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PBT assessment

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PBT assessment: overall result

Reference
Name:
T002102
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Related composition:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

An evaluation of the inherent properties of T002102 is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2014) were applied.

The persistency assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The biodegradation potential of the test substance has been assessed in a OECD 301F study (Peither, 2002). The substance is considered not to be readily biodegradable, since it did not biodegrade under the conditions of the test (-2% based calculations for theoretical oxygen demand). It can therefore be concluded that based on the criteria mentioned above the substance is persistent in the environment. The substance is concluded to be P/vP.

The bioaccumulation assessment is based on the screening criteria in Annex XIII of the REACH Regulation. A main test according to the OECD guidelines 107/117 (either HPLC or flask shaking method) could not be applied. Therefore the partition coefficient was estimated using the solubility data in n-octanol and in water. A Log Kow of -2.9 was determined (RCC, 2002). Since the log Kow of the parent compound is below the criterium of log Kow ≤ 4.5 no further assessment on bioaccumulation is needed. The test substance is concluded to be not B/vB.

The available evidence on the toxicity potential for the substance is sufficient for an assessment based on the Annex XIII criteria for this endpoint. Since, the substance is classified as mutagenic category 2, toxic for reproduction category 2 and STOT RE 2, it fulfills the criteria for being considered as Toxic.

Taking into account the conclusions derived for each of the criteria, the substance is P/vP, not B/vB and T. Hence, the substance should not be considered as a PBT/vPvB substance.