Registration Dossier
Registration Dossier
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EC number: 258-207-9 | CAS number: 52829-07-9
Biodegradation in soil
Administrative data
Link to relevant study record(s)
Description of key information
In accordance with Regulation (EC) No 1907/2006, Annex IX, Section 9.2 and 9.2.1.2, Column 2, the simulation test on biodegradation in soil 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 test item and the hydrolytic products were assessed. The test item is poorly biodegradable and hydrolyses slowly. Nevertheless, it gets degraded and metabolized. Sebacic acid was a metabolite that was detected. It is readily biodegradable. The other metabolite that was detected during the hydrolytic process was 2,2,6,6-tetramethylpiperidin-4-ol which is not classified as PBT substance. Furthermore, QSAR predictions by CATALOGIC revealed, that no hazard regarding the potential for bioaccumulation for the degradation products was shown. Therefore, neither a risk nor a hazard for the environment could be identified. Moreover, the risk characterization ratios (RCRs) of the chemical safety assessment are below 1, indicating that the risks are acceptable. Therefore, no simulated biodegradation studies in water and sediment are provided.
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 indicate 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 log Kow is low. The estimation model CATALOGIC BCF base-line model v03.10 (OASIS Catalogic v5.13.1) calculated for the parent compound Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate (CAS 52829-07-9) a log Kow of 6.5, while in a test according to OECD 107 a log Kow of 0.35 at pH 7 was measured (BASF SE 1988, see IUCLID Ch. 4.7). However, the substance is predominantly positively charged at environmentally relevant pH conditions (pKa = 9.5 – 11 at 25°C, see IUCLID Ch. 4.21). Since the substance occurs as charged species in aqueous media at environmentally relevant pH (4-9), all results for physico-chemical properties and environmental fate that were obtained by QSAR modeling have to be regarded with caution because the calculations only consider the uncharged species which occurs only under high pH conditions (pH > 10). Therefore, the experimental log Kow value is considered to be more accurate for the environmental conditions (pH 4 – 9). (0.35, meas., see IUCLID Ch. 4.7).
Therefore, it is not considered necessary to conduct a soil simulation test. and no biodegradation studies in soil will be provided.
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