Alcohols, C20-22, reaction products with phosphorus oxide (P2O5)

Biodegradation in water: screening tests

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

biodegradation in water: ready biodegradability

Remarks:

Enhanced ready biodegradability test OECD 310 extended to 60 days

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August 06, 2020 - October 14, 2020

Reliability:

1 (reliable without restriction)

Qualifier:

according to guideline

Guideline:

OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test)

Version / remarks:

2014

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, non-adapted

Details on inoculum:

A sample of aerobic sludge has been selected by the mixed treatment plant of urban (about 66%) and industrial (about 34%) liquid sewage situated at San Rocco - Monza (MB), Italia. The plant of treatment is managed by “BRIANZACQUE SRL (Monza)”.

Duration of test (contact time):

ca. 60 d

Initial conc.:

ca. 19.86 mg/L

Based on:

TOC

Parameter followed for biodegradation estimation:

inorg. C analysis

Details on study design:

see details below

Reference substance:

other: 1-Octanol

Key result

Parameter:

% degradation (inorg. C analysis)

Value:

ca. 79

Sampling time:

60 d

Parameter:

% degradation (inorg. C analysis)

Value:

ca. 56

Sampling time:

28 d

Details on results:

Validity criteria of the test are satisfied.
The mean amount of TIC present in the blank controls at 28 days is: 1.8542 and it satisfied the validity criteria (< 3 mg C/L).
Abiotic degradation has not occurred because amount of TIC during the test in the abiotic bottles has been lower than 10%.
The percentage of average degradation of the reference substance is more than 60% after 14 days of incubation (66%).

Results with reference substance:

The trend of the inorganic carbon and related biodegradation percentages (see table below - column % of biodegradation Reference substance + test item) in the bottle contained both the test sample and the reference substance confirms the absence of an inhibitory effect of the test sample on inoculum at the concentration at which it was applied in the test at t=28 and at t=60 days).

Check point (Days)	% of Biodegradation Reference substance	% of Biodegradation Test item	% of Biodegradation Reference substance + Test item
0	0	0	0
1	5	4	6
5	10	21	-
11	18	41	-
14	66	51	-
28	78	56	65
35	79	54	-
42	81	86	-
49	72	75	-
56	80	62	-
60	86	79	73

 

Validity criteria fulfilled:

yes

Interpretation of results:

inherently biodegradable

Conclusions:

On the basis of results obtained, interpreted in accordance to OECD 310:2014, the test item
“REACTION PRODUCTS BETWEEN C20/22(EVEN NUMBERED) ALCOHOL AND PHOSPHORIC
ANHYDRIDE” has a biodegradability at 60 days, in aerobic conditions, of 79%.

Executive summary:

On the test item, “REACTION PRODUCTS BETWEEN C20/22(EVEN NUMBERED) ALCOHOL AND PHOSPHORIC ANHYDRIDE”, the analysis of inorganic carbon for the evaluation in an aqueous medium of the aerobic biodegradability has been performed following screening method described in OECD 310:2014.
For this purpose the amount of developed inorganic carbon has been measured and reported in comparison to the blank.
The test has been done using the test item with a fixed concentration of organic carbon. Samples have been kept at the temperature of 20 ± 1 °C.
Test lasted 60 days.
On the basis of results obtained, interpreted in accordance to OECD 310:2014, the test item “REACTION PRODUCTS BETWEEN C20/22(EVEN NUMBERED) ALCOHOL AND PHOSPHORIC ANHYDRIDE” has a biodegradability at 60 days, in aerobic conditions, of 79%.

Reference 2

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

February 05th 2020 to March 26th 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 310 (Ready Biodegradability - CO2 in Sealed Vessels (Headspace Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch number of test material: Sponsor and batch number 190604011722
- Expiration date of the lot/batch: 2022/06/03
- Purity test date: 2019/06/14

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
Store in accordance with local regulations. Store in original container protected from direct sunlight in a dry, cool and well-ventilated area, away from incompatible materials and food and drink. Keep container tightly closed and sealed until ready for use. Containers that have been opened must be carefully resealed and kept upright to prevent leakage. Do not store in unlabelled containers. Use appropriate containment to avoid environmental contamination.
- Stability under storage conditions: the product is stable, keep away from oxidizing agents.
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium: Because of the slight solubility of the test item (< 1 mg/L), the sample was prepared by ultrasonic dispersion.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: About 10 g of the test sample was added to 400 mL of deionised water. Then the sample was stirred for 40 minutes at 40°C. Finally the sample was let settle (1 hour) and the surplus was removed. The sample was analyzed at TOC analyzer and the value obtained was considered as the initial measured concentration.
- Final preparation of a solid: The sample has been used with the measured initial concentration of 3.63 mg/L of organic carbon (TOC).

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic, non-adapted

Details on inoculum:

Biodegradability of a substance is based on different parameters and, among them, composition and concentration of bacterial biomass play an important role.
For the preparation of the inoculum a sample of aerobic sludge has been selected by the mixed
treatment plant of urban (about 66%) and industrial (about 34%) liquid sewage.

In the laboratory, the sampled muds have been mixed and let settle, keeping them in aerobic
conditions for 2 days.
The mud samples, before their use, have been analysed to check its ability to form colony units.
Then it has been centrifuged, washed and analyzed to quantify the suspended solids concentration for the inoculum preparation. The inoculum was prepared in order to have a
concentration of suspended solid of about 4 mg/L.

Duration of test (contact time):

ca. 28 d

Initial conc.:

ca. 3.63 mg/L

Based on:

TOC

Parameter followed for biodegradation estimation:

inorg. C analysis

Details on study design:

TEST CONDITIONS
- Composition of medium: mineral salts medium according to OECD 310
- Test temperature: 20 ± 1 °C
- pH: 7.41
- Suspended solids concentration: The inoculum was prepared in order to have a concentration of suspended solid of about 4 mg/L.
- Continuous darkness: no

TEST SYSTEM
Bottles type: Blank / Test sample / Reference substance/ Test sample + / Abiotic
reference substance check
N. of total replica used: 17 / 17/ 17/ 8/ 8
N. replica/ check points (days): 3 replica once a week and 5 replica at 28th day for Blank, test sample and reference substance. And 3 replica /t=1st day 5 replica at 28th day for Test sample + reference substance and abiotic check

Test sample: The sample has been used with the measured initial concentration of 3.63 mg/L of organic carbon (TOC).
Reference substance: Considering 1-Octanol as reference substance using its molecular formula, a starting measured concentration of 16.52mg/l of organic carbon (TOC) has been used.
Blank:
Blank has been used which contained water, culture medium and the inoculum of the mud.
Test sample + reference substance: Test sample and reference substance have been put together in order to have a final concentration given by the sum of organic carbon (TOC) of the 2
substances.
Abiotic check:
Test item has been put together with 50 mg/L HgCl2 in order to check a possible abiotic degradation.

Reference substance:

other: 1-octanol

Key result

Parameter:

% degradation (inorg. C analysis)

Value:

ca. 52

Sampling time:

28 d

Details on results:

Validity criteria of the test are satisfied.
The mean amount of TIC present in the blank controls at the end of the test is < 3 mg C/L.
Abiotic degradation has not occurred because amount of TIC during the test in the abiotic bottles has been lower than 10%.
The trend of the inorganic carbon and related biodegradation percentages in the bottle contained both the test sample and the reference substance confirms the absence of an inhibitory effect of the test sample on inoculum at the concentration at which it was applied in the test (8%).

Results with reference substance:

The percentage of average degradation of the reference substance is more than 60% after 14 days of incubation (81%).

Check point (days)	% of biodegradation Reference substance	% of biodegradation Test item	% of biodegradation Reference substance + Test item
0	0	0	0
1	59	8	38
7	80	30	-
14	81	18	-
21	82	39	-
28	84	52	77

Validity criteria fulfilled:

yes

Interpretation of results:

inherently biodegradable

Conclusions:

On the basis of results obtained, interpreted in accordance to OECD 310:2014, the test item
“REACTION PRODUCTS BETWEEN C20/22(EVEN NUMBERED) ALCOHOL AND PHOSPHORIC
ANHYDRIDE” is considered not readily biodegradable in aerobic conditions (52% in 28 days).

Executive summary:

On the test item, “REACTION PRODUCTS BETWEEN C20/22(EVEN NUMBERED) ALCOHOL AND PHOSPHORIC ANHYDRIDE”, the analysis of inorganic carbon for the evaluation in an aqueous medium of the aerobic biodegradability has been performed following screening method described in OECD 310:2014.

For this purpose the amount of developed inorganic carbon has been measured and reported in comparison to the blank.

The test has been done using the test item with a fixed concentration of organic carbon. Samples have been kept at the temperature of 20 ± 1 °C for the whole period of the test (28 days).

On the basis of results obtained, interpreted in accordance to OECD 310:2014, the test item “REACTION PRODUCTS BETWEEN C20/22(EVEN NUMBERED) ALCOHOL AND PHOSPHORIC ANHYDRIDE” is considered not readily biodegradable in aerobic conditions (52% in 28 days). 

Reference 3

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

BPL 11-0012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study has its good laboratory compliance statement signed on September 9th 2011 (SGS)

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)

Deviations:

no

Principles of method if other than guideline:

The amendement has been performed because initial way of solubilisation wasn't appropriated

GLP compliance:

yes (incl. QA statement)

Remarks:

the GLP and Quality assurance statements have signed by SGS Multilab

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, adapted

Details on inoculum:

Activated sludge was centrifuged at 1000 rpm during 5 min and the supernatant was eliminated. Then, fresh media was added, mixed and centrifuged one more time. the supernatant was eliminated and fresh media was added. 5 mL of final sludge was filtered and dried to determine suspended mater. The result was as follow:

Filter and crucible = 2.13602 g
Volume of sludge = 5 mL
Final total dry wait = 2.2285 g

(2.2285 – 2.13602) / 0.005 = 18.496 g/l

To obtain final sludge concentration of 30 mg/L in reaction vessel we have inoculated 2L of media with 3.2 mL of this mixture

Duration of test (contact time):

>= 28 - < 29 d

Initial conc.:

10 mg/L

Based on:

other: TOC (test item) Total Organic Carbon introduced in essay vessel

Parameter followed for biodegradation estimation:

CO2 evolution

Remarks:

CO2 produced by microbial activities were determined by titration of barium bubbling with hydrochloric acid 0.05M and phenolphthalein. For 100ml of Ba(OH)2 0.0125 M, CO2 produced were calculated as follow : CO2 (mg) = 1.1 x (50 – HCl vol (ml))

Details on study design:

As follow the design:
- 2 bottles with test media and inoculum (control),
- 2 bottles with test media, inoculum and reference item (sodium benzoate) (reference test),
- 2 bottles with test media, inoculum and test item to have a concentration from 10 mg/L of TOC (test item solution),
- 1 bottle with test media, inoculum, test item and reference item (sodium benzoate) (toxicity test).
-3 bottles with test media, inoculum and test item water emulsion to have a concentration from 10 mg/L of TOC (test item solution),
- 1 bottle with test media, inoculum, test item water emulsion and reference item (sodium benzoate) (toxicity test).

Reference substance:

benzoic acid, sodium salt

Parameter:

% degradation (CO2 evolution)

Value:

ca. 40

Sampling time:

28 d

Interpretation of results:

other: This key study, shows clearly that SENSANOV WR deserved the more the qualification of inherently than not biodegradable.

Conclusions:

Test item is not readily biodegradable according to the OECD criteria.

Executive summary:

	LCE11034  Batch T02411, Product 36500Z
	BPL11-0012.001
Percentage of biodegradation at 28 days	44 %
Conclusion	Not Readily Biodegradable

 

Reference 4

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study doesn't take into account recent improvements required for difficult substances

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test)

Deviations:

no

GLP compliance:

no

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: 70-75°C
- Boiling point: >300°C
- Vapour pressure: 6.66 x 10-5 Pa.
- Water solubility (under test conditions): <1mg/L
- Solubility in organic solvents: no data
- log Pow: 9.7

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge (adaptation not specified)

Duration of test (contact time):

ca. 28 d

Initial conc.:

20 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

CO2 evolution

Reference substance:

benzoic acid, sodium salt

Parameter:

% degradation (O2 consumption)

Value:

ca. 16.9

Sampling time:

28 d

Results with reference substance:

Sample Biodegradability = 16,9%
Reference Biodegradability = 80,4% / Blank control = 16,0mg.
N.B.: The Reference Biodegradability must be >60%. The Blank control must be <50mg

Validity criteria fulfilled:

yes

Interpretation of results:

other: not readily biodegradable

Conclusions:

Biodegradability according to OECD 301B= 16,9%

Executive summary:

Biodegradability according to OECD 301B= 16,9% after 28 days.

Reference 5

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

September 9 2009

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study doesn't take into account recent improvements required for difficult substances

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, adapted

Details on inoculum:

The inoculum was derived from the secondary effluent of Shangai Longhua sewage plant. The inoculum was pre-conditioned by aerating the secondary effluent, without other treatement or addition, for 5-7 days at the test temperature of 20°C. Control microbe counted at the range of 10000-1000000 orgs/l.

Duration of test (contact time):

>= 7 - 28 d

Initial conc.:

>= 2 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

O2 consumption

Remarks:

Calculate the BOD exerted afetr each time preiod by susbstracting the oxygen depletion (mg O2/l) of the inoculum blank from that exhibited by the test substance. Divide this corrected depletion by the concentration (mg/l) of the test susbstance.

Interpretation of results:

other: Under the condition of this test, SENSANOV WR in concluded non ready biodegradable

Conclusions:

As a result, the average percent biodegradation of the test substance SENSANOV WR on days 7, 14, 21, and 28 was calculated as 7.97%, 10.9%, 11.5% and 11.9%

Executive summary:

Even if this test comply with OECD Guidelines, it make sense reminding that SENSANOV WR tests performed at concentrations higher than the water solubility remains debatable.

Reference 6

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2008-02-01 to 2008-04-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study doesn't take into account recent improvements required for difficult substances

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

not concerned

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):
PHYSICO-CHEMICAL PROPERTIES
- Melting point: 70-75°C
- Vapour pressure: 6.66 x 10-5 Pa.
- Water solubility (under test conditions): 0.5 mg/L.
- log Pow: 9.70
- Stability of test material at room temperature: stable

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic (adaptation not specified)

Details on inoculum:

- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): aerobic activated sludge, micro-organism from a domestic waste water treatment plant was supplied by the sewage plant dermstadt, Germany.
- Conditioning: the aerobic activated sludge used for this study was washed by centrifugation and the supernatant liquid phase was decanted. the solid materiekl was re-suspended in tap water and centrifugated again. this procedure was done threetimes. the sediment was re-suspended in test water and aerated for two days. an aliquot of the final sludge suspension was weighed , dried and the ration of wet wsludge to its dry weight was determined . based on this ration , calculated aliquots of washed sludge suspension, corresponding to 1.5g dry mateerial per liter were mixed with test water (see 6.5). this suspension was used for the experiment.

Duration of test (contact time):

ca. 28 d

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

TEST CONDITIONS
- surrounding type: climatised room
- Test temperature: 22°C
- pH: 7.6 (measured at the start of the test); 6.8-7.7 (measured at the end of the test)
- pH adjusted: no
- CEC (meq/100 g):
- Aeration of dilution water:
- Continuous darkness: yes/no
- light conditions: Darkness


TEST SYSTEM
- Culturing apparatus: BSB sensomat system , aqualytic langen
- Number of culture flasks/concentration: 7 flasks with the controls
- Method used to create aerobic conditions: the flasks were closed and incubatedin a climatised room under contiunous stirring.
- Measuring equipment:the change of pressure in the test flask was measured by means of a manometric method --> BSB/BOD sensor system , aqualytic , 63231 Neu Isenburg, Germany ) ; pH -electrode WTW pH 340i.



CONTROL AND BLANK SYSTEM
- Inoculum blank: ativated sludge+ test water
- Abiotic sterile control: test item + HgCL2 + test Water
- Toxicity control: test item+ reference Item+ activated Sludge+test water

Reference substance:

benzoic acid, sodium salt

Preliminary study:

no preliminary study

Parameter:

% degradation (O2 consumption)

Value:

ca. 17

Sampling time:

10 d

Details on results:

the criterion for ready biodegradability under the conditions of the manometric respirometry test is the 10 day window, describing the period between reaching at least 10% degradation and 60% degradation . This period should not exceed 10 days. the mean biodegradation of LCE07105 was 17% after 28 days (ThODnh4); the 10 day window failed; Therefore, the LCE07105 is considered not to be radily biodegradable, but an inherent biodegradation potential was found.

Results with reference substance:

88% after 14 days and 92% after 28 days of incubation

Validity criteria fulfilled:

yes

Interpretation of results:

inherently biodegradable

Conclusions:

the degradation rate of LCE07105 did not reach 60% within the 10-day window and after 28 days of incubation when no nitrification is considered. According to the guideline, LCE07105 is considered not to be readily biodegradable.

Executive summary:

Biodegradation of LCE07105: the criterion for ready biodegradability under the conditions of the manometric respirometry test is the 10 day window, describing the period between reaching at least 10% degradation and 60% degradation . This period should not exceed 10 days. the mean biodegradation of LCE07105 was 17%(ThODnh4); the 10 day window failed; Therefore, the LCE07105 is considered not to be readily biodegradable, but an inherent biodegradation potential was found.

Biodegradation of reference Item : Sodium Benzoate

The reference item sodium benzoate was sufficiently degraded to a mean of 88% after 14 days and to a mean of 92% after 28 days of incubation, thus confirming the suitability of the aerobic activated sludge inoculum used.

Biodegradation of the toxicity control:

In the toxicity control containing both, the test item and the reference item sodium benzoate, a mean of 36% biodegradation after 28 was noted within the 14 days and 42% biodegradation after 28 days of incubation . Thus , the test item can be assumed to be not inhibitoryto the aerobic activated sludge micro organisms.

Description of key information

Three ready biodegradation studies (OECD 301 D, 301 F and 301B) have been performed on the registered substance (active substance) and shown 11.9%, 17% and 16.9% respectively. However the registered substance is poor soluble in water, an OECD 301B has been conducted with a stable emulsion of the registered substance by improving solubilizing (test item heated at 80°C and mixed with deionised water heated to 80°C in order to obtain a stable emulsion). The result obtained is 44% and show an inherent biodegradation potential.

Two other ready biodegradation test (OECD 310) have been performed, one over 28 days and one extended over 60 days. The results show 52% of biodegradation at 28 days in first OECD 310 study and 79% at 60 days in second OECD 310 study.

To conclude, on the weight of evidence, the registered substance is considered "inherently biodegradable".

Key value for chemical safety assessment

Biodegradation in water:

inherently biodegradable

Type of water:

freshwater