Cholcha W, Leuschner J, Leuschner F
Ichthyol-Gesellschaft Cordes, Hermanni & Co., Hannover.
Arzneimittelforschung. 1994 Jul;44(7):844-9.
Ichthyol (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 oral application of dark sulfonated shale oil. Corresponding to the administration route envisaged for man the drug was applied by topical and systemic administration. Studies were conducted on the acute, subacute 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 carcinogenic effect. The therapeutic index (ratio of the toxic dose in animals 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 posed. The results of the toxicological studies coincide with more than 110 years of experience that the drug is well-tolerated by man.
鱼石脂（药用级氨化沥青磺酸盐，深色磺化页岩油，CAS 8029-68-3）用于治疗炎性皮肤病、风湿性疾病和钝性创伤。开展这些研究是为了获取有关深色磺化页岩油经皮肤和口服应用后的风险信息。根据预期的人体给药途径，该药物通过局部和全身给药方式应用。进行了急性、亚急性和慢性毒性、局部耐受性以及致畸、致突变和致癌潜力的研究。结果发现，无论是短期还是长期给药，深色磺化页岩油的耐受性都良好。没有致畸、致突变或致癌作用的迹象。根据动物种类、给药频率、所用剂量水平以及提出的毒理学问题，深色磺化页岩油局部给药的治疗指数（动物中毒剂量与人体治疗剂量之比）>7。毒理学研究结果与110多年来该药物在人体中耐受性良好的经验相符。
