Section 1 - CHEMICAL PRODUCT AND COMPANY IDENTIFICATION

PRODUCT NAME

RANITIDINE IMPURITY B CRS

NFPA

PRODUCT USE

Synthesis or degradation product of ranitidine. Ranitidine is used for the management of
duodenal and gastric ulcers, in reflux oesophagitis, in pathological hypersecretion (e.g.
Zollinger- Ellison syndrome), and for stress- related ulceration of the upper
gastrointestinal tract. Ranitidine is a histamine H2- receptor antagonist which inhibits
gastric acid secretion and reduces pepsin output.

SYNONYMS

C10-H18-N2-O-S, C10-H18-N2-O-S, "gastrointestinal agent"

Section 2 - HAZARDS IDENTIFICATION

CANADIAN WHMIS SYMBOLS

None

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.  Considered an unlikely route of entry in commercial/industrial environments.  H2-receptor antagonist antihistamines, such as Ranitidine (Zantac), can change the heart rate, cause a rash, blisters and redness, skin death and inflammation.  

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).  

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.  

INHALED

  Inhalation may produce health damage*.  The material is not thought to produce respiratory irritation (as classified using animal models). Nevertheless inhalation of the material, especially for prolonged periods, may produce respiratory discomfort and occasionally, distress.  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 usually by skin contact/absorption and inhalation of generated dust.  No human exposure data available. For this reason health effects described are based on experience with chemically related materials.  As with any chemical product, contact with unprotected bare skin; inhalation of vapor, mist or dust in work place atmosphere; or ingestion in any form, should be avoided by observing good occupational work practice.