Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

USP MITOXANTRONE SYSTEM SUITABILITY MIXTURE RS

NFPA

PRODUCT USE

Antineoplastic.

SYNONYMS

antineoplastic, reference, standard

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

Harmful if swallowed.
Toxic in contact with skin.
Irritating to eyes.
May cause CANCER.
May cause heritable genetic damage.
May cause harm to breastfed babies.

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.  The killing action of antineoplastic drugs used for cancer chemotherapy is not selective for cancerous cells alone but affect all dividing cells. Acute side effects include loss of appetite, nausea and vomiting, allergic reaction (skin rash, itch, redness, low blood pressure, unwellness and anaphylactic shock) and local irritation. Gout and renal failure can occur.  

EYE

  This material can cause eye irritation and damage in some persons.  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

  Skin contact with the material may produce toxic effects; systemic effectsmay result following absorption.  Skin contact with the material may be harmful; systemic effects may resultfollowing absorption.  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 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 dusts, or fume, especially for prolonged periods, may produce respiratory discomfort and occasionally, distress.  Anthracyclines, which are used in chemotherapy, has been shown to cause nausea and vomiting, suppression of bone marrow, inflammation of the oral cavity, hair loss and leukemia. It is also toxic to the heart, causing changes in the ECG and heart failure can result later, after months of treatment.  

CHRONIC HEALTH EFFECTS

  There is ample evidence that this material can be regarded as being able to cause cancer in humans based on experiments and other information.  Based on experiments and other information, there is ample evidence to presume that exposure to this material can cause genetic defects that can be inherited.  

  Anti-cancer drugs used for chemotherapy can depress the bone marrow with reduction in the number of white blood cells and platelets and bleeding. Susceptibility to infections and bleeding is increased, which can be life- threatening. Digestive system effects may include inflammation of the mouth cavity, mouth ulcers, esophagus inflammation, abdominal pain and bleeds, diarrhea, bowel ulcers and perforation. Reversible hair loss can result and wound healing may be delayed. Long-term effects on the gonads may cause periods to stop and inhibit sperm production. Most anti-cancer drugs can potentially cause mutations and birth defects, and coupled with the effects of the suppression of the immune system, may also cause cancer.  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 has been concern that this material can cause cancer or mutations, but there is not enough data to make an assessment.  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 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).  The inhibitory effects of the aminoglycoside antibiotics on calcium ion homeostasis in peripheral neurones, vascular smooth muscle and the myocardium are thought to be the cause of disruption to haemodynamic control mechanisms. Therefore the adverse effect of aminoglycosides on blood circulation does not seem to be due to cytotoxic damage of cardiovascular tissues but is related to a reversible interaction with calcium ion binding sites of excitable membranes. Many of the biological actions of aminoglycosides in mammals, including cellular damage of the kidney an inner ear tissues, are also associated with disturbance of membrane phospholipids where calcium ion is normally distributed. Kerzee, J. Kevin et al: Cardiovascular Toxicology, Part 7, Third Edition; Edited Daniel Acosta Jr.; Published Taylor and Francis 2001.