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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In-vivo skin irritation studies carried out on rabbits for Laponite type 2 (a read-across substance of virtually identical composition and structure) gave Primary Irritation Index scores of 0.18 and 0.5 respectively. According to the scoring system these results imply only mild irritation in rabbits and no requirement for human classification. 
Since no in-vivo tests existed for this substance, an in-vitro human epidermis test was commissioned to strengthen the evidence from the read-across test data. This test suggested that Laponite type 1 was non-irritant - giving a similar result to the negative control item.
No in-vivo eye irritation studies have been carried out on this material previously. As a result, an in vitro test was commissioned based on the effect of the substance on a dead cow's eye. Based on the in vitro test results for the effect of this substance on bovine corneal opacity and permeability, the score result was of the same order as the -ve control used (saline solution) and thus deemed to be not irritating to eyes.
Based on this finding and on other supporting evidence from manufacturing experience and from other in-vivo testing carried out on Laponite type 2, it was considered there was sufficient evidence to suggest that in-vivo testing was not necessary to confirm the conclusion that this material is a non-irritant to both eyes and skin.

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

Laponite type 1 is not classified as an irritant.

Justification for classification or non-classification

Results of in vitro and in vivo studies undertaken, in addition to evidence from human exposure to this substance both at the manufacturing site and in the consumer market, indicate that this material is not an irritant to neither skin nor eyes.