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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
Disperse Brown 27
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
Disperse Brown 27
PBT status:
the substance is not PBT / vPvB
Justification:

The relative biodegradation values calculated from the measurements performed during the Sturm test period revealed no significant biodegradation of Disperse Brown 27. It was reasoned that Disperse Brown 27 was not biodegradable. Ready biodegradation is listed in Section 3.1 of ANNEX XIII of REACH, indicating Disperse Brown 27 is persistent.

During partition coefficient extermination Disperse Brown 27 was calculated to have logPow and Pow values of >7.2 and >1.6x107 respectively. Based on these results test material is most likely B potentially vB

No immobility was observed in the control and at any of the test concentrations during the test period, the 48h-EC50 for Daphnia magna exposed to Disperse Brown 27 exceeded an average exposure concentration of 0.22 μg/L, which was considered to be the maximum solubility limit of Disperse Brown 27 in medium.

In the study with Pseudokirchneriella subcapitata, no inhibition of growth rate or inhibition of yield was recorded at any of the concentrations of Disperse Brown 27 tested. The EC50 for growth rate (72h-ERC50) and yield inhibition (72h-EYC50) was beyond the range tested, i.e. exceeded a TWA concentration of 0.085 μg/L. The 72h-NOEC for both growth rate and yield inhibition was 0.085 μg/L. Due to the very low solubility of Disperse Brown 27 in water, concentration levels that might be toxic for algae could not be reached

Data points to potential for Disperse Brown 27 to be P and B, also possibly vPvB, but no indication of T.