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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

RED JB 747 is hydrolytically stable at pH range from 4 to 9, with an estimated t1/2 > 1 year at 25 °C and it is not readily and inherently biodegradable by microorganisms. Despite its persistence, RED JB 747 shows a very high affinity to the water phase (logKow = -2.9) which excludes a bioaccumulation potential in organisms.

The substance is neither classified for CMR properties nor for specific target organ toxicity, repeat exposure.

Despite no long term toxicity data are available for aquatic organisms, it could be possible to conclude that the substance will not be chronically toxic for aquatic organisms and, with reasonable probability, its LC/E50 or NOEC will not be below the threshold value of 0.01 mg/L required for the toxicity “T” classification.

For these reasons, according to REACH regulation, Annex XIII (section 1), the substance does not meet the criteria for PBT classification, since only the criteria for persistence has been satisfied.

Likely routes of exposure:

Due to its high affinity to the hydrophilic phase and because bioaccumulation is not significant, exposure from the consumption of contaminated water seems to be the most relevant route.