Aplisol

Hazard statements (CLP)

H317, H334

Code

Statements

H317

May cause an allergic skin reaction

SECTION 2: Hazards identification

GHS Classification Classification of the substance or mixture Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labeling listed below is for bulk Aplisol® Tuberculin Purified Protein Derivative, Diluted [Stabilized Solution] 5TU/0.1 ml) in multi-dose vials HAZARDS IDENTIFICATION …continued Regulation (EC) 1272/ 2008 [GHS] Skin sensitizer - Category 1. Respiratory sensitizer - Category 1 Directive 67/548/EEC Xn - R42/R43 or 1999/45/EC

2.2 Label elements

CLP/GHS hazard

Signal word

Danger CLP/GHS hazard H334 - May cause allergy or asthma symptoms or breathing difficulties if inhaled US Hazard overview Danger Contains a purified protein. May cause an allergic respiratory reaction. May cause an allergic skin reaction. Note This mixture is classified as dangerous according to directive 1999/45/EC,

Hazard statements

H317 - May cause allergic skin reaction. CLP/GHS P261 - Avoid breathing mist or vapor. P272 - Contaminated work clothing should

Precautionary statements

not be allowed out of the workplace. P280 - Wear eye/face protection. P285 - In case of inadequate ventilation wear respiratory protection. P304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. P342 + P311 - If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. P302 + P352 - IF ON SKIN: Wash with plenty of soap and water. P333 + P313 - If skin irritation or rash occurs: Get medical advice/attention. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations. EU symbol/indication of danger Xn - Harmful Risk (R) Phrase(s) R42/43 - May cause sensitization by inhalation and skin contact. S23 - Do not breathe vapor/spray. S24 - Avoid contact with skin. S36/37 - Wear suitable protective clothing and gloves. S63 - In case of accident by inhalation: remove casualty to fresh air and keep at rest.

2.3 Other hazards

Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction isolated from a human strain of Mycobacterium tuberculosis for intradermal administration as an aid in the diagnosis of tuberculosis. Common adverse effects associated with use include local, as well as, systemic hypersensitivity reactions (redness, rash, swelling, itching, anaphylaxis). In a workplace setting, the likelihood of systemic effects following accidental SECTION 2 - HAZARDS IDENTIFICATION …continued

Other hazards

ingestion is low, due to the rapid breakdown of proteins in the digestive tract. …continued Although purified protein particles are fairly large in size, it is not known if systemic effects can occur following accidental inhalation. Proteins, in general, can cause skin and/or respiratory sensitization.

2.1 Classification of the substance or mixture

Drugs in the finished state and intended for the final user are not subject to substance or mixture