Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

OESTRADIOL UNDECANOATE

NFPA

PRODUCT USE

Oestradiol is used in replacement therapies in deficiency states, for the treatment of
conditions such as primary amenorrhoea, delayed onset of puberty, and the management of
menopausal syndrome. Also used for the treatment of malignant neoplasms of the prostate
and of the breast of menopausal women. Oestradiol is administered as tablets, implants, by
intramuscular injection or topically. Oestradiol is the most active of the naturally
occurring oestrogenic hormones formed in the ovarian follicles under the influence of the
pituitary. The hormone controls the development and maintenance of female sex organs,
secondary sex characteristics, the mammary glands, functions of the uterus and accessory
organs, and the cyclic changes in the cervix and vagina. Low physiological amounts
stimulate the gonadotrophic and lactogenic activities of the anterior pituitary whilst
large amounts are inhibitory. In late pregnancy oestradiol increases the spontaneous
activity of the uterine muscle and its response to oxytocic drugs.

SYNONYMS

C29-H44-O3, "estradiol undecanoate", "beta-estradiol undecanoate", "beta-oestradiol
undecanoate", "oestradiol undecylate", "SQ 9993", "estra-1, 3, 5(10)-triene-3, 17beta-
diol 17-undecanoate", "estra-1, 3, 5(10)-triene-3, 17beta-diol 17-undecanoate", Progynon-
Retard, Progynon-Depot, "sex hormone/ oestrogen/ estrogen steroid"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Although ingestion is not thought to produce harmful effects, the material may still be damaging to the health of the individual following ingestion, especially where pre-  existing organ (e.g. liver, kidney) damage is evident. Present definitions of harmful or toxic substances are generally based on doses producing mortality (death) rather than those producing morbidity (disease, ill-health). Gastrointestinal tract discomfort may produce nausea and vomiting. In an occupational setting however, ingestion of insignificant quantities is not thought to be cause for concern.  The estrogens may produce dose-related nausea and vomiting, undesirable uterine growth, proliferation and withdrawal bleeding or loss of periods. It causes enlargement of the breasts in males. Other side effects include weight gain, swelling, breast tenderness, liver dysfunction, jaundice, depression, headache, and dizziness. Growth may be stunted due to premature closing of the growth plates. Skin reactions can include excess pigmentation of the face, rashes, and hives. Redness, itching and blistering has also been reported.  

EYE

  Although the material is not thought to be an irritant, direct contact with the eye may produce transient discomfort characterized by tearing or conjunctival redness (as with windburn).  The dust may produce eye discomfort causing smarting, pain and redness.  

SKIN

  Skin contact with the material may damage the health of the individual; systemic effects may result following absorption.  The material is not thought to be a skin irritant (as classified using animal models). Temporary discomfort, however, may result from prolonged dermal exposures. Good hygiene practice requires that exposure be kept to a minimum and that suitable gloves be used in an occupational setting.  Toxic effects may result from skin absorption.  

INHALED

  The material is not thought to produce adverse health effects or irritation of the respiratory tract (as classified using animal models). Nevertheless, 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.  

CHRONIC HEALTH EFFECTS

  Principal routes of exposure are by accidental skin and eye contact andinhalation of generated dusts.  When administered orally to female mice, oestradiol induced increased adenocarcinomas of the mammary gland, cervix and uterus, and osteosarcomas of the cranium and adenoacanthomas of the uterus. Subcutaneous or intramuscular injection induced increased incidences of lymphosarcomas in mice of both sexes. Subcutaneous implants induced mammary tumours, including adenocarcinomas, papillary carcinomas and anaplastic carcinomas in adult and newborn male and female mice and female rats; pituitary chromophobe adenomas in male rats, fibromyomas of the uterus, mesentary and abdomen in female guinea pigs; and malignant tumours in hamsters of both sexes.  Long term administration of estrogens can greatly increase the risk of endometrial cancer,  especially after menopause. Males exposed can develop enlarged breasts and other feminizing effects, nipple pigmentation, withering of testicles, sterility, impotence and altered distribution of hair. Females exposed can develop breast enlargement and menstrual disorders and other effects on the reproductive system. Children born to exposed mothers can show breast enlargement in boys and early puberty in girls. Children who are themselves exposed may develop increased rate of bone maturation (leading to reduced final stature), strong pigmentation of the sexual organs and feminizing syndrome. Exposure before birth may be associated with limb defects and congenital heart deformities. Repeated swallowing can cause nausea, vomiting, abdominal cramps, loss of appetite, bowel inflammation, headache, dizziness, irritability, depression, general unwellness, involuntary jerky movements and convulsions. Swelling, weight change, increased blood pressure and risk of clotting, liver abnormalities, uremia have all been reported. Long-term users may also show an increased risk of developing gallstones, increased blood fats, acute pancreas inflammation and aggravation of porphyria. The eye may develop damage, increased corneal curvature with contact lens intolerance. Skin effects include itching, hives, inflammation, increased pigmentation, sensitivity to light, loss of scalp hair and hairiness. Allergic reactions include a red rash and jaundice. Susceptibility to Candida infections and changes to sex drive may occur. Application of estrogen-containing cream had produced breast enlargement.