Clindamycin Injection

Hazard statements (CLP)

H317, H319, H334, H373

Code

Statements

H317

May cause an allergic skin reaction

SECTION 2: Hazards identification

1999/45/EC EMERGENCY OVERVIEW

Product definition

Clindamycin Injection, USP is a solution containing clindamycin phosphate, a water soluble ester of the semi-synthetic antibiotic clindamycin. Clinically, it is intended for oral, parenteral, and topical use and indicated for the treatment of serious respiratory tract infections, pelvic inflammatory disease, bacterial vaginosis, hematogenous osteomycelitis and endocarditis.

Health hazards

This material should be considered a potential sensitizer and potentially irritating to the skin, eyes, and respiratory tract. Based on clinical use, possible target organs include the gastrointestinal system, blood, liver, kidneys, and skin. Flammability Hazards: This product is non-flammable. Reactivity Hazards: None known

Environmental hazards

The Environmental effects of this product have not been investigated. Release of this product is not expected to have significant adverse effects in the aquatic environment. US DOT SYMBOLS

Signal word

Danger!

Classification according to GHS

Eye Irritant Category 2 Skin Sensitizer Category 1 Respiratory Sensitizer Category 1 STOT RE Category 2

Precautionary statements

H319: Causes serious eye irritation P260: Do not breathe vapor or spray. H317: May cause an allergic skin reaction P264: Wash skin after handling. H334: May cause allergy or asthma symptoms or breathing P2280: Wear protective gloves difficulties if inhaled H373: Causes damage to organs through prolonged or repeated exposure 2.3 HEALTH HAZARDS OR RISKS FROM EXPOSURE: SYMPTOMS OF OVEREXPOSURE BY ROUTE OF EXPOSURE: The most significant routes of exposure for this product are by skin or eye contact, inhalation and ingestion. ACUTE: INHALATION: Inhalation of vapor or spray may cause irritation with possible allergic reaction. CONTACT WITH SKIN: Contact with the skin during product use may cause irritation. Possible allergic reaction. May be absorbed through skin and cause target organ damage. EYE CONTACT: Contact may irritate the eyes, resulting in redness or watering. INGESTION: May be absorbed following ingestion and cause target organ effects. CHRONIC: Contains a chemical or chemicals which cause target organ damage. TARGET ORGANS Acute Eyes, Skin, Respiratory System Chronic: Blood, Liver, Kidney, Skin

2.1 Classification of the substance or mixture

EUROPEAN UNION DIRECTIVES: This product does meet the definition of a hazardous substance or preparation as defined by 29 CFR 1910.1200 and the European Union Council Directives 67/548/EEC, 1999/45/EC, 1272/2008/EC and subsequent Directives. EU HAZARD CLASSIFICATION OF INGREDIENTS PER DIRECTIVE 1272/2008/EC: Index Number: EC# 246-433-0 This substance is not classified in the Annex VI of Directive 67/548/EEC Substances not listed either individually or in group entries must be self classified. Component(s) Contributing to Classification(s) Clindamycin Phosphate