Registration Dossier
Registration Dossier
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EC number: 203-183-7 | CAS number: 104-19-8
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
An evaluation of the inherent properties of N,N,4 -trimethylpiperazine-1-ethylamine 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 (2014) were applied.
The persistency assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The biodegradation potential of the test substance has been assessed in two biodegradability studies according to according to OECD Guideline 301B. The studies meaasured 5% and 0% biodegradation respectively. Under the conditions of the test, the test substance was determined to be not readily biodegradable within 28 days. It can therefore be concluded that based on the criteria mentioned above the substance is potentially persistent in the environment. The substance is concluded to be P/vP.
The bioaccumulation assessment is based on the screening criteria in Annex XIII of the REACH Regulation. The available evidence on the bioaccumulation potential for the substance indicates that the screening criteria for bioaccumulation potential (B and vB) are not met. Based on a log Pow of -2.5 at neutral pH, a low BCF can be estimated. Since the log Pow of the substance is far below the threshold of 4.5, the screening criteria for bioaccumulation are not fulfilled and the substance is concluded not to have a bioaccumulative potential (not B / not vB).
The available evidence on the toxicity potential for the test substance is sufficient for an assessment based on Annex XIII criteria for this endpoint. The substance is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2), and is not classified for specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to the CLP Regulation. Therefore, the substance can be concluded not to fulfil the Annex XIII criteria for "T".
Taking into account the conclusions that the substance is P/vP, not B/vB and not T, the substance should not be considered as a PBT/vPvB substance.
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