Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

HYOSCINE BUTYLBROMIDE

NFPA

PRODUCT USE

A quaternary ammonium anticholinergic agent widely used in conditions asscociated with
visceral spasm. Stimulates both central and peripheral actions. It first stimulates and
then depresses the central nervous system and has antispasmodic actions on smooth muscle.
CAUTION: Hyoscine may cause drowsiness and dulling of mental alertness. Patients
undergoing treatment with hyoscine should not take charge of vehicles, other means of
transport, or machinery where loss of attention may lead to accidents. Patients should
abstain from alcohol.

SYNONYMS

C21-H30-Br-NO4, "1-alpha-H, 5-alpha-H-tropanium, ", "1-alpha-H, 5-alpha-H-tropanium, ",
"8-butyl-6-beta-7, beta-epoxy-3-alpha-hydroxy-, bromide, (-)-tropate", "8-butyl-6-beta-
7, beta-epoxy-3-alpha-hydroxy-, bromide, (-)-tropate", butylhyoscine, "N-butylhyoscine
bromide", "N-butylhyoscine bromide", "N-butylhyoscinium bromide", "N-butylhyoscinium
bromide", "butylscopolamine bromide", "N-butylscopolamine bromide", "N-butylscopolamine
bromide", "N-butylscopolammonium bromide", "N-butylscopolammonium bromide", "hyoscin N-
butylbromide", "hyoscin N-butylbromide", "hyoscin N-butyl bromide", "hyoscin N-butyl
bromide", "hyoscin butobromide", "hyoscine butyl bromide", "hyoscine N-butyl bromide",
"hyoscine N-butyl bromide", "scopolamine bromobutylate", "scopolamine butobromide",
"scopolamine N-butyl bromide", "scopolamine N-butyl bromide", Amisepan, Buscapina,
Buscapine, Buscol, Buscolamin, Buscolysine, Buscopan, Butylmin, Donopon, Joscine,
Monospan, Scobro, Scobron, Scobutil, Scobutyl, Scopolan, Sparicon, Sporamin, Stilbron,
Tirantil, "quaternary ammonium anticholinergic alkaloid"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

Very toxic by inhalation, in contact with skin and if swallowed.

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Severely toxic effects may result from the accidental ingestion of the material; animal experiments indicate that ingestion of less than 5 gram may be fatal or may produce serious damage to the health of the individual.  Anticholinergics can cause loss of vision. Effects associated with their use include increased heart rate, decreased saliva production and other secretions and reduction in bowel movements. Adverse effects include dry mouth, difficulty swallowing and speaking, thirst, dilated pupils, loss of focus, sensitivity to light, skin flushing and dryness, a temporary slowing of heart rate followed by rapid heart rate with palpitations and irregularities in rhythm. There may be vomiting, pain in the chest and dizziness. Toxicity due to overdose may result in rapid breathing, high fever, restlessness, confusion, excitement, paranoia, psychosis, hallucinations, delirium, seizures and convulsions. A rash may occur on the face or upper trunk. Severe intoxication can depress the central nervous system, causing inco-ordination, drowsiness, stupor, unconsciousness, coma, stoppage of circulation and breathing, and death.  Quaternary ammonium anticholinergic agents, in high doses, can cause postural hypotension and impotence. Paralysis may occur at very high doses.  

EYE

  There is some evidence to suggest that this material can causeeye irritation and damage in some persons.  Anticholinergic eye drops can cause stinging, dryness, redness, itch, dilated pupils, and loss of focus with blurred vision. Pupil Reflexes may be lost or diminished for 3 days.  

SKIN

  Skin contact with the material may produce severely toxic effects; systemic effects may result following absorption and these may be fatal.  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.  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 of dusts, generated by the material, during the course of normal handling, may produce severely toxic effects; these may be fatal.  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.  

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 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.  Prolonged exposure to anticholinergic agents may irritate the eyes, causing allergic lid reactions, conjunctivitis, swelling, excess blood flow to the eyes, and sensitivity to light. Increase in eye pressure may lead to closed angle glaucoma. There may be hypersensitivity shown by conjunctivitis, rash and eczema. Anticholinergics can also cause chronic constipation with blockage of the intestine by feces.  Chronic intoxication with ionic bromides, historically, has resulted from medical use of bromides but not from environmental or occupational exposure; depression, hallucinosis, and schizophreniform psychosis can be seen in the absence of other signs of intoxication. Bromides may also induce sedation, irritability, agitation, delirium, memory loss, confusion, disorientation, forgetfulness (aphasias), dysarthria, weakness, fatigue, vertigo, stupor, coma, decreased appetite, nausea and vomiting, diarrhoea, hallucinations,  an acne like rash on the face, legs and trunk, known as bronchoderma (seen in 25-30% of case involving bromide ion), and a profuse discharge from the nostrils (coryza). Ataxia and generalised hyperreflexia have also been observed. Correlation of neurologic symptoms with blood levels of bromide is inexact. The use of substances such as brompheniramine, as antihistamines, largely reflect current day usage of bromides; ionic bromides have been largely withdrawn from therapeutic use due to their toxicity. Several cases of foetal abnormalities have been described in mothers who took large doses of bromides during pregnancy.