Registration Dossier
Registration Dossier
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EC number: 226-166-6 | CAS number: 5308-25-8
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
Significant accumulation in organisms is not to be expected.
Key value for chemical safety assessment
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. Furthermore according to Article 25 of the same Regulation testing on vertebrate animals shall be undertaken only as a last resort.
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.
For the assessment of 1-(2-Aminoethyl)piperazine (CAS 5308-25-8) (Q)SAR results were used for aquatic bioaccumulation. 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.
Therefore, and for reasons of animal welfare, further experimental studies on aquatic bioaccumulation are not provided.
Assessment:
In accordance with column 2 of REACH Annex IX the study does not need to be conducted since the substance has a log Kow less or equal than 3. The substance has a log Kow of -0.10 (estimated with KOWWIN v1.68, EPI Suite v4.11, BASF SE, 2018). Moreover, in order to assess the bioaccumulation potential of the substance, the BCF was calculated with two estimation models (BCFBAF v3.01 and OASIS Catalogic BCF baseline model v02.09).
Considering all models applied 1-Ethylpiperazine (CAS 5308-25-8), the estimated BCF values range from 0.94 to 10 L/kg.
1) EPI Suite v4.11: BCFBAF v3.01:- Meylan et al. 1997/1999: BCF = 3.2 L/kg (in AD)
- Arnot & Gobas, upper trophic level incl. biotransformation: BCF = 0.94 (not in AD)
- Arnot & Gobas, upper trophic level excl. biotransformation: BCF = 0.98 (not in AD)
2) Catalogic v5.12.1: BCF baseline model v02.09:
- considering all mitigation factors: BCF = 2.34 L/kg (in AD)
- without considering all mitigation factors: BCF = 10 L/kg (in AD)The substance was within the applicability domain of Catalogic BCF Baseline model and of BCFBAF v3.01 model according Meylan et al., but not in the aplicability domain of the Arnot-Gobas model.
Based on the available information on the log Kow (log Kow = -0.1; estimated; BASF SE, 2018, see IUCLID Ch. 4.7) and supported by a weight-of-evidence approach from calculated data it can be concluded that significant accumulation of 1-Ethylpiperazine (CAS 5308-25-8) in organisms is not to be expected.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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