Registration Dossier
Registration Dossier
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EC number: 203-639-5 | CAS number: 109-01-3
Biodegradation in soil
Administrative data
Link to relevant study record(s)
Description of key information
No data are available on degradation rates in soil; therefore, the substance is regarded as P/vP from a precautionary point of view.
Degradation products were predicted using a QSAR model. The relevant degradation product is not readily biodegradable.
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.
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 the substance, (Q)SAR results were used for the prediction of potential degradation products. 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, experimental simulation testing on sediment and surface water is not provided.
Assessment:
1-Methylpiperazine is poorly biodegradable. The substance is not readily biodegradable according to a GLP guideline study (OECD 301D; Ginkel, 2011; report no. F11080CG). The substance proved to be degradable only after adaptation of the inoculum to the substance (OECD 301D, non-GLP; Ginkel et al., 2013; report no. F12023 CG). As the conditions for biodegradation in the requested simulation study are less favorable compared to the ready biodegradability tests, the substance will most likely persist in the study with no formation of degradation products.
In accordance with Regulation (EC) No 1907/2006, Annex XI, Section 1.3, it is concluded to assess potentially forming degradation products using QSAR models for predicting their composition, quantity, biodegradability, and bioaccumulation potential. Potentially forming degradation products have been predicted using a valid QSAR model (CATALOGIC v.5.14.5 BOD 28 days MITI (OECD 301C) v.11.16). The substance is within the applicability domain of the model. The model predicted four degradation products, of which one can be regarded as relevant based on the predicted quantity (> 0.1%; 1-piperazinemethanol, CAS 90324-69-9). This relevant degradation product was evaluated with regard to its biodegradability and bioaccumulation potential based on QSAR data. The substance was not readily biodegradable, but significant accumulation is not to be expected. Thus, it is neither PBT, nor vPvB.
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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