SAFETY DATA SHEET

SECTION 1 : IDENTIFICATION

Product Nam e: Oxaliplatin Injection

Manufacturer Nam e: Fresenius Kabi USA, LLC
Address: Three Corporate Drive
Lak e Zurich, Illinois 60047
General Phone Num ber: (847) 550-2300
Custom er Service Phone (888) 386-1300
Num ber:
Health Issues Inform ation: (800) 551-7176
SDS Creation Date: January 08, 2009
SDS Revision Date: June 01, 2015

SECTION 2 : HAZARD(S) IDENTIFICATION

GHS Pictogram s:

Signal Word: DANGER.

GHS Class: Respiratory sensitisation. Category 1.

Reproductive tox icity. Category 2.
Sk in Sensitization. Category 1.
Reproductive tox icity. Effects on or via lactation.

Hazard Statem ents: May cause allergy or asthm a sym ptom s or breathing difficulties if inhaled.
Suspected of dam aging fertility or the unborn child.
May cause an allergic sk in reaction.
May cause harm to breast-fed children.

Precautionary Statem ents: O btain special instructions before use.

Do not handle until all safety precautions have been read and understood.
Do not breathe dust/fum e/gas/m ist/vapours/spray.
Avoid breathing dust/fum e/gas/m ist/vapours/spray.
Avoid contact during pregnancy and while nursing.
Wash hands thoroughly after handling.
Do not eat, drink or sm ok e when using this product.
Contam inated work clothing should not be allowed out of the work place.
Wear protective gloves/protective clothing/eye protection/face protection.
In case of inadequate ventilation wear respiratory protection.
IF O N SKIN: Wash with plenty of water.
IF INHALED: Rem ove victim to fresh air and k eep at rest in a position com fortable for breathing.
IF ex posed or concerned: Get m edical advice/attention.
Specific treatm ent (see ... on this label).
If sk in irritation or rash occurs: Get m edical advice/attention.
If ex periencing respiratory sym ptom s: Call a PO ISO N CENTER or doctor/physician.
Tak e off contam inated clothing and wash it before reuse.
Store lock ed up.
Dispose of contents/container in accordance with Local, State, Federal and Provincial regulations.

Em ergency O verview: W ARNING! The drug substance O x aliplatin is m utagenic, cytotox ic, neurotox ic and fetotox ic. The drug
substance is a possible carcinogen and a severe eye irritant. This product is intended for therapeutic
use only when prescribed by a physician. Potential adverse reactions from prescribed doses and
overdoses are described in the pack age insert.

Route of Ex posure: Inhalation Ingestion Eye contact Sk in Absorption. Injection.

Potential Health Effects:

Eye: Contact with eyes m ay cause irritation.

Signs/Sym ptom s: Anticipated signs of overex posure include nausea, vom iting, diarrhea, peripheral neurotox icity (with
cold sensitivity and rare laryngeal dysesthesias, sensation of difficulty with breathing or swallowing),
and possible m yelosuppression (low blood counts). Mucositis (sore m outh, or soreness of other
m ucous m em branes) and transient elevation of liver enzym es have been observed. As with other
platinum com pounds allergic reactions have been observed. In therapeutic use very rare anaphylactoid
reactions (severe, possibly life-threatening allergic reactions) have been observed.
Aggravation of Pre-Ex isting Individuals with a history of k nown allergy to ox aliplatin or other platinum com pounds.
Conditions:

SECTION 3 : COMPOSITION/INFORMATION ON INGREDIENTS

Chemical Name CA S# Ingredient Percent

EC Num.

Succinic acid 110-15-6 0.01 m g /m L

Sodium hydrox ide 1310-73-2 0.0033 m g /m L

Oxaliplatin Injection Fresenius Kabi USA, LLC

Revision: 06/01/2015 Page 1 of 5
O x aliplatin
Water for Injection
SECTION 4 : FIRST AID MEASURES
Eye Contact:
Sk in Contact:
Inhalation:
Ingestion:
O ther First Aid:
SECTION 5 : FIRE FIGHTING MEASURES
Flash Point:
Flash Point Method:
Auto Ignition Tem perature:
Lower Flam m able/Ex plosive Lim it:
Upper Flam m able/Ex plosive Lim it:
Fire Fighting Instructions:
Ex tinguishing Media:
Protective Equipm ent:
Hazardous Com bustion
Byproducts:
SECTION 6 : ACCIDENTAL RELEASE MEASURES
Personnel Precautions:
Environm ental Precautions:
Methods for containm ent:
Methods for cleanup:
SECTION 7 : HANDLING and STORAGE
Handling:
Storage:
Work Practices:
Hygiene Practices:
SECTION 8: EXPOSURE CONTROLS, PERSONAL PROTECTION
Engineering Controls:
Eye/Face Protection:
Sk in Protection Description:
Oxaliplatin Injection
Revision: 06/01/2015
61825-94-3 5 m g /m L
7732-18-5 Q uantity sufficient to 1 m L
Im m ediately flush eyes with plenty of water for at least 15 to 20 m inutes. Ensure adequate flushing of
the eyes by separating the eyelids with fingers. Get im m ediate m edical attention.
Im m ediately wash sk in with plenty of soap and water for 15 to 20 m inutes, while rem oving
contam inated clothing and shoes.
Get m edical attention if irritation develops or persists.
If inhaled, rem ove to fresh air. If not breathing, give artificial respiration or give ox ygen by trained
personnel. Seek im m ediate m edical attention.
If conscious, flush m outh out with water im m ediately. Call a physician or poison control center
im m ediately. Do not induce vom iting unless directed to do so by m edical personnel. Never give
anything by m outh to an unconscious person.
For Adverse Event Inform ation, please call (800) 551-7176.
Not established.
Not established.
Not established.
Not established.
Not established.
Evacuate area of unprotected personnel. Use cold water spray to cool fire ex posed containers to
m inim ize risk of rupture. Do not enter confined fire space without full protective gear. If possible,
contain fire run-off water.
Use alcohol resistant foam , carbon diox ide, dry chem ical, or water fog or spray when fighting fires
involving this m aterial.
Use ex tinguishing m easures that are appropriate to local circum stances and the surrounding
environm ent.
As in any fire, wear Self-Contained Breathing Apparatus (SCBA), MSHA/NIO SH (approved or equivalent)
and full protective gear.
Therm al decom position products m ay include sm ok e and tox ic fum es. O x ides of carbon, ox ides of
nitrogen and other organic substances m ay be form ed. O ther undeterm ined low m olecular weight
hydrocarbon com pounds m ay be released in sm all quantities depending upon specific conditions of
com bustion.
Evacuate area and k eep unnecessary and unprotected personnel from entering the spill area.
Avoid personal contact and breathing vapors or m ists. Use proper personal protective equipm ent as
listed in Section 8.
Avoid runoff into storm sewers, ditches, and waterways.
Contain spills with an inert absorbent m aterial such as soil, sand or oil dry.
Absorb spill with inert m aterial (e,g., dry sand or earth), then place in a chem ical waste container. After
rem oval, flush spill area with soap and water to rem ove trace residue.
W hen handling pharm aceutical products, avoid all contact and inhalation of vapor, m ists and/or fum es.
Use with adequate ventilation. Use only in accordance with directions.
Store at 25°C (77°F); ex cursions perm itted to 15 to 30°C (59 to 86°F). Protect from light. Do not
freeze. Retain vial in carton until tim e of use.
Facilities storing or utilizing this m aterial should be equipped with an eyewash facility and a safety
shower.
Wash thoroughly after handling. Avoid contact with eyes and sk in. Avoid inhaling vapor or m ist.
General ventilation is sufficient if this product is being used in a controlled m edical setting (clinic,
hospital, m edical office) for its sole intended parenteral (injection) purpose. O therwise, use appropriate
engineering control such as process enclosures, local ex haust ventilation, or other engineering controls
including use of a biosafety cabinet / fum e hood to control airborne levels below recom m ended
ex posure lim its.
Chem ical splash goggles. Wear a face shield also when splash hazard ex ist.
Protective laboratory coat, apron, or disposable garm ent recom m ended.
Fresenius Kabi USA, LLC
Page 2 of 5
 Hand Protection Description: Wear appropriate protective gloves. Consult glove m anufacturer's data for perm eability data.
Nitrile rubber or natural rubber gloves are recom m ended.

Respiratory Protection:
No personal respiratory protective equipm ent is norm ally required when this product is being
used/adm inistered by a licensed healthcare practitioner (i.e. an end-user such as a clinician / doctor /
nurse) for its sole intended parenteral (injection) purpose in a controlled m edical setting. The need for
respiratory protection will vary according to the airborne concentrations and environm ental conditions. A
NIO SH approved air-purifying respirator with an organic vapor cartridge or canister m ay be perm issible
under certain circum stances. Consult the NIO SH web site
(http://www.cdc.gov/niosh/npptl/topics/respirators/) for a list of respirator types and approved suppliers.

O ther Protective: Consult with local procedures for selection, training, inspection and m aintenance of the personal
protective equipm ent.

EXPO SURE GUIDELINES

Sodium hydroxide :
Guideline ACGIH: TLV-Ceiling/Peak : 2 m g/m 3
Guideline O SHA: O SHA-TW A: 2 m g/m 3

SECTION 9 : PHYSICAL and CHEMICAL PROPERTIES

Physical State: Liquid solution.

Color: Colorless.

Boiling Point: Not established.

Melting Point: Not established.

Solubility: 6 m g/m lin water. 20 °C

Vapor Density: Not established.

Vapor Pressure: Not established.

Percent Volatile: Not established.

pH: 4.0-7.0

Molecular Form ula: Mix ture

Molecular Weight: 397.3

Flash Point: Not established.

Flash Point Method: Not established.

Auto Ignition Tem perature: Not established.

SECTION 10 : STABILITY and REACTIVITY

Chem ical Stability: Stable under norm al tem peratures and pressures.

Hazardous Polym erization: Not reported.

Conditions to Avoid: Protect from freezing.

SECTION 11 : TOXICOLOGICAL INFORMATION

Succinic acid :

RTECS Num ber: W M4900000

Eye: Eye - Rabbit Standard Draize test.: 750 ug [severe]

Ingestion: O ral - Rat LD50 : 2260 m g/k g [Details of tox ic effects not reported other than lethal dose value]

Sodium hydroxide :

Eye: Eye - Rabbit Standard Draize test.: 400 ug

Eye - Rabbit Standard Draize test.: 50 ug/24H (RTECS)

Sk in: Adm inistration onto the sk in - Rabbit Standard Draize test.: 500 m g/24H

Oxaliplatin :

RTECS Num ber: TP2275850

Ingestion: LD50 O ral Rat: > 100 m g/k g

Carcinogenicity: May be carcinogenic based on cytotox ic and genotox ic data.

Mutagenicity: Positive genotox ic agent in both in vitro and in vivo tests. O x aliplatin interacts with DNA, block ing DNA
replication and transcription.
Reproductive Tox icity: There was no im pairm ent of fertility of treated rats. However, testicular hypoplasia has been detected in
dogs following repeated doses of ox aliplatin.

Teratogenicity: O x aliplatin produced evidence of fetal tox icity in the rat but it was not teratogenic to the rat or rabbit.
Pregnancy Category D: May cause harm when adm inistered to a pregnant wom an.

O ther Tox icological Inform ation:
Intravenous. - Hum an TDLo: 2.19 m g/k g [Nutritional and Gross Metabolic - body tem perature
increase]
Intravenous. - Hum an TDLo: 2.125 m g/k g [Gastrointestinal - hyperm otility, diarrhea Gastrointestinal -
nausea or vom iting Im m unological Including Allergic - other im m ediate (hum oral): urticaria, allergic
rhinitis, serum sick ness]

Oxaliplatin Injection Fresenius Kabi USA, LLC

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 Intravenous. - Hum an TDLo: 2.125 m g/k g [Cardiac - arrhythm ias (including changes in conduction)]
Intravenous. - Hum an TDLo: 4.6 m g/k g/4W (interm ittent) [Gastrointestinal - colon tum ors Tum origenic
- active as anti-cancer agent]
Intravenous. - Mouse TDLo: 16 m g/k g/4D (interm ittent) [Nutritional and Gross Metabolic - weight loss
or decreased weight gain Tum origenic - protects against induction of ex perim ental tum ors]
Intravenous. - Mouse TDLo: 21 m g/k g/4D (interm ittent) [Nutritional and Gross Metabolic - weight loss
or decreased weight gain Tum origenic - protects against induction of ex perim ental tum ors Related to
Chronic Data - death]
Intravenous. - Hum an TDLo: 5.14 m g/k g/74D (interm ittent) [Lungs, Thorax , or Respiration - dyspnea
Lungs, Thorax , or Respiration - other changes Im m unological Including Allergic - other im m ediate
(hum oral): urticaria, allergic rhinitis, serum sick ness]
Intravenous. - Hum an TDLo: 4.25 m g/k g/15D (interm ittent) [Peripheral Nerve and Sensation -
paresthesis]
Intravenous. - Hum an TDLo: 19.5 m g/k g/18W (interm ittent) [Peripheral Nerve and Sensation -
sensory change involving peripheral nerve]
Intravenous. - Hum an TDLo: 6.5 m g/k g/42D (interm ittent) [Blood - granulocytopenia Blood -
throm bocytopenia]
Intraperitoneal. - Rat LD50: 14300 ug/k g [Details of tox ic effects not reported other than lethal dose
value]
Intraperitoneal. - Mouse LD50: 19800 ug/k g [Details of tox ic effects not reported other than lethal
dose value]
Intraperitoneal. - Rat TDLo: 3 m g/k g [Peripheral Nerve and Sensation - structural change in nerve or
sheath]
Intraperitoneal. - Rat TDLo: 4.24 m g/k g [Spinal Cord - other degenerative changes]
Intraperitoneal. - Rat TDLo: 10 m g/k g [Spinal Cord - other degenerative changes Peripheral Nerve and
Sensation - recording from afferent nerve]
Intraperitoneal. - Rat TDLo: 3 m g/k g [Peripheral Nerve and Sensation - sensory change involving
peripheral nerve]
Intraperitoneal. - Mouse TDLo: 45 m g/k g/9D (interm ittent) [Tum origenic - active as anti-cancer agent]
Intraperitoneal. - Mouse TDLo: 25 m g/k g/5D (interm ittent) [Tum origenic - active as anti-cancer agent]

SECTION 12 : ECOLOGICAL INFORMATION

Biodegradation: Hydrolysis test data indicate that O x aliplatin will not readily hydrolyze in the environm ent.

Bioaccum ulation: The octanol / water partition coefficient (Kow) value of 0.02 indicates that O x aliplatin is not lik ely to
bioaccum ulate. Dissociation constant (pKa) data indicate that ox aliplatin will not dissociate in the
environm ental pH range.

Mobility In Environm ental Media: Water Solubility, Kow and Henry's Law Constant data indicate that O x aliplatin will m igrate to the water
com partm ent of the environm ent.

SECTION 13 : DISPOSAL CONSIDERATIONS

Waste Disposal: Dispose of in accordance with Local, State, Federal and Provincial regulations.

SECTION 14 : TRANSPORT INFORMATION

DO T Shipping Nam e: Not Regulated.

DO T UN Num ber: Not Regulated.

SECTION 15 : REGULATORY INFORMATION

Risk Phrases: R60 May im pair fertility.

R61 May cause harm to the unborn child.
R64 May cause harm to breastfed babies.
R68 Possible risk of irreversible effects.
R40 Lim ited evidence of a carcinogenic effect.
R42/43 May cause sensitization by inhalation and sk in contact.
R48/23/24/25 Tox ic: danger of serious dam age to health by prolonged ex posure through inhalation, in
contact with sk in and if swallowed.

Safety Phrase: S45 In case of accident or if you feel unwell, seek m edical advice im m ediately (show the label where
possible).
S53 Avoid ex posure — obtain special instructions before use.

Succinic acid :

TSCA Inventory Status: Listed

Canada DSL: Listed

Sodium hydroxide :

TSCA Inventory Status: Listed

Canada DSL: Listed

SECTION 16 : ADDITIONAL INFORMATION

HMIS Ratings:

HMIS Health Hazard: 4*

HMIS Fire Hazard: 0
HMIS Reactivity: 0
HMIS Personal Protection: X

SDS Creation Date: January 08, 2009

Oxaliplatin Injection Fresenius Kabi USA, LLC
Revision: 06/01/2015 Page 4 of 5
SDS Revision Date: June 01, 2015

Disclaim er: The inform ation contained herein pertains to this m aterial. It is the responsibility of each individual
party to determ ine for them selves the proper m eans of handling and using these m aterials based on
their purpose and intended use. Fresenius-Kabi assum es no liability resulting from the use of or
reliance upon the inform ation contained in this m aterial safety data sheet. This m aterial safety data
sheet does not constitute the guaranty or specifications of the product.

Copyright© 1996-2015 Actio Corporation. All Rights Reserved.

Oxaliplatin Injection Fresenius Kabi USA, LLC

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