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Description of key information

Key value for chemical safety assessment

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The physico-chemical properties of the substance suggest that Amber core should be available for absorption by oral or dermal route as it has a low water solubility and a fairly high partition coefficient. Its low vapour pressure value suggests that it would not be an inhalation hazard.

The histopathological effects on the liver and kidney observed in the sub-acute study and considered as a strong adapatative response at the intermediate dose demonstrated that the test material is absorbed via the gastro-intestinal tract and distributed to at least the major organs. The lack of full recovery two weeks after withdrawal of treatment suggests that there may be a degree of bio-accumulation.

The increase in liver weights and the hepatocytic hypertrophy observed in the sub-acute study and the one-generation reproduction study indicated that the test substance is metabolised in the liver.

The increase in water consumption and the urinary changes observed in the oral sub-acute study indicate that the kidney is a major route of excretion of the test material and/or its metabolites. The increase in hepatic bile pigments without any change in haematology, and the observed cholangitis, suggested that a proportion of the test material or its metabolites are eliminated by biliary excretion.

The low water solubility and a fairly high partition coefficient of the substance suggest that it may be absorbed by skin contact.