Hazardous Materials

Section 1: Identification

Name: VARENICLINE

MEDICATION
Nicotinic Agonists[National Library of Medicine's Medical Subject Headings. Varenicline. Online file (MeSH, 2014). Available from, as of December 18, 2014: http://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html]

Section 2: Hazard(s) Identification

Signal Word(s): Warning

Section 3: Composition/Information on Ingredients

Name: VARENICLINE

CAS Registry Number: 249296-44-4

UNII: W6HS99O8ZO

6,10-Methano-6H-pyrazino(2,3-h)(3)benzazepine, 7,8,9,10-tetrahydro-[National Library of Medicine, SIS; ChemIDplus Lite Record for Varenicline (249296-44-4). Available from, as of December 30, 2014: http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp]
7,8,9,10-Tetrahydro-6,10-methano-6H-pyrazino(2,3-h)(3)benzazepine[National Library of Medicine, SIS; ChemIDplus Lite Record for Varenicline (249296-44-4). Available from, as of December 30, 2014: http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp]
5,8,14-Triazatetracyclo(10.3.1.0(2,11).0(4,9))hexadeca-2(11)-3,5,7,9-pentaene[O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Cambridge, UK: Royal Society of Chemistry, 2013., p. 1844]
UNII-W6HS99O8ZO[National Library of Medicine, SIS; ChemIDplus Lite Record for Varenicline (249296-44-4). Available from, as of December 30, 2014: http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp]

Section 4: First-Aid Measures

Section 5: Fire-Fighting Measures

Advice for firefighters: Wear self contained breathing apparatus for fire fighting if necessary.[Sigma-Aldrich; Material Safety Data Sheet for Varenicline tartrate, Product Number: PZ0004, Version 5.3 (Revision Date 08/01/2014). Available from, as of September 2, 2015: http://www.sigmaaldrich.com/safety-center.html]

Suitable extinguishing media: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.[Sigma-Aldrich; Material Safety Data Sheet for Varenicline tartrate, Product Number: PZ0004, Version 5.3 (Revision Date 08/01/2014). Available from, as of September 2, 2015: http://www.sigmaaldrich.com/safety-center.html]

Section 6: Accidental Release Measures

ACCIDENTAL RELEASE MEASURES. Personal precautions, protective equipment and emergency procedures: Use personal protective equipment. Avoid dust formation. Avoid breathing vapours, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Avoid breathing dust.; Environmental precautions: Prevent further leakage or spillage if safe to do so. Do not let product enter drains. Discharge into the environment must be avoided.; Methods and materials for containment and cleaning up: Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal.[Sigma-Aldrich; Material Safety Data Sheet for Varenicline tartrate, Product Number: PZ0004, Version 5.3 (Revision Date 08/01/2014). Available from, as of September 2, 2015: http://www.sigmaaldrich.com/safety-center.html]

Section 7: Handling and Storage

Respiratory protection: For nuisance exposures use type P95 (US) or type P1 (EU EN 143) particle respirator.For higher level protection use type OV/AG/P99 (US) or type ABEK-P2 (EU EN 143) respirator cartridges. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).[Sigma-Aldrich; Material Safety Data Sheet for Varenicline tartrate, Product Number: PZ0004, Version 5.3 (Revision Date 08/01/2014). Available from, as of September 2, 2015: http://www.sigmaaldrich.com/safety-center.html]
Body Protection: impervious clothing, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.[Sigma-Aldrich; Material Safety Data Sheet for Varenicline tartrate, Product Number: PZ0004, Version 5.3 (Revision Date 08/01/2014). Available from, as of September 2, 2015: http://www.sigmaaldrich.com/safety-center.html]
Skin protection: Handle with gloves.[Sigma-Aldrich; Material Safety Data Sheet for Varenicline tartrate, Product Number: PZ0004, Version 5.3 (Revision Date 08/01/2014). Available from, as of September 2, 2015: http://www.sigmaaldrich.com/safety-center.html]
Eye/face protection: Safety glasses with side-shields conforming to EN166 Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).[Sigma-Aldrich; Material Safety Data Sheet for Varenicline tartrate, Product Number: PZ0004, Version 5.3 (Revision Date 08/01/2014). Available from, as of September 2, 2015: http://www.sigmaaldrich.com/safety-center.html]

Section 8: Exposure Controls/Personal Protection

Section 9: Physical and Chemical Properties

211.27[O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Cambridge, UK: Royal Society of Chemistry, 2013., p. 1844]

pKa1 = 1.82 (amine); pKa2 = 9.73 (secondary amine) (est)[ChemSpider; Varenicline. (249296-44-4) CSID: 148958. London, UK: Royal Chemical Society. Available from, as of Feb 13, 2015: http://www.chemspider.com/Search.aspx]

log Kow = 1.03 (est)[US EPA; Estimation Program Interface (EPI) Suite. Ver. 4.11. Nov, 2012. Available from, as of Feb 13, 2015: http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm]

In water, 5.15X10+4 mg/L at 25 deg C (est)[US EPA; Estimation Program Interface (EPI) Suite. Ver. 4.11. Nov, 2012. Available from, as of Feb 13, 2015: http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm]

4.65X10-6 mm Hg at 25 deg C (est)[US EPA; Estimation Program Interface (EPI) Suite. Ver. 4.11. Nov, 2012. Available from, as of Feb 13, 2015: http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm]

White to off-white to slightly yellow solid; highly soluble in water /Verencline tartrate/[O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. Cambridge, UK: Royal Society of Chemistry, 2013., p. 1844]

Henry's Law constant = 2.68X10-11 atm-cu m/mol at 25 deg C (est)[US EPA; Estimation Program Interface (EPI) Suite. Ver. 4.11. Nov, 2012. Available from, as of Feb 13, 2015: http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm]

Hydroxyl radical reaction rate constant = 3.77X10-11 cu cm/molec-sec at 25 deg C (est)[US EPA; Estimation Program Interface (EPI) Suite. Ver. 4.11. Nov, 2012. Available from, as of Feb 13, 2015: http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm]

Section 10: Stability and Reactivity

Stable under recommended storage conditions.[Sigma-Aldrich; Material Safety Data Sheet for Varenicline tartrate, Product Number: PZ0004, Version 5.3 (Revision Date 08/01/2014). Available from, as of September 2, 2015: http://www.sigmaaldrich.com/safety-center.html]

Hazardous decomposition products: Hazardous decomposition products formed under fire conditions. - Carbon oxides, nitrogen oxides (NOx)[Sigma-Aldrich; Material Safety Data Sheet for Varenicline tartrate, Product Number: PZ0004, Version 5.3 (Revision Date 08/01/2014). Available from, as of September 2, 2015: http://www.sigmaaldrich.com/safety-center.html]

Section 11: Toxicological Information

All references are peer reviewed