Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No fertility tests have been performed with Si/FeSi silicate. One dominal lethal assay done with Ca-silicate does not indicate any reprotoxicity.

Silicates are 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 practically non-toxic. Therefore it is very unlikely that Si/FeSi silicate would cause any fertility effects


Short description of key information:
No data are available on fertility effects caused by Si/FeSi silicate. And no guideline studies were found for other silicates. Silicates are also widely used as food additives (approved by EFSA). However, based on the lack of systemic effects in repeated-dose toxicity studies, the silicates can be regarded as practically non-toxic. Therefore, it is very unlikely that Si/FeSi silicate would cause any fertility effects

Effects on developmental toxicity

Description of key information
The main phase of Si/FeSi silicate consists of practically insoluble silicates, and therefore read-across to other insoluble silicates is applicable in cases where no data is available on Si/FeSi silicate.
Ca-silicate and Na-Al-silicate did not cause developmental toxicity/teratogenicity in various animal species. Based on read-across to these silicates, supported by the lack of general systemic effects caused by silicates, there are no indications of potential risks of developmental toxicity to be induced by Si/FeSi silicate.

Justification for classification or non-classification

No classification is suggested.

Si/FeSi silicate has not been tested for toxicity to reproduction, but based on the poor solubility and general non-toxic nature of the substance, and read-across from teratogenicity studies with insoluble silicates, it can be assumed that Si/FeSi silicate is not likely to cause any fertility or developmental toxicity effects.

Additional information