Silicic acid, aluminum calcium sodium salt

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

calculation (if not (Q)SAR)

Remarks:

Migrated phrase: estimated by calculation

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Reliability of 1 given in view of the well documented biological activity of aluminium, calcium, sodium and silicates.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Objective of study:

other: assessment

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Assessment based on test data and public information.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Silicic acid, aluminium, calcium, sodium salt

IUPAC Name:

Silicic acid, aluminium, calcium, sodium salt

Constituent 2

Reference substance name:

Silicic acid, aluminum calcium sodium salt

EC Number:

215-685-3

EC Name:

Silicic acid, aluminum calcium sodium salt

Cas Number:

1344-01-0

Molecular formula:

3.0-3.9 SiO2 . Al2O3 . 0.4-0.6 CaO . 0.4-0.6 Na2O . nH2O

IUPAC Name:

aluminium(3+) calcium sodium tris(oxosilanebis(olate))

Results and discussion

Main ADME results

Main ADME results 1

Type:

absorption

Results:

Inorganic ions likely to be absorbed

Main ADME results 2

Type:

distribution

Results:

Inorganic ions likely to be transported

Main ADME results 3

Type:

excretion

Results:

Inorganic ions will be excreted in urine

Metabolite characterisation studies

Metabolites identified:

not measured

Details on metabolites:

The inorganic ions will not metabolise.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): no bioaccumulation potential based on study results
The absence of specific toxicokinetic data from animal testing on the anhydride means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism or excretion.

However, there is sufficient evidence from the fact that the ions will probably by absorbed from ingestion and excreted in the urine. With the exception of aluminium, the ions present are essential for healthy living and are required as part of a healthy diet.

There is no suggestion that the ions will accumulate in the body to cause and adverse effects as a result of exposure to the substance.

Executive summary:

The bioaccumulation potential of the registered substance was determined via an assessment of the toxicokinetics of the substance. The substance is sparingly soluble in water and this limits its bioavailability. However, in water it will exist in ionised form and any toxicity and metabolic activity needs to be considered with regard to the metal ions aluminium, calcium and sodium and in regard to silicates. The absence of specific toxicokinetic data from animal testing on the anhydride means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolism or excretion. However, there is sufficient evidence from the fact that the ions will probably by absorbed from ingestion and excreted in the urine. With the exception of aluminium, the ions present are essential for healthy living and are required as part of a healthy diet. There is no suggestion that the ions will accumulate in the body and research on aluminium entering the brain is considered invalid in view of the expected levels of exposure. The substance is not expected to bioaccumulate based on the results of the assessment.