N6-(1-oxododecyl)-L-lysine

PBT assessment

PBT assessment: overall result

Reference

Name:

Composition of the LR product

Type of composition:

legal entity composition of the substance

State / form:

solid: particulate/powder

Reference substance:

Composition of the LR product

PBT status:

the substance is not PBT / vPvB

Justification:

The test item proved to be readily biodegradable under aerobic conditions. In a BOD study conducted according to OECD Guideline 301 guidelines, the substance was readily biodegraded to > 90% of the initial TS concentration within an incubation period of 28 d;  the validity criteria of OECD Guideline were fulfilled. Based on the determined log Pow (1.9) and the ready biodegradability any significant bioaccumulation of the test substance is not to be expected.

Relevant and reliable results from acute toxicity testing of the test item itself are not available. However, relevant data determined for strucurally closely related chemicals are available. As for the latter compounds higher water solubility was found than for the test item it can be assumed that their aquatic effect values can be regarded in the sense of worst-case for the assessment of the test item due to their expected better bioavailability for exposed test organisms.

Based on the available data, algae proved to be, by far, the most sensitive organism (Pseudokirchneriella subcapitata: inhibition of growth rate: 72 h ErC50=15.41 mg test item dry matter/L nominal). In consequence of the data, the test item is not to be classified according to Commission regulation (EU) No. 286/2011. Considering all available toxicity data, the test item is not to be regarded as a substance exhibiting PBT or vPvB properties.