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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated, low sulphonated, saponified
Type of composition:
legal entity composition of the substance
State / form:
other: paste
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Based on available data and considerations, including exposure scenarios, Paraffin waxes and Hydrocarbon waxes C14-17, chloro, sulfochlorinated does not fulfil the PBT and vPvB criteria.

  • The substance shows a ready biodegradability under the conditions applied in a Manometric Respirometry test, having reached the pass level (60% biodegradation) at the end of the 28 days test, showing a total 78.3% during the test period (mean values between two replicates). Being an UVCB substance, following Regulation 286/2011 (emending the regulation 1272/2008 for the purposes of its adaptation to technical and scientific progress), point 4.1.2.9.5 part c, the 10-day window condition can be waived and the pass level applied at 28 days.
  • The substance and its components have a LogPow below 4 and a BCF value below 2000 (apart some borderline situation relating to some minor components.
  •  The IC50 (48h) for Daphnia Magna is 0.22 mg/L (NOEC of 0.09 mg/l). According to Regulation 286/2011 (emending the regulation 1272/2008 for the purposes of its adaptation to technical and scientific progress), the substance does not meet criteria for classification into the categories Chronic 1 to 3.
  • The substance has no Carcinogenic, Mutagenic or Toxic for reproduction effects

Refer to the attached document for the whole PBT assessment.