Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

OESTRIOL 16ALPHA-(BETA-D-GLUCURONIDE), SODIUM SALT

NFPA

PRODUCT USE

Oestriol 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. Other uses include the treatment of malignant neoplasms of the
prostate and of the breast of menopausal women. Normally administered by mouth. Oestriol
is a naturally occurring oestrogenic hormone claimed to have a selective action on the
cervix and vagina and to have little effect on the endometrium. 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 cyclic changes in the
cervix and vagina. Obtained from human placental tissue and urine of pregnant women. A
metabolite of 17beta- oestradiol with a much lower activity, it is the primary oestrogen
found in the urine. Large quantities of oestriol and oestrone are produced by the placenta
during pregnancy. These are also the primary oestrogens produced by the adipose tissue in
men and in post- menopausal women.

SYNONYMS

C24-H31-O9.Na, "16alpha-(beta-D-glucuronide), sodium salt of:", "16alpha-(beta-D-
glucuronide), sodium salt of:", "1, 3, 5(10)-estratrien-3, 16alpha, 17beta-triol",
"estra-1, 3, 5(10)-triene-3, 16-alpha, 17-beta-triol", "estra-1, 3, 5(10)-triene-3, 16-
alpha, 17-beta-triol", "1, 3, 5-estratriene-3-beta, 16-alpha, 17-beta-triol", "1, 3, 5-
estratriene-3-beta, 16-alpha, 17-beta-triol", "(16alpha, 17beta)-estra-1, 3, 5(10)-
triene-3, 16, 17-triol", "(16alpha, 17beta)-estra-1, 3, 5(10)-triene-3, 16, 17-triol",
estriol, estratriol, "3, 16-alpha, 17beta-estratriol", "3, 16-alpha, 17beta-estratriol",
"16alpha, 17beta-estratriol", "follicular hormone hydrate", 16alpha-hydroxyestradiol,
16alpha-hydroxyoestradiol, "oestra-1, 3, 5(10)-triene-3, 16alpha, 17beta-triol",
"oestratriene-3beta, 16alpha, 17beta-triol", "(16alpha, 17beta)oestra-1, 3, 5(10)-triene-
3, 16, 17-triol", "(16alpha, 17beta)oestra-1, 3, 5(10)-triene-3, 16, 17-triol",
oestratriol, "3, 16-alpha, 17beta-oestriol", "3, 16-alpha, 17beta-oestriol", "16alpha,
17beta-oestriol", "3, 16alpha, 17beta-trihydroxy-delta-1, 3, 5-oestratriene", "3, 16alpha,
17beta-trihydroxy-delta-1, 3, 5-oestratriene", "3, 16alpha, 17beta-trihydroxyestra-1, 3,
5(10)-triene", trihydroxyestrin, trihydroxyoestrin, "sex hormone/ oestrogen/ estrogen
steroid"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

None

EMERGENCY OVERVIEW

RISK

Toxic to aquatic organisms, may cause long- term adverse effects in the aquatic
environment.

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Accidental ingestion of the material may be damaging to the health of the individual.  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 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

  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.  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.  

CHRONIC HEALTH 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 may cause concerns for human fertility, on the basis that similar materials provide some evidence 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 are not a secondary non-specific consequence of other toxic effects..  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.  Exposure to the material for prolonged periods may cause physical defects in the developing embryo (teratogenesis).  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.  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.