Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

Criteria for assessing PBT properties are defined in Annex XIII, REACH Regulation (EC) No. 1907/2006. Further details are laid down in ECHA Guidance on Information Requirements and Chemical Safety Assessment; Chapter R.11: PBT Assessment (May 2008). The assessment of PBT / vPvB properties is based upon a separate assessment for each parameter (i.e. P or vP, B or B and T). Substances are only assigned as PBT or vPvB when they fulfil the criteria for all three properties (persistency, bioaccumulation and toxicity in case of PBT substance) or both criteria (i.e. very persistent and very bioaccumulative) in case of vPvB, respectively.

Experimental results from different read-across candidates were taken into account to complete the PBT/vPvB assessment for Cu(II)-IDHA. This procedure is reliable; for justification, please refer to the separate read-across statement performed by Chemservice S.A. (2014). Thus the same conclusions regarding PBT properties are drawn for the registered substance. The assessment applies to Cu(II)-IDHA as well as to all read-across substances taken into account.

Due to the results of the biodegradability tests, Cu(II)-IDHA is considered as not persistent (not P) and not very persistent (not vP). The B criterion (bioaccumulative substance) is not fulfilled, due to the determined logPow of -3.09 (at 23 °C) and predicted Bioconcentration factor (BCF) below the trigger value of 2000 L/kg.

Concerning available ecotoxicity data, the T criterion is not fulfilled either. Furthermore, no classification exists as carcinogenic, mutagenic or toxic for reproduction according to Regulation (EC) No. 1272/2008. The test substance is neither classified as "T, R48" or as "Xn, R48" based on the criteria laid down in Directive 67/548/EEC nor as STOT RE category 1 or 2 so far.

In conclusion, Cu(II)-IDHA fulfils no relevant criterion for P/vP, B/vB or T. Therefore, making all allowances for regulatory parameters available, the substance is neither PBT nor vPvB.

Likely routes of exposure:

Cu(II)-IDHA is produced, supplied and marketed as solid in form of microgranules. Due to the intended use as fertilizer, direct exposure of the solely substance to soil is intended. Workers and consumers may be exposed via the dermal route due to substance handling during manufacture, further processing and the end-use of the substance. Based on the substance specific properties (i.e. logPow of -3.09), the substance is not likely to penetrate skin to a large extent.

Based on the low vapour pressure of the substance, an uptake via the inhalative route is not relevant. Oral exposure is not relevant for workers based on the handling, education and safety precautions in industrial and/or professional settings. Oral exposure of consumers cannot be completely ruled out and is, thus, considered as relevant. In conclusion, dermal and oral exposure route may be relevant for humans.