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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:
experimental study
Adequacy of study:
weight of evidence
Study period:
1979
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD Guideline 301 C but with deviations: no detail on material and methods
Qualifier:
according to
Guideline:
OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
Deviations:
yes
Remarks:
no detail on material and methods
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified
Specific details on test material used for the study:
No data
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge (adaptation not specified)
Details on inoculum:
- Concentration of sludge: 30 mg/L
Duration of test (contact time):
2 wk
Initial conc.:
100 mg/L
Based on:
test mat.
Details on study design:
No data
Preliminary study:
No data
Test performance:
No data
Parameter:
% degradation (O2 consumption)
Value:
>= 85 - <= 98
Sampling time:
2 wk
Details on results:
- Indirect analysis (BOD): 85%
- Direct analysis (TOC) & (UV-VIS): 98% and 100% respectively.
Results with reference substance:
No data

None

Validity criteria fulfilled:
not specified
Interpretation of results:
readily biodegradable
Conclusions:
Under the test conditions, the test item was readily biodegradable.
Executive summary:

In a ready biodegradation study performed according to OECD Guideline 301 C, the test item was tested at concentrations of 100 mg/L and the inoculum was activated sludge (30 mg/L). The degradation of the test material was assessed by the determination of the oxygen consumption.

At 100 mg/L test concentration, 85 % degradation (biochemical oxygen demand) was reached in 2 weeks.

 

Under the test conditions, the test item was readily biodegradable.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1996
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD Guideline 301 C but with deviations: no detail on material and methods
Qualifier:
according to
Guideline:
OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
Deviations:
yes
Remarks:
no detail on material and methods
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified
Specific details on test material used for the study:
No data
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge (adaptation not specified)
Details on inoculum:
- Concentration of sludge: 30 mg/L
Duration of test (contact time):
4 wk
Initial conc.:
100 mg/L
Based on:
test mat.
Details on study design:
No data
Preliminary study:
No data
Test performance:
No data
Parameter:
% degradation (O2 consumption)
Value:
90
Sampling time:
4 wk
Details on results:
- Indirect analysis (BOD): 90%
- Direct analysis (HPLC): 100%
Results with reference substance:
No data

None

Validity criteria fulfilled:
not specified
Interpretation of results:
readily biodegradable
Conclusions:
Under the test conditions, the test item was readily biodegradable.
Executive summary:

In a ready biodegradation study performed according to OECD Guideline 301 C, the test item was tested at concentrations of 100 mg/L and the inoculum was activated sludge (30 mg/L). The degradation of the test material was assessed by the determination of the oxygen consumption.

At 100 mg/L test concentration, 90% degradation (biochemical oxygen demand) was reached in 4 weeks.

 

Under the test conditions, the test item was readily biodegradable.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1993
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD Guideline 301 C but with deviations: no detail on material and methods
Qualifier:
according to
Guideline:
OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
Deviations:
yes
Remarks:
no detail on material and methods
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified
Specific details on test material used for the study:
No data
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge (adaptation not specified)
Details on inoculum:
- Concentration of sludge: 30 mg/L
Duration of test (contact time):
2 wk
Initial conc.:
100 mg/L
Based on:
test mat.
Details on study design:
No data
Preliminary study:
No data
Test performance:
No data
Parameter:
% degradation (O2 consumption)
Value:
>= 97 - <= 99
Sampling time:
2 wk
Details on results:
- Indirect analysis (BOD): 97%
- Direct analysis (TOC) & (HPLC): 99% and 100% respectively.
Results with reference substance:
No data

None

Validity criteria fulfilled:
not specified
Interpretation of results:
readily biodegradable
Conclusions:
Under the test conditions, the test item was readily biodegradable.
Executive summary:

In a ready biodegradation study performed according to OECD Guideline 301 C, the test item was tested at concentrations of 100 mg/L and the inoculum was activated sludge (30 mg/L). The degradation of the test material was assessed by the determination of the oxygen consumption.

At 100 mg/L test concentration, 97% degradation (biochemical oxygen demand) was reached in 2 weeks.

 

Under the test conditions, the test item was readily biodegradable.

Endpoint:
biodegradation in water: screening tests
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2017-07-27 to 2017-07-27
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Remarks:
The value is not an experimental result, however the QSAR model is recommended by the ECHA guidance document on information requirements, is well documented with regard to validation parameters according to OECD principles. Moreover, the substance is fully characterised towards the applicability domain.
Justification for type of information:
QSAR prediction
Qualifier:
according to
Guideline:
other: Reach Guidance on QSAR - R.6
Deviations:
no
Principles of method if other than guideline:
QSAR, Biowin v4.10. More details are given in QMRF/QPRF attached to the dossier.
GLP compliance:
no
Oxygen conditions:
not specified
Inoculum or test system:
not specified
Details on inoculum:
not applicable
Details on study design:
not applicable
Preliminary study:
not applicable
Test performance:
not applicable
Parameter:
probability of ready biodegradability (QSAR/QSPR)
Remarks on result:
readily biodegradable based on QSAR/QSPR prediction
Details on results:
Biowin 1 (linear model prediction) = Biodegrades Fast
Biowin 2 (non-linear model prediction) = Biodegrades Fast
Biowin 3 (ultimate biodegradation timeframe) = Weeks-Months
Biowin 4 (Primary biodegradation timeframe) = Days
Biowin 5 (MITI linear model prediction) = Readily Degradable
Biowin 6 (MITI non-linear model prediction) = Readily Degradable
Biowin 7 (Anaerobic model prediction) = Biodegrades Fast
Results with reference substance:
not applicable

Please see the attached documents.

Validity criteria fulfilled:
not applicable
Interpretation of results:
readily biodegradable
Conclusions:
It is expected that the substance is readily biodegradable.
Executive summary:

The ready biodegradation property of the substance was investigated using QSAR approach with Biowin v4.10 plug-in from EPISUITE v4.1 from US EPA.

It's expected that the test item is readily biodegradable.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1993
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD Guideline 301 C but with deviations: no detail on material and methods
Qualifier:
according to
Guideline:
OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))
Deviations:
yes
Remarks:
no detail on material and methods
Principles of method if other than guideline:
Not applicable
GLP compliance:
not specified
Specific details on test material used for the study:
No data
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge (adaptation not specified)
Details on inoculum:
- Concentration of sludge: 30 ppm
Duration of test (contact time):
2 wk
Initial conc.:
100 other: ppm
Based on:
test mat.
Details on study design:
Standard type
Preliminary study:
No data
Test performance:
No data
Parameter:
% degradation (O2 consumption)
Value:
>= 89 - <= 95
Sampling time:
2 wk
Details on results:
- Indirect analysis (BOD): 89%
- Direct analysis (TOC) & (GC): 95% and 100% respectively.
Results with reference substance:
No data

None

Validity criteria fulfilled:
not specified
Interpretation of results:
readily biodegradable
Conclusions:
Under the test conditions, the test item was readily biodegradable.
Executive summary:

In a ready biodegradation study performed according to OECD Guideline 301 C, the test item was tested at concentrations of 100 mg/L and the inoculum was activated sludge (30 mg/L). The degradation of the test material was assessed by the determination of the oxygen consumption.

At 100 mg/L test concentration, 89% degradation (biochemical oxygen demand) was reached in 2 weeks.

 

Under the test conditions, the test item was readily biodegradable.

Endpoint:
biodegradation in water: screening tests
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2018-02-09 to 2018-02-09
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Remarks:
The value is not an experimental result, however the QSAR model is recommended by the ECHA guidance document on information requirements, is well documented with regard to validation parameters according to OECD principles. Moreover, the substance is fully characterised towards the applicability domain.
Justification for type of information:
QSAR prediction
Qualifier:
according to
Guideline:
other: Reach Guidance on QSAR - R.6
Deviations:
no
Principles of method if other than guideline:
QSAR, Biowin v4.10. More details are given in QMRF/QPRF attached to the dossier.
GLP compliance:
no
Oxygen conditions:
not specified
Inoculum or test system:
not specified
Details on inoculum:
not applicable
Details on study design:
not applicable
Preliminary study:
not applicable
Test performance:
not applicable
Parameter:
probability of ready biodegradability (QSAR/QSPR)
Remarks on result:
readily biodegradable based on QSAR/QSPR prediction
Details on results:
Biowin 1 (linear model prediction) = Biodegrades Fast
Biowin 2 (non-linear model prediction) = Biodegrades Fast
Biowin 3 (ultimate biodegradation timeframe) = Weeks
Biowin 4 (Primary biodegradation timeframe) = Days
Biowin 5 (MITI linear model prediction) = Readily Degradable
Biowin 6 (MITI non-linear model prediction) = Readily Degradable
Biowin 7 (Anaerobic model prediction) = Biodegrades Fast
Ready Biodegradability Prediction: YES
Results with reference substance:
not applicable

Please see the attached documents.

Validity criteria fulfilled:
not applicable
Interpretation of results:
readily biodegradable
Conclusions:
It is expected that the substance is readily biodegradable.
Executive summary:

The ready biodegradation property of the substance was investigated using QSAR approach with Biowin v4.10 plug-in from EPISUITE v4.1 from US EPA.

It's expected that the test item is readily biodegradable.

Description of key information

Based on a weight of evidence approach with data on constituents, the registered substance cannot be considered readily biodegradable.

Key value for chemical safety assessment

Biodegradation in water:
under test conditions no biodegradation observed

Additional information

Individual data about the ready biodegradability of the major known constituents of the substance are provided in the table below:

Constituents

CAS No

% ranges*

Biodegradation results

Reference

Benzyl benzoate

120-51-4

0 - 3

Readily Biodegradable

MITI, 1996

Benzoic acid

65-85-0

10 - 32

Readily Biodegradable

MITI, 1979

Vanilin 121-33-5 0 - 4 Readily Biodegradable MITI, 1993
Coniferyl benzoate 4159-29-9 0 - 25 Readily biodegradable  QSAR, BioWin v4.10 
 Ethyl benzoate 93-89-0 0 - 3 Readily Biodegradable 

QSAR, BioWin v4.10

 Ethanol 64-17-5 0 - 4 Readily Biodegradable MITI, 1993

* % ranges of constituents have been taken from the SIP of the substance, taking into consideration only constituents > 1% based on upper value of the range.

Regarding these ranges, the unknown part of the NCS composition remains high. According to the SIP of the substance, the unknown constituents represent 40 to 80%.

With data on individual constituents, it is therefore not possible to consider that the substance is readily biodegradable, because of a lack of data at the whole substance scale.

By default, the registered substance is considered not readily biodegradable.