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PBT assessment

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PBT assessment: overall result

PBT status:
further information relevant for the PBT assessment is necessary

Overall Conclusion

Criteria for assessing PBT properties are defined in Annex XIII of 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/vPvB Assessment (November 2014). The PBT or vPvB assessment should be based on assessments for each parameter (i.e. P or vP, B or vB and T). Substances are only assigned as PBT or vPvB when they fulfil the criteria for all three properties persistency, bioaccumulation and toxicity (i.e. PBT substance) or both criteria (very persistent and very bioaccumulative) in case of vPvB.

The assessment of the persistence of the registered substance is performed using the revised integrated assessment and testing strategy (ITS) as in ECHA REACH Guidance Chapter R.11 (June, 2017). So far, the assessment of persistency can be based on available half-life data of the study on ready biodegradability in water and calculated degradation half-lives from the results of the study on hydrolysis as described in ECHA REACH Guidance Chapter R.7b (February, 2016).

To enable the possibility to draw a definitive conclusion on persistence as in ECHA REACH Guidance Chapter R.11 (November, 2017), higher tier information in addition to the screening information are needed to conclude the P/vP-assessment on all three compartments. Hence, simulation tests are necessary and are being currently prepared to assess biodegradation in sediment and soil. The respective studies are scheduled in a tiered approach and results will be included in an additional update of the technical dossier, containing a definitive conclusion on persistence as well as a final PBT assessment for the registered substance. This can also cover additional data on the e-fate of hydrolysis products.

Aside from the registered substance, the final hydrolysis product 2,6-diisopropylaniline (DIPA) has been assessed towards its potential PBT and vPvB properties as well. Based on the assessment described in the subsections above, DIPA is not a PBT / vPvB substance.

Thus, overall further information relevant for the pbt assessment is necessary to conclude if the registered substance has to be regarded as not PBT and not vP/vB also.