MATERIAL SAFETY DATA SHEET
Prepared to U.S. OSHA, CMA, ANSI and Canadian WHMIS Standards
PART I What is the material and what do I need to know in an emergency?
1. PRODUCT IDENTIFICATION
VITRASERT
TRADE NAME (AS LABELED):
Cytovene餂?
SYNONYMS:
Ganciclovir
PRODUCT USE: Intra-Vitro Implant
DOSE: Not applicable
MANUFACTURED FOR: BAUSCH & LOMB
BY: 9342 Jeronimo Road
Irvine, CA 92718
EMERGENCY PHONE: CHEMTREC: 800-424-9300, Intl: 1-202-483-7616
MORE INFO? CUSTOMER SERVICE: 1-800-338-2020
2. COMPOSITION and INFORMATION ON INGREDIENTS
Vitrasert contains a compound called Ganciclovir. Ganciclovir is a synthetic nucleoside analogue of 2鈥?-deoxyguanosine that inhibits replication of the herpes
virus, both in vitro and in vivo. Sensitive human viruses include cytomegalovirus (CMV), herpes simplex virus-1 and -2 (HSV-1, HSV-2), Epstein-Barr Virus,
and varicella zoster virus. The product is in the form of small implants for the eyes, which are supplied in individual unit boxes in sterile Tyvek packaging.
The composition of the implants is described in the following table.
% w/w
CHEMICAL NAME CAS # EXPOSURE LIMITS IN AIR
ACGIH OSHA
TLV STEL PEL STEL IDLH OTHER
Manufacturer
Ganciclovir: Not 4.5 NE NE NE NE NE
Recommended
Established mg/tablet
9-[[2-hydroxy-1-(hydroxymethyl)- Occupational Exposure
ethoxy]methyl]guanine Limit: 5 碌g/m3 (Syntex)
10 mg/m3
Magnesium Stearate 557-04-0 <1 NE NE NE NE NE
(for stearates;
A4, Not
Classifiable as
a Human
Carcinogen)
Polyvinylalcohol Polymer 9002-89-5 >1 NE NE NE NE NE NE
(for monomer)
Ethylene-Vinyl Acetate Co-Polymer 108-05-4 Balance NE NE NE NE NE NE
(for monomer)
NE = Not Established. C = Ceiling Limit See Section 16 for Definitions of Terms Used.
NOTE: All WHMIS required information is included. It is located in appropriate sections based on the ANSI Z400.1-1993 format.
VITRASERT MSDS
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3. HAZARD IDENTIFICATION
EMERGENCY OVERVIEW: This product is an off-white colored tablet. This product is odorless. Acute over-exposures,
prolonged over-exposures, or repeated exposures to this product may cause adverse effects on the reproductive and blood
systems. This product is a possible human carcinogen and reproductive toxin. The product is not flammable. Emergency
responders must wear proper personal protective equipment.
SYMPTOMS OF OVER-EXPOSURE BY ROUTE OF EXPOSURE: No
HAZARDOUS MATERIAL
adverse health effects should occur from routine use of this material in
SYSTEM
the manner specified by the manufacturer's instructions. The health
effects describe below are usually associated with therapeutic use of this
HEALTH
product. These health effects may also be observed in accidental over- 2
(BLUE)
exposures in occupational use situations.
INHALATION: Because of the form and size of this product, inhalation is
not anticipated to be a significant route of occupational exposure.
Inhalation of dusts or particulates generated from this product may
FLAMMABILITY 1
(RED)
cause mild irritation of the nose and throat. Symptoms are generally
alleviated upon breathing fresh air.
CONTACT WITH SKIN or EYES: Contact with the skin is not reported to
be irritating. However, prolonged or repeated skin exposures may cause
REACTIVITY (YELLOW) 0
reddening and irritation in sensitive individuals.
This product is designed to be implanted in the eyes for the treatment of
specific eye disorders. The product is not reported to be irritating, X
PROTECTIVE EQUIPMENT
however therapeutic effects of such exposure include the following health
effects: decrease in visual acuity, cataract formation, hemorrhages in
eye tissue, and other adverse effects of the eye tissue. Other health EYES HANDS BODY
RESPIRATORY
effects which have been reported during therapeutic use of this product
include the following: headaches, central nervous system effects, acne,
rashes, dry skin, hair loss, changes in the senses (hearing, taste), See See
digestive system problems, blood and lymphatic system disorders, and Section 8 Section 8
metabolic system changes.
For routine industrial applications
Though over-exposure via eye contact is not anticipated to be a
significant route of occupational over-exposure, if eye contact occurs, then the exposure symptoms described in the paragraph
above may be observed. Additionally, contact with broken or abraded skin with this product may cause adverse health effects.
SKIN ABSORPTION: Skin absorption is not anticipated to be a significant route of exposure for the components of this product.
INGESTION: Ingestion is not anticipated to be a significant route of occupational exposure for this product. If ingestion of this
product occurs, symptoms which may develop can include nausea, vomiting, diarrhea and gastric distress. Ingestion may also
cause the development of symptoms described under 鈥淐ontact with Skin or Eyes鈥?.
INJECTION: Injection of this product鈥檚 solutions may cause local reddening, tissue swelling, and discomfort. Symptoms described
under 鈥淐ontact with Skin or Eyes鈥? may also occur after injection over-exposures.
HEALTH EFFECTS OR RISKS FROM EXPOSURE: An Explanation in Lay Terms.
ACUTE: Over-exposures to small quantities of this product for brief periods of time is not reported to cause any immediate,
observable effect. Over-exposure to large quantities of this product via eye-contact, contact with broken skin, or ingestion can
include visual disturbances, central nervous s system effects, and systemic problems.
CHRONIC: Clinical studies involving animals exposed to Ganciclovir, the active component of this product, indicate carcinogenic
effects and adverse effects on the reproductive system. Refer to Section 11 (Toxicological Information) on this MSDS for additional
information.
VITRASERT MSDS
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PART II What should I do if a hazardous situation occurs?
4. FIRST-AID MEASURES
SKIN EXPOSURE: The practice of basic work place hygiene should prevent any problems. If contact with this product occurs,
flush the exposed area with running water for 15 minutes. Remove any contaminated clothing, taking care not to contaminate eyes.
Victim must seek medical attention.
EYE EXPOSURE: If the product contaminates the eyes via an occupational exposure, open person's eyes while under gentle
running water. Use sufficient force to open eyelids. Have person "roll" eyes. Minimum flushing is for 15 minutes. Victim must seek
medical attention.
INHALATION: If dusts or particulates of this product are inhaled, causing irritation, remove person to fresh air. If necessary, use
artificial respiration to support vital functions. Remove or cover gross contamination to avoid exposure to rescuers.
INGESTION: If chemical is swallowed, CALL PHYSICIAN OR POISON CONTROL CENTER FOR MOST CURRENT
INFORMATION. If professional advice is not available, do not induce vomiting. Person should drink milk, egg whites, or large
quantities of water. Never induce vomiting or give diluents (milk or water) to someone who is unconscious, having convulsions, or
who cannot swallow.
Persons who may be over-exposed to a chemical, must be taken for medical attention. Rescuers should be taken for medical
attention, if necessary. Take copy of label and MSDS to physician or health professional with the person.
5. FIRE-FIGHTING MEASURES
FLASH POINT, 掳C (method): Not applicable.
AUTOIGNITION TEMPERATURE, 掳C: Not applicable.
FLAMMABLE LIMITS (in air by volume, %): Lower (LEL): Not applicable.
NFPA RATING
Upper (UEL): Not applicable.
FLAMMABILITY
FIRE EXTINGUISHING MATERIALS: In the event of a fire, use suppression methods for
surrounding materials. 1
Water Spray: YES Carbon Dioxide: YES Foam: YES 0
2
HEALTH REACTIVITY
Dry Chemical: YES Halon: YES Other: Any "ABC" Class.
UNUSUAL FIRE AND EXPLOSION HAZARDS: This product presents a slight fire hazard at
elevated temperatures. When involved in a fire, this material may decompose and produce OTHER
irritating fumes and toxic gases including carbon monoxide, carbon dioxide, and oxides of
nitrogen and magnesium.
Explosion Sensitivity to Mechanical Impact: Not sensitive.
Explosion Sensitivity to Static Discharge: Not sensitive.
SPECIAL FIRE-FIGHTING PROCEDURES: Incipient fire responders should wear eye
protection. Structural fire fighters must wear self-contained Breathing Apparatus and full protective equipment. If possible, fire-
response actions should avoid generating dusts or particulates of this product.
6. ACCIDENTAL RELEASE MEASURES
SPILL and LEAK RESPONSE: For small releases of this product (i.e. one tablet) wear double latex or nitrile gloves, safety glasses,
and appropriate body protection. Large or uncontrolled releases should be responded to by trained personnel using pre-planned
procedures. Proper protective equipment should be used, including double latex or nitrile gloves, full body gown, and full-face
respirator equipped with a High Efficiency Particulate (HEPA) filter. Self-Contained Breathing Apparatus (SCBA) can be used
instead of the air-purifying respirator. SCBA must be worn in environments in which oxygen levels are below 19.5% or are
unknown.
In case of a spill, clear the affected area, protect people, and respond with trained personnel. If necessary, sweep-up or vacuum
spilled material. Avoid generating dusts of this product. Triple rinse area thoroughly with soap and water. Place all spill residue in a
double plastic bag. Dispose of in accordance with Federal, State, and local waste disposal regulations.
VITRASERT MSDS
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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 this material ON YOU or IN YOU. Wash
hands after handling this product. Do not eat or drink while handling this product. Wash hands thoroughly after handling this
product or equipment and containers which contain this product. Follow SPECIFIC USE INSTRUCTIONS supplied with product.
Particular care in working with this product must be practiced in pharmacies and other preparation areas, during manufacture of this
product, and during patient administration. Operations of risk associated with the use of this product include:
鈥? Opening packets containing this product.
鈥? Opening damaged packages containing this material.
鈥? Placement of implant.
DO NOT CLIP OR CRUSH NEEDLE WITH WHICH THIS PRODUCT WAS IN CONTACT. Use of this product should meet the
following provisions.
鈥? Work should be performed in a designated area for working with hazardous drugs;
鈥? Containment devices, such as a Biological Safety Cabinet, should be used;
鈥? Contaminated waste must be properly handled; and,
鈥? Work areas must be regularly decontaminated.
STORAGE and HANDLING PRACTICES: Employees must be trained to properly use the product. Ensure packages of this
product are properly labeled. Store the product away from incompatible materials. Store product in original container.
Recommended storage temperature is 15-30 掳C (59-86 掳F). Protect from light. Protect from exposures to excessive heat.
PROTECTIVE PRACTICES DURING MAINTENANCE OF CONTAMINATED EQUIPMENT: When cleaning non-disposable
equipment, wear gloves (double-gloving is recommended), goggles, and lab coat. Wash equipment with soap and water. All
needles, syringes, vials, and other disposable items contaminated with this product should be disposed of properly.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION
VENTILATION and ENGINEERING CONTROLS: Use with adequate ventilation. Follow standard medical product handling
procedures. Admixtures or manipulations of this drug should be carried out in an antineoplastic drug safety cabinet. The cabinet
should be regularly cleaned following the manufacturer's recommendations, but no less frequently than weekly. All surfaces should
be thoroughly washed with water and detergent and triple rinsed. During decontamination, workers should wear the same
equipment recommended in Section 6 (Accidental Release Measures) of this MSDS for the clean-up of a large spill. HEPA filters
on the antineoplastic drug safety cabinet should be changed every six months. Technicians should be aware of the risks associated
with this drug via training, and should use the same equipment recommended in Section 6 (Accidental Release Measures) of this
MSDS for the clean-up of large spills. The safety cabinet should be tested and certified as recommended by the National Sanitation
Foundation in Standard Number 49.
RESPIRATORY PROTECTION: A full-face respirator with a HEPA filter should be used until a Biological Safety Cabinet is
installed. A respirator is not required for routine conditions of use with a Biological Safety Cabinet.
EYE PROTECTION: Chemical splash goggles, or regular splash goggles, with a full face-shield.
HAND PROTECTION: Double glove, using latex, nitrile, or rubber gloves. Check gloves for leaks. Wash hands before putting on
gloves and after removing gloves. Gloves should cover the gown cuff.
BODY PROTECTION: A full body gown which is closed at the front and has long sleeves. The gown should be made of Tyvek(TM),
PE-Coated Tyvek(TM) and SARANEX(TM).
PRODUCT PREPARATION INSTRUCTIONS FOR MEDICAL PERSONNEL: Handle this material following standard medical
practices and following the recommendations presented on the Package Insert.
VITRASERT MSDS
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9. PHYSICAL and CHEMICAL PROPERTIES
RELATIVE VAPOR DENSITY (air = 1): Not applicable. EVAPORATION RATE (water = 1): Not applicable.
SPECIFIC GRAVITY (water = 1): >1.0 FREEZING/MELTING POINT: 242-255掳C, (467-472掳F -decomposition)
SOLUBILITY IN WATER: Soluble. BOILING POINT: Not applicable.
VAPOR PRESSURE, mm Hg @ 25 掳C: 4.3 mg/mL pH: Not applicable.
ODOR THRESHOLD: Not available.
LOG OIL/WATER DISTRIBUTION COEFFICIENT: Not available.
APPEARANCE AND COLOR: This product is an odorless, off-white, crystalline solid.
HOW TO DETECT THIS SUBSTANCE (warning properties): This product does not have any unique warning properties.
10. STABILITY and REACTIVITY
STABILITY: Stable.
DECOMPOSITION PRODUCTS: Thermal decomposition of the components of this product may produce carbon dioxide, carbon
monoxide, and oxides of nitrogen and magnesium.
MATERIALS WITH WHICH SUBSTANCE IS INCOMPATIBLE: This product is not compatible with strong oxidizers.
HAZARDOUS POLYMERIZATION: Will not occur.
CONDITIONS TO AVOID: Avoid exposure to elevated temperatures and contact with incompatible chemicals.
PART IV Is there any other useful information about this material?
11. TOXICOLOGICAL INFORMATION
TOXICITY DATA: The following toxicity data are available for the components of this product.
Ganciclovir: Magnesium Stearate: Polyvinylalcohol Polymer: No toxicology
LD50 (oral, mice)> 2000 mg/kg LD50 (oral, rat) > 10000 mg/kg information is currently available for this
LD50 (oral, dog) > 1000 mg/kg LC70 (inhalation, rat) = 200 mg/L (one hour) component.
LC20 (inhalation, rat) = 2 mg/L (two weeks)
Draize test (eye, rabbit) = Non-irritating
Ethylene Vinyl Acetate Copolymer:
Draize Test (skin, rabbit) = Non-irritating
LD50 (oral, rat) > 1000 mg/kg
Long Term Chronic Ingestion: Increased
incidence of stone formation in the lower
urinary tract, reduced liver weights, and
death were seen in rats.
SUSPECTED CANCER AGENT: The components of this product are not found on the following lists: NTP, IARC, Federal OSHA. Z
List, and CAL/OSHA, and therefore they are not considered to be, nor suspected to be, cancer causing agents by these agencies.
However, the following information is available for Ganciclovir (the active component of this product) from clinical studies of
laboratory animals.
Ganciclovir: Ganciclovir was carcinogenic in mice after daily oral doses of 20 mg/kg/day and 1000 mg/kg/day. The tissues most affected by doses of 100
mg/kg/day in mice were the preputial gland in males, in the reproductive system and liver in females, and the fore-stomach in both males and females. All
Ganciclovir-induced tumors were of epithelial or vascular origin, except for histiocytic sarcoma of the liver. No carcinogenic effect occurred at doses of 1
mg/kg/day. The preputial and clitoral glands, fore-stomach, and harderian glands of mice do not have human counterparts. Based on these results,
Ganciclovir should be handed as a potential human carcinogen.
IRRITANCY OF PRODUCT: While not tested, this product is not reported to cause irritancy to the skin or eyes.
SENSITIZATION TO THE PRODUCT: No component of this product is reported to be a sensitizer with repeated or prolonged use..
VITRASERT MSDS
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11. TOXICOLOGICAL INFORMATION (Continued)
REPRODUCTIVE TOXICITY INFORMATION: Listed below is information concerning the effects of this product and its components
on the human reproductive system.
Mutagenicity: Ganciclovir (the active component of this product) increased mutations in mouse lymphoma cells and DNA damage
in lymphocytes in vitro at concentrations between 50-500 and 25-2000 碌g/mL, respectively. In the mouse micronucleus assay,
Ganciclovir was clastogenic at doses of 150 and 500 mg/kg (2.8 to 10 times greater than the anticipated dosage to humans), but
not 50 mg/kg (the approximate level of human dosage). Ganciclovir was not mutagenic in the Ames Salmonella assay of
concentrations of 500-5000 碌g/mL.
Embryotoxicity: This product is not reported to produce embryotoxic effects in humans. Refer to the following paragraph for
additional information.
Teratogenicity: Ganciclovir (the active component of this product) has been shown to be embryotoxic in rabbits and mice following
intravenous administration and teratogenic in rabbits. Fetal resorbtions were observed in at least 85% of rabbits and mice
administered 60 mg/kg/day and 108 mg/kg/day, respectively. Effects observed in rabbits include: fetal growth retardation,
embryolethality, teratogenicity, and maternal toxicity. In mice, the observed effects were maternal and fetal toxicity and
embryolethality.
Reproductive Toxicity: Ganciclovir (the active component of this product) caused decreased mating behavior, decreased fertility,
and an increased incidence of embryolethality in female mice following dices of 90 mg/kg/day. Ganciclovir caused decreased
fertility in male mice and hypospermatogenesis in mice and dogs.
A mutagen is a chemical which causes permanent changes to genetic material (DNA) such that the changes will propagate
through generational lines. An embryotoxin is a chemical which 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 which
causes damage to a developing fetus, but the damage does not propagate across generational lines. A reproductive toxin is
any substance which interferes in any way with the reproductive process.
BIOLOGICAL EXPOSURE INDICES: Currently, there are no Biological Exposure Indices (BEIs) associated with this product.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: No specific medical conditions are known to be aggravated by
occupational over-exposures to this product.
RECOMMENDATIONS TO PHYSICIANS: Refer to adverse reaction information provided with this product. Employees should
receive routine medical surveillance before job placement, periodically (following acute exposures), and at the job termination or
transfer.
12. ECOLOGICAL INFORMATION
ALL WORK PRACTICES MUST BE AIMED AT ELIMINATING ENVIRONMENTAL CONTAMINATION.
ENVIRONMENTAL STABILITY: The components of this product will degrade in the environment into smaller organic and inorganic
constituents.
EFFECT OF MATERIAL ON PLANTS or ANIMALS: Because of the size of the product, no unusual effects on plants or animals are
expected if this product is released into the environment; however, because of the potential for harm to contaminated plants and
animals.
EFFECT OF PRODUCT ON AQUATIC LIFE: This product is not known to cause adverse effects on aquatic life; however, because
of the potential for harm to contaminated aquatic plant and animal life.
13. DISPOSAL CONSIDERATIONS
PREPARING WASTES FOR DISPOSAL: 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. All gowns, gloves, and disposable materials used in the preparation or handling of this drug
should be disposed of in accordance with established hazardous waste disposal procedures. Reusable equipment should be
cleaned with soap and water.
EPA WASTE NUMBER: Not applicable to the product.
VITRASERT MSDS
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14. TRANSPORTATION INFORMATION
THIS MATERIAL IS NOT HAZARDOUS AS DEFINED BY 49 CFR 172.101 BY THE U.S. DEPARTMENT OF TRANSPORTATION.
PROPER SHIPPING NAME: Not applicable.
HAZARD CLASS NUMBER and DESCRIPTION: Not applicable.
UN IDENTIFICATION NUMBER: Not applicable.
PACKING GROUP: Not applicable.
DOT LABEL(S) REQUIRED: Not applicable.
NORTH AMERICAN EMERGENCY RESPONSE GUIDEBOOK NUMBER (1996): Not Applicable.
MARINE POLLUTANT: Not applicable (49 CFR 172.101, Appendix B).
TRANSPORT CANADA TRANSPORTATION OF DANGEROUS GOODS REGULATIONS: THIS MATERIAL IS NOT
CONSIDERED AS DANGEROUS GOODS.
15. REGULATORY INFORMATION
SARA REPORTING REQUIREMENTS: No component of this product is subject to the reporting requirements of Sections 302, 304
and 313 of Title III of the Superfund Amendments and Reauthorization Act, as follows:
SARA Threshold Planning Quantity: Not applicable.
TSCA INVENTORY STATUS: Magnesium Stearate is listed on the TSCA Inventory. The polymer compounds are exempted from
this Act.
CERCLA REPORTABLE QUANTITY (RQ): Not applicable.
OTHER FEDERAL REGULATIONS: Employers should refer to the OSHA Technical Instructions, TED 1.15, when employees are
working with hazardous drugs.
STATE REGULATORY INFORMATION: No component of this product is covered under specific State regulations, as denoted
below:
Alaska - Designated Toxic and Hazardous Minnesota - List of Hazardous Pennsylvania - Hazardous Substance
Substances: None. Substances: None. List: None.
California - Permissible Exposure Limits Missouri - Employer Information/Toxic Rhode Island - Hazardous Substance
for Chemical Contaminants: None. Substance List: None. List: None.
Florida - Substance List: None. New Jersey - Right to Know Hazardous Texas - Hazardous Substance List: None.
Illinois - Toxic Substance List: None. Substance List: None. West Virginia - Hazardous Substance
Kansas - Section 302/313 List: None. North Dakota - List of Hazardous List: None.
Massachusetts - Substance List: None. Chemicals, Reportable Quantities: Wisconsin - Toxic and Hazardous
None. Substances: None.
CALIFORNIA PROPOSITION 65: No component of this solution is on the California Proposition 65 lists.
LABELING (Precautionary Statements): WARNING! Possible Human Carcinogen. Possible Human Reproductive Toxin. May
cause blood disorders. Animal studies indicate over-exposure to this product can cause cancer , birth defects, and other
reproductive harm. Avoid contact with skin, eyes, and mucous membranes. Avoid generating dusts. Product must be administered
only by a qualified health-care professional. Avoid contact with strong oxidizers. Flush contaminated skin and eyes for 15 minutes,
and seek prompt medical attention. Consult Material Safety Data Sheet before use.
In addition to standard pharmacy labeling practices, all syringes and IV bags containing this product should be labeled as follows:
SPECIAL HANDLING AND DISPOSAL REQUIRED
TARGET ORGANS: Eyes, reproductive system, blood system.
WHMIS SYMBOLS:
VITRASERT MSDS
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16. OTHER INFORMATION
PREPARED BY: CHEMICAL SAFETY ASSOCIATES, Inc.
9163 Chesapeake Drive, San Diego, CA 92123-1002
619/565-0302
DATE OF PRINTING: January 29, 2002
Updated Company information on 1/22/01 鈥? No technical information was changed.
The information contained herein is based on data considered accurate. However, no warranty is expressed or implied regarding the accuracy of these data or the results to
be obtained from the use thereof. Bausch & Lomb assumes no responsibility for injury to the vend or third persons proximately caused by the material if reasonable safety
procedures are not adhered to as stipulated in the data sheet. Additionally, Bausch & Lomb assumes no responsibility for injury to vendee or third persons proximately
caused by abnormal use of the material even if reasonable safety procedures are followed. Furthermore, vendee assumes the risk in his use of the material.
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 which uniquely identifies each constituent. It is used for computer-related searching.
EXPOSURE LIMITS IN AIR: TOXICOLOGICAL INFORMATION:
Possible health hazards as derived from human data, animal studies, or
ACGIH - American Conference of Governmental Industrial Hygienists, a
from the results of studies with similar compounds are presented.
professional association which establishes exposure limits.
Definitions of some terms used in this section are: LD50 - Lethal Dose
TLV - Threshold Limit Value - an airborne concentration of a substance
(solids & liquids) which kills 50% of the exposed animals; LC50 - Lethal
which represents conditions under which it is generally believed that
nearly all workers may be repeatedly exposed without adverse effect. Concentration (gases) which kills 50% of the exposed animals; ppm
The duration must be considered, including the 8-hour Time Weighted concentration expressed in parts of material per million parts of air or
water; mg/m3 concentration expressed in weight of substance per
Average (TWA), the 15-minute Short Term Exposure Limit, and the
instantaneous Ceiling Level. Skin adsorption effects must also be volume of air; mg/kg quantity of material, by weight, administered to a
considered. test subject, based on their body weight in kg. Data from several
sources are used to evaluate the cancer-causing potential of the
OSHA - U.S. Occupational Safety and Health Administration.
material. The sources are: IARC - the International Agency for Research
PEL - Permissible Exposure Limit - This exposure value means
on Cancer; NTP - the National Toxicology Program, RTECS - the
exactly the same as a TLV, except that it is enforceable by OSHA. The
OSHA Permissible Exposure Limits are based in the 1989 PELs and the Registry of Toxic Effects of Chemical Substances, OSHA and
June, 1993 Air Contaminants Rule (Federal Register: 58: 35338-35351 CAL/OSHA. IARC and NTP rate chemicals on a scale of decreasing
and 58: 40191). Both the current PELs and the vacated PELs are potential to cause human cancer with rankings from 1 to 4. Subrankings
indicated. The phrase, 鈥淰acated 1989 PEL,鈥? is placed next to the PEL (2A, 2B, etc.) are also used. Other measures of toxicity include TDLo,
which was vacated by Court Order. the lowest dose to cause a symptom and TCLo the lowest concentration
IDLH - Immediately Dangerous to Life and Health - This level to cause a symptom; TDo, LDLo, and LDo, or TC, TCo, LCLo, and
represents a concentration from which one can escape within 30-minutes LCo, the lowest dose (or concentration) to cause death. BEI - Biological
without suffering escape-preventing or permanent injury. The DFG - Exposure Indices, represent the levels of determinants which are most
MAK is the Republic of Germany鈥檚 Maximum Exposure Level, similar to likely to be observed in specimens collected from a healthy worker who
the U.S. PEL. NIOSH is the National Institute of Occupational Safety has been exposed to chemicals to the same extent as a worker with
and Health, which is the research arm of the U.S. Occupational Safety inhalation exposure to the TLV.
and Health Administration (OSHA). NIOSH issues exposure guidelines
called Recommended Exposure Levels (RELs). When no exposure REGULATORY INFORMATION:
This section explains the impact of various laws and regulations on the
guidelines are established, an entry of NE is made for reference.
material. EPA is the U.S. Environmental Protection Agency. WHMIS is
the Canadian Workplace Hazardous Materials Information System. DOT
FLAMMABILITY LIMITS IN AIR:
and TC are the U.S. Department of Transportation and the Transport
Much of the information related to fire and explosion is derived from the
National Fire Protection Association (NFPA). LEL - the lowest percent of Canada, respectively. Other acronyms used are: Superfund
vapor in air, by volume, that will explode or ignite in the presence of an Amendments and Reauthorization Act (SARA); the Toxic Substance
ignition source. UEL - the highest percent of vapor in air, by volume, that Control Act (TSCA); Marine Pollutant status according to the DOT;
will explode or ignite in the presence of an ignition source. California's Safe Drinking Water Act (Proposition 65); the
Comprehensive Environmental Response, Compensation, and
Liability Act (CERCLA or Superfund); and various state regulations.
This section also includes information on the precautionary warnings
which appear on the materials package label.
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