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PBT assessment

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PBT assessment: overall result

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

The criteria given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT Assessment” (ECHA, 2017) are used to decide if the substance fulfils the PBT or vPvB criteria.

 

Persistence Assessment

The test substance is considered to be not readily biodegradable according to OECD criteria. However the substance was degraded in soil under aerobic conditions. The calculated half-lives ranged between 2.7 and 14.7 days under the chosen test conditions, which correspond to temperature corrected DT50 values of 5.9 – 32.1 days at 12 °C (average environmental temperature in Europe). Therefore, the substance is not expected to have a potential for accumulation in the environment.  

 

Bioaccumulation Assessment

The partition coefficient log Pow = 1.9 was determined at pH 2.0 and 25 °C. Based on the the measured partition coefficient of the unionized form at pH 2 and the pKa of 3.2 of the substance following partition coefficients for the (partly) dissociated form are estimated:

log D (pH 4): ca. 1.0

log D (pH 7): ca. -1.9

log D (pH 9): ca. -3.9

The log Kow and all Log D values for the dissociated form are below the treshold value of 4.5.

Therefore, the substance is not expected to have a potential for bioaccumulation.

 

Toxicity Assessment

Based on the available data 2-{2-chloro-4-mesyl-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione is considered to be toxic. Ecotoxicology studies show the substance to exhibit neither chronic effects on aquatic organisms at or below 0.01 mg/L nor are acute effect values below 0.01 mg/L. However, 2-{2-chloro-4-mesyl-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione is classified for specific target organ toxicity as STOT RE 1 (oral route) and STOT RE 2 (dermal route). The criteria for “T” based on mammalian effects are therefore met. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are met and the substance is considered to be T.

 

In conclusion, the substance is not PBT/vPvB