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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:

Persistence:

1,2 -Benzenedicarboxylic acid, di-C8 -10 -alkyl esters is readily biodegradable and therefore not persistent. This conclusion is based on a reliable biodegradation study according to OECD 301B. Several studies with structurally related substances (e.g. linear C6-C10 and linear C11 phthalate) support the result.

Therefore 1,2 -Benzenedicarboxylic acid, di-C8 -C10 -alkyl esters does not fulfil the criteria “persistent (P)” or “very persistent (vP)”.

Bioaccumulation:

The individual isomers of 1,2 -Benzenedicarboxylic acid, di-C8 -10 -alkyl esters have logKow values >8. 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 values have been calculated using the computer program BCFBAF (v3.01). The highest BCF value was calculate for the C10 -C10 isomer of 1,2- Benzenedicarboxylic acid, di-C8-10-alkyl esters and given as 333.4 L/kg wet weight. Therefore the substance is regarded as not bioaccumulative. For other, structurally similar materials assessments have been conducted within the EU. Further evidence is provided in the literature, e. g. Staples et al. (1997) state that the bioaccumulation of phthalate esters in general is limited by biotransformation which increases with increasing trophic level.

All available data indicate that the estimated BCF for the test material is likely to reflect the real bioaccumulation and therefore the substance does not fulfil the criteria “bioaccumulative (B) ” or “very bioaccumulative (vB) ”.

Toxicity:

The available reliable aquatic data for 1,2 -Benzenedicarboxylic acid, di-C8 -C10-alkyl esters show that the substance does not exhibit acute or chronic toxicity in aquatic organisms up to the limit of water solubility. The derived NOEC values are >0.01 mg/L. Furthermore 1,2- Benzenedicarboxylic acid, di-C8-10-alkyl esters is not classified into carcinogenic, germ cell mutagenic, or toxic for reproduction or STOT.

Therefore 1,2 -Benzenedicarboxylic acid, di-C8 -C10 -alkyl esters does not fulfil the criteria “toxic (T)” . 

The overall conclusion is that 1,2 -Benzenedicarboxylic acid, di-C8 -10 -alkyl esters does not meet the PBT or vPvB criteria. No further testing is required.