Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

JUROX AMACIN EAR AND EYE OINTMENT

NFPA

PRODUCT USE

An antibiotic sulfacetamide steroid combination for the topical treatment of various ear
and eye infections

SYNONYMS

"topical treatment for eye and ear treatment antibiotic Amasin (misspelling)"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  The material has NOT been classified as "harmful by ingestion". This is because of the lack of corroborating animal or human evidence. The material may still be damaging to the health of the individual, following ingestion, especially where pre-existing organ (e.g. liver, kidney) damage is evident. Present definitions of harmful or toxic substances are generally based on doses producing mortality (death) rather than those producing morbidity (disease, ill-health). Gastrointestinal tract discomfort may produce nausea and vomiting. In an occupational setting however, unintentional ingestion is not thought to be cause for concern.  

EYE

  There is some evidence to suggest that this material can causeeye irritation and damage in some persons.  Eye drops with sulfonamides can cause local irritation, sensations of burning and stinging, blurred vision and loss of depth perception. The conjunctiva and cornea may become inflamed, and the cornea and lens may become clouded.  

SKIN

  There is some evidence to suggest that the material may cause mild but significant inflammation of the skin either following direct contact or after a delay of some time. Repeated exposure can cause contact dermatitis which is characterized by redness, swelling and blistering.  Entry into the blood-stream, through, for example, cuts, abrasions or lesions, may produce systemic injury with harmful effects. Examine the skin prior to the use of the material and ensure that any external damage is suitably protected.  

INHALED

  The material is not thought to produce adverse health effects or irritation of the respiratory tract (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable control measures be used in an occupational setting.  Not normally a hazard due to non-volatile nature of product.  

CHRONIC HEALTH EFFECTS

  Limited evidence suggests that repeated or long-term occupational exposure may produce cumulative health effects involving organs or biochemical systems.  There is some evidence to provide a presumption that human exposure to the material may result in impaired fertility on the basis of: some evidence in animal studies of impaired fertility in the absence of toxic effects, or evidence of impaired fertility occurring at around the same dose levels as other toxic effects but which is not a secondary non-  specific consequence of other toxic effects.  Prolonged oral treatment with sulfonamides has caused nausea, vomiting, diarrhea, abdominal pain, loss of appetite, inflammation of the mouth cavity, impaired folic acid absorption, exacerbation of porphyria, acidosis, liver damage with impaired blood clotting, jaundice and inflammation of the pancreas. Effects on the kidney include blood and crystals in the urine, painful and frequent urination or lack of urine with nitrogen retention. Nervous system symptoms include headache, drowsiness, trouble sleeping, dizziness, ringing in the ears, hearing loss, depression, hallucinations, inco-ordination,  paralysis of muscles, numbness in the extremities, spinal cord damage and inflammation, convulsions and unconsciousness. Effects on the blood includes a change in blood cell distribution with loss of white blood cells and platelets, and anemia, which Africans seem to be more prone to developing than Europeans. Cyanosis can occur owing to complexes being formed by hemoglobin. Eye effects include inflamed cornea and conjunctiva with eyelid swelling and in severe cases, fear of the light. Allergies and cross-sensitivity is common, and can cause itches, wheals and sometimes a severe red rash with blisters that is often fatal. This class of drugs can scar the cornea and conjunctiva, swelling around the eyes, painful and inflamed joints, reduced sperm counts, pneumonia, fever, chills, hair loss, inflammation of vessels, lupus, reduced lung function, infertility, hypothyroidism and goiter, and increased urinary output. More seriously, the lungs may become permanently scarred and there may be irreversible damage to the nervous system and muscles. Inflammation of the skin has occurred after the drug is ingested and has traveled through the bloodstream. Skin effects often occur when there has been exposure in conjunction with UV light. Clothed areas are initially less likely to be affected but may be in later stages. Rarely there may be persistence of inflammation on light contact even after the drug has been removed.  Long-term exposure to aminoglycoside antibiotics (such as gentamicin) can damage the kidneys and malabsorption with a fatty, foul-smelling diarrhea. In some patients, there may be hearing loss and damage to the balancing system, after topical application or injection. Respiratory depression and paralysis of muscle has also been caused by this class of antibiotic. Some patients may display visual hallucinations, multiple nerve disorders and brain damage. Especially in those patients receiving cancer chemotherapy, there may be electrolyte imbalance in the blood following long-term use (reduced magnesium, calcium and potassium).  Chronic exposure to glucocorticoids can lead to changes in hormone production, a characteristic "moon face" appearance and a "lemon with matchsticks" fat distribution (central obesity with wasting of limbs), susceptibility to infections, osteoporosis, cataracts, glaucoma, mental disturbance, high blood sugar and sugar in the urine. There may be muscular weakness and fatigue, acne, period disturbances in women and peptic ulcers. Growth retardation can occur in children and birth defects are possible. Corticosteroids appear in human milk and ' may stunt the growth of infants.  One ingredient of the product has caused skin sensitization reactions, shown as localized reddening and hives, or may produce respiratory sensitization characterized by asthma-  like symptoms and runny nose.