Note: Ingredients listed on restricted chemical lists
EC/CAS
203-632-7/108-95-2
Name of the chemical
Phenol
Concentration
0.1-0.3%
General Information
Version
3.0.0
Revision date
2018-07-17
Product name
Aplisol
Product Synonyms
Tuberculin PPD, Diluted
Chemical name
Mixture - contains tuberculin purified protein derivative
1.2.1 Relevant identified uses
Bulk formulated pharmaceutical mixture product packaged in final form for patient of the substance or
Emergency telephone
+1 (800) 424-9300, +1 (703) 527-3887
Icons in SDS
Company Information
company name
drugsafety@parpharm.com
e-mail address of the competent person responsible for the Safety Data Sheet
drugsafety@parpharm.com
GHS Information
Signal word
Danger
Hazard Codes
Hazard statements (CLP)
H317, H334
Hazard statements
Code
Statements
H317
May cause an allergic skin reaction
Section 2
SECTION 2: Hazards identification
WHMIS 2015 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 Globally Harmonized System [GHS] Skin sensitizer - Category 1. Respiratory sensitizer - Category 1 HAZARDS IDENTIFICATION …continued
Signal word
Danger
Hazard statements
H334 - May cause allergy or asthma symptoms or breathing difficulties if inhaled. H317 - May cause allergic skin reaction. 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.
Precautionary statements
P261 - Avoid breathing mist or vapor. P272 - Contaminated work clothing should
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 ingestion is low, due to the rapid breakdown of proteins in the digestive tract. 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. Note This mixture is classified as hazardous under GHS as implemented by Regulation
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