Registration Dossier
Registration Dossier
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EC number: 931-299-4 | CAS number: 68390-94-3
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).
Persistence
Amides, C16-C18 (even), N,N'-ethylenebis is not readily biodegradable (5.5% after 28 days, OECD 301B). QSAR data available for the main substance components predict a possible ready biodegradability of the substance and a biodegradation over “days” or “weeks to months”, respectively. Since degradation of the substance cannot be clearly demonstrated, the substance is considered as potentially P/vP. Since the substance is not potentially B further development of a testing strategy for simulation testing is not considered to be necessary in accordance with ECHA Guidance R.11 (ECHA, 2017).
Bioaccumulation
The substance is in insoluble in water (< 0.1 mg/L) and has a high potential for adsorption (log Koc (7.87 - 8.91). Based on the physico/chemical properties such as low water solubility and high potential for adsorption a reduced availability in water is expected. The assumption is supported by an experimentally determined BCF < 6.2 (OECD 305) and BCF/BAF values well below 2000 L/kg estimated by QSAR (BCFBAF v3.01, VEGA 1.1.4). Please refer to IUCLID Section 5.3 of the Technical dossier for a detailed overview on bioaccumulation. Based on the available information the substance is not considered to be B or vB.
Toxicity
The available short-term and long-term toxicity studies determined no toxic effects in the range of water solubility. The available acute effect concentrations for the substance are > 0.1 mg/L (fish, aquatic invertebrates, algae) and the chronic effect concentrations≤0.01 mg/L were not determined (aquatic invertebrates, algae). 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) according to Regulation (EC) No 1272/2008. In addition, the substance shows no specific target organ toxicity after repeated exposure (STOT RE category 1 or 2) according to Regulation (EC) No 1272/2008. Therefore, the substance does not meet the T criterion.
In conclusion, the substance is not PBT/vPvB.
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