Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The assessment of the PBT or vPvB properties of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid is based on the screening criteria given in the “Guidance on information requirements and chemical safety assessment, chapter R.11: PBT assessment” (ECHA, 2017).
Persistence
The substance Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid is readily biodegradable (96% after 28 days, OECD 301 A). Based on the available results the substance does not meet the screening criterion for persistence and is not P or vP.
Bioaccumulation
Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid is highly water-soluble and has been demonstrated to be readily biodegradable. Due to the physicochemical properties of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid molecules the BCF estimations based on the log Kow are not considered to be reliable. According to the Guidance on information requirements and chemical safety assessment, chapter R.7a, log Dow values are considered more realistic for an assessment of bioaccumulation. Log Dow values for the individual constituents of Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid ranged between -3.742 and 2.599. The predicted BCF in freshwater fish based on a log Dow of 2.599 was estimated to be 32.3 L/kg wwt indicating that the substance is not bioaccumulative. Based on the available results the substance does not meet the B or vB criterion.
Toxicity
Long-term effects below the trigger value of 0.01 mg/L (EC10 or NOEC) were determined in the available aquatic toxicity tests. The lowest long-term effect value is a NOEC (21 d) of 0.0023 mg/L determined in a chronic toxicity study on aquatic invertebrates (OECD 211). The substance is not classified according to the consolidated version of Regulation (EC) No 1272/2008 as carcinogen, germ cell mutagenic or toxic for reproduction.
Based on the available data Amines, N-C10-C16-alkyltrimethylenedi-, reaction products with chloroacetic acid meets the T criterion.
In conclusion, the substance is not PBT/vPvB.
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