Section 1. Chemical Product and Company Identification
Levothyroxine Sodium Hydrate Catalog
T1281, T1432, T3183
Common Name/
Number(s).
Trade Name
CAS# 25416-65-3; 55-03-8
(anhydrous CAS number)
Manufacturer
Commercial Name(s)
Levothyroxine Sodium Hydrate
Section 3. Hazards Identification
Potential Acute Health Effects Slightly hazardous in case of skin contact (irritant), of eye contact (irritant), of ingestion, of inhalation.
Potential Chronic Health CARCINOGENIC EFFECTS: Not available.
Effects MUTAGENIC EFFECTS: Not available.
TERATOGENIC EFFECTS: Not available.
DEVELOPMENTAL TOXICITY: Not available.
Repeated or prolonged exposure is not known to aggravate medical condition.
Section 4. First Aid Measures
Eye Contact Check for and remove any contact lenses. In case of contact, immediately flush eyes with plenty of water for at
least 15 minutes. Get medical attention.
Skin Contact In case of contact, immediately flush skin with plenty of water. Cover the irritated skin with an emollient. Remove
contaminated clothing and shoes. Wash clothing before reuse. Thoroughly clean shoes before reuse. Get
medical attention.
Serious Skin Contact Wash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical
attention.
Inhalation If inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get
medical attention.
Serious Inhalation Not available.
Ingestion
Do NOT induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an
unconscious person. If large quantities of this material are swallowed, call a physician immediately. Loosen tight
clothing such as a collar, tie, belt or waistband.
Serious Ingestion Not available.
Section 5. Fire and Explosion Data
Flammability of the Product May be combustible at high temperature.
Auto-Ignition Temperature Not available.
Flash Points Not available.
Flammable Limits Not available.
Products of Combustion These products are carbon oxides (CO, CO2), nitrogen oxides (NO, NO2...). Some metallic oxides.
Fire Hazards in Presence of Slightly flammable to flammable in presence of open flames and sparks, of heat.
Various Substances Non-flammable in presence of shocks.
Explosion Hazards in Presence Risks of explosion of the product in presence of mechanical impact: Not available.
of Various Substances Risks of explosion of the product in presence of static discharge: Not available.
Fire Fighting Media SMALL FIRE: Use DRY chemical powder.
and Instructions LARGE FIRE: Use water spray, fog or foam. Do not use water jet.
Special Remarks on Not available.
Fire Hazards
Special Remarks on Explosion Not available.
Hazards
Levothyroxine Sodium Hydrate
Section 6. Accidental Release Measures
Small Spill Use appropriate tools to put the spilled solid in a convenient waste disposal container. Finish cleaning by
spreading water on the contaminated surface and dispose of according to local and regional authority
requirements.
Large Spill Use a shovel to put the material into a convenient waste disposal container. Finish cleaning by spreading water
on the contaminated surface and allow to evacuate through the sanitary system.
Section 7. Handling and Storage
Precautions Keep away from heat. Keep away from sources of ignition. Ground all equipment containing material. Do not
breathe dust. Wear suitable protective clothing. In case of insufficient ventilation, wear suitable respiratory
equipment. If you feel unwell, seek medical attention and show the label when possible. Avoid contact with skin
and eyes.
Keep container tightly closed. Keep container in a cool, well-ventilated area. Do not store above 8°C (46.4°F).
Storage
Refrigerate. Sensitive to light. Store in light-resistant containers.
Section 8. Exposure Controls/Personal Protection
Engineering Controls Use process enclosures, local exhaust ventilation, or other engineering controls to keep airborne levels below
recommended exposure limits. If user operations generate dust, fume or mist, use ventilation to keep exposure to
airborne contaminants below the exposure limit.
Personal Protection Safety glasses. Lab coat. Dust respirator. Be sure to use an approved/certified respirator or equivalent. Gloves.
Personal Protection in Case of Splash goggles. Full suit. Dust respirator. Boots. Gloves. A self contained breathing apparatus should be used
a Large Spill to avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist
BEFORE handling this product.
Exposure Limits Not available.
Section 9. Physical and Chemical Properties
Physical state and appearance Solid. (crystalline powder. Powdered solid.) Odor Odorless.
Not available.
Taste
Molecular Weight 798.86 g/mole + xH2O
Off-white. White to yellowish.
Color
Not available.
pH (1% soln/water)
Boiling Point Not available.
Decomposition temperature: 207°C (404.6°F) - 210 C.
Melting Point
Critical Temperature Not available.
Specific Gravity Not available.
Not applicable.
Vapor Pressure
Vapor Density Not available.
Not available.
Volatility
Odor Threshold Not available.
Water/Oil Dist. Coeff. Not available.
Ionicity (in Water) Not available.
Dispersion Properties Not available.
Solubility Partially soluble in cold water.
Solubilitiy in Water: 0.15 g/l @ 25 C.
Levothyroxine Sodium Hydrate
Section 10. Stability and Reactivity Data
The product is stable.
Stability
Instability Temperature Not available.
Excess heat, incompatible materials, light
Conditions of Instability
Not available.
Incompatibility with various
substances
Corrosivity Not available.
Special Remarks on Light Sensitive
Reactivity
Special Remarks on Not available.
Corrosivity
Polymerization Will not occur.
Section 11. Toxicological Information
Routes of Entry Inhalation. Ingestion.
Toxicity to Animals LD50: Not available.
LC50: Not available.
Chronic Effects on Humans Not available.
Other Toxic Effects on Slightly hazardous in case of skin contact (irritant), of ingestion, of inhalation.
Humans
Special Remarks on Not available.
Toxicity to Animals
Special Remarks on May cause adverse reproductive effects (Maternal effects on fertility, fetotoxicity) based on animal data.
Chronic Effects on Humans
Special Remarks on other Acute Potential Health Effects;
Toxic Effects on Humans Skin: May cause skin irritation.
Eyes: May cause eye irritation by mechanical action.
Inhalation: May cause respiratory tract irritation.
Ingestion: May cause digestive tract irritation. May affect metabolism, thyroid, urinary sytem, behavior
(excitement, headache, coma), cardiovascular system (increased pulse rate),
Section 12. Ecological Information
Ecotoxicity Not available.
Not available.
BOD5 and COD
Possibly hazardous short term degradation products are not likely. However, long term degradation products may
Products of Biodegradation
arise.
Toxicity of the Products The product itself and its products of degradation are not toxic.
of Biodegradation
Not available.
Special Remarks on the
Products of Biodegradation
Levothyroxine Sodium Hydrate
Section 13. Disposal Considerations
Waste Disposal Waste must be disposed of in accordance with federal, state and local environmental
control regulations.
Section 14. Transport Information
DOT Classification Not a DOT controlled material (United States).
Not applicable.
Identification
Not applicable.
Special Provisions for
Transport
DOT (Pictograms)
Section 15. Other Regulatory Information and Pictograms
No products were found.
Federal and State
Regulations
California California prop. 65: This product contains the following ingredients for which the State of California has found
to cause cancer which would require a warning under the statute: No products were found.
Proposition 65
Warnings
California prop. 65: This product contains the following ingredients for which the State of California has found
to cause birth defects which would require a warning under the statute: No products were found.
Other Regulations Not available.
Other Classifications WHMIS (Canada) Not controlled under WHMIS (Canada).
DSCL (EEC) This product is not classified according S24/25- Avoid contact with skin and eyes.
to the EU regulations.
Health Hazard
HMIS (U.S.A.) 1 National Fire Protection
1 Flammability
1 Association (U.S.A.)
Fire Hazard
1 0 Reactivity
Health
Reactivity
0
Specific hazard
Personal Protection
E
WHMIS (Canada)
(Pictograms)
DSCL (Europe)
(Pictograms)
TDG (Canada)
(Pictograms)
Levothyroxine Sodium Hydrate
ADR (Europe)
(Pictograms)
Protective Equipment
Gloves.
Lab coat.
Dust respirator. Be sure to use an
approved/certified respirator or
equivalent.
SECTION 16 - ADDITIONAL INFORMATION
N/A
Xn:Harmful;
