Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

LANSOPRAZOLE

NFPA

PRODUCT USE

Anti- ulcerative. Medicine

SYNONYMS

C16-H14-F3-N3-O2-S, "2-[((3-methyl-4-(2, 2, 2-trifluoroethoxy-2-
pyridinyl)methyl)sulfinyl]-", "2-[((3-methyl-4-(2, 2, 2-trifluoroethoxy-2-
pyridinyl)methyl)sulfinyl]-", 1H-benzimidazole, "2-(2-benzimidazolylsulfinylmethyl)-3-
methyl-4-(2, 2, 2-trifluoroethoxy)pyridine", "2-(2-benzimidazolylsulfinylmethyl)-3-methyl-
4-(2, 2, 2-trifluoroethoxy)pyridine", A-65006, A65006, AG-1749, AG1749, Agopton, Bamalite,
Dakar, Estomil, Lisatec, Lanfast, Lansox, Lanzo, Lanzor, Limpidex, Monoliturn, Ogast,
Ogastro, Opiren, Prevacid, Prezal, "Pro Ulco", Takepron, Ulpax, Zoton, anti-ulcerative,
antiulcerative, "gastric proton pump inhibitor", "substituted benzimidazole"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

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.  Limited evidence exists that the substance may cause irreversible but non-lethal mutagenic effects following a single exposure.  

EYE

  There is some evidence to suggest that this material can causeeye irritation and damage in some persons.  This material can cause eye irritation and damage in some persons.  

SKIN

  Skin contact is not thought to have harmful health effects, however the material may still produce health damage following entry through wounds, lesions or abrasions.  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.  This material can cause inflammation of the skin oncontact in some persons.  

INHALED

  There is some evidence to suggest that this material, if inhaled, can irritate the throat and lungs of some persons.  Inhalation of dusts, generated by the material, during the course of normalhandling, may be harmful.  There is some evidence to suggest that this material can cause, if inhaled once, irreversible damage of organs.  The material can cause respiratory irritation in some persons. The body's response to such irritation can cause further lung damage.  

CHRONIC HEALTH EFFECTS

  There has been some concern that this material can cause cancer or mutations but there is not enough data to make an assessment.  Limited evidence suggests that repeated or long-term occupational exposure may produce cumulative health effects involving organs or biochemical systems.  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.  Exposure to the material may result in a possible risk of irreversible effects. The material may produce mutagenic effects in man. This concern is raised, generally, on the basis ofappropriate studies with similar materials using mammalian somatic cells in vivo. Such findings are often supported by positive results from in vitro mutagenicity studies.  Exposure to small quantities may induce hypersensitivity reactions characterized by acute bronchospasm, hives (urticaria), deep dermal wheals (angioneurotic edema), running nose (rhinitis) and blurred vision . Anaphylactic shock and skin rash (non-thrombocytopenic purpura) may occur. An individual may be predisposed to such anti-body mediated reaction if other chemical agents have caused prior sensitization (cross-sensitivity).  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 rats there was no evidence of foetal abnormalities at doses 40 times the  recommended human dose (RHD). The substance is not a teratogen and shows no  adverse effects on fertility.  In a two-year study in mice and rats, at doses up to 40 times the RHD, the  substance produced mouse liver adenomas, rat gastric cell hyperplasia/  carcinoids/ metaplasia and testicular interstitial cell adenoma. Ames test  results were negative.  In an in-vitro human lymphocyte assay, there was one-positive result and  chromosomal aberration. There were no pre-cancerous lesions or carcinoid tumours  seen in a treated human population.  Pregnancy Category B.