Registration Dossier
Registration Dossier
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EC number: 632-619-2 | CAS number: 881685-58-1
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
It can be stated that the substance and its major metabolites do not fulfil the PBT criteria (not PBT) or the vPvB criteria (not vPvB).
Persistence:
The substance is not readily biodegradable. In a weight-of-evidence approach, the available data on (a)biotic degradation is assessed. Based on the available data, the test substance meets very persistence criteria. The persistence information on its major metabolites is not available. Therefore, the substance and its major metabolites are considered to be 'P/vP'
Bioaccumulation:
The test substance is considered to be not bioaccumulative based on its Log Kow value and a bioaccumulation in fish study and may therefore be considered to be “Not B/vB”. The Log Kow values for its major metabolites are all < 4.5, they are considered to be not B/vB either.
Toxicity:
The substance does not meet the criteria for classification as carcinogenic in Category 1A or 1B, mutagenic in Category 1A or 1B, or STOT RE in Category 1 or 2 according to Regulation EC No 1272/2008. However, it does meet the criteria for classification as reproduction in Category 2. In addition, chronic data on aquatic organisms show that the T-criterion of < 0.01 mg/L is met. Considering all criteria, the substance is considered Toxic (T).
The major metabolites M1 and M3 do not meet the criteria for classification as carcinogenic in Category 1A or 1B, mutagenic in Category 1A or 1B, STOT RE in Category 1 or 2 or reproduction Category 1A, 1B or 2 according to Regulation EC No 1272/2008. The available data on toxicity to aquatic organisms show that both metabolites do not fulfil the T criterion or the screening criterion (NOEC or EC10 < 0.01 mg/L and L(E)C50 < 0.01 mg/L). Based on these results, M1 and M3 are considered to be not Toxic (not T).
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