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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:

Evidence of the biodegradation potential for 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters can be observed with the results from the OECD 301B ready biodegradability studies. After 29 d 87 % was biodegraded. The 10 -day window is reached because during 10 d > 60 % was biodegraded. Therefore 1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters is regarded as readily biodegradable. Because the substance can be regarded as readily biodegradable, the results indicate that the substance is not persistent (P).

The octanol water partition coefficient of the substance (Log Kow > 8.2) suggests the potential for the substance to be bioaccumulative. In general, at log Kow values between 4 and 5, log BCF increases linearly with log Kow. At high log Kow (> 6), a decreasing relationship between the two parameters is observed and for very hydrophobic chemicals, reduced uptake due to the increasing molecular size may occur. The aquatic BCF of a substance is probably lower than 2000 L/kg if the calculated log Kow is higher than 10. BCF has been calculated using the computer program BCFBAF (v3.00). BCF has been calculated using the computer program BCFBAF (v3.00). It is predicted that the substance has BCF of 1033 L/kg wet weight. The substance is not bioaccumulative. For other, structurally similar materials assessments have been conducted within the EU. A phthalate ester with branched alcohol chains (as opposed to linear alcohol chains) has undergone risk assessment (European Union Risk Assessment Report on 1,2-benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich and di-“isodecyl” phthalate, Final Report, 2003).The report considers bioaccumulation in aquatic organisms and cites a single test where a BCF of < 14.4 was determined for fish (Cyprinus carpio) according to OECD test guideline No. 305C. Other studies showed BCF’s in the same order of magnitude. All available data indicate that the estimated BCF for the test material is likely to reflect the real bioaccumulation and therefore the substance is considered not to be bioaccumulative (B).

Aquatic toxicity tests do not indicate the substance meets the criteria to be regarded as toxic (T). Furthermore 1,2- Benzenedicarboxylic acid, di-C6-10-alkyl esters is not classified into carcinogenic, germ cell mutagenic, or toxic for reproduction or STOT.