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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:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP, QSAR calculation, acceptable with restrictions.
Justification for type of information:
Episuite and the BIOWIN models are well documented and commonly used QSARs for predicting the biodegradation potential of chemicals. Constituents within LOA streams fall within the applicability domain of these models and they have been recommended by ECHA in the Information Requirement Guidelines.
Reason / purpose for cross-reference:
assessment report
Reason / purpose for cross-reference:
(Q)SAR model reporting (QMRF)
Qualifier:
no guideline followed
Principles of method if other than guideline:
BIOWIN v4.1 in EPISuite 4.1 (2017). The Biodegradation Probability Program (Biowin) estimates the probability for the rapid aerobic biodegradation of an organic chemical in the presence of mixed populations of environmental microorganisms. As recommended in the ECHA guidance R.7b, BIOWIN 2, 3, 5 and 6 were used to predict the ready biodegradability of constituents of the category:

BIOWIN 2 =  nonlinear probability model
BIOWIN 3  =  expert survey ultimate biodegradation model
BIOWIN 5  =  MITI linear model
BIOWIN 6  =  MITI nonlinear model

Biodegradability estimates are based upon fragment constants that were developed using multiple linear or non-linear regression analyses, depending on the model. BIOWIN 2 is intended to convey a general indication of biodegradability under aerobic conditions, and not for any particular medium (Howard et al., 1992). BIOWIN 3 yield estimates for the time required to achieve complete ultimate and primary biodegradation in a typical or "evaluative" aquatic environment (Boethling et al., 1994). BIOWIN 5 and 6 are predictive models for assessing a compound’s biodegradability in the Japanese MITI (Ministry of International Trade and Industry) ready biodegradation test; i.e. OECD 301C (Tunkel et al., 2000).

The use of QSAR estimates to predict the biodegradability of hydrocarbons are included in the training sets of the BIOWIN. The databases were created using experimental biodegradation data for compounds found in crude oil and its products, with biodegradation references obtained for each of these compounds, mainly from the BIOLOG and DATALOG files of EFDB, TOXLINE and American Chemical Society Chemical Abstracts as well as literature searches.
GLP compliance:
no
Specific details on test material used for the study:
Not applicable
Oxygen conditions:
aerobic
Inoculum or test system:
not specified
Details on inoculum:
Not applicable
Based on:
other: QSAR calculation
Parameter followed for biodegradation estimation:
other: QSAR calculation
Details on study design:
Not applicable
Preliminary study:
Not applicable
Test performance:
Not applicable
Parameter:
probability of ready biodegradability (QSAR/QSPR)
Remarks:
BIOWIN 2
Value:
>= 0.42 - <= 1
Remarks on result:
other: Result from QSAR prediction. Range based on the measured constituents in the streams.
Parameter:
calculated rating of total degradation time (QSAR/QSPR)
Remarks:
BIOWIN 3
Value:
>= 2.33 - <= 3.54
Remarks on result:
other: Result from QSAR prediction.Range based on the measured constituents in the streams.Range based on the measured constituents in the streams. Range based on the measured constituents in the streams. Range based on the measured constituents in the streams.
Parameter:
probability of ready biodegradability (QSAR/QSPR)
Remarks:
BIOWIN 5
Value:
>= 0.191 - <= 0.618
Remarks on result:
other: Result from QSAR prediction. Range based on the measured constituents in the streams.
Parameter:
probability of ready biodegradability (QSAR/QSPR)
Remarks:
BIOWIN 6
Value:
>= 0.12 - <= 0.87
Remarks on result:
other: Result from QSAR prediction. Range based on the measured constituents in the streams.
Details on results:
BIOWIN 2, 5, and 6 Result Classification: A probability greater than or equal to 0.5 indicates “Biodegrades Fast” and a probability less than 0.5 indicates “Does NOT Biodegrade Fast”
BIOWIN 3 Result Classification (primary and ultimate): 5.00 - hours, 4.00 - days, 3.00 - weeks, 2.00 - months, 1.00 - longer. A probability greater than or equal to 2.75 indicates "Biodegrades Fast".
Details of the constituents and how their BIOWIN values relate to their persistence assessment are found in the PBT report attached to Section 13 (see cross-reference), and also in the document attached as background material.
Results with reference substance:
Not applicable

 

 Model Biodegrades fast (No. of consituents)  Does not biodegrade fast  (No. of consituents)
 BIOWIN 2 118 1
 BIOWIN 3 101 18
 BIOWIN 5 22 97
 BIOWIN 6 55 64
Validity criteria fulfilled:
not applicable
Conclusions:
The BIOWIN models predict a high probability of ready biodegradability for a number of constituents of these streams. Out of the 119 constituents of the category, and according to the criteria in the R.7b Information Requirement Guidance from ECHA, the following is concluded:

- BIOWIN 2 predicted 118 constituents biodegrade fast
- BIOWIN 3 predicted 101 constituents biodegrade fast (within weeks)
- BIOWIN 5 predicted 22 constituents biodegrade fast
- BIOWIN 6 predicted 55 constituents biodegrade fast

Details of the constituents and how their BIOWIN values relate to their persistence assessment are found in the PBT report attached to Section 13 (see cross-reference), and also in the document attached as background material.
Executive summary:

The predictions of ready biodegradability of the measured constituents of this category (at equal or above 0.1% w/w) have been predicted using the EPISUITE v4.11 BIOWIN models (2017), which use methodology described by Howard et al. (1992), Boethling et al. (1994) and Tunkel et al. (2000). Of the 119 constituents, and according to the criteria set out in the ECHA R.7b Information Requirements Guidance, 118 (BIOWIN 2), 101 (BIOWIN 3), 22 (BIOWIN 5) and 55 (BIOWIN 6) were predicted to be readily biodegradable based on the different models, with 118 constituents having at least one prediction of a high probability that it will biodegrade fast.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 March 2003 to 6 March 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guidelines study, available as unpublished report, acceptable with restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Version / remarks:
inoculum preparation which was performed in general agreement with ASTM D5864
Deviations:
yes
Remarks:
inoculum preparation which was performed in general agreement with ASTM D5864,
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
not reported
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, adapted
Details on inoculum:
obtained from Clinton Sanitary Wastwater Treatment Plant, Annandale, New Jersey on March 5 2003.
Duration of test (contact time):
41 d
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
Low DCPD resin oil evaluated at a mean concentration of 50.13 mg/L; postiive control substance, sodium benzoate evaluated at a concentratio of 49.13 mg/L. Triplicate test systems were used to evaluate the iodegradability of the test and positive control substances at mean concentrations of 50.13 mg/L and 49.13 mg/L, respectively. Blank test systems, which did not contain the test or positive control substance, were run concurrently in triplicate. The total suspended solids (TSS) of the activated sludge was determined to be 4.13 g/L. The inoculum was added at a 1% loading volume of sludge supernatant to test medium. The microbial count of the inoculum was 106 CFU/mL. One liter of test medium, which was aerated for 24 hours with carbon dioxide free air, was added to each one liter respirometer flask. The test substance was weighed in an air tight syringe and injected into the test medium. The test system was sealed immediately after addition of the test substance. An aliquot of the positive control stock solution was added to the appropriate test flasks. An unacclimated activated sludge inoculum was used in this study. The inoculum was obtained from the Clinton Sanitary Wastewater Treatment Plant, Annandale, NJ, USA. The treatment plant receives domestic sewage. All test systems were placed on a Coordinated Environmental Services
(CES) automated respirometer which automatically recorded the oxygen uptake in general agreement with the OECD guideline. The 41-day study was conducted at a temperature range of 22 ± 1°C.
Reference substance:
other: Sodium Benzoate
Preliminary study:
not reported
Test performance:
not reported
Key result
Parameter:
% degradation (O2 consumption)
Value:
6.48
Sampling time:
41 d
Details on results:
Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance as calculated using results of an elemental analysis of the test substance.
Results with reference substance:
86.4% over 28 days. By day 14, >60% biodegradation of positive control was observed, which meets the guideline requirement. No deviations from the protocol occurred that affected the integrity of the study data.
Validity criteria fulfilled:
yes
Interpretation of results:
not readily biodegradable
Conclusions:
The average percent biodegradation of the test substance was determined to be 6.48% on day 41.
Executive summary:

This is a GLP Compliant study following OECD guidelines and is considered adequate for assessment. The average percent biodegradation of the test substance was determined to be 6.48% on day 41.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
16 April 2003 to 17 April 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guidelines study, available as unpublished report, acceptable with restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Principles of method if other than guideline:
clarifications and exceptions provided but would not affect result
GLP compliance:
yes
Oxygen conditions:
aerobic
Inoculum or test system:
other: Activated Sludge
Details on inoculum:
Acclimated inoculum prepared from study 163094A obtained from Clinton Sanitary Wastwater Treatment Plant, Annandale, New Jersey on March 5 2003.
Duration of test (contact time):
56 d
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
Low DCPD resin oil evaluated at a mean concentration of 47.20 mg/L; postiive control substance, sodium benzoate evaluated at a concentratio of 51.49 mg/L.. Triplicate test systems with acclimated inoculum were used to evaluate the biodegradability of the test and positive control substances at mean concentrations of 47.20 mg/L and 51.49 mg/L, respectively. Blank test systems, which did not contain the test or positive control substance, were run concurrently in triplicate. Triplicate toxicity control test systems, containing both test and positive control substance, were also run concurrently.Acclimated Inoculum was prepared from solids filtered from 163094A test systems. The inoculum for 163094A test systems was obtained from the Clinton Sanitary Wastewater Treatment Plant, Annandale, NJ, USA which receives domestic sewage. The solids were mixed with 200 mL of fresh test medium and added at a 1% loading volume of solids mixture to test medium. The microbial count of the inoculum was 104 CFU/mL. The test medium was aerated for 24 hours with carbon dioxide free air and one liter added to each one liter respirometer flask.The test substance was weighed in an air tight syringe and injected into the test medium. The test system was sealed immediately after addition of the test substance. An aliquot of the positive control stock solution was added to the appropriate test flasks. All test systems were placed on a Coordinated Environmental Services (CES) automated respirometer which automatically recorded the oxygen
uptake in general agreement with the OECD guideline. The 56 day study was conducted at a temperature range of 22 ± 1°C.
Reference substance:
other: Sodium Benzoate
Parameter:
% degradation (O2 consumption)
Value:
43.87
Sampling time:
56 d
Details on results:
The average percent biodegradation of the test substance was determined to be 43.87% by day 56. . The toxicity control exceeded 25% therefore the test substance cannot be considered inhibitory.
Results with reference substance:
By day 14, >60% biodegradation of the positive control was observed.
Validity criteria fulfilled:
yes
Interpretation of results:
not readily biodegradable
Conclusions:
The mean biodegradation of the test substance was determined to be 43.87% by day 56. The toxicity control exceeded 25% therefore the test substance cannot be considered inhibitory.
Executive summary:

This is a GLP Compliant study following OECD guidelines and is considered adequate for assessment. The average percent biodegradation of the test substance was determined to be 43.87% by day 56. The toxicity control exceeded 25% therefore the test substance cannot be considered inhibitory.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 January 2003 - 5 March 2003
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP Compliant, guideline study, available as unpublished report, acceptable with restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Deviations:
yes
Remarks:
inoculum preparation which was performed ASTM D5864 and Additional exceptions reported none which would affected the quality or integrity of the study data
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not reported
Oxygen conditions:
aerobic
Inoculum or test system:
other: Activated Slude supernatant
Details on inoculum:
Fresh activated sludge from Clinton Sanitary Wastewater Treatment plan, Annandale, New Jersey.
Duration of test (contact time):
28 d
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
Triplicate test systems were used to evaluate the biodegradability of the test and positive control substances at mean concentrations of 49.00 mg/L and 47.39 mg/L, respectively. Blank test systems, which did not contain the test or positive control substance, were run concurrently in triplicate. The total suspended solids (TSS) of the activated sludge was determined to be 4.41 g/L. The inoculum was added at a 1% loading volume of sludge supernatant to test medium. The microbial count of the inoculum was 106 CFU/mL. One liter of test medium, which was aerated for 24 hours with carbon dioxide free air, was added to each one liter respirometer flask. The test substance was weighed in an air tight syringe and injected into the test medium. The test system was sealed immediately after addition of the test substance. An aliquot of the positive control stock solution was added to the appropriate test flasks. An unacclimated activated sludge inoculum was used in this study. The inoculum was obtained from the Clinton Sanitary Wastewater Treatment Plant, Annandale, NJ, USA. The treatment plant receives domestic sewage. All test systems were placed on a Coordinated Environmental Services (CES) automated respirometer which automatically recorded the oxygen uptake in general agreement with the OECD guideline. The 28-day study was conducted at a temperature range of 21.0°C to 22.2°C.
Reference substance:
other: Sodium Benzoate
Preliminary study:
Not reported
Test performance:
Not reported
Key result
Parameter:
% degradation (O2 consumption)
Value:
0
Sampling time:
28 d
Remarks on result:
other: No measurable biodegradation observed over a 28 day testing period
Details on results:
No measurable biodegradation observed over a 28 day testing period.
Results with reference substance:
Biodegradation of positive control substance sodium benzoate measured in triplicate test systems at an average concentration of 47.39 mg/L. Sodium benzoate biodegraded to >60% of the ThOD by day 2.
Validity criteria fulfilled:
yes
Interpretation of results:
not readily biodegradable
Conclusions:
DCPD/Codimer Concentrate cannot be considerd readily biodegradable.
Executive summary:

This study was GLP compliant and followed guidelines. The study is considered adequate for assessment. DCPD/Codimer Concentrate cannot be considerd readily biodegradable as there was no measurable biodegradation observed over a 28 day testing period.

Description of key information

Three biodegradation studies were available for two streams within this Category. All three studies showed that the streams could not be considered readily biodegradable.

However, of the 119 constituents, and according to the criteria set out in the ECHA R.7b Information Requirements Guidance, 118 (BIOWIN 2), 101 (BIOWIN 3), 22 (BIOWIN 5) and 55 (BIOWIN 6) were predicted to be readily biodegradable based on the different models, with 119 constituents having at least one prediction of a high probability that it will biodegrade fast.

The category is considered inherently biodegradable based on ready biodegradability tests and QSAR data. It is not feasible to perform simulation tests on complex, volatile UVCBs.

Key value for chemical safety assessment

Biodegradation in water:
inherently biodegradable

Additional information

Three proprietary studies are available for this Category (ACC, 2007a; 2004a,b).

One of the studies is performed with DCPD/Codimer Concentrate (CAS No. 68478-10-4). This study is GLP compliant and followed OECD guideline 301F and therefore the study is considered adequate for assessment. DCPD/Codimer Concentrate cannot be considered readily biodegradable as there was no measurable biodegradation observed over a 28 day testing period.

Two studies are available for the stream with CAS No. 68477-54-3. Both studies are GLP compliant studies following OECD guideline 301F and are considered adequate for assessment. The average percent biodegradation of the test substance in one of the studies was determined to be 43.87% by day 56. The toxicity control exceeded 25% therefore the test substance cannot be considered inhibitory. The average percent biodegradation of the test substance in the other study was determined to be 6.48% on day 41.

The predictions of ready biodegradability of measured constituents of this category (at equal or above 0.1% w/w) have been predicted using the EPISUITE v4.11 BIOWIN models (2017), which use methodology described by Howard et al. (1992), Boethling et al. (1994) and Tunkel et al. (2000). Of the 119 constituents, and according to the criteria set out in the ECHA R.7b Information Requirements Guidance, 118 (BIOWIN 2), 101 (BIOWIN 3), 22 (BIOWIN 5) and 57 (BIOWIN 6) were predicted to be readily biodegradable based on the different models, with 119 constituents having at least one prediction of a high probability that it will biodegrade fast.