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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

Based on limited degradation following a Zahn-Wellens test, a TOC removal analysis, and the nature of the disperse dyes, the substance is considered to be persistent. Very low log Pow values (calculated to be 1.98) indicate a low potential for bioaccumulation. A 28-day repeated dose study in rats resulted in mortality of male and/ or female animals at 300 mg/kg/d and at 750 mg/kg/d. There was also an adverse effect of FAT 92368 treatment on kidney weight was associated with tubular degeneration, necrosis and/or regeneration in the pars recta of the kidney in all test-item treatment groups. Subsequently, a NOAEL could not be determined and a LOAEL of 100 mg/kg bw/day was established. These data resulted in a classification for Specific Target Organ Toxicity, Repeated Exposure (STOT-RE) Category 2 which indicates a potential for chronic toxicity. While the substance fulfills the P and T criteria, the B and vB criteria are not met according to Annex XIII of the REACH Regulation. Therefore, the substance is not a PBT or vPvB substance according to the REACH Regulation.