Additional Toxicity
Information
The following table contains
mammalian toxicity data for bupropion hydrochloride.
|
Lethal Doses in Animals |
|
|
LD50
(male mice) |
544
mg/kg (20) |
|
LD50
(female mice) |
636
mg/kg (20) |
|
LD50
(male rate) |
607
mg/kg (20) |
|
LD50
(female rat) |
482
mg/kg (20) |
|
Intraperitoneal
LD50 (rat) |
263
mg/kg (20) |
|
Oral
LD50 (rat) |
482
mg/kg (21) |
|
Intraperitoneal
LD50 (rat) |
210
mg/kg (22) |
|
Oral
LD50 (mouse) |
544
mg/kg (21) |
|
Intraperitoneal
LD50 (mouse) |
230
mg/kg (22) |
The lowest toxicity measure available is the
intraperitoneal LD50 for rats: LD50 = 210 ppm.
Summary
The calculated EEC (see information in CONFIDENTIAL Appendix
B) (NOT PROVIDED THROUGH FOI ACT) in the aquatic compartment is
compared to 1% of 210 ppm, that is 2.10 ppm.
the calculated EEC is much lower than 2.10 ppm. No further testing should be required based
upon the low toxicity and the efficient removal mechanism of photodegradation.
9.
USE OF RESOURCES AND ENERGY
9.a Use of Water and Energy:
Drug Substance
Water used during manufacture of the drug substance
is supplied from the Greenville Utilities Commission water treatment plant, which
draws its raw water supply from the Tar River.
The amount of water used during manufacture, including process water and
water for waste disposal is slightly less than 0.08% of total plant use per
year. Annual energy use during
manufacture of bupropion hydrochloride will constitute approximately 12% of
total plant consumption. Waste disposal
will also account for approximately 0.75% of natural gas usage (firm gas).
Drug Product
Water used during product formulation, including
disposal is supplied from the Greenville Utilities Commission water treatment
plant, which draws it
GCPV/93/0011/03 14
Back a Page
Next Page
Back to Wellbutrin SRŪ NDA Index Page
Back to Main
Index