Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

OMEPRAZOLE SODIUM

NFPA

PRODUCT USE

Antiulcerative in the treatment of pathological hypersecretion (e.g. Zollinger- Ellison
syndrome). A substituted benzimidazole which does not exhibit anticholinergic or H2
histamine antagonist properties but suppresses gastric acid secretion by specific
inhibition of the H+/K+ ATPase enzyme system at the secretary surface of the gastric
parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the
gastric mucosa, omeprazole has been characterised as a gastric- pump inhibitor

SYNONYMS

C17-H19-N3-O3-S.Na, "1H-benzimidazole, 5-methoxy-2-[((4-methoxy-3, 5-dimethyl-2-
pyridinyl)-methyl]sulfinyl-, sodium", "1H-benzimidazole, 5-methoxy-2-[((4-methoxy-3, 5-
dimethyl-2-pyridinyl)-methyl]sulfinyl-, sodium", "5-methoxy-2-[((4-methoxy-3, 5-dimethyl-
2-pyridyl)methyl)sulfinyl]-benzimidazole sodium", "5-methoxy-2-[((4-methoxy-3, 5-dimethyl-
2-pyridyl)methyl)sulfinyl]-benzimidazole sodium", "Losec Infusion", "gastrointestinal
agent/ gastric proton-pump inhibitor", anti-ulcerative

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

May cause long- term adverse effects in the aquatic environment.

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Although ingestion is not thought to produce harmful effects, 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, ingestion of insignificant quantities is not thought to be cause for concern.  Considered an unlikely route of entry in commercial/industrial environments.  

EYE

  Although the material is not thought to be an irritant, direct contact with the eye may produce transient discomfort characterized by tearing or conjunctival redness (as with windburn).  

SKIN

  The material is not thought to produce adverse health effects or skin irritation following contact (as classified using animal models). Nevertheless, good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  

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.  Persons with impaired respiratory function, airway diseases and conditions such as emphysema or chronic bronchitis, may incur further disability if excessive concentrations of particulate are inhaled.  

CHRONIC HEALTH EFFECTS

  Principal routes of exposure are usually by skin contact/absorption and inhalation of generated dust.  The use of gastric proton pump inhibitors (antiulceratives) has been associated with the induction of carcinoid-like tumours of the gastric mucosa. This is thought to be associated with a complete block of gastric acid secretion leading to hypergastrinaemia and hyperplasia of enterochromaffin-like cells. As a result, the therapeutic use of these inhibitors is generally restricted.  In two 24-month carcinogenicity studies in rats, the omeprazole (given at  4-352 times the human dosage) produced gastric ECL cell carcinoids in a  dose-related manner in both male and female rats ECL cell hyperplasia was  present in all treatment groups. A 78-week mouse carcinogenicity study did  not show increased tumor occurrence.  Omeprazole was not mutagenic in an in vitro Ames Salmonella typhimurium  assay, an in vitro mouse lymphoma cell assay and an in vivo liver DNA  damage assay. A mouse micronucleus test at 625 and 6250 times the human  dose gave a borderline result, as did an in vivo bone marrow chromosome  aberration test.  In developmental studies with rabbits (at 17-172 times the human dose)  omeprazole produced dose-related increases in embryo-lethality, foetal  resorptions, and pregnancy disruptions. In rats, dose-related embryo/foetal  toxicity and post-natal developmental toxicity was seen in offspring of  parents treated with 13-138 times the human dose.  Sporadic reports have been received of congenital abnormalities occurring  in infants born to woman receiving the omeprazole during pregnancy.