Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

Reference
Name:
β-Alanine, N-coco alkyl derivatives
Type of composition:
legal entity composition of the substance
State / form:
other: The substance is a solid in the pure state but is supplied as a liquid. The substance is not normally isolated and is manufactured and supplied as a UVCB liquid.
Reference substance:
Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
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Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

Not P or vP

 

The substance is readily biodegradable and will not persist in the environment.

 

Bioaccumulation

Not B or vB

 

Bioconcentration factor (BCF) for the registered substance is predicted to be 3.162 L/kg wet weight and, in accordance with ECHA guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 3.0; June 2017), bioaccumulation is not expected when the aquatic BCF of a substance is < 2000 L/kg.

 

Toxicity

 

Potentially T

Based on available evidence for an analogue substance (EC271-657-0), and in accordance with Regulation (EC) No. 1272/2008, the registered substance does not meet criteria for classification as a carcinogen (category 1A or 1B), germ cell mutagen (category 1A or 1B) or reproductive toxin (category 1A, 1B or 2). Chronic toxicity leading to classification as a specific target organ toxicant (STOT RE 1 or STOT RE 2) is also considered to be unlikely. With respect to the environment, the registered substance meets Aquatic Acute 1 and Aquatic Chronic 3 environmental classification criteria for rapidly biodegradable substances for which there are no adequate long-term data available. Present regulatory obligations do not require investigation of long-term exposure to the substance in fish or aquatic invertebrates and it is not possible to definitively conclude on T properties (see ECHA guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 3.0; June 2017).