Registration Dossier
Registration Dossier
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EC number: 203-756-1 | CAS number: 110-31-6
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
Description of key information
not readily biodegradable: < 16% in 28 days (CO2 evolution) (OECD 301B)
Key value for chemical safety assessment
- Biodegradation in water:
- under test conditions no biodegradation observed
Additional information
There is no data available on the biodegradation potential of Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis. In order to fulfil the standard information requirements set out in Annex VII, 9.2.1.1, in accordance with Annex VIII, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance is conducted.
A detailed justification for the grouping of chemicals and read-across is provided in the technical dossier (see IUCLID Sections 5 and 13).
The biodegradability of Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis was assessed in a read across approach using the structural analogue Amides, C16-C18 (even), N,N'-ethylenebis. Two studies investigating the ready biodegradability of the test item were available. The CO2 evolution test (Coenen, 1991) was chosen as key study. This test was performed following the OECD 301B under GLP conditions. Activated sludge was used as inoculum and test material concentrations were 10 and 20 mg/L. On day 28 (end of the test) biodegradation values reached 15% and 5.5% at 10 and 20 mg/L test concentrations, respectively. The pass-level of at least 60% biodegradation in a 10-day window was not reached. Degradation of >60% of reference substance was reached within 14 days. An additional supporting study was obtained from the Japanese Ministry of International Trade and Industry (MITI, 1976). This ready biodegradability test was carried out according to the OECD 301C, using activated sludge as inoculum at a concentration of 30 ppm. The test concentration used in the study was 100 ppm. After 14 days (end of the study), the test substance reached a biodegradation value of 1.1%. Thus, these results support those from the key study, and Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis can be considered as not readily biodegradable; but the substance is hardly soluble in water, and the very low solubility of the test substance may reduce the availability of the substance in the test medium. Therefore, an additional calculation was used to assess Amides, C16 and C18-C20 (even numbered, unsaturated), N,N’-ethylenebis. A QSAR prediction using the following models Biowin1, Biowin2, Biowin3, Biowin4, Biowin5, Biowin6 and Biowin7 shows that the substance is not persistent in the environment and the biodegradation takes place in a time frame of weeks (Cuesta, 2013).
--------------------------- BIOWIN v4.10 Results ----------------------------
Biowin1 (Linear Model Prediction): Biodegrades Fast
Biowin2 (Non-Linear Model Prediction): Biodegrades Fast
Biowin3 (Ultimate Biodegradation Timeframe): Weeks-Months
Biowin4 (Primary Biodegradation Timeframe): Days
Biowin5 (MITI Linear Model Prediction): Biodegrades Fast
Biowin6 (MITI Non-Linear Model Prediction): Biodegrades Fast
Biowin7 (Anaerobic Model Prediction): Does Not Biodegrade Fast
Ready Biodegradability Prediction: NO
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