Registration Dossier

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:
experimental study
Adequacy of study:
supporting study
Study period:
2 June 1992 - 30 June 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Performed under GLP, according to international guideline, test substance defined. Not all test details reported
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
not relevant
Oxygen conditions:
aerobic
Inoculum or test system:
other: secondary effluent from an unacclimated activated sludge plant
Details on inoculum:
Secondary effluent from an unacclimated activated sludge plant at URL North.
Inoculum used was 10% by volume of the effluent, filtered through a Whatman filter paper (541) to remove coarse particluate matter.
Duration of test (contact time):
28 d
Initial conc.:
10 mg/L
Based on:
DOC
Parameter followed for biodegradation estimation:
CO2 evolution
Details on study design:
Medium as proposed in 1988 OECD RIng Test on BIodegradation with deviation: Feriic chloride stock solution contained 0.25 g not 0.2 g. The EDTA stock solution contained 0.4 g and not 0.5 g.
100 ml medium in 160 ml vessels (hypovials)
Analysis of the headspace gas and liquid medium for CO2/DIC was performed on days 3,7,10,14,16,21,24,28, using a Ionics 555 Inorganic Carbon Analyser.
Preliminary study:
not relevant
Test performance:
No data on reference substance. However, the inoculum activity was proven by the ready biodegradation of the test substance
Key result
Parameter:
% degradation (CO2 evolution)
Value:
60.5
Sampling time:
14 d
Key result
Parameter:
% degradation (CO2 evolution)
Value:
72
Sampling time:
28 d
Remarks on result:
other: 95% confidence 69.3 - 74.8 %
Details on results:
The biodegradation curve is attached. It is concluded that Orange oil florida is classified as readily (meeting the 10d-window) and ultimately biodegradable.
Results with reference substance:
no information
Validity criteria fulfilled:
not specified
Interpretation of results:
readily biodegradable
Conclusions:
The test substance is readily biodegradable.
Executive summary:

The substance 'Orange terpenes' (purity 96% limonene) was assessed in a test for ready biodegradation according to OECD TG 301B (CO2 production) under GLP. After 28 days the biodegradation was 72 % (95% confidence interval 69.3 - 74.8%). Thus the test substance is classified as readily biodegradable. The report does not present all test details and therefore the study is rated reliability 2.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
31 August 1990 - 28 September 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
Performed under GLP, according to international guideline, test substance defined. Not all test details reported
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)
GLP compliance:
yes
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
not relevant
Oxygen conditions:
aerobic
Inoculum or test system:
other: secondary effluent from an unacclimated activated sludge plant
Details on inoculum:
Secondary effluent from an unacclimated activated sludge plant at URL North.
Inoculum used was 10% by volume of the effluent, filtered through a Whatman filter paper (541) to remove coarse particluate matter.
Duration of test (contact time):
28 d
Initial conc.:
10 mg/L
Based on:
DOC
Parameter followed for biodegradation estimation:
CO2 evolution
Details on study design:
Medium as proposed in 1988 OECD RIng Test on BIodegradation with deviation: Feriic chloride stock solution contained 0.25 g not 0.2 g. The EDTA stock solution contained 0.4 g and not 0.5 g.
100 ml medium in 160 ml vessels (hypovials)
Analysis of the headspace gas and liquid medium for CO2/DIC was performed on days 4,7,14,18,21,25,28, using a Ionics 555 Inorganic Carbon Analyser.
Preliminary study:
not relevant
Test performance:
No data on reference substance. However, the inoculum activity was proven by the ready biodegradation of the test substance
Key result
Parameter:
% degradation (CO2 evolution)
Value:
62
Sampling time:
14 d
Key result
Parameter:
% degradation (CO2 evolution)
Value:
83.4
Sampling time:
28 d
Remarks on result:
other: 95% confidence 76.4 - 90.4 %
Details on results:
The biodegradation curve is attached. It is concluded that Orange oil florida is classified as readily (meeting the 10d-window) and ultimately biodegradable.
Results with reference substance:
no information
Validity criteria fulfilled:
not specified
Interpretation of results:
readily biodegradable
Conclusions:
The test substance is readily biodegradable.
Executive summary:

Orange oil was assessed in a test for ready biodegradation according to OECD TG 301B (CO2 production) under GLP. After 28 days the biodegradation was 83 % (95% confidence interval 76.4 - 90.4%). Thus the test substance is classified as readily biodegradable. The report does not present all test details and therefore the study is rated reliability 2.

Endpoint:
biodegradation in water: inherent biodegradability
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
30/11/2007 - 07/01/2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
performed under GLP
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 302 C (Inherent Biodegradability: Modified MITI Test (II))
Deviations:
no
Principles of method if other than guideline:
Not relevant
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 relevant
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Duration of test (contact time):
28 d
Initial conc.:
31.6 - 35.7 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Reference substance:
benzoic acid, sodium salt
Remarks:
Sigma-Aldrich , lot nr 02720
Parameter:
% degradation (O2 consumption)
Value:
75
Sampling time:
28 d
Details on results:
After 28d a mean degradation value of 75% of the test item was measured. An abiotical degradation of the test item can be excluded as there was no oxygen uptake within the abiotic control. The calculated "toxic effect" of the test item towards microorganisms at the concentration tested can be
neglected as the oxygen uptake within the test solution with the test item was higher than within that of the toxicity control. This special behaviour can be explained by the so-called diauxic effect (in the presence of a second carbon and energy source not always both components are degraded simultaneously as much as within the individual test solutions with the test or control item alone). As there was a degradation >60% of the test item, there is evidence of an inherent biodegradability.
Results with reference substance:
The control item sodium benzoate was degraded 90% within 28d.

Summary of results of testing biodegradability according to OECD 302 C

Time (d)

% Degradation

TS 1

TS 2

TS 3

TS, Mean value

Tox-control

Sodium Benzoate

0

0.0

0..0

0.0

0

0.0

0.0

0.8

3.8

4.2

3.3

4

15.6

6.3

2.0

7.5

10.7

9.4

9

20.2

36.2

2.9

22.5

25.8

17.9

22

20.9

47.6

3.9

27.9

36.6

24.6

30

26.2

54.4

4.9

30.9

45.2

29.6

35

33.8

58.1

5.9

33.6

49.0

32.7

38

38.0

61.6

6.9

36.4

51.2

35.5

41

40.4

65.9

7.8

38.4

52.4

37.3

43

41.5

69.0

8.8

40.9

54.3

39.8

45

42.5

73.8

9.9

43.8

56.7

42.8

48

44.0

79.7

10.7

45.5

58.3

44.2

49

44.9

82.7

11.8

47.5

60.6

46.1

51

45.8

85.1

12.9

49.5

62.2

48.1

53

47.2

86.9

13.9

51.0

63.9

49.9

55

48.4

88.0

14.8

52.4

65.2

51.9

56

49.6

89.3

16.0

53.5

67.4

55.0

59

51.3

90.2

17.0

54.1

69.9

57.6

61

52.5

90.6

17.9

55.2

72.7

59.9

63

53.6

90.6

19.0

56.4

75.4

61.4

64

55.1

90.8

20.0

57.4

77.7

62.4

66

56.6

90.6

21.0

58.9

79.8

64.0

68

58.4

90.8

22.0

59.8

80.7

64.6

68

59.3

90.8

23.0

60.6

81.7

65.7

69

60.5

90.8

24.0

61.7

83.5

66.8

71

61.3

90.4

25.0

62.8

85.4

68.2

72

61.9

90.4

26.0

63.4

86.7

69.1

73

62.6

90.4

27.0

64.1

88.1

69.8

74

62.8

90.6

28.0

64.6

89.7

71.0

75

63.4

90.2

Validity criteria fulfilled:
yes
Interpretation of results:
inherently biodegradable
Conclusions:
Regarding the results obtained within this study the test item may be considered "inherently biodegradable".
Executive summary:

"Orangenol WMB" was tested for biodegradability according to 'MITI-[II]-Test' (OECD Guideline 302C using a mixture of two natural inocula). The test was performed under GLP. The degradation process was followed by the oxygen uptake in the test solutions. After 28d a mean degradation value of 75% of the test item was measured. An abiotical degradation of the test item can be excluded as there was no oxygen uptake within the abiotoc control. The calculated "toxic effecf' of the test item towards microorganisms at the concentration tested can be neglected as the oxygen uptake within the test solution with the test item was higher than within that of the

toxicity control. This special behaviour can be explained by the so-called diauxic effect (in the presence of a second carbon and energy source not always both components are degraded simultaneously as much as within the individual test solutions with the test or control item alone). As there was a degradation >60% of the test item, there is evidence of an inherent biodegradability. Regarding the results obtained within this study the test item may be considered "inherently biodegradable". The control item sodium benzoate was degraded 90% within 28d. The threshold of ~60% was met within 6d of incubation. Therefore, the test is considered valid.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
other: constituent approach was followed.
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Orange Oil is a Natural Complex Substance (NCS). WIth 96% of the constituents of Orange oil known, this NCS can be considered as a well defined NCS. If the fraction of readily biodegradable constituents of the NCS exceeds 75%, the NCS itself is readily biodegradable as well.
Justification for type of information:
The conclusion for this NCS is based on the constituent approach as explained in the 'principles of the method' section
Principles of method if other than guideline:
Assessment of the Ready biodegradability of the known constituents; addition of the percentage of readily biodegradable constituents in the mixture gives the fraction of readily biodegradable substances. If this fraction exceeds 75%, the NCS is classified as 'readily biodegradable'.
GLP compliance:
no
Oxygen conditions:
aerobic
Inoculum or test system:
other: the results originate from multiple test set-ups
Duration of test (contact time):
28 d
Key result
Parameter:
other:
Value:
>= 60
Sampling time:
28 d
Remarks on result:
other: based on > 75% of the constituents being readily biodegradable
Details on results:
Details for all constituents are summarised in window "Any other information on results" and in attached document

Assessment of the biodegradability of ORANGE OIL:

Each of the identified constituents, totalling 96% of the composition, is readily biodegradable, see underlying data in table below.

Constituent

Results of Ready biodegradation

D-limonene

C10H16

READILY BIODEGRADABLE:

- Headspace CO2: 71.4% (Quest 1993). The biodegradability of perfume ingredients in the sealed vessel test.

- MITI (I) / OECD 301C, improved for volatile substance:

Limonene 14d - BOD: 41, 81, 98%

Direct analysis: GC: 100%; TOC 50, 73, 81% (MITI 1980 http://www.safe.nite.go.jp/sitemap/db_map_e.html)

- Readily biodegradable (Misra, G.; Pavlostathis, S. G.; Perdue, E. M.; Araujo, R. Applied Microbiology and Biotechnology (1996), 45(6), 831-838.)

 

Linalool

READILY BIODEGRADABLE:

- OECD 301C: 80% (Givaudan 1991)

- OECD Modified 301B, sealed CO2: 97.1% (QUEST 1994)                              

- Readily biodegradable (Misra, G.; Pavlostathis, S. G.; Perdue, E. M.; Araujo, R. Applied Microbiology and Biotechnology (1996), 45(6), 831-838.) 

- MITI (I) / OECD 301C: 28d - BOD: 90%

Direct analysis: TOC 99% GC: 100%; (MITI 1996 http://www.safe.nite.go.jp/sitemap/db_map_e.html)

 

Octanal

C8H16O

 

READILY BIODEGRADABLE:

Read across from decanal

 

supported by prediction from EPISuite/ BIOWIN v4.10 (March 2009): readily biodegradable - yes

Decanal

C10H20O

 

READILY BIODEGRADABLE:

- OECD 301D Closed Bottle test: BOD 66% (14d) AND
- OECD 310 Carbon Dioxide Headspace test: CO2 production 72% (14d), > 80% (28d)

(RIFM/Givaudan/Akzo Nobel: A. Lapczynski, D. Salvito, K. Jenner, R. Geerts, C. Van Ginkel: Ready biodegradability testing of volatile poorly water soluble fragrances; Possible pitfalls. Poster SETAC North America 29th Ann. Meeting Tampa, Fl, November 2008, http://rifm.org/doc/RIFM%20SETAC%20Tampa%20Poster%20112008.pdf) 

 

Myrcene

C10H16O

READILY BIODEGRADABLE:

- OECD 310 Carbon Dioxide Headspace test: CO2 production: 73% (Van Ginkel 2009)

- MITI (I) / OECD 301C, improved for volatile substance:

14d - BOD: 86%

Direct analysis: GC: 99%; TOC: 97% (MITI 1987: http://www.safe.nite.go.jp/sitemap/db_map_e.html)

 

alpha-Pinene

C10H16

 

READILY BIODEGRADABLE:

- OECD301B, sealed vessels: 62% (28d), 70% (42d) (Astra Zeneca, 2001, ECB PBT#84

http://ecb.jrc.ec.europa.eu/documents/PBT_EVALUATION/PBT_sum084_CAS_91770-80-8.pdf).                                                

- MITI (I) / OECD 301C: 28d - BOD: 91, 90, 95%

Direct analysis: GC: 100, 100, 100%

(MITI 2007: http://www.safe.nite.go.jp/sitemap/db_map_e.html)

 

alpha-Terpineol

C10H18O

READILY BIODEGRADABLE:

- OECD 310 Carbon Dioxide Headspace test, CO2 production: 80% degradation for Isomeric terpineol mixtures [CAS 8000-41-7] e.g. mixture containing 86% alpha, 11% gamma & 1% beta (Van Ginkel 2008).

 

Primary degradation and complete mineralisation demonstrated using soil inoculum under aerobic conditions (Misra, G.; Pavlostathis, S. G.; Perdue, E. M.; Araujo, R. Applied Microbiology and Biotechnology (1996), 45(6), 831-838.)                                                                                                                                

 

Citral

C10H16O

READILY BIODEGRADABLE:

- Modified 301B, sealed vessels CO2: 92.1% in 28 d (Quest 1994)

- MITI (I) / OECD 301C,improved for volatile substance (Citral is mixture of neral and geranial): 28d - BOD: 92%

Direct analysis: TOC: 78%; GC: 100%

The test substance formed 6-Methyl-5-hepten-2-one (2-2480) and Geranic acid in (Water + Test Substance) system.

(MITI 1991: http://www.safe.nite.go.jp/sitemap/db_map_e.html)

 

Supported by prediction from EPISuite/ BIOWIN v4.10 (March 2009): readily biodegradable - yes

Citronellal

C10H18O

OECD 301F: 61% (28d), 51% in 10d-window (Givaudan 1994)

 

Supported by prediction from EPISuite/ BIOWIN v4.10 (March 2009): readily biodegradable - yes

 

Fraction of NCS READILY BIODEGRADABLE

 The complete asssessment is added attached to this study record. Studies mentioned by Company Name are included in the RIFM database.

 
Validity criteria fulfilled:
not applicable
Interpretation of results:
readily biodegradable
Conclusions:
Orange oil is considered as readily biodegradable.
Executive summary:

Orange oil is a Natural Complex Substance (NCS) for which 96% of the constituents is identified. Orange oil consists for 80% of d-limonene and a range of minor constituents. An assessment of the biodegradability of Orange oil was made based on the degradability of its constituents. The underlying assumption is that if the constituents of the NCS are readily biodegradable, the NCS itself is readily biodegradable as well.

With the exception of one minor constituent, for all constituents the available data are obtained in tests on the ready biodegradability. For one minor constituent the ready biodegradability is based on a structurally related substance.

The cut-off level for ready biodegradability of the NCS is derived from the approach used for the classification as R53 in the Preparations Directive 1999/45/EC and the CLP Regulation 1272/2008/EC. If more then 25% of a mixture is not readily biodegrable, the mixture is considered as not ready biodegradable. This implies that if more then 75% of the fraction is biodegradable, the mixture (in this case the Natural Complex Substance Orange oil) is to be considered ready biodegradable.

All known constituents, comprising 96% of the composition of this NCS, are in the category of ready biodegradable substances. Therefore, Orange oil is considered readily biodegradable.

Description of key information

All known constituents of Orange oil, comprising 96% of the composition of this NCS, are in the category of readily biodegradable substances. Therefore, Orange oil is considered readily biodegradable. 

Key value for chemical safety assessment

Biodegradation in water:
readily biodegradable

Additional information

Orange oil is a Natural Complex Substance (NCS) typically consisting for 80% of d-limonene and a range of minor constituents. Therefore the asssessment of the biodegradability of Orange oil is based on its constituents. The assumption is that if the constituents of the NCS are readily biodegradable, the NCS itself is readily biodegradable as well. All known constituents, comprising 96% of the composition of this NCS, are in the category of ready biodegradable substances. Therefore, Orange oil is considered ready biodegradable.

This finding is supported by the results of two studies on the ready biodegradation of Orange oil florida and on Orange terpenes (King 1993, 1992) showing a mineralisation (CO2 production) of 83 and 72% after 28 days , respectively (Rel. 2 due to concise reporting). Moreover a high degree of biodegradation found in an inherent biodegradability study with Orange oil (Orangenöl, Lebertz, 2008) carried out according to OECD TG 302 C (MITI [II]) with a reliability of 1. This test revealed a biodegradation percentage of 75% (O2 consumption) in 28 days.