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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:

There are no experimental data available for the substance itself in regards to PBT properties. However, a read-across approach is applied taking into account the respective constituents of the test item as well as a similar composed UVCB substance. Therefore, PBT properties of the source substances are considered to adequately reflect the test items PBT properties. For more detailed information on the read-across apporach please refer to read-across justification attached to IUCLID section 13.

All source substances were found to be readily biodegradable. Therefore, there is no evidence that the test item could not be readily biodegradable.

LAS Na (Source substance 2) was demonstrated to not have a potential for bioaccumulation in a respective study.

Based on its physico-chemical properties, DEA (source substance 3) would also not be considered to be bioaccumulative. However, respective toxicokinetic studies revealed an accumulation in liver and kidney with an elimination half-life of 6 days. Mechanistically, a missuse of DEA in the endogenous phospholipid pathway is assumed.

Concluding, the test item itself is not considered as substantially bioaccumulative.

Regarding toxicity, LAS Na is neither classified as CMR nor as STOT RE according to Regulation (EC) No 1272/2008.

Based on available acute aquatic toxicity studies, lowest EC50 was determined to be 1.67 mg/L for LAS Na and EC50 of  5.7 mg/L for DEA, respectively, with fish as most sensitive species in both cases. Thus, the screening criteria threshold value of 0.01 mg/L is not met.

DEA is not considered as CMR, but classified as STOT RE 2 under Regulation (EC) No 1272/2008. As DEA is considered to be a constituent of the test item > 10 % and there is no experimental data available with the test item itself, it is also classified as STOT RE 2  (please refer to IUCLID section 7.5 for repeated dose toxicity). Therefore, the T criterion applies.