D-Glucitol, 1,5-anhydro-1-C-[3-[[5-(4-fluorophenyl)-2-thienyl]methyl]-4-methylphenyl]-, 2,3,4,6-tetraacetate, (1S)-

PBT assessment

PBT assessment: overall result

Reference

Name:

T003066

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Related composition:

T003066-boundary

Reference substance:

T003066

PBT status:

the substance is not PBT / vPvB

Justification:

The PBT properties were assessed according to the screening criteria laid down in the ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2017).

One key study is available (Desmares-Koopmans, 2017) where the ready biodegradability of the substance was determined according to OECD 301 B (Klimisch score of 1). The relative biodegradation values calculated from the measurements performed during the text period relealed 6% and 23% biodegradation of the test item based on ThCO2, for the duplicate bottles tested. The criterion for ready biodegradability was not met (at least 60% biodegration within a 10-day window).

According to the screening criteria laid down in the ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2017), a biodegradation of <60% measured as ThCO2 according to OECD 301 B indicates that substance is potentially P or vP.

The bioaccumulation assessment is based on the screening criteria in Annex XIII of the REACH Regulation. A measured Log Kow of 5.5 at pH 7 has been determined in an OECD 117 study (Reingruber, 2017).

No full bioaccumulation test with T003066 is available but the estimated BCF value (using the measured log Kow value of 5.5) is 1977 L/kg ww (BCFBAF v3.01 program; Estimation Programs Interface Suite™ for Microsoft® Windows v 4.11., US EPA), which indicates that the substance does not fulfill the screening criteria in Annex XIII of the REACH Regulation for bioaccumulation assessment (BCF > 2000 L/kg ww) but the predicted value is close to the cut-off value.

Since the measured log Kow of the parent compound is above the criterium of log Kow > 4.5 and the predicted BCF value is close to the cut-off value of 2000 L/kg, the test substance is considered potentially B.

Chronic toxicity data are available for algae only. Due to the very low solubility of T003066, concentration levels that might be toxic for algae could not be reached and no effects on growth rate and yield were seen in 100% of a saturated solution prepared at a loading rate of 100 mg/L. In addition, the substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to the CLP Regulation and the substance is not classified for specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to the CLP Regulation. Therefore the substance can be concluded not to fulfil the criteria for "T".

Taking into account all available data, it can be concluded that the substance is not PBT/vPvB.