Safety Data Sheet

SAFETY DATA SHEET - LC LABORATORIES
REVISION DATE: JULY 1, 2019

SECTION 1. IDENTIFICATION:
Trade name: Azacitidine, Free Base
Product Number: A-5959
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: Toxic; Irritant
RTECS Substance category: Tumorigen; Drug; Mutagen; Reproductive Effector; Human Data; Primary Irritant
Harmful if swallowed, inhaled, or absorbed through the skin
Ingestion may cause myelosuppression (suppression of the bone marrow's production of blood cells and platelets) leading to thrombocytopenia (decreased blood platelets), neutropenia (reduced levels of a certain type of white blood cells), anemia, bleeding, and infections
Other adverse effects of ingestion include nausea, vomiting, diarrhea, constipation, anorexia (loss of apetite), fatigue, asthenia (muscle weakness), pyrexia (fever), rigors (shaking/shivering), arthralgia (joint pain), myalgia (muscle pain), pain in limb, cough, dyspnea (shortness of breath), ecchymoses (subcutaneous spot of bleeding), rash, erythema (skin redness)
Exposure may impair fertility, may be harmful to a developing fetus, and may cause cancer
Causes irritation of the skin, eyes, mucous membranes, upper respiratory tract, and gastrointestinal tract
Very toxic to aquatic life
Signal Word: Danger
GHS Hazard Statements:
H302+312+332 - Harmful if swallowed, in contact with skin or if inhaled
GHS Precautionary Statements:
P2562 - Do not get in eyes, on skin or on clothing
WARNING: For Laboratory Research Use Only
Harmful


SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: 4-Amino-1-β-D-ribofuranosyl-1,3,5-triazin-2(1H)-one
Synonyms: 5-AC, 5-AzaC, 5-Azacytidine, 5-AZC, 5-AZCR, Antibiotic U 18496, Azadine, Ladakamycin, Ledakamycin, Mylosar, NSC-102816, NSC-103627, U 18496, Vidaza, WR 183027
Hazardous Ingredient: Azacitidine, Free Base
CAS Registry Number: 320-67-2
Molecular Weight: 244.20
Molecular Formula: C8H12N4O5


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: handle with Nitrile rubber gloves with minimum thickness of 0.11 mm (4.3 mil). This recommendation should not be interpreted as offering an approval for any specific use conditions. Please review this recommendation with a safety officer to evaluate if it is appropriate for the anticipated use.
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: 208-219 ºC
Danger of explosion: none
Solubility in / Miscibility with water: not determined
Solvent content:
Organic solvents: soluble in DMSO


SECTION 10. STABILITY AND REACTIVITY:
Stability: avoid acids and bases
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 #: XZ3017500
Acute toxicity: intraperitoneal toxicity (LD50): 68-100 mg/kg (mouse); intravenous toxicity (LD50): 229 mg/kg (mouse), 7.2 mg/kg (dog); oral toxicity (LD50): 572 mg/kg (mouse), >100 mg/kg (quail); intravenous toxicity (TDLo): 0.5-6 mg/kg (woman); in vitro toxicity (ICLo): 1-300 µmol/L (dog kidney)
Primary irritant effect:
On the skin: causes skin irritation; may be harmful if absorbed through the skin
On the eye: causes eye irritation
Inhalation: causes respiratory tract irritation; may be harmful if inhaled
Ingestion: harmful if swallowed

 

SECTION 12. ECOLOGICAL INFORMATION:
General notes: Very toxic to aquatic life with long lasting effects
Releases to the environment should be avoided
Aquatic Toxicity: - toxicity data from the Celgene SDS dated November 15, 2012 for Azacitidine

Compound

Type

Species

Concentration

Azacitidine

EC50

Activated sludge

>100,000 µg/L

 

EC50/72h

Algae

~0.1-1.0 mg/L

 

NOEC (growth rate reduction)

Algae

31 µg/L

 

EC50/72h (growth rate reduction)

Desmodesmus subspicatus

9.6 mg/L

 

NOEC (growth rate reduction)

Desmodesmus subspicatus

0.53 mg/L

 

NOEC/21 days (reproduction)

Daphnia magna

730 µg/L

 

NOEC (Fish early life stage test)

Fathead minnow

1000 µg/L

 

NOEC/7 day (growth inhibition)

Lemna minor

0.068 mg/L

 

EC50/7d (growth rate reduction)

Lemna minor

1.8/2 mg/L (frond numbers/wet weight)

Azacitidine is biodegradable, but does not meet the criteria for "rapid biodegradability"
Based on the octanol/water partition coefficient, azacitidine is unlikely to bioaccumulate
Azacitidine is not stable in water. It is not expected to significantly adhere to sediment
Adsorption coefficient (Koc): <33 L/kg
Results of PBT and vPvB assessment: Not performed
Other adverse effects: No data available


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; Xi: Irritant; N: Dangerous to the environment
EU Risk And Safety phrases:
S22: Do not breathe dust
S24/25: Avoid contact with skin and eyes
S26: In case of contact with eyes, rinse immediately with plenty of water and seek medical advice
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)
R22: Harmful if swallowed
R36/37/28: Irritating to eyes, respiratory system and skin 
R45: May cause cancer
R48/25: Toxic: danger of serious damage to health by prolonged exposure if swallowed
R50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment
R60: May impair fertility R61: May cause harm to the unborn child R68: Possible risk of irreversible effects

 

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
Reviewed:  July 1, 2019