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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:

The substance diethyl carbonate is not persistent (not P or vP) since it is readily biodegradable. The Log Kow lies with 1.21 below the value of 4.5 which indicates that there is no bioaccumulative potential for the test substance (not B or vB). Diethyl carbonate is also not toxic for aquatic organisms. The short-term aquatic toxicity evaluation revealed a NOEC ≥ 100 mg/L (for algae and daphnia, LC0 ≥ 65 mg/L for fish). As the revealed short-term NOEC is much greater than the assessment criterium (long-term NOEC ≥ 0.01 mg/L), it can be assumed that the corresponding long-term NOEC of the test substance diethyl carbonate is also ≥ 0.01 mg/L.

According to genotoxicity the substance diethyl carbonate showed a negative result in bacteria (in vitro Ames-test) and a positive result in mammalian cells (in vitro micronucleus test). These results are not sufficient for classification as mutagenic (category 1 or 2, see "Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures"), but the generation of genotoxicity data in vivo is proposed (Testing proposal, in accordance with Regulation (EC) No 1907/2006, REACH).

Regarding the published results of Brown, D. et al. (1978), Salaman & Roe (1956) and Roe & Salaman (1955) (see endpoint records 7.7.004 and 7.5.3.001 in this IUCLID dossier) a cancerogenic potential of diethyl carbonate cannot be completely excluded.

The PBT assessment was based on Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment, R.11.1.2 PBT and vPvB criteria (ECHA, May 2008)