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.

Toxicological studies available for dark sulfonated shale oil.
StudySpecies DosageAppli-
cation
Results
Acute
toxicity

rat

rat

to 21,500 mg/kg BW

to 10,000 mg/kg BW
topical

oral
no signs of poisoning
ataxia from 7,900
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
Terato-
genicity
rat


rabbit
300; 900; 2700 mg/kg
BW daily 6-15 day of
pregnancy
330; 1000; 3000 mg/kg
BW daily 6-15 day of
pregnancy
oral


oral
no teratogenic
characteristics

no teratogenic
characteristics
Cancero-
genicity
rat 5 mg/kg BW daily until
natural death
oral no substance-related
changes
Muta-
genicity
       
- AMES
  Test
Salmonella
typhimu-
rium
3.16-10,000 µg/plate plate no mutagenic
characteristics
- HGPRT
  Test
V79-Zellen
(hamster)
31.3-3,000 µg/ml
medium
In vitro no mutagenic
characteristics
- Chro-
  mosome-
  analysis
hamster 2500; 5000 and
10,000 mg/kg
BW (single application)
oral no mutagenic
characteristics

  BW = body weight
  *slight (1), clearly demarcated (2) reversible erythema


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).