Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Regardless of wide-spread exposure to silicon compounds, including synthetic amorphous silicas, no cases of sensitisation to silicon compounds have been described.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Silica fume has not been tested for its sensitising properties. Neither has synthetic amorphous silica been tested for skin sensitisation. But long and wide-spread use of synthetic amorphous silica (including, for example, in cosmetics) without any single cases of silica sensitisation supports the lack of sensitising properties of amorphous silica. Silica fume is considered to resemble synthetic amorphous silica in this respect. The lack of skin sensitising properties is supported also by the lack of case reports from the ferrosilicon/silicon metal industry, despite decades of exposure of workers to silica fume. Silicon ion is ubiquitous in the environment and amorphous silica is used also as a food additive. Its main impurities, which have been shown to be dissolved in artificial biological fluids, (iron, magnesium, lead, aluminium and zinc), do not exert skin-sensitising properties.



Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No cases of respiratory tract sensitisation caused by synthetic amorphous silica or silica fume have been reported in the literature from the silica/ferrosilicon/silicon manufacturing industry or on the use of synthetic amorphous silicas or silica fu

Justification for classification or non-classification

Based on the ubiquitous nature of silicon ion and the lack of cases of skin or respiratory tract sensitisation to amorphous silica, despite the widespread use of amorphous silica, amorphous silica is unlikely to exert sensitising properties. Thus, silica fume is also not considered sensitising to skin or the respiratory system.