MSDS: Apraclonidine Ophthalmic Solution USP, 0.5%
Material Safety Data Sheet
Manufacturer: Akorn Incorporated
Address: 150 South Wyckles Road, Decatur, IL 62522
Telephone: 18009325676
Email: customer.service@akorn.com
Section 1 IDENTIFICATION
TRADE NAME: Apraclonidine Ophthalmic Solution, USP
Description: Apraclonidine Ophthalmic Solution contains apraclonidine hydrochloride, an
alphaadrenergic agonist, in a sterile isotonic solution for topical application to
the eye.
Composition CAS# TLV (mg/m? PEL (mg/m? %Content
Apraclonidine Hydrochloride, USP 73218798 Not Established Not Established 0.575
Benzalkonim Chloride, NF 8001545 Not Established Not Established 0.01
Sodium Acetate, Trihydrate, USP 6131904 Not Established Not Established <0.1
Sodium Chloride, USP 7647145 Not Established Not Established <1.0
Water for Injection 7732185 Not Established Not Established QS
Hydrochloric acid, NF / Sodium Hydroxide, NF for pH adjustment
NE = Not Established
Common name of active ingredient: Apraclonidine Hydrochloride
Chemical Formula: C9H10Cl2N4 . HCl
Molecular Weight: 281.57 g/mole
Legal Category: Prescription Only
Section 2 HAZARDOUS INGREDIENTS
Principal Hazardous Ingredients: Apraclonidine Hydrochloride
Eyes: May cause eye irritation. Systemically absorbed by this route.
Skin: May cause skin irritation. Systemically absorbed by this route.
Ingestion: May cause irritation. Systemically absorbed by this route.
Inhalation: May cause respiratory tract irritation.
Target Organs: Central Nervous System.
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MSDS: Apraclonidine Ophthalmic Solution USP, 0.5%
Section 3 PHYSICAL AND CHEMICAL CHARACTERISTICS
Appearance: Clear, colorless to pale yellow solution
Boiling Point (癈): Aqueous
Vapor Pressure (mmHg at 20癈): Not Established
Vapor Density (g/m?: Not Established
Viscosity: Aqueous
Osmolality: ~ 300 mOsm/Kg
pH: 4.4 to 7.8
Specific Gravity: ~1.01 g/mL
Solubility in Water: Highly Soluble
Latex Free: Yes
Section 4 FIRE AND EXPLOSION HAZARD DATA
Flammable Properties
Flash point: Not Established
Method: Not Established
Extinguishing Media Dry chemical, carbon dioxide, halon, water spray, alcohol resistant foam
on surrounding materials.
Firefighting Procedures Wear selfcontained breathing apparatus and protective clothing.
Section 5 STABILITY AND REACTIVITY DATA
Chemical Stability: Stable under recommended storage conditions.
Conditions to Avoid: Protect from light exposure. Protect from freezing.
Materials to Avoid: Oxidizing agents.
Hazardous Decomposition Products: Carbon monoxide, carbon dioxide, nitrogen oxides, and
hydrogen chloride gas.
Hazardous Polymerization: Will not occur.
Section 6 HEALTH HAZARDS
Carcinogenesis, Mutagenesis, Impairment of Fertility: No significant change in tumor incidence or type
was observed following two years of oral administration of Apraclonidine HCl to rats and mice at
dosages of 1.0 and 0.6 mg/kg, up to 20 and 12 times, respectively, the maximum dose recommended for
human topical ocular use.
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MSDS: Apraclonidine Ophthalmic Solution USP, 0.5%
Apraclonidine HCl was not mutagenic in a series of in vitro mutagenicity tests, including the Ames test, a
mouse lymphoma forward mutation assay, a chromosome aberration assay in cultured Chinese hamster
ovary (CHO) cells, a sister chromatid exchange assay in CHO cells, and a cell transformation assay.
An in vivo mouse micronucleus assay conducted with Apraclonidine HCl also provided no evidence of
mutagenicity.
Reproduction and fertility studies in rats showed no adverse effect on male or female fertility at a dose
of 0.5mg/kg (5 to 10 times the maximum recommended human dose).
Pregnancy: Pregnancy Category C: Apraclonidine HCl has been shown to have an embryocidal effect in
rabbits when given in an oral dose of 3.0 mg/kg (60 times the maximum recommended human dose).
Dose related maternal toxicity was observed in pregnant rats at 0.3mg/kg (6 times the maximum
recommended human dose). There are no adequate and well controlled studies in pregnant women.
Apraclonidine Ophthalmic Solution should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are
excreted in human milk, caution should be exercised when Apraclonidine Ophthalmic Solution is
administered to a nursing woman.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and
younger patients
Section 7 PROTECTION INFORMATION
Engineering Controls: Topical use leads to systemic absorption.
Eye Protection: Safety glasses.
Skin Protection: Gloves and protective clothing.
Respiratory Protection: None required when used as directed.
Contaminated Equipment: Wash contaminated clothing and equipment with soap and water.
Section 8 HANDLING AND STORAGE
Handling: Avoid contact with product.
Storage: Store at controlled room temperature 20?to 25癈 (68?to 77?F).
Protect from freezing and light.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN
Section 9 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 then
dispose of material according to Federal, State and Local regulations.
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MSDS: Apraclonidine Ophthalmic Solution USP, 0.5%
Section 10 TOXICOLOGY INFORMATION
Acute toxicity: Oral LD50 for rat = 38mg/kg for mouse = 3mg/kg.
Irritation and corrosion: May irritate eyes, skin, gastric and respiratory tracts.
Sensitization: Persons sensitive to clonidine may be sensitive to this product also.
Chronic exposure: Possible hypersensitization.
IARC: No component of this product present at levels greater than or equal to
0.1% is identified as probable, possible or confirmed human carcinogen.
ACGIH: No component of this product present at levels greater than or equal to
0.1% is identified as a carcinogen or potential carcinogen.
NTP: No component of this product present at levels greater than or equal to
0.1% is identified as a known or anticipated carcinogen.
OSHA: No component of this product present at levels greater than or equal to
0.1% is identified as a carcinogen or potential carcinogen.
LD50
Section 11 ECOLOGICAL INFORMATION
Chemical Fate Information: Product as administered to patients presents a negligible impact on
the environment.
Section 12 REGULATORY INFORMATION
OSHA Hazards: For Raw Material Only
Target Organ Effect, Highly toxic by inhalation, Toxic by ingestion, Toxic by skin absorption.
DSL Status:
This product contains the following components that are not on the Canadian DSL nor NDSL lists:
Apraclonidine Hydrochloride (pAminoclonidine hydrochloride), CASNo. 66711215.
SARA 302 Components:
No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.
SARA 313 Components:
This material does not contain any chemical components with known CAS numbers that exceed the
threshold (De Minimis) reporting levels established by SARA Title III, Section 313.
SARA 311/312 Hazards:
Acute Health Hazard, Chronic Health Hazard.
Massachusetts Right To Know Components:
No components are subject to the Massachusetts Right to Know Act.
Pennsylvania Right To Know Components:
Apraclonidine Hydrochloride (pAminoclonidine hydrochloride), CASNo. 66711215.
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MSDS: Apraclonidine Ophthalmic Solution USP, 0.5%
New Jersey Right to Know Components:
Apraclonidine Hydrochloride (pAminoclonidine hydrochloride), CASNo. 66711215.
California Proposition 65 Components:
This product does not contain any chemicals known to State of California to cause cancer, birth, or any
other reproductive defects.
Section 13 DISPOSAL INFORMATION
Dispose of material according to Federal, State, and Local regulations. The method typically used is
incineration.
Section 14 TRANSPORTATION INFORMATION
DOT (US)
UNNumber: 2811 Class: 6.1 Packing group: I
Proper shipping name: Toxic solids, organic, n.o.s. (pAminoclonidine hydrochloride)
Marine pollutant: No
Poison Inhalation Hazard: No
IMDG
UNNumber: 2811 Class: 6.1 Packing group: I EMSNo: FA, SA
Proper shipping name: Toxic solids, organic, n.o.s. (pAminoclonidine hydrochloride)
Marine pollutant: No
IATA
UNNumber: 2811 Class: 6.1 Packing group: I
Proper shipping name: Toxic solid, organic n.o.s. (pAminoclonidine hydrochloride)
The information given herein is in good faith and to the best of our knowledge but no warranty,
expressed or implied, is made.
Disclaimer: This document is generated to distribute health, safety and environmental data. It is not a specification
sheet and none of the displayed data should be construed as a specification. Information on this MSDS sheet was
obtained from sources which we believe are reliable, and we believe that the information is complete and
accurate. However, the information is provided without any warranty, express or implied, regarding its
correctness. Some of the information presented and conclusions drawn are from sources other than direct test
data of the substance. The conditions or methods of handling, storage, use and disposal of the product are beyond
our control and may also be beyond our knowledge. It is the user's responsibility to determine the suitability of
any material for a specific purpose and to adopt such safety precautions as may be necessary. If the product is
used as a component in another product, this MSDS information may not be applicable. For these reasons, we do
not assume any responsibility and expressly disclaim liability for any loss, damage or expense arising out of or in
any way connected with the handling, storage, use or disposal of this product.
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