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To: axial who wrote (9034)3/16/2002 6:24:32 PM
From: Joe Krupa  Read Replies (1) | Respond to of 14101
 
Jim, in reference to DMSO, you stated "I think it is very likely that DMX has overcome that bias."

I'd say that is very likely, considering the evidence you've already listed. The following posted by JimmyD21 on SH, also tells me that this is the case:

fda.gov

Notice from this document that DMSO is listed as a Class 3 drug by the FDA. A Class 3 drug is described as follows:

"Solvents in Class 3 (Table 3) may be regarded as less toxic and of lower risk to human health.
Class 3 includes no solvent known as a human health hazard at levels normally accepted in
pharmaceuticals."


Class 1 drugs "should not be employed in the manufacture of drug substances,
excipients, and drug products because of their unacceptable toxicity or their deleterious
environmental effect."


Class 2 drugs "should be limited in pharmaceutical products because of their
inherent toxicity."


However, it's the Class 4 drugs that, IMO, provide a nice clue about the FDA's bias toward DMSO. In this document, Class 4 drugs are described as "Solvents for Which No Adequate Toxicological Data Were Found"

By extension this description of Class 4 drugs implies that toxicological data DOES EXIST for Class 3 drugs, which includes DMSO. On the basis of this toxicological data, the FDA has classified DMSO as being at the safest level of its scale for human pharmaceuticals.

So there IS a bias. The bias however, is not one of danger, but clearly, safety. As DI7026 pointed out on SH, DMSO has been placed in the same category as ethanol, which is 5% of the average beer we drink.

Unless some renegade at the FDA has clandestinely slipped DMSO on to that list without the knowledge of Agency, then I would suggest the FDA is not harbouring any fears of the substance melting away human tissue, Russet!

joe