Registration Dossier
Registration Dossier
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EC number: 203-640-0 | CAS number: 109-02-4
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
An evaluation of the inherent properties of the test substance is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2008) were applied.
The available evidence on degradation is not sufficient for an assessment based on the Annex XIII criteria for persistence (P and vP). As the substance is concluded to be rapidly biodegradable in an OECD 301F study (fulfilling the 10-day window criterion) and inherently biodegradable in an OECD 302B study, the screening criteria for persistence are not fulfilled. Based on available evidence it is thus concluded that the substance is not P and not vP.
The screening criteria for bioaccumulation potential are not met as the log Kow of the substance is determined to be -0.32, which is below the cutoff value of 4.5. Based on this information, the substance is conclude to be not B and not vB.
The Annex XIII criteria and screening criteria for toxicity (T) are not met. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), toxic for reproduction (category 1A, 1B or 2) or STOT RE (category 1 or 2) according to Regulation EC No 1272/2008. Furthermore, the lowest acute EC50/LC50 is higher than the cutoff value of 0.1 mg/L. Based on this information, the substance is concluded to be not T.
In conclusion, the substance should not be considered as a PBT/vPvB substance.
In addition, the CATALOGIC 301C model was used to predict biotransformation products likely or very likely to be formed through aerobic microbial degradation. Six transformation products were identified and assessed for potential PBT/vPvB properties. Of the 6 transformation products, 2 were predicted to be not readily biodegradable and the remaining 4 were predicted to be readily biodegradable. The log Kow values for all the predicted transformation products were estimated to be less than 4.5 (all were below zero) and therefore all the transformation products are predicted to be not B/vB. As none of the degradation products were found to be B/vB, no further information on T properties is required to conclude on the PBT/vPvB status of the 6 degradation products. None of the of the degradation products are a potential PBT/vPvB substance, which further supports the conclusion that the substance should not be considered as a PBT/vPvB substance.
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