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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 Reaction mass of Heptanoic acid 3-pentanoyloxy-2,2-bis-pentanoyloxymethyl-propyl ester, Heptanoic acid 2-heptanoyloxymethyl-3-pentanoyloxy-2-pentanoyloxymethyl-propyl ester and Heptanoic acid 3-heptanoyloxy-2-heptanoyloxymethyl-2-pentanoyloxymethyl-propyl ester (CAS 68441-94-1) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).

Persistence

Reaction mass of Heptanoic acid 3-pentanoyloxy-2,2-bis-pentanoyloxymethyl-propyl ester, Heptanoic acid 2-heptanoyloxymethyl-3-pentanoyloxy-2-pentanoyloxymethyl-propyl ester and Heptanoic acid 3-heptanoyloxy-2-heptanoyloxymethyl-2-pentanoyloxymethyl-propyl ester (CAS 68441-94-1) is considered to be readily biodegradable (75.7% (CO2 evolution) after 26 d (OECD 301B)). Thus, the test substance does not meet the screening criterion for persistence and it is not considered to be P or vP.

Bioaccumulation

The bioaccumulation potential of Reaction mass of Heptanoic acid 3-pentanoyloxy-2,2-bis-pentanoyloxymethyl-propyl ester, Heptanoic acid 2-heptanoyloxymethyl-3-pentanoyloxy-2-pentanoyloxymethyl-propyl ester and Heptanoic acid 3-heptanoyloxy-2-heptanoyloxymethyl-2-pentanoyloxymethyl-propyl ester (CAS 68441-94-1) is expected to be low. This assumption is based on a low bioavailability of the substance due to its ready biodegradability and low water solubility. Furthermore the substance is rapidly metabolised and excreted by organisms and thus an accumulation is not expected. This is supported by calculated low BCF value (53.59 - 550.4 L/kg; regression based estimate). Since this value is below the trigger value of 2000 to be bioaccumulative, the substance is not considered to be B or vB.

Toxicity

Reaction mass of Heptanoic acid 3-pentanoyloxy-2,2-bis-pentanoyloxymethyl-propyl ester, Heptanoic acid 2-heptanoyloxymethyl-3-pentanoyloxy-2-pentanoyloxymethyl-propyl ester and Heptanoic acid 3-heptanoyloxy-2-heptanoyloxymethyl-2-pentanoyloxymethyl-propyl ester (CAS 68441-94-1) is considered to be not toxic. The assessment is based on a read across to the structurally similar PE group memberDecanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9).In a study on the long-term toxicity of Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) to Daphnia magna a NOELR (15 d) of ≥ 2570 mg/L (nominal; WAF) was recorded. Furthermore the substance is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the substance is considered to be not T.

Conclusion

In conclusion the substance is not considered to meet the criteria to be classified as PBT or vPvB based on the available data.