Safety Data Sheet

SECTION 1. IDENTIFICATION:
Trade name: Temsirolimus
Product Number: T-8040
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: Immunosuppressant
Harmful if swallowed, inhaled, or absorbed through the skin
Exposure may result in hypersensitivity reactions, nausea, diarrhea, anorexia (decreased appetite), weight loss, asthenia (muscle weakness), dyspnea (shortness of breath), pneumonitis/interstitial lung disease, mucositis/stomatitis (inflammation/ulceration of the mucous membranes lining of the mouth and digestive tract), skin rash, pruritus (itching), leukopenia (decreased white blood cell levels), thrombocytopenia (decreased blood platelets), anemia, hyperglycemia (elevated blood sugar level), hypercholesterolemia (elevated serum cholesterol level), hypertriglyceridemia (elevated serum triglyceride level), and hypophosphatemia (low serum phosphorus)
Exposure may cause irritation of the respiratory tract, digestive tract, skin, and eyes
Signal Word: Danger
GHS Hazard Statements:
H302 - Harmful if swallowed
H312 - Harmful in contact with skin
H332 - Harmful if inhaled
H335 - May cause respiratory irritation
H350 - May cause cancer
H360 - May damage fertility or the unborn child
H373 - May cause damage to organs through prolonged or repeated exposure
GHS Precautionary Statements:
P261 - Avoid breathing dust/fume/gas/mist/vapours/spray
P264 - Wash any exposed skin thoroughly after handling
P280 - Wear protective gloves/eye protection/face protection
P301 + P312 - IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell
P330 - Rinse mouth
P302 + P352 - IF ON SKIN: Wash with plenty of soap and water
P304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing
P305 + P351 + P338 - IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing
P308 + P313 - IF exposed or concerned: Get medical advice/attention
P501 - Dispose of contents/container in accordance with local/regional/national/international regulations

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: 42-[3-Hydroxy-2-(hydroxymethyl)-2-methylpropanoate]-rapamycin
Synonyms: CCI-779, C15182, NSC-683864, Torisel, WAY-CCI 779
Hazardous Ingredient: Temsirolimus
CAS Registry Number: 162635-04-3
Molecular Weight: 1030.29
Molecular Formula: C56H87NO16

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; 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: may emit toxic fumes under fire conditions such as carbon monoxide, etc.

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: no data
Danger of explosion: none
Solubility in / Miscibility with water: very poorly soluble in water; maximum solubility in plain water is estimated to be about 10-20 µM; buffers, serum, or other additives may increase or decrease the aqueous solubility
Solvent content: none
Organic solvents: soluble in DMSO at 200 mg/mL; soluble in ethanol at 200 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 and carbon dioxide, and nitrogen oxides

SECTION 11. TOXICOLOGICAL INFORMATION:
RTECS #: VE6257000
Acute toxicity: intravenous toxicity (TDLo): 0.28-0.5 mg/kg (human)
Primary irritant effect:
On the skin: may cause skin irritation; harmful if absorbed through the skin
On the eye: may cause eye irritation
Inhalation: harmful if inhaled; may cause respiratory tract irritation
Ingestion: 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:
T: Toxic
EU Risk And Safety phrases:
S22: Do not breathe dust
S24/25: Avoid contact with skin and eyes
S28: After contact with skin, wash immediately with plenty of water
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)
S53: Avoid exposure - obtain special instructions before use
R20/21/22: Harmful by inhalation, in contact with skin and if swallowed
R33: Danger of cumulative effects
R48: Danger of serious damage to health by prolonged exposure
R60: May impair fertility
R61: May cause harm to the unborn child

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