Registration Dossier
Registration Dossier
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EC number: 203-232-2 | CAS number: 104-74-5
Endpoint summary
Administrative data
Description of key information
Biodegradation in water
35-days Closed Bottle test following the OECD guideline 301 D to determine the ready biodegradability of the test chemical (Experimental study report, 2018). The study was performed at a temperature of 20°C. The test system included control, test item and reference item. Polyseed were used as a test inoculum for the study.The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 32 ml/l. OECD mineral medium was used for the study. ThOD (Theoretical oxygen demand) of test and reference item was determined by calculation. % degradation was calculated using the values of BOD and ThOD for test item and reference item. The % degradation of procedure control (reference item) was also calculated using BOD & ThOD and was determined to be 75.3%. Degradation of Sodium Benzoate exceeds 45.18% on 7 days & 70.48% on 14th day. The activity of the inoculum was thus verified and the test can be considered as valid.The BOD35 value of test chemical was observed to be 1.1 mgO2/mg. ThOD was calculated as 2.64 mgO2/mg. Accordingly, the % degradation of the test item after 35 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 41.66%. Based on the results, the test item, under the test conditions, was considered to be ultimate inherently biodegradable in nature.
Biodegradation in water and sediment
Estimation Programs Interface (2017) prediction model was run to predict the half-life in water and sediment for the test chemical. If released in to the environment, 9.39% of the chemical will partition into water according to the Mackay fugacity model level III and the half-life period of test chemical in water is estimated to be 15 days (360 hrs). The half-life (15 days estimated by EPI suite) indicates that the chemical is not persistent in water and the exposure risk to aquatic animals is moderate to low whereas the half-life period of test chemical in sediment is estimated to be 135 days (3240 hrs). Based on this half-life value, it indicates that test chemical is persistent in sediment.
Biodegradation in soil
The half-life period of test chemical in soil was estimated using Level III Fugacity Model by EPI Suite version 4.1 estimation database (2017). If released into the environment, 59.8% of the chemical will partition into soil according to the Mackay fugacity model level III. The half-life period of test chemical in soil is estimated to be 30 days (720 hrs). Based on this half-life value of test chemical, it is concluded that the chemical is not persistent in the soil environment and the exposure risk to soil dwelling animals is moderate to low.
Additional information
Biodegradation in water
Various experimental studies of the test chemical were reviewed for the biodegradation end point which are summarized as below:
In an experimental key study from study report (2018),35-days Closed Bottle test following the OECD guideline 301 D to determine the ready biodegradability of the test chemical. The study was performed at a temperature of 20°C. The test system included control, test item and reference item. Polyseed were used as a test inoculum for the study. The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 32 ml/l. OECD mineral medium was used for the study. ThOD (Theoretical oxygen demand) of test and reference item was determined by calculation. % degradation was calculated using the values of BOD and ThOD for test item and reference item. The % degradation of procedure control (reference item) was also calculated using BOD & ThOD and was determined to be 75.3%. Degradation of Sodium Benzoate exceeds 45.18% on 7 days & 70.48% on 14th day. The activity of the inoculum was thus verified and the test can be considered as valid. The BOD35 value of test chemical was observed to be 1.1 mgO2/mg. ThOD was calculated as 2.64 mgO2/mg. Accordingly, the % degradation of the test item after 35 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 41.66%. Based on the results, the test item, under the test conditions, was considered to be ultimate inherently biodegradable in nature.
Another Biodegradation study from peer reviewed journal (ROBERT S. BOETHLING, et. al., 1984) was conducted for 30 days for evaluating the percentage biodegradability of test chemical. The study was performed according to die-way test. Sewage and river water were used as a test inoculums for the study. Initial test substance conc. used in the study was 30 mg/l. The percentage degradation of test chemical was determined to be 0% after a period of 30 days. Thus, based on percentage degradation, test chemical is considered to be not readily biodegradable in nature.
For the test chemical, additional biodegradation study was conducted for 28 days for evaluating the percentage biodegradability of test chemical (B. BALEUX et. al., 1977). The study was performed using residual bottle method under aerobic conditions. Waste water was used as a test inoculums for the study. Initial test substance conc. used in the study was 20 mg/l. The percentage degradation of test chemical was determined to be 0% by using spectrophotometer parameter after a period of 28 days. Thus, based on percentage degradation, test chemical is considered to be not readily biodegradable in nature.
Although other studies from peer reviewed journal indicates that the test chemical is not readily biodegradable, but on the basis of detailed experimental study result from study report (K1) and as per the OECD guideline, it has been concluded that the test chemical is considered to be ultimate inherently biodegradable in nature.
Biodegradation in water and sediment
Estimation Programs Interface (2017) prediction model was run to predict the half-life in water and sediment for the test chemical. If released in to the environment, 9.39% of the chemical will partition into water according to the Mackay fugacity model level III and the half-life period of test chemical in water is estimated to be 15 days (360 hrs). The half-life (15 days estimated by EPI suite) indicates that the chemical is not persistent in water and the exposure risk to aquatic animals is moderate to low whereas the half-life period of test chemical in sediment is estimated to be 135 days (3240 hrs). Based on this half-life value, it indicates that test chemical is persistent in sediment.
Biodegradation in soil
The half-life period of test chemical in soil was estimated using Level III Fugacity Model by EPI Suite version 4.1 estimation database (2017). If released into the environment, 59.8% of the chemical will partition into soil according to the Mackay fugacity model level III. The half-life period of test chemical in soil is estimated to be 30 days (720 hrs). Based on this half-life value of test chemical, it is concluded that the chemical is not persistent in the soil environment and the exposure risk to soil dwelling animals is moderate to low.
On the basis of available information, the test chemical can be considered to be ultimate inherently biodegradablein nature.
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