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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

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 vB and T). Substances are only assigned as PBT or vPvB when they fulfill 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 the calcium sulfonate target substance (C15 -C36). This procedure is reliable; for justification, please refer to the separate Read-Across Statement of Chemservice S.A. (2013). Thus the same conclusions regarding PBT properties are drawn for the registered substance. In the following, the read across procedure is not mentioned separately, however, the assessment applies to the calcium sulfonate target substance (C15 -C36) as well as to all read-across substances taken into account.

Due to results of ready-biodegradability tests, the calcium sulfonate target substance (C15 -C36) is considered as persistent (P), but not very persistent (not vP). The B criterion (bioaccumulative substance) is not fulfiled, due to the predicted logPow of >8 and predicted Bioconcentration factor (BCF) below the trigger value of 100 L/kg (70.8 L/kg). Due to the lack of toxicity observed in ecotoxicity studies, also the T criterion is not fulfilled. 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.

As conclusion, the calcium sulfonate target substance (C15 -C36) fulfills only one relevant criterion (Persistency). Therefore, making all allowances for regulatory parameters available, the substance is neither PBT nor vPvB.

Likely routes of exposure:

The calcium sulfonate target substance is produced, supplied and marketed in the presence of a liquid mineral oil solvent, thus neither direct nor indirect exposure of the solely substance to the environmental compartments is intended. Workers may be exposed via the dermal route due to substance handling during manufacture. Based on the substance specific properties (i.e. logPow > 6.65; Fox and White, 2011) the substance will be able to diffuse into the dermis but no deeper layers of the skin, i.e. neither the epidermis nor any bloodstream layers will be crossed. Based on the low vapour pressure of the substance, an uptake via the inhalative route is not relevant. Oral exposure is not relevant based on the handling, education and safety precautions in the factory. As conclusion, only the dermal exposure route may be relevant for humans.