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Description of key information

FAT 41045 has a low accumulation potential in the human body and absorption by oral, dermal or inhalative route also is considered to be low (10 % assumed for each pathway following a conservative approach).

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential
Absorption rate - oral (%):
10
Absorption rate - dermal (%):
10
Absorption rate - inhalation (%):
10

Additional information

Studies on which this toxicokinetic assessment is based were performed in compliance with GLP with FAT 41030 a structural analogue of FAT 41045. In addition, water solubility and Log Pow (by HPLC at pH ca. 6) were measured for FAT 41045. Both substances are very similar in their chemical structure and, as demonstrated, in a number of physicochemical properties. Therefore, the use of the studies conducted with FAT 41030 for read-across extrapolation to FAT 41045 is considered to be appropriate and the conclusions drawn regarding the toxicokinetic profile are considered to be valid and identical for both substances.

Absorption of FAT 41045 in humans is expected to be low via the different routes - oral (10%), dermal (10%) and inhalation (10% only if exposed to dust) due to its physico-chemical properties (i.e. high molecular weight of 502.53, poor water solubility, log Pow > 6.2 and the majority of particles > 100 µm in diameter thus belonging to the fraction non-inhalable by humans). Following absorption, both substances are assumed to be distributed to liver and kidneys mainly. Excretion is expected via urine, bile or faeces. Excretion via urine and faeces is consistent with the observation of treatment related dark red discoloration of the faeces and bedding material in a 28-day repeated dose oral (gavage) toxicity study in the rat which was attributed to the darkish red coloured FAT 41030 test material. In conclusion, FAT 41045 has a low accumulation potential in human body.