(3-chloro-2-hydroxypropyl)trimethylammonium chloride

Biodegradation in water: screening tests

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

biodegradation in water: inherent biodegradability

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 302 A (Inherent Biodegradability: Modified SCAS Test)

Deviations:

yes

Remarks:

Test duration = 25 days; fill and draw procedure on days 1 and 14 only

Principles of method if other than guideline:

The test method followed was similar to the OECD 302A SCAS-test. However, rather than use a daily fill-and-draw procedure, filling in this test was done twice, on day 1 and on day 14, and the duration of test was 25 days.

GLP compliance:

not specified

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, industrial (adaptation not specified)

Details on inoculum:

- Source of inoculum/activated sludge: Activated sludge from Foxhol WWTP
- Pretreatment: Washed with mineral medium
- Concentration of organic matter 0.2 g/l

Duration of test (contact time):

25 d

Initial conc.:

395 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

DOC removal

Details on study design:

In a modified semi-static test 12.3 mM CHPTAC-C (2.1 mM=395 mg/l CHPTAC) and 10 mM acetate-C (as an alternative source of carbon) were introduced in the effluent containing adapted sludge (volume 100 ml). Continuous cultures were grown under at 30 °C and at a dilution rate of 0.02/h. The pH was between 6.5 and 7.3 and it was not adjusted during the experiment.

Reference substance:

not required

Preliminary study:

Not applicable.

Parameter:

% degradation (DOC removal)

Value:

ca. 60

Sampling time:

14 d

Details on results:

Degradation: 60 % 14 d, 73% 10 d.
Filling in this test was done twice, on day 1 and on day 14 and the duration of test was 25 days. DOC concentration in the effluent increased to 6.7 mM on day 2 and stayed relatively constant till day 5. From day 5 onwards the DOC concentration slowly decreased up to 2.7 mM (at day 14). On day 14 new bottle of medium was connected to the culture which caused an increase of DOC to 5.2 mM. From day 23 onwards a stable DOC concentration of 1.4 mM C was measured.
The author of the test concludes that this corresponds to a removal efficiency of 97 %. It is not clear how the author has calculated this result. Calculating removal by separating the two additions, gives 60 % removal at the first addition and 73% removal at second.
In reference/similar test, but without acetate as an alternative carbon source, the concentration of DOC and chloride were virtually the same.

Validity criteria fulfilled:

not applicable

Interpretation of results:

other: under test condition biodegradable

Conclusions:

In a continous degradation test similar to the OECD 302A SCAS-test, 73 % degradation of CHPTAC was observed after 10 days under aerobic conditions at 30 °C.

Reference 2

Endpoint:

biodegradation in water: screening tests

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

The biodegradability of the test substance was studied by adding the material as the sole source of carbon to batch cultures with activated sludge from an industrial waste water treatment plant (AVEBE - Foxhol), which was previously adapted to the substance. Degradation was measured by removal of Dissolved Organic Carbon (DOC) and release of chloride (Cl-). The biological nature of the degradation was confirmed by comparison of the DOC-removal in sterilized batches.

GLP compliance:

no

Specific details on test material used for the study:

QUAS058

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, industrial (adaptation not specified)

Details on inoculum:

- Source of inoculum/activated sludge: Activated sludge from Foxhol WWTP
- Pretreatment: Washed with mineral medium
- Concentration of organic matter 0.2 g/l

Duration of test (contact time):

10 d

Initial conc.:

2.5 mmol/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

DOC removal

Details on study design:

TEST CONDITIONS
- Composition of medium: The mineral medium was prepared by adding 10 ml phosphate solution, 1 ml magnesium sulphate solution, and 1 ml trace solution to 1 litre of demineralised water. The phosphate solution contained 33 g/l (NH4)2HPO4, 43.5 g/l K2HPO4, 54.6 g/l NaH2PO4and 62.3 g/l Na2HPO4. The magnesium sulphate solution contained 246 g/l MgSO4.7H20. The trace solution in 1M HNO3 contained 5.56 g/l FeSO4.7H2O, 1.69 g/l MnSO4.HO0, 2.81 g/l CoSO4.7H2O, 1.47 g/l CaCl2, 0.25 g/l CuSO4.5H2O and 0.29 g/l ZnSo4.7H2O. The medium was sterilised at 120 °C in an autoclave.

- Test temperature: 30 °C
- pH: 7
- pH adjusted: no

TEST SYSTEM
- Culturing apparatus: Serum bottles (1100 ml) sealed with butyl rubber septum
- Measuring equipment: DOC was measured using a Dohrmann DC-190 TOC analyser
- Test performed in closed vessels due to significant volatility of test substance: No
- Test performed in open system: No

CONTROL AND BLANK SYSTEM
- Inoculum blank: Yes
- Abiotic sterile control: Yes
- Toxicity control: Yes

Reference substance:

not required

Preliminary study:

No preliminary study.

Test performance:

See details on results

Parameter:

% degradation (DOC removal)

Value:

90

Sampling time:

3 d

Details on results:

Under aerobic conditions 90 % removal of DOC was observed after three days using an initial CHPTAC concentration of 563 mg/l (3 mM). No further degradation was observed from day three till day 10. In the sterile control sample no DOC removal was observed.

Results with reference substance:

Not applicable.

In the sterile batches chemical dechlorination was observed; no DOC removal, the chloride concentration increased over the 10 day period from 3.5 mM to 5.3 mM.

Validity criteria fulfilled:

not applicable

Interpretation of results:

other: under test condition biodegradable

Conclusions:

In a biodegradation test using previously adapted activated sludge, 90% removal of the test substance was observed following 3 days incubation at 30°C. Under the conditions of the test, CHPTAC is therefore considered to be biodegradable. The test does not meet the standards required to assess ready or inherent biodegradation under EC criteria.

Reference 3

Endpoint:

biodegradation in water: screening tests

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

The biodegradability was studied by adding the reagent, as the sole source of carbon to batch cultures with active sludge. The incubation was carried out under anoxic conditions in a shaking incubator (150 rpm) at 30 °C. A sterile control was incubated at the same time.

GLP compliance:

not specified

Oxygen conditions:

other: anoxic

Inoculum or test system:

activated sludge, industrial (adaptation not specified)

Details on inoculum:

Active sludge from an industrial waste water treatment plant (AVEBE-Foxhol) was incubated under anoxic conditions for 4 days and then washed twice in mineral medium. Concentration 0.5 g organic matter/l.

Duration of test (contact time):

38 d

Initial conc.:

2.5 mmol/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

DOC removal

Details on study design:

The anoxic incubation was carried out in serum bottles (total volume 315 ml) with 250 ml mineral medium, spiked with active sludge. After flushing the medium with nitrogen gas for 5 minutes, 1ml of 5M sodium nitrate was added, giving a concentration of 280 mg NO3-. 2.5 mM test substance was added ahd the bottles were sealed with a butyl rubber septum and the headspace was flushed with nitrogen gas.

- Composition of medium: The mineral medium was prepared by adding 10 ml phosphate solution, 1 ml magnesium sulphate solution, and 1 ml trace solution to 1 litre of demineralised water. The phosphate solution contained 33 g/l (NH4)2HPO4, 43.5 g/l K2HPO4, 54.6 g/l NaH2PO4and 62.3 g/l Na2HPO4. The magnesium sulphate solution contained 246 g/l MgSO4.7H20. The trace solution in 1M HNO3 contained 5.56 g/l FeSO4.7H2O, 1.69 g/l MnSO4.HO0, 2.81 g/l CoSO4.7H2O, 1.47 g/l CaCl2, 0.25 g/l CuSO4.5H2O and 0.29 g/l ZnSo4.7H2O. The medium was sterilised at 120°C in an autoclave.

Reference substance:

not required

Preliminary study:

Not applicable.

Parameter:

% degradation (DOC removal)

Value:

ca. 44

Sampling time:

38 d

Details on results:

The DOC concentration during anoxic incubation decreased from day 17 onwards. Between day 17 and day 38 the DOC concentration decreased from 16 mM to 9 mM; there is no further removal up to day 51. This corresponds to 44 % DOC removal. In addition, formation of chloride ( i.e. dechlorination) ocurred at the same rate in the sterile control as in the bottle with microbes, so the dechlorination was not caused by micro-organisms.

Results with reference substance:

Not applicable

Validity criteria fulfilled:

not applicable

Interpretation of results:

other: under the test conditions degradable

Conclusions:

Under anoxic conditions, CHPTAC attained 44 % biodegradation in 38 days.

Reference 4

Endpoint:

biodegradation in water: screening tests

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not stated

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

The biodegradability of the test substance was studied by adding the material as the sole source of carbon to batch cultures with granular sludge from an industrial waste water treatment plant (AVEBE - Foxhol), which was previously adapted to the substance. Degradation was measured by removal of Dissolved Organic Carbon (DOC) and release of chloride (Cl-). The biological nature of the degradation was confirmed by comparison of the DOC-removal in sterilized batches.

GLP compliance:

not specified

Oxygen conditions:

anaerobic

Inoculum or test system:

activated sludge, industrial (adaptation not specified)

Details on inoculum:

- Source of inoculum/activated sludge: Granular sludge from Cerestar
- Pretreatment: Washed with mineral medium
- Concentration of organic matter 3 g/l

Duration of test (contact time):

43 d

Initial conc.:

2.5 mmol/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

DOC removal

Details on study design:

Batch cultures were inoculated with activated sludge presumably adapted to the test substance and incubated in closed bottles at 30 °C. Biodegradation was monitored by measuring the removal of dissolved organic carbon (DOC) and the release of chloride in a low chloride mineral medium inoculated with sludge.

The anaerobic incubation was carried out in serum bottles( total volume 3 15 ml) with 250 ml mineral medium, spiked w ith methanogen granular sludge from an industrial source (Cerestar) that was washed once in mineral medium. After flushing the medium for 5 minutes with nitrogen gas, 1 ml fatty acids solution was added. The concentration in the bottle was 15 g VFA-COD/l. The bottles were then sealed with a butyl rubber septum. After all DOC had been removed from the fatty acids, 2.5 mM test substance was added.

Composition of medium: The mineral medium was prepared by adding 10 ml phosphate solution, 1 ml magnesium sulphate solution, and 1 ml trace solution to 1 litre of demineralised water. The phosphate solution contained 33 g/l (NH4)2HPO4, 43.5 g/l K2HPO4, 54.6 g/l NaH2PO4and 62.3 g/l Na2HPO4. The magnesium sulphate solution contained 246 g/l MgSO4.7H20. The trace solution in 1M HNO3 contained 5.56 g/l FeSO4.7H2O, 1.69 g/l MnSO4.HO0, 2.81 g/l CoSO4.7H2O, 1.47 g/l CaCl2, 0.25 g/l CuSO4.5H2O and 0.29 g/l ZnSo4.7H2O. The medium was sterilised at 120°C in an autoclave.

Reference substance:

not required

Parameter:

% degradation (DOC removal)

Value:

0

Sampling time:

43 d

Details on results:

During incubation under anaerobic conditions, no DOC was removed over a period of 43 days.

Validity criteria fulfilled:

not applicable

Interpretation of results:

under test conditions no biodegradation observed

Conclusions:

No biodegradation of CHPTAC was observed under anaerobic conditions in a batch test at 30 °C for 43 days using industrial granular sludge.

Reference 5

Endpoint:

biodegradation in water: screening tests

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1978-08-20 to 1978-09-11

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

Fill and draw repeatability tests, BOD5 tests and electrolytic respirometer tests were performed on samples of background (uncontaminated) and cationic waste waters from an industrial site in order to determine if the test substance was harmful to the biological treatment of total plant waste water.

GLP compliance:

no

Oxygen conditions:

aerobic

Inoculum or test system:

sewage, industrial, non-adapted

Duration of test (contact time):

20 d

Initial conc.:

1 000 mg/L

Parameter followed for biodegradation estimation:

CO2 evolution

Reference substance:

not required

Parameter:

% degradation (CO2 evolution)

Value:

ca. 22

Sampling time:

20 d

Concentration: 2000 mg Quat 188/l (=1000 mg chlorohydrin/l)

Degradation: 375 mg O2 elimination (375/1700 × 100 % = 22 %)

Based on the theoretical oxygen demand of 1700 mg O2/g test substance approximately 22 % of Quat 188 was degraded after 20 days. Oxygen consumed by bacteria was regenerated electrolytically to maintain a constant atmosphere within the bottle. At the end of the incubation period samples were analysed for level of Quat 188 remaining in the sample. The analytical method was based on the conversion of Quat 188 to trimethylamine. The analytical results indicated that 56 % of Quat 188 was degraded after 20 days. It can be concluded that bacteria will utilize Quat 188 if it is the only source of food for microorganisms.

Validity criteria fulfilled:

not applicable

Interpretation of results:

inherently biodegradable

Conclusions:

In a non-standard to study to determine any adverse effect of the substance QUAB 188 on a waste water treatment plant it was concluded that the subsubstance was neither inhibitory nor toxic toward the biological treatment of waste water. The test substance was found to be degradable but microorganisms in the test system preferred to utilise other sources of organic carbon in the waste water.

Reference 6

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Remarks:

Test was conducted under GLP, except for the stability of the test substance (no further information has been given in the test report to what this GLP statement means). The full study report was not available for review and the information is taken from the IUCLID 4 HPV submission only.

Qualifier:

equivalent or similar to guideline

Guideline:

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

Deviations:

yes

Remarks:

Pre-adapted inoculum was used

GLP compliance:

yes

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, adapted

Details on inoculum:

The source of test organism was activated sludge freshly obtained from a municipal sewage treatment plant.

Duration of test (contact time):

27 d

Initial conc.:

20 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

CO2 evolution

Details on study design:

The test was conducted with pre-adapted microorganisms in activated sludge. Temperature was 20 ± 2 °C with incidental extremes down to 17.3 °C. The pH values of the different test media were: a. blank: 6.0; b. positive control: 6.0; c. test substance low: 5,4; d. test substance high: 5.1. Test concentrations were nominal (10 and 20 mg/l). Test duration was 27 days, preceded by 19 days of acclimatisation.

Reference substance:

acetic acid, sodium salt

Parameter:

% degradation (CO2 evolution)

Value:

ca. 42

Sampling time:

27 d

Details on results:

Two test concentrations were used in the study; 10 and 20 mg/l.
Degradation of the test substance at the test concentration of 10 mg/l:
6 days 0.2 %
8 days 8.9 %
11 days 8.9 %
15 days 8.9 %
20 days 8.9 %
The results revealed no significant biodegradation (< 10 %) of the test substance at 10 mg/l.
At the concentration of 20 mg/l, the test substance was biodegraded by 42 % during the test period of 27 days.
Under the same conditions the reference compound sodium acetate was degraded for 60 % during the test period.
Because biodegradation of more than 20 % was recorded at the high concentration of 20 mg/l, the test substance appeared to be inherently biodegradable under the conditions of the modified Sturm test with pre-adapted inoculum presently performed.
Kinetics of the test substance when the 20 mg/l are added (in %):
3.4 after 6 day(s)
4.1 after 8 day(s)
6.1 after 11 day(s)
27 after 15 day(s)
41.2 after 20 day(s)

Validity criteria fulfilled:

not specified

Interpretation of results:

inherently biodegradable

Reference 7

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The study was conducted according to an appropriate OECD test guideline and in compliance with GLP, with acceptable restrictions. The test material was the hydrolysis product of the registered substance.

Qualifier:

according to guideline

Guideline:

OECD Guideline 301 E (Ready biodegradability: Modified OECD Screening Test)

GLP compliance:

yes

Oxygen conditions:

aerobic

Inoculum or test system:

activated sludge, non-adapted

Details on inoculum:

Activated sludge was taken from an oxidation ditch situated on the premises of TNO, Delft, The Netherlands. The oxidation ditch was used to treat domestic sewage.

Duration of test (contact time):

28 d

Initial conc.:

20 mg/L

Based on:

test mat.

Initial conc.:

10 mg/L

Based on:

test mat.

Parameter followed for biodegradation estimation:

DOC removal

Details on study design:

Two concentration of the test substance (10 and 20 mg/l), corresponding to 5 and 9 mg/l DOC, were tested by adding 0.5 and 1.0 ml respectively of the stock solution to the flasks. After addition of inoculum (1 ml), the volume was brought up to 1 l by the addition of medium. This medium contained a buffer of higher capacity than that described in the OECD Guideline. Two control flasks without test substance and a sterile control containing 10 mg/l of test substance (10 ml of a 1% solution of HgCl2 was added) were included in the test. One 5 ml sample was collected from each flask after 0,1,2,3, and 4 weeks, and preserved with mercury chloride and stored in a scintillation vial at -20 °C pending analysis.

Parameter:

% degradation (DOC removal)

Value:

100

Sampling time:

28 d

Details on results:

Complete degradation was reached in one week at concentration 20 mg/L initial concentration (no variability between replicates) and 67–100 % was reached in one week at 10 mg/l initial concentration (slightly variability between replicates).
Inoculum activity was sufficient, test substance was stable under sterile control and it was not toxic for the inoculum. According to this study dihydroxypropyltrimethylammonium chloride is regarded as readily biodegradable.

Validity criteria fulfilled:

yes

Interpretation of results:

readily biodegradable

Conclusions:

In a test conducted according to OECD test guideline 301E and in compliance with GLP, the test substance attained 100 % degradation in 28 days at a starting concentration of 20 mg/l. At a starting concentration of 10 mg/l, 67–100 % degradation was observed. Based on the results for the 20 mg/l test concentration it was concluded that the substance is readily biodegradable. The test substance was the hydrolysis product of the registered substance CHPTAC.

Reference 8

Endpoint:

biodegradation in water: ready biodegradability

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

The study was conducted according to an appropriate OECD test guideline and in compliance with GLP, with acceptable restrictions. The test material was the hydrolysis product of the registered substance.

Justification for type of information:

Read-across information from the Diol is included in the present dossier as it is the main degradation product taken into account in the EU Risk Assessment Report on CHPTAC (2008)

Reason / purpose for cross-reference:

read-across source

Parameter:

% degradation (DOC removal)

Value:

100

Sampling time:

28 d

Details on results:

Complete degradation was reached in one week at concentration 20 mg/L initial concentration (no variability between replicates) and 67–100 % was reached in one week at 10 mg/l initial concentration (slightly variability between replicates).
Inoculum activity was sufficient, test substance was stable under sterile control and it was not toxic for the inoculum. According to this study dihydroxypropyltrimethylammonium chloride is regarded as readily biodegradable.

Validity criteria fulfilled:

yes

Interpretation of results:

readily biodegradable

Conclusions:

In a test conducted according to OECD test guideline 301E and in compliance with GLP, the test substance attained 100 % degradation in 28 days at a starting concentration of 20 mg/l. At a starting concentration of 10 mg/l, 67–100 % degradation was observed. Based on the results for the 20 mg/l test concentration it was concluded that the substance is readily biodegradable. The test substance was the hydrolysis product of the registered substance CHPTAC.

This information is used in a read-across approach in the assessment of the target substance. Read-across information from the Diol is included in the present dossier as it is the main degradation product taken into account in the EU Risk Assessment Report on CHPTAC (2008).

Description of key information

Taking into account the available information CHPTAC is not readily biodegradable.

Key value for chemical safety assessment

Biodegradation in water:

under test conditions no biodegradation observed

Type of water:

freshwater