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Toxicological information

Direct observations: clinical cases, poisoning incidents and other

Administrative data

direct observations: clinical cases, poisoning incidents and other
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Review of studies. Long-term data on toxicokinetics for slags, ferronickel-manufg. is not available for the whole substance and is impossible to derive because of the nature of the substance. Being a UVCB, it consists of a number of different substances (mainly metals and metal oxides) that are bound together in a number of phases. Therefore it was attempted to identify possible adverse effects based on data for its recognised constituents, even though the results cannot be applied directly, due to the way the constituents are bound in the matrix of the substance and are not as bioavailable as the free substances that are examined (it is also supported by the low water solubility). So, the results must be taken into consideration with care. The object of this paper was to summarise the general principles and scope for the application of 26Al as a tracer to investigate human or animal biochemistry.

Data source

Reference Type:
Biological chemistry of aluminium studied using 26Al and accelerator mass spectrometry
J.P. Day, J. Barker, S.J. King, R.V. Miller, J. Templar, J.S. Lilley, P.V. Drumm, G.W.A. Newton, L.K. Fifield , J.O.H. Stone , G.L. Allan , J.A. Edwardson , P.B. Moore, I.N. Ferrier, N.D. Priest, D. Newton, R.J. Talbot, J.H. Brock , L. S5nchez , C.B. Dobson, R.F. Itzhaki, A. RadunoviC and M.W.B. Bradbury.
Bibliographic source:
Nuclear Instruments and Methods in Physics Research B, vol.92 (1994), pp. 463-468

Materials and methods

Study type:
study with volunteers
Endpoint addressed:
basic toxicokinetics
Test guideline
no guideline required
Principles of method if other than guideline:
No guideline is mentioned in the study.
GLP compliance:
Not applicable for human data.

Test material

Constituent 1
Reference substance name:
EC Number:
EC Name:
Cas Number:
Details on test material:
Aluminium 26 isotope.


Type of population:
Ethical approval:
confirmed and informed consent free of coercion received
Route of exposure:
other: injection
Reason of exposure:
Exposure assessment:
Details on exposure:
i) ingestion of 26Al with excess amounts of the stable isotope 27Al and citrate carriers. Blood samples taken sequentially for determination of maximum plasma levels, gastrointestinal uptake factor, speciation in blood. 26Al measured by accelerator mass spectrometry
ii) injection of 26Al in citrate solution. Whole body measurements by gamma spectroscopy for determination of retention t1/2, volume of distribution
Whole body measurements by gamme spectroscopy of retention to determine half-life and volume of distribution.

Results and discussion

Clinical signs:
No effects.
Results of examinations:
Main ADME parametres: maximum plasma levels after ingestion were found within 1h. Gastrointestinal uptake factor: 1.2 (in healthy population). Speciation in blood: 80% bound to transferrin at 1h. Volume of distribution: 10l (equal to extracellular fluid).
Details on absorption: about 1.2% of ingested 26Al was absorbed. Absorption was highly affected by excess of citrate, nosological entities, added silicate.
Details on distribution: 80% of absorbed 26Al is bound to transferrin at 1h. Volume of distribution: 10l (equal to extracellular fluid)
Details on excretion: Rapid urinary excretion (80% of dose excreted in 10 days). Whole body measurements show retention of 4% of dose with residual half-life more than 6 years
No metabolites were identified.

Applicant's summary and conclusion

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