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Environmental fate & pathways

Biodegradation in water: screening tests

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Endpoint:
biodegradation in water: screening tests
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2018-02-02 to 2018-02-02
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:
not readily biodegradable based on QSAR/QSPR prediction
Details on results:
Biowin 1 (linear model prediction) = Does not Biodegrade Fast
Biowin 2 (non-linear model prediction) = Does not Biodegrade Fast
Biowin 3 (ultimate biodegradation timeframe) = Weeks-Months
Biowin 4 (Primary biodegradation timeframe) = Weeks
Biowin 5 (MITI linear model prediction) = Not Readily Degradable
Biowin 6 (MITI non-linear model prediction) = Not Readily Degradable
Biowin 7 (Anaerobic model prediction) = Does not Biodegrade Fast
Results with reference substance:
not applicable

Please see attached documents.

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

Endpoint:
biodegradation in water: screening tests
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2018-02-02 to 2018-02-02
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:
not 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-Weeks
Biowin 5 (MITI linear model prediction) = Not Readily Degradable
Biowin 6 (MITI non-linear model prediction) = Not Readily Degradable
Biowin 7 (Anaerobic model prediction) = Does not Biodegrade Fast
Results with reference substance:
not applicable

Please see the attached documents.

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

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1978
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:
No data
Preliminary study:
No data
Test performance:
No data
Parameter:
% degradation (O2 consumption)
Value:
84.6
Sampling time:
2 wk
Details on results:
- Indirect analysis (BOD): 84.6%
- Direct analysis (GC): 100%
- Direct analysis (TOC): 93%
Results with reference substance:
No data

None

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

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

At 100 ppm test concentration, 84.6% degradation by biochemical oxygen demand was reached in 2 weeks.

 

Under the test conditions, alpha-terpineol 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, benzyl benzoate was readily biodegradable.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1980
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):
14 d
Initial conc.:
100 other: ppm
Based on:
test mat.
Details on study design:
No data
Preliminary study:
No data
Test performance:
No data
Parameter:
% degradation (O2 consumption)
Value:
>= 41 - <= 98
Sampling time:
14 d
Details on results:
- Indirect analysis (BOD): 41, 81 and 98%
- Direct analysis (GC): 100%
- Direct analysis (TOC): 50, 73 and 81%
Results with reference substance:
No data

None

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

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

At 100 ppm test concentration, 41-98% degradation by biochemical oxygen demand was reached in 14 days.

 

Under the test conditions, Limonene was readily biodegradable.

 

Endpoint:
biodegradation in water: screening tests
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2018-02-02 to 2018-02-02
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-Weeks
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.

Biowin 1, 2, 5 & 6 are the most relevant because they are quantitative models while the others are semi-quatitative.

Therefore, it's expected that the substance is readily biodegradable.

Description of key information

Based on a weight of evidence approach with data on constituents, the registered substance is regarded as not 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 main known constituents of the substance are provided in the table below:

Constituents CAS No Range in the NCS* Biodegradation result Reference
Benzyl benzoate 120 -51 -4 45 - 55 Readily Biodegradable MITI, 1996
Dipentene 138-86-3 3 - 7 Readily Biodegradable MITI, 1980
Elemol alpha 639-99-6 1 - 7 Not Readily Biodegradable QSAR, BioWin v4.10
Elemicin 487-11-6 1 - 4 Readily Biodegradable QSAR, BioWin v4.10
Alpha-phellandrene 99-83-2 1 - 4 Not Readily Biodegradable QSAR, BioWin v4.10
Alpha-terpineol 98 -55 -5 0 - 1 Readily Biodegradable MITI, 1978

* % ranges have been taken from the SIP of the substance. Only major constituents (>= 1% based on upper value of the range) were taken into account for this assessment.

Regarding the minimum values of the ranges, readily biodegradable components would represent slightly less than 50% of the NCS, based on available information.

Furthermore, the unknown part of the NCS composition remains high. Indeed, unknown constituents represent 30 to 47% according to the SIP of the substance.

With data on individual constituents, it is therefore not possible to consider that the substance is readily biodegradable.

By default, the substance is considered not readily biodegradable.