EXPERIMENTAL STUDIES ON THE TOLERABILITY OF PALE SULFONATED SHALE OIL FOLLOWING LOCAL AND SYSTEMIC APPLICATION

Ichthyol(R), pale, a pale sulfonated shale oil, is used for the treatment of inflammatory skin diseases. The studies conducted were carried out to obtain information on the risk following dermal application of sulfonated shale oil, pale. Corresponding to the administration route planned for man the drug was applied by topical and systemic administration. Studies were conducted on the acute, subacute and chronic toxicity, and the teratogenic, mutagenic and carcinogenic potential. Sulfonated shale oil, pale was found to be very well tolerated whether administered for a short period or over a long time. There were no indications for tetratogenic, mutagenic or carcinogenic effects. The therapeutic range (ratio of the toxic dose in animals and the therapeutic human dose) for topical administration is > 30 depending on animal species, frequency of administration, dose-level employed and the toxicological question posed. The results of the toxicological studies coincide with the almost 70 years of experience that the drug is well-tolerated by man.