Registration Dossier
Registration Dossier
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EC number: 210-323-0 | CAS number: 612-83-9
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
Data on toxicokinetics were reported from secondary sources. However, often no clear distinction was made whether the testing was performed with the submission subtance (3,3'-dichlorobenzidine dihydrochloride) or the free base (3,3'-dichlorobenzidine). In the following it is assumed, that the findings for the free base also apply to the submission substance.
Reliable data on the toxicokinetics of the submission substance in humans are missing. Based on animal data, mainly in the rat, it can be concluded that the submission substance is absorbed after oral and dermal exposure. After oral exposure absorption is nearly complete. Dermal exposure for 24 hours to the base resulted in about 50% absorption which can also be assumed for the submission substance. Information on absorption in animals following inhalative exposure are missing.
The submission substance is rapidly distributed throughout the body and there is evidence that the test item can cross the placental barrier. There is no information whether it can be transferred to the breast milk.
N-acetylation seems to be the major pathway for metabolism of the submission substance in mammals. The metabolites N,N'-diacetyl-3,3'dichlorobenzidine and N-acetyl-3,3'-dichlorobenzidine have been identified in the urine. Additionally, there is indirect evidence for the formation of N-oxidation, nitroso-formation in the rat. Glucuronidation has been described.
The submission substance and its metabolites are mainly excreted via feces and partially via urine. Mainly unconjugated metabolites are excreted via urine whereas most of the material found in bile and feces consisted of conjugated metabolites. The submission substance seems to be subject to enterohepatic recirculation. Biphasic elimination has been described for plasma, liver, kidneys and lungs of rats. The half lives in plasma were 6 hours and 14 hours for the rapid and slow phase. For the individual organs even longer half-lives were reported.
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