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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

The available evidence on degradation, bioaccumulation potential, and toxicity for C.I. Solvent Blue 79B indicates that the screening criteria for persistence (P) is met, the screening criteria for bioaccumulation potential (B) is not met, and the screening criteria for toxicity (T) is not met. Based on the information described below, the substance is not PBT nor vP/vB.

Persistence assessment: Solvent Blue 79B was tested for biodegredability in a manometric respirometry test.   The degradation rate of Solvent Blue 79B was <10% after a test duration of 28 days. Based on screening level criteria, the test substance is considered persistent (P).

Bioaccumulation assessment: The measured log (base 10) of the n-octanol/water partition coefficient for the components of C.I. Solvent Blue 79B was > 6.5.   The bioaccumulation potential of C.I. Solvent Blue 79B was assessed via an EpiSuite QSAR, and the predicted BCF (BCFBAF V3.01) for all of the evaluated components ranged from 6 to 9.2 L/kg wet weight.   This, along with the high Kow indicates a low probability of the test material to bioconcentrate in fish.  

Toxicity assessment: The screening assessment for environmental toxicity is based on acute aquatic toxicity testing. No aquatic toxicity testing is available for C.I. Solvent Blue 79B since the main components are highly water insoluble.  To estimate acute aquatic toxicity, EPISUITE ECOSAR was conducted for the main components of C.I. Solvent Blue 79. ECOSAR estimates indicated that acute toxicity is not expected at concentrations below the predicted water solubility limit for this material.  Furthermore, reproductive, genotoxicity and repeat dose toxicity studies on an analogue read across substance (C.I. Solvent Blue 98) indicated no concerns for reproductive, mutagenic, or repeat dose toxicity, respectively.  Thus C.I. Solvent Blue 79B does not meet the criteria to be considered toxic (T).