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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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
March to April 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a standard guideline, but it was not conducted under GLP guidelines and oxygen consumption was not reported.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
EPA OTS 796.3100 (Aerobic Aquatic Biodegradation)
Deviations:
yes
Remarks:
The test was conducted without a negative control, but this does not invalidate the results.
GLP compliance:
no
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, non-adapted
Duration of test (contact time):
31 d
Initial conc.:
>= 22.97 - <= 23.35 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
CO2 evolution
Reference substance:
benzoic acid, sodium salt
Parameter:
% degradation (CO2 evolution)
Value:
0
Sampling time:
3 d
Parameter:
% degradation (CO2 evolution)
Value:
2.47
Sampling time:
8 d
Parameter:
% degradation (CO2 evolution)
Value:
5.44
Sampling time:
16 d
Parameter:
% degradation (CO2 evolution)
Value:
7.34
Sampling time:
24 d
Key result
Parameter:
% degradation (CO2 evolution)
Value:
8.74
Sampling time:
31 d
Details on results:
The positive control, sodium benzoate, biodegraded to 60.15% on day 16, 63.62% on day 24, and 65.70% on day 31.
Validity criteria fulfilled:
yes
Remarks:
The test was conducted without a negative control, but this does not invalidate the results.
Interpretation of results:
not inherently biodegradable
Conclusions:
The test substance biodegraded to an extent of 7.34% after 24 days and 8.74% after 31 days. The test substance is not inherently biodegradable.
Executive summary:

The test substance biodegraded to an extent of 7.34% after 24 days and 8.74% after 31 days. The test substance is not inherently biodegradable.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
experimental study
Adequacy of study:
key study
Study period:
May to August 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a standard guideline without deviations from the protocol, but it was not conducted under GLP guidelines and oxygen consumption was not reported.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Deviations:
no
Principles of method if other than guideline:
The test included two consecutive 41-day phases. The first phase of the test was conducted following the OECD Guideline 301 F (Ready Biodegradability Test) and using a non acclimated, domestic, sewage sludge inoculum, but extending the duration to 41 days. The second phase of the test was conducted following the OECD Guideline 301 F (Ready Biodegradability Test), and using the day 41 acclimated inoculum from the first phase of the test, with a duration of another 41 days.
GLP compliance:
no
Oxygen conditions:
aerobic
Inoculum or test system:
other: Activated sludge, domestic, non-adapted was used in the non acclimated phase of the test. The acclimated phase of the test used the inoculum collected from the non acclimated test phase at its termination.
Details on inoculum:
The non acclimated activated sludge inoculum used in this study was obtained from a domestic wastewater treatment plant, in New Jersey, USA.
Duration of test (contact time):
82 d
Initial conc.:
ca. 48 - <= 60 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
Quadruplicate test systems were used to evaluate the biodegradability of the test substance at a concentration range of 48 to 60 mg/L. Duplicate test systems were used to evaluate the positive control substance at approximate concentrations of 51 mg/L. Blank test systems, which did not contain the test or positive control substance, were run concurrently.
Reference substance:
benzoic acid, sodium salt
Preliminary study:
A preliminary study was not conducted.
Key result
Parameter:
% degradation (O2 consumption)
Value:
31.3
St. dev.:
2.5
Sampling time:
28 d
Remarks on result:
other: From the non acclimated test
Key result
Parameter:
% degradation (O2 consumption)
Value:
40.5
St. dev.:
2.8
Sampling time:
41 d
Remarks on result:
other: From the non acclimated test
Key result
Parameter:
% degradation (O2 consumption)
Value:
41.7
St. dev.:
3.1
Sampling time:
28 d
Remarks on result:
other: From the acclimated test
Key result
Parameter:
% degradation (O2 consumption)
Value:
47.5
St. dev.:
1.4
Sampling time:
41 d
Remarks on result:
other: From the acclimated test
Details on results:
The test material was not readily biodegradable. The test material reached 10% biodegradation on day 13 of the non acclimated test phase and on day 7 of the acclimated test phase. A half-life was not determined. By Day 41, the average percent biodegradation of quadruplicate test systems was 41% in the non acclimated test and 48% in the acclimated test.

Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance.

Interval results for the test substance are as follows:

Day % Degradation % Degradation
Non Acclimated Test Acclimated Test
(mean of quadruplicate systems) (mean of quadruplicate systems)

3 0.24 0.35
7 0.53 13.1
13 10.6 25.9
18 19.4 32.7
25 28.3 39.5
28 31.3 41.7
41 40.5 47.5

Results with reference substance:
The reference substance biodegraded to an extent of 89% in the non acclimated test and 87% in the acclimated test after 28 days. By Day 3, >60% biodegradation of the positive control was observed in both tests, which meets the guideline requirement.
Validity criteria fulfilled:
yes
Remarks:
The test guideline validity criteria require that the oxygen uptake in the inoculum blank should not exceed 60 mg/L in 28 days, which it did not, therefore, the results are considered valid. These data were contained in the laboratory notebook.
Interpretation of results:
inherently biodegradable
Conclusions:
The test substance biodegraded to an extent of 31% after 28 days and 41% after 41 days during a non acclimated phase of the test. The test substance biodegraded to an extent of 42% after 28 days and 48% after 41 days during an acclimated phase of the test.
Executive summary:

The test substance biodegraded to an extent of 31% after 28 days and 41% after 41 days during a non acclimated phase of the test. The test substance biodegraded to an extent of 42% after 28 days and 48% after 41 days during an acclimated phase of the test. The test substance can be characterized as inherently biodegradable.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2013-10-16 to 2013-11-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The study was conducted according to a standard guideline without deviations from the protocol, and was conducted under GLP guidelines.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Deviations:
yes
Remarks:
pH readings of the test item on day 28 was not taking due to the volatile and oily nature of test substance. This deviation was considered have had no adverse effect on the outcome of the test given the >60% degradation was achieved.
Qualifier:
according to guideline
Guideline:
EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test)
Deviations:
yes
Remarks:
pH readings of the test item on day 28 was not taking due to the volatile and oily nature of test substance. This deviation was considered have had no adverse effect on the outcome of the test given the >60% degradation was achieved.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 835.3110 (Ready Biodegradability)
Deviations:
yes
Remarks:
pH readings of the test item on day 28 was not taking due to the volatile and oily nature of test substance. This deviation was considered have had no adverse effect on the outcome of the test given the >60% degradation was achieved.
GLP compliance:
yes (incl. QA statement)
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Details on inoculum:
A mixed population of sewage treatment micro-organisms was obtained on 11 October 2013 from the final effluent stage of the Severn Trent Water Plc sewage treatment plant at Loughborough, Leicestershire, UK. The site treats predominantly domestic sewage. Sample of the inoculum was filtered through a coarse filter paper (first approximate 200 ml discarded) and maintained on aeration in a temperature controlled room at 21±1°C before use.
Duration of test (contact time):
28 d
Initial conc.:
100 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Reference substance:
aniline
Preliminary study:
Preliminary solubility/dispersibility study was performed in order to determine the most suitable method of preparation.
Parameter:
% degradation (O2 consumption)
Value:
14
Sampling time:
5 d
Parameter:
% degradation (O2 consumption)
Value:
33
Sampling time:
10 d
Parameter:
% degradation (O2 consumption)
Value:
50
Sampling time:
15 d
Parameter:
% degradation (O2 consumption)
Value:
67
Sampling time:
20 d
Key result
Parameter:
% degradation (O2 consumption)
Value:
88
Sampling time:
28 d
Details on results:
The test substance exhibited rapid biodegradation and assessed as readily biodegradable. By Day 28, the average percent biodegradation of the test substance was 88%. The test substance reached 14% biodegradation on approximately Day 5 and 50% biodegradation on approximately Day 15.

Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance.
Results with reference substance:
The reference substance biodegraded to an extent of 79% at Day 28. At Day 14, 63% biodegradation was observed, at Day 20, the biodegradation was 77%.

Results:

Daily BOD values for the test substance, procedure control, toxicity control and inoculum control vessels are in Table 1. The percentage biodegradation values of the test and reference substance and toxicity controls are shown in Table 3 below. The pH results are in Table 2.

Table 3: Biodegradation values

Day

Procedure control

Test item

 

Toxicity control

 

 

R1

R2

Mean

 

0

0

0

0

0

0

1

0

0

0

0

0

2

0

0

0

0

0

3

0

2

1

2

0

4

0

6

4

5

1

5

1

14

13

14

6

6

1

19

18

19

21

7

1

23

21

22

34

8

1

27

24

26

39

9

1

31

28

30

42

10

1

35

31

33

45

11

4

38

34

36

48

12

20

42

37

40

50

13

49

46

40

43

52

14

63

51

43

47

54

15

68

55

45

50

56

16

71

59

48

54

58

17

73

63

51

57

61

18

75

66

53

60

64

19

76

70

56

63

66

20

77

74

59

67

69

21

77

77

61

69

72

22

78

80

64

72

75

23

78

83

67

75

77

24

78

86

71

79

79

25

78

88

75

82

80

26

79

90

78

84

82

27

79

92

81

87

84

28

79

93

83

88

85

R1, R2= Replicates 1 and 2

Validation criteria:

The mean BOD of the inoculated mineral medium (control) was 33.72 mg O2/L after 28 days and therefore satisfied the validation criterion of the test guideline.

The difference between extremes of replicate BOD values at the end of the test and at the end of the 10-day window was <20% and therefore satisfied the validation criterion of the test guideline.

Biodegradation:

The test item achieved 88% biodegradation after 28 days and is therefore considered readily biodegradable.

The toxicity control attained 54% biodegradation after 14 days and 85% biodegradation after 28 days, thereby confirming that the test item was not toxic to the sewage treatment micro-organisms used during the study.

Aniline (procedure control) attained 63% biodegradation after 14 days and 79% biodegradation after 28 days thereby confirming the suitability of the inoculum and test conditions.

Chemical analysis of the 100 mg/l test preparation at 0 hours, showed that a mean measured concentration of 82% of nominal was obtained. A decline in measured test concentration was observed at day 28 to less than the limit of quantification (LOQ) of the analytical method used which was determined to be 0.60 mg/l.

The losses observed by chemical analysis were higher that those observed by oxygen consumption, this was considered to be due to possible losses of the test substance due to its volatility during sampling and analytical procedures.

Another factor in the apparent reduced biodegradation value based on oxygen consumption values compared to losses calculated from the chemical analysis conducted may be due to incorporation of the test substance or degradation products of the test substance into the microbial biomass. In such cases, the micro-organisms present utilise carbon originating from the test substance to increase their biomass by incorporating the carbon into new cells. This effectively removes the test substance from the aqueous phase and hence reduces the apparent biodegradation of the test item by oxygen consumption.

Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable
Conclusions:
A ready biodegradation value of 88% after 28 days was observed for the substance in accordance with OECD 301F and in compliance with GLP. The result is considered reliable.
Executive summary:

The test substance biodegraded to an extent of 88% after 28 days. The data support characterizing the test substance as readily biodegradable, not expected to persist in the environment under aerobic conditions. Although it did not meet the 10 -day window requirement, it is characterized as readily biodegradable because the criterium is not applied to multi-component substances when assessing their ready biodegradability.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
March to April 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a standard guideline, but it was not conducted under GLP guidelines and oxygen consumption was not reported.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
EPA OTS 796.3100 (Aerobic Aquatic Biodegradation)
Deviations:
yes
Remarks:
The test was conducted without a negative control, but this does not invalidate the results.
GLP compliance:
no
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, non-adapted
Duration of test (contact time):
31 d
Initial conc.:
>= 22.55 - <= 23.45 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
CO2 evolution
Reference substance:
benzoic acid, sodium salt
Parameter:
% degradation (CO2 evolution)
Value:
1.74
Sampling time:
3 d
Parameter:
% degradation (CO2 evolution)
Value:
5.66
Sampling time:
8 d
Parameter:
% degradation (CO2 evolution)
Value:
13.63
Sampling time:
16 d
Parameter:
% degradation (CO2 evolution)
Value:
16.07
Sampling time:
24 d
Key result
Parameter:
% degradation (CO2 evolution)
Value:
18.39
Sampling time:
31 d
Details on results:
The positive control, sodium benzoate, biodegraded to 60.15% on day 16, 63.62% on day 24, and 65.70% on day 31.
Validity criteria fulfilled:
yes
Remarks:
The test was conducted without a negative control, but this does not invalidate the results.
Interpretation of results:
not inherently biodegradable
Conclusions:
The test substance biodegraded to an extent of 16.07% after 24 days and 18.39% after 31 days. The test substance is not inherently biodegradable.
Executive summary:

The test substance biodegraded to an extent of 16.07% after 24 days and 18.39% after 31 days. The test substance is not inherently biodegradable.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
February to March 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a standard guideline without deviations from the protocol and conducted under GLP guidelines.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Deviations:
no
GLP compliance:
yes
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Duration of test (contact time):
30 d
Initial conc.:
37 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
Duplicate test systems were used to evaluate the biodegradability of the test substance at a concentration of 37 mg/L. One test system was used to evaluate the positive control substance at a concentration of approximately 31 mg/L. Duplicate blank test systems, which did not contain the test or positive control substance, were run concurrently.
Reference substance:
benzoic acid, sodium salt
Preliminary study:
A preliminary study was not conducted.
Parameter:
% degradation (O2 consumption)
Value:
ca. 10
Sampling time:
3 d
Parameter:
% degradation (O2 consumption)
Value:
ca. 50
Sampling time:
9 d
Parameter:
% degradation (O2 consumption)
Value:
61.3
Sampling time:
12 d
Key result
Parameter:
% degradation (O2 consumption)
Value:
76.6
Sampling time:
28 d
Remarks on result:
other: Percent biodegradation was still increasing.
Key result
Parameter:
% degradation (O2 consumption)
Value:
76.6
Sampling time:
30 d
Details on results:
The test substance exhibited rapid biodegradation, and was assessed as readily biodegradable. The half-life was approximately 9 days. By Day 30, the average percent biodegradation of the test substance was 76.6%. The test substance reached 10% biodegradation on Day 3, and approximately 60% biodegradation on Day 12.

Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance.
Results with reference substance:
The reference substance biodegraded to an extent of 88% after 28 days. By Day 5, >60% biodegradation of the positive control was observed, which meets the guideline requirement.
Validity criteria fulfilled:
yes
Remarks:
The test guideline validity criteria require that the oxygen uptake in the inoculum blank should not exceed 60 mg/L in 28 days, which it did not, therefore, the results are considered valid.
Interpretation of results:
readily biodegradable
Conclusions:
The test substance biodegraded to an extent of approximately 77% after 28 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
Executive summary:

The test substance biodegraded to an extent of approximately 77% after 28 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
March to April 1993
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a standard guideline, but it was not conducted under GLP guidelines and oxygen consumption was not reported.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
EPA OTS 796.3100 (Aerobic Aquatic Biodegradation)
Deviations:
yes
Remarks:
The test was conducted without a negative control, but this does not invalidate the results.
GLP compliance:
no
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, non-adapted
Duration of test (contact time):
31 d
Initial conc.:
>= 23.3 - <= 23.98 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
CO2 evolution
Reference substance:
benzoic acid, sodium salt
Parameter:
% degradation (CO2 evolution)
Value:
5.03
Sampling time:
3 d
Parameter:
% degradation (CO2 evolution)
Value:
8.69
Sampling time:
8 d
Parameter:
% degradation (CO2 evolution)
Value:
11.69
Sampling time:
16 d
Parameter:
% degradation (CO2 evolution)
Value:
12.69
Sampling time:
24 d
Key result
Parameter:
% degradation (CO2 evolution)
Value:
13.69
Sampling time:
31 d
Details on results:
The positive control, sodium benzoate, biodegraded to 60.15% on day 16, 63.62% on day 24, and 65.70% on day 31.
Validity criteria fulfilled:
yes
Remarks:
The test was conducted without a negative control, but this does not invalidate the results.
Interpretation of results:
not inherently biodegradable
Conclusions:
The test substance biodegraded to an extent of 12.69% after 24 days and 13.69% after 31 days. The test substance is not inherently biodegradable.
Executive summary:

The test substance biodegraded to an extent of 12.69% after 24 days and 13.69% after 31 days. The test substance is not inherently biodegradable.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
August to September 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a standard guideline without deviations from the protocol and was conducted under GLP guidelines.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Deviations:
no
GLP compliance:
yes
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Details on inoculum:
An un-acclimated activated sludge inoculum was used in this study. The inoculum was obtained from the Somerset Raritan Valley Sewage Authority, Bridgewater, New Jersey, USA. The treatment plant receives predominantly domestic sewage. The sewage sample was obtained one day prior to test initiation. The microbial count was 106 CFU/mL. The sludge supernatant was added at a 1% loading volume of to test medium. Test medium consisted of glass distilled water and mineral salts (phosphate buffer, ferric chloride, magnesium sulfate, calcium chloride). One liter of test medium and activated sludge, which was aerated for 24 hours with carbon dioxide free air, was added to each one liter respirometer flask.
Duration of test (contact time):
28 d
Initial conc.:
ca. 38 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
Triplicate test systems were used to evaluate the biodegradability of the test substance and the positive control substance at mean concentrations of approximately 38 mg/L and 50 mg/L, respectively. Blank test systems, which did not contain the test or positive control substance, were run concurrently in triplicate. The test substance was weighed in an air tight syringe and injected into the test medium. The test system was sealed immediately after addition of the test substance. An aliquot of the positive control stock solution was added to the appropriate test flasks. All test vessels were stirred constantly using magnetic stir bars and plates. The study was conducted at a temperature of 21°C.
Reference substance:
benzoic acid, sodium salt
Preliminary study:
A preliminary study was not conducted.
Test performance:
No deviations from the protocol occurred that affected the integrity of the study data.
Parameter:
% degradation (O2 consumption)
Value:
4.8
Sampling time:
2 d
Parameter:
% degradation (O2 consumption)
Value:
12.7
Sampling time:
3 d
Parameter:
% degradation (O2 consumption)
Value:
53
Sampling time:
12 d
Parameter:
% degradation (O2 consumption)
Value:
60.2
Sampling time:
18 d
Key result
Parameter:
% degradation (O2 consumption)
Value:
67.6
Sampling time:
28 d
Remarks on result:
other: Percent biodegradation was still increasing.
Details on results:
The test substance exhibited rapid biodegradation, and assessed as readily biodegradable. The half-life was approximately 12 days. By Day 31, the average percent biodegradation of the test substance was 68.7%. The test substance reached 10% biodegradation on approximately Day 3 and 60% biodegradation on approximately Day 18.

Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance.
Results with reference substance:
The reference substance biodegraded to an extent of 88.7% after 28 days. By Day 3, >60% biodegradation of the positive control was observed, which meets the guideline requirement.
Validity criteria fulfilled:
yes
Interpretation of results:
readily biodegradable, but failing 10-day window
Conclusions:
The test substance, a multi-component substance, biodegraded to an extent of 68% after 28 days and 69% after 31 days. The data support characterizing the test substance as rapidly biodegradable, readily biodegradable, not expected to persist in the environment under aerobic conditions. Although it did not meet the 10-day window requirement, it is characterized as readily biodegradable because the criterium is not applied to multi-component substances when assessing their ready biodegradability.
Executive summary:

The test substance, a multi-component substance, biodegraded to an extent of 68% after 28 days and 69% after 31 days. The data support characterizing the test substance as rapidly biodegradable, readily biodegradable, not expected to persist in the environment under aerobic conditions. Although it did not meet the 10-day window requirement, it is characterized as readily biodegradable because the criterium is not applied to multi-component substances when assessing their ready biodegradability.

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
July to August 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a standard guideline without deviations from the protocol and conducted under GLP guidelines.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Deviations:
no
GLP compliance:
yes
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Duration of test (contact time):
38 d
Initial conc.:
49.4 mg/L
Based on:
other: test mat., replicate 1
Initial conc.:
32 mg/L
Based on:
other: test mat., replicate 2
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
Duplicate test systems were used to evaluate the biodegradability of the test substance at a concentration of 49.4 mg/L. One test system was used to evaluate the positive control substance at a concentration of 40.6 mg/L. Duplicate blank test systems, which did not contain the test or positive control substance, were run concurrently.
Reference substance:
benzoic acid, sodium salt
Preliminary study:
A preliminary study was not conducted.
Parameter:
% degradation (O2 consumption)
Value:
ca. 10
Sampling time:
2 d
Parameter:
% degradation (O2 consumption)
Value:
ca. 50
Sampling time:
8 d
Parameter:
% degradation (O2 consumption)
Value:
ca. 63
Sampling time:
12 d
Key result
Parameter:
% degradation (O2 consumption)
Value:
ca. 79
Sampling time:
28 d
Key result
Parameter:
% degradation (O2 consumption)
Value:
79
Sampling time:
38 d
Details on results:
The test substance exhibited rapid biodegradation, and was assessed as readily biodegradable. The half-life was approximately 8 days. By Day 38, the average percent biodegradation of the test substance was 79%. The test substance reached 10% biodegradation on Day 2, and approximately 60% biodegradation on Day 12.

Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance.
Results with reference substance:
The reference substance biodegraded to an extent of approximately 90% after 28 days. By Day 4, >60% biodegradation of the positive control was observed, which meets the guideline requirement.
Validity criteria fulfilled:
yes
Remarks:
The test guideline validity criteria require that the oxygen uptake in the inoculum blank should not exceed 60 mg/L in 28 days, which it did not, therefore, the results are considered valid.
Interpretation of results:
readily biodegradable
Conclusions:
The test substance biodegraded to an extent of approximately 79% after 28 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).
Executive summary:

The test substance biodegraded to an extent of approximately 79% after 28 days. The data support characterizing the test material as rapidly biodegradable (readily biodegradable).

Endpoint:
biodegradation in water: ready biodegradability
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
February to March 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a standard guideline without deviations from the protocol, but it was not conducted under GLP guidelines and oxygen consumption was not reported.
Justification for type of information:
A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Reason / purpose for cross-reference:
read-across: supporting information
Qualifier:
according to guideline
Guideline:
OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
Deviations:
no
GLP compliance:
no
Oxygen conditions:
aerobic
Inoculum or test system:
activated sludge, domestic, non-adapted
Details on inoculum:
An un-acclimated activated sludge inoculum was used in this study. The inoculum was obtained from a domestic wastewater treatment plant, in New Jersey, USA.
Duration of test (contact time):
28 d
Initial conc.:
ca. 39 - <= 40 mg/L
Based on:
test mat.
Parameter followed for biodegradation estimation:
O2 consumption
Details on study design:
Triplicate test systems were used to evaluate the biodegradability of the test substance at concentrations of 39 to 40 mg/L. Duplicate test systems were used to evaluate the positive control substance at an approximate concentration of 51 mg/L. Blank test systems, which did not contain the test or positive control substance, were run concurrently.
Reference substance:
benzoic acid, sodium salt
Preliminary study:
A preliminary study was not conducted.
Parameter:
% degradation (O2 consumption)
Value:
7.1
St. dev.:
6.3
Sampling time:
6 d
Parameter:
% degradation (O2 consumption)
Value:
12.4
St. dev.:
8.2
Sampling time:
7 d
Parameter:
% degradation (O2 consumption)
Value:
47.8
St. dev.:
11
Sampling time:
24 d
Parameter:
% degradation (O2 consumption)
Value:
52.2
St. dev.:
9
Sampling time:
27 d
Key result
Parameter:
% degradation (O2 consumption)
Value:
53.4
St. dev.:
8.5
Sampling time:
28 d
Remarks on result:
other: Percent biodegradation was still increasing.
Details on results:
The test substance exhibited moderately rapid biodegradation, and assessed as inherently biodegradable. The half-life was approximately 27 days. By Day 28, the average percent biodegradation of the test substance was 53.4%. The test substance reached approximately 10% biodegradation on Day 7.

Biodegradation was based on oxygen consumption and the theoretical oxygen demand of the test substance was calculated using results of an elemental analysis of the test substance.
Results with reference substance:
The reference substance biodegraded to an extent of 94.2% (s.d. = 2.5) after 28 days. By Day 4, >60% biodegradation of the positive control was observed, which meets the guideline requirement.
Validity criteria fulfilled:
yes
Remarks:
The test guideline validity criteria require that the oxygen uptake in the inoculum blank should not exceed 60 mg/L in 28 days, which it did not, therefore, the results are considered valid. These data were contained in the laboratory notebook.
Interpretation of results:
inherently biodegradable
Conclusions:
The test substance biodegraded to an extent of 53% after 28 days. The data support characterizing the test material as exhibiting moderate rate of biodegradation (inherently biodegradable).
Executive summary:

The test substance biodegraded to an extent of 53% after 28 days. The data support characterizing the test material as exhibiting moderate rate of biodegradation (inherently biodegradable).

Description of key information

There is data available for this substance. Additionally, key data is available for structural analogues, Hyd C9-C11, cyclics, <2% arom; Hyd C10-C12, ic, <2% arom; Hyd C10-C13, ni, <2% arom; Hyd C10-C14, ic, <2% arom; Hyd C11-C12, n-alkanes, <2% arom; Hyd C12-C13, ic, <2% arom; Hyd C12-C16, nic, <2% arom; Hyd C13-C14, n-alkanes, <2% arom; and presented in the dossier. The data is read across to this substance based on analogue read across and a discussion and report on the read across strategy is provided as an attachment in IUCLID Section 13.

Hyd C9-C11, cyclics, <2% arom attained 53% degradation after 28 days. The data support characterizing the test material as exhibiting moderate rate of biodegradation (inherently biodegradable).

Hyd C10-C12, ic, <2% arom attained a degradation of 7.34% after 24 days and 8.74% after 31 days. The test substance is not inherently biodegradable.

Hyd C10-C12, isoalkanes, <2% arom attained a degradation of 31% after 28 days and 41% after 41 days during a non acclimated phase of the test. The test substance biodegraded to an extent of 42% after 28 days and 48% after 41 days during an acclimated phase of the test. The test substance can be characterized as inherently biodegradable.

 

Hyd C10-C13, ni, <2% arom attained 88 % degradation in 28 days. The substance was therefore concluded to be readily biodegradable

Hyd C10-C14, ic, <2% arom attained a degradation of 16.07% after 24 days and 18.39% after 31 days. The test substance is not inherently biodegradable.

Hyd C11-C12, n-alkanes, <2% arom attained 77% degradation in 28 days. The substance was therefore concluded to be readily biodegradable

Hyd C12-C13, ic, <2% arom attained a degradation of 12.69% after 24 days and 13.69% after 31 days. The test substance is not inherently biodegradable.

Hyd C12-C16, nic, <2% arom attained a degradation 68% after 28 days and 69% after 31 days. The data support characterizing the test substance as rapidly biodegradable, reaily biodegradable, not expected to persist in the environment under aerobic conditions. Although it did not meet the 10-day window requirement, it is characterized as readily biodegradable because the criterium is not applied to multi-component substances when assessing their ready biodegradability.

 

Hyd C13-C14, n-alkanes, <2% arom attained 79% degradation in 28 days. The substance was therefore concluded to be readily biodegradable

Key value for chemical safety assessment

Biodegradation in water:
readily biodegradable

Additional information