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PBT assessment

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PBT assessment: overall result

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

The registered substance is not readily biodegradable but disappears totally (100% biodegradation after 28 days, calculated from direct quantitative analysis by GC method) to form two degradation products: succinic acid (degraded and mineralized completely) and 3,3-dimethyl cyclohexanone (called DMCH, which is present at 100% after 28 days). Therefore, the registered substance is not persistent in the environment. In addition, according to a QSAR prediction, the relevant degradation product of the registered substance (DMCH) is not readily biodegradable but achieves > 60% of biodegradation after 60 days. Additionally, the predicted ultimate half life is 19 days, well below the threshold value of 40 days and 60 days for persistence and very persistence. Therefore, it can be concluded that DMCH also is not persistent in the environment.

With measured log Kow values at 4.1 and 2.0 for the registered substance and its relevant degradation product (DMCH), respectively, both substances are not considered bioaccumulable.

Finally, for the registered substance, one long-term aquatic toxicity data is available on algae with an ErC10 value greater than 0.01 mg/L (at 1.7 mg/L). In addition, short-term aquatic toxicity data are available on the three aquatic trophic levels (algae, daphnia, fish) with E(L)C50 values greater than 0.1 mg/L (lowest value at 1.7 mg/L). The registered substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to Regulation EC No 1272/2008 and no other evidence of chronic toxicity was observed, as identified by the classification specific target organ toxicity after repeated exposure (STOT RE Category 1 or 2) according to Regulation EC No 1272/2008. Therefore, the registered substance is not toxic.

For its relevant degradation product (DMCH), the estimated acute endpoint values (E(L)C50), determined with a QSAR model, were well greater than 0.1 mg/L (greater than 40 mg/L). Therefore, DMCH is presumably not toxic.

In conclusion, the registered substance and its relevant degradation product does not fulfill any of the PBT or vPvB criteria.