Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

JUROX TRIBRISSEN 20 TABLETS

NFPA

PRODUCT USE

Tablets for the treatment of susceptible infections in dogs and cats.

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

May cause harm to the unborn child.

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  There is some evidence to suggest that this material can cause, if swallowed once, irreversible damage of organs.  Large doses of cellulose may be administered orally as non-nutritive bulk. Doses of up to 30 g/day can be tolerated as bulk laxative. Extremely large oral doses may produce gastrointestinal disturbances.  Polysaccharides are not substantially absorbed from the gastrointestinal tract but may produce a laxative effect. Larger doses may produce intestinal obstruction or stomach concretions.Large quantities of the substituted polysaccharide, methylcellulose (as with other bulk laxatives), may temporarily increase flatulence. Oesophageal obstruction, by swelling, may occur if the material is swallowed dry.Doses of 3-9 gm hydroxypropylcellulose, fed to human subjects, at least one week apart, were eliminated within 96 hours. Animals fed on diets containing 3% or less, experienced no adverse effects. Higher levels produced malnutrition due to excessive bulk but caused no organic damage. In one dog, an oral dose of hydroxypropylcellulose produced diarrhoea and blood cell depression.Ingestion of hetastarch (hydroxyethyl amylopectin) has reportedly produced fever, chills, urticaria and salivary gland enlargement. Several of these effects may be due to contamination by other naturally occurring macromolecules extracted from the source material. Large volumes of ingested hetastarch may interfere with coagulation mechanisms and increase the risk of haemorrhage. Anaphylaxis has occurred.Infusions of dextrans may occasionally produce allergic reactions such as urticaria,hypotension and bronchospasm. Severe anaphylactic reactions may occasionally occurand death may result from cardiac and respiratory arrest. Nausea, vomiting, fever, joint pains, and flushing may also occur. Similarly, allergic reactions, sometimes severe (but rare) have been reported following ingestion or inhalation of tragacanth gums.  

EYE

  There is some evidence to suggest that this material can causeeye irritation and damage in some persons.  Eye drops with sulfonamides can cause local irritation, sensations of burning and stinging, blurred vision and loss of depth perception. The conjunctiva and cornea may become inflamed, and the cornea and lens may become clouded.  

SKIN

  Skin contact with the material may damage the health of the individual; systemic effects may result following absorption.  There is some evidence to suggest that this material can cause inflammation of the skin on contact in some persons.  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 is a photosensitizer. Certain individuals working with this substance may show allergic reaction of the skin under sunlight. This results in sensitivity to sunburn (may be severe) unless protective covering and 15+PF sunscreen are used. Responses may vary from sunburn-like effects to swelling and blistering lesions.  

INHALED

  Inhalation may produce health damage*.  Inhalation of vapors or aerosols (mists, fumes), generated by the material during the course of normal handling, may be damaging to the health of the individual.  The material is not thought to produce respiratory irritation (as classified using animal models). Nevertheless inhalation of the material, especially for prolonged periods, may produce respiratory discomfort and occasionally, distress.  Cellulose, after a single intratracheal dose (15 mg per animal) brought about fibrosing granulomatous bronchioloalveolitis and an increase of IgA production in the bronchioalveolar lavage. Fibrosing alveolitis showed moderate progression as a function of time. Injury of Type I pneumocytes and incomplete repair of Type II pneumocytes were detected. The damage of alveolar epithelium initiated and activated a series of processes that led to definite pulmonary alterations and pulmonary fibrosis leading to disintegration of the alveolo-capillary morphological functional unit.  Tatrai, E. et al: Journal of Applied Toxicology; 16(2) 129-135 (1996)Some health effects associated with wood, cotton, flax, jute and hemp particles or fibres are not attributable to cellulose content but to other substances and/or impurities.  

CHRONIC HEALTH EFFECTS

  Ample evidence exists, from results in experimentation, that developmental disorders are directly caused by human exposure to the material.  

  This material contains a polymer with a functional group considered to be of low concern. Non-ring hydroxyl (-OH) groups in polymers (polyols) are not reactive, and are considered to be of low risk. Polyols occur naturally in the body and also include starch and cellulose.  Studies indicate that diets containing large amounts of non-absorbable polysaccharides, such as cellulose, might decrease absorption of calcium, magnesium, zinc and phosphorus.  Limited evidence suggests that repeated or long-term occupational exposure may produce cumulative health effects involving organs or biochemical systems.  There is limited evidence that, skin contact with this product is more likely to cause a sensitization reaction in some persons compared to the general population.  There is some evidence to provide a presumption that human exposure to the material may result in impaired fertility on the basis of: some evidence in animal studies of impaired fertility in the absence of toxic effects, or evidence of impaired fertility occurring at around the same dose levels as other toxic effects but which is not a secondary non-  specific consequence of other toxic effects.  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.  Exposure to the material for prolonged periods may cause physical defects in the developing embryo (teratogenesis).  Inhalation studies indicate that cellulose fibres may be fibrogenic; this finding continues to be the subject of extensive research. Cellulose is not considered an inert substance because:  ·  in rats, it causes granulomatous fibrosing alveolitis at the end of the third month after exposure,  · in rats there was an increase in the secretion of plasminogen activator and interleukin 1 as well as the release of lactate dehydrogenase from macrophages, in a manner similar to asbestos,  · there were increases in the incidence of obstructive lung diseases and bronchial asthma in humans at work and in the residential environment where exposure to cellulose was common,  · the substance may induce free radical production in human leucocytes.  Cotton dust disease, "byssinosis", is well known among cotton mill workers. Cotton dust consists largely of cellulose fibre. Exposure to two components of the total dust, the "respirable" and "medium" fraction correlated significantly with the prevalence of respiratory symptoms. Inhalation exposure to a concentration of 0.3 to 0.4 mg/m3 of "fly-  free" dust results in a 20% occurrence of byssinosis. "Fly-free" dust is the sum of respirable and medium-length fibres. At 0.46 mg/m3, Grade II byssinosis occurs. A byssinosis (all grades) prevalence of 20%, at 0.3 mg/m3 occurs when the fibre length is less than 15 um (aerodynamic equivalent diameter). Byssinosis is not caused by mechanical irritation but by reactions caused by pharmacologically active substances producing oedema or contraction of the smooth musculature of the airways. The causative agent is suspected to be an endotoxin, in turn, thought to be a cell wall component of bacteria found in cotton. Symptoms of byssinosis include chest tightness, wheezing and dyspnoea. Symptoms usually appear after an absence from work and may subside after 2-days of exposure. As the disease progresses, symptoms may persist for longer periods until they are constant. The individual may eventually exhibit chronic bronchitis and emphysema. Increased physical exertion may produce shortness of breath.  Sensitization may result in allergic dermatitis responses includingrash, itching, hives or swelling of extremities.