MATERIAL SAFETY DATA SHEET
PART I What is the material and what do I need to know in an emergency?
1. PRODUCT IDENTIFICATION
OCUCOAT
TRADE NAME (AS LABELED):
PRODUCT USE: Preparation for IntraOcular Lenses
MANUFACTURED FOR: BAUSCH & LOMB
21 Park Place Blvd N.
Clearwater, FL 33759
EMERGENCY PHONE: CHEMTREC: 800-424-9300
BUSINESS PHONE: 1-800-338-2020
DATE OF PREPARATION: July 29, 1994; updated July 01, 2002
2. COMPOSITION and INFORMATION ON INGREDIENTS
CHEMICAL NAME % w/w EXPOSURE LIMITS IN AIR
ACGIH OSHA
TLV STEL PEL STEL IDLH OTHER
2 NE
NE NE
Hydroxypropyl Methyl NE NE NE
Cellulose
<0.5 NE
NE NE
Sodium Chloride NE NE NE
< 0.01 NE
NE NE
Potassium Chloride NE NE NE
< 0.05 NE
NE NE
Calcium Chloride NE NE NE
< 0.05 NE
NE NE
Magnesium Chloride NE NE NE
<0.4 NE
NE NE
Sodium Acetate NE NE NE
< 0.2 NE
NE NE
Sodium Citrate NE NE NE
> 96 NE
NE NE
Water NE NE NE
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.
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3. HAZARD IDENTIFICATION
EMERGENCY OVERVIEW: This substance consists of colorless, transparent viscous liquid with no odor. The primary
health hazard associated with emergency response to this material is the potential for mild irritation of skin, eyes, and other
contaminated tissue. When involved in a fire, this material and its packaging may decompose and produce irritating vapors
and toxic compounds (including carbon monoxide, carbon dioxide, nitrogen oxides, and benzene). This substance is not
reactive. Emergency responders must wear adequate personal protective equipment for the situations to which they are
responding. Use in accordance with product literature. If you are allergic to any ingredient in this product, DO NOT
USE. Keep this and all other drugs out of the reach of children.
HMIS RATINGS
Health 鈥? 0
Flammability - 0
Reactivity 鈥? 0
PART II What should I do if a hazardous situation occurs?
4. FIRST-AID MEASURES
If discomfort or irritation develops, immediately discontinue product use and contact
EYE EXPOSURE:
your eye care professional.
SKIN EXPOSURE: No specific treatment is necessary since this material is not likely to be hazardous by
contact with the skin or mucous membranes.
INGESTION: No specific treatment is necessary since this material is not likely to be hazardous by
ingestion. If large quantities are accidentally ingested (greater than a tablespoon), get medical
attention immediately.
INHALATION: No specific treatment is necessary since this material is not likely to be hazardous by
inhalation. If exposed to excessive levels of mists, remove to fresh air and get medical attention if
cough or other symptoms develop.
Note to Physicians: Additional details are available on the package or in the Physician鈥檚 Desk
Reference.
CALL PHYSICIAN OR POISON CONTROL CENTER FOR MOST CURRENT INFORMATION. If
professional advice is not available, do not induce vomiting. Victim 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 unable to swallow.
Victims of chemical exposure must be taken for medical attention. Rescuers should be taken for
medical attention, if necessary. Take a copy of the label and the MSDS to health professional with
victim.
5. FIRE-FIGHTING MEASURES
FLASH POINT: Not flammable.
AUTOIGNITION TEMPERATURE: Not applicable.
FLAMMABLE LIMITS (in air by volume, %): Not applicable.
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FIRE EXTINGUISHING MATERIALS:
Water Spray: OK Carbon Dioxide: OK Other: "ABC" type
Foam: OK Dry Chemical: OK Halon: OK
UNUSUAL FIRE AND EXPLOSION HAZARDS: This material must be substantially pre-heated before ignition can occur.
When involved in a fire, this material may decompose and produce irritating vapors and toxic compounds (including carbon
monoxide, carbon dioxide).
Explosion Sensitivity to Mechanical Impact: Not applicable.
Explosion Sensitivity to Static Discharge: Not applicable.
SPECIAL FIRE-FIGHTING PROCEDURES: Structural fire fighters must wear Self-Contained Breathing Apparatus and full
protective equipment. All personal protective gear and contaminated fire-response equipment should be decontaminated with
soapy water before being returned to service. Move fire-exposed containers, if it can be done without risk to firefighters. If
possible, prevent run-off water from entering storm drains, bodies of water, or other environmentally sensitive areas.
6. ACCIDENTAL RELEASE MEASURES
SPILL AND LEAK RESPONSE: In case of a spill, clear the affected area and protect people. Trained personnel using pre-
planned procedures should respond to uncontrolled releases.
Use appropriate personal protective equipment. Contain the spill to prevent drainage into sewers, drains or streams. Use
absorbent material to solidify the spill. Shovel or scoop up solidified waste. Decontaminate the area thoroughly. Place all
spill residue in an appropriate, labeled container and seal immediately. Dispose of in accordance with U.S. Federal, State,
and local hazardous waste disposal regulations, or those of Canada and its Provinces (see Section 13, Disposal
Considerations).
PART III How can I prevent hazardous situations from occurring?
7. HANDLING and STORAGE
No special handling is required. Use in accordance with product literature.
Store product in original containers with the cap tightly closed at a controlled room temperature 15 -30 degrees C
(59 - 86 F). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION
RESPIRATORY PROTECTION:
No special controls or personal protection required under conditions of intended use.
SKIN PROTECTION:
No special controls or personal protection required under conditions of intended use.
EYE PROTECTION:
No special controls or personal protection required under conditions of intended use.
ADDITIONAL PROTECTIVE CLOTHING & EQUIPMENT:
NA
9. PHYSICAL and CHEMICAL PROPERTIES
RELATIVE VAPOR DENSITY (air = 1): Not applicable. EVAPORATION RATE (n-BuAc=1): Not applicable.
SPECIFIC GRAVITY (water = 1): 1.006 MELTING/FREEZING POINT: Not Applicable
SOLUBILITY IN WATER: Soluble. BOILING POINT: 100 C
VAPOR PRESSURE, mm Hg: 23.8 @ 25 C . pH: Not applicable.
ODOR THRESHOLD: Not applicable.
COEFFICIENT OF OIL/WATER DISTRIBUTION (PARTITION COEFFICIENT): Not available.
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10. STABILITY and REACTIVITY
STABILITY: Stable.
DECOMPOSITION PRODUCTS: None
MATERIALS WITH WHICH SUBSTANCE IS INCOMPATIBLE: Strong oxidizing agents.
HAZARDOUS POLYMERIZATION: Will not occur.
CONDITIONS TO AVOID: Avoid exposure or contact to extreme temperatures and incompatible chemicals.
PART IV Is there any other useful information about this material?
11. TOXICOLOGICAL INFORMATION
CAS# 9004-65-3 Hydroxypropyl Methylcellulose
May cause irritation to the eyes, skin and respiratory tract. Dust exposure to the eyes, skin, respiratory and digestive
tract can cause hypersensitivity in some individuals. Intraperitoneal-rat LD50 5200 mg/kg, intraperitoneal-mouse LD50
5000 mg/kg.
12. ECOLOGICAL INFORMATION
No specific ecological data are available for this product.
13. DISPOSAL CONSIDERATIONS
PREPARING WASTES FOR DISPOSAL: Waste disposal must be in accordance with appropriate U.S. Federal, State, and
local regulations or those of Canada and its Provinces. If unaltered by use, may be disposed of by treatment at a permitted
facility or as advised by your local waste regulatory authority.
U.S. EPA WASTE NUMBER: Not applicable to wastes consisting only of Ocucoat.
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 designated as a marine pollutant, per Appendix B to U.S. EPA, 49 CFR 172.101.
TRANSPORT CANADA, TRANSPORTATION OF DANGEROUS GOODS REGULATIONS: THIS MATERIAL IS NOT
CONSIDERED A DANGEROUS GOODS.
15. REGULATORY INFORMATION
ADDITIONAL U.S. REGULATIONS:
U.S. SARA REPORTING REQUIREMENTS: Not subject to the reporting requirements of Sections 302, 304, and 313 of Title
III of the Superfund Amendments and Reauthorization Act.
U.S. SARA THRESHOLD PLANNING QUANTITY: Not applicable.
U.S. CERCLA REPORTABLE QUANTITY (RQ): Not applicable.
U.S. TSCA INVENTORY STATUS: This product is regulated under Food and Drug Administration Standards and is not
subject to the requirements of TSCA.
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OTHER U.S. FEDERAL REGULATIONS: Not applicable.
U.S. STATE REGULATORY INFORMATION: Not covered under specific State regulations, as denoted below:
Alaska - Designated Toxic and Hazardous Michigan - Critical Materials Register: No. Pennsylvania - Hazardous Substance List:
No.
Substances: No. Minnesota - List of Hazardous Substances:
Rhode Island - Hazardous Substance List:
No.
California - Permissible Exposure Limits for
No.
Missouri - Employer Information/Toxic
Chemical Contaminants: No.
Texas - Hazardous Substance List: No.
Substance List: No.
Florida - Substance List: No.
West Virginia - Hazardous Substance List:
New Jersey - Right to Know Hazardous
Illinois - Toxic Substance List: No.
No.
Substance List: No.
Kansas - Section 302/313 List: No.
Wisconsin - Toxic and Hazardous
North Dakota - List of Hazardous Chemicals,
Massachusetts - Substance List: No.
Substances: No.
Reportable Quantities: No.
CALIFORNIA SAFE DRINKING WATER AND TOXIC ENFORCEMENT ACT (PROPOSITION 65 No listed substances on
the California Proposition 65 lists.
ADDITIONAL CANADIAN REGULATIONS:
CANADIAN DSL/NDSL INVENTORY STATUS: Regulated under the Canadian Food and Drugs Act; the requirements of
CEPA are not applicable to this product.
OTHER CANADIAN REGULATIONS: Not applicable.
CANADIAN ENVIRONMENTAL PROTECTION ACT (CEPA) PRIORITIES SUBSTANCES LISTS: Not on the CEPA Priorities
Substances Lists.
CANADIAN WHMIS SYMBOLS: Not applicable.
16. OTHER INFORMATION
To the best of our knowledge, the information contained herein is accurate. However, neither Bausch & Lomb
Incorporated nor any of its subsidiaries assumes any liability whatsoever for the accuracy or completeness of the
information contained herein. Final determination of suitability of any material is the sole responsibility of the user. All
materials may present unknown hazards and should be used with caution. Although certain hazards are described
herein, we cannot guarantee that these are the only hazards that exist. NO WARRANTY, EXPRESS OR IMPLIED, OF
MERCHANTABILITY, FITNESS OR OTHERWISE IS MADE. In no event shall Bausch & Lomb Incorporated or any of
itssubsidiaries be liable for any special, incidental or consequential damages.
OCUCOAT MSDS
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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: FLAMMABILITY LIMITS IN AIR:
Much of the information related to fire and explosion is derived from the
ACGIH - American Conference of Governmental Industrial Hygienists, a
National Fire Protection Association (NFPA). Flash Point - Minimum
professional association which establishes exposure limits. TLV -
temperature at which a liquid gives off sufficient vapors to form an ignitable
Threshold Limit Value - an airborne concentration of a substance which
mixture with air. Autoignition Temperature: The minimum temperature
represents conditions under which it is generally believed that nearly all
required to initiate combustion in air with no other source of ignition. LEL -
workers may be repeatedly exposed without adverse effect. The duration
the lowest percent of vapor in air, by volume, that will explode or ignite in
must be considered, including the 8-hour Time Weighted Average (TWA),
the presence of an ignition source. UEL - the highest percent of vapor in air,
the 15-minute Short Term Exposure Limit, and the instantaneous Ceiling
by volume, that will explode or ignite in the presence of an ignition source.
Level (C). Skin absorption effects must also be considered.
OSHA - U.S. Occupational Safety and Health Administration.
TOXICOLOGICAL INFORMATION:
PEL - Permissible Exposure Limit - This exposure value means exactly the
Human and Animal Toxicology: Possible health hazards as derived from
same as a TLV, except that it is enforceable by OSHA. The OSHA
human data, animal studies, or from the results of studies with similar
Permissible Exposure Limits are based in the 1989 PELs and the June,
compounds are presented. Definitions of some terms used in this section
1993 Air Contaminants Rule (Federal Register: 58: 35338-35351 and 58:
are: LD50 - Lethal Dose (solids & liquids) which kills 50% of the exposed
40191). Both the current PELs and the vacated PELs are indicated. The
animals; LC50 - Lethal Concentration (gases) which kills 50% of the
phrase, 鈥淰acated 1989 PEL,鈥? is placed next to the PEL which was vacated
exposed animals; ppm concentration expressed in parts of material per
by Court Order. IDLH - Immediately Dangerous to Life and Health - This
million parts of air or water; mg/m3 concentration expressed in weight of
level represents a concentration from which one can escape within 30-
substance per volume of air; mg/kg quantity of material, by weight,
minutes without suffering escape-preventing or permanent injury. The DFG
administered to a test subject, based on their body weight in kg. Other
- MAK is the Republic of Germany鈥檚 Maximum Exposure Level, similar to
measures of toxicity include TDLo, the lowest dose to cause a symptom
the U.S. PEL. NIOSH is the National Institute of Occupational Safety and
and TCLo the lowest concentration to cause a symptom; TDo, LDLo, and
Health, which is the research arm of the U.S. Occupational Safety and
LDo, or TC, TCo, LCLo, and LCo, the lowest dose (or concentration) to
Health Administration (OSHA). NIOSH issues exposure guidelines called
cause lethal or toxic effects. Cancer Information: The sources are:
Recommended Exposure Levels (RELs). When no exposure guidelines
IARC - the International Agency for Research on Cancer; NTP - the
are established, an entry of NE is made for reference.
National Toxicology Program, RTECS - the Registry of Toxic Effects of
HAZARD RATINGS: Chemical Substances, OSHA and CAL/OSHA. IARC and NTP rate
HAZARDOUS MATERIALS IDENTIFICATION SYSTEM: Health Hazard: 0 chemicals on a scale of decreasing potential to cause human cancer with
(minimal acute or chronic exposure hazard); 1 (slight acute or chronic rankings from 1 to 4. Subrankings (2A, 2B, etc.) are also used. Other
exposure hazard); 2 (moderate acute or significant chronic exposure Information: BEI - ACGIH Biological Exposure Indices, represent the
levels of determinants which are most likely to be observed in specimens
hazard); 3 (severe acute exposure hazard; onetime overexposure can result
collected from a healthy worker who has been exposed to chemicals to the
in permanent injury and may be fatal); 4 (extreme acute exposure hazard;
same extent as a worker with inhalation exposure to the TLV. Ecological
onetime overexposure can be fatal). Flammability Hazard: 0 (minimal
Information: EC is the effect concentration in water. BCF =
hazard); 1 (materials that require substantial pre-heating before burning); 2
Bioconcentration Factor, which is used to determine if a substance will
(combustible liquid or solids; liquids with a flash point of 38-93掳C [100-
concentrate in lifeforms which consume contaminated plant or animal
200掳F]); 3 (Class IB and IC flammable liquids with flash points below 38掳C
matter. Coefficient of Oil/Water Distribution is represented by log Kow or
[100掳F]); 4 (Class IA flammable liquids with flash points below 23掳C [73掳F]
log Koc and is used to assess a substance鈥檚 behavior in the
and boiling points below 38掳C [100掳F]. Reactivity Hazard: 0 (normally
environment.
stable); 1 (material that can become unstable at elevated temperatures or
which can react slightly with water); 2 (materials that are unstable but do not REGULATORY INFORMATION:
detonate or which can react violently with water); 3 (materials that can This section explains the impact of various laws and regulations on the
detonate when initiated or which can react explosively with water); 4 material. U.S.: EPA is the U.S. Environmental Protection Agency. DOT is
(materials that can detonate at normal temperatures or pressures). the U.S. Department of Transportation. SARA is the Superfund
NATIONAL FIRE PROTECTION ASSOCIATION: Health Hazard: 0 Amendments and Reauthorization Act. TSCA is the U.S. Toxic Substance
(material that on exposure under fire conditions would offer no hazard Control Act. CERCLA (or Superfund) refers to the Comprehensive
beyond that of ordinary combustible materials); 1 (materials that on Environmental Response, Compensation, and Liability Act. Labeling is per
exposure under fire conditions could cause irritation or minor residual the American National Standards Institute (ANSI Z129.1). CANADA:
injury); 2 (materials that on intense or continued exposure under fire CEPA is the Canadian Environmental Protection Act. WHMIS is the
conditions could cause temporary incapacitation or possible residual injury); Canadian Workplace Hazardous Materials Information System. TC is
3 (materials that can on short exposure could cause serious temporary or Transport Canada. DSL/NDSL are the Canadian Domestic/Non-Domestic
residual injury); 4 (materials that under very short exposure causes death Substances Lists.
or major residual injury). Flammability Hazard and Reactivity Hazard: Refer
to definitions for 鈥淗azardous Materials Identification System鈥?.
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