Registration Dossier
Registration Dossier
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EC number: 226-166-6 | CAS number: 5308-25-8
Biodegradation in water: screening tests
Administrative data
Link to relevant study record(s)
Description of key information
The substance is not readily biodegradable (according to OECD criteria).
Key value for chemical safety assessment
- Biodegradation in water:
- under test conditions no biodegradation observed
Additional information
QSAR-disclaimer
In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met.
According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.
Assessment:
For the assessment of the bidoegradability of 1-Ethylpiperazine (CAS 5308-25-8) a weight-of-evidence approach based on experimental and (Q)SAR data for the substance and a structurally similar substance was performed. The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.
The assessment of biodegradability is based on a weight-of-evidence approach. The approach consists of an inherent biodegradability study with 1-ethylpiperazine, three QSAR models (CATALOGIC), one QSAR model BIOWIN and a ready biodegradability studiy with structurally similar read-across substance (1-(2-Aminoethyl)piperazine (CAS 140-31-8).
The experimental study with 1-Ethylpiperazine (CAS 5308-25-8) is an inherent biodegradability test (OECD 302B) using activated sludge from an industrial source (BASF AG, 1988). However, no biodegradation was observed in the study within the observation period of 28 days (0% DOC-removal after 28 d). The study is not valid according to the test guideline since the inhibitions control failed a biodegradation of at least 25% after 14d (here: 0%).
As no experimental data are available on the ready biodegradability of the substance, a read-across approach to the source substance 1-(2-aminoethyl)piperazine (CAS 140-31-8) was performed with an OECD 301C ready biodegradability test (1% O2-consumption after 28 d; NITE, J-CHECK, 2011).
This result is supported by QSAR models (BASF SE 2018):
- CATALOGIC v5.12.1 MITI OECD 301 C v10.14: 32 % after 28d, based on O2 consumption
- CATALOGIC v5.12.1 BOD Kinetic OECD 301F v13.16: 33% after 28d, based on O2 consumption
- CATALOGIC v5.12.1 CO2 Kinetic OECD 301B v02.09: 31.5% after 28d, based on CO2 evolution
- BIOWIN v4.10 prediction: Not readily biodegradable.
[Type of water: freshwater]
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