Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No fertility tests have been performed with silicocalcium. Therefore a read-across approach was utilized, based on the constituents of silicocalcium. It is relevant to consider the systemic availability of silicon and level of silicon in blood in the evaluation of reproductive toxicity of CaSi as well as silicas and silicates. Amorphous silica is absorbed from the gastrointestinal tract but it has very low effects on systemic silicon levels, i. e. the levels of silicon in blood, urine or tissues.

One dominal lethal assay done with Ca-silicate does not indicate any reprotoxicity.

The data on studies from high-dose oral administration of silica gel supports the conclusion that amorphous silica (and therefore also silicocalcium with oxidised surface layer) has no toxic effect on development. Silicates (e. g. Ca- and Al-silicates) are also widely used as food additives (approved by EFSA). Based on the lack of systemic effects in repeated dose toxicity studies, the silicates can be regarded as non-toxic. Therefore, it is not likely that silicon, calcium and aluminium released from silicocalcium matrix would cause any reproductive toxicity, either.

Calcium and iron species dissolved from CaSi do not detectably affect their physiological levels.


Short description of key information:
Read-across from amorphous silica is used. It is very unlikely that CaSi would cause any reprotoxic effects.
The studies of amorphous silica show no toxic effect on development or fertility.
Silica and silicates (e.g. Ca- and Al-silicates) are also used as food additives.
Based on the lack of systemic effects in repeated dose toxicity studies, the silicates can be regarded as non-toxic. Therefore, it is not likely that silicon, calcium and aluminium released from silicocalcium matrix would cause any reproductive toxicity.
Calcium and iron species dissolved from CaSi do not detectably affect their physiological levels.

Effects on developmental toxicity

Additional information

see above

Justification for classification or non-classification

Conclusion: Silicocalcium demonstrates no reproductive toxicity. No classification or further testing of reproduction toxicity is suggested