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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 extensive conclusions concerning absorption, metabolism or excretion to be conclusively drawn. As the substance was deemed to be corrosive, minimal vertebrate studies have been conducted.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

The substance is a UVCB with many high-molecular weight components of which adsorption and systemic exposure would not be expected. However, repeated oral administration of the test substance (in an OECD 422 study) to rats provided a parental NOAEL of 250 mg/kg/day. This was based on minimal to mild atrophy of the thymus observed in half of the high dose (5 out of 10) females receiving 500 mg/kg/day, when compared to the controls. This lesion was characterized by thymic lymphocyte depletion correlated with reduced thymus size and weight. Also observed were epithelial changes ranging from focal or multifocal erosion of the glandular region of the stomach seen in a few high dose animals of both sexes at the high dose.

These and other minor changes indicate that the substance (or components of the substance) are likely to be adsorbed and enter systemic circulation. Based on the relatively low Log Kow values (<4.5), bioaccumulation of the test substance is not expected.

No adverse treatment related changes were observed in any of the developmental or reproductive parameters in the OECD 422 study, possibly indicating low adsorption through the placenta to directly affect the foetuses and similarly as no effects were observed in pups during the lactation phase, low exposure to the developing pups via lactation is likely.

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