Registration Dossier
Registration Dossier
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EC number: 216-940-1 | CAS number: 1704-62-7
Biodegradation in soil
Administrative data
Link to relevant study record(s)
Description of key information
No data
Key value for chemical safety assessment
Additional information
In accordance with Regulation (EC) No 1907/2006, Annex IX, Section 9.2, 9.2.1.3, Column 2, soil simulation testing does not need to be conducted as the chemical safety assessment according to Annex I indicates that there is no need to investigate further the degradation of the substance and its degradation products. The risk characterization ratios (RCRs) of the chemical safety assessment are below 1, indicating that the risks are acceptable. In addition, the substance does not have a high potential for adsorption to soil. The log Kow is low (-0.78, meas., see IUCLID Ch. 4.7). The estimated adsorption coefficients for the charged and the uncharged molecule is also low (charged molecule: log Koc = 1.59 at pH 7; uncharged molecule: -0.002 to -0.07; see IUCLID Ch. 5.4.1). Therefore, it is not considered necessary to conduct a soil simulation test. and no biodegradation studies in soil will be provided.
In addition, the model CATALOGIC 301C v11.15 (OASIS Catalogic v5.13.1) was used to predict potential metabolites of the substance. In contrast to the experimental data, the model predicted the substance to be readily biodegradable (78% removal in 28 d, based on BOD). The substance was within the applicability domain of the model. The model predicted 19 metabolites, identifying 8 metabolites as relevant degradation products in terms of PBT/vPvB assessment, with an estimated quantity of ≥ 0.1% (for details see ‘Attached background material’ of the respective Endpoint Study Record in IUCLID Ch. 5.2.1). Two of the 8 relevant metabolites were calculated to be not readily biodegradable (between 11 and 41% after 28 days, based on BOD). The other relevant metabolites were estimated to be readily biodegradable (≥ 60% after 28 days, based on BOD). In conclusion, the majority of the predicted metabolites present in a concentration of ≥ 0.1% are estimated to be readily biodegradable.
All 19 predicted metabolites have log Kow values clearly below 3 (range: -5.65 to 0.35). Nine of the metabolites are registered under REACH and have been assessed to be not PBT/vPvB. Therefore, it can be concluded that none of these degradation products is potentially PBT/vPvB.
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