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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

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 Specific Target Organ Toxicity, Repeated Exposure (STOT-RE) Category 2 classification 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.