Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

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

The substance was shown to be not readily biodegradable in a study according to OECD Guideline 301B. Consequently, the test substance is likely to have a half-life in marine water higher than 60 days or a half-life in fresh water higher than 40 days therefore the substance is considered to be persistent.

Based on the results of the bioaccumulation study in fish with a closely related structural analogue and the QSAR modelling, the BCF value for the test substance is estimated to be 4.1 L/kg ww (geometric mean), which is well below the threshold value quoted in the REACH Regulation of 2000 or 5000 which indicates the potential to bioaccumulate. The substance is therefore not considered to be “bioaccumulative” or “very bioaccumulative” on the basis of the available data.

In a long-term fish toxicity study with a closely related structural analogue, tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, the 14 day NOEC was determined to be >75.0 mg/L. A NOEC value of 55.6 mg/L was obtained in a Daphnia 21-day reproduction study with the same closely related analogue.

The mutagenicity of closely related structural analogue,tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, was evaluated in three in vitro assays with and without metabolic activation. All endpoints demonstrated a lack of mutagenic response.

The reproduction/developmental screening test using read-across substance, 1,2,4 -benzenetricarboxylic acid, trioctyl ester, provided a NOAEL value of 500 mg/kg bw/day and showed no treatment-related effects on parents or offspring.

No carcinogenicity studies have been conducted, however, there is no evidence from the repeated dose toxicity studies to suggest that the substance is carcinogenic.

The 90-day repeated dose toxicity study conducted with read-across substance,tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate, provided a NOAEL value of 225 mg/kg bw/day. The substance is not classified on the basis of this data and no further toxicological examination is considered necessary for hazard assessment.

Therefore, the substance does not fulfil the requirements of Annex XIII, Para 1.3 based on evaluation of available data, and cannot be considered as “T” for the purposes of the assessment.

Summary and overall Conclusions on PBT or vPvB Properties

 

The substance cannot be considered to fulfil all the criteria for Persistence, Toxicity or Bioaccumulation, as specified in REACH Annex XIII. As such, the substance cannot be considered a PBT or vPvB substance, based on the available data.