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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin and eye irritation studies with magnesium silicate were available for evaluation.  None of the results indicated any irritant effects of synthetic amorphous magnesium silicate administration.  The silicon dioxide results were reported to show the similarity in effect in terms of irritation to the skin and eyes.  

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Synthetic amorphous magnesium silicate, with molar ratio (SiO2:MgO) range of 1.4-4

Transient slight dermal and ocular reactions were observed following 4 hour semi-occluded application to intact rabbit skin or instillation of the weight equivalent of a volume of 0.1 mL into rabbit eyes. The reactions rapidly resolved and in no case were classification thresholds breached.

In a separate study with synthetic amorphous magnesium silicate, with molar ratio (SiO2:MgO) range of 1.4-4 (known as Magnesol), no erythema or oedema were observed in any rabbit throughout the study.

Silicon dioxide:

In four studies, silicon dioxide applied to intact or abraded skin sites elicited no more than transient slight erythema which had resolved in all case within 72 hours.

In six studies where silicon dioxide was instilled into rabbit eyes as a known weight of powder, other than isolated incidences of slight transient ocular irritation, there were no reactions that indicated an ocular irritant effect.

None of the available data for magnesium silicate or read-across analogues, such as silicon dioxide, gave any indications of irritation/corrosion. The toxicity profile and physico-chemical properties for silicon dioxide and magnesium silicate are similar and warrant read-across for endpoints without additional experimental data on magnesium silicate.

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Skin Irritation/Corrosion:

Magnesium silicate was not classified as a skin irritant as it did not fulfil the criteria detailed in Regulation EC No. 1272/2008

Eye Irritation/Corrosion:

Magnesium silicate was not classified as an eye irritant as it did not fulfil the criteria detailed in Regulation EC No. 1272/2008