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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The registered substance is readily biodegradable and no transformation product was detected after 28 days. Therefore, the registered substance and the potentiel degradation product(s) are not considered persistent (P) in the environment.


 



Then, according to ECHA Guidance Chapter R.11 Version 3.0 (June 2017), the B-criterion is unlikely to be triggered for substances with a log Kow higher than 10. Indeed, for highly hydrophobic substances, like the registered substance with a log Kow value > 6, experimentally derived BCF values tend to decrease with increasing log Kow. This was confirmed with predicted BCF values, all comprised between 0.94 and 9.42 L/kg. The registered substance is not considered bioaccumulable (B) or very bioaccumulable (vB) (BCF < 2000). In addition, the registered substance presents no toxicity for mammals. The "No Observed Adverse Effect Level", NOAEL, was determined at the highest tested dose in the sub-acute and sub-chronic oral toxicity studies. This observation confirms the limited absorption and therefore the limited bioaccumulation of the registered substance.


 



Finally, no toxic effects were observed up to the highest loading rate of 10000 mg/L (or 10 mg/L in the chronic fish test) in experimental acute and chronic studies for the three aquatic trophic levels (fish, aquatic invertebrates and algae). The substance is not classified as carcinogenic, mutagenic, or toxic for reproduction according to Directive 67/548/EEC or carcinogenic, germ cell mutagenic, or toxic for reproduction according to Regulation EC No 1272/2008. In addition, there is no evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specific target organ toxicity after repeated exposure according to Regulation EC No 1272/2008. Therefore, the registered substance is not toxic (T).


 


As the potentiel degradation product(s) of the registered substance are not considered Persistent in the environment, there is no need to assess whether the Bioaccumulation and/or Toxicity criterion is/are fulfilled, for the PBT Assessment.


 


In conclusion, the registered substance and the potentiel degradation product(s) could not be considered as a PBT or vPvB substances.

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