toxology

Dermal Evaluation ( 100% in 10ml in Water ) 48 Hour 100/100 completely non-irritating Human Patch Test (non-erythema causing Alpha Lipoic Acid) 100 Test Subjects
IN-VITRO OCULAR EVALUATION ( 10 % soluble In 10ml Water )
Ropak, Eyetex™                   Eyetex Classification
Rapid Membrane Assay       Minimal/ Mild
Biological effect:
Lipoic acid is observed to be biologically active and can be used clinically at dosages as low as 0.14-0.28 milligrams/kilogram of body weight (i.e., mg/kg), which would be equivalent to 10-22 mg. in an average person.
Toxicology:
Small animals injected with 100-200 mg/kg (i.e., the human equivalent of 7,800 - 15,500 mg.) produced depressive symptoms with tonic-clonic convulusions.
In mice the convulsive dosage for 50% is 140-180 mg/kg (i.e., the human equivalent of 11,000 - 15,000 mg.).
In mice, the lethal dose for 50% was 160-275 mg/kg, (i.e., the human equivalentof 13,000 - 22,000 mg.).
There were no toxic effects in mice treated by injection for 40 days with 75 mg/kg (human equivalent 6,000 mg.) nor in rats treated by injection for 60 days with 15 mg/kg (human equivalent of 1,200 mg.) nor in guinea pigs injected for 20 days at 10 mg/kg (human equivalent of 800 mg.).
Lipoic acid in 0.5% solution had no undesirable effect on the mucosa, serous membrane, endothelium, or subcutaneous and muscular membranes.

"Lipoic acid is rapidly absorbed and eliminated from the organism and its accumulation iis improbable." Intravenous administration of lipoic acid in high dosages in humans were "well tolerated".

Additional pharmacology has been detailed in numerous subsequent reports over the years. With oral supplementation, there is about 80% absorption into the blood stream (Harrison EH, McCormick DB, 1974), and it is distributed generally throughout all tissues and most cellular components.

See the table below for some representative references ON PHARMACOLOGY

Eye lens (Maitra I, Serbinova E, Trischler H, Packer L, 1995)
Cardiac muscle (Haramaki N, Assadnazari H, Zimmer G, Schepkin V, Packer L, 1995)
Brain and nerve tissue (Whiteman M, Tritschler H, Halliwell B, 1996)
Lungs (Busse E, Zimmer G, Schopohl B, Kornhuber B, 1992)
Pancreas (Kallmann B, Burkart V, Kroncke KD, Kolb-Bachofen V, Kolb H, 1992)
Liver (Loginov AS, Nilova TV, Bendikov EA, Petrakov AV, 1990)
Mitochondria (Skrede S, 1968)
Liposomes (Kagan VE, Shvedova A, Serbinova E, Khan S, Swanson C, Powell R, Packer L, 1992)

BOTANICAL SOURCE INFORMATION - ALPHA LIPOIC ACID

LATIN Azadrichtha indica leaves
ENGLISH Neem Leaves
NCI/CTFA NAME I Azadrichtha indica Extract
PROPOSED INCI NAME Alpha Lipoic Acid
PLANT MATERIAL Leaves Choloroplast cells
ACTIVE COMPONENTS OF PLANT MATERIAL: Thioctic Acid (Alpha Lipoic Acid).
Introduction Lipoic Acid from vegetable source-neem tree
abstracts product attributes application & dosage