MATERIAL SAFETY DATA SHEET

GXSD/90/0001-1

GXSD/90/0001-1

 

SECTION I: IDENTIFICATION

 

 

BW Intermediate Names: BUPA: BUPB: BUPC: BUPD: BUPE: GUPG: BUPH.              Product Name: Wellbutrin

 

Chemical Name:    1-(3-Chlorophenyl)—[(1,1-dimethylethyl)amino]-1-propanone hydrochlroide

 

Formula:  C13H18ClNO-HCl

 

Generic Name: Bupropion hydrochloride

 

For Information on Health Hazards Call: Ext. 77014

 

Information Effective: 07/14/93

 

 

SECTION II: HAZARDOUS INGREDIENTS OF MIXTURES

 

 

Principal Hazardous Component(s): Bupropion hydrochloride

 

Toxicity: Oral LD50 (Male Rate = 606.9 ± 51 mg/kg.1

            Oral LD50 (Female Rat) = 481.7 ± 91 mg/kg.1

            Oral LD50 (Male Mice) = 544 ± 29 mglkg.1

            Oral LD50 (Female Mice) = 636 ± 23 mg/kg.1

            Intraperitoneal LD50 (Rat) = 263 ± 18mg/kg.1

 

Chronic Toxicity: Oral dose of up 300 mg/kg/day in rats for 55 weeks and 150-200 mg/kg in dogs for 26 weeks are well tolerated.  A dose related increase in liver growth, considered to be related to enzyme induction and not a toxic effect was noted in some treated animals.1

 

NOTE: Crude products may contain trace amounts of starting materials

 

 

GCPV/93/0011/03                                  29

 

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