Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

HALOPERIDOL DECANOATE

NFPA

PRODUCT USE

Major butyrophenone tranquilliser (antipsychotic/ neuroleptic) which depresses the central
nervous system. Widely used in the management of psychotic conditions, to control
hyperkinetic states and aggression, for the control of anxiety and tension, as an anti-
emetic to control nausea and vomiting, in the management of Gilles de la Tourrette' s
syndrome. Given by mouth or by injection (as the decanoate). CAUTION: May modify behaviour
and state of alertness; exposed individuals taking charge of vehicles or machinery should
be warned of the hazards.

SYNONYMS

C31-H41-Cl-F-N-O2, C31-H41-Cl-F-N-O2, "decanoate of:", "1-butanone, 4-(4-(4-chlorophenyl)-
4-hydroxy-1-piperidinyl)-1-(4-fluorophenyl)-", "1-butanone, 4-(4-(4-chlorophenyl)-4-
hydroxy-1-piperidinyl)-1-(4-fluorophenyl)-", "butyrophenone, 4'-fluoro-4-(4-(p-
chlorophenyl)-4-hydroxypiperidino)-", "butyrophenone, 4'-fluoro-4-(4-(p-chlorophenyl)-4-
hydroxypiperidino)-", gamma-(4-(p-chlorphenyl)-4-hydroxypiperidino)-p-fluorbutyrophenone,
gamma-(4-(p-chlorphenyl)-4-hydroxypiperidino)-p-fluorbutyrophenone, 4-(4-(4-chlorophenyl)-
4-hydroxy-1-piperidinyl-1-(4-fluorophenyl)-1-butenone, 4-(4-(4-chlorophenyl)-4-hydroxy-1-
piperidinyl-1-(4-fluorophenyl)-1-butenone, 1-(3-p-fluorobenzoylpropyl)-4-p-chlorophenyl-4-
hydroxypiperidine, 1-(3-p-fluorobenzoylpropyl)-4-p-chlorophenyl-4-hydroxypiperidine, 4'-
fluoro-4-(4-(p-chlorophenyl)-4-hydroxypiperidinyl)butyrophenone, 4'-fluoro-4-(4-(p-
chlorophenyl)-4-hydroxypiperidinyl)butyrophenone, 4'-fluoro-4-(4-hydroxy-4-(4'-
chlorophenyl)piperidino)butyrophenone, 4'-fluoro-4-(4-hydroxy-4-(4'-
chlorophenyl)piperidino)butyrophenone, 4-4-(hydroxy-4'-chloro-4-phenylpiperidino)-4'-
fluorobutyrophenone, 4-4-(hydroxy-4'-chloro-4-phenylpiperidino)-4'-fluorobutyrophenone,
"Haldol Decanoate", KD-136, Halomonth, Neoperidole, "tranquilliser/ antipsychotic/
neuroleptic/ ataractic"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

Harmful if swallowed.

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.  A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been associated with the use of antipsychotic drugs. Clinical manifestations include hyperpyrexia, muscle rigidity, altered mental state, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.Antipsychotic drug therapy may also produce potentially irreversible, involuntary, dyskinetic movements, especially in the elderly and in particular, in elderly women. The development of this syndrome appears to be related to the duration of treatment and the total cumulative dose of antipsychotic drugs administered; the syndrome can, however, develop after relatively brief treatment periods at low doses.Other side-effects of drug therapy may include a disruption to the body's ability to reduce body core temperature and dysphagia (oesophageal dysmotility and aspiration - aspiration pneumonia is a common cause of morbidity or mortality in elderly patients especially those with advanced Alzheimer's dementia).  

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

  The material is not thought to be a skin irritant (as classified using animal models). Abrasive damage however, may result from prolonged exposures. Good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  Skin contact with the material may damage the health of the individual; systemic effects may result following absorption.  Open cuts, abraded or irritated skin should not be exposed to this material.  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*.  The material is not thought to produce respiratory irritation (as classified using animal models). Nevertheless inhalation of dusts, or fume, especially for prolonged periods, may produce respiratory discomfort and occasionally, distress.  Inhalation of dusts, generated by the material during the course of normal handling, may be damaging to the health of the individual.  

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.  There is some evidence that human exposure to the material may result in developmental toxicity. This evidence is based on animal studies where effects have been observed in the absence of marked maternal toxicity, or at around the same dose levels as other toxic effects but which are not secondary non-specific consequences of the other toxic effects.  Antipsychotic drugs have been shown to chronically elevate prolactin levels in rodents. Increases in mammary neoplasms have been found in rodents after chronic administration of antipsychotic drugs and are considered to be prolactin-mediated.  Increased prolactin levels in serum are a secondary consequence of chronic dopamine antagonism of pituitary lactotrophs.  The relevance of the increased incidence of prolactin-mediated mammary gland tumours in rats, to human risk, is unknown.  Reproductive and developmental toxicity may also result from exposure to dopamine antagonists; these may result from elevation of serum prolactin. Effects may include prolonged oestrus, pre-implantation loss and alterations to the length of the gestational cycle.  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 for prolonged periods may cause physical defects in the developing embryo (teratogenesis).