MATERIAL SAFETY DATA SHEET
Prepared to U.S. OSHA, CMA, ANSI, Canadian WHMIS, European Union, and Australian NOHSC Standards
PART I What is the material and what do I need to know in an emergency?
1. PRODUCT IDENTIFICATION
VITALAB® SERUM CONTROL KIT
TRADE NAME (AS LABELED):
PRODUCT NUMBER (AS LABELED): 33120
CHEMICAL FORMULA: Not Applicable-Mixture
SYNONYMS: None
U.N. NUMBER: Not Applicable
U.N. DANGEROUS GOODS CLASS/SUBSIDIARY RISK: Not Applicable
HAZCHEM CODE (AUSTRALIA): Not Applicable
POISONS SCHEDULE NUMBER (AUSTRALIA): Not Applicable
PRODUCT USE: Medical Diagnostics
U.S. SUPPLIER/MANUFACTURER'S NAME: Vital Diagnostics
ADDRESS: 27 Wellington Road
Lincoln, RI 02865 USA
EMERGENCY PHONE: United States/Canada: 1-760-602-8700 (3E Company) [24-hours]
International: 01-760-602-8700 (3E Company) [24-hours]
BUSINESS PHONE: 1-401-642-8400; 1-800-345-2822
EMAIL ADDRESS/COMPETENT PERSON FOR MSDS Technical Services: techserv@vitaldiagnostics.com
DATE OF PREPARATION: December 17, 2007
NOTE: ALL Canadian WHMIS, European Union and Australian NOHSC required information is included in appropriate sections based on the U.S. ANSI Z400.1-2004 format. This
product has been classified in accordance with the hazard criteria of the countries listed above and the MSDS contains all the information required by the Canadian
WHMIS (Controlled Products Regulations), European Union [Regulation (EC) 1907/2006 Annex II], and Australian [NOHSC:2011 (2003)].
2. HAZARD IDENTIFICATION
EU/AUSTRALIAN LABELING/CLASSIFICATION: This product does not meet the definition of any hazard class as defined
by the European Union Council Directive 67/548/EEC and subsequent Directives and by the Australian National
Occupational Health and Safety Commission [NOHSC(1008:2004)].
CLASSIFICATION: Not Classified
RISK PHRASES: Not Applicable
SAFETY PHRASES: Not Applicable
HAZARD SYMBOL: Not Applicable
EMERGENCY OVERVIEW: Product Description: The components of this product are slightly yellow, odorless,
lyophilized powders. Health Hazards: The chief hazard in event of contamination or overexposure to the components of
this product is the potential for mild irritation of contaminated skin or eyes. The source materials in the components of this
product have been tested for human immunodeficiency virus (HIV1, HIV2) antibody, hepatitis B surface antigen
(HBsAg), and hepatitis C (HCV) antibody and found to be non-reactive. However, no known test method can offer
complete assurance that products derived from human blood will not transmit infectious agents. It is prudent practice to
regard the components of this product as potentially infectious materials and to handle them in accordance with Universal
Precautions and the OSHA Bloodborne Pathogen Standard (29 CFR 1910.1030). Flammability Hazards: The
components of this product must be substantially pre-heated before ignition can occur. If the components of this product
are ignited, the decomposition products generated will include irritating vapors and toxic gases (e.g., carbon oxides,
nitrogen oxides, sulfur oxides, sodium chloride, and hydrogen chloride). Reactivity Hazards: Negligible. Environmental
Hazards: Negligible. Emergency Recommendations: Emergency responders must wear personal protective
equipment suitable for the situation to which they are responding.
MSDS-33120, Rev. A, DCO: 08-004 Page 1 of 11
3. COMPOSITION and INFORMATION ON INGREDIENTS
®
This Material Safety Data sheet describes the VITALAB SERUM CONTROL KIT. This product consists of the following two reagents: Vitalab Serum
Control 1 and Vitalab Serum Control 2.
CHEMICAL NAME % w/v CAS # EINECS # AIC INVENTORY EU/AUSTRALIAN CLASSIFICATION FOR
LISTING COMPONENTS
COMPONENTS 1 & 2: VITALAB SERUM CONTROL 1 & VITALAB SERUM CONTROL 2
Blood Extracts 35�50 68070-90-6 268-338-3 Not Listed Hazard Classification: Not established.
Risk Phrases: Not established.
D-Lactose Monohydrate 20�35 10039-26-6 Listed as Anhydrous: Excepted as a Hazard Classification: Not established.
200-559-2 Hydrate Risk Phrases: Not established.
Cholesterol 1�5 57-88-5 200-353-7 Listed Hazard Classification: Not established.
Risk Phrases: Not established.
Glucose 1�5 50-99-7 200-075-7 Listed Hazard Classification: Not established.
Risk Phrases: Not established.
4-(2-Hydroxyethyl)piperazine-1- 1�5 7365-45-9 230-907-9 Listed Hazard Classification: Not established.
ethanesulfonic Acid Risk Phrases: Not established.
Sodium Acetate Trihydrate 1�5 6131-90-4 Listed as Anhydrous: Listed Hazard Classification: Not established.
204-823-8 Risk Phrases: Not established.
Sodium Chloride 1�5 7647-14-5 231-598-3 Listed Hazard Classification: Not established.
Risk Phrases: Not established.
Other constituents. Each of the other The remaining constituents do not contribute any significant additional hazards. All Balance
constituents is present in less than 1 percent pertinent information has been provided in this document, per the requirements of the
concentration (0.1% concentration for Federal Occupational Safety and Health Administration Standard (29 CFR 1910.1200),
potential carcinogens, reproductive toxins, U.S. State equivalent Standards, and Canadian Workplace Hazardous Materials
respiratory tract sensitizers, and mutagens). Identification System Standards (CPR 4).
See Section 16 for full text of Ingredient Risk Phrases
PART II What should I do if a hazardous situation occurs?
4. FIRST-AID MEASURES
Victims of chemical exposure must be taken for medical attention. Remove or cover gross contamination to avoid exposure
to rescuers. Rescuers should be taken for medical attention if necessary. Take a copy of label and MSDS to physician or
health professional with victim.
SKIN EXPOSURE: Basic hygiene should prevent any problems. If contact with the components of this product causes
redness, inflammation, or irritation, flush the exposed area with running water. Remove any contaminated clothing, taking
care not to contaminate eyes. Seek medical attention if adverse effect occurs after flushing.
EYE EXPOSURE: If airborne dusts of the components of this product enter the eyes, open victim's eyes while under gently
running water. Use sufficient force to open eyelids. Have victim "roll" eyes. Minimum flushing is for 15 minutes. Seek
medical attention if adverse effect occurs after flushing.
INHALATION: If airborne dusts of the components of this product are inhaled, causing irritation, remove victim to fresh air. If
necessary, use artificial respiration to support vital functions. Seek medical attention if adverse effect occurs after removal to
fresh air.
INGESTION: If the components of this product are swallowed, CALL PHYSICIAN OR POISON CONTROL CENTER FOR
MOST CURRENT INFORMATION. If professional advice is not available, do not induce vomiting. Never induce vomiting or
give diluents (milk or water) to someone who is unconscious, having convulsions, or unable to swallow. If vomiting occurs,
lean patient forward or place on left side (head-down position, if possible) to maintain an open airway and prevent
aspiration. Seek medical attention if adverse effect occurs.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: Pre-existing dermatitis and other skin conditions may be
aggravated by overexposure to components of this product.
RECOMMENDATIONS TO PHYSICIANS: Treat symptoms and eliminate overexposure.
5. FIRE-FIGHTING MEASURES
FLASH POINT: Not flammable.
AUTOIGNITION TEMPERATURE: Not applicable.
FLAMMABLE LIMITS (in air by volume, %):
(LEL): Not applicable. (UEL): Not applicable.
FIRE EXTINGUISHING MATERIALS: In the event of a fire, use suppression methods for surrounding materials.
Water Spray: Yes Carbon Dioxide: Yes Dry Chemical: Yes
Halon: Yes Other: Any "ABC" Class. Foam: Yes
FIRE EXTINGUISHING MATERIALS NOT BE USED: None known.
UNUSUAL FIRE AND EXPLOSION HAZARDS: The components of this product must be substantially pre-heated before
ignition can occur. If involved in a fire, this material may decompose and produce irritating vapors and toxic gases (including
carbon oxides, nitrogen oxides, sulfur oxides, sodium chloride, and hydrogen chloride). Accumulated dusts of the
components of this product can create a serious hazard of explosion.
MSDS-33120, Rev. A, DCO: 08-004 Page 2 of 11
5. FIRE-FIGHTING MEASURES (Continued)
UNUSUAL FIRE AND EXPLOSION HAZARDS (continued): If the fire scene
NFPA RATING
includes high levels of airborne dusts from the components of this product,
firefighters should take great care as an explosive ignition may occur. FLAMMABILITY
Explosion Sensitivity to Mechanical Impact: Not sensitive.
Explosion Sensitivity to Static Discharge: Although the components of this
1
product are not sensitive to static discharge, dusts of organic compounds,
such as this material, can be ignited by static discharge especially if large 0
1
HEALTH INSTABILITY
amounts of dusts accumulate. All equipment used in the handling of this
material should be electrically grounded.
SPECIAL FIRE-FIGHTING PROCEDURES: Move containers from fire area if it
can be done without risk to personnel. Incipient fire responders should wear eye
OTHER
protection. Structural firefighters must wear Self-Contained Breathing Apparatus
and full protective equipment. Chemical resistant clothing may be necessary. If Hazard Scale: 0 = Minimal 1 = Slight
possible, prevent runoff water from entering storm drains, bodies of water, or 2 = Moderate 3 = Serious 4 = Severe
other environmentally sensitive areas.
6. ACCIDENTAL RELEASE MEASURES
SPILL AND LEAK RESPONSE: For small releases take basic hygiene precautions. Lightweight gloves and eye protection
should be worn if dusts may be generated during the cleanup process. Sweep up, vacuum, or wipe up spilled material with
damp sponge or polypad. Trained personnel using pre-planned procedures should respond to large releases that are not
immediately controlled. Proper protective equipment should be used. In case of a spill, clear the affected area, protect
people, and respond with trained personnel. In the event of a non-incidental release, minimum Personal Protective
Equipment should be the following: dust mask, gloves, eye protection, and suitable body protection. Eliminate all
sources of ignition before clean-up operations begin. Use non-sparking tools. Sweep up or vacuum spilled solid (an
explosion-proof vacuum should be used). Disinfect area with 0.5% hypochlorite solution (a freshly prepared 1:10 dilution of
Chlorox). Decontaminate the area thoroughly. Place all spill residue in a double plastic bag or other containment and seal.
Do not mix with wastes from other materials. Dispose of in accordance with applicable Federal, State, and local procedures
(see Section 13, Disposal Considerations). For spills on water, contain, minimize dispersion and collect. Dispose of
recovered material and report spill per regulatory requirements.
PART III How can I prevent hazardous situations from occurring?
7. HANDLING and STORAGE
WORK PRACTICES AND HYGIENE PRACTICES: As with all chemicals, avoid getting the components of this product ON
YOU or IN YOU. Wash thoroughly after handling the components of this product. Avoid generating airborne dusts of the
components of this product. Do not eat or drink while handling the components of this product. Sweep up, vacuum, or wipe
down use areas often to avoid accumulation of dusts in the workplace. It is prudent practice to regard the components of
this product as potentially infectious materials and to handle them in accordance with Universal Precautions and the OSHA
Bloodborne Pathogen Standard (29 CFR 1910.1030). Follow SPECIFIC USE INSTRUCTIONS supplied with this product.
STORAGE AND HANDLING PRACTICES: All employees who handle this material should be trained to handle it safely.
Open containers slowly on a stable surface. Keep containers tightly closed when not in use. Empty containers may contain
residual amounts of the components of this product; therefore, empty containers should be handled with care. Store away
from incompatible materials (see Section 10, Stability and Reactivity). Store the components of this product in original
containers refrigerated at 2�8°C (35�46°F). Inspect all incoming containers before storage to ensure containers are
properly labeled and not damaged.
SPECIFIC USE(S): This product is for use in medical diagnostic procedures. Follow all industry standards for use of this
product.
PROTECTIVE PRACTICES DURING MAINTENANCE OF CONTAMINATED EQUIPMENT: Follow practices indicated in
Section 6 (Accidental Release Measures). Make certain that application equipment is locked and tagged-out safely, as
applicable. Collect all rinsates and dispose of according to applicable Federal, State, and local procedures standards. All
disposable items contaminated with the components of this product should be disposed of properly.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION
VENTILATION AND ENGINEERING CONTROLS: Use with adequate ventilation to ensure exposure levels are maintained
below the limits provided in this section, if applicable. Ensure eyewash/safety shower stations are available near areas
where this product is used. If necessary, refer to Australian National Code of Practice for the Control of Workplace
Hazardous Substances [NOHSC: 2007 (1994)] for further information, or regulations of the country product is used in.
INTERNATIONAL OCCUPATIONAL EXPOSURE LIMITS: Currently, there are international exposure limits for components
of this product as follows. These limits may not be the most current; consult appropriate authority in your country for
information on any new limits.
SODIUM CHLORIDE:
Russia: STEL = 5 mg/m3, JUN 2003
MSDS-33120, Rev. A, DCO: 08-004 Page 3 of 11
8. EXPOSURE CONTROLS - PERSONAL PROTECTION (Continued)
EXPOSURE LIMITS/GUIDELINES:
CHEMICAL NAME CAS # EXPOSURE LIMITS IN AIR
ACGIH-TLVs OSHA-PELs NIOSH-RELs NIOSH OTHER
TWA STEL TWA STEL TWA STEL IDLH
mg/m3 mg/m3
mg/m3 mg/m3 mg/m3 mg/m3 mg/m3 mg/m3
This product is composed of a variety of materials NE NE 50 mppcf or 15 NE NE NE NE DFG MAK:
(Total Dust)
as described below. It is recommended that the TWA = 4 (Inhalable
following exposure limits for “Particulates Not fraction) 1.5
15 mppcf or 5
(Respirable fraction)
Otherwise Classified� (PNOC) be used to address (Respirable
occupational exposures to this mixture. Fraction)
Blood Extracts 68070-90-6 NE NE NE NE NE NE NE NE
D-Lactose Monohydrate 10039-26-6 NE NE NE NE NE NE NE NE
Cholesterol 57-88-5 NE NE NE NE NE NE NE NE
Glucose 50-99-7 NE NE NE NE NE NE NE NE
4-(2-Hydroxyethyl) piperazine- 7365-45-9 NE NE NE NE NE NE NE NE
1-ethanesulfonic Acid
Sodium Acetate Trihydrate 6131-90-4 NE NE NE NE NE NE NE NE
Sodium Chloride 7647-14-5 NE NE NE NE NE NE NE NE
NE = Not Established See Section 16 for Definitions of Terms Used
The following information on appropriate Personal Protective Equipment is provided to assist employers in complying with regulations
found in U.S. OSHA 29 CFR Subpart I (beginning at 1910.132), equivalent standards of Canada (including CSA Standard Z94.4-02 and
CSA Standard Z94.3-02), standards of EU member states (including EN 529:2005 for respiratory PPE, CEN/TR 15419:2006 for hand
protection, and CR 13464:1999 for face/eye protection), or standards of Australia (including AS/NZS 1715:1994 for respiratory PPE,
AS/NZS 4501.2:2006 for protective clothing, AS/NZS 2161.1:2000 for glove selection, and AS/NZS 1336:1997 for eye protection). Please
reference applicable regulations and standards for relevant details.
RESPIRATORY PROTECTION: If necessary, use only respiratory protection authorized in the U.S. Federal OSHA
Respiratory Protection Standard (29 CFR 1910.134), equivalent U.S. State standards, Canadian CSA Standard Z94.4-02,
the European Standard EN 529:2005, and EU member state standards, the Australian Standard 1716-Respiratory
Protective Devices and Australian Standard 1715-Selection, Use, and Maintenance of Respiratory Protective Devices, or
Singapore standards. Oxygen levels below 19.5% are considered IDLH by OSHA. In such atmospheres, use of a full-
facepiece pressure/demand SCBA or a full facepiece, supplied air respirator with auxiliary self-contained air supply is
required under OSHA’s Respiratory Protection Standard (1910.134-1998).
EYE PROTECTION: For operations in which airborne dusts of the components of this product may be generated, wear
splash goggles or safety glasses. If necessary, refer to U.S. OSHA 29 CFR 1910.133, Canadian CSA Standard Z94.3-02,
European Standard CR 13464:1999 or the Australian Standard 1337-Eye Protection for Industrial Applications and
Australian Standard 1336-Recommended Practices for Eye Protection in the Industrial Environment.
HAND PROTECTION: Wear lightweight gloves for routine industrial use. Check gloves for leaks. Wash hands before
putting on gloves and after removing gloves. If necessary, refer to U.S. OSHA 29 CFR 1910.138, appropriate Standards
of Canada or the Australian Standard 2161-Industrial Safety Gloves and Mittens, or the European Standard CEN/TR
15419:2006.
BODY PROTECTION: Use body protection appropriate for task (e.g., light-weight cotton gown or other medical attire is
recommended). If necessary, refer to the OSHA Technical Manual (Section VII: Personal Protective Equipment)
appropriate Standards of Canada, appropriate Standards of Canada, the European Standard CEN/TR 15419:2006 or
Australian Standard 3765-Clothing for Protection Against Hazardous Chemicals.
ENVIRONMENTAL EXPOSURE CONTROLS: Controls should be engineered to prevent release to the environment,
including procedures to prevent spills, atmospheric release and release to waterways.
9. PHYSICAL and CHEMICAL PROPERTIES
RELATIVE VAPOR DENSITY (air = 1): Not established. EVAPORATION RATE (nBuAc = 1): Not established.
DENSITY @ 20°C: Not established. FREEZING/MELTING POINT: Not established.
VAPOR PRESSURE, mmHg: Not established. pH: Not applicable.
ODOR THRESHOLD: Odorless. OXIDIZING PROPERTIES: Not applicable.
SHOCK SENSITIVTY: Not applicable. VISCOSITY: Not determined.
FLASH POINT: Not applicable. FLAMMABILITY LIMITS: Not applicable.
LOG WATER/OIL DISTRIBUTION COEFFICIENT: Not available.
APPEARANCE, ODOR and COLOR: Slightly yellow, odorless, lyophilized powders.
HOW TO DETECT THIS SUBSTANCE: The appearance may act as an identifying property for components of this product
in event of a accidental release.
10. STABILITY and REACTIVITY
STABILITY: Stable.
DECOMPOSITION PRODUCTS: Thermal decomposition of the components of this product may product carbon oxides,
nitrogen oxides, sulfur oxides, sodium chloride, and hydrogen chloride.
MSDS-33120, Rev. A, DCO: 08-004 Page 4 of 11
10. STABILITY and REACTIVITY (Continued)
MATERIALS WITH WHICH SUBSTANCE IS INCOMPATIBLE: Strong acids, strong oxidizers.
HAZARDOUS POLYMERIZATION: Will not occur.
CONDITIONS TO AVOID: Incompatible chemicals, extreme temperatures.
PART IV Is there any other useful information about this material?
11. TOXICOLOGICAL INFORMATION
SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: No
adverse health effects should occur from routine, occupational use of the HAZARDOUS MATERIAL IDENTIFICATION SYSTEM
components of this product in the manner specified by the manufacturer's
instructions. The potential health effects of the components of this product
HEALTH HAZARD
are described as follows: 1
(BLUE)
INHALATION: Inhalation of airborne dusts of the components of this product
may mildly irritate the nose, throat, and lungs. Symptoms of such
overexposure may include sneezing, coughing, and nasal congestion.
FLAMMABILITY HAZARD (RED) 1
Symptoms are generally alleviated upon breathing fresh air.
CONTACT WITH SKIN or EYES: Dusts from the components of this product
may irritate contaminated skin (especially in the event of prolonged
PHYSICAL HAZARD
overexposures). Symptoms of skin overexposure may include redness and (YELLOW) 0
itching. Repeated skin contact may cause dermatitis (dry, red skin). Dusts
from the components of this product can irritate the eyes (i.e., foreign object).
Symptoms of eye overexposure can include redness and tearing. Prolonged PROTECTIVE EQUIPMENT
or severe eye exposure may cause increased irritation.
SKIN ABSORPTION: The components of this product are not known to be EYES HANDS BODY
RESPIRATORY
absorbed through intact skin.
See See
INGESTION: Ingestion is not anticipated to be a significant route of exposure
Section 8 Section 8
for the components of this product. Acute ingestion of large quantities of the
components of this product caused by poor hygiene practices may cause For Routine Industrial Use and Handling Applications
nausea, vomiting, and diarrhea.
INJECTION: Though not anticipated to be a significant route of exposure, Hazard Scale: 0 = Minimal 1 = Slight 2 = Moderate
injection of the components of this product can cause reddening and local 3 = Serious 4 = Severe * = Chronic hazard
swelling. The source materials in the components of this product have been
tested for human immunodeficiency virus (HIV1, HIV2) antibody, hepatitis B surface antigen (HBsAg), and hepatitis C
(HCV) antibody and found to be non-reactive. However, no known test method can offer complete assurance that products
derived from human blood will not transmit infectious agents. It is prudent practice to regard the components of this product
as potentially infectious materials and to handle them in accordance with Universal Precautions and the U.S. OSHA
Bloodborne Pathogen Standard (29 CFR 1910.1030).
HEALTH EFFECTS OR RISKS FROM EXPOSURE: An Explanation in Lay Terms.
Acute: The chief health hazard associated with exposure to this product during occupational use is the potential for
irritation of contaminated skin, eyes, nose, and upper respiratory tract. Adverse symptoms after ingestion of large
quantities of the product may include nausea, vomiting, and diarrhea.
Chronic: Repeated skin overexposure may cause dermatitis (dry, red skin).
Target Organs: ACUTE: Eyes, skin. CHRONIC: Skin.
TOXICITY DATA: The following information is available for the components of this product present in greater than 1%
concentration.
BLOOD EXTRACTS: CHOLESTEROL (continued): CHOLESTEROL (continued):
Currently, there are no toxicological data available for this TDLo (Oral-Rabbit) 17.85 gm/kg/17 weeks-intermittent: TDLo (Subcutaneous-Rat) 175 mg/kg: female 8-14 day(s)
compound. Vascular: other changes; Blood: changes in serum after conception: Reproductive: Specific
CHOLESTEROL: composition (e.g. TP, bilirubin, cholesterol); Biochemical: Developmental Abnormalities: craniofacial (including
TDLo (Oral-Rat) 14,700 mg/kg/14 weeks-continuous: Metabolism (Intermediary): lipids including transport nose and tongue)
Skin and Appendages: tumors; Tumorigenic: protects TDLo (Oral-Rabbit) 100.6 gm/kg/61 days-continuous: Liver: TDLo (Subcutaneous-Rat) 1900 mg/kg: female 1-19
against induction of experimental tumors, active as change in gall bladder structure or function; Biochemical: day(s) after conception: Reproductive: Fertility: post-
anti-cancer agent Metabolism (Intermediary): lipids including transport implantation mortality (e.g. dead and/or resorbed
TDLo (Oral-Rabbit) 2100 mg/kg/12 weeks-continuous: TDLo (Oral-Rabbit) 6 gm/kg: female 1-31 day(s) after implants per total number of implants), litter size (e.g. #
Peripheral Nerve and Sensation: recording from conception: Reproductive: Effects on Embryo or Fetus: fetuses per litter; measured before birth)
peripheral motor nerve; Sense Organs and Special extra-embryonic structures (e.g., placenta, umbilical TDLo (Subcutaneous-Mouse) 15 gm/kg/47 weeks-
Senses (Ear): changes in cochlear structure or cord); Effects on Newborn: stillbirth intermittent: Tumorigenic: carcinogenic by RTECS
function; Blood: changes in serum composition (e.g. TDLo (Oral-Hamster) 62.5 gm/kg/3 weeks-intermittent: criteria, tumors at site of application
TP, bilirubin, cholesterol) Liver: multiple effects; Blood: changes in serum TDLo (Subcutaneous-Mouse) 60 gm/kg/2 weeks-
TDLo (Oral-Rabbit) 12,180 mg/kg/40 weeks-continuous: composition (e.g. TP, bilirubin, cholesterol); Biochemical: intermittent: Tumorigenic: carcinogenic by RTECS
Liver: changes in liver weight; Endocrine: changes in Metabolism (Intermediary): lipids including transport criteria, tumors at site of application
spleen weight; Blood: pigmented or nucleated red TDLo (Intraperitoneal-Rat) 800 mg/kg/43 weeks- TDLo (Implant-Mouse) 800 mg/kg: Tumorigenic:
blood cells intermittent: Tumorigenic: equivocal tumorigenic agent equivocal tumorigenic agent by RTECS criteria;
by RTECS criteria, tumors at site of application Kidney/Ureter/Bladder: tumors; Tumorigenic: tumors at
site of application
MSDS-33120, Rev. A, DCO: 08-004 Page 5 of 11
11. TOXICOLOGICAL INFORMATION (Continued)
TOXICITY DATA (continued):
CHOLESTEROL (continued): SODIUM CHLORIDE (continued):
GLUCOSE (continued):
Mutation in Microorganisms (Bacteria-Salmonella TDLo (oral, rat) = 145 g/kg/female 7 days pre-
Mutation Test Systems (microorganism) = 1 mol/L
typhimurium) 500 µg/plate mating/female 1�22 days after conception;
DNA Damage (microorganism) = 150 mmol/L
DNA Adduct (Mouse Cells-Not Otherwise Specified) 1 Reproductive: Effects on Newborn: delayed effects
DNA Damage (human cells) = 30 mmol/L
µmol/L TDLo (oral, rat) = 56400 mg/kg/female 5 days pre-
DNA Damage (human cells) = 225 mmol/L/5 days
mating/21 days post-birth; Reproductive: Maternal
GLUCOSE: DNA Damage (human cells) = 315 mmol/L/7 days
Effects: postpartum, Effects on Newborn: biochemical
TDLo (oral, woman) = 2 g/kg/female 28 weeks after Mutation in Mammalian Somatic Cells (lymphocyte, mouse)
and metabolic
conception; Reproductive: Specific Developmental = 179 mmol/L
TDLo (oral, rat) = 16800 mg/kg/28 days/continuous;
D-LACTOSE MONOHYDRATE:
Abnormalities: craniofacial (including nose and tongue),
Endocrine: changes in adrenal weight
other developmental abnormalities Currently, there are no toxicological data available for this
TDLo (intraperitoneal, rat) = 1710 mg/kg/female 13days
TDLo (intravenous, woman) = 2 g/kg/female 39 weeks after compound.
post; Teratogenic effects
4-(2-HYDROXYETHYL)PIPERAZINE-1-
conception; Reproductive: Maternal Effects: other effects;
TDLo (parenteral, rat) = 10 mg/kg/female 1 day pre-mating;
ETHANESULFONIC ACID
Reproductive: Effects on Embryo or Fetus: other effects to
Reproductive: Maternal Effects: ovaries, fallopian tubes
embryo LD50 (Oral-Rat) > 316 mg/kg
TDLo (intravenous, woman) = 1057 µg/kg/female 39 weeks TDLo (intrauterine, rat) = 500 mg/kg/female 4 days after
SODIUM ACETATE TRIHYDRATE:
conception; Reproductive: Fertility: pre-implantation
Currently, there are no toxicological data available for this
after conception; Reproductive: Specific Developmental
mortality (e.g., reduction in number of implants per
compound.
Abnormalities: hepatobiliary system
female; total number of implants per corpora lutea)
SODIUM CHLORIDE:
TDLo (intravenous, woman) = 1300 mg/kg/female 39 weeks
TDLo (subcutaneous, mouse) = 1900 mg/kg/female 10�11
TDLo (intraplacental, woman) = 27 mg/kg/15 weeks
after conception; Reproductive: Effects on Newborn:
days after conception; Reproductive: Effects on Embryo
pregnant; Reproductive effects
biochemical and metabolic, behavioral
or Fetus: fetal death, Specific Developmental
TDLo (oral, human) = 12,357 mg/kg/23 days/continuous;
LD50 (oral, rat) = 25,800 mg/kg; Behavioral: coma; Lungs,
Abnormalities: musculoskeletal system
Cardiovascular effects
Thorax, or Respiration: cyanosis; Gastrointestinal:
TDLo (subcutaneous, mouse) = 2500 mg/kg/female 10
DNA Inhibition (fibroblast, human) = 125 mmol/L
hypermotility, diarrhea
days after conception; Reproductive: Effects on Embryo
LD50 (oral, rat) = 3000 mg/kg
LD50 (intraperitoneal, mouse) = 18 g/kg
or Fetus: fetotoxicity (except death, e.g., stunted fetus)
LD50 (intravenous, mouse) = 9 g/kg LC50 (inhalation, rat) > 42 g/m3/1 hour
Skin Irritancy (rabbit) = 50 mg/24 hours; mild
LDLo (oral, dog) = 8 g/kg LDLo (subcutaneous, rat) = 3500 mg/kg
Skin Irritancy (rabbit) = 500 mg/24 hours; mild
LDLo (oral, rabbit) = 20 g/kg LD50 (oral, mouse) = 4000 mg/kg
Eye Irritancy (rabbit) = 100 mg; mild
LDLo (intravenous, rabbit) = 12 g/kg LD50 (intraperitoneal, mouse) = 6614 mg/kg
Eye Irritancy (rabbit) = 100 mg/24 hours; moderate
TDLo (subcutaneous, rat) = 15,400 gm/kg/22 LD50 (subcutaneous, mouse) = 3 g/kg
Eye Irritancy (rabbit) = 10 mg; moderate
weeks/continuous; Tumorigenic: equivocal tumorigenic LD50 (intravenous, mouse) = 645 mg/kg
Mutation in Microorganisms (yeast, Saccharomyces
agent by RTECS criteria, tumors at site of application LD50 (intracervical, mouse) = 131 mg/kg
cerevisiae) = 2 mol/L
TDLo (intraperitoneal, rat) = 300 g/kg/female 30 days pre- LDLo (intraperitoneal, dog) = 364 mg/kg
Unscheduled DNA Synthesis (oral, rat) = 16800 mg/kg/4
mating; Reproductive: Maternal Effects: ovaries, fallopian LDLo (intravenous, dog) = 2 g/kg
weeks/continuous
tubes, uterus, cervix, vagina LDLo (oral, rabbit) = 8 g/kg
Cytogenetic Analysis (intraperitoneal, rat) = 2338 mg/kg
TDLo (intraperitoneal, hamster) = 20 g/kg/female 6�8 days LD50 (skin, rabbit) > 10 g/kg
DNA Damage (lymphocyte, mouse) = 101 mmol/L
after conception; Reproductive: Specific Developmental LDLo (intravenous, rabbit) = 1100 mg/kg
Mutation in Mammalian Somatic Cells (lymphocyte,
Abnormalities: eye/ear LDLo (subcutaneous, guinea pig) = 2160 mg/kg
mouse) = 57200 µmol/L
TDLo (subcutaneous, hamster) = 20 g/kg/female 6�8 days LDLo (intravenous, guinea pig) = 2910 mg/kg
Micronucleus Test (lung, hamster) = 4 g/L
after conception; Reproductive: Specific Developmental LDLo (parenteral, guinea pig) = 300 mg/kg
DNA Damage (ovary, hamster) = 275 mmol/L
Abnormalities: eye/ear LDLo (intraarterial, guinea pig) = 300 mg/kg
Cytogenetic Analysis (ovary, hamster) = 160 mmol/L
Mutation in Microorganisms (bacteria, Salmonella
Cytogenetic Analysis (lung, hamster) = 7500 mg/L
typhimurium) = 25 mg/plate
CARCINOGENIC INFORMATION: The Cholesterol constituent in components of this product is listed by agencies tracking
the carcinogenic potential of chemical compounds as follows:
IARC-3: (Unclassifiable as to carcinogenicity in Humans)
The other components of this product are not found on the following lists: U.S. EPA, U.S. NTP, U.S. OSHA, U.S. NIOSH,
GERMAN MAK, IARC, or ACGIH and therefore are neither considered to be nor suspected to be cancer causing agents
by these agencies.
IRRITANCY OF PRODUCT: Contact with the skin or eyes may cause mild irritation.
SENSITIZATION TO THE PRODUCT: The components of this product are not known to be sensitizers with prolonged or
repeated use.
REPRODUCTIVE TOXICITY INFORMATION: Listed below is information concerning the effects of this product and its
components on the human reproductive system.
Mutagenicity: The components of this product are not reported to cause human mutagenic effects.
Embryotoxicity: The components of this product are not reported to cause human embryotoxic effects.
Teratogenicity: The components of this product are not reported to cause human teratogenic effects.
Reproductive Toxicity: The components of this product are not reported to cause human reproductive effects.
A mutagen is a chemical that causes permanent changes to genetic material (DNA) such that the changes will propagate through
generation lines. An embryotoxin is a chemical that causes damage to a developing embryo (i.e. within the first eight weeks of pregnancy
in humans), but the damage does not propagate across generational lines. A teratogen is a chemical that causes damage to a
developing fetus, but the damage does not propagate across generational lines. A reproductive toxin is any substance that interferes in
any way with the reproductive process.
BIOLOGICAL EXPOSURE INDICES: Currently, there are no Biological Exposure Indices (BEIs) determined for the
components of this product.
12. ECOLOGICAL INFORMATION
ALL WORK PRACTICES MUST BE AIMED AT ELIMINATING ENVIRONMENTAL CONTAMINATION.
MOBILITY: This product has not been tested for mobility in soil. The following mobility information is available for some
constituents of the components of this product.
CHOLESTEROL:
The Koc of Cholesterol is estimated as 16,000, using a water solubility of 0.095 mg/L and a regression-derived equation. According to a classification scheme, this
estimated Koc value suggests that cholesterol is expected to be immobile in soil.
PERSISTENCE AND BIODEGRADABILITY: This product has not been tested for persistence or biodegradability. It is
expected that some biodegradation will occur to this product; however, no specific information is known.
MSDS-33120, Rev. A, DCO: 08-004 Page 6 of 11
12. ECOLOGICAL INFORMATION (Continued)
PERSISTANCE AND BIODEGRADABILITY (continued): The following data are available for some constituents of the
components of this product.
CHOLESTEROL:
Based on a classification scheme, an estimated Koc value of 16,000, determined from a water solubility of 0.095 mg/L and a regression-derived equation, indicates that
Cholesterol is expected to be immobile in soil. Volatilization of Cholesterol from moist soil surfaces is expected to be an important fate process given an estimated
Henry's Law constant of 1.7X10-4 atm-cu m/mole, using a fragment constant estimation method. However, volatilization from moist soil surfaces is expected to be
attenuated by adsorption. Cholesterol is not expected to volatilize from dry soil surfaces based upon an estimated vapor pressure of 7.8X10-10 mm, determined from a
fragment constant method. An estimated Koc value of 16,000, determined from a water solubility of 0.095 mg/L and a regression-derived equation, indicates that
cholesterol is expected to adsorb to suspended solids and sediment. Volatilization from water surfaces is expected based upon an estimated Henry's Law constant of
1.7X10-4 atm-cu m/mole, developed using a fragment constant estimation method. Using this Henry's Law constant and an estimation method, volatilization half-lives for
a model river and model lake are 8.9 hours and 11 days, respectively. However, volatilization from water surfaces is expected to be attenuated by adsorption to
suspended solids and sediment. The estimated volatilization half-life from a model pond is 145 years if adsorption is considered. According to a model of gas/particle
partitioning of semi-volatile organic compounds in the atmosphere, Cholesterol, which has an estimated vapor pressure of 7.8X10-10 mm Hg at 25°C, determined from a
fragment constant method, is expected to exist solely in the particulate phase in the ambient atmosphere. Particulate-phase cholesterol may be removed from the air by
wet and dry deposition.
BIO-ACCUMULATION POTENTIAL: This product has not been tested for bio-accumulation potential. The following
information is available for some constituents in the components of this product.
CHOLESTEROL:
An estimated BCF of 270 was calculated for Cholesterol, using an estimated log Kow of 8.7 and a regression-derived equation. According to a classification scheme, this
BCF suggests the potential for bioconcentration in aquatic organisms is high.
ECOTOXICITY: This product has not been tested for aquatic or animal toxicity. All release to terrestrial, atmospheric and
aquatic environments should be avoided. The following aquatic toxicity data are available for some constituents in the
components of this product.
SODIUM CHLORIDE:
LC50 (Carassius auratus goldfish) 240 hours = 11,764.3 mg/L (@ 23.5°C, tap water, static bioassay)
LC50 (Tinca tinca tench) 12 hours = 112 mg/L @ 25°C, freshwater, static bioassay)
LC50 (Tinca tinca tench) 12 hours = 1142 mg/L @ 20°C, freshwater, static bioassay)
LC50 (Tinca tinca tench) 24 hours = 119 mg/L @ 25°C, freshwater, static bioassay)
LC50 (Tinca tinca tench) 24 hours = 104 mg/L @ 20°C, freshwater, static bioassay)
EC50 (Daphnia magna water flea) 48 hours = 340.7-469.2 mg/L s.c. (11.5-14.5°C, well water, static bioassay)
OTHER ADVERSE EFFECTS: This product does not contain any component with ozone depletion potential.
13. DISPOSAL CONSIDERATIONS
DISPOSAL METHODS: It is the responsibility of the generator to determine at the time of disposal whether the product
meets the criteria of a hazardous waste per regulations of the area in which the waste is generated and/or disposed of.
Waste disposal must be in accordance with appropriate Federal, State, and local regulations. This product, if unaltered by
use, may be disposed of by treatment at a permitted facility or as advised by your local hazardous waste regulatory authority.
Shipment of wastes must be done with appropriately permitted and registered transporters.
DISPOSAL CONTAINERS: Waste materials must be placed in and shipped in appropriate 5-gallon or 55 gallon poly or
metal waste pails or drums. Permeable cardboard containers are not appropriate and should not be used. Ensure that any
required marking or labeling of the containers be done to all applicable regulations.
PRECAUTIONS TO BE FOLLOWED DURING WASTE HANDLING: Wear proper protective equipment when handling
waste materials. Dispose of in accordance with applicable Federal, State, and local procedures and standards
U.S. EPA WASTE NUMBER: Not applicable.
EUROPEAN WASTE CODES: Wastes from Human or Animal Health Care or Related Research: 18 01 08: Medicines
Other Than Those Mentioned in 18 01 07.
14. TRANSPORTATION INFORMATION
U.S. DEPARTMENT OF TRANSPORTATION REGULATIONS: This product is not classified as dangerous goods, per U.S.
DOT regulations, under 49 CFR 172.101.
TRANSPORT CANADA, TRANSPORTATION OF DANGEROUS GOODS REGULATIONS: This product is not classified as
Dangerous Goods, per regulations of Transport Canada.
INTERNATIONAL AIR TRANSPORT ASSOCIATION SHIPPING INFORMATION (IATA): This product is not classified as
dangerous goods, per the International Air Transport Association.
INTERNATIONAL MARITIME ORGANIZATION SHIPPING INFORMATION (IMO): This product is not classified as
dangerous goods, per the International Maritime Organization.
AUSTRALIAN FEDERAL OFFICE OF ROAD SAFETY CODE FOR THE TRANSPORTATION OF DANGEROUS GOODS
BY ROAD OR RAIL: This product is not classified as dangerous goods, per regulations of the Federal Office of Road
Safety.
EUROPEAN AGREEMENT CONCERNING THE INTERNATIONAL CARRIAGE OF DANGEROUS GOODS BY ROAD
(ADR): This product is not classified by the United Nations Economic Commission for Europe to be dangerous goods.
15. REGULATORY INFORMATION
ADDITIONAL UNITED STATES REGULATIONS:
U.S. SARA REPORTING REQUIREMENTS: The components of this product are not subject to Sections 302, 304, and 313
reporting requirements under the Superfund Amendment and Reauthorization Act.
U.S. SARA THRESHOLD PLANNING QUANTITY: Not applicable.
U.S. CERCLA REPORTABLE QUANTITY (RQ): Not applicable.
MSDS-33120, Rev. A, DCO: 08-004 Page 7 of 11
15. REGULATORY INFORMATION (Continued)
ADDITIONAL UNITED STATES REGULATIONS (continued):
U.S. TSCA INVENTORY STATUS: All chemical substances in this material are included on or exempted from listing on
the TSCA Inventory of Chemical Substances.
OTHER U.S. FEDERAL REGULATIONS: The requirements of the OSHA Bloodborne Pathogen Standard (29 CFR
1910.1030) may be applicable, based on the use of this product.
CALIFORNIA SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT (PROPOSITION 65): No component of this
product is on the California Proposition 65 lists.
U.S. ANSI STANDARD LABELING (Z129.1): CAUTION! MAY CAUSE RESPIRATORY TRACT, SKIN, AND EYE
IRRITATION. Do not taste or swallow. Avoid skin and eye contact. Avoid contact with clothing. Avoid prolonged or
repeated skin contact. Avoid breathing dusts. Keep container closed. Use only with adequate ventilation. Wash thoroughly
after handling. Wear gloves, goggles, dust mask, and appropriate body protection during operations that can generate dust.
FIRST-AID: In case of contact, immediately flush skin or eyes with plenty of water. If inhaled, remove to fresh air. If
ingested, do not induce vomiting. Get medical attention if necessary. IN CASE OF FIRE: Use water fog, dry chemical, CO2,
or “alcohol� foam. IN CASE OF SPILL: Absorb spill with polypads and place in suitable container. Consult Material Safety
Data Sheet for additional information.
ADDITIONAL CANADIAN REGULATIONS:
CANADIAN DSL/NDSL STATUS: The components of this product are listed on the DSL Inventory or are exempt.
CANADIAN WHMIS IDL DISCLOSURE STATUS: The components of this product do not have disclosure requirement
levels.
OTHER CANADIAN REGULATIONS: Not applicable.
CANADIAN ENVIRONMENTAL PROTECTION AGENCY (CEPA) PRIORITY SUBSTANCES LISTS: No component of this
product is on the Priority Substances List.
WHMIS CLASSIFICATION AND SYMBOLS: Not applicable.
ADDITIONAL EUROPEAN UNION REGULATIONS:
EU LABELING/CLASSIFICATION: This product does not meet the definition of any hazard class as defined by the
European Union Council Directive 67/548/EEC and subsequent Directives.
EU Classification: Not applicable.
EU Risk Phrases: Not applicable.
EU Safety Phrases: Not applicable.
European Union Annex II Hazard Symbol: Not applicable.
ADDITIONAL AUSTRALIAN REGULATIONS:
AUSTRALIAN INVENTORY OF CHEMICAL SUBSTANCES (AICS) STATUS: The components of this product are listed on
the AICS or are excepted as hydrates of listed compounds or as biological materials. Any chemical not included in AICS is
regarded as a new industrial chemical unless it is outside the scope of the Industrial Chemicals (Notification and
Assessment) Act 1989 OR is otherwise exempt from notification. New industrial chemicals must be notified and assessed
before being manufactured or imported into Australia.
HAZARDOUS SUBSTANCES INFORMATION SYSTEM (HSIS): No component of this product is listed in the HSIS.
AUSTRALIAN LABELING/CLASSIFICATION: This product does not meet the definition of any hazard class as defined by
the Australian National Occupational Health and Safety Commission [NOHSC(1008:2004)].
Classification: Not applicable.
Risk Phrases: Not applicable.
Safety Phrases: Not applicable.
Hazard Symbol: Not applicable.
POISONS SCHEDULE NUMBER: Not applicable.
ADDITIONAL LABELING: Not applicable.
16. OTHER INFORMATION
PREPARED BY: CHEMICAL SAFETY ASSOCIATES, Inc.
PO Box 3519, La Mesa, CA 91944-3519
800/441-3365
DEFINITIONS OF TERMS
A large number of abbreviations and acronyms appear on a MSDS. Some of these, which are commonly used, include the following:
CAS #: This is the Chemical Abstract Service Number that uniquely identifies each EXPOSURE LIMITS IN AIR (continued):
constituent. DFG MAK Germ Cell Mutagen Categories (continued): 3A: Substances which
EXPOSURE LIMITS IN AIR: have been shown to induce genetic damage in germ cells of human of animals, or
CEILING LEVEL: The concentration that shall not be exceeded during any part of which produce mutagenic effects in somatic cells of mammals in vivo and have been
the working exposure. shown to reach the germ cells in an active form. 3B: Substances which are
DFG MAK Germ Cell Mutagen Categories: 1: Germ cell mutagens which have suspected of being germ cell mutagens because of their genotoxic effects in
been shown to increase the mutant frequency in the progeny of exposed humans. mammalian somatic cell in vivo; in exceptional cases, substances for which there are
2: Germ cell mutagens which have been shown to increase the mutant frequency in no in vivo data, but which are clearly mutagenic in vitro and structurally related to
the progeny of exposed mammals. known in vivo mutagens.
c
MSDS-33120, Rev. A, DCO: 08-004 Page 8 of 11
DEFINITIONS OF TERMS (Continued)
EXPOSURE LIMITS IN AIR (continued): HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
DFG MAK Germ Cell Mutagen Categories (continued): 4: Not applicable RATINGS (continued):
(Category 4 carcinogenic substances are those with non-genotoxic mechanisms of FLAMMABILITY HAZARD:
action. By definition, germ cell mutagens are genotoxic. Therefore, a Category 4 for 0 (Minimal Hazard-Materials that will not burn in air when exposure to a temperature
germ cell mutagens cannot apply. At some time in the future, it is conceivable that a of 815.5°C [1500°F] for a period of 5 minutes.); 1 (Slight Hazard-Materials that must
Category 4 could be established for genotoxic substances with primary targets other be pre-heated before ignition can occur. Material require considerable pre-heating,
than DNA [e.g. purely aneugenic substances] if research results make this seem under all ambient temperature conditions before ignition and combustion can occur,
sensible.). 5: Germ cell mutagens, the potency of which is considered to be so low Including: Materials that will burn in air when exposed to a temperature of 815.5°C
that, provided the MAK value is observed, their contribution to genetic risk for (1500°F) for a period of 5 minutes or less; Liquids, solids and semisolids having a
humans is expected not to be significant. flash point at or above 93.3°C [200°F] (e.g. OSHA Class IIIB, or; Most ordinary
DFG MAK Pregnancy Risk Group Classification: Group A: A risk of damage to combustible materials [e.g. wood, paper, etc.]; 2 (Moderate Hazard-Materials that
the developing embryo or fetus has been unequivocally demonstrated. Exposure of must be moderately heated or exposed to relatively high ambient temperatures
pregnant women can lead to damage of the developing organism, even when MAK before ignition can occur. Materials in this degree would not, under normal
and BAT (Biological Tolerance Value for Working Materials) values are observed. conditions, form hazardous atmospheres in air, but under high ambient temperatures
Group B: Currently available information indicates a risk of damage to the or moderate heating may release vapor in sufficient quantities to produce hazardous
developing embryo or fetus must be considered to be probable. Damage to the
atmospheres in air, Including: Liquids having a flash-point at or above 37.8°C
developing organism cannot be excluded when pregnant women are exposed, even
[100°F]; Solid materials in the form of course dusts that may burn rapidly but that
when MAK and BAT values are observed. Group C: There is no reason to fear a
generally do not form explosive atmospheres; Solid materials in a fibrous or
risk of damage to the developing embryo or fetus when MAK and BAT values are
shredded form that may burn rapidly and create flash fire hazards (e.g. cotton, sisal,
observed. Group D: Classification in one of the groups A-C is not yet possible
hemp; Solids and semisolids that readily give off flammable vapors.); 3 (Serious
because, although the data available may indicate a trend, they are not sufficient for
Hazard- Liquids and solids that can be ignited under almost all ambient temperature
final evaluation.
conditions. Materials in this degree produce hazardous atmospheres with air under
IDLH-Immediately Dangerous to Life and Health: This level represents a
almost all ambient temperatures, or, unaffected by ambient temperature, are readily
concentration from which one can escape within 30-minutes without suffering
ignited under almost all conditions, including: Liquids having a flash point below
escape-preventing or permanent injury.
22.8°C [73°F] and having a boiling point at or above 38°C [100°F] and below 37.8°C
LOQ: Limit of Quantitation.
[100°F] [e.g. OSHA Class IB and IC]; Materials that on account of their physical form
MAK: Federal Republic of Germany Maximum Concentration Values in the
or environmental conditions can form explosive mixtures with air and are readily
workplace.
dispersed in air [e.g., dusts of combustible solids, mists or droplets of flammable
NE: Not Established. When no exposure guidelines are established, an entry of NE
liquids]; Materials that burn extremely rapidly, usually by reason of self-contained
is made for reference.
oxygen [e.g. dry nitrocellulose and many organic peroxides]); 4 (Severe Hazard-
NIC: Notice of Intended Change.
Materials that will rapidly or completely vaporize at atmospheric pressure and normal
NIOSH CEILING: The exposure that shall not be exceeded during any part of the
ambient temperature or that are readily dispersed in air, and which will burn readily,
workday. If instantaneous monitoring is not feasible, the ceiling shall be assumed as
including: Flammable gases; Flammable cryogenic materials; Any liquid or gaseous
a 15-minute TWA exposure (unless otherwise specified) that shall not be exceeded
material that is liquid while under pressure and has a flash point below 22.8°C [73°F]
at any time during a workday.
and a boiling point below 37.8°C [100°F] [e.g. OSHA Class IA; Material that ignite
NIOSH RELs: NIOSH’s Recommended Exposure Limits.
PEL-Permissible Exposure Limit: OSHA’s Permissible Exposure Limits. This spontaneously when exposed to air at a temperature of 54.4°C [130°F] or below
exposure value means exactly the same as a TLV, except that it is enforceable by [e.g. pyrophoric]).
OSHA. The OSHA Permissible Exposure Limits are based in the 1989 PELs and PHYSICAL HAZARD:
the June, 1993 Air Contaminants Rule (Federal Register: 58: 35338-35351 and 58: 0 (Water Reactivity: Materials that do not react with water. Organic Peroxides:
40191). Both the current PELs and the vacated PELs are indicated. The phrase, Materials that are normally stable, even under fire conditions and will not react with
“Vacated 1989 PEL,� is placed next to the PEL that was vacated by Court Order. water. Explosives: Substances that are Non-Explosive. Unstable Compressed
SKIN: Used when a there is a danger of cutaneous absorption. Gases: No Rating. Pyrophorics: No Rating. Oxidizers: No �0� rating allowed.
STEL-Short Term Exposure Limit: Short Term Exposure Limit, usually a 15- Unstable Reactives: Substances that will not polymerize, decompose, condense or
minute time-weighted average (TWA) exposure that should not be exceeded at any self-react.); 1 (Water Reactivity: Materials that change or decompose upon exposure
time during a workday, even if the 8-hr TWA is within the TLV-TWA, PEL-TWA or to moisture. Organic Peroxides: Materials that are normally stable, but can become
REL-TWA. unstable at high temperatures and pressures. These materials may react with water,
TLV-Threshold Limit Value: An airborne concentration of a substance that but will not release energy. Explosives: Division 1.5 & 1.6 substances that are very
represents conditions under which it is generally believed that nearly all workers may insensitive explosives or that do not have a mass explosion hazard. Compressed
be repeatedly exposed without adverse effect. The duration must be considered, Gases: Pressure below OSHA definition. Pyrophorics: No Rating. Oxidizers:
including the 8-hour. Packaging Group III; Solids: any material that in either concentration tested, exhibits
TWA-Time Weighted Average: Time Weighted Average exposure concentration a mean burning time less than or equal to the mean burning time of a 3:7 potassium
for a conventional 8-hr (TLV, PEL) or up to a 10-hr (REL) workday and a 40-hr bromate/cellulose mixture and the criteria for Packing Group I and II are not met.
workweek. Liquids: any material that exhibits a mean pressure rise time less than or equal to
the pressure rise time of a 1:1 nitric acid (65%)/cellulose mixture and the criteria for
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD
Packing Group I and II are not met. Unstable Reactives: Substances that may
RATINGS: This rating system was developed by the National Paint and Coating
decompose, condense or self-react, but only under conditions of high temperature
Association and has been adopted by industry to identify the degree of chemical
and/or pressure and have little or no potential to cause significant heat generation or
hazards.
explosive hazard. Substances that readily undergo hazardous polymerization in the
HEALTH HAZARD:
absence of inhibitors.); 2 (Water Reactivity: Materials that may react violently with
0 (Minimal Hazard: No significant health risk, irritation of skin or eyes not
water. Organic Peroxides: Materials that, in themselves, are normally unstable and
anticipated. Skin Irritation: Essentially non-irritating. PII or Draize = �0�. Eye
will readily undergo violent chemical change, but will not detonate. These materials
Irritation: Essentially non-irritating, or minimal effects which clear in < 24 hours [e.g.
may also react violently with water. Explosives: Division 1.4 � Explosive substances
mechanical irritation]. Draize = �0�. Oral Toxicity LD50 Rat: < 5000 mg/kg. Dermal
where the explosive effect is largely confined to the package and no projection of
Toxicity LD50Rat or Rabbit: < 2000 mg/kg. Inhalation Toxicity 4-hrs LC50 Rat: < 20
fragments of appreciable size or range are expected. An external fire must not
mg/L.); 1 (Slight Hazard: Minor reversible Injury may occur; slightly or mildly
cause virtually instantaneous explosion of almost the entire contents of the package.
irritating. Skin Irritation: Slightly or mildly irritating. Eye Irritation: Slightly or mildly
Compressed Gases: Pressurized and meet OSHA definition but < 514.7 psi
irritating. Oral Toxicity LD50 Rat: > 500-5000 mg/kg. Dermal Toxicity LD50Rat or
absolute at 21.1°C (70°F) [500 psig]. Pyrophorics: No Rating. Oxidizers: Packing
Rabbit: > 1000-2000 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: > 2-20 mg/L); 2
Group II Solids: any material that, either in concentration tested, exhibits a mean
(Moderate Hazard: Temporary or transitory injury may occur. Skin Irritation:
burning time of less than or equal to the mean burning time of a 2:3 potassium
Moderately irritating; primary irritant; sensitizer. PII or Draize > 0, < 5. Eye Irritation:
bromate/cellulose mixture and the criteria for Packing Group I are not met. Liquids:
Moderately to severely irritating and/or corrosive; reversible corneal opacity; corneal
any material that exhibits a mean pressure rise time less than or equal to the
involvement or irritation clearing in 8-21 days. Draize > 0, < 25. Oral Toxicity LD50
pressure rise of a 1:1 aqueous sodium chlorate solution (40%)/cellulose mixture and
Rat: > 50-500 mg/kg. Dermal Toxicity LD50Rat or Rabbit: > 200-1000 mg/kg.
the criteria for Packing Group I are not met. Unstable Reactives: Substances that
Inhalation Toxicity LC50 4-hrs Rat: > 0.5-2 mg/L.); 3 (Serious Hazard: Major injury
may polymerize, decompose, condense, or self-react at ambient temperature and/or
likely unless prompt action is taken and medical treatment is given; high level of
pressure, but have a low potential for significant heat generation or explosion.
toxicity; corrosive. Skin Irritation: Severely irritating and/or corrosive; may destroy
Substances that readily form peroxides upon exposure to air or oxygen at room
dermal tissue, cause skin burns, dermal necrosis. PII or Draize > 5-8 with
temperature); 3 (Water Reactivity: Materials that may form explosive reactions with
destruction of tissue. Eye Irritation: Corrosive, irreversible destruction of ocular
water. Organic Peroxides: Materials that are capable of detonation or explosive
tissue; corneal involvement or irritation persisting for more than 21 days. Draize >
reaction, but require a strong initiating source, or must be heated under confinement
80 with effects irreversible in 21 days. Oral Toxicity LD50 Rat: > 1-50 mg/kg. Dermal
before initiation; or materials that react explosively with water. Explosives: Division
Toxicity LD50Rat or Rabbit: > 20-200 mg/kg. Inhalation Toxicity LC50 4-hrs Rat: >
1.2 � Explosive substances that have a fire hazard and either a minor blast hazard
0.05-0.5 mg/L.); 4 (Severe Hazard: Life-threatening; major or permanent damage
or a minor projection hazard or both, but do not have a mass explosion hazard.
may result from single or repeated exposure. Skin Irritation: Not appropriate. Do not
Compressed Gases: Pressure > 514.7 psi absolute at 21.1°C (70°F) [500 psig].
rate as a �4�, based on skin irritation alone. Eye Irritation: Not appropriate. Do not
Pyrophorics: No Rating.
rate as a �4�, based on eye irritation alone. Oral Toxicity LD50 Rat: < 1 mg/kg.
Dermal Toxicity LD50Rat or Rabbit: < 20 mg/kg. Inhalation Toxicity LC50 4-hrs Rat:
< 0.05 mg/L).
MSDS-33120, Rev. A, DCO: 08-004 Page 9 of 11
DEFINITIONS OF TERMS
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM HAZARD NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS
RATINGS (continued): (continued):
PHYSICAL HAZARD (continued): FLAMMABILITY HAZARD (continued): 1 (continued): Liquids with a flash point
3 (continued): Oxidizers: Packing Group I Solids: any material that, in either greater than 35°C (95°F) that do not sustain combustion when tested using the
concentration tested, exhibits a mean burning time less than the mean burning time Method of Testing for Sustained Combustibility, per 49 CFR 173, Appendix H or the
of a 3.:2 potassium bromate/cellulose mixture. Oxidizers: Packing Group I Solids: UN Recommendation on the Transport of Dangerous Goods, Model Regulations
any material that, in either concentration tested, exhibits a mean burning time less (current edition) and the related Manual of Tests and Criteria (current edition).
than the mean burning time of a 3.:2 potassium bromate/cellulose mixture. Liquids with a flash point greater than 35°C (95°F) in a water-miscible solution or
Oxidizers: Liquids: Any material that spontaneously ignites when mixed with dispersion with a water non-combustible liquid/solid content of more than 85 percent
cellulose in a 1:1 ratio, or which exhibits a mean pressure rise time less than the by weight. Liquids that have no fire point when tested by ASTM D 92 Standard Test
pressure rise time of a 1:1 perchloric acid (50%)/cellulose mixture. Unstable Method for Flash and Fire Points by Cleveland Open Cup, up to a boiling point of the
Reactives: Substances that may polymerize, decompose, condense or self-react at liquid or up to a temperature at which the sample being tested shows an obvious
ambient temperature and/or pressure and have a moderate potential to cause physical change. Combustible pellets with a representative diameter of greater than
significant heat generation or explosion.); 4 (Water Reactivity: Materials that react 2 mm (10 mesh). Solids containing greater than 0.5 percent by weight of a
explosively with water without requiring heat or confinement. Organic Peroxides: flammable or combustible solvent are rated by the closed up flash point of the
Materials that are readily capable of detonation or explosive decomposition at solvent. Most ordinary combustible materials. 2 Materials that must be moderately
normal temperature and pressures. Explosives: Division 1.1 & 1.2-explosive heated or exposed to relatively high ambient temperatures before ignition can occur.
substances that have a mass explosion hazard or have a projection hazard. A mass Materials in this degree would not under normal conditions form hazardous
explosion is one that affects almost the entire load instantaneously. Compressed atmospheres with air, but under high ambient temperatures or under moderate
Gases: No Rating. Pyrophorics: Add to the definition of Flammability �4�. heating could release vapor in sufficient quantities to produce hazardous
Oxidizers: No �4� rating. Unstable Reactives: Substances that may polymerize, atmospheres with air: Liquids having a flash point at or above 37.8°C (100°F) and
decompose, condense or self-react at ambient temperature and/or pressure and below 93.4°C (200°F) (i.e. Class II and Class IIIA liquids.) Solid materials in the form
have a high potential to cause significant heat generation or explosion.) of powders or coarse dusts of representative diameter between 420 microns (40
NATIONAL FIRE PROTECTION ASSOCIATION HAZARD RATINGS: mesh) and 2 mm (10 mesh) that burn rapidly but that generally do not form explosive
HEALTH HAZARD: 0 (materials that, under emergency conditions, would offer no mixtures in air. Solid materials in fibrous or shredded form that burn rapidly and
hazard beyond that of ordinary combustible materials): Gases and vapors whose create flash fire hazards, such as cotton, sisal and hemp. Solids and semisolids that
LC50 for acute inhalation toxicity is greater than 10,000 ppm. Dusts and mists whose readily give off flammable vapors. Solids containing greater than 0.5 percent by
LC50 for acute inhalation toxicity is greater than 200 mg/L. Materials whose LD50 for weight of a flammable or combustible solvent are rated by the closed cup flash point
acute dermal toxicity is greater than 2000 mg/kg. Materials whose LD50 for acute of the solvent. 3 Liquids and solids that can be ignited under almost all ambient
oral toxicity is greater than 2000 mg/kg. Materials that are essentially non-irritating temperature conditions. Materials in this degree produce hazardous atmospheres
to the respiratory tract, eyes and skin. 1 (materials that, under emergency conditions, with air under almost all ambient temperatures or, though unaffected by ambient
can cause significant irritation): Gases and vapors whose LC50 for acute inhalation temperatures, are readily ignited under almost all conditions: Liquids having a flash
toxicity is greater than 5,000 ppm but less than or equal to 10,000 ppm. Dusts and point below 22.8°C (73°F) and having a boiling point at or above 37.8°C (100°F) and
mists whose LC50 for acute inhalation toxicity is greater than 10 mg/L but less than or those liquids having a flash point at or above 22.8°C (73°F) and below 37.8°C
equal to 200 mg/L. Materials whose LD50 for acute dermal toxicity is greater than (73°F) and below 37.8°C (100°F) (i.e. Class IB and IC liquids). Materials that, on
1000 mg/kg but less than or equal to 2000 mg/kg. Materials whose LD50 for acute account of their physical form or environmental conditions, can form explosive
oral toxicity is greater than 500 mg/kg but less than or equal to 2000 mg/kg. mixtures with air and are readily dispersed in air. Flammable or combustible dusts
Materials that cause slight to moderate irritation to the respiratory tract, eyes and with a representative diameter less than 420 microns (40 mesh). Materials that burn
skin. 2 (materials that, under emergency conditions, can cause temporary with extreme rapidity, usually by reason of self-contained oxygen (e.g. dry
incapacitation or residual injury): Gases and vapors whose LC50 for acute inhalation nitrocellulose and many organic peroxides). Solids containing greater than 0.5
toxicity is greater than 3,000 ppm but less than or equal to 5,000 ppm. Dusts and percent by weight of a flammable or combustible solvent are rated by the closed cup
mists whose LC50 for acute inhalation toxicity is greater than 2 mg/L but less than or flash point of the solvent. 4 Materials that will rapidly or completely vaporize at
equal to 10 mg/L. Materials whose LD50 for acute dermal toxicity is greater than 200 atmospheric pressure and normal ambient temperature or that are readily dispersed
mg/kg but less than or equal to 1000 mg/kg. Materials whose LD50 for acute oral in air and will burn readily: Flammable gases. Flammable cryogenic materials. Any
toxicity is greater than 50 mg/kg but less than or equal to 500 mg/kg. Any liquid liquid or gaseous materials that is liquid while under pressure and has a flash point
whose saturated vapor concentration at 20°C (68°F) is equal to or greater than one- below 22.8°C (73°F) and a boiling point below 37.8°C (100°F) (i.e. Class IA liquids).
fifth its LC50 for acute inhalation toxicity, if its LC50 is less than or equal to 5000 ppm Materials that ignite when exposed to air, Solids containing greater than 0.5 percent
and that does not meet the criteria for either degree of hazard 3 or degree of hazard by weight of a flammable or combustible solvent are rated by the closed cup flash
4. Compressed liquefied gases with boiling points between -30°C (-22°F) and -55°C point of the solvent.
(-66.5°F) that cause severe tissue damage, depending on duration of exposure. INSTABILITY HAZARD: 0 Materials that in themselves are normally stable, even
Materials that are respiratory irritants. Materials that cause severe, but reversible under fire conditions: Materials that have an estimated instantaneous power density
irritation to the eyes or are lachrymators. Materials that are primary skin irritants or (product of heat of reaction and reaction rate) at 250°C (482°F) below 0.01 W/mL.
sensitizers. 3 (materials that, under emergency conditions, can cause serious or Materials that do not exhibit an exotherm at temperatures less than or equal to
permanent injury): Gases and vapors whose LC50 for acute inhalation toxicity is 500°C (932°F) when tested by differential scanning calorimetry. 1 Materials that in
greater than 1,000 ppm but less than or equal to 3,000 ppm. Dusts and mists whose themselves are normally stable, but that can become unstable at elevated
LC50 for acute inhalation toxicity is greater than 0.5 mg/L but less than or equal to 2 temperatures and pressures: Materials that have an estimated instantaneous power
mg/L. Materials whose LD50 for acute dermal toxicity is greater than 40 mg/kg but density (product of heat of reaction and reaction rate) at 250°C (482°F) at or above
less than or equal to 200 mg/kg. Materials whose LD50 for acute oral toxicity is 0.01 W/mL and below 10 W/mL. 2 Materials that readily undergo violent chemical
greater than 5 mg/kg but less than or equal to 50 mg/kg. Any liquid whose saturated change at elevated temperatures and pressures: Materials that have an estimated
vapor concentration at 20°C (68°F) is equal to or greater than one-fifth its LC50 for instantaneous power density (product of heat of reaction and reaction rate) at 250°C
acute inhalation toxicity, if its LC50 is less than or equal to 3000 ppm and that does
(482°F) at or above 10 W/mL and below 100W/mL.3 Materials that in themselves
not meet the criteria for degree of hazard 4. Compressed liquefied gases with boiling
are capable of detonation or explosive decomposition or explosive reaction, but that
points between -30°C (-22°F) and -55°C (-66.5°F) that cause frostbite and require a strong initiating source or that must be heated under confinement before
irreversible tissue damage. Materials that are respiratory irritants. Cryogenic gases initiation: Materials that have an estimated instantaneous power density (product of
that cause frostbite and irreversible tissue damage. Materials that are corrosive to
heat of reaction and reaction rate) at 250°C (482°F) at or above 100 W/mL and
the respiratory tract. Materials that are corrosive to the eyes or cause irreversible
below 1000 W/mL. Materials that are sensitive to thermal or mechanical shock at
corneal opacity. Materials that are corrosive to the skin. 4 (materials that, under
elevated temperatures and pressures. 4 Materials that in themselves are readily
emergency conditions, can be lethal): Gases and vapors whose LC50 for acute
capable of detonation or explosive decomposition or explosive reaction at normal
inhalation toxicity less than or equal to 1,000 ppm. Dusts and mists whose LC50 for
temperatures and pressures: Materials that have an estimated instantaneous power
acute inhalation toxicity is less than or equal to 0.5 mg/L. Materials whose LD50 for
density (product of heat of reaction and reaction rate) at 250°C (482°F) of 1000
acute dermal toxicity is less than or equal to 40 mg/kg. Materials whose LD50 for
W/mL or greater. Materials that are sensitive to localized thermal or mechanical
acute oral toxicity is less than or equal to 5 mg/kg. Any liquid whose saturated vapor
shock at normal temperatures and pressures.
concentration at 20°C (68°F) is equal to or greater than one-fifth its LC50 for acute
FLAMMABILITY LIMITS IN AIR:
inhalation toxicity, if its LC50 is less than or equal to 1000 ppm.
Much of the information related to fire and explosion is derived from the National Fire
FLAMMABILITY HAZARD: 0 Materials that will not burn under typical fire
Protection Association (NFPA). Flash Point - Minimum temperature at which a
conditions, including intrinsically noncombustible materials such as concrete, stone,
liquid gives off sufficient vapors to form an ignitable mixture with air. Autoignition
and sand: Materials that will not burn in air when exposed to a temperature of 816°C
Temperature: The minimum temperature required to initiate combustion in air with
(1500°F) for a period of 5 minutes in according with Annex D. 1 Materials that must
no other source of ignition. LEL - the lowest percent of vapor in air, by volume, that
be preheated before ignition can occur. Materials in this degree require considerable
will explode or ignite in the presence of an ignition source. UEL - the highest percent
preheating, under all ambient temperature conditions, before ignition and
of vapor in air, by volume, that will explode or ignite in the presence of an ignition
combustion can occur: Materials that will burn in air when exposed to a temperature
source.
of 816°C (1500°F) for a period of 5 minutes in accordance with Annex D. Liquids,
solids and semisolids having a flash point at or above 93.4°C (200°F) (i.e. Class IIIB
liquids).
MSDS-33120, Rev. A, DCO: 08-004 Page 10 of 11
DEFINITIONS OF TERMS
TOXICOLOGICAL INFORMATION: ECOLOGICAL INFORMATION:
Human and Animal Toxicology: Possible health hazards as derived from human EC is the effect concentration in water. BCF = Bioconcentration Factor, which is
data, animal studies, or from the results of studies with similar compounds are used to determine if a substance will concentrate in lifeforms which consume
presented. Definitions of some terms used in this section are: LD50 - Lethal Dose contaminated plant or animal matter. TLm = median threshold limit; Coefficient of
(solids & liquids) which kills 50% of the exposed animals; LC50 - Lethal Oil/Water Distribution is represented by log Kow or log Koc and is used to assess a
Concentration (gases) which kills 50% of the exposed animals; ppm concentration substance’s behavior in the environment.
expressed in parts of material per million parts of air or water; mg/m3 concentration REGULATORY INFORMATION:
expressed in weight of substance per volume of air; mg/kg quantity of material, by U.S. and CANADA: ACGIH: American Conference of Governmental Industrial
weight, administered to a test subject, based on their body weight in kg. Other Hygienists, a professional association which establishes exposure limits. This
measures of toxicity include TDLo, the lowest dose to cause a symptom and TCLo section explains the impact of various laws and regulations on the material. EPA is
the lowest concentration to cause a symptom; TDo, LDLo, and LDo, or TC, TCo, the U.S. Environmental Protection Agency. NIOSH is the National Institute of
LCLo, and LCo, the lowest dose (or concentration) to cause lethal or toxic effects. Occupational Safety and Health, which is the research arm of the U.S. Occupational
Cancer Information: The sources are: IARC - the International Agency for Research Safety and Health Administration (OSHA). WHMIS is the Canadian Workplace
on Cancer; NTP - the National Toxicology Program, RTECS - the Registry of Toxic Hazardous Materials Information System. DOT and TC are the U.S. Department of
Effects of Chemical Substances, OSHA and CAL/OSHA. IARC and NTP rate Transportation and the Transport Canada, respectively. Superfund Amendments
chemicals on a scale of decreasing potential to cause human cancer with rankings and Reauthorization Act (SARA); the Canadian Domestic/Non-Domestic Substances
from 1 to 4. Subrankings (2A, 2B, etc.) are also used. List (DSL/NDSL); the U.S. Toxic Substance Control Act (TSCA); Marine Pollutant
Other Information: BEI - ACGIH Biological Exposure Indices, represent the levels of status according to the DOT; the Comprehensive Environmental Response,
determinants which are most likely to be observed in specimens collected from a Compensation, and Liability Act (CERCLA or Superfund); and various state
healthy worker who has been exposed to chemicals to the same extent as a worker regulations. This section also includes information on the precautionary warnings
with inhalation exposure to the TLV. which appear on the material’s package label. OSHA - U.S. Occupational Safety
and Health Administration.
EUROPEAN: EU is the European Union (formerly known as the EEC, European
Economic Community). EINECS: This the European Inventory of Now-Existing
Chemical Substances. The ARD is the European Agreement Concerning the
International Carriage of Dangerous Goods by Road and the RID are the International
Regulations Concerning the Carriage of Dangerous Goods by Rail. AUSTRALIAN:
AICS is the Australian Inventory of Chemical Substances. NOHSC: National
Occupational Health & Safety Code.
MSDS-33120, Rev. A, DCO: 08-004 Page 11 of 11
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