1-Propanaminium, 2-hydroxy-N-(2-hydroxypropyl)-N,N-dimethyl-, esters with fatty acids, C16-18 (even numbered) and C18 unsatd., Me sulfates (salts)

Toxicity to microorganisms

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

activated sludge respiration inhibition testing

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2011-02-10 to 2011-03-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Principles of method if other than guideline:

From biodegradation in water: screening test, toxicity control is used to derive Effect concentration

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Test organisms (species):

activated sludge of a predominantly domestic sewage

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

28 d

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

> 28.2 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: CO2 evolution

Remarks on result:

other: comparison of procedural and toxicity control

Details on results:

OECD301B screening test, the reference item sodium benzoate was degraded to 100 % within the first 14 days.
The toxicity control test with 20 mg DOC/L resp. 28.2 mg a.i./L test substance and 20 mg/L reference item resulted in 61% degradation after 14 days and 91% degradation after 28 days.

Validity criteria fulfilled:

yes

Conclusions:

The toxicity of MDIPA-Esterquat C16-18 and C18 unsatd. to microorganisms was investigated during a ready biodegradation study. The test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 28.2 mg/L.

Executive summary:

The toxicity of MDIPA-Esterquat C16-18 and C18 unsatd. to microorganisms was investigated during a ready biodegradation study according to OECD guideline 301 F (1992) over a period of 28 days and using an inoculum obtained from activated sludge from a predominantly domestic sewage treatment plant.

With 20 mg DOC/L resp. 28.2 mg a.i./L test substance and 20 mg/L reference substance the degradation was 61% after 14 days and 91% after 28 compared to 100% degradation with the reference substance alone. From this it can be concluded, that the 14 d NOEC is >/= 28.2 mg/L.

Reference 2

Endpoint:

activated sludge respiration inhibition testing

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2015-06-24 to 2015-07-24

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: EU Method C.4-C (Determination of the "Ready" Biodegradability - Carbon Dioxide Evolution Test). 2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test), 1992

Deviations:

no

Principles of method if other than guideline:

From biodegradation in water: screening test, toxicity control is used to derive Effect concentration

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Test organisms (species):

activated sludge, domestic

Details on inoculum:

- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): Ruhrverband Kläranlage, Sunthelle 6, 57392 Schmallenberg, Germany; sample from June 24th, 2015

The sludge was washed in mineral medium and centrifuged (at 1100 g for 10 minutes). The supernatant was discarded. The concentrated sludge was suspended in mineral medium to a concentration of 1 – 3 g suspended solids/L. The sludge was aerated with CO2-free air over night to purge the system of carbon dioxide. A sample was withdrawn just before use for the determination of the dry weight of the suspended solids. The concentration used in the test was 10 mg dry mass/litre (30 mg dry mass/3 L).

Test type:

static

Water media type:

freshwater

Total exposure duration:

28 d

Details on test conditions:

TEST CONDITIONS
- Composition of medium: as stipulated in OECD guideline 301
- Additional substrate: no
- Test temperature: 22±2°C
- pH: 7.4, no adjustment required
- Suspended solids concentration: 9.9 mg/L
- Continuous darkness: yes

TEST SYSTEM
- Culturing apparatus: 5 L flasks
- Number of culture flasks/concentration: 3
- Method used to create aerobic conditions: aeration
- Measuring equipment: absorption bottles, each containing 200 mL of 0.05 M sodium hydroxide solution

SAMPLING
The process of biodegradation was followed by CO2 trapped in sodium hydroxide and measured as inorganic carbon. On the days of CO2 measurement, the sodium hydroxide absorbers were disconnected and aliquots of the solutions were measured regarding the TIC concentration. New absorbers (each containing 200 mL fresh 0.05 M sodium hydroxide) were connected to the test vessel.
On the 28th day 1 mL of concentrated hydrochloric acid was added to each test vessel. Subsequently, they were aerated overnight to drive off the carbon dioxide present in the test suspensions. On day 29 the last analysis of evolved carbon dioxide was done.
Days of sampling for CO2 measurement were day 3, 5, 7, 11, 15, 21, and 29

CONTROL AND BLANK SYSTEM
- Inoculum blank: 2 vessels containing only inoculum
- Procedural control: 1 vessel containing reference item (20 mg DOC/L) and inoculum
- Test suspension: 3 vessels containing test item (17 mg TOC/L) and inoculum
- Toxicity control: 1 vessel containing test item (17 mg TOC/L), reference item (20 mg DOC/L) and inoculum
- Medium control: 1 vessel containing only mineral medium

Reference substance (positive control):

no

Duration:

11 d

Dose descriptor:

NOEC

Effect conc.:

>= 24.3 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

other: CO2 production

Duration:

11 d

Dose descriptor:

NOEC

Effect conc.:

17 mg/L

Nominal / measured:

nominal

Conc. based on:

other: TOC

Basis for effect:

other: CO2 production

Details on results:

The biodegradation of the test item was found to be 69 % after 28 days, considering the amount of IC measured after acid dissolving on day 28. The degradation within the 10-day-window was 36 % on the basis of the values obtained by measurement of the trap solutions in the course of the study. The 10-day window started at day five. No significant lag phase / adaptation phase was noticeable.
The biodegradation of the item mixture in the toxicity control was found to be 48 % after 11 days of incubation. Thus, the demanded threshold value of 25 % within 14 days is exceeded and the test item can be identified as non-toxic in a ready biodegradability test.

The CO2 Evolution Test fulfills the validity criteria of the guideline:

- With 5 % the difference of extremes of replicate values of the removal of the test item at the end of the test was less than 20 %.

- The percentage degradation of the reference item has exceeded the pass level of 60 % by day 14.

- With 19.8 mg CO2 per liter (7.8 mg C/L), the total CO2 evolution in the inoculum blank at the end of the test is below the demanded value of 70 mg CO2 per liter.

- With 1.1 %, the mean IC content in the mineral medium used for assay preparation fall below the demanded threshold value of 5 % of the TC (nominal) in the test assays.

Validity criteria fulfilled:

yes

Conclusions:

The toxicity of MDIPA-Esterquat C16-18 and C18 unsatd. to microorganisms was investigated during a ready biodegradation study. The test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 24.3 mg/L.

Executive summary:

The toxicity to microorganisms of MDIPA-Esterquat C16-18 and C18 unsatd. was investigated during a ready biodegradation study according to EU method C.4-C (2008) and OECD guideline 301 B (1992) over a period of 28 days and using an inoculum obtained from activated sludge from a predominantly domestic sewage treatment plant.

Inoculum blank, procedural/functional control with the reference substance Sodium benzoate and a toxicity control with 17 mg TOC/L (24.3 mg a.i. mg/L) test item and 20 mg DOC/L reference item Sodium benzoate were performed.

The biodegradation of the item mixture in the toxicity control was found to be 48 % after 11 days of incubation. Thus, the demanded threshold value of 25 % within 14 days is exceeded and the test item can be identified as non-toxic in a ready biodegradability test.

Reference 3

Endpoint:

activated sludge respiration inhibition testing

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2015-06-25 to 2015-07-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test), 1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test), 2008

Deviations:

no

Principles of method if other than guideline:

From biodegradation in water: screening test, toxicity control is used to derive Effect concentration

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Test organisms (species):

activated sludge, domestic

Details on inoculum:

- Source of inoculum/activated sludge (e.g. location, sampling depth, contamination history, procedure): sewage treatment plant Ruhrverband Kläranlage, Sunthelle 6, 57392 Schmallenberg, Germany; sample from June 24th, 2015 (one day before test start)

Since the sludge had not been taken from a high rate treatment plant and was not thought to contain inhibitors, the samples were not washed with mineral medium after the arrival at the laboratory, they were kept aerobic until use. The sludge was left for settlement for ca. an hour. Subsequently the supernatant was discarded and the concentration of suspended solids was measured in the remaining sludge. The concentration was adjusted to 3.6 g/L and verified by dry mass measurement. The sludge was kept aerated overnight. Before test start, the concentration was adjusted to 4.5 g/L and verified by dry mass measurement. The
concentration used in the test was 29.5 mg dry mass/litre (7.38 mg dry mass/250 mL).

Test type:

static

Water media type:

freshwater

Total exposure duration:

28 d

Details on test conditions:

TEST CONDITIONS
- Composition of medium: as stipulated in OECD guideline 301
- Additional substrate: no
- Test temperature: 22±1°C
- pH: 7.4,no adjustment required
- Suspended solids concentration: 3.6 mg/L
- Continuous darkness: yes

TEST SYSTEM
- Culturing apparatus: 500 mL glass vessels, medium volume of 250 mL
- Number of culture flasks/concentration: 2
- Method used to create aerobic conditions: aeration

SAMPLING
continuous measurement and recording of oxygen demand

CONTROL AND BLANK SYSTEM
- Test suspension: 2 vessels containing test item (460 mg/L) and inoculum
- Inoculum blank: 2 vessels containing only inoculum
- Procedural control: 2 vessels containing reference item (100 mg/L) and inoculum
- Toxicity control: 2 vessels containing test item (460 mg/L), reference item (100 mg/L) and inoculum

Reference substance (positive control):

no

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

>= 460 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

inhibition of total respiration

Remarks:

respiration rate

Details on results:

The biodegradation of the test item after 28 days of incubation was found to be 79 % (SD = 4.8 %) in assays with 460 mg/L. The biodegradation within the 10-daywindow was 65 %. The 10-day-window started at day 2.
The biodegradation of the item mixture in the toxicity control was found to be 75 % after 14 days of incubation. Thus, the demanded threshold value of 25 % is exceeded and the test item can be identified as non-toxic in a ready biodegradability test.

The Manometric Respirometry Test fulfills the validity criteria of the guideline:

- With 7 % the difference of extremes of replicate values of the removal of the test item at the end of the test was less than 20 %.

- The percentage degradation of the reference item has exceeded the pass level of 60 % by day 14.

- The oxygen uptake of the inoculum blank is < 60 mg/L in 28 days and the pH value was inside the range of 6.0 - 8.5.

Validity criteria fulfilled:

yes

Conclusions:

The toxicity of MDIPA-Esterquat C16-18 and C18 unsatd. to microorganisms was investigated during a ready biodegradation study. The test item had no inhibitory effect on activated sludge microorganisms at the tested concentration of 460 mg/L.

Executive summary:

The toxicity to microorganisms of MDIPA-Esterquat C16-18 and C18 unsatd. was investigated during a ready biodegradation study according to EC method C.4-D (2008) and OECD guideline 301 F (1992) over a period of 28 days and using an inoculum obtained from activated sludge from a predominantly domestic sewage treatment plant.

Inoculum blank, procedural/functional control with the reference substance Sodium benzoate and a toxicity control with 460 mg a.i. mg/L) test item and 100 mg/L reference item Sodium benzoate were performed.

The biodegradation of the item mixture in the toxicity control was found to be 75 % after 14 days of incubation. Thus, the demanded threshold value of 25 % within 14 days is exceeded and the test item can be identified as non-toxic in a ready biodegradability test.

Description of key information

14 d NOEC = 68 mg a.i./L (OECD guideline 301B/OECD Guideline301F, geom. mean from 3 studies), GLP, RL 1

Key value for chemical safety assessment

EC10 or NOEC for microorganisms:

68 mg/L

Additional information

For the assessment of toxicity to microorganisms of MDIPA-Esterquat C16-18 and C18 unsatd. three studies are available, two studies according to OECD guideline 301 B, and one study according to OECD guideline 301 F:

The toxicity of MDIPA-Esterquat C16-18 and C18 unsatd. to microorganisms was investigated during a ready biodegradation study according to OECD guideline 301 F (1992) over a period of 28 days and using an inoculum obtained from activated sludge from a predominantly domestic sewage treatment plant.

With 20 mg DOC/L resp. 28.2 mg a.i./L test substance and 20 mg/L reference substance the degradation was 61% after 14 days and 91% after 28 compared to 100% degradation with the reference substance alone. From this it can be concluded, that the 14 d NOEC is >/= 28.2 mg/L.

 

The toxicity to microorganisms of MDIPA-Esterquat C16-18 and C18 unsatd. was investigated during a ready biodegradation study according to EU method C.4-C (2008) and OECD guideline 301 B (1992) over a period of 28 days and using an inoculum obtained from activated sludge from a predominantly domestic sewage treatment plant.

Inoculum blank, procedural/functional control with the reference substance Sodium benzoate and a toxicity control with 17 mg TOC/L (24.3 mg a.i. mg/L) test item and 20 mg DOC/L reference item Sodium benzoate were performed.

The biodegradation of the item mixture in the toxicity control was found to be 48 % after 11 days of incubation. Thus, the demanded threshold value of 25 % within 14 days is exceeded and the test item can be identified as non-toxic in a ready biodegradability test.

 

The toxicity to microorganisms of MDIPA-Esterquat C16-18 and C18 unsatd. was investigated during a ready biodegradation study according to EC method C.4-D (2008) and OECD guideline 301 F (1992) over a period of 28 days and using an inoculum obtained from activated sludge from a predominantly domestic sewage treatment plant.

Inoculum blank, procedural/functional control with the reference substance Sodium benzoate and a toxicity control with 460 mg a.i. mg/L) test item and 100 mg/L reference item Sodium benzoate were performed.

The biodegradation of the item mixture in the toxicity control was found to be 75 % after 14 days of incubation. Thus, the demanded threshold value of 25 % within 14 days is exceeded and the test item can be identified as non-toxic in a ready biodegradability test.

 

For chemical safety assessment, the geometric mean (14 d NOEC = 68 mg/L) of these results will be used.

 

Similar results were also obtained with the closely related source substance MDEA-Esterquat C16-18 and C18 unsatd.: In a 3-hour toxicity study, activated sludge fed with synthetic sewage was exposed to MDEA-Esterquat C16-18 and C18 unsatd. at nominal concentrations of 0 and 47.4 mg a.i./L in accordance with OECD 209 (Activated Sludge Respiration Inhibition). The NOEC based on respiration rate was >47.4 mg a.i./L.