Registration Dossier
Registration Dossier
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EC number: 221-950-4 | CAS number: 3290-92-4
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
In a CO2 evolution test conducted according to OECD guideline 301B, the test substance was biodegraded at 53% after 28 days. According to these results, the test item showed an high potential for biodegradation even if it did not fulfill the criterion to be readily biodegradable. In addition, the biodegradation potential of the test substance was assessed using an in-silico approach (supporting study), the BOD QSAR Model “LMC OASIS CATALOGIC 301C”. This model also identifies the likely biotic degradation products of the test substance. The in silico approach was chosen as an appropriate method to assess the degradation products and to conduct a screening assessment of their persistence potential. The parent substance was predicted as not readily biodegradable, which confirms the results of the available experimental ready biodegradation study. In addition, the primary half life was calculated as 2.79 days and the ultimate half-life value was equal to 21.91 days. These results indicate that none of the assessed substances (parent substance and its degradation products) are likely to persist in the environment. The substance and its degradation products cannot be considered persistent nor very persistent.
Furthermore, as the substance is not P/vP and the measured log Kow of the test substance is lower than the screening B properties threshold of 4.5 (measured log Kow = 4.19), no further B assessment is considered necessary. Nevertheless, a well-documented and reliable QSAR approach is provided in order to evaluate the bioaccumulation potential of the test substance. The bioaccumulation potential of the substance in fish was estimated using the OASIS CATALOGIC BCF model (OASIS LMC, 2022). The Log BCF was calculated as 0.72, which corresponds to a BCF value of 5.25 L/kg ww. This value is clearly below the screening threshold of 2000 L/kg. Therefore, the test substance cannot be considered B nor vB.
In conclusion, the test substance is not classified as PBT and not vPvB.
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