MATERIAL SAFETY DATA SHEET
Product Name: Iron Sucrose Injection, USP
1. CHEMICAL PRODUCT AND COMPANY INFORMATION
Manufacturer Name And
Address
Hospira Inc.
275 North Field Drive
Lake Forest, Illinois USA
60045
Emergency Telephone
CHEMTREC: North America: 800-424-9300;
International 1-703-527-3887; Australia (02) 8014 4880
Hospira, Inc., Non-Emergency
224-212-2000
Product Name
Iron Sucrose Injection, USP
Synonyms
Iron Sucrose; Iron Complex
2. COMPOSITION/INFORMATION ON INGREDIENTS
Active Ingredient Name
Iron Sucrose
Chemical Formula
[Na Fe O (OH) 3(H O)]n m(C H O )
Preparation
Component
Iron Sucrose
12
22
11
Non-hazardous ingredients include Water for Injection. Hazardous ingredients
present at less than 1% include sodium hydroxide which is added to adjust the pH of
the product. Approximate concentration of Iron Sucrose 20 mg/ml for elemental iron
and ~300 mg/ml sucrose.
Approximate Percent by
Weight
20 mg/ml for elemental iron
~ 300 mg/ml sucrose
CAS Number
8047-67-4
RTECS Number
NA
3. HAZARD INFORMATION
Carcinogen List
Substance
Iron Sucrose
IARC
Not Listed
NTP
Not Listed
OSHA
Not Listed
Emergency Overview
Iron Sucrose Injection, USP, is a sterile, colloidal solution of ferric hydroxide in complex with
sucrose in water for injection. Each milliliter of formulation contains 20 mg elemental iron and
up to about 340 mg of sucrose as iron sucrose in water. Clinically, this product is used in the
treatment of iron-deficiency anemia. In the workplace, this material should be considered
potentially irritating to the eyes, mucus membranes, and the respiratory tract. Based on clinical
use, potential target organs include the gastrointestinal tract and blood.
Occupational Exposure
Potential
Information on the absorption of this product via inhalation or skin contact is not available.
Avoid liquid aerosol generation and skin contact.
Signs and Symptoms
None known from occupational exposures. Inadvertent contact of this product with the eyes or
mucus membranes may produce irritation. In clinical use, adverse events may include
Product Name: Iron Sucrose Injection, USP
hypotension, cramps/leg cramps, nausea, headache, vomiting, and diarrhea. Infrequently, mild
or moderate hypersensitivity reactions including wheezing, dyspnea, hypotension, rashes, or
pruritus have been reported. Very rarely, life-threatening reactions (anaphylactic shock, loss of
consciousness or collapse, bronchospasm with dyspnea, or convulsion) have also occurred.
Chronic or excess intake of iron may lead to accumulation of iron in storage sites resulting in
hemosiderosis.
Medical Conditions
Aggravated by Exposure
Pre-existing hypersensitivity to iron or iron compounds; pre-existing gastrointestinal or
hematological ailments.
4. FIRST AID MEASURES
Eye contact
Remove from source of exposure. Flush with copious amounts of water. If
irritation persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Skin contact
Remove from source of exposure. Flush with copious amounts of water. If
irritation persists or signs of toxicity occur, seek medical attention. Provide
symptomatic/supportive care as necessary.
Inhalation
Remove from source of exposure. If signs of toxicity occur, seek medical
attention. Provide symptomatic/supportive care as necessary.
Ingestion
Remove from source of exposure. If signs of toxicity occur, seek medical
attention. Provide symptomatic/supportive care as necessary
5. FIRE FIGHTING MEASURES
Flammability
None anticipated for this aqueous product.
Fire & Explosion Hazard
None anticipated for this aqueous product.
Extinguishing media
As with any fire, use extinguishing media appropriate for primary cause of fire.
Special Fire Fighting
Procedures
No special provisions required beyond normal firefighting equipment such as
flame and chemical resistant clothing and self contained breathing apparatus.
6. ACCIDENTAL RELEASE MEASURES
Spill Cleanup and Disposal
Isolate area around spill. Put on suitable protective clothing and equipment as
specified by site spill procedures. Absorb the liquid with suitable material and
clean affected area with soap and water. Dispose of spill materials according to
the applicable federal, state, or local regulations.
7. HANDLING AND STORAGE
Handling
No special handling required for hazard control under conditions of normal
product use.
Storage
No special storage required for hazard control. For product protection, follow
storage recommendations noted on the product case label, the primary
container label, or the product insert.
Product Name: Iron Sucrose Injection, USP
Special Precautions
No special precautions required for hazard control.
8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Exposure Guidelines
Component
Iron
Sucrose
Sucrose
Type
ACGIH 8hr TWA
OSHA 8hr TWA
OSHA 8hr TWA
mg/m3
ppm
Exposure limits
g/m3
Note
1000
As Fe
15,000 As total dust
5,000
As respirable dust
Respiratory
protection
Respiratory protection is normally not needed during intended product use. However, if the
generation of aerosols is likely, and engineering controls are not considered adequate to
control potential airborne exposures, the use of an approved air-purifying respirator with a
HEPA cartridge (N95 or equivalent) is recommended under conditions where airborne
aerosol concentrations are not expected to be excessive. For uncontrolled release events, or if
exposure levels are not known, provide respirators that offer a high protection factor such as a
powered air purifying respirator or supplied air. A respiratory protection program that meets
OSHA's 29 CFR 1910.134 and ANSI Z88.2 requirements must be followed whenever
workplace conditions require respirator use. Personnel who wear respirators should be fit
tested and approved for respirator use as required.
Skin protection
If skin contact with the product formulation is likely, the use of latex or nitrile gloves is
recommended.
Eye protection
Eye protection is normally not required during intended product use. However, if eye contact
is likely to occur, the use of chemical safety goggles (as a minimum) is recommended.
Engineering Controls
Engineering controls are normally not needed during the normal use of this product.
9. PHYSICAL/CHEMICAL PROPERTIES
Appearance/Physical State
Color
Odor
Odor Threshold:
pH:
Melting point/Freezing point:
Initial Boiling Point/Boiling Point
Range:
Evaporation Rate:
Flammability (solid, gas):
Upper/Lower Flammability or
Explosive Limits:
Vapor Pressure:
Vapor Density:
Specific Gravity:
Solubility:
Partition coefficient: n-octanol/water:
Auto-ignition temperature:
Decomposition temperature:
Liquid
Brown
NA
NA
10.5 to 11.1 at 20
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
NA
Product Name: Iron Sucrose Injection, USP
10. STABILITY AND REACTIVITY
Reactivity
Not determined
Chemical Stability
Stable under standard use and storage conditions.
Hazardous Reactions
Not determined
Conditions to avoid
Not determined
Incompatibilities
Strong oxidizers, acids
Hazardous decomposition
products
Not determined. During thermal decomposition, it may be possible to generate
irritating vapors and/or toxic fumes of carbon oxides, sodium peroxide, and
iron oxide.
Hazardous Polymerization
Not anticipated to occur with this product.
11. TOXICOLOGICAL INFORMATION
Acute Toxicity
Not determined for the product formulation. Information for the ingredients is as follows:
Ingredient(s)
Percent
Test Type
Iron Sucrose
100%
100%
LD50
LD50
Route of
Administration
Intravenous
Intravenous
Value
100
150
Units
mg/kg
mg/kg
Species
Rat
Mouse
Aspiration Hazard
None anticipated from normal handling of this product.
Dermal Irritation/Corrosion
None anticipated from normal handling of this product.
Ocular Irritation/Corrosion
None anticipated from normal handling of this product. Inadvertent contact of
this product with eyes may produce moderate to severe irritation with redness
and discomfort.
Dermal or Respiratory
Sensitization
None anticipated from normal handling of this product. Rarely, serious or life
threatening reactions (anaphylactic shock, loss of consciousness or collapse,
bronchospasm with dyspnea, or convulsion) have occurred during the clinical
use of this product.
Reproductive Effects
Intravenous administration of iron sucrose at dosages up to 15 mg iron/kg/day
was reported to have no effect on fertility and reproductive performance of
male and female rats. Intravenous administration of iron sucrose to rats at
dosages up to 13 mg iron/kg/day and to rabbits at dosages up to 13 mg
iron/kg/day resulted in no evidence of impaired fertility or harm to the fetus.
Mutagenicity
Iron sucrose was not genotoxic in the Ames test, the mouse lymphoma cell
(L5178Y/TK+/-) forward mutation test, the human lymphocyte chromosome
aberration test, or the mouse micronucleus test.
Carcinogenicity
The carcinogenic potential of iron sucrose has not been evaluated in long-term
studies in animals.
Product Name: Iron Sucrose Injection, USP
This product should be considered potentially irritating to the eyes, mucus
membranes, and respiratory tract. Following an accidental over-exposure,
possible target organ may include the gastrointestinal tract and blood.
Target Organ Effects
12. ECOLOGICAL INFORMATION
Aquatic Toxicity
Not determined for product
Persistence/Biodegradability
Not determined for product
Bioaccumulation
Not determined for product
Mobility in Soil
Not determined for product
13. DISPOSAL CONSIDERATIONS
Waste Disposal
All waste materials must be properly characterized by the waste generator.
Further, disposal of all pharmaceuticals should be performed in accordance
with the federal, state or local regulatory requirements.
Container Handling and
Disposal
Dispose of container and unused contents in accordance with federal, state and
local regulations.
14. TRANSPORTATION INFORMATION
ADR/ADG/ DOT STATUS:
Not regulated
IMDG STATUS:
Not regulated
ICAO/IATA STATUS:
Not regulated
Transport Comments:
None
15. REGULATORY INFORMATION
USA Regulations
Substance
TSCA Status
Iron Sucrose
Not Listed
CERCLA
Status
Not Listed
SARA 302
Status
Not Listed
SARA 313
Status
Not Listed
PROP 65
Status
Not Listed
RCRA Status
Not Listed
U.S. OSHA Classification
Possible Irritant
Target Organ Toxin
GHS Classification
*In the EU, classification under GHS/CLP does not apply to certain substances and mixtures,
such as medicinal products as defined in Directive 2001/83/EC, which are in the finished state,
intended for the final user.:
Product Name: Iron Sucrose Injection, USP
Hazard Class
Not Applicable
Hazard Category
Not Applicable
Signal Word
Not Applicable
Symbol
Not Applicable
Prevention
P260 - Do not breathe dust/fume/gas/mist/vapors/spray.
Hazard Statement
Not Applicable
Response:
IF IN EYES: Rinse cautiously with water for several minutes. Remove contact
lenses, if present and easy to do. Continue rinsing. If eye irritation persists, get
medical attention. Wash hands after handling.
Get medical attention if you feel unwell.
EU Classification*
*Medicinal products are exempt from the requirements of the EU Dangerous Preparations Directive. Information provided below is
for the pure drug substance Iron Sucrose
.
Classification(s):
Not Applicable
Symbol:
Not Applicable
Indication of Danger:
Not Applicable
Risk Phrases:
Not Applicable
Safety Phrases:
S23 - Do not breathe vapor.
S24 - Avoid contact with skin.
S25 - Avoid contact with eyes.
S37/39 - Wear suitable gloves and eye/face protection.
16. OTHER INFORMATION:
Notes:
ACGIH TLV American Conference of Governmental Industrial Hygienists Threshold Limit Value
CAS Chemical Abstracts Service Number
CERCLA US EPA law, Comprehensive Environmental Response, Compensation, and Liability Act
DOT US Department of Transportation Regulations
EEL Employee Exposure Limit
IATA International Air Transport Association
LD50 Dosage producing 50% mortality
NA Not applicable/Not available
NE Not established
NIOSH National Institute for Occupational Safety and Health
OSHA PEL US Occupational Safety and Health Administration Permissible Exposure Limit
Prop 65 California Proposition 65
RCRA US EPA, Resource Conservation and Recovery Act
RTECS Registry of Toxic Effects of Chemical Substances
SARA Superfund Amendments and Reauthorization Act
STEL 15-minute Short Term Exposure Limit
TSCA Toxic Substance Control Act
TWA 8-hour Time Weighted Average
Product Name: Iron Sucrose Injection, USP
MSDS Coordinator: Hospira GEHS
Date Prepared: 07/08/2011
Obsolete Date: 03/10/2008
Disclaimer:
The information and recommendations contained herein are based upon tests believed to be reliable. However,
Hospira does not guarantee their accuracy or completeness NOR SHALL ANY OF THIS INFORMATION
CONSTITUTE A WARRANTY, WHETHER EXPRESSED OR IMPLIED, AS TO THE SAFETY OF THE
GOODS, THE MERCHANTABILITY OF THE GOODS, OR THE FITNESS OF THE GOODS FOR A
PARTICULAR PURPOSE. Adjustment to conform to actual conditions of usage may be required. Hospira
assumes no responsibility for results obtained or for incidental or consequential damages, including lost profits,
arising from the use of these data. No warranty against infringement of any patent, copyright or trademark is made
or implied.
