Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

P-AMINOCLONIDINE HYDROCHLORIDE

NFPA

PRODUCT USE

Partial agonist for alpha2- adrenergic receptors. Used in the treatment of post- surgical
elevated intraocular pressure. When instilled into the eye reduces elevated as well as
normal intraocular pressure (IOP) whether or not accompanied by glaucoma.

SYNONYMS

C9-H10-Cl2-N4.HCl, "1, 4-benzenediamine, 2, 6-dichloro-N(sup 1)-(4, 5-dihydro-1H-
imidazol-2-yl)-, monohydrochloride", "1, 4-benzenediamine, 2, 6-dichloro-N(sup 1)-(4, 5-
dihydro-1H-imidazol-2-yl)-, monohydrochloride", "2-(4-amino-2, 6-dichloroanilino)-2-
imidazoline hydrochloride", "2-(4-amino-2, 6-dichloroanilino)-2-imidazoline
hydrochloride", "2-(4-amino-2, 6-dichlorophenylimino)imidazoline hydrochloride", "2-(4-
amino-2, 6-dichlorophenylimino)imidazoline hydrochloride", "2, 6-dichloro-N(sup 1)-(4, 5-
dihydro-1H-imidazol-2-yl)-1, 4-benzenediaminemonohydrochloride", "2, 6-dichloro-N(sup 1)-
(4, 5-dihydro-1H-imidazol-2-yl)-1, 4-benzenediaminemonohydrochloride", "2, 6-dichloro-
N(sup 1)-(2-imidazolidinylidene)-1, 4-benzenediaminehydrochloride", "2, 6-dichloro-N(sup
1)-(2-imidazolidinylidene)-1, 4-benzenediaminehydrochloride", "3, 5-dichloro-4-(2-
imidazolidinylideneimino)aniline hydrochloride", "3, 5-dichloro-4-(2-
imidazolidinylideneimino)aniline hydrochloride", "clonidine hydrochloride, p-amino-",
"clonidine hydrochloride, p-amino-", "aplonidine hydrochloride", ALO-2145,
"Apraclonidine hydrochloride", "Iopidine ophthalmic solution", "NC-14 hydrochloride"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

EMERGENCY OVERVIEW

RISK

Toxic if swallowed.

POTENTIAL HEALTH EFFECTS

ACUTE HEALTH EFFECTS

SWALLOWED

  Toxic effects may result from the accidental ingestion of the material; animal experiments indicate that ingestion of less than 40 gram may be fatal or may produce serious damage to the health of the individual.  Sympathomimetics, which mimic stimulation of the sympathetic nerves, causing a stimulatory effect on the heart and central nervous system, constriction of blood vessels supplying the skin and mucous membranes, dilation of blood vessels supplying muscles of movement, and widening of the airways. These drugs may act on the receptor or the release of the neurotransmitter noradrenaline. Central nervous effects include fear (feeling of "impending disaster"), anxiety, restlessness, tremor, sleep disturbance, confusion, irritability, weakness and hallucinations. There can be nausea and vomiting, loss of appetite, problems with urination, shortness of breath, disturbance in glucose levels and acid-base balance, sweating, excess saliva production and headache. Cardiovascular effects include changes in heart rate, irregularities in heart rhythm, low blood pressure with dizziness, fainting and flushing, or high blood pressure. Aerosols may cause death due to irregularities in the rhythm of the ventricles (two of the four chambers of the heart). Inhaling the material may cause death of heart tissue and heart attack.  

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).  Allergic reactions of the conjunctiva (blepharoconjunctivitis) are often a result of interaction of the allergen with antibodies of the IgE class.  

SKIN

  The material is not thought to produce adverse health effects or skin irritation following contact (as classified using animal models). Nevertheless, 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.  

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.  No significant change in tumour incidence or type was seen following two  years oral administration of the drug to rats and mice at 1, 0.6 mg/kg (20  and 12 times respectively, the maximum dose recommended for human topical  ocular use). The drug was not mutagenic in a series of in vitro  mutagenicity tests including the Ames test, a mouse lymphoma forward  mutation assay, a chromosome aberration assay in cultured Chinese hamster  ovary (CHO) cells, a sister chromatid exchange assay in CHO cells and a  cell transformation assay. An in vivo mouse micronucleus assay also was  negative.  Reproduction and fertility studies in rats showed no adverse effects on  male or female fertility at a dose of 0.5 mg/kg (5-10 times the maximum  recommended human dose.  The material was embryocidal in rabbits when given as an oral dose of 3  mg/kg (60 times the maximum recommended human dose).