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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:
1987
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
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study
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:
Details on properties of test surrogate or analogue material (migrated information):
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:
86
Sampling time:
2 wk
Details on results:
- Indirect analysis (BOD): 86%
- Direct analysis (GC): 99%
- Direct analysis (TOC): 87%
Results with reference substance:
No data

None

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

In a ready biodegradation study performed according to OECD Guideline 301 C, myrcene beta 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, 86% degradation by biochemical oxygen demand was reached in 2 weeks.

 

Under the test conditions, myrcene beta was readily biodegradable.

 

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2007
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):
28 d
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 - <= 95
Sampling time:
28 d
Details on results:
- Indirect analysis (BOD): 91, 90 and 95%
- Direct analysis (GC): 100, 100 and 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 -95% degradation (biochemical oxygen demand) was reached in 28 days.

 

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:
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:
1988-12-28
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):
4 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:
94
Sampling time:
4 wk
Details on results:
- Indirect analysis (BOD): 94%
- Direct analysis (GC): 100%
- Direct analysis (TOC): 77%
Results with reference substance:
No data

None

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

In a ready biodegradation study performed according to OECD Guideline 301 C, 1,4 -p-menthadiene (Terpinene gamma) 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, 94% degradation by biochemical oxygen demand was reached in 4 weeks.

 

Under the test conditions, Terpinene gamma was readily biodegradable.

 

Endpoint:
biodegradation in water: screening tests
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2017-06-30 to 2017-06-30
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
Specific details on test material used for the study:
-SMILES: OC(CCC(=C1)C)(C1)C(C)C
- CHEM: 4-methyl-1-propan-2-ylcyclohex-3-en-1-ol
- MOL FOR: C10 H18 O1
- MOL WT: 154.25
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) = 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
Ready Biodegradability Prediction: NO
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: screening tests
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2018-02-08 to 2018-02-08
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) = 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
Ready Biodegradability Prediction: NO
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: screening tests
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2018-02-08 to 2018-02-08
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) = 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
Ready Biodegradability Prediction: NO
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: screening tests
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2018-02-15 to 2018-02-15
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) = 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
Ready Biodegradability Prediction: NO
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.

Description of key information

Based on a Weight of Evidence approach with data on constituents, the substance is regarded as not readily biodegradable.

Key value for chemical safety assessment

Biodegradation in water:
under test conditions no biodegradation observed

Additional information

To determine the ready biodegradability of the registered substance, a constituents approach with data on constituents is performed, based on a typical composition. Regarding this typical composition, main constituents (above 1%) represent ca. 94% of the whole substance.

Individual data about ready biodegradability of these constituents can be found in the table below:

Constituents

CAS No

Typical %*

Biodegradation results

Reference

 alpha-pinene  80 -56 -8  5.38  Readily biodegradable MITI, 2007
 beta-pinene 127 -91 -3   3.72  Not Readily biodegradable QSAR, BioWin v4.10
 sabinene 3387 -41 -5  16.58  Not Readily biodegradable  QSAR, BioWin v4.10
 cineol 1,8  470 -82 -6  55.75  Not Readily biodegradable QSAR, BioWin v4.10
 myrcene  123 -35 -3 1.82 Readily biodegradable  MITI, 1987
 gamma-terpinene 99 -85 -4 1.22 Readily Biodegradable MITI, 1988
Terpinen-4-ol 562 -74 -3 2.26 Not readily biodegradable QSAR, BioWin v4.10
Terpineol alpha 98 -55 -5 7.23 Readily biodegradable MITI, 1978

* Typical % taken from the certificate of analysis related to the batch no B790145. Only constituents above 1% were taken into account for the assessment.

As it can be seen in the table above, an important part of the substance is composed by non-readily biodegradable constituents.

Based on a weight of evidence approach with data on major constituents, we cannot consider the substance as readily biodegradable.