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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Link to relevant study record(s)

Description of key information

Only standard information required at REACH Annex VIII is available for assessing the toxicokinetics for the test substance. The available test data do not permit conclusions concerning absorption, metabolism or excretion to be drawn conclusively. The test substance data indicates that the test substance is not classified for acute toxicity effects via the oral and inhalation routes and the effects observed in these studies and in the repeated dose and developmental screening test indicate that absorption and distribution of the test material in vivo is likely to be low. No assessment of PBT or vPvB in accordance with REACH Annex XIII is required for the substance as it is inorganic and accordingly the bioaccumulation potential is expected to be low.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

The available test data do not permit conclusions concerning absorption, metabolism or excretion to be drawn. In the acute oral study, no mortality was observed at 2000 mg/kg (the limit dose) as was the case with the acute inhalation study (i.e. no effects observed up to the limit concentration)

In the combined repeated dose and developmental screening assay (OECD 422 study), there was no adverse test substance related effects. Minimal vacuolation of the squamous epithelium at the limiting ridge in the stomach was observed in a low number of males treated at 1000 mg/kg/day. However, this was minimal and indicative of minor local irritation at the point of contact.

The lack of study findings potentially indicate that the test substance is not absorbed via oral and inhalation exposure and distributed systemically.

No reproductive toxicity or developmental effects were observed at any dose tested indicating either low absorption to the relevant tissues involved or low general tissue toxicity.

There were no positive findings in any of the in vitro genotoxicity assays conducted.