Registration Dossier

Administrative data

basic toxicokinetics
Adequacy of study:
other information
Study period:
November 2008

Data source

Reference Type:
other: Body responsible for the test
Report date:

Materials and methods

Objective of study:
Test guideline
no guideline required
Principles of method if other than guideline:
Experimental data, literary data obtained from internet, data obtained from commercial toxicological databases and from Scientific and Tehnical
Information Network.

Test material


Results and discussion

Applicant's summary and conclusion

Executive summary:

Because no relevant toxicokinetic literary references were found, about behaviour of the test substance in organism of experimental animals was presumed only from results of toxicological testing, which was performed previously. The test substance applied to experimental animals (rat, rabbit, guinea pig) during studies with different way of entry (eye, oral or intradermal) into organism after single application, invoke the toxic answer of organism: death of animals, clinical and pathological findings. The test substance may be considered as substance, which very rapidly penetrated into organism after single application of high dose level - death or clinical toxicological symptoms occurred very soon after application. Absorption and distribution of the test substance in organism was recorded after repeated per-oral application to experimental animals. Long-term application had lethal effect only in one pregnant female (dose level 120 mg/kg/day). The test substance probably influenced digestion of animals (diarrhoea or watery excrements) but without negative effect on growth of animals. After absorption from the digestive system the test substance is probably distributed into nervous system (apathy, decreased activity)and urogenital system (changes in metabolism of water and ions and decreased fertility of males and females). In pregnant females the test substance influenced development of organism in uterus. Absorption of the test substance through skin was not confirmed according to the results of Acute toxicity: Dermal Irritation / Corrosion. According to the results of Inhalation study it is not possible to confirm absorption of the test substance from respiration system.