Ferula galbaniflua, ext.

Biodegradation in water: screening tests

Link to relevant study record(s)

Reference

Reference 1

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

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):

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.

 

Reference 2

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2010-06-09 to 2010-07-08

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: disseminated data

Justification for type of information:

https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/15934/5/3/2

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)

Deviations:

yes

Remarks:

ammonium chloride was omitted from the medium to prevent oxygen consumption due to nitrification (omission does not result in nitrogen limitation); activated sludge instead of an effluent/extract/mixture was used as inoculum

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Not applicable

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

- Source of secondary activated sludge: Activated sludge plant treating predominantly domestic waste water (Nieuwgraaf, Duiven, The Netherlands)
- Preconditioning: 400 mg Dry Weight (DW)/L of activated sludge was aerated for one week and then diluted in the BOD bottles
- Concentration of sludge: 400 mg DW/L

Duration of test (contact time):

28 d

Initial conc.:

2 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

TEST CONDITIONS
- Composition of medium: Nutrient medium contained per liter of deionised water: 8.5 mg KH2PO4, 21.75 mg K2HPO4, 33.3 mg Na2HPO4.2H2O, 22.5 mg MgSO4.7H2O, 27.5 mg CaCI2, 0.25 mg FeCI3.6H2O
- Source/preparation of dilution water: Deionised water containing no more than 0.01 mg/L Cu was prepared in a water purification system.
- Test temperature: 22-24 °C
- pH (at start of test): 7.0; pH (at end of test): 6.8 (control, control with silica gel and test)
- Continuous darkness: Yes

TEST SYSTEM
- Culturing apparatus: 0.30 L BOD (biological oxygen demand) bottles with glass stoppers
- Number of culture flasks/concentration: 10 bottles containing only inoculum, 10 bottles containing inoculum and silica gel, 10 bottles containing inoculum and silica gel dosed with test substance, and 6 bottles containing sodium acetate and inoculum
- Test performed in closed vessels due to significant volatility of test substance: Yes

MEASURING EQUIPMENTS:
- Dissolved oxygen concentrations were determined electrochemically using an oxygen electrode (WTW TrioXmatic EO 200) and meter (WTW OXI 530) (Retsch, Ochten, The Netherlands)
- pH was measured using a Knick 765 calimatic pH meter (Elektronische Messgerate GmbH, Germany).
- Temperature was measured and recorded with a sensor connected to a data logger.

SAMPLING
- Sampling frequency: Two duplicate bottles of all series were withdrawn for analyses of the dissolved oxygen concentration at Days 0, 7, 14, 21 and 28.

CONTROL AND BLANK SYSTEM
- Inoculum blank: Yes; containing inoculum only
- Procedure control: Yes; containing reference substance (sodium acetate) with inoculated medium
- Toxicity control: No; test material was considered to be non-toxic to micro-organisms as inhibition of the endogenous respiration of the inoculum was not detected during the biodegradation test
- Other: Containing inoculum and silica gel

Reference substance:

acetic acid, sodium salt

Remarks:

6.7 mg/L; source: Acros organics, Belgium; purity: > 99%

Preliminary study:

No data

Test performance:

The validity of the test is demonstrated by an endogenous respiration of 1.0 mg/L at day 28. Sodium acetate was degraded 83% of its ThOD after 28 days. The validity of the test is also shown by oxygen concentrations > 0.5 mg/L in all bottles during the test period.

Parameter:

% degradation (O2 consumption)

Value:

76

Sampling time:

28 d

Details on results:

Initial test material concentration: 2 mg/L
- Theoretical oxygen demand (ThOD) = 3.3 mg/mg
- % biodegradation on Day 3: > 10%
- % biodegradation on Day 13: > 60%
- % biodegradation on Day 28 = 76%

Results with reference substance:

- Theoretical oxygen demand (ThOD) = 0.8 mg/mg
- % biodegradation on Day 1: > 10%
- % biodegradation on Day 6: > 60%
- % biodegradation on Day 14 = 83%

Table 1:Dissolved oxygen concentrations (mg/L) in the closed bottles

 

Time (days)	Oxygen concentration (mg/L)
	Ocs	Ot	Oc	Oa
0	8.6	8.6	8.6	8.6
	8.6	8.6	8.6	8.6
Mean (M)	8.6	8.6	8.6	8.6
7	7.8	5.7	8	3.9
	8	5.7	7.9	3.9
Mean (M)	7.9	5.7	8	3.9
14	7.8	3.3	7.7	3.4
	7.6	3.5	7.8	3.2
Mean (M)	7.7	3.4	7.8	3.3
21	7.7	3	7.8
	7.6	2.8	7.6
Mean (M)	7.7	2.9	7.7
28	7.6	2.6	7.5
	7.6	2.6	7.6
Mean (M)	7.6	2.6	7.6

O_cs: Mineral nutrient solution without test material but with inoculum and silica gel

O_t: Mineral nutrient solution with test material (2.0 mg/L), silica gel, and inoculum

O_c: Mineral nutrient solution with only inoculum

O_a: Mineral nutrient solution with sodium acetate (6.7 mg/L) and with inoculum

 

Table 2: Oxygen consumption (mg/L) and the percentages biodegradation of the test substance, β-pinene (BOD/ThOD) and sodium acetate (BOD/ThOD) in the Closed Bottle test.

 

Time (days)	Oxygen consumption (mg/L)		Biodegradation (%)
	Test substance	Acetate	Test substance	Acetate
0	0	0	0	0
7	2.2	4.1	33	76
14	4.3	4.5	65	83
21	4.8		74
28	5		76

Validity criteria fulfilled:

yes

Remarks:

endogenous respiration at Day 28 was 1.0 mg/L; differences of the replicate values at Day 28 were < 20%; degradation in reference material was 83% at Day 14; O2 concentration during the test was > 0.5 mg/L

Interpretation of results:

readily biodegradable

Conclusions:

(-)-β-Pinene was readily biodegradable in a test carried out according to OECD Guideline No 301 D.

Executive summary:

In a ready biodegradation study performed according to OECD Guideline 301 D and GLP, (-)-β-pinene was tested at a concentration of 2 mg/L and the inoculum was domestic activated sewage sludge. The degradation of the test material was assessed by the determination of the oxygen consumption. The test treatments, inoculum blank, and reference (sodium acetate) were measured in duplicates.

 

At 2 mg/L test concentration, greater than 10% biodegradation of the test substance was reached on Day 3 and greater than 60% biodegradation was reached on Day 13.The pass level for ready biodegradability was reached in the required 14-d window: 76% on Day 28.

 

The reference material (sodium acetate) reached greater than 60% biodegradation on Day 6. β-Pinene was considered to be non-toxic to micro-organisms as inhibition of the endogenous respiration of the inoculum was not detected during the test. Therefore, the study met the validity criteria for reference material and toxicity control. The endogenous respiration at Day 28 was 1.0 mg/L and oxygen concentration during the test was greater than 0.5 mg/L.

 

Therefore, (-)-β-pinene was readily biodegradable.

Reference 3

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

January-february 2016

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: disseminated data: GLP study conducted according to OECD guideline 301 D

Justification for type of information:

https://echa.europa.eu/fr/registration-dossier/-/registered-dossier/2226/5/3/2

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test)

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Not applicable

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic (adaptation not specified)

Details on inoculum:

The inoculum is derived from a domestic wastewater treatment plant from the aeration tank of a sewage treatment plant receiving predominantly domestic sewage. A fresh sample is collected, and then filtered through a coarse filter about 1 mm). The decanted effluent is kept until required. Inoculum is pre-conditioned to the experimental conditions by aeration in mineral medium during 5 - 7 days at the test temperature.

Duration of test (contact time):

28 d

Initial conc.:

ca. 2 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

TEST CONDITIONS
- Composition of medium: as described in the OECD TG 301 guideline
- Additional substrate: No
- pH adjusted: no
- Continuous darkness: yes

Reference substance:

benzoic acid, sodium salt

Preliminary study:

None

Test performance:

None

Parameter:

% degradation (O2 consumption)

Value:

79.3

Sampling time:

28 d

Details on results:

None

Results with reference substance:

62.5% biodegraded at Day 4.
78.1% biodegraded at Day 14.

No data

Validity criteria fulfilled:

yes

Interpretation of results:

readily biodegradable

Conclusions:

Delta-3-carene was readily biodegradable was readily biodegradable in a test carried out according to OECD Guideline No 301 D.

Executive summary:

In a ready biodegradation study performed according to OECD Guideline 301 D and GLP, Delta-3-carene was tested at a concentration of 2 mg/L and the inoculum was domestic activated sewage sludge. The degradation of the test material was assessed by the determination of the oxygen consumption. The test treatments, inoculum blank, and reference (benzoic acid, sodium salt) were measured in duplicates. At 2 mg/L test concentration, greater than 10% biodegradation of the test substance was reached between Day 4 and Day 7 and greater than 60% biodegradation was reached on Day 14.The pass level for ready biodegradability was reached in the required 10-d window: 79.3% on Day 28. The reference material (benzoic acid, sodium salt) reached greater than 60% biodegradation on Day 4. Delta-3-carene was considered to be non-toxic to micro-organisms as inhibition of the endogenous respiration of the inoculum was not detected during the test. Therefore, the study met the validity criteria for reference material and toxicity control. The endogenous respiration at Day 28 was below 1.5 mg/L and oxygen concentration during the test was greater than 0.5 mg/L. Therefore, delta-3-carene was readily biodegradable.

Reference 4

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

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.

 

Reference 5

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Study period:

2017-03-30 to 2017-03-30

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

results derived from a (Q)SAR model, with limited documentation / justification

Justification for type of information:

QSAR prediction

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)

Deviations:

yes

Remarks:

QSAR prediction

Principles of method if other than guideline:

No data

GLP compliance:

no

Specific details on test material used for the study:

Not applicable

Oxygen conditions:

other: Not applicable

Inoculum or test system:

other: Not applicable

Details on inoculum:

Not applicable

Duration of test (contact time):

28 d

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

Not applicable

Preliminary study:

Not applicable

Test performance:

Not applicable

Parameter:

% degradation (O2 consumption)

Value:

11

Sampling time:

28 d

Remarks on result:

not readily biodegradable based on QSAR/QSPR prediction

Details on results:

The outcome of the model for delta-cadinene is considered suitable to support the assessment of its biodegradability potential.
The model indicates that delta-cadinene acid achieves 11% biodegradation (BOD) after 28 days, not exceeding the 60 % pass level set by the OECD Guidelines for testing of Chemicals (301) for ready biodegradability of a substance.

Results with reference substance:

Not applicable

No data

Validity criteria fulfilled:

not specified

Interpretation of results:

not readily biodegradable

Conclusions:

Delta-cadinene is predicted to be not readily biodegradable by the present model based on the large portion of the structure which is correctly predicted (i.e. >80% of the atom centered fragments).

Executive summary:

The ready biodegradability of delta-cadinene has been investigated using the QSAR model CATALOGIC Kinetic 301F v.13.16 within LMC OASIS CATALOGIC v5.11.19. This model allows to predict the ready biodegradability of a substance in an OECD 301F study.

The outcome of the model for delta-cadinene is considered suitable to support the assessment of its biodegradability potential.

The model indicates that delta-cadinene acid achieves 11% biodegradation (BOD) after 28 days, not exceeding the 60 % pass level set by the OECD Guidelines for testing of Chemicals (301) for ready biodegradability of a substance.

Delta-cadinene is predicted to be not readily biodegradable by the present model based on the large portion of the structure which is correctly predicted (i.e. >80% of the atom centered fragments).

Reference 6

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

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, 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.

 

Description of key information

Based on a Weight of Evidence approach with data on constituents, it can be possible to consider that the substance is readily biodegradable.

Key value for chemical safety assessment

Biodegradation in water:

readily biodegradable

Additional information

The major part of the mixture is composed by readily biodegradable constituents (see table below):

Constituents	CAS No	% in the mixture*	Biodegradation Results	Reference
β-pinene	127-91-3	58.97	Ready biodegradable	ECHA, 2010
Δ-3-carene	13466-78-9	7.72	Ready biodegradable	ECHA, 2016
α-pinene	80-56-8	7.17	Ready biodegradable	MITI, 2007
limonene	138-86-3	5.40	Ready biodegradable	MITI, 1980
myrcene	123-35-3	2.91	Ready biodegradable	MITI, 1987
Δ-cadinene	483-76-1	1.29	Not RB	Firmenich SA, 2017

* these percentage values corresponds to the composition provided by the supplier of the substance in which all constituents above 1% are taken into account.

Based on a Weight of Evidence approach, it can be possible to consider that the substance is readily biodegradable.

Indeed, 5 constituents representing 82.17% of the substance (corresponding to more than 98% of the known constituents > 1% of the mixture) are readily biodegradable.

Moreover, 1 constituent representing 1.29% of the substance (equivalent to 1.55% of the known constituents > 1% of the mixture) is considered as not readily biodegradable.