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EC number: 695-748-3
CAS number: 65286-55-7
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 the 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 (Envigo, 2018) and regarded as a key study
(Klimisch score of 1).
The test item attained 36% biodegradation after 28 days. According to
the screening criteria as laid down in the ECHA Guidance on information
requirements and chemical safety assessment Chapter R.11: PBT Assessment
(2014), >= 70% mineralisation should be obtained in an OECD 302 B
biodegradation study in order to conclude that the test substance is not
P or vP. If < 70% mineralisation is observed the substance should be
considered as potentially P or vP. Indeed, as specified in the ECHA
guidance on information requirements Chapter R.7b, Section R184.108.40.206 (to
which the PBT assessment guidance refers), > 20% biodegradation in an
OECD 302 B study provides evidence for inherent, primary biodegradation
and suggests that stable degradation products are likely to be formed.
Therefore, no conclusion can be drawn based on the available data and
the substance is therefore to be considered as potentially P or vP until
additional information would become available allowing to draw a
definitive conclusion on whether the substance is to be considered as
P/vP or not.
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 -0.0386 (Harlan, 2015), 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 /
Long-term or chronic toxicity data are available for algae only,
which were most sensitive in the acute toxicity studies. The 72-h NOEC
was determined to be 2.9 mg/L and is above the critical value of 0.01
mg/L for chronic aquatic studies. In addition, 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 all available data, it can be concluded that the
substance does not fulfil the PBT/vPvB criteria.
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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