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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

Assessment of PBT/vPvB Properties

An assessment of the PBT status of TAEE has been made using all available data. The information available suggests that TAEE does not meet the PBT screening criteria as outlined in Directive 2006/121/EC.

Persistence Assessment

TAEE is not readily biodegradable in the aquatic environment according to a GLP-compliant standardised aerobic ready-biodegradation test (OECD 301D guideline; Closed Bottle test) (Harlan Laboratories, 2008). TAEE is therefore identified as potentially persistent.

Bioaccumulation Assessment

No bioconcentration tests are available for TAEE, but data are available for the structurally related aliphatic ether MTBE. Experimental bioconcentration factors (BCF) of 1.5 and 1.4 l/kg were determined (Fujiwara e al., 1984). However, as TAEE has a higher log Kow than MTBE (3.15 and 1.06, respectively), it is expected that the bioaccumulation for TAEE is higher than the bioaccumulation observed for MTBE. QSAR calculations have been performed for both substances using the program BCFWIN™ v3.00. For TAEE the estimated BCF was 55.6 l/kg and for MTBE it was 2.32 l/kg. As the calculated BCF for TAEE and MTBE differ approximately a factor of ca. 25, this factor is used as the safety factor for the experimental BCF of TAEE. The experimental BCF was 1.5 l/kg for MTBE and thus, a BCF in fish of 37.5 l/kg for TAEE is determined. TAEE is therefore identified as not bioaccumulative.

Toxicity Assessment

The short-term effect concentrations for all three trophic levels are higher than the screening criterion of 0.1 mg/l (lowest effect concentration is 143.2 mg/l in Daphnia magna [Brixham Environmental Laboratory, 2010a]). It can therefore be expected that TAEE is not potentially toxic towards aquatic organisms. Long-term tests with Daphnia magna and algae show effect concentrations far above the criterion of 0.01 mg/l. TAEE is not classified for CMR properties. Therefore TAEE is not identified as toxic.

Summary and overall Conclusions on PBT or vPvB Properties

The overall conclusions, based on the present available data, of the preliminary PBT assessment are that the (screening) criteria for PBT/vPvB are not met and that further testing in the scope of the final PBT assessment is not considered to be required.

Likely routes of exposure:

TAEE is not a PBT/vPvB substance, therefore the emission characterisation need not to be conducted.