Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines

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:

15 January to 26 February 2007

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study was conducted in accordance with draft international guidelines in a GLP testing laboratory. Study, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

ISO Draft (BOD Test for Insoluble Substances)

Version / remarks:

ISO/TC 147/SC 5/WG 4N 141

Deviations:

no

GLP compliance:

yes

Remarks:

GLP Statement

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
n/a

Oxygen conditions:

aerobic

Inoculum or test system:

natural water

Details on inoculum:

Natural seawater continuously pumped to testing laboratory from pier in Scapa Flow, Flotta, Orkney (5 January 2007), depth of collection 2 metres below MLWS, Salinity at collection 34-37 parts per thousand. Temperature range 6-14 deg C. 5-7 days before test, seawater passed by gravity through a 45µm filter into an aging tank. Seawater was aged for 10 days at a temperature of 18.9-19.7 deg C.

Duration of test (contact time):

42 d

Initial conc.:

11.11 mg/L

Based on:

test mat.

Initial conc.:

5.56 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

DOC removal

Details on study design:

The study was undertaken with the Test material, test material + soluble reference (Sodium benzoate), and control/blank/reference.
Three replicates were prepared and tested for each test condition.

Reference substance:

benzoic acid, sodium salt

Preliminary study:

n/a

Test performance:

The test was performed at two different addition concentrations:
PR-4758(a) = 11.11 mg/L
PR-4758(b) = 5.56 mg/L

Key result

Parameter:

% degradation (DOC removal)

Value:

63

Sampling time:

28 d

Remarks on result:

other: PR-4758(a) Addition rate 11.11 mg/L

Key result

Parameter:

% degradation (DOC removal)

Value:

69

Sampling time:

42 d

Remarks on result:

other: PR-4758(a) Addition rate 11.11 mg/L

Key result

Parameter:

% degradation (DOC removal)

Value:

80

Sampling time:

28 d

Remarks on result:

other: PR-4758(b) Addition rate 5.56 mg/L

Key result

Parameter:

% degradation (DOC removal)

Value:

85

Sampling time:

42 d

Remarks on result:

other: PR-4758(b) Addition rate 5.56 mg/L

Parameter:

COD

Value:

1.8 g O2/g test mat.

Results with reference substance:

The results with the reference substance were valid, reaching 99 % biodegradation within 14 days, indicating that the sea water used in the test contained a satisfactory population of viable bacteria.

Summary of Results Table

Test Material	PR-4758(a)	PR-4758(b)
Solubility in Water	Soluble	Soluble
COD (mg O2/mg)	1.8	1.8
Addition rate (mg/L)	11.11	5.56
% inhibition (day 28)	23%	24%
28 day biodegradation	63%	80%
Final 42 day biodegradation	69%	85%
% inhibition (day 42)	20%	18%

Average dissolved oxygen concentration (mg O2/L) corrected for barometric pressure

	Day
	0	7	14	21	28	35	42
Oxygen consumption blank	6.92	6.74	6.93	7.15	7.09	6.76	6.84
Sodium benzoate	6.97	3.70	4.72	6.63	6.73	6.69	6.89
PR-4758(a)	6.89	5.46	6.00	6.75	6.44	6.48	6.77
PR-4758(a) + Sodium benzoate	6.95	2.93	5.45	6.23	6.18	6.24	6.74

 

Percentage Degradation of PR-4758(a)

	100% BOD	Sum of BOD (mg O2 per bottle)
		7	14	21	28	35	42
PR-4758(a)	20	4.90	8.51	10.04	12.55	13.62	13.89
PR-4758(a) + Sodium benzoate	40	14.67	20.38	23.88	27.38	29.39	29.78

 

	100% BOD	Percentage biodegradation
		7	14	21	28	35	42
PR-4758(a)	20	25	43	50	63	68	69
PR-4758(a) + Sodium benzoate	40	37	51	60	69	74	75

 

 

Average dissolved oxygen concentration (mg O2/L) corrected for barometric pressure

	Day
	0	7	14	21	28	35	42
Oxygen consumption blank	6.92	6.74	6.93	7.15	7.09	6.76	6.84
Sodium benzoate	6.97	3.70	4.72	6.63	6.73	6.69	6.89
PR-4758(b)	6.97	5.93	6.50	6.67	6.72	6.60	6.89
PR-4758(b) + Sodium benzoate	6.97	2.87	6.05	6.54	6.30	6.32	6.72

 

Percentage Degradation of PR-4758(b)

	100% BOD	Sum of BOD (mg O2 per bottle)
		7	14	21	28	35	42
PR-4758(b)	10	3.11	4.78	6.60	8.02	8.66	8.48
PR-4758(b) + Sodium benzoate	30	14.88	18.28	20.61	23.68	25.36	25.84

 

	100% BOD	Percentage biodegradation
		7	14	21	28	35	42
PR-4758(b)	10	31	48	66	80	86	85
PR-4758(b) + Sodium benzoate	30	50	61	69	79	85	86

 

Validity criteria fulfilled:

yes

Interpretation of results:

readily biodegradable, but failing 10-day window

Conclusions:

The ISO Marine BODIS study indicated that the test substance (PR-4758) did degrade in seawater (63% in 28 days at an addition concentration of 11.11mg/L) and exhibited an inhibition of 23% to seawater bacteria.

Executive summary:

Biodegradation testing was performed on the test substance PR-4758 based on the ISO TC/147, SC5/WG4 Marine BODIS study. The test substance was degraded by 63 % after 28 days and 69 % after 42 days based on COD calculations and measurements to account for oxygen consumption. Therefore, test substance PR-4758 was shown to biodegrade in seawater.

Reference 2

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

11 Sept to 9 Oct 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was conducted in accordance with international guidelines in a GLP testing laboratory

Qualifier:

according to guideline

Guideline:

other: OECD 306 - Biodegradability in Seawater

Deviations:

no

Principles of method if other than guideline:

n/a

GLP compliance:

yes

Remarks:

GLP Statement

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
n/a

Oxygen conditions:

aerobic

Inoculum or test system:

natural water

Details on inoculum:

Natural seawater sample taken from NIVA's research station at Solbergstrand (5 September 1995), depth of collection 40 metres, Salinity at collection 34 parts per thousand. Seawater was aged by storing at the test temperature and by gentle aeration, with coarse particles removed by sedimentation and decanting prior to use.

Duration of test (contact time):

28 d

Initial conc.:

3 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

DOC removal

Details on study design:

Test conditions:
- Temperature 20.0 +/- 2.4 deg C
- closed bottle in the dark

Reference substance:

benzoic acid, sodium salt

Remarks:

2.5 mg/L

Preliminary study:

n/a

Test performance:

Being a UVCB it was not possible to quantify and determine all components fo the test substance and thus the Chemical Oxygen Demand (COD) value was used instead of the Theoretical Oxygen Demand (ThOD).

Key result

Parameter:

% degradation (DOC removal)

Value:

ca. 26

Sampling time:

5 d

Key result

Parameter:

% degradation (DOC removal)

Value:

ca. 36

Sampling time:

15 d

Key result

Parameter:

% degradation (DOC removal)

Value:

ca. 48

Sampling time:

28 d

Remarks on result:

other: Oxygen consumption due to nitrification taken into consideration

Details on results:

See Table below

Results with reference substance:

See Table below

Summary Table of Result

Time (days)	% Biodegradation
	Inoculum Control	Test Substance	Control for inhibitory action
5	69	26	44
15	69	36	51
28	68	48	56

Validity criteria fulfilled:

yes

Interpretation of results:

other: further study is required

Conclusions:

The OECD 306 Guideline is not a ready biodegradability test; a positive result (>70% DOC removal; >60% ThOD) demonstrates a potential for biodegradation in the marine environment, but a negative result only indicates that further study is necessary.

The result of this study was negative, and therefore indicates that further investigation is required.

Executive summary:

A study was completed to examine the potential for biodegradation of PR-4758 (also known as F-9069) in seawater.

The study met the validation criteria, with the reference substance (inoculum control) achieving 50% degradation within 5 days (actual value = 69%), and the blank respiration did not exceed 30% of the oxygen in the test bottle.

 

PR-4758 gave a negative result (48% after 28 days) in this study. Whilst this result does not indicate that the test substance does not have the potential to degrade in the marine environment it does indicate that further investigation is necessary.

Description of key information

Not readily biodegradable; OECD 306; Bjorg S. Nesgard (1995)

Readily biodegradable; ISO BODIS; Hudson B. (2007)

Key value for chemical safety assessment

Biodegradation in water:

readily biodegradable

Additional information

Two studies exist for the biodegradation of PR-4758 in marine water, these are to be used in combination in a weight-of-evidence. The studies were conducted to GLP standards in a GLP certified laboratory. The study was in accordance with OECD guideline 306 (1992). Both studies met the qualifying criteria.