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EC number: 413-920-6
CAS number: 88949-33-1
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.
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
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
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.
bioavailable after single oral administration to rats.
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