In contrast to production of tars at processing temperatures well above 1000°C, favoring formation of polycyclic aromatic hydrocarbons (PAH), the gentle production of ICHTHAMMOL® from the dry distillation process in Orbagnoux, France, to its completion in Seefeld, Tyrol, is associated with an exceptionally low PAH content.
According to gas chromatography / mass spectrometry PAH are so low in ICHTHAMMOL® from Seefeld, that the substance is toxicologically safe.
By studies on acute, subacute and chronic toxicity, local compatibility as well as teratogenic, mutagenic and cancerogenic potential, a good tolerance of ICHTHAMMOL® could be determined both for short-term and long-term administration. There were no indications for teratogenic, mutagenic or cancerogenic properties.
|Toxicological studies available for dark sulfonated shale oil.|
|Acute toxicity||rat||to 21,500 mg/kg BW||topical||no signs of poisoning ataxia from 7,900|
|rat||to 10,000 mg/kg BW||oral||sedation from 10,000|
|Subacute toxicity||rat||to 8,000 mg/kg BW daily over 2 weeks||oral||no substance-related changes|
|Chronic toxicity||rat||330; 1000; 3000 mg/kg BW daily over 6 months||oral||no substance-related changes|
|Teratogenicity||rat||300; 900; 2700 mg/kg BW daily 6-15 day of pregnancy||oral||no teratogenic characteristics|
|rabbit||330; 1000; 3000 mg/kg BW daily 6-15 day of pregnancy||oral||no teratogenic characteristics|
|Cancerogenicity||rat||5 mg/kg BW daily until natural death||oral||no substance-related changes|
|Mutagenicity - AMES Test||Salmonella typhimurium V79-Zellen (hamster)||3.16-10,000 µg/plate||plate||no mutagenic characteristics|
|- HGPRT Test||hamster||31.3-3,000 µg/ml medium||In vitro||no mutagenic characteristics|
|- Chromosome-analysis||2500; 5000 and 10,000 mg/kg BW (single application)||oral||no mutagenic characteristics|
|Skin compatibility||rabbit||2 ml/kg KG (12.5; 25; 50 and 100% in aqueous solution)||topical||12.5% well-tolerated, 25%, 50%, 100% DRAIZE grade 1-2*|
The safety and good tolerance of ICHTHAMMOL® are a guarantee for its safe and broad application in veterinary medicine.
In course of the procedure for establishing maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (MRL procedure according to Directive 2377/90/EEC) ICHTHAMMOL® was included in annex II. In annex II, substances are listed for which there is no necessity to fix maximum residue limits for the consumers’ protection. This classification makes possible unrestricted topical application of ICHTHAMMOL® in all mammalian food producing species – including milk producing ones.
Further information on toxicological properties of ICHTHAMMOL® are available on request from ICHTHYOL-Gesellschaft (contact).