MATERIAL SAFETY DATA SHEET
-Amylase Test Reagent (CNPG3)
1. PRODUCT AND COMPANY IDENTIFICATION
.
Product Name: -Amylase Test Reagent (CNPG3)
Product Number: 80-3500-20; 80-3500-50; 80-3603-01; 80-3844-03; 80-5260-00; 80-5383-00; 80-5451-00
Synonym(s): Liquid Select Amylase; Direct Amylase Reagent; Amylase Direct; alpha-Amylase Test Reagent
(CNPG3)
Product Use: For the quantitative determination of alpha-amylase activity in serum and plasma; to assist in
the diagnosis of acute pancreatitis. For In Vitro Diagnostic Use Only.
Description: Aqueous solution containing chromogenic substrate, buffer, preservative and salts.
Distributor Emergency Telephone Numbers
Corporate Headquarters
Genzyme (U.S.): 617-562-4555
Genzyme Diagnostics
Genzyme Corporation
CHEMTREC (U.S.): 800-424-9300
50 Gibson Drive
500 Kendall Street
CHEMTREC (Outside U.S.): 703-527-3887
Kings Hill, West Malling
Cambridge, MA 02142
Kent, ME19 4AF
USA
UK
Phone: 617-252-7500
Phone: 44 (0) 1732 220022
Manufacturer/Distributor
Genzyme Diagnostics
31 New York Avenue
Framingham, MA 01701-9322
USA
Phone: 800-332-1042
2. HAZARDS IDENTIFICATION
.
Precautionary Statements:
CAUTION! The chemical, physical and toxicological properties of this preparation have not been thoroughly
characterized. May be irritating to eyes, respiratory system and skin. May be harmful in contact with skin and if
swallowed. Avoid contact with eyes and skin. Do not ingest or inhale. Preparation appearance: clear, faint yellow
liquid.
Routes of Exposure:
Occupational exposure routes may include eye contact, skin contact, skin absorption and inhalation.
Potential Health Effects:
Symptoms of acute potassium thiocyanate exposure may be similar to acute cyanide toxicity:
Inhalation
Acute inhalation may cause coughing, mucosal irritation and dyspnea (shortness of breath).
No data available. Eye exposure may cause irritation, redness, watering and pain.
Eye
Symptoms of acute potassium thiocyanate exposure may be similar to acute cyanide toxicity:
Skin
Skin contact may cause irritation, redness, itching and pain. Dermal absorption and eye contact
may result in systemic effects.
Symptoms of acute potassium thiocyanate exposure may be similar to acute cyanide toxicity:
Ingestion
Low oral doses of cyanides produce symptoms of weakness, headache, confusion, and
occasionally nausea and vomiting.
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MATERIAL SAFETY DATA SHEET
-Amylase Test Reagent (CNPG3)
Potential Health Effects:
Symptoms of potassium thiocyanate intoxication may be similar to chronic cyanide toxicity.
Chronic Effects
Subchronic and chronic effects of cyanide inhalation include: CNS effects, such as vertigo
(dizziness), nystagmus (abnormal eye movement), nervousness, headache, weakness, loss of
appetite, and changes in smell and taste; CVS effects, such as precordial (central chest) pain,
EKG abnormalities, and breathing difficulties; GI tract effects, such as nausea, vomiting, and
gastritis (stomach lining inflammation); enlarged thyroid/goiter; and skin effects, such as
dermatitis, itching, scarlet rash, papules (bumps) and severe irritation of the nose and throat.
Symptoms of chronic ingestion of cyanide include: CNS effects, such as neuropathies (nerve
problems) and amblyopia (lazy eye); and thyroid abnormalities. Subchronic dermal exposure
symptoms include itching, rash, papules, dermatitis, skin and nail discoloration, diarrhea,
headache, and body and limb numbness, weakness and pain.
Potassium thiocyanate: central nervous system, cardiovascular system and thyroid.
Target Organs
Regulatory Status:
This preparation is classified as hazardous under U.S. OSHA 29 CFR 1910.1200; E.C. Directive 1999/45/EC;
Canadian R.S. 1985, c. H-3; U.K. CHIP 2002 No. 1689; and/or U.N. GHS ST/SG/AC 10/30. Refer to Sec. 15,
Regulatory Information, for details regarding hazard classification.
None of the components present in this preparation at concentrations equal to or greater than 0.1% are listed by
IARC, NTP, OSHA or ACGIH as a carcinogen.
Potential Environmental Effects:
See Section 12.
3. COMPOSITION / INFORMATION ON INGREDIENTS
. .
CAS # EC #
Ingredient Name % (wt/wt)
Water 7732-18-5 231-791-2 81 - 91
EC R-Phrases: None EC Hazard Class: None
Potassium thiocyanate 333-20-0 206-370-1 7-8
EC R-Phrases: R20/21/22, R52/53 EC Hazard Class: Xn
Sodium chloride 7647-14-5 231-598-3 1-2
EC R-Phrases: None EC Hazard Class: None
4-Morpholineethanesulfonic (MES) monohydrate, free acid 4432-31-9 224-632-3 1-8
EC R-Phrases: None EC Hazard Class: None
2-Chloro-4-nitrophenyl maltotrioside (CNPG3) Not Assigned Not Assigned < 0.2
EC R-Phrases: None EC Hazard Class: None
Calcium acetate 62-54-4 200-540-9 < 0.1
EC R-Phrases: None EC Hazard Class: None
Sodium azide 26628-22-8 247-852-1 < 0.1
EC R-Phrases: R28, R32, R50, R53 EC Hazard Class: T+, N
4. FIRST AID MEASURES
.
Inhalation:
If inhaled, move from exposure area to fresh air. Seek medical attention if breathing becomes difficult or if cough or
other symptoms develop.
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MATERIAL SAFETY DATA SHEET
-Amylase Test Reagent (CNPG3)
Eye Contact:
Immediately flush eyes with plenty of tepid water for 15 minutes while separating eyelids with fingers. Remove contact
lenses 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 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 water
spray.
Unsuitable Extinguishing Media:
Unknown.
Specific Hazards Arising from the Chemical:
Unknown.
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. Wash
hands thoroughly after handling.
Environmental Precautions:
This preparation contains a small amount of sodium azide which can react with copper, lead, brass or solder in
plumbing systems and form potentially explosive metal azides. Follow proper disposal procedures.
Methods and Materials for Containment and Clean-Up:
Absorb spill with inert material/sorbent. Decontaminate the spill site following standard procedures. Dispose of
materials in accordance with all applicable federal, 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 contamination
of personal clothing and skin. Wash hands thoroughly after handling.
Storage:
Store at 2 - 8癈 (36 - 46癋). Do not freeze. Do not store with incompatible substances. See Section 10.
8. EXPOSURE CONTROLS / PERSONAL PROTECTION
.
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MATERIAL SAFETY DATA SHEET
-Amylase Test Reagent (CNPG3)
Engineering Controls:
Minimize potential for aerosolization. Handle within a containment system, with local exhaust ventilation, or with
dilution ventilation at a minimum. Facilities storing or using this preparation should be equipped with an eyewash
fountain.
Personal Protective Equipment (PPE):
A respirator is not required under normal conditions of use.
Respiratory
Wear appropriate protective chemical safety glasses.
Eye/Face
Wear lab coat or other protective garments. Remove contaminated clothing promptly.
Skin
Wear chemical resistant protective gloves.
Gloves
Follow company-specific safety procedures.
General
9. PHYSICAL AND CHEMICAL PROPERTIES
.
Clear, faint yellow liquid 6.0
Appearance: pH:
Not available Water-soluble
Odor: Solubility:
1.04 Not available
Specific Gravity: Evaporation Rate:
Not available Not available
Boiling Point: Vapor Pressure:
Not applicable Not available
Melting Point: Partition Coefficient
(n-octanol/water):
Not available
Freezing Point:
Not available
Vapor Density:
Not available
Viscosity:
Not available
Flammability/Explosivity Limits in Air, Lower:
Not available
Flammability/Explosivity Limits in Air, Upper:
Auto-Ignition Temperature: Not applicable
Not available
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:
Avoid strong oxidizing agents, acids, heavy metals and their salts. Thiocyanates can develop toxic gas in contact with
strong acids.
Hazardous Decomposition Products:
None expected under normal conditions of use.
Possibility of Hazardous Reactions:
Hazardous polymerization will not occur.
11. TOXICOLOGICAL INFORMATION
.
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MATERIAL SAFETY DATA SHEET
-Amylase Test Reagent (CNPG3)
Acute Effects:
Toxicology Data - Selected LD50s and LC50s
Potassium thiocyanate 333-20-0 Oral LD50 Rat: 854 mg/kg
Sodium chloride 7647-14-5 Inhalation LC50 Rat: >42 g/m3/1H; Oral LD50 Rat: 3 g/kg;
Dermal LD50 Rabbit: >10 g/kg
Local Effects:
No data available.
Chronic Effects:
No data available.
Carcinogenicity:
No data available.
Mutagenicity:
No data available.
Teratogenicity:
No data available.
Reproductive Effects:
No data available.
Sensitization:
No data available.
12. ECOLOGICAL INFORMATION
.
Ecotoxicity:
Ecotoxicity - Freshwater Fish Species Data
Sodium chloride 7647-14-5 96 Hr LC50 Lepomis macrochirus: 9675 mg/L [flow-through];
96 Hr LC50 Lepomis macrochirus: 12946 mg/L [static]; 96 Hr
LC50 Pimephales promelas: 7650 mg/L [static]
Ecotoxicity - Water Flea Data
Sodium chloride 7647-14-5 48 Hr EC50 Daphnia magna: 1000 mg/L
Persistance and Degradability:
No data available.
Bioaccumulative Potential:
No data available.
Mobility in Environmental Media:
No data available.
13. DISPOSAL CONSIDERATIONS
.
Methods of Disposal:
This preparation contains a small amount of sodium azide which can react with copper, lead, brass or solder in
plumbing systems and form potentially explosive metal azides. If preparation enters drain, flush with a large volume of
water to prevent azide build-up. Dispose of unused product, spilled material and waste in accordance with all applicable
federal, state, local and provincial environmental and hazardous waste regulations.
14. TRANSPORT INFORMATION
.
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MATERIAL SAFETY DATA SHEET
-Amylase Test Reagent (CNPG3)
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)
4-Morpholineethanesulfonic (MES) monohydrate, 4432-31-9 Present
free acid
Potassium thiocyanate 333-20-0 Present
Sodium chloride 7647-14-5 Present
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
Potassium thiocyanate 333-20-0 Uncontrolled product according to WHMIS classification
criteria
Sodium chloride 7647-14-5 Uncontrolled product according to WHMIS classification
criteria
Germany - Water Classification (VwVwS) - Annex 2 - Water Hazard Classes
Sodium chloride 7647-14-5 ID Number 270, hazard class 1 - low hazard to waters
Inventory - Australia - Inventory of Chemical Substances (AICS)
4-Morpholineethanesulfonic (MES) monohydrate, 4432-31-9 Present
free acid
Potassium thiocyanate 333-20-0 Present
Sodium chloride 7647-14-5 Present
Inventory - Canada - Domestic Substances List (DSL)
4-Morpholineethanesulfonic (MES) monohydrate, 4432-31-9 Present
free acid
Potassium thiocyanate 333-20-0 Present
Sodium chloride 7647-14-5 Present
Inventory - China
4-Morpholineethanesulfonic (MES) monohydrate, 4432-31-9 Present
free acid
Potassium thiocyanate 333-20-0 Present
Sodium chloride 7647-14-5 Present
Inventory - European Union - European Inventory of Existing Commercial Chemical Substances (EINECS)
4-Morpholineethanesulfonic (MES) monohydrate, 4432-31-9 224-632-3
free acid
Potassium thiocyanate 333-20-0 206-370-1
Sodium chloride 7647-14-5 231-598-3
Inventory - Japan Existing and New Chemical Substances (ENCS)
Potassium thiocyanate 333-20-0 1-152
Sodium chloride 7647-14-5 1-236
Inventory - Korea - Existing and Evaluated Chemical Substances
4-Morpholineethanesulfonic (MES) monohydrate, 4432-31-9 KE-25529
free acid
Potassium thiocyanate 333-20-0 KE-29216
Sodium chloride 7647-14-5 KE-31387
Canadian Hazardous Products:
Exempt
WHMIS Status
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MATERIAL SAFETY DATA SHEET
-Amylase Test Reagent (CNPG3)
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 criteria
and content requirements of the U.S. OSHA Hazard Communication Standard, Canadian Controlled Products Regulation (CPR), UK
Chemical Hazard Information and Packaging Regulations, European Communities REACH Regulation, and UN Globally Harmonized
System of Classification and Labelling of Chemicals.
MSDS Origination Date: April 12, 2005
Version #: 3
Revision Date: October 29, 2008
Disclaimer:
The information above is provided in good faith. It is believed to be accurate and represents the best information currently available to
us. HOWEVER, WE MAKE NO WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR OF ANY
OTHER TYPE, EXPRESSED OR IMPLIED, WITH RESPECT TO PRODUCTS DESCRIBED OR DATA OR INFORMATION
PROVIDED, 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 user
assumes all risk arising from their use of the material. The user is required to comply with all laws and regulations relating to the
purchase, 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 such
damages.
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