Recyclamine R 501

Endpoint summary

Description of key information

Hydrolysis

In accordance with column 2 of Annex VIII of the REACH regulation, testing for this endpoint is scientifically not necessary and does not need to be conducted since the test chemical is readily biodegradable.

Biodegradation in water

Biodegradation study was conducted for 28-days Closed Bottle test following the OECD guideline 301 D for determining 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. Activated sludge, collected from Bhandewadi STP, Nagpur, was used as inoculum in the study. This was pre-conditioned at the test temperature. 1 mL supernatant was diluted to 100 mL with mineral medium and from this solution 0.05 mL was added to 125 mL test bottles. This gave the bacterial count as 10E4 to 10E6 CFU/L. The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 0.4 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 91.62%. Degradation of Sodium Benzoate exceeds 32.93% on 7 days & 74.85% on 14th day. The activity of the inoculum is thus verified and the test can be considered as valid.The BOD28 value of test chemical was observed to be 1.50 mgO2/mg. ThOD was calculated as 2.2 mgO2/mg. Accordingly, the % degradation of the test chemical after 28 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 68.18%. Based on the results, the test item, under the test conditions, was considered to be readily biodegradable in nature.

Biodegradation in water and sediment

Estimation Programs Interface prediction model was run to predict the half-life in water and sediment for the test chemical. If released in to the environment, 19.9% 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 60 days (1440 hrs). The half-life (60 days estimated by EPI suite) indicates that the chemical is persistent in water and the exposure risk to aquatic animals is moderate to high whereas the half-life period of test chemical in sediment is estimated to be 541.6 days (13000 hrs). However, as the percentage release of test chemical into the sediment is less than 1% (i.e, reported as 0.0971%), indicates that test chemical is not 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. If released into the environment, 80% 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 120 days (2880 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.

Bioaccumulation: aquatic / sediment

BCFBAF model of Estimation Programs Interface was used to predict the bioconcentration factor (BCF) of test chemical. The bioconcentration factor (BCF) of test chemical was estimated to be 2.72 L/kg whole body w.w (at 25°C) which does not exceed the bio concentration threshold of 2000, indicating that the test chemical is not expected to bioaccumulate in the food chain.

Adsorption / desorption

The adsorption coefficient Koc in soil and in sewage sludge of test chemical was determined by the Reverse Phase High Performance Liquid Chromatographic method according to OECD Guideline No. 121 for testing of Chemicals. A test chemical solution was prepared by accurately weighing 10 µL of test item and diluted with acetonitrile up to 10 ml. Thus, the test solution concentration was 900 mg/l. The pH of test substance was 7.9. Each of the reference substance and test substance were analysed by HPLC at 210 nm. After equilibration of the HPLC system, Urea was injected first, the reference substances were injected in duplicate, followed by the test chemical solution in duplicate. Reference substances were injected again after test sample, no change in retention time of reference substances was observed. Retention time tR were measured, averaged and the decimal logarithms of the capacity factors k were calculated. The graph was plotted between log Koc versus log k. The linear regression parameter of the relationship log Koc vs log k were also calculated from the data obtained with calibration samples and therewith, log Koc of the test substance was determined from its measured capacity factor. The reference substances were chosen according to estimated Koc range of the test substance and generalized calibration graph was prepared. The reference substances were Acetanilide, N,N-dinitrobenzamide, Aniline, 1,2,3-Trichlorobenzene, Phenanthrene, and DDT having Koc value ranging from 1.1 to 5.0. The Log Koc value was determined to be 4.020±0.050 at 25°C. This log Koc value indicates that the test chemical has a strong sorption to soil and sediment and therefore have negligible to slow migration potential to ground wate.

Additional information

Hydrolysis

In accordance with column 2 of Annex VIII of the REACH regulation, testing for this endpoint is scientifically not necessary and does not need to be conducted since the test chemical is readily biodegradable.

Biodegradation in water

Biodegradation study was conducted for 28-days Closed Bottle test following the OECD guideline 301 D for determining 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. Activated sludge, collected from Bhandewadi STP, Nagpur, was used as inoculum in the study. This was pre-conditioned at the test temperature. 1 mL supernatant was diluted to 100 mL with mineral medium and from this solution 0.05 mL was added to 125 mL test bottles. This gave the bacterial count as 10E4 to 10E6 CFU/L. The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 0.4 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 91.62%. Degradation of Sodium Benzoate exceeds 32.93% on 7 days & 74.85% on 14th day. The activity of the inoculum is thus verified and the test can be considered as valid.The BOD28 value of test chemical was observed to be 1.50 mgO2/mg. ThOD was calculated as 2.2 mgO2/mg. Accordingly, the % degradation of the test chemical after 28 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 68.18%. Based on the results, the test item, under the test conditions, was considered to be readily biodegradable in nature.

Biodegradation in water and sediment

Estimation Programs Interface prediction model was run to predict the half-life in water and sediment for the test chemical. If released in to the environment, 19.9% 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 60 days (1440 hrs). The half-life (60 days estimated by EPI suite) indicates that the chemical is persistent in water and the exposure risk to aquatic animals is moderate to high whereas the half-life period of test chemical in sediment is estimated to be 541.6 days (13000 hrs). However, as the percentage release of test chemical into the sediment is less than 1% (i.e, reported as 0.0971%), indicates that test chemical is not 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. If released into the environment, 80% 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 120 days (2880 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.

Bioaccumulation: aquatic / sediment

Various predicted data of the target chemical were reviewed for the bioaccumulation end point which are summarized as below:

 

In a prediction done using the BCFBAF model of Estimation Programs Interface, the bioconcentration factor (BCF) of test chemical was predicted. The bioconcentration factor (BCF) of test chemical was estimated to be 2.72 L/kg whole body w.w (at 25 deg C).

 

For the test chemical, SciFinder database (American Chemical Society (ACS)) was used for predicting the bioconcentration factor (BCF) of test chemical. The bioconcentration factor (BCF) of test chemical was estimated to be 1 & 1.42 dimensionless at pH range 1-9 & pH 10, respectively (at 25°C).

 

On the basis of above results, it can be concluded that the BCF value of test chemical was evaluated to be ranges from 1 to 2.72, respectively, which does not exceed the bioconcentration threshold of 2000, indicating that the test chemical is not expected to bioaccumulate in the food chain.

 

In addition to this, bioaccumulation endpoint can also be considered for waiver as per in accordance with column 2 of Annex IX of the REACH regulation, testing for this end pointis scientifically not necessary and does not need to be conducted because the substance has a low potential for bioaccumulation based on logKow ≤ 3.

Adsorption / desorption

The adsorption coefficient Koc in soil and in sewage sludge of test chemical was determined by the Reverse Phase High Performance Liquid Chromatographic method according to OECD Guideline No. 121 for testing of Chemicals. A test chemical solution was prepared by accurately weighing 10 µL of test item and diluted with acetonitrile up to 10 ml. Thus, the test solution concentration was 900 mg/l. The pH of test substance was 7.9. Each of the reference substance and test substance were analysed by HPLC at 210 nm. After equilibration of the HPLC system, Urea was injected first, the reference substances were injected in duplicate, followed by the test chemical solution in duplicate. Reference substances were injected again after test sample, no change in retention time of reference substances was observed. Retention time tR were measured, averaged and the decimal logarithms of the capacity factors k were calculated. The graph was plotted between log Koc versus log k. The linear regression parameter of the relationship log Koc vs log k were also calculated from the data obtained with calibration samples and therewith, log Koc of the test substance was determined from its measured capacity factor. The reference substances were chosen according to estimated Koc range of the test substance and generalized calibration graph was prepared. The reference substances were Acetanilide, N,N-dinitrobenzamide, Aniline, 1,2,3-Trichlorobenzene, Phenanthrene, and DDT having Koc value ranging from 1.1 to 5.0. The Log Koc value was determined to be 4.020±0.050 at 25°C. This log Koc value indicates that the test chemical has a strong sorption to soil and sediment and therefore have negligible to slow migration potential to ground wate.