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EC number: 215-691-6
CAS number: 1344-28-1
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 of26Al-labelled compounds
several weeks apart: 1) Al hydroxide (100 mg stable Al3+ion
and 120 Bq of26Al 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 of26Al 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 for26Al determination by AMS.
Similar 10-ml blood samples were also taken for26Al
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 for26Al using coincidence gamma-counting, blood and
urine samples - using accelerator mass spectrometry (AMS).
The cumulative faecal excretion of26Al
during the 6-day period following administration of each test material
was similar in the two volunteers. In both, the faecal excretion of
unabsorbed26Al was virtually complete by 6 days
post-administration. There were differences between the volunteers in
the pattern of faecal excretion of26Al: 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 of26Al (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
After administration of26Al-labelled
aluminium hydroxide there were no temporal differences between the two
volunteers in blood26Al concentrations, peak blood
concentration of26Al was observed 4 hours
post-administration. After administration of26Al-labelled
aluminium citrate, or aluminium hydroxide in the presence of citrate,
temporal differences were observed between the volunteers: blood26Al
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 blood26Al
concentrations. The least bioavailable was aluminium hydroxide.
Co-administration of the stable citrate solution increased and delayed
the uptake of 26Al
from the26Al-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 from26Al
or27Al levels at a single time after administration.”
Absorbed fractions of26Al determined on the basis of
calculated blood volumes and blood26Al concentrations
measured 1, 4 or 24 hours post-administration were inconsistent.
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 of26Al as aluminium citrate. The26Al
urinary excretion was slowest after administration of26Al-labelled
aluminium hydroxide. Co-administration of the citrate increased the
levels of26Al urinary excretion. In volunteer B the excretion
was slower than in volunteer A. By day 3 post-administration, cumulative
urinary excretion of26Al reached plateau for all three Al
species Absorbed fractions calculated on the basis of26Al
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
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