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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:

The submission substance, the ester reaction products of branched tridecanol, isodecanol and trimellitic anhydride (CAS No. 70225-05-7), is not expected to be persistent (P) or very persistent (vP) based on the overall findings and assessment for a series of structurally similar trimellitate ester HPV chemicals (US EPA 2009; ACC Phthalate /Trimellitate HPV Panel, 2006). This conclusion is consistent with the 2009 SIDS evaluation by the US EPA that chemical category trimellitate HPV esters similar to the submission substance are considered sufficiently biodegradable and are not expected to be persistent or bioaccumulative (U.S. EPA 2009).  

 

The submission substance is not bioaccumulative (B) or very bioaccumulative (vB) based on its calculated bioconcentration factor (BCF) value. The very low water solubility and high octanol-water partition coefficient of the submission substance makesit extremely difficult to conduct an aqueous BCF study. However, using the U.S. EPI SuiteTMmodel (v3.12), the submission substance (CAS No. 70225-05-7) has a calculated log BCF value of 3.16 indicating that it is not bioaccumulative or very bioaccumulative (US EPA, 2000d). In addition, the submission substance has a calculated log Kow of 16.01 which severely limits its ability to cross membrane (i.e., bioavailability). These data support the fact that the BCF for the submission substance is well below 2000 L/kg which is the criterion for not being considered bioaccumulative (B) and is well below 5000 L/kg which is the criterion for not being considered very bioaccumulative (vB).

 

The ester reaction products of branched tridecanol, isodecanol and trimellitic anhydride (CAS No. 70225-05-7) are not toxic (T) to aquatic organisms based on read-across results from chronic aquatic toxicity studies for the trimellitate esters (ACC Phthalate/Trimellitate HPV Panel, 2006) that show no effects at levels equal to or exceeding the maximum water solubility Read-across data from 21-day invertebrate (i.e.,Daphnia magna) chronic toxicity studies for a structurally related trimellitate surrogate support the assessmentthatthe submission substance ester (CAS No. 70225-05-7) would not be expected tocause chronic toxicity at its maximum water solubility limit(ACC Phthalate/Trimellitate HPV Panel, 2006e)Similarly, read-across 14-day prolonged toxicity studies in fish showed no chronic toxicity to fish for trimellitates attheir maximum water solubility limits(ACC Phthalate/Trimellitate HPV Panel, 2006c). Collectively, these read-across findings indicate that the submission substance would not be expected to produce chronic toxicity to fish or invertebrates (e.g.,Daphnia magna) at its maximum water solubility levels. The ester reaction products of branched tridecanol, isodecanol and trimellitic anhydride (CAS No. 70225-05-7) are not toxic (T) to aquatic organisms based on read-across results from chronic aquatic toxicity studies for the trimellitate esters (ACC Phthalate/Trimellitate HPV Panel, 2006) that show no effects at levels equal to or exceeding the maximum water solubility Read-across data from 21-day invertebrate (i.e., Daphnia magna) chronic toxicity studies for a structurally related trimellitate surrogate support the assessment that the submission substance ester (CAS No. 70225-05-7) would not be expected to cause chronic toxicity at its maximum water solubility limit (ACC Phthalate/Trimellitate HPV Panel, 2006e). Similarly, read-across 14-day prolonged toxicity studies in fish showed no chronic toxicity to fish for trimellitates at their maximum water solubility limits (ACC Phthalate/Trimellitate HPV Panel, 2006c). Collectively, these read-across findings indicate that the submission substance would not be expected to produce chronic toxicity to fish or invertebrates (e.g., Daphnia magna) at its maximum water solubility levels.

 

Additionally, based on read across to members of the trimellitates category, the substance does not meet the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to the CLP Regulation. Neither is there other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: STOT RE 1, or STOT RE 2 according to the CLP Regulation.

 

Based on the criteria listed in the above-mentioned assessment, the registered substance does not qualify as Toxic under Annex XIII, Section 1.1.3 of REACH.