Tall oil, maleated

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:

key study

Study period:

Studi initiation: November 14 2013 - Experimental competion date: December 13 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

There were two deviations to the Study plan, which did not impact the integrity of the study

GLP compliance:

yes (incl. QA statement)

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, domestic (adaptation not specified)

Details on inoculum:

Domestic activated sludge (mixed microbial population) was collected from the Guelph Wastewater Treatment Plant, Guelph, Ontario on 2013-11-13. The sludge was gently aerated and then settled prior to the supernatant being poured off and added to mineral media. this procedure was repeated twice. After the third time the supernatant was poured off and 2.0 mL of stirred concentrated sludge was dispensed onto pre-weighed aluminium weigh boats. Weigh boats were oven-dried fro dry weight determination of the sludge inoculum. Based on dried weight, the final concentration of inoculum in the reaction vessels was 13.3 mg/L suspended solids.

Duration of test (contact time):

28 d

Initial conc.:

15 mg/L

Based on:

TOC

Parameter followed for biodegradation estimation:

CO2 evolution

Details on study design:

Testing (non-renewal) was conducted according to the 28-day ready biodegradability carbon dioxide (CO2) evolution test with aerobic bacteria OECD guideline 301B.
A procedural control (to verify that the test system is working appropiriately) and an inhibition test (to determine whether the test item was inhibitory to aerobic bacteria) were conducted in parallel with the definitive test.

Reference substance:

other: canola oil

Remarks:

Canola oil was used as the reference compound for this test because it more closely resembles the test item and was thought to be a better indicator of test performance because the two insoluble oil products can be handled in the same manner.

Preliminary study:

The carbon content of the test item and reference item was established before testing by elemental analyser.

Test performance:

The validity of the test is confirmed by test on blank control and on reference substance.
Total CO2 evolution in the inoculated control (nutrient blank) did not exceed 70 mg/L at any point thoughout the test, thereby meeting the test validity criteria.
The reference substance achieved 68.3% biodegradation in 14 days and 78.8% in 28 days satisfying the acceptability criteria (i.e. ≥ 60% biodegradation in 14 days).

Key result

Parameter:

% degradation (CO2 evolution)

Value:

44

Sampling time:

28 d

Parameter:

% degradation (CO2 evolution)

Value:

33

Sampling time:

10 d

Details on results:

Based on data calculations, tall oil maleated achieved 44.0% biodegradation by day 28.

Results with reference substance:

The reference substance (canola oil) was tested in triplicate at a mean concentration of 15 mg/L as total carbon, under the same conditions and with the same sampling intervals used in the definitive test. The reference substance achieved 68.3% biodegradation in 14 days and 78.8% in 28 days satisfying the acceptability criteria (i.e. ≥ 60% biodegradation in 14 days). Reference test results indicated that the test system was acceptable for the determination of ready biodegradability.

Validity criteria fulfilled:

yes

Interpretation of results:

not readily biodegradable

Conclusions:

Based on the results of this study, the test item did not meet the requirement for ready biodegradability (i.e. did not achieve ≥60% degradation in 28 days)

Executive summary:

A 28-d ready biodegradability carbon dioxide evolution test was performed and conducted in compliance with GLP principle to assess test item for ready biodegradability, according to OECD 301B (OECD 1992).

The test exposed microorganism (a bacterial inoculum obtained from a local sewage treatment plant) to the test item for a period of 28 days.

The validity of the test is confirmed by test on blank control and on reference substance.

Total CO2 evolution in the inoculated control (nutrient blank) did not exceed 70 mg/L at any point thoughout the test, thereby meeting the test validity criteria.

The reference substance achieved 68.3% biodegradation in 14 days and 78.8% in 28 days satisfying the acceptability criteria (i.e. ≥60% biodegradation in 14 days).

Based on data calculations, tall oil maleated achieved 44.0% biodegradation by day 28 and therefore, the test item did not meet the requirement for ready biodegradability (i.e. did not achieve ≥60% degradation in 28 days).

Reference 2

Endpoint:

biodegradation in water: inherent biodegradability

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study initiation date: November 10, 2014; Study completion date: July 17, 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 302 C (Inherent Biodegradability: Modified MITI Test (II))

Qualifier:

according to guideline

Guideline:

other: The guidelines for the testing of chemicals (HJ/T 153-2004)

Qualifier:

according to guideline

Guideline:

other: The guidelines for the testing of chemicals, degradation and accumulation (the 2nd edition) (Bejing:China envonment Press, 2013)

GLP compliance:

yes (incl. QA statement)

Oxygen conditions:

aerobic

Inoculum or test system:

other: activated sludge, surface soil and surface water samples

Details on inoculum:

Activated sludge, surface soil and surface water were sampled from ten sites distributed in four districts throughout Najing city. 1L of the sludge, soil and water were collected and mixed thoroughly together. After removing floating matter the mixture was allowed to stand and then the supernatant is filtrated through 0.45 µm Millipore filter. After that the filtrate was adjusted the supernatant to pH 7.0 with sodium hydroxide or phosphoric acid. Finally an appropriate volume of the filtered supernatant was transferred to a fill-and-draw activated sludge vessel and aerated for about 23.5 h. Thirty minutes after stopping the aeration, about one third of the whole volume of supernatant was discarded. then an equal volume of the solution (pH 7.0) containing 0.1% each of glucose, peptone and potassium orthophosphate was added into the settled material and aerated again. this procedure was repeated once per day during one month. Before use the mixture was allowed to stand and the supernatant was removed. A small quantity of sludge was taken to be centrifudged (2500 r/min x 10 min) and then weighed. then the sludge was dried in the oven and weighed again in order to calculate the content of dried sludge was 10%.
At last 10g of centrifugated sludge was diluted 1L with basal culture medium (BSM) to get activated sludge suspension with a concentration of 1000 mg/L (dry basis).

Duration of test (contact time):

28 d

Initial conc.:

31.3 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

other: BOD/COD ratio

Details on study design:

Test solutions were prepared in an organic salts medium, inoculated with a number of microrganisms collected from not less than 10 places in Najing city.
Four groups were set up simultaneously : the "abiotic" contained mineral salts medium and a measured amount of test substance in order to determine, whether there was any change in the test chemical during the testing period, the "procedure control" contained inoculated mineral salts medium and a measured amount of a reference substance for validating the test results. The "control" only contained inoculated mineral salts medium, while the "test" contained inoculated mineral salts medium and a measured amount of test substance.
The progress of degradation was followed by the determination BOD in the "test" and "control". Degradation was expressed as the rationof the biochemical oxygen demand (BOD) and chemical oxygen demand (COD) in order to evaluate the inherent biodegradability of chemical substance. The inherent degradation rate was also expressed as percentage of initial concentration of test substance where the residue analysis of the test substance was performed at the end (28d) of the test.

Reference substance:

benzoic acid, sodium salt

Remarks:

1.0011 g of reference substance was dissolve din 1L volumetric flask with base salted medium

Test performance:

The test was considered to be valid if biodegradation of the reference substance reached >40% and 65% on 7 day and 14 day, respectively, and if the recovery rate of residual amount (experimental, mg) of the test compound in the "abiotic" test is found to be more than 10%.The test was valid because the level of biodegradation of the reference substance sodium benzoate was 78.7% after 7 days and 81.8 after 14 days and recovery rate of residual amount of the test compound in the "abiotic" test is found to be more than 10% after 28 days.

Key result

Parameter:

% degradation (O2 consumption)

Value:

45.2

Sampling time:

28 d

Key result

Parameter:

COD

Value:

1.96 mg O2/g test mat.

Results with reference substance:

The level of biodegradation of the reference substance sodium benzoate was 78.7% after 7 days and 81.8 after 14 days and recovery rate of residual amount of the test compound in the "abiotic" test is found to be more than 10% after 28 days.

Validity criteria fulfilled:

yes

Interpretation of results:

inherently biodegradable

Conclusions:

The BOD results showed that biodegradation of the test substance tall oil, maleated was 45.2 % after 28 days.
Based on the residue analysis, biodegradation of the test susbtance tall oil, maleated was 48.4% during the tesing period.

Executive summary:

The inherent biodegradation test for the test item of the test substance (tall oil, maleated) was performed according to "The guidelines for the testing of chemicals (HJ/T 153 -2004), "the guidelines for testing of chemicals, Degradation and accumulation" (the 2nd edition) and Procedure 302C of the guidelines for testing of chemicals of the OECD "Inherent biodegradability: Modified MITI test (II)" (1981).

Test solutions were prepared in an inorganic salts medium, inoculated with a number of microrganisms collected from 10 places in Nanjing city. During the test, the temperature was kept at 25 ±1 °C and pH was kept at 7.12 -7.44. The test was valid because the level of biodegradation of the reference substance sodium benzoate was 78.7% after 7 days ( >40%) and 81.8% after 14 days ( >65%) and recovery rate of residual amount of the test compound in the "abiotic" test is found to be more than 10% after 28 days.

The BOD results showed that biodegradation of the test substance tall oil, maleated was 45.2 % after 28 days.

Based on the residue analysis, biodegradation of the test susbtance tall oil, maleated was 48.4% during the tesing period.

Reference 3

Endpoint:

biodegradation in water: screening test, other

Remarks:

Biodegradability in seawater

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 to 17 July 2013- open reflux COD test; 25 July to 22 August 2013 - BODIS test

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

other: Regulation of Marine BOD28 for Water Insoluble substances, Marine BODIS Test (OSPAR Ringtest, 1995)

GLP compliance:

yes (incl. QA statement)

Oxygen conditions:

aerobic

Inoculum or test system:

natural water: marine

Duration of test (contact time):

28 d

Parameter followed for biodegradation estimation:

O2 consumption

Details on study design:

As the empirical formula was unavailable for the calculation of the Theoretical Oxygen Demand (ThOD), the Chemical Oxygen Demand (COD) was determined experimentally

Reference substance:

acetic acid, sodium salt

Preliminary study:

For Harmonised Offshore Chemical Notification Format (HOCNF), submission to the regulatory authority (CEFAS) require a physical parameter to be measures by the test facility to corroborate sample identity. For this purpose a density test has been conducted on the test item. The identity of the received sample has been confirmed as EnvaMul 600.

Test performance:

To check the integrity of the test procedures a readily biodegradable (for BOD test) reference chemical (sodium acetate) and a readily oxidisable reference test (for COD test) were also tested.

Key result

Parameter:

% degradation (O2 consumption)

Value:

7

Sampling time:

28 d

Key result

Parameter:

COD

Value:

2.49 other: mg O2/ mg test item

Results with reference substance:

The guideline requires that the reference material degrades by at least 60% of the ThOD and that the blank dissolved oxygen uptake does not exceed 30% of that of the referene. A value of 87% was achieved on day 28 of the test and the maximum blank dissolved oxygen uptake was -0.63%.

Validity criteria fulfilled:

yes

Interpretation of results:

other: not biodegradable in seawater

Conclusions:

EnvaMul 600 failed to meet the requirements for a pass in this test (≥60% degradation relative to the COD value - a maximum of 7% was recorded)

Executive summary:

To measure the biodegradability of the water insoluble sample (EnvaMul 600) in marine environment a biodegradability test in seawater was conducted using the BOD test method for insoluble substances (Marine BODIS - sample on microscope cover slip).

As the empirical formula was unavailable for the calculation of the Theoretical Oxygen Demand (ThOD), the Chemical Oxygen Demand (COD) was determined experimentally.

For Harmonised Offshore Chemical Notification Format (HOCNF), submission to the regulatory authority (CEFAS) require a physical parameter to be measures by the test facility to corroborate sample identity. For this purpose a density test has been conducted on the test item. The identity of the received sample has been confirmed as EnvaMul 600.

To check the integrity of the test procedures a readily biodegradable (for BOD test) reference chemical (sodium acetate)  and a readily oxidisable reference test (for COD test) were also tested.

The guideline requires that the reference material degrades by at least 60% of the ThOD and that the blank dissolved oxygen uptake does not exceed 30% of that of the referene. A value of 87% was achieved on day 28 of the test and the maximum blank dissolved oxygen uptake was -0.63%.

EnvaMul 600 failed to meet the requirements for a pass in this test (≥60% degradation relative to the COD value - a maximum of 7% was recorded)

Description of key information

Ready biodegradation study conclusion:

Based on data calculations, Tall oil maleated achieved 44.0% biodegradation by day 28, therefore, the test item did not meet the requirement for ready biodegradability (i.e. did not achieve ≥60% degradation in 28 days).

Inherent biodegradability study conclusion:

The BOD results showed that biodegradation of the test substance tall oil, maleated was 45.2 % after 28 days.

Based on the residue analysis, biodegradation of the test substance tall oil, maleated was 48.4% during the testing period.

Biodegradation in seawater:

EnvaMul 600 failed to meet the requirements for pass Biodegradability for insoluble substances test in seawater: ≥ 60% degradation relative to the COD value - a maximum of 7% was recorded.

Key value for chemical safety assessment

Biodegradation in water:

inherently biodegradable

Type of water:

freshwater