Registration Dossier
Registration Dossier
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EC number: 304-780-6 | CAS number: 94279-36-4
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment for 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters (CAS 94279-36-4) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistence
A valid screening criterion to evaluate persistence (P) is the potential of a substance for ready biodegradability. 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters is not readily biodegradable but enhanced ultimately biodegradable (71.4 - 78% within 40-50 d). Therefore, it is not expected to be persistent in the environment and it does not meet the Persistent (P) or very Persistent (vP) criteria.
Bioaccumulation
An evaluation of the bioaccumulation potential of 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters is presented in Section 5.3 of the technical dossier indicating that bioaccumulation is expected to be low. Due to its low water solubility, enhanced ultimate biodegradability, high molecular weight which significantly reduces the absorption due to steric hindrance to cross biological membranes, metabolism (see IUCLID section 5.3.1) and the estimated BCF/BAF values, this substance is likely to show low bioaccumulation potential. Based on the above information, the test substance does not meet the Bioaccumulative (B) or very Bioaccumulative (vB) criteria.
Toxicity
The hazard assessment is based on the current data available. New aquatic toxicity studies (OECD 201, OECD 211, OECD 210) are requested for 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters (CAS 94279-36-4) based on the ECHA decision on a compliance check (decision number CCH-D-2114517125-59-01/F). The aquatic studies could not finalised until now due to the reasons explained under the respective endpoints (see chapters 6.1.2, 6.1.4 and 6.1.5). The finalised studies will be submitted later based on ECHA decision number CCH-D-2114517125-59-01/F. The aquatic toxicity will be re-evaluated in the update of this dossier as soon as the final aquatic studies will be available.
Long-term toxicity testing with aquatic invertebrates and algae show no effects in the range of water solubility (NOEC values > 0.01 mg/L). The L(E)50 values reported in the tests conducted with fish, aquatic invertebrates and algae show no toxic effects in the range of water solubility and the substance 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. Therefore, the test substance does not meet the T criterion according to Regulation (EC) No. 1907/2006, Annex XIII.
Conclusion
In conclusion, 1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters is considered not to be PBT or vPvB.
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