1-[([[(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl]oxy]carbonyl)oxy]pyrrolidine-2,5-dione

PBT assessment

PBT assessment: overall result

Reference

Reference 1

Name:

T002632 - LE composition

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Related composition:

T002632 - Boundary composition

Reference substance:

T002632 - LE composition

Reference 2

Name:

T002632 - Boundary composition

Type of composition:

boundary composition of the substance

State / form:

solid: particulate/powder

Reference substance:

T002632 - Boundary composition

PBT status:

the substance is not PBT / vPvB

Justification:

An evaluation of the inherent properties of T002632 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. T002632 was biodegraded significantly (31% and 35% in bottle A and B respectively) during the test period of a ready biodegradability study according to OECD guideline 301B. However, since at least 60% biodegradation was not reached within 10 days immediately following the attainment of 10% biodegradation (10-day window), the criterion for ready biodegradability was not met. Hence the substance could be classified as preliminary persistent according to screening criteria. However, the half-life of T002632 in water is below 1hour, which is much lower than the P(vP) criterion of t1/2> 40 (60) days. Based on this, T002632 is not considered to be persistent in the environment and is identified as not P. It can therefore be concluded that based on the criteria mentioned above the substance is not be persistent in the environment. The substance is concluded to be not P/vP.

The bioaccumulation assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The log Kow of T002632 was determined according to OECD guideline 117. The Pow value of the test item at 20°C and pH 7 was <2.0, which corresponds to a log Pow value of <0.3 and is below the trigger value of 4.5. The substance is therefore not considered B or vB.

The available evidence on the toxicity potential for the substance is sufficient for an assessment based on the Annex XIII criteria for this endpoint. Based on a 72-h growth inhibition test with the unicellular green alga Pseudokirchneriella subcapitata according to the OECD guideline 201. The 72h-NOEC for growth rate was 32 mg/l based on statistical significance and 100 mg/L based on biological relevance, which is above the trigger value of 0.01 mg/L. Furthermore, the substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), toxic for reproduction (category 1A, 1B or 2), or classified for specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to the CLP 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.

To conclude, T002632 is not considered a PBT or a vPvB substance according to the EU criteria.