Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Environmental fate & pathways

Biodegradation in water: screening tests

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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 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):
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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
From June 09 to July 08, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted according to OECD guideline 301 D with only minor deviations.
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 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:
Details on properties of test surrogate or analogue material (migrated information):
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 5.2.1/1: 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

 

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

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

Oc: Mineral nutrient solution with only inoculum

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

 

Table 5.2.1/2: 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:
Under the test conditions, β-pinene was readily biodegradable.
Executive summary:

In a ready biodegradation study performed according to OECD Guideline 301 D and GLP, β-pinene was tested at concentrations of 2 mg/L and the inoculum was activated sewage sludge, domestic. 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. Hence, the test material met the 14 day window requirement for ready biodegradability. On Day 28, the biodegradation was 76%.

 

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. Hence, 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.

 

Under the test conditions, β-pinene was readily biodegradable.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
2010-05-02 to 2010-08-30
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Toxicity control was not performed.
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 F (Ready Biodegradability: Manometric Respirometry Test)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
Molecular weight: 136.2 g/mol
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Details on inoculum:
- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Fresh activated sludge from a biological waste water treatment plant treating predominantly domestic sewage in the city of Bois-de-Bay, 1242 Satigny, switzerland.
- The sludge is collected in the morning, washed 3 times in the mineral medium and kept aerobic being used in the same day
- Concentration of sludge: 3.66 g/L (dry weight of suspended solids); to obtain a concentration of 30 mg/L (dry weight) in a 250 mL flask, 5.00 mL of sludge is needed (inoculum).
Duration of test (contact time):
61 d
Initial conc.:
100 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
TEST CONDITIONS
- Composition of medium: compliant with recommendations of TG on mineral medium
- Additional substrate: no
- Solubilising agent (type and concentration if used): no
- Test temperature: 22°C
- pH: 7.6 (initial) to a mean of 7.72 (final) from 7.50 to 8.15.
- pH adjusted: no
- Suspended solids concentration: 30 mg/l
- Continuous darkness: not stated

TEST SYSTEM
- Number of culture flasks/concentration: 2
- Method used to create aerobic conditions: stirring
- Method used to create anaerobic conditions: not applicable
- Measuring equipment: Oxitop control System
- Test performed in closed vessels due to significant volatility of test substance: yes
- Test performed in open system: no
- Details of trap for CO2 and volatile organics if used: soda lime pellets

SAMPLING
- Sampling frequency: everyday O2 consumption is recorded and correct temperature and stirring are checked
- Sampling method: Oxitop control System

CONTROL AND BLANK SYSTEM
- Inoculum blank: yes
- Toxicity control: no

Reference substance:
benzoic acid, sodium salt
Remarks:
Purity 99.0 %
Preliminary study:
No data
Test performance:
No data
Parameter:
% degradation (O2 consumption)
Value:
76
Remarks on result:
other: 28 days
Parameter:
% degradation (O2 consumption)
Value:
81
Remarks on result:
other: 61 days
Details on results:
- Initial test material concentration: 100 mg/L (nominal)
- Theoretical oxygen demand (ThOD) = 3.29 mg O2/mg
- % biodegradation on Day 61 = 81%
Results with reference substance:
Degradation of the reference substance exceeds 40% after 7 days and 65% after 14 days. The test is the considered as valid.

Table 1 Biological Oxygen Demand (BOD, mg O2/L, adjusted to nominal concentrations)

Days

2

3

7

13

21

28

61

O2 uptake of sludge (inoculum blank)

1

B1

12.1

17.5

24.2

29.6

35.0

37.7

48.5

2

B2

10.6

16.2

21.5

26.9

33.7

35.0

45.8

mean

B

11.5

16.9

22.9

28.3

34.4

36.4

47.2

O2 uptake of test

Subst.+ sludge

3

C1

14.8

26.9

59.1

88.6

103.8

108.8

128.8

4

C2

14.8

26.9

60.6

90.2

108.0

114.0

125.0

O2 uptake of test substance

 

C1-B

3.3

10.0

36.3

60.4

69.5

72.5

81.6

C2-B

3.4

10.1

37.8

62.0

73.7

77.7

77.9

% degr. of test substance

 

D1

3

10

37

61

70

73

83

 

D2

3

10

38

63

75

79

79

mean

D

3

10

37

62

73

76

81

B1, B2, C1, C2, A1, A2, E1 : experimental O2 uptake values

B=(B1 +B2)/2

D1=100*(C1 -B) / ThOD * S

D2=100*(C2 -B) / ThOD * S

D=(D1 +D2) / 2

 [S] : initial test substance concentration (mg/l)

ThOD = 3.29 mg O2 / mg

MW = 136.24 g/mol

formula = C10H16N0O0

Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
Under the test conditions, the substance is considered as readily biodegradable.
Executive summary:
 

The biodegradation of Sabinene was studied using a Manometric Respirometry Test according to the OECD Guidelines for Testing of Chemicals, Method No. 301F. Inoculum came from fresh activated sludge from a biological waste water treatment plant in the city of Bois-de-Bay that treated predominantly domestic sewage. Sodium Benzoate was used as a reference substance. Toxicity of the test substance has been investigated and showed no inhibition. Initial concentration of the test substance was 100 mg/l. Biodegradation of the test substance is recorded by the evolution of the O2 consumption during the study. O2 consumption was recorded every day.

Sabinene undergoes 76% biodegradation after 28 days and 81% after 61 days. Therefore, and in accordance with The OECD Guidelines 301F, Sabinene is considered as ready biodegradable. Validity criteria are all met, the study is considered as acceptable for the endpoint.

Description of key information

Based on the results from ready biodegradability tests showing that all major constituents are readily biodegradable, it can be concluded that Juniper oil is expected to be readily biodegradable.

Key value for chemical safety assessment

Biodegradation in water:
readily biodegradable

Additional information

All major constituents of Juniperoil are considered readily biodegradable (see table below).

Constituents

Typical composition

Biodegradation results

Reference in IUCLID 6

(d,l)-limonene

9 %

Readily biodegradable

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

alpha-pinene

50 %

Readily biodegradable

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

beta-pinene

8 %

Readily biodegradable

beta-pinene, 127-91-3, Biodegradation in water: screening tests, van Ginkel, 2010, RS, W

Myrcene beta

15 %

Readily biodegradable

beta-myrcene, 123-35-3, Biodegradation in water: screening tests, MITI, 1987, RS, W

Sabinene

15%

Readily biodegradable

sabinene, 3387-41-5, Biodegradation in water: screening tests, Kreutzer, 2010, RS, W

 

 

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