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Environmental fate & pathways

Biodegradation in water: screening tests

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Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reason / purpose for cross-reference:
read-across source
Parameter:
% degradation (CO2 evolution)
Value:
94
Sampling time:
10 d
Parameter:
% degradation (CO2 evolution)
Value:
94
Sampling time:
28 d
Details on results:
- The test item is considered as "readily biodegradable".
- The degree of biodegradation reached 94 % after 28 days.
- The 10-day-window began on day 3, at its end, 94 % were reached, surpassing the pass level of 60 % given in the OECD guideline.
- Abiotic degradation was not observed.
- Degradation in the toxicity flask was 88% after 14 days, the test item can be stated as "not toxic towards the inoculum in a concentration of 173.4 mg/L.
Results with reference substance:
Degradation of positive control >60 % was found at 7 days (valid).

Table 1: Degradation values in %

 Day Positive Control 1  Positive Control 2  Positive Control Mean  Test 1  Test 2  Test Mean  Abiotic Control  Toxicity Control 
 2  -0.1 -0.1  -0.1  2.0  5.2 3.6  1.4 1.1
 4  56.0  45.3  50.6  70.6  61.2  65.9  0.9  56.1
 7  86.5  80.5  83.5  95.3  91.5  93.4  0.8

84.0

 9

 89.8

 82.5

 86.2

 90.4

 89.5

 90.0

 0.1

 83.0

 11

 89.5

 89.2

 89.4

 94.9

 91.2

 93.1

 0.0

 85.8

 14

 88.9

 91.0

 89.9

 97.0

 95.0

 96.0

 0.3

 87.6

 18

 88.4

 86.5

 87.4

 93.6

 91.1

 92.3

-0.9

 87.9

 23

90.1

 88.1

 89.1

 93.0

 91.9

 92.5

 -2.5

 87.4

 29

 89.3

 90.6

 89.9

 94.0

 93.7

 93.9  -2.7  90.3
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
All validity criteria were met. Degradation behaviour of positive control and toxicity control was normal. Abiotic degradation was not observed. Both replicates of the test item showed very good correspondence. Degradation took place completely and rapidly. If degradation in the toxicity flask is below 25% after 14 days, the test item can be considered as toxic towards the inoculum. As degradation in the toxicity flask was 88% after 14 days, the test item can be stated as "not toxic towards the inoculum in a concentration of 173.4 mg/L.
The result of the test can be considered valid. The test item is readily biodegradable.
Executive summary:

The test item Disodium hydroxy(sulfonato)acetate was tested under GLP conditions and according to OECD guideline 301B and EU Method C.4 -C using a concentration of nominally 20 mg organic carbon/L (corresponding to 173.4 mg Disodium hydroxy-(sulfonato)acetate/L) in test medium following OECD 301B and EU-Method C.4-C.

Aniline was chosen as positive control.

Activated sludge was used as inoculum (concentration in the test 25 mg dry matter/L). The test was left running for 28 days. All validity criteria were met. Degradation of the positive control was 84 % after seven days. The following data were determined for the test item Disodium hydroxy(sulfonato)acetate:

10-day-window: day 3-13

degradation at the end of 10 -day-window: 94 %

degradation at the end of the test: 94 %

pass level: 60% at the end of 10-day-window

Therefore it is concluded, that when applying the 10-day-window, the test item Disodium hydroxy(sulfonato)acetate is readily biodegradable following OECD 301 B/EU C.4-C.

The source substance contains the major organic moiety (hydroxysulfonatoacetates) that is identical to the target substance. Therefore, the results from this study can be attributed to the hydroxysulfonatoacetate moiety of the target substance TP 1740.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reason / purpose for cross-reference:
read-across source
Parameter:
% degradation (O2 consumption)
Value:
70.9
Sampling time:
28 d
Details on results:
Test article:
- Test concentration (organic part): 167.7 mg/L
- ThOD of the test article: 0.24 mg O2/mg test mat.
- ThOD in the test flasks: 40.2 mg O2/L
- BOD in flask 1 after 28 days: 44.3 mg O2/L (including blank)
- flask 2 was not used for calculations: After 10 days of incubation, the parallel flasks with test article show a beginning
deviation in the BOD, which grew to 60 % deviation by the end of incubation (desired value: =s 20 %). This is interpreted as a leak in the system.
In arrangement with Dr. Franke (German environmental bureau, UBA; telephone call with Dr. Kuttler on the 15th of December 1997) the flask with the lower BOD was taken for calculating the biodegradation. The parallel flasks with test article showed similar values till day 10 (< 20 % deviation) and the criteria for the 10-day-window-concept were met till day 10.
- BOD(test article) - BOD(inoculum blank): 0.17 mg O2/mg test mat. or 28.5 mg O2/L
- BOD in flask 3 after 28 days (inoculum blank): 16.0 mg O2/L
- BOD in flask 4 after 28 days (inoculum blank): 15.6 mg O2/L
- mean value (Inoculum blank, required: < 60 mg 02/L): 15.8 mg O2/L
- maximum BOD-difference in flasks 1 - 2 at the end of the test (required: < 20 %): - %
- BOD in flask 6 after 28 days (abiotic degradation):0.0 mg O2/L

Biodegradation after 28 days: 70.9 %

Reference substance:
- Test concentration: 100 mg/L
- Theoretical Oxygen demand (ThOD): 1.67 mg O2/mg substance
- ThOD in flask 5: 167 mg O2/L
- BOD in flask 5 after 28 days: 1.52 mg O2/mg substance or 151.6 mg O2/L (including control)

Biodegradation after 14 Days (Soil: > 60 %): 88.4 %
Biodegradation after 28 Days: 90.8 %

The measurements concerning the inoculum blank, the reference substance and the test article comply with the criteria for validity in the OECD Guideline 301 F, except flask No. 2.
Parameter:
ThOD
Value:
0.24 g O2/g test mat.
Results with reference substance:
Biodegradation after 28 days: 90.8 %
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
Assuming that the sulphur-proportion is transferred to the highest oxidation-level in the pre-treatment-phase, and that in the biotic treatment the organic carbon-proportion is transferred to CO2 and the hydrogen-proportion to H2O, the application of 300 mg/L of the technical product leads to an organic proportion of 167.7 mg/L (considering the chemical formula, defined by the study sponsor). This organic proportion leads to a ThOD of 40,2 mg/L. In the biotic treatment according to the Manometric Respiration Test (OECD 301 F) 70.9 % of this ThOD are consumed after 28 days.
Executive summary:

The study on the biodegradability of the test item was conducted following OECD guideline 301 F and EU method C.4 -D under GLP compliance. A total amount of 300 mg/L results in 167.7 mg/L organic rest. After 10 days of incubation, the parallel flasks with test article show a beginning deviation in the BOD, which grew to 60 % deviation by the end of incubation (desired value: s 20 %). The biodegradation rate in the flask with the higher values would be > 110 %, which is probably due to a leak in the system. Assuming that the sulphur-proportion is transferred to the highest oxidation-level in the pre-treatment-phase, and that in the biotic treatment the organic carbon-proportion is transferred to CO2 and the hydrogen-proportion to H20, the application of 300 mg/L of the technical product leads to an organic proportion of 167.7 mg/L (considering the chemical formula, defined by the study sponsor). This organic proportion leads to a ThOD of 40.2 mg/L. In the biotic treatment according to the Manometric Respiration Test (OECD 301 F) 70.9 % of this ThOD are consumed after 28 days.

The organic proportion of the test item is readily biodegradable.

The source substance contains the major organic moiety (hydroxysulfonatoacetates) that is identical to the target substance. Therefore, the results from this study can be attributed to the hydroxysulfonatoacetate moiety of the target substance TP 1740.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reason / purpose for cross-reference:
read-across source
Parameter:
% degradation (CO2 evolution)
Value:
95
St. dev.:
3.3
Sampling time:
10 d
Parameter:
% degradation (CO2 evolution)
Value:
97
St. dev.:
1.8
Sampling time:
28 d
Details on results:
Results for the Test Item
- The test item is considered as “readily biodegradable“.
- The degree of biodegradation reached 97 % after 28 days.
- The 10-day-window began on day 2, at its end, 95 % degradation were reached (graphic evaluation), surpassing the pass level of 60 % given in the OECD guideline.
- Because the test item is a mixture, the 10-day window has not to be taken into account. Therefore, regardless of the 10-day-window the test item is considered as “readily biodegradable within 28 days”.
- The abiotic degradation reached 5 %.

Degradation values in %

 Day Positive Control 1  Positive Control 2  Positive Control Mean  Test 1  Test 2  Test Mean  Abiotic Control  Toxicity Control 
 2  -0.4  0.0  -0.2  5.0  6.4  5.7  4.5  -0.2
 4  3.2  22.2  12.7  62.3  69.8  66.1  6.3  16.3
 7  57.1  57.7  57.4  75.1  76.1  75.6  5.1 61.8 
 9  80.5  80.1  80.3  89.2  98.9  94.1  5.3  77.9
 11  87.4  92.6  90.0  91.2  97.8  94.5  5.4  79.9
 14  95.2  96.3  95.8  92.3  98.6  95.5  5.2  84.3
 18  95.4  97.3  96.4  98.4  102.6  100.5  4.9  87.6
 23 102.6   101.0  101.8  96.7  100.6.  98.6  5.1  87.0
 29  100.8  101.3  101.1  95.3  98.9  97.1  4.9  87.0
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
All validity criteria were met.
Degradation behaviour of positive control and toxicity control was normal. Abiotic degradation reached 5 %. Both replicates of the test item showed very good correspondence.
Degradation values of more than 100 % were calculated. This is due to the fact that the measurement errors of test flasks and control flasks add up when using the equation proposed in the guideline.
If degradation in the toxicity flask is below 25 % after 14 days, the test item can be considered as toxic towards the inoculum. As degradation in the toxicity flask was 84.3 % after 14 days, the test item can be stated as “not toxic towards the inoculum in a concentration of 181.4 mg/L”.
For pure substances, ready biodegradability is defined in the guidelines as degradation surpassing 60 % within 10 days after reaching a level of 10 %.
Because the test item is a mixture, the 10-day window has not to be taken into account.
Therefore, regardless of the 10-day-window the test item is considered as “readily biodegradable within 28 days”.
No observations were made which might cause doubts concerning the validity of the study outcome.
The result of the test can be considered valid.
Executive summary:

The test item was tested under GLP conditions and according to OECD guideline 301B and EU Method C.4 -C using a concentration of nominally 20 mg organic carbon/L (corresponding to 181.4 mg test item/L) in test medium.

Aniline was chosen as positive control.

Activated sludge was used as inoculum (concentration in the test 25.0 mg dry matter/L). The test was left running for 28 days. All validity criteria were met. Degradation of the positive control was 80 % after 9 days.

The following data were determined for the test item :

10-day-window: day 2 – 12

degradation at the end of 10-day-window: 95 %

degradation at the end of the test: 97 %

pass level following guideline: 60 % at the end of 10-day-window for pure substances respective 60 % at the end of the test for mixtures

Therefore, when applying the 10-day-window, the sample is readily biodegradable following OECD 301B and EU C.4-C respectively.

Because the test item is a mixture, the 10-day-window does not have to be taken into account. Therefore, regardless of the 10-day-window the test item is considered as “readily biodegradable” within 28 days.

The source substance contains the major organic moieties that are identical to the target substance. Therefore, the results from this study are also valid for the target substance TP 1740.

Description of key information

Muckle 2018a

The test item was tested under GLP conditions and according to OECD guideline 301B and EU Method C.4 -C using a concentration of nominally 20 mg organic carbon/L (corresponding to 181.4 mg test item/L) in test medium.

Aniline was chosen as positive control.

Activated sludge was used as inoculum (concentration in the test 25.0 mg dry matter/L). The test was left running for 28 days. All validity criteria were met. Degradation of the positive control was 80 % after 9 days.

The following data were determined for the test item:

10-day-window: day 2 – 12

degradation at the end of 10-day-window: 95 %

degradation at the end of the test: 97 %

pass level following guideline: 60 % at the end of 10-day-window for pure substances respective 60 % at the end of the test for mixtures

Therefore, when applying the 10-day-window, the sample is readily biodegradable following OECD 301B and EU C.4-C respectively.

Because the test item is a mixture, the 10-day-window does not have to be taken into account. Therefore, regardless of the 10-day-window the test item is considered as “readily biodegradable” within 28 days.

The source substance contains the major organic moieties that are identical to the target substance. Therefore, the results from this study are also valid for the target substance TP 1740.

Muckle 2009

The test item Disodium hydroxy(sulfonato)acetate was tested under GLP conditions and according to OECD guideline 301B and EU Method C.4 -C using a concentration of nominally 20 mg organic carbon/L (corresponding to 173.4 mg Disodium hydroxy-(sulfonato)acetate/L) in test medium following OECD 301B and EU-Method C.4-C.

Aniline was chosen as positive control.

Activated sludge was used as inoculum (concentration in the test 25 mg dry matter/L). The test was left running for 28 days. All validity criteria were met. Degradation of the positive control was 84 % after seven days. The following data were determined for the test item Disodium hydroxy(sulfonato)acetate:

10-day-window: day 3-13

degradation at the end of 10 -day-window: 94 %

degradation at the end of the test: 94 %

pass level: 60% at the end of 10-day-window

Therefore it is concluded, that when applying the 10-day-window, the test item Disodium hydroxy(sulfonato)acetate is readily biodegradable following OECD 301 B/EU C.4-C.

The source substance contains the major organic moiety (hydroxysulfonatoacetates) that is identical to the target substance. Therefore, the results from this study can be attributed to the hydroxysulfonatoacetate moiety of the target substance TP 1740.

Kuttler 1998

The study on the biodegradability of the test item was conducted following OECD guideline 301 F and EU method C.4 -D under GLP compliance. A total amount of 300 mg/L results in 167.7 mg/L organic rest. After 10 days of incubation, the parallel flasks with test article show a beginning deviation in the BOD, which grew to 60 % deviation by the end of incubation (desired value: s 20 %). The biodegradation rate in the flask with the higher values would be > 110 %, which is probably due to a leak in the system. Assuming that the sulphur-proportion is transferred to the highest oxidation-level in the pre-treatment-phase, and that in the biotic treatment the organic carbon-proportion is transferred to CO2 and the hydrogen-proportion to H2O, the application of 300 mg/L of the technical product leads to an organic proportion of 167.7 mg/L (considering the chemical formula, defined by the study sponsor). This organic proportion leads to a ThOD of 40.2 mg/L. In the biotic treatment according to the Manometric Respiration Test (OECD 301 F) 70.9 % of this ThOD are consumed after 28 days.

The organic proportion of the test item is readily biodegradable.

The source substance contains the major organic moiety (hydroxysulfonatoacetates) that is identical to the target substance. Therefore, the results from this study can be attributed to the hydroxysulfonatoacetate moiety of the target substance TP 1740.

Key value for chemical safety assessment

Biodegradation in water:
readily biodegradable
Type of water:
freshwater

Additional information

Based on the results of the source substnces TP 1740 is classified as readily biodegradable.