Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The test substance was unlikely to have dermal absorption, however, a partial oral reabsorption can be assumed. The substance was unlikely to accumulate in the body, while can get excreted via urine and feces.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

A toxicokinetic assessment was conducted based on available physico-chemical properties and toxicological data of the test substance. Oral reabsorption of test substance is also restricted due to the low partition coefficient of -6.2 since most substances with a partition coefficient < 0.5 are only marginally reabsorbed. However, a partial reabsorption after oral gavage can be assumed, since the substance caused discoloration of the serum and some organs. As test substance is an azo dye with an azo bond, a partial metabolic cleavage by bacterial azo-reductases in the intestine resulting in two hydrophilic amines seems to be presumably. Due to the low partition coefficient and the acidic character of test substance, dermal absorption is also unlikely. Due to the physico-chemical properties of test substance, accumulation of the chemical in the body is unlikely. This assumption is supported by the decolorisation of the serum, organs and tissues after terminating the application in repeated dose toxicity study, as the blood serum, organs and tissues of the animals of the recovery group were not stained or only in a few animals (testes). Excretion of the test substance via urine and feces is likely, owing to the fact that molecules up to 15,000 g/mol are easily excreted via the kidneys, as proved by the pigment deposits in the kidneys in repeated dose toxicity study, and substances with a molecular weight above 300 g/mol are preferentially excreted via the feces in rats. In light of available information, it can be concluded that test substance does not show any toxicokinetic peculiarity.