MATERIAL SAFETY DATA SHEET
Issued: 07/17/98 Prepared by: Gary Wong
Revised: 01/29/02 Manager EHS
Revision: 01 Core No. 367
1. PRODUCT AND COMPANY IDENTIFICATION
Carteolol Hydrochloride Ophthalmic Solution USP, 1%
Product Name:
Same
Generic Name:
24208-367-05 ( 5 ml)
NDC No.
24208-367-10 (10 ml)
24208-367-15 (1 5 ml)
Prescription medication, filled in plastic bottles with dropper
Legal Category:
tips comprised of low density polyethylene, and overpacked
inside a cardboard carton.
Drug Composition: Non-selective beta-adrenoceptor blocking agent for
ophthalmic use.
BAUSCH & LOMB PHARMACEUTICALS, INC.
8500 Hidden River Parkway
Tampa, FL 33637
Information: (800) 323-0000 (M-F) 8am-5pm EST
Emergency: (800) 227-1427 24 hrs
2. COMPOSITION/INFORMATION ON INGREDIENTS
3 3
Description CAS # TLV (mg/m ) PEL(mg/m ) % Content
Carteolol 51781-21-6 NE NE 1.0
hydrochloride
Purified Water 7732-18-5 NE NE >1
Ingredients <1% - Sodium Chloride, Monobasic and Dibasic Sodium Phosphate,
Benzalkonium Chloride
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MSDS: Carteolol Hydrochloride Ophthalmic Solution USP, 1%
3. HAZARDS IDENTIFICATION
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EMERGENCY OVERVIEW
Plastic bottle with dropper tip in cardboard box. Clear colorless solution. Toxic
by ingestion. Presents little or no hazard if spilled and no unusual hazard if
involved in fire.
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POTENTIAL HEALTH HAZARDS
(NTP) No No No
Carcinogenicity: (IARC) (OSHA)
Eye: May cause irritation, burning or stinging on installation. Can cause
hypersensitivity (anaphylactic) in some individuals.
Skin: May cause irritation and hypersensitivity in some individuals.
Ingestion: May cause irritation and hypersensitivity in some individuals.
Inhalation: May cause irritation and hypersensitivity in some individuals. Vapors
produced at controlled room temperature are negligible.
Chronic Effects: May cause hypersensitivity. Prolonged use can cause
conjunctival injection, watery eyes, itchy eyes, dryness around the eye, puffy eyes,
eye irritation and styes. It is unclear if these effects are attributable to the drug.
Target Organs: Eyes.
Medical Conditions Aggravated by Long Term Exposure: Hypersensitivity to
any of the components of the product.
路 Reproduction studies have been performed in rats and mice. There are,
however, no adequate and well controlled studies in pregnant women. Because
animal reproduction studies are not always predictive of human response, this
drug should be used during pregnancy only if clearly needed.
Overdosage: No specific information on emergency treatment of overdosage in
humans is available. Should accidental ocular overdosage occur, flush eye(s) with
water or normal saline. The most common effects expected with overdosage of a
beta-adrenergic blocking agent are bradychardia, bronchospasm, congestive heart
failure and hypotension. On the basis of the pharmacologic profile, the following
additional measures should be considered as appropriate:
路 Symptomatic sinus bradychardia or heart block: Administer atropine. If there is
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MSDS: Carteolol Hydrochloride Ophthalmic Solution USP, 1%
no response to vagal blockade, administer isoproterenol cautiously.
路 Bronchospasm: Administer a beta2-stimulating agent such as isoproterenol
and/or theophylline derivative.
路 Congestive heart failure: Administer diuretics and digitalis glycosides as
necessary.
路 Hypotension: Administer vasopressors such as intravenous dopamine,
epinephrine or neoepinephrine bitartrate.
Contraindications: Contraindicated in those individuals with bronchial asthma or
with a history of bronchial asthma, or severe chronic obstructive pulmonary
disease; sinus bradychardia; second or third degree atrioventricular block; overt
cardiac failure; cardiogenic shock; or hypersensitivity to any component of this
product.
4. FIRST AID MEASURES
Eyes: If not prescribed this medication, rinse immediately with copious amounts of
water for at least 20 minutes. Contact a physician.
Skin: Remove all contaminated clothing and wash skin with copious amounts of
water for at least 20 minutes. Contact physician if skin becomes irritated.
Ingestion: Wash out mouth. Person should tell health personnel if he/she has an
ulcer of the G.I. tract. Give plenty of water and bland fluids. If breathing stops,
give artificial respiration. Do not give anything to an unconscious person. Contact
physician.
Inhalation: Remove person to fresh air, and if breathing stops, use artificial
respiration. Contact physician immediately.
Note to Physicians: Additional details are available on the package insert or in the
Physicians鈥? Desk Reference.
5. FIRE FIGHTING MEASURES
Flammable Properties: Flash point: NE Method: NE
Hazardous Products: May emit toxic or irritant fumes when heated.
Extinguishing Media: Dry chemical, carbon dioxide, halon, water spray or fog, and
foam on surrounding materials.
Fire Fighting Instructions: Wear self-contained breathing apparatus and protective
clothing. Use water spray to keep fire-exposed containers cool.
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MSDS: Carteolol Hydrochloride Ophthalmic Solution USP, 1%
6. ACCIDENTAL RELEASE MEASURES
Large/Small Spills: Use 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. Dispose of material according to
Federal, State and Local regulations.
7. HANDLING AND STORAGE
This material should be handled and stored per label and other instructions to
ensure product integrity.
Handling: Avoid contact with product and use caution to prevent puncturing
containers. No special protective equipment or procedures are required in the
clinical or home environment. Protect from heat. Wash hands after using.
Storage: Store product upright in original containers with the cap tightly closed at a
0 0 0 0
controlled room temperature 15 -25 C (59 - 75 F). KEEP THIS AND ALL DRUGS
OUT OF THE REACH OF CHILDREN.
8. EXPOSURE CONTROL/PERSONAL PROTECTION
Engineering Controls: In the manufacturing plant, provide adequate ventilation for
the raw material handling and compounding process which will maintain the dust
and vapor levels below the TLV, STEL, and PEL values for the ingredients.
Ventilation fans should be explosion proof. Use adequate personal protective
equipment e.g. NIOSH-approved respirators, goggles or safety glasses, gloves and
protective clothing. Ensure training in the handling of chemical material and use
current Material Safety Data Sheets.
Eye Protection: (29 CFR 1910.133) Recommend goggles or chemical safety
glasses.
Skin Protection: Thick impermeable gloves and protective clothing.
Respiratory Protection: (29 CFR 1910.134) NIOSH approved respirator, with
organic vapor, acid gas and HEPA filter recommended for handling raw materials.
Warning: Do not use air purifying respirators in oxygen depleted
environments. No respiratory protection is required in the clinical or home
environment.
Other: None
Ventilation: Recommended
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MSDS: Carteolol Hydrochloride Ophthalmic Solution USP, 1%
Contaminated Equipment: Wash contaminated clothing separately. Wash
equipment with soap and water. Release rinse water into an approved wastewater
system or according to Federal, State and Local regulations.
9. CHEMICAL & PHYSICAL PROPERTIES
Appearance & Odor: Clear, colorless aqueous solution.
Boiling Point: NE Evaporation Rate: NE
Specific Gravity: 1.0 Vapor Density: NE
Vapor Pressure: NE Viscosity: NE
Water Solubility: Complete Percent Volatile by Volume: <1
10. STABILITY AND REACTIVITY
Chemical Stability: Aqueous solutions are stable at ambient room temperature at
neutral pH.
Conditions to avoid: Extreme heat or cold.
Incompatibility: N.D..
Hazardous Decomposition Products: Emits toxic fumes.
Hazardous Polymerization: Should not occur.
11. TOXICOLOGY INFORMATION
Summary of Risks: Toxicological information refers to raw materials product.
Concentrations and toxicological effects are substantially reduced in the product. For
more detailed information see MSDS on chemical material.
CAS #
51781-21-6 Carteolol Hydrochloride
There is no evidence of mutagenicity, carcinogenicity, teratogenicity, or
impairment of reproduction and fertility in studies investigating potential carteolol
preclinical toxicity. When maternally toxic, there is a delayed ossification of
fetus鈥? bones. Slight embryolethality at 75 and 150 and equivocal at 3 and 15 mg.
More stillborn fetuses in the 3 and 150 mg group (but not in the 30 mg group)
F1A pups compared to the 0 group. Fetuses from orally administered mice
found to have cleft palates, but it is a statistically insignificant number.
All formulations < 2% in an eye irritation study with rabbits showed evidence of
being non-irritating except 2% Carteolol, which was considered non-irritating in
females and practically non-irritating in males.
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MSDS: Carteolol Hydrochloride Ophthalmic Solution USP, 1%
Toxicity:
Oral LD50 (male mouse) = 630 mg/kg Oral LD50 (female rat) = 1330 mg/kg
Oral LD50 (female mouse) = 650 mg/kg Oral LD50 (male rat) = 1380 mg/kg
Intravenous LD50 (male rat) = 158 mg/kg Intravenous LD50 (female rat) = 153
mg/kg.
12. ECOLOGICAL INFORMATION
Chemical Fate Information: Product administered to patients presents a negligible
impact on the environment.
13. DISPOSAL INFORMATION
Dispose of material according to Federal, State, and Local regulations. The
method typically used is incineration.
RCRA Hazardous Waste: Not Listed
EPA Designations:
Not Listed
SARA Title III:
14. TRANSPORTATION INFORMATION
Not classified as hazardous by DOT regulations.
Transportation Data:
15. REGULATORY INFORMATION
Not classified as hazardous by DOT regulations.
DOT Designations:
RCRA Hazardous Waste
EPA Designations:
(40 CFR 261.33) Not Listed
Prescription only medication.
FDA Designations:
NDC No. 24208-367-05 ( 5 ml)
NDC No. 24208-367-10 (10 ml)
NDC No. 24208-367-15 (15 ml)
(29 CFR 1910.1000, Table Z)
OSHA Designations:
Not Listed
Not listed under Section 313 of Toxic Release Reporting.
SARA Title III:
CALIFORNIA PROPOSITION 65: Not Listed
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MSDS: Carteolol Hydrochloride Ophthalmic Solution USP, 1%
16. OTHER INFORMATION
None
The information contained herein is furnished without warranty of any kind. The
above information is believed to be correct but does not purport to be all-inclusive
and should be used only as a guide. Users should make independent
determinations of the suitability and completeness of information from all sources to
assure proper use and disposal of these materials and the safety and health of
employees and customers.
NE- Not Established
< - Less Than
> - Greater Than
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