Toxicity of Active Materials

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In the preceding chapter, solubilities of the APIs were presented. Likewise, the toxicities of the same active materials are shown in the matrix below. Toxicity was taken from the material safety data sheets of the respective materials.

Active Ingredients

Toxicity

Activated attapulgite

Amphotericin

Acyclovir

Acebutolol hydrochloride Acetazolamide Albendazole Aluminum hydroxide Alprostadil

Alprenolol hydrochloride

Amantadine hydrochloride

Ambroxol hydrochloride

Amiodarone

Ammonium chloride

Amoxicillin

Ampicillin trihydrate

Amikacin sulfate

Aminophylline

Aspirin

Astemizole

Atropine sulfate

Atenolol

Azithromycin dihydrate Betamethasone valerate Bacitracin USP Bacampicillin hydrochloride Bisacodyl

Beclomethasone dipropionate

Nontoxic

LD50 88.0 g/kg intraperitoneal mouse

LD50 20.0 g/kg oral rat; LD50 10.0 g/kg oral mouse

LD50 6620.0 g/kg oral rat

LD50 4300 mg/kg oral mouse

LD50 2400.0 mg/kg oral rat

LD50 9500 mg/kg oral rat

LD50 186.0 mg/kg oral mouse

LD50 590.0 mg/kg oral rat

LD50 700.0 mg/kg oral mouse

LD50 13,400.0 mg/kg oral rat

LD50 2600.0 mg/kg oral rat

LD50 1650.0 mg/kg oral rat

LD50 15.0 g/kg oral rat; LD50 25 g/kg oral mouse

LD50 10,000 mg/kg oral rat

LD 5o >6000 mg/kg oral mouse

LD^ 243 mg/kg oral rat

LDjo 200 mg/kg oral rat

LD^ 2560.0 g/kg oral rat; LD50 2560.0 g/kg oral mouse

LD^ 600 mg/kg oral rat

LD^ 2000.0 mg/kg oral mouse/rat

LDjo 3.0 g/kg oral rat; LD50 4067 mg/kg oral mouse

LDjo 3750.0 mg/kg oral mouse

LDjo 10,000.0 g/kg oral rat

LDjc 4320 mg/kg oral rat

LDjc 3750.0 mg/kg oral rat

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Active Ingredients

Toxicity

Betaxolol hydrochloride

Bezafibrate

Benzocaine

Benzalkonium chloride Bromhexine HCl Bifonazole Budesonide

Buprenorphine hydrochloride Bufexamac

Bupivacaine hydrochloride

Calcium pantothenate

Caffeine

Carbamazepine

Carbinoxamine

Carbachol

Captopril

Carbidopa

Cetylpyridinium chloride

Calcitriol

Calcium ascorbate

Cinnarizine theophyllinate

Clobetasol propionate

Cephalexin monohydrate

Cefaclor monohydrate

Cefixime

Cefazolin sodium

Ceftazidime

Cefuroxime axetil

Cefotaxime

Ceftriaxone

Cetirizine HCl

Cephradine

Chlorpheniramine maleate

Chlorambucil

Chloramphenicol

Chlorcyclizine hydrochloride

Chlorhexidine

Chlorpromazine

Ciclopirox

Cimetidine

Cincochain HCl

Ciprofloxacin

LD50 998.0 mg/kg oral rat; LD50 48.0 mg/kg oral mouse

LD50 1082.0 mg/kg oral rat

LD50 1150.0 mg/kg oral rabbit

LD50 240.0 mg/kg oral rat

LD50 1226 mg/kg oral rat

LD50 1463.0 mg/kg oral rat; LD50 2629.0 mg/kg oral mouse LD50 4750.0 mg/kg oral mouse LD50 1000 mg/kg oral rat

LD50 3370.0 mg/kg oral rat; LD50 8000.0 mg/kg oral mouse

LD50 43 mg/kg subcutaneous rat

LD50 10 g/kg oral rat

LD50 127 mg/kg oral mouse

LD50 1957 mg/kg oral rat

LD50 162 mg/kg oral mouse

LD50 40.0 mg/kg oral rat; LD50 15.0 mg/kg oral mouse LD50 4245 mg/kg oral rat LD^ 1750 mg/kg oral mouse

LDjo 200.0 mg/kg oral rat; LD50 108.0 mg/kg oral mouse LDjo 0.62 mg/kg oral rat

LDjo 14,500.0 mg/kg oral rat; LD^, 1600.0 mg/kg oral mouse

LD^, 6500.0 g/kg oral rat; LD50 4500.0 mg/kg oral mouse

LDjo 3.0 g/kg oral rat; LD50 3.0 mg/kg oral mouse

LDjo 1495 mg/kg oral mouse

LDjo >20,000 g/kg oral rat

Nontoxic

LDjo 11,000.00 mg/kg oral rat LDjo >20,000 mg/kg oral rat LDjo 5000 mg/kg oral rat LDjo 20,000.00 mg/kg oral rat LDJ010.0 g/kg oral rat and oral mouse LDJ0 703.0 mg/kg oral rat LDJ0 5000 mg/kg oral mouse

LDJ0 130 mg/kg oral mouse; LD50 300 mg/kg oral rat LDJ0 80 mg/kg oral mouse; LDJ0 76 mg/kg oral rat LDJ0 2500 mg/kg oral rat; LDJ0 1500.0 mg/kg oral mouse LDJ0 300 mg/kg oral mouse LDJ0 9200 |iL/kg oral rat

LDJ0 145.0 mg/kg oral rat; LD50 135.0 mg/kg oral mouse LDJ0 2350 mg/kg oral rat LDJ0 5000 mg/kg oral rat LDJ0 42 mg/kg oral bird

LDJ0 5000 mg/kg oral rat; LDJ0 5000 mg/kg oral mouse

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Active Ingredients

Toxicity

Clarithromycin

LDjo 2700 mg/kg oral rat

Clavulanate potassium

LDjo 5000 mg/kg oral rat

Clobutinol HCl

LD^ 802 mg/kg oral rat

Codeine phosphate

LD50 85 mg/kg oral rat

Colchicine

LD50 5886 |ig/kg oral mouse

Cloxacillin sodium

LD50 5000 mg/kg oral rat

Cyanocobalamin

LD50 2 g/kg oral mouse

Cyclosporine

LD50 15,800 mg/kg oral rabbit

Dextromethorphan HBr

LD50 350 mg/kg oral rat

Diphenhydramine HCl

LD50 500 mg/kg oral rat

Diclofenac sodium

LD50 390 mg/kg oral mouse; LD50 150 mg/kg oral rat

Diflunisal

LD50 392 mg/kg oral mouse; LD50 439 mg/kg oral rat

Diethylcarbamazine citrate

LD^ 660 mg/kg oral mouse; LD50 1400 mg/kg oral rat

Dexpanthenol

LD^ 15,000 mg/kg oral mouse

Diazepam

LDjo 48 mg/kg oral mouse

Dimenhydrinate

LDjo 681 mg/kg oral rat

Diphenoxylate HCl

LDjo 221 mg/kg oral rat

Doxycycline hyclate

LDjo 1900.0 g/kg oral mouse

Ephedrine HCl

LDjo 710 mg/kg oral rat

Enalapril maleate

LDjo 2973 mg/kg oral rat

Erythromycin

LDjo 10.0 g/kg oral mouse

Etodolac

LDjo 95 mg/kg oral rat

Famotidine

LDjo 4049 mg/kg oral rat

Felodipine

LDjo 1050 mg/kg oral rat

Fenoprofen calcium

LDjo 439 mg/kg oral mouse; LD50 415 mg/kg oral rat

Fluxetine HCl

LDjo 452 mg/kg oral rat

Fluticasone propionate

LDjo 2000 mg/kg oral rat

Fluvoxamine maleate

LDjo 1100.0 mg/kg oral mouse

Flutamide

LDjo 787 mg/kg oral rat

Folic acid

LDjo 8000 mg/kg oral rat

Fusidic acid

LDjo 975.0 mg/kg oral mouse

Flunitrazepam

LDjo 415 mg/ kg oral rat

Flutamide

LDjo 787 mg/kg oral rat

Fluvoxamine maleate

LDjo 1100.0 mg/kg oral mouse

Ferrous sulfate (dried)

LDjo 1520 mg/kg oral mouse

Ferrous fumarate

LDjo 3850 mg/kg oral rat

Furosemide

LDjo 2600 mg/kg oral rat

Gemfibrozil

LDjo 1414 mg/kg oral rat

Ginseng

LDjo 750 mg/kg oral rat

Glibenclamide

LDjo >20,000 mg/kg oral rat

Gliclazide

LDjo 3000 mg/kg oral rat

Glycerin

LDjo 17 g/kg oral rat

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Active Ingredients

Toxicity

Glyceryl guaiacolate

Gramicidin

Heparin calcium

Hydrocortisone

Hyoscine-N-butyl bromide

Ibuprofen

Indapamide

Indomethacin

Kaopectate

Ketotifen fumarate

Ketoconazole

Lamotrigine

Lomefloxacin HCl

Loratadine

Levofloxacin

Lidocaine HCl

Magnesium aluminum silicate

Magnesium hydroxide

Miconazole nitrate

Mebendazole

Menthol

Metronidazole

Metoclopramide HCl

Metformin HCl

Nifedipine

Nicotinamide

Norfloxacin

Nystatin topical

Neomycin sulfate

Omeprazole

Orphenadrine citrate

Orciprenaline sulfate

Orphenadrine hydrochloride

Oxazepam

Oxybuprocaine HCl

Oxymetazoline HCl

Oxytetracycline

Paracetamol

Papaverine hydrochloride Paroxetine HCl hemihydrate Penicillamine Pentoxifylline

LDjo 12600 mg/kg oral rat LDjo 1000 mg/kg oral mouse

LDjc >200 KU/kg oral rat; LD^, >400 KU/kg oral mouse LD^ 150 mg/kg oral rat

LD^ 1170 mg/kg oral mouse; LD50 1040 mg/kg oral rat LD50 636 mg/kg oral rat; LD50 740 mg/kg oral mouse LD50 >3000 mg/kg oral rat LD50 2.42 mg/kg oral rat LD50 >5000 mg/kg oral rat

LD50 360 mg/kg oral rat; LD50 585 mg/kg oral mouse LD50 166.0 mg/kg oral rat; LD50 618 mg/kg oral mouse LD^ 185 mg/kg oral rat; LD50 269 mg/kg oral mouse LD^ 1556 mg/kg oral rat LDjo >5000 mg/kg oral rat

LD^ 35,900 mg/kg oral rat; LD^ 3366 mg/kg oral mouse LDjo 292 mg/kg oral mouse LDjo 16,000 mg/kg oral rat LDjo 8500 mg/kg oral rat

LDjo 920 mg/kg oral rat; LD50 578 mg/kg oral mouse

LD50 714 mg/kg oral rat; LD50 620 mg/kg oral mouse

LDjo 3300 mg/kg oral rat

LDjo 3000 mg/kg oral rat

LDjo 280 mg/kg oral mouse

LDjo 4000 mg/kg oral rat

LDjo 1022 mg/kg oral rat

LDjo 3500 mg/kg oral rat

LDjo >4000 mg/kg oral rat

LDjo 10,000 mg/kg oral rat; LD50 8000 mg/kg oral mouse LDjo 8.0 g/kg oral mouse

LDjo 2210 mg/kg oral rat; LD50 4.0 g/kg oral mouse

LDjo 150 mg/kg oral mouse

LDjo 5538 mg/kg oral rat

LDjo 255 mg/kg oral rat

LDjo >8000 mg/kg oral rat

LDjo 0.88 mg/kg oral rat

LDjo 4700 mcg/kg oral mouse; LDjo 680 mcg/kg oral rat LDjo 2404 mg/kg oral rat LDjo 68.8 mg/kg oral rat

LDjo 374 mg/kg oral rat; LD50 341 mg/kg oral mouse LDjo 3670 mg/kg oral mouse LDjo 1170 mg/kg oral rat

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Active Ingredients

Toxicity

Phenobarbital sodium Phenylephrine HCl Phenylalanine Piperazine citrate Propranolol HCl Prazosin hydrochloride Prednisolone Promethazine HCl Procaine hydrochloride Pheniramine maleate Pseudoephedrine HCl Ranitidine HCl

Recombinant human erythropoietin

Resorcinol

Rifampicin

Risperidone

Salbutamol sulfate

Salicylamide

Salicylic acid

Sertaconazole nitrate

Silver sulfadiazine

Simvastatine sodium

Sodium alendronate

Sodium citrate

Sodium valproate

Sodium iodide

Somatostatin

Simethicone

Sucralfate

Succinylsulfathiazole Tamoxifene citrate Tetracycline HCl Theophylline Tribenoside

Triamcinolone acetonide Triprolidine HCl Trimethoprim Tyrothricin Xylometazoline Vancomycin HCl

LDjo 150 mg/kg oral rat LDjo 350 mg/kg oral rat Not known

LDjo 11,200 mg/kg oral rat LDjo 466 mg/kg oral rat LDjo 1950 mg/kg oral rat LDjo 1680 mg/kg oral mouse LDjo 255 mg/kg oral rat

LDjo 184 mg/kg IP rat; LD50 180 mg/kg IP mouse

LDjo 520 mg/kg oral rat

LDjo 202 mg/kg IP mouse

LDjo >5 mg/kg oral rat; LDjo 884 mg/kg

LDjo 301 mg/kg oral rat Not known

LDjo 56.6 mg/kg oral rat

LDjo 1950 mg/kg oral mouse; LDjo 2500 mg/kg oral rat LDjo 1700 mg/kg oral rat

LDjo 1500 mg/kg oral mouse; LDjo 700 mg/kg oral rat

Not available

LDjo 1000 mg/kg oral rat

LDjo 4438 mg/kg oral rat; LDjo 3.0 g/kg oral mouse Not available Not known

LDjo 870 mg/kg oral rat

LDjo 4340 mg/kg oral rat

LDjo 21 mg/kg IV rat; LDjo 33 mg/kg IV mouse

LDjo 2000 mg/kg oral rat

LDjo 12 g/kg oral rat

LDjo 10 g/kg IV rat; LDjo 5700 mg/kg IP mouse LDjo 1190 g/kg oral rat

LDjo 6443 mg/kg oral rat; LDjo 2759 mg/kg oral mouse LDjo 666 mg/kg oral rat LDjo 10.0 mg/kg oral rat LDjo 5000 mg/kg oral mouse

LDjo 840 mg/kg oral rat; LD50 495 mg/kg oral mouse LDjo >5300 mg/kg oral rat; LD50 2764 mg/kg oral mouse LDjo >3000 mg/kg oral mouse LDjo 230.0 mg/kg oral rat

LDjo 10.0 g/kg oral rat; LDjo 5.0 g/kg oral mouse

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Active Ingredients

Toxicity

Verapamil hydrochloride

Vitamin A

Vitamin D

Vitamin C

Vitamin B1

Vitamin B2

Vitamin B6

Vitamin B12

Xylometazoline hydrochloride Zinc oxide

LDJ0 108.0 mg/kg oral rat

LDJ0 7910 mg/kg oral rat; LD50 6060 mg/kg oral mouse

LDJ0 2000 mg/kg oral rat

LDJ0 11,900 mg/kg oral rat

LDJ0 10,000 mg/kg oral rat and oral mouse

LDJ0 20,000 mg/kg oral rat

LDJ0 5500 mg/kg oral mouse; 4000 mg/kg oral rat LDJ0 8000 mg/kg oral mouse LDJ0 230 mg/kg oral rat; LDJ0 75 mg/kg oral mouse LDJ0 >8437.0 mg/kg oral rat; LDJ0 7950 mg/kg oral mouse

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