Chlormadinone Acetate

SECTION 2: Hazards identification

CHEMWATCH HAZARD RATINGS Min Max Flammability 1 Toxicity 2 Min/Nil=0 Body Contact 2 Low=1 Reactivity Moderate=2 1 High=3 Chronic 3 Extreme=4 CANADIAN WHMIS SYMBOLS EMERGENCY OVERVIEW RISK Danger of serious damage to health by prolonged exposure. Limited evidence of a carcinogenic effect. May impair fertility. May cause harm to the unborn child. Toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment.

Potential Acute Health Effects

SWALLOWED ■ Accidental ingestion of the material may be damaging to the health of the individual. ■ Oral contraceptives may produce side-effects as a result of altering the normal balance of oestrogenic and progestogenic effects. Such effects may include nausea, vomiting, chloasma and other skin and hair changes, headache, oedema, weight gain and breast tenderness. 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. SKIN ■ The material is not thought to be a skin irritant (as classified using animal models). Abrasive damage however, may result from prolonged exposures. ■ 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 ■ The material is not thought to produce either adverse health effects or irritation of the respiratory tract following inhalation (as classified using animal models). Nevertheless, adverse 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.

Potential chronic health

There has been concern that this material can cause cancer or mutations, but there is not enough data to make an assessment. This material can cause serious damage if one is exposed to it for long periods. It can be assumed that it contains a substance which can produce severe defects. Ample evidence exists from experimentation that reduced human fertility is directly caused by exposure to the material. Ample evidence exists, from results in experimentation, that developmental disorders are directly caused by human exposure to the material. 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. The use of oral contraceptives has been associated with an increased risk of thrombo-embolic and cardiovascular disease, related, at least in part, to the oestrogen content of combined oral contraceptives. An increased risk of the incidence of benign liver tumours, though marked, is thought to be rare. Large doses of chlormadinone acetate and megestrol acetate given to beagle dogs induced mammary tumours. This was not considered to be a useful indicator of carcinogenicity in women.