DEXAMETHASONE, USP Safety Data Sheets

Reproductive toxicity, Category 2

Specific target organ toxicity – repeated exposure, Category 2

If inhaled

Following skin contact

Following eye contact

Following ingestion

SYMPTOMS: Symptoms of exposure to this type of compound include fluid and electrolyte disturbances, pituitary-adrenal suppression, hyperglycemia, increased susceptibility to infection including tuberculosis, myopathy, growth arrest, hypokalemic alkalosis and Cushing's syndrome consisting of "moon-face", "buffalo-hump", striae, acne and hirsuitism. Other symptoms of Cushing's syndrome include enlargement of supraclavicular fat pads, "central obesity" and ecchymoses. Flushing and increased bruising may also occur with this syndrome. Other symptoms of exposure include behavioral disturbances, glycosuria, nervousness, changes in mood or psyche, psychopathies of the manic-depressive or schizophrenic type and suicidal tendencies. Exposure may cause candidiasis, gluconeogenesis, cardiac failure (in extreme cases), spontaneous fractures, increased appetite, delayed wound healing, hyperhidrosis, mental and neurological disturbances, intracranial hypertension and increase in coagulability of the blood. It may also cause peptic ulceration with perforation or hemorrhage, amenorrhea, aseptic necrosis of the bone, muscular weakness, salt and water retention, hypertension, edema, increase in severity of diabetes, pancreatitis, thrombatic episodes and osteoporosis. Other symptoms of exposure to this type of compound include sleeplessness, skin eruptions, depression, euphoria, decrease in pain sensation, weakness, deafness, convulsions, intestinal perforation in ulcerative colitis, hypokalemia, muscle degeneration, rupture of the Achilles tendon, pseudotumor cerebri and cardiac conduction defect. It may cause congestive heart failure, suppression of the immune response mechanism, impairment of glucose tolerance, habituation and unmasking of latent psychiatric disorder. It may also cause potassium loss, loss of muscle mass, vertebral compression fractures, abdominal distention, ulcerative esophagitis, thin and fragile skin, petechiae, erythema, increased sweating, suppressed reactions to skin tests, allergic dermatitis, urticaria, angioneurotic edema, vertigo, headache, menstrual irregularities, secondary adrenocorticol and pituitary unresponsiveness, decreased carbohydrate tolerance, exophthalmos, hypersensitivity, thromboembolism, malaise, weight gain, nausea and intracranial pressure with papilledema. Ascites may occur. Skin exposure to this type of compound may cause loss of skin collagen and subcutaneous atrophy. Other symptoms via this route include burning, secondary infections, itching, irritation, pigmentation, dryness, folliculitis and hypertrichosis. Eye exposure to this type of compound may lead to corneal ulceration, raised intraocular pressure, reduced visual function and cataracts. Glaucoma may also occur. ACUTE/CHRONIC HAZARDS: This compound may be harmful by inhalation, ingestion or skin absorption. It may cause irritation. It may cause lacrimation. When heated to decomposition it emits toxic fumes of carbon monoxide, carbon dioxide and hydrogen fluoride. (NTP, 1992)

Flash point data for this chemical are not available; however, it is probably combustible. (NTP, 1992)

Wear self-contained breathing apparatus for firefighting if necessary.

Avoid dust formation. Avoid breathing mist, gas or vapours.Avoid contacting with skin and eye. Use personal protective equipment.Wear chemical impermeable gloves. Ensure adequate ventilation.Remove all sources of ignition. Evacuate personnel to safe areas.Keep people away from and upwind of spill/leak.

Personal protection: particulate filter respirator adapted to the airborne concentration of the substance. Do NOT let this chemical enter the environment. Sweep spilled substance into covered plastic containers. If appropriate, moisten first to prevent dusting. Carefully collect remainder. Then store and dispose of according to local regulations.

Collect and arrange disposal. Keep the chemical in suitable and closed containers for disposal. Remove all sources of ignition. Use spark-proof tools and explosion-proof equipment. Adhered or collected material should be promptly disposed of, in accordance with appropriate laws and regulations.

Handling in a well ventilated place. Wear suitable protective clothing. Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Use non-sparking tools. Prevent fire caused by electrostatic discharge steam.

Separated from food and feedstuffs, acids and metals. See Chemical Dangers. Provision to contain effluent from fire extinguishing. Store in an area without drain or sewer access.

Occupational Exposure limit values

Biological limit values

Eye/face protection

Skin protection

Respiratory protection

Thermal hazards

Decomposes on heating above 275°C . This produces toxic fumes. This generates fire and explosion hazard. Reacts with copper, lead, silver, mercury and carbon disulfide. This produces particularly shock-sensitive compounds. Reacts with acids. This produces toxic and explosive hydrogen azide. See Notes.

Dexamethasone sodium phosphate ophthalmic solution should be stored in tight, light-resistant containers. Dexamethasone sodium phosphate

See Notes.DEXAMETHAZONE may be sensitive to prolonged exposure to light. This chemical is incompatible with strong oxidizers, strong acids, acid chlorides and acid anhydrides. Oxidation may occur with bases. (NTP, 1992)

no data available

CHEMICAL PROFILE: An azide is a compound of hydrogen or a metal and the monovalent triatomic nitrogen anion. All azide salts and the acid are unstable and some decompose explosively. Extremely dangerous, shock or heat may explode them. If exposed to carbon disulfide, they form violentluy explosive salts. They can be sensitized by metal salts (especially heavy metal salts such as silver chloride etc.) or by traces of strong acids. They decompose explosively if heated or on impact. [Sax, 9th ed., 1996, p. 298]. (REACTIVITY, 1999)

When heated to decomposition it emits toxic fumes of /hydrogen fluoride/.

Acute toxicity

• Oral: no data available
• Inhalation: no data available
• Dermal: no data available

Skin corrosion/irritation

Serious eye damage/irritation

Respiratory or skin sensitization

Germ cell mutagenicity

Carcinogenicity

Reproductive toxicity

STOT-single exposure

STOT-repeated exposure

Aspiration hazard

• Toxicity to fish: no data available
• Toxicity to daphnia and other aquatic invertebrates: no data available
• Toxicity to algae: no data available
• Toxicity to microorganisms: no data available

no data available

An estimated BCF of 14 was calculated for dexamethasone(SRC), using a log Kow of 1.83(1) and a regression-derived equation(2). According to a classification scheme(3), this BCF suggests the potential for bioconcentration in aquatic organisms is low(SRC).

The Koc of dexamethasone is estimated as 240(SRC), using a log Kow of 1.83(1) and a regression-derived equation(2). According to a classification scheme(3), this estimated Koc value suggests that dexamethasone is expected to have moderate mobility in soil.

no data available

Product

Contaminated packaging

no data available

no data available

Information on revision

Abbreviations and acronyms

• CAS: Chemical Abstracts Service
• ADR: European Agreement concerning the International Carriage of Dangerous Goods by Road
• RID: Regulation concerning the International Carriage of Dangerous Goods by Rail
• IMDG: International Maritime Dangerous Goods
• IATA: International Air Transportation Association
• TWA: Time Weighted Average
• STEL: Short term exposure limit
• LC50: Lethal Concentration 50%
• LD50: Lethal Dose 50%
• EC50: Effective Concentration 50%

References

• IPCS - The International Chemical Safety Cards (ICSC), website: http://www.ilo.org/dyn/icsc/showcard.home
• HSDB - Hazardous Substances Data Bank, website: https://toxnet.nlm.nih.gov/newtoxnet/hsdb.htm
• IARC - International Agency for Research on Cancer, website: http://www.iarc.fr/
• eChemPortal - The Global Portal to Information on Chemical Substances by OECD, website: http://www.echemportal.org/echemportal/index?pageID=0&request_locale=en
• CAMEO Chemicals, website: http://cameochemicals.noaa.gov/search/simple
• ChemIDplus, website: http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp
• ERG - Emergency Response Guidebook by U.S. Department of Transportation, website: http://www.phmsa.dot.gov/hazmat/library/erg
• Germany GESTIS-database on hazard substance, website: http://www.dguv.de/ifa/gestis/gestis-stoffdatenbank/index-2.jsp
• ECHA - European Chemicals Agency, website: https://echa.europa.eu/