SAFETY STUDIES OF DARK SULFONATED SHALE O IL FOLLOWING LOCAL AND SYSTEMIC APPLICATION

Ichthyol(R) (Ammoniumbituminosulfonat DAB, dark sulfonated shale oil, CAS 8029-68-3) is used for the treatment of inflammatory skin diseases and rheumatic diseases and blunt traumata. The studies conducted were carried out to obtain information on the risk following dermal and or al application of dark sulfonated shale oil. Corresponding to the admi nistration route envisaged for man the drug was applied by topical and systemic administration. Studies were conducted on the acute, subacut e and chronic toxicity, local tolerance and the teratogenic, mutagenic and carcinogenic potential. Dark sulfonated shale oil was found to be well tolerated whether administered for a short period or over a long time. There were no indications for a teratogenic, mutagenic or carci nogenic effect. The therapeutic index (ratio of the toxic dose in anim als and the therapeutic human dose) for topical administration of dark sulfonated shale oil is > 7 depending on animal species, frequency of administration, dose-level employed and the toxicological question po sed. The results of the toxicological studies coincide with more than 110 years of experience that the drug is well tolerated by man.