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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:

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.

Due to results of ready-biodegradability tests, "Reaction Products of alcohols, C14-18, C18 unsat., esterified with phosphorus pentoxide and salted with amines, C12-14,-tert-alkyl" 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 a long-term toxicity potential, 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 substance "Reaction Products of alcohols, C14-18, C18 unsat., esterified with phosphorus pentoxide and salted with amines, C12-14,-tert-alkyl" 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:

Workers may be exposed via the dermal route due to substance handling during manufacture. Based on the substance specific properties (i.e. logPow > 8) the substance will in principle 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.