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Evaluating the PBT/vPvB potential of multi-constituent substances is known to be difficult as persistence and bioaccumulation testing methods are not applicable (or at least difficult to apply) for these substances. Therefore, an evaluation based on experimental results of the multi-constituent substance and constituents as well as QSARs of the constituents and the most probable abiotic degradation products was performed.
Reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide was ready biodegradable failing the 10 days window according to testing. It can therefore be concluded that reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide do not fulfil the criteria for P and vP in the environment. In addition, the main abiotic degradations products of the consitutents N-butylphthalimide, N-propylphthalimide and N-sec-butylphthalimide are not expected to meet the P and vP criteria based on estimation performed with the Biowin 3, 5 and 6 models.
The evaluation of the bioaccumulation potential of reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide was based on the measured Log Kow values of all three constituents as well as of the corresponding most probable abiotic degradation products. All Log Kow values reported were below 4.5. Even if the log Koa of all constituents were estimated to be above 5, the vapour pressures of reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide and the corresponding abiotic degradation products were measured/estimated to be rather low (< 0.04 hPa) indicating that these substances are not very volatile. Therefore, reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide and its abiotic degradtation products are expected to have a limited potential to be taken up via the air by air breathing organisms. Based on the available data, the constituents of reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide as well as the corresponding most probable abiotic products are considered not to meet the criteria for a classification as B or vB.
Finally, reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide does not fulfil the T screening criteria based on acute aquatic toxicity data and currently available human toxicity data. Concerning the abiotic degradation products, no further assessment was performed since the most probable abiotic degradation products of all constituents did not fulfill the criteria for B or vB.
In conclusion, reaction mass of N-butylphthalimide and N-propylphthalimide and N-sec-butylphthalimide and the abiotic degradation products of its constituents do not fulfill the criteria for PBT or vPvB.
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