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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 PBT Assessment for 2 -Hexyl-2 '-hydroxy-5 -methyldecananilide (AF-654) is based on the criteria set out in the "Guideline on information requirements and chemical safety assessment, Chapter R. 11: PBT Assessment" (ECHA 2012a).

Persistence:

For AF-654 a study on ready biodegradability according to EU Method C.4 -C and OECD 301 B is conducted resulting in 4% biodegradation after 29 days based on CO2 evolution. As no further data is available, a final conclusion on the persistency of the substance cannot be reached. Thus, based on the screening data, the substance has to be considered to be persistent (P) or very persistent (vP).

Bioaccumulation:

In the absence of experimental bioaccumulation data, the log Kow value obtained for this substance, determined to be > 6.2 (HPLC-value, according to OECD 117) and 8.4 (calculated value), indicates that AF-654 has bioaccumulation potential and therefore the Bioaccumulative (B) criterion cannot be excluded. Nevertheless, the information gathered on physicochemical properties and metabolism in combination with the QSAR-estimated BCF values provide evidence (in accordance to the REACh Regulation (EC) No 1907/2006, Annex XI General rules for adaptation of the standard testing regime set out in Annexes VII to X, 1.2, to cover the data requirements of Regulation (EC) No. 1907/2006, Annex IX) to state that this substance is likely to fulfil the Bioaccumulative (B) but not the very Bioaccumulative (vB) criteria (see IUCLID section 5.3.1 for details).

Toxicity:

Long-term toxicity testing with algae (Pseudokirchneriella subcapitata) resulted in a NOEC of 0.01 mg/L (mean measured) and 100 mg/L (nominal, based on filtered test solution) for AF-654 (OECD 201, EU Method C.3). Thus, no effects in the range of water solubility could be observed. The criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T criterion.

This substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to Directive 67/548/EEC and Regulation (EC) No 1272/2008. Therefore, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T criterion.