Toxicology

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.

BW = body weight, *slight (1), clearly demarcated (2) reversible erythema
Toxicological studies available for dark sulfonated shale oil.        
Study Species Dosage Application Results
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).