cis-2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-ylmethyl benzoate

PBT assessment

PBT assessment: overall result

Reference

Name:

T001095

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Related composition:

T001095

Reference substance:

T001095

PBT status:

the substance is not PBT / vPvB

Justification:

An evaluation of the inherent properties of T001095 is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2014) were applied.

The persistency assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The biodegradation potential of the test substance has been assessed in an OECD 301B study (Desmares-Koopmans, 2017). JNJ-16479671-AAA (T001095) was biodegraded significantly (22% and 30%) during the test period. A degradation of > 20% in an ready biodegradability study provides an indication of the potential non-persistence of the substance. In the absence of higher tier data and since at least 60% biodegradation was not reached within 10 days immediately following the attainment of 10% biodegradation (10-day window), persistence (potentially P or vP) is assumed.

The bioaccumulation assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The log n-octanol/water partition coefficient (log Pow) of the test substance was determined to be slightly above the cut-off value of 4.5 in the study performed (Ciric, 2017) which may indicate a potential for bioaccumulation. The study showed that the substance was unstable as 2 chromatographic peaks were observed corresponding to log Kow values of 5.4 and 5.8 respectively. The latter value can be assigned to the major peak.

Biodegradation up to 30% was observed in an OECD 301B study also indicating that the parent compound is unstable. No hydrolysis study was performed since the water solubility of the test item was 0.012 mg/L and no analytical method was available to support the hydrolysis test at this low concentration level. No toxic effects were observed in any of the ecotoxicity testing performed at the highest tested concentrations, however analytical results reveal that test concentrations were unstable and significantly decreased in the course of the studies.

Taking all of these factors into account, the substance can be considered as unstable which is an indication that the actual measurement of the log Kow may not be very reliable, therefore bioaccumulation is expected to be rather low. Furthermore, the utility of a partition coefficient in determining the bioaccumulation potential of unstable substances is questionable. Therefore the substance is considered not to meet the B/vB criterion.

The toxicity assessment is based on the screening criteria in Annex XIII of the REACH Regulation. Taking into account the available data and the criteria of the CLP regulation (REGULATION (EC) N° 1272/2008), the substance does not fulfill the screening criterium for being considered as T.

Taking into account the conclusions above, at this stage the substance should not be considered as a PBT or vPvB substance.