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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Ecotoxicological information

Long-term toxicity to fish

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Administrative data

Link to relevant study record(s)

Description of key information

This end point has been waived. This substance has been assessed as not having a long term toxic effect on fish - see discussion

Key value for chemical safety assessment

Additional information

This substance is an inorganic synthetic version of Hectorite clay, which commonly occurs in nature and is in the same family of clays as bentonite. The material is inorganic and thus non-biodegradable, retaining its clay structure in the environment. At normal water course pH’s this material is stable and insoluble. It does not dissolve in water but disperses to form a clear sol and in the pH range 4 – 9 does not hydrolyse. The majority of the applications for which this substance is used will not result in the material being released to water courses directly. Personal care product applications such cosmetics will result in very low concentrations of this substance (100 mg/l) being released into the domestic sewage system and finding its way into water treatment works. This substance has a high molecular weight, when hydrated forms a sol (or a gel at higher concentrations) and studies within the manufacturing effluent treatment facility suggest that the material sediments and is retained in the solid waste rather than going forward in the flume / purified water released to the river. If low concentrations do get through the water treatment process and enter the water course, the fact that the material does not biodegrade, is not soluble, does not hydrolyse and is of a high molecular weight suggest that transfer across biological membranes is unlikely. In addition, short term aquatic toxicity tests carried out on fish and daphnia show this substance is not toxic to marine life. On this basis the need for long term aquatic testing is waived.