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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
Reaction mass of ethylenebis(oxyethylene) dibenzoate and oxydiethylene dibenzoate and oxydipropyl dibenzoate
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

8.1. Assessment of PBT/vPvB Properties

8.1.1. Persistence Assessment

In modified Sturm tests for two of the constituents of this reaction mass, DEGDB and DPGDB were found to be readily biodegradable. Moreover TEGDB has been found to be readily biodegradable in a CO2 evolution test. Based upon these results the reaction mass would not be rated as persistent according to REACH Annex XIII regulation and would not be rated as a P or vP substance (half-life in fresh-water of greater than 60 days).

8.1.2. Bioaccumulation Assessment

A study measuring bioconcentration was not available for the reaction mass substance or its constituents. QSAR estimates have been made for the two components (DPGDB, DEGDB) of the reaction mass. Evidence of a low bioaccumulation potential is provided by these estimates, showing BCF values <200 L/kg for DPGDB and <100 L/kg for DEGDB, using a regression method based upon the experimental log Kow of 3.9 for DPGDB (HLS, 1999, VCL249/972399) and of 3.2 for DEGDB (HLS 1999, VCL261/972408) and using the Arnot-Gobas QSAR method the BCF/BAF values for all trophic levels are < 10 L/kg when biotransformation rates are utilized. The QSAR values support a low potential to bioaccumulate and are well below the REACH Annex XIII criteria for B or vB.

8.1.3. Toxicity Assessment

For each of the constituents of this reaction mass all three trophic levels were represented in aquatic toxicity studies: primary producers represented by algae, plant eating invertebrate animals represented by daphnids, and freshwater fish. LC/EC50 values for all of these organisms were > 1 mg/L. The reaction mass and the individual constituents are not classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2) or toxic for reproduction (category 1, 2 or 3). There is no evidence to suggest that this reaction mass would be classified as T/R48 or XN/R48 for chronic toxicity. Therefore this reaction mass does not meet the T criterion.

8.1.4. Summary and overall conclusions on PBT or vPvB properties

This reaction mass is readily biodegradable and therefore is not P or vP. QSAR data suggests a low potential for this reaction mass to bioaccumulate. However, as an experimental BCF study is not available for this reaction mass the lack of B or vB criterion is not definitive. Aquatic toxicity is minimal and it is not rated as a mutagen or toxic for reproduction and available studies do not support this reaction mass as having adverse chronic toxicity or being a carcinogen, therefore the T criterion is not met. Based upon the fact that substances are classified when they fulfil the criteria for all three inherent properties for P, B and T, this reaction mass cannot be classified as a PBT or vPvB as it is not Persistent (P) or Toxic (T) based upon experimental data, In addition, QSAR data suggests that this reaction mass is not B or vB as well.