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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB

Persistence assessment:

Based on the fact that the substance was not ready biodegradable under the stringent conditions of a ready biodegradability test, it fulfills the screening criterion for vP and P. However, the Annex XIII criterion is inconclusive due to the lack of data.


Bioaccumulation assessment:

Even though no confirmatory data are present, a weight-of-evidence approach based on the bioconcentration study, data from mammalian toxicity and the QSAR estimation shows that SPS-100 is not likely to be bioaccumulative and certainly not very bioaccumulative.


Toxicity assessment:

The tested substance does not fulfil the T criterion within Annex XIII.

The NOEC of SPS-100 for the long term toxicity test for fish and aquatic invertebrates equals the maximum soluble concentration in test medium.

and substance is not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) according to Directive 67/548/EEC or carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008

and no other evidence of chronic toxicity, as identified by the classifications T, R48 or Xn, R48 according to Directive 67/548/EEC or specifc target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation EC No 1272/2008.


Additionally, a long-term toxicity study to terrestrial organisms (OECD 222, earthworm reproduction study) indicated no evidence of chronic toxicity (i.e., ≥ NOEC

1000 mg/kg soil dry weight).



SPS-100 does not fulfill the T criterion. SPS-100 could not be classified as a PBT compound. The provisional BCF and the QSAR estimations showed that the BCF/BMF is well below the 5000 L/kg and therefore it can be concluded that the substance is not vP/vB.