Registration Dossier
Registration Dossier
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EC number: 928-226-3 | CAS number: 1179884-99-1
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
On the basis of its properties the substance will have very minimal absorption via the gastrointestinal tract or via dermal uptake.
Oral uptake or inhalation of the grease containing the substance would be highly unlikely. The prime route of exposure would be via the skin.
Key value for chemical safety assessment
Additional information
Components of this UVCB substance are known and known to be of relatively high molecular weight (range 789 - >1829). The substance has very low solubility in water (estimated by atom fragment contribution method ) (WSWIN) as <= 4.57 x 10-19g/l at 25º C. very high solubility in oil (log10Powof >= 19.1. – by atom fragment contribution method – WSWIN). On this basis it can be predicted that the substance will have very minimal absorption via the gastrointestinal tract or via dermal uptake. Should the substance be taken up eg as particulate via pinocytosis in the gut its properties indicate that it will be not be bioavailable due to its very low solubility. Granulometry of the test material shows that 95.5% by mass is mass median aerodynamic diameter >= 100 µm so the material is not inhalable. Should fine dust from this test material be inhaled then the very low water solubility and high molecular weight would mitigate against absorption and clearance via the mucillary escalator would be expected.
Whilst the key test material used in hazard determination was an isolated solid, in commerce this material is manufactured and used for thickening lubricating greases only in oil solution. In this context oral uptake or inhalation of the grease containing the substance would be highly unlikely. The prime route of exposure would be via the skin. Despite being formulated in an oil phase the high molecular weight of the components of the substance (range 789 - >1829) and the test substances low solubility in water indicate that uptake will be minimal.
No data from existing toxicology studies from the oral and dermal routes or from local tolerance studies provide a basis for contradicting the above interpretation. This is further supported by the work attempted at CXR Biosciences. Although it was not possible to proceed with absorption testing due to the difficulties in finding a suitable solvent/quantitative analytical method this provides further evidence for the lack of bioavailability of the registered substance as for a compound to be absorbed in the intestine after oral administration the solid form must disintegrate, dissolve and diffuse to the surface of the intestinal epithelium to be absorbed into the systemic circulation. Materials such as the registered substance will not dissolve and will therefore have negligible bioavailability.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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