Registration Dossier
Registration Dossier
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EC number: 240-566-8 | CAS number: 16499-88-0
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 (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 a biodegradability study according to OECD Guideline No. 302B (Covance, 2019) and regarded as a key study (Klimisch score of 1). The test substance attained 99% biodegradation after 28 days. OECD Guideline No. 302B does not give any definitive pass levels for test items, however the “Revised Introduction to the OECD Guidelines for Testing of Chemicals, Section 3 (2006)” suggests that a figure of more than 20% biodegradation may be regarded as evidence for inherent, primary biodegradability. A figure of more than 70% mineralization may be regarded as evidence for ultimate inherent biodegradation. The test item can therefore be considered to have exhibited evidence of ultimate biodegradation under the experimental conditions employed in this study. It can therefore be concluded that based on the criteria mentioned above the substance is not persistent in the environment. The substance is concluded to be not 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 1.05 (Dekra, 2014), 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 the 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 not P/vP, not B/vB and not T, the substance should not be considered as a PBT/vPvB substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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