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Description of key information

Key value for chemical safety assessment

Additional information

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

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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.