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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:

Persistence:

Stability: Study on hydrolysis waived due to the extremely poor water solubility of the test item of 0.027 mg/L.
Biodegradation: Both a study on anaerobic biodegradability and a study on (aerobic) inherent biodegradability revealed that the substance is not biodegradable.
In further biodegradation simulation tests, it was shown that the BMDBM is degrading in the water phase with a half-life of up to 12 days. Based on these results, the substance does not meet criteria for persistence in fresh water. Whereas, the half-life of BMDBM in the sediment phase can take up to more than 150 days. Based on these results, BMDBM meets the criteria for persistence in fresh water sediment.
The major observed degradation products in both simulation studies were 4-Methoxybenzoic acid (CAS 100-09-4) and 4-Tert-butyl benzoic acid (CAS 98-73-7). 4-Methoxybenzoic acid is readily biodegradable and not a PBT/vPvB substance.

4-Tert-butyl benzoic acid is not readily biodegradable, but can be considered primarily inherently biodegradable, as biodegradation up to 46 % could be observed on an OECD 301F study. The substance has been assessed to fulfill the criteria for P and T, but not for B, therefore, it is not classified as a PBT/vPvB substance.

 

Bioaccumulation:

It can be concluded that the substance does not meet criteria for B / vB substance. The bioaccumulation study in fish was performed via dietary exposure route. The result obtained shows that the biomagnification factor is far below 1 and the half-life for elimination of BMDBM during depuration phase is 3.8 days. Following the ECHA Endpoint specific guidance R.7c, the BCF value of 1807 L/kg was calculated on the basis of the experimental data obtained in the bioaccumulation study. The BCF value is below the cut-off value of 2000 for B/vB. These results indicate that risk for bioaccumulation and biomagnification in fish is low.

 

Toxicity:

The substance has no CMR or STOT RE toxicity classification. Acute aquatic toxicity studies as well as a long-term aquatic study according to OECD 211 study conducted up to the level of maximum water solubility revealed no detrimental effects. Based on these results, the assignment is "not T".