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EC number: 617-901-5
CAS number: 866607-35-4
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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