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The read-across substance 3,6-bis(4-chlorophenyl)-2,5- dihydropyrrolo-[3,4 -c]pyrrol-1,4-dione was investigated for absorption, distribution and excretion after a single gavage application in rats (RCC 1992). The study was performed under GLP and followed the principles outlined in OECD testing guideline 417. The study is valid without restriction, but assigned a validity score of 2 because of the use as read-across data. The read-across pigment is smaller in molecular diameter and lower in molecular weight and it shares the same core structure. Both pigments are equally poorly soluble in water and organic solvents. The smaller size is more favourable in regard to uptake. Therefoe, since no uptake was observed for the smaller read-across substance, the same can be derived for the target substance.

14C-labelled test compound was administered at two target dose levels of 100 mg/kg (low dose) and 1000 mg/kg (high dose) to male rats and radioactivity appearing in urine, feces, blood/plasma and organs/tissues was measured for various intervals up to 168 hours. In plasma, values which exceeded the limit of quantitation by less than 1.5fold were found around 2h after dosing. This is considered to be related to the 0.2% extractable radioactive impurity in the test material and not to indicate uptake of the pigment.

At both dose levels minimal amounts (<0.6% of the total dose) were excreted via the urine. This was considered to be caused by contamination with feces, but it may also be related to the radioactive impurity in the test material. Excretion of 14C-labelled pigment proceeded exclusively via the feces and amounted after 168 hours, on average, to 119.7 % and 96.0 % at the low and high dose level, respectively.

14C-3,6-bis(4-chlorophenyl)-2,5- dihydropyrrolo-[3,4 -c]pyrrol-1,4-dione is not bioavailable after single oral administration to rats.