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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:

PBT assessment is done only on the product since there are no degradation products.FR-245 is a hydrophobic molecule with molecular weight of 1067g/mol. The substance has an extremely low water solubility (< 1μg/l), and a high estimated logPow of 8.63. Accordingly, it seems very unlikely that the substance will be available for aquatic organisms through the water compartment.

The persistency of the substance was investigated and confirmed in simulation tests conducted in water sediment systems. The transformation of 14C- FR-245 was assessed in aerobic and anaerobic systems. The

DT50 calculated from the simulation studies exceeded 180 days under both conditions. The results of these studies indicate that FR-245 can be considered as very persistent (vP).

The bioaccumulation potential of FR-245 was assessed in a bioconcentration test. Fish were exposed to 0.5 mg/l which is much above the maximum level of water solubility of the substance. Therefore, no conclusive results could be obtained. Performing the study at the level of water solubility is quite impossible since the concentrations of the substance cannot be technically confirmed in water. However, results from the ADME study in rats show only minor absorption and retention of FR-245 in tissues (<0.2%), indicating virtually negligible uptake of the substance. These findings further support the conclusion that FR-245 will not be bioavailable and therefore will not bioaccumulate.

FR-245 did not show toxicity to aquatic organisms (fish, Daphnia and algae), although the tests were performed above the substance water solubility.

FR-245 did not show toxicity to the MidgeChironomus riparius, in a prolonged sediment toxicity test, NOEC greater than 1000 mg/Kg dry sediment.

FR-245 did not show toxicity to the survival and reproduction of the earthwormEsenia fetida, NOEC greater than 1000 mg/Kg dry soil.

The effect of FR-245 on the seedling emergence and growth of six species of terrestrial non-target higher plants was tested. Minimal toxicity effects were noted in all species tested (EC50 greater than 1000 mg/kg dry soil was achieved for all six species tested). The most sensitive species wasLycopersicon esculentumwith an NOEC 12.3mg/kg dry soil.

The substance is not a CMR and does not exhibit sub chronic toxicity systemic or target organ toxicity to human health.

Therefore, FR-245 does not fulfill the toxicity criterion.

The exposure assessment and risk characterization only needs to be performed if the substance is identified as a PBT, vPvB or meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EEC.

FR-245 is not PBT or vPvB and does not meet the criteria for classification as dangerous and therefore the exposure assessment and risk characterization sections of the chemical safety report are not required.