TLV 鈥? Threshold Limit Value
PEL 鈥? Permissible Exposure Limit
TWA 鈥? Time Weighted Average
STEL 鈥? Short Term Exposure Limit
NTP 鈥? National Toxicology Program
IARC 鈥? International Agency for Research on Cancer
The information contained herein is based on the data available to us and is believed to be
correct. However Gen Probe Incorporated makes no warranty, expressed or implied regarding the
accuracy of this data or the results to be obtained from the use thereof.
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