25416-65-3

CAS#25416-65-3; 55-03-8
(anhydrous CAS number)
Manufacturer
Commercial Name(s)
Levothyroxine Sodium Hydrate

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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 HealthCARCINOGENIC EFFECTS: Not available.
EffectsMUTAGENIC EFFECTS: Not available.
TERATOGENIC EFFECTS: Not available.
DEVELOPMENTAL TOXICITY: Not available.
Repeated or prolonged exposure is not known to aggravate medical condition.

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Section 4. First Aid Measures
Eye ContactCheck 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 ContactIn 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 ContactWash with a disinfectant soap and cover the contaminated skin with an anti-bacterial cream. Seek medical
attention.
InhalationIf inhaled, remove to fresh air. If not breathing, give artificial respiration. If breathing is difficult, give oxygen. Get
medical attention.
Serious InhalationNot 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 IngestionNot available.

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Section 5. Fire and Explosion Data
Flammability of the Product May be combustible at high temperature.
Auto-Ignition Temperature Not available.
Flash PointsNot available.
Flammable LimitsNot available.
Products of CombustionThese 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 SubstancesNon-flammable in presence of shocks.
Explosion Hazards in Presence Risks of explosion of the product in presence of mechanical impact: Not available.
of Various SubstancesRisks of explosion of the product in presence of static discharge: Not available.
Fire Fighting MediaSMALL FIRE: Use DRY chemical powder.
and InstructionsLARGE FIRE: Use water spray, fog or foam. Do not use water jet.
Special Remarks onNot available.
Fire Hazards
Special Remarks on Explosion Not available.
Hazards
Levothyroxine Sodium Hydrate

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Section 6. Accidental Release Measures
Small SpillUse 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 SpillUse 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.

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Section 7. Handling and Storage
PrecautionsKeep 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.

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Section 8. Exposure Controls/Personal Protection
Engineering ControlsUse 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 ProtectionSafety 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 Spillto avoid inhalation of the product. Suggested protective clothing might not be sufficient; consult a specialist
BEFORE handling this product.
Exposure LimitsNot available.

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Section 9. Physical and Chemical Properties
Physical state and appearance Solid. (crystalline powder. Powdered solid.)OdorOdorless.
Not available.
Taste
Molecular Weight798.86 g/mole + xH2O
Off-white. White to yellowish.
Color
Not available.
pH (1% soln/water)
Boiling PointNot available.
Decomposition temperature: 207°C (404.6°F) - 210 C.
Melting Point
Critical TemperatureNot available.
Specific GravityNot available.
Not applicable.
Vapor Pressure
Vapor DensityNot available.
Not available.
Volatility
Odor ThresholdNot available.
Water/Oil Dist. Coeff.Not available.
Ionicity (in Water)Not available.
Dispersion PropertiesNot available.
SolubilityPartially soluble in cold water.
Solubilitiy in Water: 0.15 g/l @ 25 C.
Levothyroxine Sodium Hydrate

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Section 10. Stability and Reactivity Data
The product is stable.
Stability
Instability TemperatureNot available.
Excess heat, incompatible materials, light
Conditions of Instability
Not available.
Incompatibility with various
substances
CorrosivityNot available.
Special Remarks onLight Sensitive
Reactivity
Special Remarks onNot available.
Corrosivity
PolymerizationWill not occur.

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Section 11. Toxicological Information
Routes of EntryInhalation. Ingestion.
Toxicity to AnimalsLD50: Not available.
LC50: Not available.
Chronic Effects on Humans Not available.
Other Toxic Effects onSlightly hazardous in case of skin contact (irritant), of ingestion, of inhalation.
Humans
Special Remarks onNot available.
Toxicity to Animals
Special Remarks onMay cause adverse reproductive effects (Maternal effects on fertility, fetotoxicity) based on animal data.
Chronic Effects on Humans
Special Remarks on otherAcute Potential Health Effects;
Toxic Effects on HumansSkin: 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),

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Section 12. Ecological Information
EcotoxicityNot 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 ProductsThe product itself and its products of degradation are not toxic.
of Biodegradation
Not available.
Special Remarks on the
Products of Biodegradation
Levothyroxine Sodium Hydrate

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Section 13. Disposal Considerations
Waste DisposalWaste must be disposed of in accordance with federal, state and local environmental
control regulations.

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Section 14. Transport Information
DOT ClassificationNot a DOT controlled material (United States).
Not applicable.
Identification
Not applicable.
Special Provisions for
Transport
DOT (Pictograms)

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Section 15. Other Regulatory Information and Pictograms
No products were found.
Federal and State
Regulations
CaliforniaCalifornia 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 RegulationsNot available.
Other ClassificationsWHMIS (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.

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SECTION 16 - ADDITIONAL INFORMATION
N/A