Safety Data Sheet

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

SECTION 1. IDENTIFICATION:
Trade name: Epirubicin, Hydrochloride Salt
Product Number: E-8000
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
RTECS Substance category: Drug; Mutagen; Human Data; Reproductive Effector
Harmful if swallowed
May be harmful if inhaled or absorbed through the skin
Exposure may impair fertility, may cause harm to the unborn child, and may cause cancer
Ingestion may cause leukopenia and neutropenia (decreased white blood cells), anemia, thrombocytopenia (decreased blood platelets), amenorrhea (suppression of menstruation), hot flashes, lethargy, pyrexia (fever), nausea/vomiting, mucositis (inflammation of the mucous membranes lining the digestive tract, especially mouth sores), diarrhea, anorexia (loss of appetite), infection, febrile neutropenia (development of fever/other signs of infection in association with abnormally low number of a certain type of white blood cells), conjunctivitis/keratitis (inflammation of the eyes), alopecia (hair loss), local toxicity, rash/pruritus (itch), skin changes
Exposure may cause irritation to eyes, mucous membranes, upper respiratory tract and skin
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

 

SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS:
Chemical Name: (8S,10S)-10-[(3-Amino-2,3,6-trideoxy-α-L-arabino-hexopyranosyl)oxy]-7,8,9,10-tetrahydro-6,8,11-trihydroxy-8-(2-hydroxyacetyl)-1-methoxy-5,12-naphthacenedione hydrochloride
Synonyms: 4'-Epidoxorubicin, Ellence, Epiadriamycin, Epirubicin Ebewe, Pharmorubicin, Ridorubicin
Hazardous Ingredient: Epirubicin, Hydrochloride Salt
CAS Registry Number: 56390-09-1
Molecular Weight: 579.98
Molecular Formula: C27H29NO11•HCl


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:
Odor:
Melting point/Melting range: not determined
Danger of explosion: none
Solubility in / Miscibility with water: not tested
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 #: QI9295750
Acute toxicity: oral toxicity (LD50): 1350 mg/kg (rat), >2000 mg/kg (mouse); intravenous toxicity (LD50): 17 mg/kg (rat), 31.5 mg/kg (mouse), 2.25 mg/kg (dog); intraperitoneal toxicity (LD50): 10.8 mg/kg(rat); subcutaneous toxicity (LD50): 17.6 mg/kg (rat), 37.5 mg/kg (mouse)
Primary irritant effect:
On the skin: may be an irritant; may be harmful if absorbed through the skin
On the eye: may cause eye irritation
Inhalation: may be an irritant; may be harmful if inhaled
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
Hazard-determining components of labeling:
EU Risk And Safety phrases:
S22: Do not breathe dust
S24/25: Avoid contact with skin and eyes
S36/37: Wear suitable protective clothing and gloves
R22: Harmful if swallowed
R45: May cause cancer
R46: May cause heritable genetic damage
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
Reviewed:  July 1, 2019