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Description of key information

Key value for chemical safety assessment

Additional information

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.