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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Endpoint summary

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Administrative data

Link to relevant study record(s)

Description of key information

Key value for chemical safety assessment

Additional information

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.