Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: 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: Assessment of Toxicokinetic Behavior of FAT 40850
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

Summary: Considering the physiochemical properties of FAT 40850, [i.e., high molecular weight for organic salts (above and around 1000), small log POW value (-4.2), and low vapor pressure of 3.04 x 10-28 Pa at 25 °C (estimate)], absorption of FAT 40850 from various routes of exposure, such as oral, dermal or inhalation is expected. However, absorption of FAT 40850 is 8 / 8 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 provide evidence that the organic components of FAT 40850 may not cross the blood-brain barrier (BBB) upon oral exposure and cause CNS effects. Retaining of small particles in the deep lungs via the inhalation route may not be excluded due to the substance physicochemical properties. Following absorption, FAT 40850 is anticipated to be distributed at the very least to the kidneys, lungs, mesenteric lymphnodes and stomach in animals following repeated oral exposure. However, excepting kidneys, bioaccumulation/deposition of the test material in a short term oral exposure may be unlikely to cause toxicity concern based on the results of the 28-day and prenatal studies which displayed no directly substance treated adverse effects in the dosed animals. The constituents of FAT 40850 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