FLUCONAZOLE

SECTION 2: Hazards identification

Classification of the substance or mixture Chemwatch Hazard Ratings Min Max Flammability: 1 Toxicity Min/Nil=0 Body Contact: 0 Low=1 Reactivity Moderate= Chronic High=3 Extreme=4

2.2 Label elements

Emergency overview Risk Harmful if swallowed. Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment. Limited evidence of a carcinogenic effect*. May possibly affect fertility*. May possibly be harmful to the foetus/embryo*. * (limited evidence).

Hazard statements

Not Known

Precautionary statements

Not Known

Potential Acute Health Effects

Eye:  Although the material is not thought to be an irritant (as classified by EC Directives), 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 is not thought to produce harmful health effects (as classified under EC Directives using animal models). Systemic harm, however, has been identified following exposure of animals by at least one other route and the material may still produce health damage following entry through wounds, lesions or abrasions. Good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  Open cuts, abraded or irritated skin should not be exposed to this material.  Entry into the blood-stream through, for example, cuts, abrasions, puncture wounds 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. Ingestion:  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.  Aromatase inhibitors (including triazoles and azoles) produce several side effects including mood swing, depression, weight gain, hot flushes, vaginal dryness, bloating, early onset of menopause. Long-term use may result in bone weakness, increased risk of blood clots, gastrointestinal disturbance,and sweats. Aromatase inhibitors lower the level of oestrogen in post-menopausal women who have hormone-receptor-positive breast cancers. Prior to menopause oestrogen is mostly produced in the ovaries. Post-menopausal women produce oestrogen from another hormone, androgen. Aromatase inhibitors prevent the enzyme, aromatase from catalysing this reaction. Breast cancer cell growth in post-menopausal women is stimulated by oestrogen. Inhalation:  The material is not thought to produce either adverse health effects or irritation of the respiratory tract following inhalation (as classified by EC Directives using animal models). Nevertheless, adverse systemic effects have been produced following exposure of animals by at least one other route and 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. If prior damage to the circulatory or nervous systems has occurred or if kidney damage has been sustained, proper screenings should be conducted on individuals who may be exposed to further risk if handling and use of the material result in excessive exposures.

Potential chronic health

There has been some concern that this material can cause cancer or mutations but there is not enough data to make an assessment. Based on experience with similar materials, there is a possibility that exposure to the material may reduce fertility in humans at levels which do not cause other toxic effects. Based on experience with animal studies, there is a possibility that exposure to the material may result in toxic effects to the development of the foetus, at levels which do not cause significant toxic effects to the mother. Azole fungicides show broad antifungal activity, and can be used to prevent or cure fungal infections. They are therefore important in agricultural production. They work by blocking the assembly of the cell membrane of fungi. Animal testing has shown inconclusive results regarding the effect of this group of fungicides on the reproductive organs in mammals. Extensive studies suggest that triazole pesticides may induce liver tumours. Administration to rats produced an increased incidence of hepatocellular adenomas. Administration to pregnant rabbits produced reduced maternal weight gain, increases in foetal anatomical variants and delayed foetal ossification. Doses of 20-60 times the recommended human level, produced abortion.

2.1 Classification of the substance or mixture

Chemwatch Hazard Ratings Min Max Flammability: 1 Toxicity: 2 Min/Nil=0 Body Contact: 0 Low=1 Reactivity: 1 Moderate= Chronic: 0 2 High=3 Extreme=4