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EC number: 939-516-4
CAS number: -
Table 3.Percentage excretion of14C or3H
in urine, faeces and expired air of ratsaintubated
with14C- or3H-labelled PGPR and14C-labelled
components of PGPR
Groups of 3–15 rats were used; seeTable
bValues for days 3 and 4 are also given.
cTotals include values for days 3 and 4.
With [1-14C]glycerol, over 84% of the
dose was excreted within 48 hr, mainly as expired14CO2.
With [14C]polyglycerol, 87.5–92.7% of the
dose was excreted within 48 hr, mainly in the
faeces, to a lesser extent in the urine and only to
a small extent as expired14CO2.
Only minor differences were observed in the
excretory pattern of the three different dose
presentations of [14C]polyglycerol,
samples of which contained 9–14% free [1-14C]glycerol.
Table 4shows that following
dosing with Sephadex fractions of [14C]polyglycerol,
the lower glycerols were preferentially excreted in
the urine, while the higher glycerols were
preferentially excreted in the faeces. About 85% of
the dose was recovered for each fraction in
agreement with the percentage excretion of
unfractionated [14C]polyglycerol (Table
3). No14CO2was expired
by the animals dosed with fractions which were free
Table 4.Percentage excretion of14C in
urine, faeces and expired air of rats up to 2 days after an
Sephadex-fractionated [14C] polyglycerol
a Oral doses of 1ml of 10% (w/v) aqueous solutions
of fractions 1, 2, 3 and 4 were given to groups of 2, 1, 2 and
1 rats (250g body weight) respectively.
bValues for fractions 1 and 3 are the averages for
two rats and for fractions 2 and 4 for one rat only.
The excretion of [14C]polyglycerol]PGPR,
dosed as a 3% dietary slurry, followed the same pattern
as that of [14C]polyglycerol but when dosed
as a 50% aqueous emulsion the recovery of [14C]PGPR
was less efficient, even though excretion was followed
for 4 days after dosing (Table 3).
TLC analysis of urine of rats dosed with [14C]polyglycerol
(10% aqueous solution) showed that14C
was mainly present as cyclic glycerols, diglycerol
and triglycerol with very small amounts of higher
glycerols. In contrast, faecal14C was
accounted for mainly by higher glycerols and only
to a smaller extent by di- and triglycerols.
[1-14C]stearic acid was
metabolized by the rat and 51.3% of the dose
was recovered, mainly as expired14CO2within
48 hr of dosing. Animals fed ([14C]stearyl)PGPR
as a dietary slurry gave similar results to [14C]
stearic acid. A total recovery of 57.7% of
the dose was made in 48 hr. The increase in
recovery was mainly due to a higher faecal14C
recovery. Urinary and expired14C
levels were similar (Table 3).
Chromatography of faeces of rats given ([14C]stearyl)PGPR
as a 3% dietary slurry showed that 97% of
faecal14C was free fatty acids or
polyricinoleic acid and reverse isotope
dilution analysis showed 44% to be free
Chromatographic analysis of the epididymal
fat of rats dosed with ([14C]stearyl)PGPR
(3% dietary slurry) revealed the presence of
saturated fatty acids (44% of fat14C)
monoenoic fatty acids (14%) and polyenoic
fatty acids (40%).
Table 5.Uptake of14C
into liver and epididymal fat 2 or 4
days after dosing with [14C]PGPR
a=fed overnight before dosing.b=starved
overnight before dosing.∗=indicates
samples 4 days after intubation, all
other values are at 2 days.
With the two [3H]PGPR
preparations, excretion was
incomplete with small amounts of
radioactivity in the urine, faeces
and expired water (Table
3). Only 4.8 or 11.6% of
the dose was excreted in the
faeces at 24 hr after dosing.
the nature of the lipid-soluble3H
present in the tissues of rats
3–24 hr after dosing with either
isomer of [3H]PGPR.
Unchanged PGPR was found only in
the stomach contents (3 hr after
dosing), polyricinoleic acid was
present in intestinal contents and
faeces, and non-hydroxy and
hydroxy fatty acids in the liver,
fat and carcass. 30% of the3H
in fat was hydroxy fatty acid .
Assay of3H in urine
showed 30% of the activity to be
volatile and removed by
freeze-drying. Less than 1% of the
remaining activity was extractable
identified in tissues or
tissue contents of rats
23–24 hr after an oral
dose of [12-3H]PGPR
or [9, 10-3H]PGPR
Groups of three rats were given a dietary slurry containing 3%3H-labelled
PGPR and killed at 3, 6 and 24 hr later.
The results obtained with lipid-soluble3H, as
presented inTable 6, show that
24 hr after dosing with tritiated PGPR, the entire
contents of the alimentary tract contained less than 1%
of the administered dose. At 24 hr, less than 0.5% of
the dose was present in stomach tissue and less than
0.1% in small intestinal tissues. The3H
content of the jejunum and upper ileum was greater than
that of the duodenum or lower ileum, indicating a major
site of absorption. Blood3H remained low
(<0.1%/ml), while epididymal fat3H
accounted for less than 5% of the dose. Liver3H
also remained low (<0.1%/g).
Table 6.Tissue distribution of
lipid-soluble3H at 3–24 hr after an
oral dose of [12-3H]PGPR or [9,10-3H]PGPR
Groups of three rats were killed at 3, 6, 12 and 24 hr after
an oral dose of 2 ml dietary slurry containing 3%3H-labelled
PGPR.aValue represents total lipid-soluble3H(μCi);
those in parentheses represent water-soluble3H in
total carcass.For doses seeTable 2,
experiments 10/ and 11/.
The3H found in the aqueous phase of the
carcass hydrolysate accounted for 75% of the dose,
administered 24 hr earlier.
Under the conditions used in the 2 or 3 hr of
incubation, 10, 6, 12–15 and 40% of [12-3H]PGPR
was degraded to polyricinoleic acid and free
ricinoleic acid by the gut contents, intestinal
mucosa, rat pancreas and hog pancreatic lipase,
respectively.3H activity was not found
in the aqueous extracts of these reaction
mixtures, apart from the gut contents, for which
less than 0.1% was recovered in the aqueous phase.
No evidence of degradation was obtained with the
boiled biological preparations.
of the emulsifier polyglycerol polyricinoleate (PGPR)
were synthesized using the radiolabelled precursors [1-14C]glycerol
PGPR), [9,10-3H] or [12-3H]ricinoleic
acid ([3H] PGPR) or [1-14C]stearic
acid ([14C]stearyl PGPR). The absorption,
metabolism and excretion of these14C- or
tritium-labelled PGPR samples administered to rats was
studied. The effects of intestinal
porcine pancreatic lipases on PGPR preparations were
examined. Rats were dosed with [1-14C]glycerol,
PGPR by gavage and their urine, faeces and expired CO2monitored
for14C. The results from the [1-14C]glycerol
showed extensive metabolism of glycerol. For [14C]polyglycerols,
the lower polyglycerols were preferentially absorbed
and were excreted unchanged in the urine while the
higher polyglycerols were found in the faeces. After 4
days, 93% of the dose of
was recovered, of which some 30% was found in the urine
and 60% in the faeces. Traces of14C activity
were found in depot fat
liver. The excretory pattern and urinary metabolites
from ([14C]polyglycerol) PGPR was very
similar to that of [14C]polyglycerol.
urinary and faecal14C material indicated that
the PGPR polymer was digested to give free polyglycerol
(called Polyglycerine-Heavy in
document) and polyricinoleic acid. PGPR was synthesised
incorporating [1-14C]stearic into
polyricinoleic acid which was then
with polyglycerol. The resulting [14C]PGPR or
[1-14C] stearic acid in a dietary slurry was
administered to groups of fed or starved
by gavage. The results indicated complete digestion of
PGPR and absorption of the fatty acids. The14C-material
absorbed was extensively
down in depot fat and some metabolism to14CO2was
demonstrated. The fate of the stearic acid was similar
whether dosed alone or
into the PGPR polymer. Samples of PGPR were synthesized
containing3H-labelled ricinoleic acid. The
resulting [3H]PGPR was
into rats as a component of a dietary slurry. The
results indicated that the polymer is extensively
digested and 90% of the administered
is absorbed. The absorbed material was extensively
metabolized within 24 hr so that large amounts of
tritium were present in the
phase of the tissues examined. After 24 hr, less than 5%
of the administered material was present as lipid
material, of which a large
was as non-hydroxy fatty acids. No traces of polymer
material were found in the tissues examined. In
vitro digestion of PGPR by
pancreatic lipase and rat intestinal fractions was
demonstrated. The results indicate very extensive
digestion of the PGPR polymer to
(called Polyglycerine-Heavy in Justification document)
and fatty acids. The fatty acids are metabolized
extensively. The mono-,
and triglycerols are extensively absorbed from the
intestinal tract and rapidly excreted in the urine
unchanged but the hexa-, penta- and
polyglycerols are essentially not absorbed and excreted
in the faeces unchanged.
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