Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

PANTOPRAZOLE 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

C16-H14-F2-N3-O4-S.Na, "1H-benzimidazole, 5-(difluoromethoxy)-2-[((3, 4-dimethoxy-2-
pyridinyl)-", "1H-benzimidazole, 5-(difluoromethoxy)-2-[((3, 4-dimethoxy-2-pyridinyl)-",
"methyl)sulfinyl]-, sodium", "5-(difluoromethoxy)-2-[((3, 4-dimethoxy-2-
pyridnyl)methyl)sulfinyl)-", "5-(difluoromethoxy)-2-[((3, 4-dimethoxy-2-
pyridnyl)methyl)sulfinyl)-", "1H-benzimidazole monosodium salt", "pentaprazole sodium",
SKF-96022, BY-1023, "gastrointestinal agent/ gastric proton-pump inhibitor", anti-
ulcerative

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

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

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Accidental ingestion of the material may be harmful; animal experiments indicate that ingestion of less than 150 gram may be fatal or may produce serious damage to the health of the individual.  

EYE

  Although the material is not thought to be an irritant, direct contact with the eye may cause transient discomfort characterized by tearing or conjunctival redness (as with windburn). Slight abrasive damage may also result. The material may produce foreign body irritation in certain individuals.  

SKIN

  Skin contact is not thought to produce harmful health effects (as classified using animal models). Systemic harm, however, has been identified following exposure of animals by at least one other route and the material may still produce health damage following entry through wounds, lesions or abrasions. Good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  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 either adverse health effects or irritation of the respiratory tract following inhalation (as classified using animal models). Nevertheless, adverse effects have been produced following exposure of animals by at least one other route and good hygiene practice requires that exposure be kept to a minimum and that suitable control measures be used in an occupational setting.  

CHRONIC HEALTH EFFECTS

  Long term exposure to high dust concentrations may cause changes in lung function i.e. pneumoconiosis; caused by particles less than 0.5 micron penetrating and remaining in the lung. Prime symptom is breathlessness; lung shadows show on X-ray.  Limited evidence suggests that repeated or long-term occupational exposure may produce cumulative health effects involving organs or biochemical systems.  There is limited evidence that, skin contact with this product is more likely to cause a sensitization reaction in some persons compared to the general population.  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 rat studies, pantoprazole produced a carcinoid-like tumour of the  gastric mucosa when given in high doses over a long period of time.  In two 24-month carcinogenicity studies in rats, a congener 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.