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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
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):
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: ready biodegradability
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study
Qualifier:
according to guideline
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 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, alpha-pinene was readily biodegradable.
Executive summary:

In a ready biodegradation study performed according to OECD Guideline 301 C, alpha-pinene 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, alpha-pinene was readily biodegradable.

 

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
2013-06-17 to 2013-07-31
Reliability:
1 (reliable without restriction)
Justification for type of information:
Experimental data on substance with similar composition than registered substance.
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
GLP compliance:
yes (incl. QA statement)
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge (adaptation not specified)
Details on inoculum:
Aerobic activated sludge (microorganisms from a domestic wastewater treatment plant) was supplied by the sewage works of Rossdorf, Germany.
The aerobic activated sludge used for this study was washed by centrifugation and the supernatant liquid phase was decanted. The solid material was re-suspended in tap water and centrifuged again. This procedure was done three times. An aliquot of the final sludge suspension was weighed, dried
and the ratio of wet sludge to its dry weight was determined.
Based on this ratio, calculated aliquots of washed sludge suspension, corresponding to 3.5 g dry material per litre were mixed with test water. This suspension was aerated overnight and was used for the experiment.
Duration of test (contact time):
28 d
Initial conc.:
78 mg/L
Based on:
test mat.
Initial conc.:
236.7 mg/L
Based on:
ThOD/L
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
The test flasks were incubated at 22 ± 1 °C. The The pressure decrease in the reaction vessels was measured over complete experimental phase of 28 days. The test flasks were closed gas-tight by a measuring head. Potassium hydroxide solution (45%) was used for trapping the produced carbon dioxide. The amount of O2 consumed by the activated sludge was calculated from the decrease of pressure in the reaction vessel.

Test conditions: climatised room 22 +-1°C
Light: Darkness
pH-value of thest solutions: 7.6 (measured at the start of the test ; 7.6 - 7.8 (measured at the end of the test)
Reference substance:
benzoic acid, sodium salt
Preliminary study:
no data
Test performance:
no data
Parameter:
% degradation (O2 consumption)
Value:
70
Sampling time:
28 d
Remarks on result:
other: failing 10-day window
Details on results:
no data
Results with reference substance:
The reference item sodium benzoate was sufficiently degraded to 85% after 14 days and to 91% after 28 days of incubation.

no data

Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
Pine needle oil undergoes 70% biodegradation after 28 days in the test conditions. Biodegradation starts on day 3 and reached 70% at the end of the 28-day period (10-day window failed). The curves obtained with the reference substance alone and with Pine needle oil + reference substance show no toxic effect of Pine needle oil on the micro-organisms at the test concentration.
Executive summary:

Pine needle oil undergoes 70% biodegradation after 28 days in the test conditions in a 301F study. Biodegradation starts on day 3 and reached 70% at the end of the 28-day period.

The degradation rate of Pine needle oil did not reach 60% within the 10-day window, but after 28 days. Therefore, Pine needle oil is considered to be readily biodegradable, but failing 10-day window.

Due to the fact that the substance is identified as an UVCB or as a complex, the 10-day window condition may be waived and the pass level applied at 28 days according to section 4.1.2.9.5 of CLP COMMISSION REGULATION (EU) No 286/2011 of 10 March 2011.

The curves obtained with the reference substance alone and with Pine needle oil + reference substance show no toxic effect of Pine needle oil on the micro-organisms at the test concentration. Therefore under the test condition Pine needle oil is considered as ready biodegradable.

Endpoint:
biodegradation in water: screening tests
Type of information:
(Q)SAR
Adequacy of study:
weight of evidence
Study period:
2014-08-19
Reliability:
2 (reliable with restrictions)
Justification for type of information:
QSAR prediction: migrated from IUCLID 5.6
Qualifier:
no guideline required
Guideline:
other: Biowin v4.10
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:
Details on properties of test surrogate or analogue material (migrated information):
not applicable
Details on inoculum:
not applicable
Details on study design:
not applicable
Preliminary study:
not applicable
Test performance:
not applicable
Remarks on result:
other: Biowin 1 = Does Not Biodegrade Fast Biowin 2 = Does Not Biodegrade Fast Biowin 3 = Weeks – Months Biowin 4 = Days - Weeks Biowin 5 = Readily Degradable Biowin 6 = readily Degradable Biowin 7 = Does Not Biodegrade Fast
Details on results:
Biowin 1 = Does Not Biodegrade Fast
Biowin 2 = Does Not Biodegrade Fast
Biowin 3 = Weeks – Months
Biowin 4 = Days - Weeks
Biowin 5 = Readily Degradable
Biowin 6 = readily Degradable
Biowin 7 = Does Not Biodegrade Fast
Results with reference substance:
not applicable
Validity criteria fulfilled:
not applicable
Interpretation of results:
under test conditions no biodegradation observed
Conclusions:
Biowin 1 = Does Not Biodegrade Fast
Biowin 2 = Does Not Biodegrade Fast
Biowin 3 = Weeks – Months
Biowin 4 = Days - Weeks
Biowin 5 = Readily Degradable
Biowin 6 = readily Degradable
Biowin 7 = Does Not Biodegrade Fast

Executive summary:

Delta-3 -carene ready biodegradation property was investigated using QSAR approach with Biowin v4.10 plug-in from EPISUITE v4.1 from USEPA.

Results are as follow:

Biowin 1 = Does Not Biodegrade Fast

Biowin 2 = Does Not Biodegrade Fast

Biowin 3 = Weeks – Months

Biowin 4 = Days - Weeks

Biowin 5 = Readily Degradable

Biowin 6 = readily Degradable

Biowin 7 = Does Not Biodegrade Fast

Therefore, it is expected that Delta-3 -carene is not readily biodegradable.

Description of key information

Based on the results from ready biodegradability tests and prediction of delta-3-carene showing that all major constituents are readily biodegradable, it can be concluded that Cypress oil is expected to be readily biodegradable.

Key value for chemical safety assessment

Biodegradation in water:
readily biodegradable

Additional information

All major constituents of Cypress oil are considered readily biodegradable, except delta-3-carene (see table below). However, it has been shown, with a similar (in composition) substance (Pine needle oil) that contains delta-3-carene (15%), that once in mixture delta-3-carene does not inhibit the ready biodegradability property of the substance.

 

Constituents

Typical composition

Biodegradation results

Reference in IUCLID 6

(d,l)-limonene

5 %

Readily biodegradable

(d,l)-limonene, 138-86-3, Biodegradation in water: screening tests, MITI, 1980, RS, W

alpha-pinene

60 %

Readily biodegradable

alpha-pinene, 80-56-8, Biodegradation in water: screening tests, MITI, 2007, RS, W

Delta-3-carene

 27 %

Not Readily biodegradable

Delta-3-carene, 13466-78-9, Biodegradation in water, screening test, Biowin v4.10, RS, W

Pine needle oil

N/A

Readily biodegradable

Biodegradation in water, Pine needle oil, 2013, RS, W

 

 

Therefore, based on a Weight of Evidence approach, it can be possible to consider that Cypress oil is readily biodegradable.