Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

LISINOPRIL

NFPA

PRODUCT USE

Antihypertensive. Inhibitor of the enzyme involved in the conversion of angiotensin I to
angiotensin II. Also used in the treatment of congestive heart failure. Normally given by
mouth. A lysine analogue of enalapril. Lisinopril appears to be less effective in blacks
than in caucasians.

SYNONYMS

C21-H31-N3-O5.2H2O, "L-proline, 1-[N(sup 2)-(1-carboxy-3-phenylpropyl)-L-lysyl]-,
dihydrate, (S)-", "L-proline, 1-[N(sup 2)-(1-carboxy-3-phenylpropyl)-L-lysyl]-,
dihydrate, (S)-", "(S)-1-[N(sup 2)-1-(carboxy-3-phenylpropyl)-L-lysyl]-L-proline
dihydrate", "(S)-1-[N(sup 2)-1-(carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate",
Lysinopril, "MK 0521", "MK 521", "MK 522", MK-521, Prinivil, Prinvil, Zestril, Carace,
"angiotensin converting enzyme (ACE) inhibitor", antihypertensive

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.  Considered an unlikely route of entry in commercial/industrial environments.  ACE inhibitors are fairly safe and serious overdoses are rare. Overdoses may cause low blood pressure, increased heart rate and reversible kidney failure. Side effects of treatment include itch, rash, taste disturbance, allergy, loss of white blood cells, stomach upset, low blood pressure, increased heart rate, mouth ulcers, "pins and needles" in the hands, cough, wheeze and swollen lymph nodes. Damage to the kidneys and low blood pressure may be severe. Large areas of swelling may occur in the tongue, lips, face, extremities, and throat, which may be life-threatening. An itchy skin rash with redness and blistering may occur. Symptoms of low blood pressure are more likely in people who have been on low salt diets and prolonged treatment with diuretics. ACE inhibitors can cause reduction in urine output, and rarely, death due to kidney failure.  

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.  Kidney and liver effects were observed in repeat-dose oral toxicity  studies with enalapril, up to 1-year in duration, in dogs.  The no-observed-adverse-effect level (NOEL) was 15 mg/kg/day.  No teratogenic effects of oral lisinopril were seen in studies of pregnant  rats and rabbits.  ACE inhibitors may aggravate kidney and collagen vascular disorders. They may cause injury and death to the fetus late in pregnancy. There has been low blood pressure of the newborn, kidney failure, underdevelopment of the skull and lungs, insufficient amniotic fluid, and fetal growth retardation and limb contractures. Miscarriage or stillbirth may occur. ACE inhibitors can cause growths in glands, but rarely cause malignant cancer.  There was no evidence of a tumourigenic effect when enalapril was  administered for 106 weeks at doses up to 90 mg/kg/day (150 times the  maximum daily human dose). Enalapril has also been administered for  94 weeks to male and female mice at doses up to 90 and 180 mg/kg/day,  respectively (150 and 300 times the maximum daily human dose) and shows  no evidence of carcinogenicity. Neither enalapril maleate or its active  diacid are mutagenic in the Ames microbial mutagen test with or without  metabolic activation.  Lisinopril is negative in a battery of mutagenic tests.  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).