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 REACH 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 (Benzene, mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salts). 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 benzene, mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salts as well as to all read-across taken into account.

Due to results of ready-biodegradability tests, the calcium sulfonate target substance (C10-C14) is considered as persistent (P), but not very persistent (not vP). The B criterion (bioaccumulative substance) is not fulfilled, due to the predicted logPow of > 8 (estimated with KOWWIN v1.68, logPow: 10.59) and predicted Bioconcentration factor (BCF) below the trigger value of 2000 L/kg (70.79 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, benzene, mono-C10-13-alkyl derivatives, distillation residues, sulfonated, sodium salts fulfills only one relevant criterion (Persistency). Therefore, making all allowances for regulatory parameters available, the substance s neither PBT nor vPvB.