Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

LANSOPRAZOLE RELATED COMPOUND A

NFPA

PRODUCT USE

Contaminant of Lansoprazole (an anti- ulcerative) Intermediate

SYNONYMS

C16-H14-F3-N3-O3-S, "2-[((3-methyl-4-(2, 2, 2-trifluoroethoxy)-2-
pyridyl)methyl)sulfonyl]benzimidazole", "2-[((3-methyl-4-(2, 2, 2-trifluoroethoxy)-2-
pyridyl)methyl)sulfonyl]benzimidazole"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  The material is not thought to produce adverse health effects following ingestion (as classified using animal models). Nevertheless, adverse systemic 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.  

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

  This material can cause inflammation of the skin oncontact in some persons.  The material may accentuate any pre-existing dermatitis condition.  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

  Inhalation may produce health damage*.  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.  Asthma-like symptoms may continue for months or even years after exposure to the material ceases. This may be due to a non-allergenic condition known as reactive airways dysfunction syndrome (RADS) which can occur following exposure to high levels of highly irritating compound. Key criteria for the diagnosis of RADS include the absence of preceding respiratory disease, in a non-atopic individual, with abrupt onset of persistent asthma-like symptoms within minutes to hours of a documented exposure to the irritant. A reversible airflow pattern, on spirometry, with the presence of moderate to severe bronchial hyperreactivity on methacholine challenge testing and the lack of minimal lymphocytic inflammation, without eosinophilia, have also been included in the criteria for diagnosis of RADS. RADS (or asthma) following an irritating inhalation is an infrequent disorder with rates related to the concentration of and duration of exposure to the irritating substance. Industrial bronchitis, on the other hand, is a disorder that occurs as result of exposure due to high concentrations of irritating substance (often particulate in nature) and is completely reversible after exposure ceases. The disorder is characterised by dyspnea, cough and mucus production.  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.  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.  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).  For lansoprazole:  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.  It is unknown whether this related compound produces the same or similar  effects.