Registration Dossier
Registration Dossier
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EC number: 471-920-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Additional information
Hydrolysis:
In accordance with the REACH Annex VIII Column 2 adaptation for this endpoint, the study does not need to be conducted if the substance is highly insoluble. A water solubility study (Section 4.8: Key water solubility Woolley 2006) has shown that the water solubility of the mixture is < 1 mg/L.
The substance is therefore not expected to be subject to hydrolysis and will be stable in the environment.
Biodegradation:
Two studies were available for this endpoint (Clarke 2006, and Kawashima 2006). Considering that Clarke (2006) followed OECD guideline, under GLP, and quality of details, this study is considered as Key study for this endpoint.
The key study (Clarke, 2006) was conducted following OECD guidelines 301B, and EU Method C.4 -C, under GLP conditions. The test material, at a concentration of 10 mg carbon/L, was exposed to activated sewage sludge micro-organisms with culture medium in sealed culture vessels in the dark at 21°C for 28 days.
The test material attained 67% degradation after 28 days. As the test material is a UVCB the 10 -day window validation criterion are not applicable. Therefore, the test material can be considered to be readily biodegradable.
The experiment conducted by Kawashima (2006) followed Biodegradability test of chemical substances by microorganisms (Yakushokuhatsu no. 1121002, Heisei 15.11.13 Seikyoku no. 2, Kanpokihatsu no. 031121002, november 21, 2003; the latest version, 2005). Measurements of Biochemical oxygen demand, Dissolved organic carbon, and residual test substance amount were estimated. From the degradability results based on the BOD (ca. 36%) and the residual test substance amount (ca. 60%), it is conducted that the test substance is not readily biodegradable under the conditions of this test. The test substance was considered to be in process of biodegradation since the BOD value was still increasing.
A new peak was observed on the chromatograms of the GPC. It was presumed that the component was derived from the pretreatment process or transformation.
Test solutions were analyzed with HPLC and LC/MS. However, the structure could not be determined, because no specific peak was detected.
Considering these two studies, the test material is considered to be readily biodegradable.
Bioaccumulation:
Only one study was available for this endpoint (Sato, 2007). The experiment was conducted following the test method relating to new chemical substances (Yakushokuhatsu no. 1121002, Heisei 15.11.13 Seikyoku no. 2, Kanpokihatsu no. 031121002, November 21, 2003; the latest version, 2006). Two different concentrations were tested: 0.05 and 0.5 mg/L, during 60 days.
After the pretreatment, analysis was conducted using liquid chromatography mass spectrometry (LC/MS). At the high concentration level, the variations of the bioconcentration factors consecutively measured 3 times at intervals of more than 48 hours could not be confirmed to fall within +/-20% for peaks A, B, and C. Because the concentration factors during the exposure period were all less than 100, the bioconcentration factors were deemed to reach the steady-state. The bioconcentration factors at the steady-state were =< 50 (peak A), <11 (peak B), and <22 (peak C).
At the low concentration level, all the bioconcentration factors during the exposure period were less than the detection limit. The bioconcentration factors during the exposure period were <191 (peak A), <102 (peak B), and <222 (peak C).
Based on the results of Sato (2007), the bioaccumulation potential of the test substance in fish tissues is judged to be low.
Adsportion/Desorption:
One study was available for this endpoint (Woolley, 2006), and it is considered as key study.
The experiment was conducted following OECD Guideline 121 (Estimation of the Adsorption Coefficient (Koc) on Soil and on Sewage Sludge using High Performance Liquid Chromatography (HPLC)). The test material (0.0542 g) was diluted to 20 mL with tetrahydrofuran. The results indicated that approximately 96% of the test material had an adsorption coefficient (Koc) > 4.27E05 (Log10 Koc > 5.63).
The substance is highly absorbing to soil and will not be mobile in the terrestrial environment
Henry's Law Constant
Henry's law constant was calculated to be 6.44E-06 Pa.m3/mol at 25 °C based on experimental water solubility vapour pressures . This value indicates a low rate of volatilisation from surface water is expected.
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