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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

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.