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EC number: 231-072-3
CAS number: 7429-90-5
calculated on the basis of26Al urinary excretion data
(assuming 72% excretion of absorbed26Al in urine*):
as aluminium hydroxide 1.04x10-4
as aluminium hydroxide with citrate 1.36x10
as aluminium citrate 5.23x10-3
*Based on results of
The calculated total
radiation dose from three administrations was 1.6 µSv, which was 320
times lower than the World Health Organization dose limit of 500 µSv for
a category 1 volunteer study.
Two healthy male volunteers received the following three oral
doses of 26Al-labelled compounds several weeks apart: 1) Al hydroxide
(100 mg stable Al3+ion and 120 Bq of 26Al at pH = 7.0) as a suspension
in water; 2) Al hydroxide (as above) followed by 100 ml of 1% aqueous
trisodium citrate, pH=6.5; 3) 100 mL Al citrate containing 100 mg stable
Al3+ion and 120 Bq of 26Al in 1% aqueous trisodium citrate, pH = 6.5.The
test materials were administered intragastrically using a paediatric
feeding tube inserted via the nose.
A venous blood sample (20 ml) was taken from each volunteer on the day
before the first dosing. This sample was analyzed for Ca2+, PO42-, Mg2+,
25-OH Vitamin D and 1.25-OH Vitamin D at the PMC Ltd ().A 10-ml
blood sample was taken on that day for 26Al determination by AMS.
Similar 10-ml blood samples were also taken for 26Al determination on
the day prior to each subsequent dosing.In these samples,
aluminium residues from previous administrations were determined and
used as base-line data.
Blood samples (10 ml) were collected 1 hour (± 10 min), 4 hour (±
30 min) and 24 hours (± 1 hour) after each administration.Daily
output of urine and faeces was collected for 6 days following each
dosing. The times of voiding and the times of each addition to the
24-hour urine sample were recorded.Faecal samples were analyzed
for 26Al using coincidence gamma-counting, blood and urine samples -
using accelerator mass spectrometry (AMS).
The cumulative faecal excretion of 26Al during the 6-day period
following administration of each test material was similar in the two
volunteers. In both, the faecal excretion of unabsorbed 26Al was
virtually complete by 6 days post-administration. There were differences
between the volunteers in the pattern of faecal excretion of 26Al:
volunteer B retained aluminium for 1-2 days longer than volunteer B, and
this was the case following administration of each test material.
Therefore, the cumulative gastro-intestinal occupancy of 26Al (expressed
as Bq-days) was higher in volunteer B, which created higher potential
for absorption in this volunteer.Aluminium administered with
citrate was retained longer in both volunteers compared to aluminium
administered as the hydroxide.
After administration of 26Al-labelled aluminium hydroxide there
were no temporal differences between the two volunteers in blood 26Al
concentrations, peak blood concentration of 26Al was observed 4 hours
post-administration. After administration of 26Al-labelled aluminium
citrate, or aluminium hydroxide in the presence of citrate, temporal
differences were observed between the volunteers: blood 26Al
concentrations were highest 1 hour post-exposure in volunteer A but 4
hours post-exposure in volunteer B. Of the three test materials, 26Al
given as aluminium citrate was most bioavailable in both volunteers,
resulting in the highest time-integrated 24-hour blood 26Al
concentrations.The least bioavailable was aluminium hydroxide.Co-administration
of the stable citrate solution increased and delayed the uptake of 26Al
from the 26Al-labelled aluminium hydroxide (the delay was more evident
in subject B). These results suggest that blood aluminium concentrations
“reach no convenient and consistent effective plateau and that
bioavailability cannot be accurately determined from 26Al or 27Al levels
at a single time after administration.” Absorbed fractions of 26Al
determined on the basis of calculated blood volumes and blood 26Al
concentrations measured 1, 4 or 24 hours post-administration were
For all the test materials, 26Al urinary excretion was highest in
the first day post-administration and rapidly declined thereafter. The
decline was sharpest after administration of 26Al as aluminium citrate.
The 26Al urinary excretion was slowest after administration of
26Al-labelled aluminium hydroxide. Co-administration of the citrate
increased the levels of 26Al urinary excretion. In volunteer B the
excretion was slower than in volunteer A. By day 3 post-administration,
cumulative urinary excretion of 26Al reached plateau for all three Al
species Absorbed fractions calculated on the basis of 26Al urinary
excretion data (assuming 72% excretion of absorbed26Al in urine) were
0.01% for aluminium hydroxide, 0.136% for aluminium hydroxide with
citrate and 0.523% for aluminium citrate.
The results of this study suggest that bioavailability of aluminium in
the citrate form and more so for the hydroxide form is relatively low
and that “consumption of either aluminium citrate or aluminium hydroxide
in normal quantities is unlikely to result in toxicologically
significant body burdens of this metal.”
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