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Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

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

The test substance Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol was demonstrated to be readily biodegradable in an OECD 301B-test. Additionally the component diisotridecyl adipate is readily biodegradable. In Episuite calculations is predicted that the components diisotridecyl adipate and diisotridecyl sebacate are readily biodegradable. This result is supported by the OECD 301B-study of the read-across substance diisotridecyl dodecandioate. Also the analogue is readily biodegradable. Therefore the substance is not persistent (P).

 

It is not possible to calculate the log KOW for the test substance Reaction product of adipic acid and sebacic acid and isotridecan-1-ol, however of the comonents. The partition coefficient of one of the components, the diisotridecyl adipate was calculated to be 13.03 with EPISuite. The partition coefficient of one of the components, the diisotridecyl decanedioic acid (diisotridecyl sebacate) was calculated to be 14.84 with EPISuite. Therefore the log KOW is at least 13.03 for the test substance. The partition coefficient of Reaction product of adipic acid and sebacic acid and isotridecan-1-ol was determined by HPLC method to be > 6.

The log BCF of the component diisotridecyl adipate (log Pow = 13.03) was estimated to be 1.17 (BCF 14.8) using the program US EPA EPI Suite v4.00. In addition, a log BAF (upper trophic) of -0.008 (BAF = 0.982) was calculated using the method of Arnot-Gobas.

The BCF for the component diisotridecyl sebacate was calculated 3.162 L/kg ww (log BCF = 0.5). In addition, a BAF was estimated to 0.935 (log BAF -0.029 - upper trophic).The low BCF/BAF values indicate a low potential of diisotridecyl adipate and diisotridecyl sebacate for bioaccumulation in aquatic organisms and therefore for the test substanceReaction product of adipic acid and sebacic acid and isotridecan-1-ol. The BCF of 14.83 is something like worst case for the components. The low BCF/BAF values indicate a low potential of Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol for bioaccumulation in aquatic organisms. Therefore the substance is considered not to be bioaccumulative (B).

Toxicity Aquatic toxicity tests do not indicate the substance meets the criteria to be regarded as toxic (T). Furthermore Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is not classified into carcinogenic, germ cell mutagenic, or toxic for reproduction or STOT.

Hence the substance does not meet the criteria to be regarded as a PBT or vPvB substance.

An emission characterisation for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol

is not needed because it is not a PBT.