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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

According to Regulation (EC) No. 1907/2006, a substance must fulfil all three criteria for persistence, bioaccumulation and toxicity to be considered as PBT, as listed in part 1 of Annex XIII, and it must fulfil the criteria for persistence and bioaccumulation stated in part 2 of Annex XIII to be considered vPvB.

Data for the definitive conclusion on the PBT or vPvB properties according to the criteria set in Regulation (EC) No. 1907/2006, Annex XIII, parts 1 and 2, are not available for all three criteria. Thus, the screening criteria given in the ‘Guidance on information requirements and chemical safety assessment - Chapter R.11: PBT assessment’ (ECHA, 2012) are used as surrogate information to decide whether the substance may potentially fulfil the PBT or vPvB criteria.

Persistence (P) Assessment

A valid screening criterion to evaluate persistence (P) is the potential of a substance for ready biodegradability. 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) is not readily biodegradable but moderately biodegradable. Thus a moderate biodegradation of the substance in aquatic and terrestrial environments is expected. However since the substance is not readily biodegradable according to OECD criteria it is considered to be potentially P as a worst case approach.

Bioaccumulation (B) Assessment

A relevant uptake and bioaccumulation of 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) in aquatic organisms is not expected. The substance has a log Kow of > 10 (KOWWIN v1.68) indicating a potential for bioaccumulation. However due to the low water solubility, molecular weight, size and structural complexity of the substance, a relevant uptake and bioaccumulation in aquatic organisms is not expected. When ingested 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters can undergo a stepwise hydrolysis into the respective alcohol as well as the di- or monoester and the aromatic acid by gastrointestinal enzymes ((Lehninger, 1970; Mattson and Volpenhein, 1972). Therefore, a relevant uptake and bioaccumulation in aquatic organisms is not expected. This is supported by calculated low BCF/BAF values calculated for the main components of the substance (0.89/0.93 L/kg; Arnot-Gobas estimate, upper trophic). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the substance. Thus the substance is not considered to be B or vB. 

Toxicity (T) Assessment

The available data on short-term and long-term toxicity indicate that 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) is not chronically toxic. All reported no-observed effect concentrations (NOEC values) are higher than 0.01 mg/L. Furthermore 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to the 2nd ATP of Regulation (EC) No. 1272/2008 (CLP) and Directive 67/548/EEC.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.

 

In conclusion, 1,2-Benzenedicarboxylic acid, di-C16-18-alkyl esters (CAS 90193-76-3) is considered not to be PBT or vPvB.