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
SURGILENS CORNEAL SHIELD
TRADE NAME (AS LABELED):
PRODUCT USE: Ocular Postsurgical Healing
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
DATE OF PREPARATION: July 13, 1998 (Updated Company information
Jan. 2002)
NOTE: This product is defined as an 鈥淎rticle鈥? under the U.S. Federal OSHA Hazard Communication Standard (29 CFR 1910.1200), and the Canadian
Workplace Hazardous Materials Standard. As an article, this product presents negligible health and physical hazards under reasonably anticipated
circumstances of use. Subsequently, a Material Safety Data Sheet is not required for this product under Standards cited above. This document is prepared
to provide persons using this product with additional safety information.
2. COMPOSITION and INFORMATION ON INGREDIENTS
CHEMICAL NAME CAS # % w/w EXPOSURE LIMITS IN AIR
ACGIH OSHA
TLV STEL PEL STEL IDLH OTHER
Gelatin 9004-70-8 1-2 NE NE NE NE NE NE
Sodium Carboxy- 9004-32-4 <1 NE NE NE NE NE NE
methyl Cellulose
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.
SURGILENS CORNEAL SHIELD MSDS
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3. HAZARD IDENTIFICATION
EMERGENCY OVERVIEW: This product consists of a clear, colorless, pliable, thin lens. This product does not have any
unusual health, fire, or reactivity hazards. If involved in a fire, this product may decomposes and generate carbon
monoxide, carbon dioxide, and other organic compounds.
HEALTH EFFECTS OR RISKS: An Explanation in Lay Terms.
HAZARDOUS MATERIAL INFORMATION SYSTEM
ACUTE: There is no health hazard anticipated to occur to medical
personnel during routine use of this product. In terms of patient-care, it
HEALTH (BLUE) 0
is important to note that this product should not be used on individuals
who have the following conditions:
鈥? Corneal Anesthesia
鈥? (RED) 0
FLAMMABILITY
Evidence of Acute External Ocular Infections
鈥? Intraocular Infections
鈥? Monocular Vision
鈥? Dysthyroid Opthalmopathy
REACTIVITY
鈥? (YELLOW) 0
Nasolacrimal Duct Obstruction
鈥? Blepharitis
鈥? Chalazion
鈥? PROTECTIVE EQUIPMENT NA
Lax Lids
鈥? Dry Eye Syndrome
鈥? Hypersensitivity to Collagen EYES HANDS BODY
RESPIRATORY
鈥? Hypersensitivity to Bovine-Derived Products
None needed under normal circumstances of use.
CHRONIC: Not applicable.
TARGET ORGANS: None.
See Section 16 for Definition of Ratings
PART II What should I do if a hazardous situation occurs?
4. FIRST-AID MEASURES
This product is not anticipated to cause injury to medical personnel under normal circumstances of use or handling. Persons
using this product should consult a physician or other medical professional in the unlikely event that an accident involving this
product results in injury.
5. FIRE-FIGHTING MEASURES
FLASH POINT: Not applicable.
NFPA RATING
AUTOIGNITION TEMPERATURE: Not applicable. FLAMMABILITY
FLAMMABLE LIMITS (in air by volume, %):
Lower (LEL): Not applicable. 0
Upper (UEL): Not applicable.
0
0
FIRE EXTINGUISHING MATERIALS: HEALTH REACTIVITY
Water Spray: YES Carbon Dioxide: YES
Foam: YES Dry Chemical: YES
Halon: YES Other: Any "ABC" Class
OTHER
See Section 16 for Definition of Ratings
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5. FIRE-FIGHTING MEASURES (Continued)
UNUSUAL FIRE AND EXPLOSION HAZARDS: This product is not flammable. If involved in a fire, this product will
decompose and produce toxic gases carbon monoxide, carbon dioxide.
Explosion Sensitivity to Mechanical Impact: Not applicable.
Explosion Sensitivity to Static Discharge: Not applicable.
SPECIAL FIRE-FIGHTING PROCEDURES: Structural firefighters must wear Self-Contained Breathing Apparatus and full
protective equipment.
6. ACCIDENTAL RELEASE MEASURES
RELEASE RESPONSE: Due to the nature of this product, no special accidental release measures are normally required.
Uncontrolled releases involving other materials released near this product should be responded to by appropriately trained
personnel using pre-planned procedures.
PART III How can I prevent hazardous situations from occurring?
7. HANDLING and STORAGE
WORK, STORAGE AND HANDLING PRACTICES: Medical personnel should review Care and Handling Instructions before
using this product. Sterile, sealed packages containing this product should be stored at a controlled room temperature, 15-
30掳C (59-86掳F). Avoid exposing this product to heat above 40掳C (104掳F) or temperatures at or below freezing, 0掳C (32掳F).
Medical personnel should not resterilize this product; all open and unused shields must be discarded. Medical personnel
must also carefully screen patients for any known hypersensitivities to collagen or bovine-derived products, In addition,
patients should be monitored for reactions to the product. The following steps summarize the recommended instructions for
use:
1. Anesthetize and hydrate the eye before applying the product. The shield should be lifted from the protective case using
blunt forceps.
2. Partially fill the holding well with a sterile, hydrating fluid (e.g. Balanced Salt Solution).
3. Return the product to holding well and add sterile hydrating fluid to cover the shield. Allow the product to hydrate for a
minimum of five minutes.
4. Moisten the eye with sterile hydrating fluid. Apply the shield to the eye using blunt forceps. Hydrate the eye and shield
thoroughly. The eye may be patched, as determined by the physician. No ointment should be used.
8. EXPOSURE CONTROLS - PERSONAL PROTECTION
VENTILATION AND ENGINEERING CONTROLS: No special ventilation and engineering controls are required for use of
this product.
RESPIRATORY PROTECTION: No special respiratory protection is required for use of this product. Respiratory protection is
required for firefighters, as authorized in the Federal OSHA Standard (29 CFR 1910.134) or applicable U.S. State or Canadian
regulations.
EYE PROTECTION: No special eye protection is required for use of this product.
HAND PROTECTION: No special hand protection is normally required for use of this product.
BODY PROTECTION: No special body protection is required for use of this product.
9. PHYSICAL and CHEMICAL PROPERTIES
RELATIVE VAPOR DENSITY (air = 1): Not applicable. EVAPORATION RATE (n-BuAc = 1): Not applicable.
SPECIFIC GRAVITY (water = 1): Not determined. MELTING/FREEZING POINT: Not applicable.
SOLUBILITY IN WATER: Soluble. BOILING POINT: Not applicable.
VAPOR PRESSURE, mm Hg @ 20掳C: Not applicable. pH: Not applicable.
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9. PHYSICAL and CHEMICAL PROPERTIES (Continued)
ODOR THRESHOLD: Not applicable.
COEFFICIENT OF OIL/WATER DISTRIBUTION (PARTITION COEFFICIENT): Not applicable.
APPEARANCE AND COLOR: Clear, colorless, pliable, thin lens
HOW TO DETECT THIS SUBSTANCE (warning properties): The appearance is a distinguishing characteristic of this
product.
10. STABILITY and REACTIVITY
STABILITY: Stable.
DECOMPOSITION PRODUCTS: If exposed to extremely high temperatures, this product will decompose to generate carbon
dioxide, carbon monoxide, and a variety of organic compounds.
MATERIALS WITH WHICH SUBSTANCE IS INCOMPATIBLE: Strong oxidizers.
HAZARDOUS POLYMERIZATION: Will not occur.
CONDITIONS TO AVOID: Avoid exposure or contact to extreme temperatures, incompatible chemicals.
PART IV Is there any other useful information about this material?
11. TOXICOLOGICAL INFORMATION
TOXICITY DATA: The specific toxicology data available for components greater than 1% in concentration are listed below. It
is important to note the data are for the components of this product, and not for the product itself.
GELATIN: SODIUM CARBOXYMETHYL CELLULOSE (continued):
TDLo - Intraperitoneal - mouse: 700 mg/kg: female 7-13 day(s) after LD50 - Oral - guinea pig: 16000 mg/kg
conception: Specific Developmental Abnormalities - urogenital TDLo - Oral - rat: 227 gm/kg/13 weeks (continuous); changes in liver
system; growth statistics weight, changes in urine composition, changes in sodium levels
TDLo - Subcutaneous - rat: 1900 mg/kg/19 weeks (intermittent):
SODIUM CARBOXYMETHYL CELLULOSE:
Tumorigenic - neoplastic
LD50 - Oral - rat: 27000 mg/kg
TD - Subcutaneous - rat: 8600 mg/kg/19 weeks (intermittent); neoplastic
LC50 - Inhalation - rat: >5800 mg/m3/4 hours
TD - Subcutaneous - rat: 33 gm/kg/22 weeks (intermittent): neoplastic
LD50 - Oral - mouse: >27 gm/kg
TDLo - Oral - rat: 140 mg/kg: male 14 day(s) pre-mating: Reproductive -
LD50 - Oral - rabbit: >27 gm/kg
Paternal Effects - prostate, seminal vesicle, Cowper's gland,
LD50 - skin - rabbit: >2 gm/kg
accessory glands
SUSPECTED CANCER AGENT: This product's components are not found on the following lists: U.S. FEDERAL OSHA Z
LIST, NTP, IARC, and CAL/OSHA and therefore are neither considered to be nor suspected to be cancer-causing agents by
these agencies
IRRITANCY OF PRODUCT: This product is not irritating under normal circumstances of use or handling.
SENSITIZATION TO THE PRODUCT: This product contains no known sensitizer after prolonged or repeated contact.
REPRODUCTIVE TOXICITY INFORMATION: Listed below is information concerning the effects of this product and its
components on the human reproductive system.
Mutagenicity: This product is not reported to produce mutagenic effects in humans.
Embryotoxicity: This product is not reported to produce embryotoxic effects in humans.
Teratogenicity: This product is not reported to cause teratogenic effects in humans.
Reproductive Toxicity: This product is not reported to cause reproductive effects in humans. Clinical studies on mice
exposed to relatively high doses of Gelatin (a component of this product) via intraperitoneal exposure provided
reproductive toxicity data; intraperitoneal exposures are not anticipated to occur when this product is used as intended.
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.
ACGIH BIOLOGICAL EXPOSURE INDICES: Currently, there are no ACGIH Biological Exposure Indices (BEIs) associated
with the components of this product.
MEDICAL CONDITIONS AGGRAVATED BY EXPOSURE: In terms of effect on medical personnel, no medical conditions
are known to be aggravated by this product. Refer to Section 3 (Hazard Identification) for information related to patent
medical conditions which could be affected by use of this product.
RECOMMENDATIONS TO PHYSICIANS: Treat symptoms.
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12. ECOLOGICAL INFORMATION
ALL WORK PRACTICES MUST BE AIMED AT ELIMINATING ENVIRONMENTAL CONTAMINATION.
ENVIRONMENTAL STABILITY: This product is biodegradable. The following environmental data are available for the
components of this product:
SODIUM CARBOXYMETHYL CELLULOSE: Inherently biodegradable.
EFFECT OF MATERIAL ON PLANTS or ANIMALS: This product is not anticipated to harm terrestrial plant or animal life.
EFFECT OF CHEMICAL ON AQUATIC LIFE: This product is not anticipated to harm aquatic plant or animal life. The
following aquatic toxicity data are available for the components (in pure form) of this product.
SODIUM CARBOXYMETHYL CELLULOSE:
No Observable effect concentration (rainbow trout) = saturated solution/96 hours
No Observable effect concentration (daphnia) = saturated solution/96 hours
No Observable effect concentration (algae) = saturated solution/96 hours
13. DISPOSAL CONSIDERATIONS
PREPARING WASTES FOR DISPOSAL: The shields will dissolve in the eyes; subsequently, waste-handling is not normally
pertinent to this product. If unused product is disposed, the shields may be disposed of as permitted by local waste-handling
authority.
U.S. EPA WASTE NUMBER: Not applicable.
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: The components of this product are not designated by the DOT to be Marine Pollutants (49 CFR
172.101, Appendix B).
TRANSPORT CANADA TRANSPORTATION OF DANGEROUS GOODS REGULATIONS: THIS MATERIAL IS NOT
CONSIDERED AS DANGEROUS GOODS.
15. REGULATORY INFORMATION
ADDITIONAL U.S. REGULATIONS:
U.S. SARA REPORTING REQUIREMENTS: The components of this product are not subject to the reporting requirements of
Sections 302, 304, and 313 of Title III of the Superfund Amendments and Reauthorization Ac.
U.S. SARA THRESHOLD PLANNING QUANTITY: Not applicable.
U.S. CERCLA REPORTABLE QUANTITY (RQ): Not applicable.
U.S. TSCA INVENTORY STATUS: The components of this product are on the TSCA inventory.
OTHER U.S. FEDERAL REGULATIONS: U.S. Federal law restricts this device to sale by, or on the order of, a physician.
Additionally, this product meets the definition of an 鈥淎rticle鈥? under the U.S. Federal OSHA Hazard Communication Standard
(29 CFR 1910.1200). For further information, the definition of 鈥淎rticle鈥? is provided below.
Article means a manufactured item other than a fluid or particle: (i) which is formed to a specific shape or design during
manufacture; (ii) which has end use function(s) dependent in whole or in part upon its shape or design during end use; and
(iii) which under normal conditions of use does not release more than very small quantities, e.g., minute or trace amounts
of a hazardous chemical, and does not pose a physical hazard or health risk to employees.
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15. REGULATORY INFORMATION (Continued)
U.S. STATE REGULATORY INFORMATION: The components of this product are 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 component of this
product is on the California Proposition 65 lists.
LABELING (Precautionary Statements): This product is an article; no label information is required under OSHA 29 CFR
1910.1200 or ANSI Z400.1 to address the chemical hazards.
ADDITIONAL CANADIAN REGULATIONS:
CANADIAN DSL INVENTORY: The components of this product are on the DSL inventory.
OTHER CANADIAN REGULATIONS: This product meets the definition of an article under WHMIS Regulations (Hazardous
Products Act, 6&7, Part II (Sections 11 and 12).
CANADIAN ENVIRONMENTAL PROTECTION AGENCY (CEPA) PRIORITIES SUBSTANCES LISTS: No component of
this product is on the Priorities Substances Lists.
CANADIAN WHMIS SYMBOLS: Not applicable.
16. OTHER INFORMATION
PREPARED BY: CHEMICAL SAFETY ASSOCIATES, Inc.
9163 Chesapeake Drive, San Diego, CA 92123-1002
(619) 565 - 0302
DATE OF PRINTING: January22, 2002
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 vendee 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.
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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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