Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Toxikokinetic Assessment
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Assessment
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: according to the requirements of Annex VIII of the EC Regulation 1907/2006
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

Summary Considering the physico-chemical properties of FAT 40849, [i.e., high molecular weight for organic salts (above 1000), small log POW value (-3.2), and low vapor pressure of 2.16 x 10-31 Pa at 25 °C (estimate)], absorption of FAT 40849 from various routes of exposure, such as oral, dermal or inhalation is expected. However, absorption of FAT 40849 is expected to mainly occur via oral (50% absorption rate) and inhalation routes (100% absorption rate), but with limited potential for dermal absorption (10% absorption rate can be expected). The results of the 28-day repeated oral toxicity study also provided the evidence that the organic components of FAT 40849 may not cross the blood-brain barrier (BBB) upon oral exposure to cause CNS effects. Retaining of small particles in the deep lungs may not be excluded due to the substance physico-chemical properties. Following absorption, FAT 40849 is anticipated to be distributed at the very least to the digestive tract, kidneys, lungs, thymus, mesenteric lymphnodes, testes, prostrate, uterus and vagina, based on the discoloration effects noted in these organs in animals following repeated oral exposure. However, deposition of test material in these organs may be unlikely to cause toxicity concern based on the results of the 28-day test, reproductive toxicity screening and prenatal studies which displayed no test item treated-related adverse effects in the dosed animals (NOAELs oral, rat ≥ 1000 mg/kg bw were observed for all the repeated toxicity studies). The constituents of FAT 40849 having large molecular weight may be metabolized in the liver and consequently excreted via bile. On the other hand, the inorganic salts/ions may be excreted mainly through urine.

Applicant's summary and conclusion