Safety Data Sheet

SECTION 1. IDENTIFICATION:
Trade name: Everolimus
Product Number: E-4040
Manufacturer/Supplier:
LC Laboratories
165 New Boston Street
Woburn, MA 01801 USA
+1-781-937-0777 Fax: +1-781-938-5420

SECTION 2. HAZARD(S) IDENTIFICATION:
Hazard Description: Harmful; potent immunosuppresant
Substance Class Identifier: Drug; Mutagen
May be harmful if swallowed, inhaled or absorbed through the skin
Ingestion may cause neutropenia (reduction of a certain type of white blood cells), thrombocytopenia (decreased blood platelets), febrile neutropenia (development of fever/other signs of infection in association with neutropenia), stomatitis/mucositis (inflammation/ulceration of the mucous membranes lining of the mouth), skin rash, fatigue, asthenia (muscle weakness), diarrhea, nausea, anorexia (decreased appetite), weight loss, infections (including upper respiratory tract infection), cough, anemia, dysgeusia (distortion of the sense of taste), inflammation of lung tissue, peripheral edema (swelling of extremities or other parts of the body), epistaxis (nose bleed), pruritus (itching), vomiting, high level of blood cholesterol, headache, hyperglycemia (elevated serum glucose level), spontaneous bleeding or bruising, and dyspnea (shortness of breath), hepatitis B reactivation, blood clots in the lung or legs, and menstruation disorders
Exposure may cause irritation to skin, eyes, mucous membranes, and upper respiratory tract
Signal Word: Warning
GHS Hazard Statements:
H303 - May be harmful if swallowed
H313 - May be harmful in contact with skin
H333 - May be harmful if inhaled
H335 - May cause respiratory irritation
H372 - Causes damage to organs through prolonged or repeated exposure
GHS Precautionary Statements:
P261 - Avoid breathing dust/fume/gas/mist/vapours/spray
P264 - Wash skin thoroughly after handling
P280 - Wear protective gloves/eye protection/face protection
P314 - Get medical advice/attention if you feel unwell

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: 42-O-(2-Hydroxyethyl)-rapamycin
Synonyms: Afinitor, Certican, RAD 001, SDZ-RAD, Votubia, Xience, Zortress
Hazardous Ingredient: Everolimus
CAS Registry Number: 159351-69-6
Molecular Weight: 958.22
Molecular Formula: C53H83NO14

SECTION 4. FIRST-AID MEASURES:
After Inhalation: If inhaled, remove to fresh air; if breathing is difficult, give oxygen; if breathing stops, give artificial respiration
After skin contact: flush with copious amounts of water; remove contaminated clothing and shoes; call a physician
After eye contact: check for and remove contact lenses and flush with copious amounts of water; assure adequate flushing by separating the eyelids with fingers; call a physician
After swallowing: if swallowed, wash out mouth with copious amounts of water; call a physician

SECTION 5. FIRE-FIGHTING MEASURES:
Suitable extinguishing agents: water spray, carbon dioxide, dry chemical powder or foam
Protective equipment: wear self-contained breathing apparatus and protective clothing to prevent contact with skin and eyes
Unusual fire hazard: none known

SECTION 6. ACCIDENTAL RELEASE MEASURES:
Person-related safety precautions: cordon off area of spill; wear self-contained breathing apparatus, protective clothing and heavy rubber gloves
Measures for cleaning/collecting: absorb solutions with finely- powdered liquid-binding material (diatomite, universal binders); decontaminate surfaces and equipment by scrubbing with alcohol; dispose of contaminated material according to Section 13

SECTION 7. HANDLING AND STORAGE:
Information for safe handling: avoid contact with skin, eyes and clothing; material may be an irritant
Storage: store solid and solutions at -20 ºC

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION:
Personal protective equipment as follows:
Breathing equipment: NIOSH/MSHA-approved respirator
Protection of hands: chemical-resistant rubber gloves
Eye protection: chemical safety goggles

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES:
Form: crystalline solid; granular or powder
Color: white to off-white
Odor: none
Melting point/Melting range:
Danger of explosion: none
Solubility in / Miscibility with water: very poorly soluble in water; maximum solubility in plain water is estimated to be about 1-10 µM; buffers, serum, or other additives may increase or decrease the aqueous solubility
Solvent content: none
Organic solvents: soluble in DMSO at 100 mg/mL; soluble in ethanol at 100 mg/mL

SECTION 10. STABILITY AND REACTIVITY:
Stability: stable if stored as directed; avoid strong oxidizing agents
Thermal decomposition / conditions to be avoided: protect from light and heat
Dangerous products of decomposition: thermal decomposition may produce toxic gases such as carbon monoxide, carbon dioxide, and nitrogen oxides

SECTION 11. TOXICOLOGICAL INFORMATION:
RTECS #: VE6255000
Acute toxicity: oral toxicity (LD50): >2000 mg/kg (mouse), >2000 mg/kg (rat) - toxicity data from the Abbott Vascular MSDS dated January 16, 2007 for Everolimus Xience V
oral toxicity (TDLo): 25-150 mg/kg (mouse), 18-21 mg/kg (rat)
Primary irritant effect:
On the skin: may be an irritant; may be harmful if absorbed through the skin
On the eye: may be an irritant
Inhalation: may cause irritation of mucous membranes and upper respiratory tract; may be harmful if inhaled
Ingestion: may be harmful if swallowed

SECTION 12. ECOLOGICAL INFORMATION:
General notes: no data available
Treat as potentially toxic if released into the environment

SECTION 13. DISPOSAL CONSIDERATIONS:
Dispose of in accordance with prevailing country, federal, state and local regulations

SECTION 14. TRANSPORT INFORMATION:
DOT:
Proper shipping name: none
Non-Hazardous for transport: this substance is considered to be non-hazardous for transport
IATA class:
Proper shipping name: none
Non-Hazardous for transport: this substance is considered to be non-hazardous for transport

SECTION 15. REGULATORY INFORMATION:
Code letter and hazard designation of product:
EU Risk And Safety phrases:
S22: Do not breathe dust
S24/25: Avoid contact with skin and eyes
S36/37/39: Wear suitable protective clothing, gloves, and eye/face protection
S45: In case of accident or if you feel unwell seek medical advice immediately (show the label where possible)

SECTION 16. OTHER INFORMATION:
The above information is believed to be correct based on our present knowledge but does not purport to be complete. For research use only by trained personnel. The burden of safe use of this material rests entirely with the user. LC Laboratories disclaims all liability
Revision Date:  February 1, 2015