Imidazolium compounds, 2-C17-unsatd.-alkyl-1-(2-C18-unsatd. amidoethyl)-4,5-dihydro-N-methyl, Me sulfates

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

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:

No data on analytical purity of the test substance is available. No analytical monitoring was conducted.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Age at study initiation: < 24h

Test type:

static

Water media type:

freshwater

Limit test:

no

Test temperature:

20°C (+-1°C)

pH:

test start: 8.5
48 h: 8.46 - 8.52

Dissolved oxygen:

test start: 9.03 mg/l
48 h: 8.84 - 9.36 mg/l

Nominal and measured concentrations:

0.32; 0.18; 0.1; 0.056; 0.032; 0.018 mg/l + control (nominal concentrations)
0.24, 0.15, 0.075, 0.042, 0.024, 0.014 mg/l based on a.i.-content ( mean 75%)

Details on test conditions:

TEST SYSTEM
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- photoperiod: 8h dark : 16h light (1500 Lux)
- no feeding during the course of the test


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water


EFFECT PARAMETERS MEASURED :
immobilisation at 24 and 48h
Each Daphnia was viewed by eye and was defined as affected if showing no whole body movement relative to the water within a persiod of 10 s. Daphnia so affected were termed immobile.

Reference substance (positive control):

no

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

87 µg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: immobilisation

Remarks on result:

other: 95% CL: 75 - 100 µg/L

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

270 µg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: immobilisation

Remarks on result:

other: 95% CL: 0.2 - 0.44 mg/l

Details on results:

48h-EC50 = 0.065 mg/l (based on a.i.-content of 75%)

Percent immobility observed:

Nominal concentration of test material [mg/l]	24 h	48 h
0.32	50	100
0.18	50	100
0.1	0	70
0.056	5	5
0.032	0	0
0.018	0	0
control	0	0

Validity criteria fulfilled:

yes

Conclusions:

Valid with restriction. No data on analytical purity of the test substance is available. No analytical monitoring was conducted. Therefore the test concentrations can only be based on nominal concentrations of the test material.

Executive summary:

The 48 –hr-acute toxicity of oleic-acid based IQAC, DMS quaternised to Daphnia magna was studied under static conditions. Daphnids were exposed to control and test chemical at (nominal) concentration of 0.32; 0.18; 0.1; 0.056; 0.032; 0.018 mg/l for 48 hr. Immobilization was observed daily. The 48 – hour EC50 was 0.087 mg/l (48 hour EC50 = 0.065 mg/l based on a.i.-content of 75%)).

This study is classified as reliable reliable with restriction and satisfies most guideline requirements for an acute toxicity study with freshwater invertebrates.

Results Synopsis

Test Organism Age (e.g. 1st instar): 24h
Test Type: Static

48 h-EC50: 0.087 mg/l  (95% C.I.: 0.075 to 0.1 mg/l)

48 h-EC50 = 0.065 mg/l (based on a.i.-content of 75%)
Endpoint(s) Effected: immobilization

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

supporting study

Study period:

2010-06-14 to 2010-07-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

An aliquot of 10 mL of the treatment and control samples were diluted with 10 mL methanol giving a sample preparation factor of two before they were deep-frozen and protected from light until analysis was performed.
Immediately after sampling, methanol (10 mL methanol to 10 mL sample volume) was added to each sample in order to stabilize the latter during the storage period. Thereafter, all samples were stored deep-frozen (at about -20 °C). In pre-experiments for investigation of the storage stability of the samples, the two main components of the test item proved to be stable under these storage conditions.

Vehicle:

no

Details on test solutions:

In order to assess the toxicity of Partially unsaturated IQAC, DMS quaternised containing different components to daphnids, water accommodated fractions (WAFs) with loading rates of 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L were tested. Additionally, a control (test water without test item) was tested in parallel. The preparation of the test media was based on the OECD Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000.
For preparation of the WAFs with the two highest loading rates of 3.2 and 10 mg/L, individual dispersions of the test item were prepared. The dispersions were stirred for 3 hours to dissolve a maximum amount of the different components of the test item in the dispersion. Then, the dispersions were filtered through membrane filters (0.45 μm) and the undiluted filtrates were tested as WAFs. Due to technical reasons, the WAFs with the lower loading rates of 0.010, 0.032, 0.10, 0.32 and 1.0 mg/L were prepared as dilutions of the WAF with the loading rate of 3.2 mg/L.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain: Straus
- Source: In-house laboratory culture with a known history.
- Age at study initiation (mean and range, SD): 6-24 hours old, not first brood progeny
- Method of breeding: no data
- Feeding during test: not fed during the test

ACCLIMATION
- Acclimation period: no data

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test temperature:

21°C

pH:

between 7.9 and 8.0

Dissolved oxygen:

at least 8.0 mg/L

Nominal and measured concentrations:

Initial concentrations: 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L based on water accommodated fractions (WAFs). At the start of the first test medium renewal period (Day 0), the measured test item concentrations (based on two main components of the test item) in the test media with the loading rates of 0.32, 1.0, 3.2 and 10 mg/L were 6.4, 22, 71 and 3332 μg/L, respectively. At the end of this period (Day 1), the values were 5.9, 14, 43 and 1173 μg/L, respectively. At the start of the second test medium renewal period (Day 1), concentrations of 33, 90, 289 and 2550 μg/L were measured, respectively. At the end of this period (Day 2), the values were 16, 69, 215 and 1374 μg/L, respectively.

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL glass beakers filled with 50 mL of test medium, covered with glass plates
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): medium renewal after 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 20

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted test water according to ISO 6341

OTHER TEST CONDITIONS
- Adjustment of pH: no data
- Photoperiod: 16-hour light to 8-hour dark cycle with a 30-minute transition period
- Light intensity: during the light period was approximately between 520 and 680 Lux

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3.2
- Range finding study: yes
- Test concentrations: water accommodated fractions (WAFs) with the loading rates of 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L were tested.
The volume of test solution provided for each daphnia was 10 mL. Thus, the requirement of the test guidelines for the minimum volume of 2 mL test medium per daphnia was fulfilled.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate (K2Cr2O7).

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

5.7 mg/L

Nominal / measured:

estimated

Conc. based on:

other: water accommodated fractions (WAFs)

Basis for effect:

mobility

Remarks on result:

other: 3.2-10 mg/L

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

3.7 mg/L

Nominal / measured:

estimated

Conc. based on:

other: water accommodated fractions (WAFs)

Basis for effect:

mobility

Remarks on result:

other: 2.6-4.9 mg/L

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.32 mg/L

Nominal / measured:

nominal

Conc. based on:

other: water accommodated fractions (WAFs)

Basis for effect:

mobility

Remarks on result:

other: no data

Details on results:

At the start of the first test medium renewal period (Day 0), the measured test item concentrations (based on two main components of the test item) in the test media with the loading rates of 0.32, 1.0, 3.2 and 10 mg/L were 6.4, 22, 71 and 3332 μg/L, respectively. At the end of this period (Day 1), the values were 5.9, 14, 43 and 1173 μg/L, respectively.

At the start of the second test medium renewal period (Day 1), concentrations of 33, 90, 289 and 2550 μg/L were measured, respectively. At the end of this period (Day 2), the values were 16, 69, 215 and 1374 μg/L, respectively.
During the first 24 hours of the test, no immobilized test organisms were determined in the control and up to and including the loading rate of 3.2 mg/L (corresponding to a mean measured test item concentration of 152 μg/L). At the highest loading rate of 10 mg/L (corresponding to a mean measured test concentration of 1924 μg/L), all test organisms were found to be immobile after 24 hours.

The 24-hour EC50 based on loading rates was calculated to be 5.7 mg/L with 95% confidence limits of 3.2 and 10 mg/L. The 24-hour EC50 based on mean measured concentrations of the test item was calculated to be 541 μg/L with 95% confidence limits of 152 and 1924 μg/L.

The 24-hour EC0 was 3.2 mg/L based on loading rates and 152 μg/L based on mean measured concentrations.
The 24-hour EC100 was 10 mg/L based on loading rates and 1924 μg/L based on mean measured concentrations.

After 48 hours of exposure, no immobilized test organisms were determined in the control and up to and including the loading rate of 0.32 mg/L (corresponding to a mean measured test item concentration of 15 μg/L). At the loading rates of 1.0, 3.2 and 10 mg/L (corresponding to mean measured concentrations of 48, 152 and 1924 μg/L) 15, 30 and 100% of daphnids, respectively, were found to be immobile.

The 48-hour EC50 based on loading rates was calculated to be 3.7 mg/L with 95% confidence limits of 2.6 and 4.9 mg/L. The 48-hour EC50 based on mean measured concentrations of the test item was 253 μg/L with 95% confidence limits of 146 and 688 μg/L.

The 48-hour EC0 and the 48-hour NOEC of test substance were both 0.32 mg/L based on loading rates and 15 μg/L based on mean measured concentrations, since no immobility was observed up to and including this test concentration.

The 48-hour EC100 was 10 mg/L based on loading rates and 1924 μg/L based on mean measured concentrations.

No remarkable observations were made concerning the appearance of the test media. All test media were clear solutions throughout the entire test duration.

The biological test results (based on loading rates and mean measured concentrations): 

	Loading rate (mg/L)	Mean measured concentration (μg/L)
24-hour EC0	3.2	152
24-hour EC50 95% confidence limits	5.7	541
	3.2 - 10	152 - 1924
24-hour EC100	10	1924
48-hour EC0	0.32	15
48-hour NOEC
48-hour EC50 95% confidence limits	3.7	253
	2.6 - 4.9	146 - 688
48-hour EC100	10	1924

Effect of test substance on the Mobility of Daphnia magna 

Loading rate (mg/L)	*Mean measured concentration (μg/L)	No. of daphnids tested	Immobilized daphnids after 24 hours		Immobilized daphnids after 48 hours
			No.	%	No.	%
Control	n.a	20	0	0	0	0
0.010	--	20	0	0	0	0
0.032	--	20	0	0	0	0
0.10	--	20	0	0	0	0
0.32	15	20	0	0	0	0
1.0	48	20	0	0	3	15
3.2	152	20	0	0	6	30
10	1924	20	20	100	20	100

n.a.: not applicable

-- : not analyzed, since below NOEC

* : measurement based on two main components

 

 

Results Obtained for the Concentrations of the Spiked Test Water Samples 

Sample No.	Nominal Concen-tration of Test Item cnom   [μg/L]	Measured Concentration of Test Item in the Spiked Sample x   [μg/L]	Concentration of Test Item Determined in the Spiked Sample c   [μg/L]	Recovery Rate R         [%]	Average           [%]
1	0	<LOQana	n.a	n.a	--
2	10.2	3.68	7.37	72
3	10.2	4.30	8.59	84	78
4	10297	26.2	8774	85
5	10297	26.5	8872	86	86
				Overall mean:	82

LOQ_ana= 0.276μg test item/L

n.a. = not applicable

The tabulated values of the samples represent rounded results obtained by calculation using the exact raw data.

Validity criteria fulfilled:

yes

Remarks:

The test is considered to be valid, as in the control, no daphnids showed immobilization or other signs of disease or stress. The dissolved oxygen concentration at the end of the test was ≥3 mg/L in the control and test vessels.

Conclusions:

The 48–hr-acute toxicity of Partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied According to OECD Guideline for Testing of Chemicals, No. 202 (2004) under semi-static conditions. Daphnids were exposed to the test chemical at water accommodated fractions (WAFs) with loading rates of 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L for 48 hr. Immobilization effects were observed at 24h and 48 h. The 48-hour EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L) confidence limits were calculated by Weibull analysis using linear maximum likelihood regression. The 48-hour EC50 based on mean measured concentrations of the test item was 253 μg/L with 95% confidence limits of 146 and 688 μg/L. The 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L based on loading rates and 15 μg/L based on mean measured concentrations.

This study is classified as reliable without restriction and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.

Executive summary:

The 48–hr-acute toxicity of Partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied According to OECD Guideline for Testing of Chemicals, No. 202 (2004) under semi-static conditions. Daphnids were exposed to the test chemical at water accommodated fractions (WAFs) with loading rates of 0.010, 0.032, 0.10, 0.32, 1.0, 3.2 and 10 mg/L for 48 hr. Immobilization effects were observed at 24h and 48 h. The 48-hour EC50 = 3.7 mg/L and the 95% (2.6 and 4.9 mg/L) confidence limits were calculated by Weibull analysis using linear maximum likelihood regression. The 48-hour EC50 based on mean measured concentrations of the test item was 253 μg/L with 95% confidence limits of 146 and 688 μg/L. The 48-hour EC0 and the 48-hour NOEC based on immobilization were both 0.32 mg/L based on loading rates and 15 μg/L based on mean measured concentrations.

This study is classified as reliable without restriction and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.

Results Synopsis

Test Organism Age: < 24 h

Test Type: semi-static

48 -hour NOEC: 0.32 mg/L                                                 (15 μg/L based on mean measured concentrations)

48-hour EC50: 3.7 mg/L; 95% C.l.: 2.6 to 4.9 mg/L (253 μg/L 95% C.I.: 146 to 688 μg/L based on mean measured concentrations)

Endpoint(s) Effected: immobilization

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

Adequacy of study:

supporting study

Study period:

2005-04-19 to 2005-04-21

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Guideline study that satisfies the requirements

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 16, 32, 64, 128 mg/L (and the control) at 0, 24 and 48 h
- Sampling method: Approximately 10 ml solution (5 mL for TIC analysis) of each concentration and the control were filled each into the measuring vessel and firmly closed with aluminium foil.

Vehicle:

no

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Strain: Straus
- Source: "Landesanstalt fur Wasser und Abfallwirtschaft", Dusseldorf, Germany.
- Age at study initiation (mean and range, SD): not older than 24h
- Method of breeding: the organisms were held in beakers with a nominal capacity of 2000 mL. Each beaker was filled with approximately 1400 mL dilution water. Between 15 and 20 adult organisms were held in one beaker in order to get a high reproduction rate and viable newborns.
The breeding beakers were kept at an additional artificial light-dark cycle of 16 to 8 hours. Breeding beakers are placed in a temperature controlled laboratory at ca. 20 °C. The breeding water was renewed three times a week
- Feeding during test: no data

ACCLIMATION
- Acclimation period: the organisms were held in the laboratory.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

24 h

Hardness:

total: 2.2 - 3.2 mmol/L

Test temperature:

21.4 - 25.4
With regard to the temperature there were deviations from preset values because of technical problems with the air condition. The required range of 18-22 °C was exceeded up to 25.4 °C. The allowed variation of 2 °C within a test was extended to 4 °C in this test. Because there were no immobilised Daphnia in the control group this deviation seems to be of no relevance for the result of the study.

pH:

8.50 - 8.66

Nominal and measured concentrations:

nominal concentrations: control (0 mg/L), 16, 32, 64, 128 mg/L and the 1 g/L stock solution
measured concentrations (TOC mean): 0, 10.2, 20.5, 43.3, 89.4 mg/L and the 692.2 mg/L stock solution

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 2000 L glass beakers
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 6
- No. of vessels per control (replicates): 6


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod:an artificial light dark cycle of 16 to 8 hours was prevalent during the experiment by using fluorescent tubes Osram L36W / 21-840 with a light intensity of approximately 700 lux

WATER SUPPLY
The dilution water was prepared separately in a silicone sealed PVC tank by mixing dechlorinated tap water from municipal source with demineralized water and a special amount of sulphuric acid.
Before usage the dilution water was filtered through an active carbon filter in order to eliminate chlorinated hydrocarbons.
The ratio of calcium/magnesium was approximately 2.7:l (titration of dilution water from 2005-04-05). The ratio of Na/K was approximately 8:l (data were taken from the tap water analysis of Stadtwerke Krefeld from 2005-03-07).
The alkalinity was approximately 1.5 mrnol/L and was determined once by Analytical Laboratory of Stockhausen GmbH (data from November 2000), not in compliance with GLP regulations.

Reference substance (positive control):

no

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

< 1 000 µg/L

Nominal / measured:

nominal

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

< 1 000 µg/L

Nominal / measured:

nominal

Basis for effect:

mobility

Details on results:

- The test substance had a negative influence on the swimming ability of the crustacean Daphnia magna.

Results with reference substance (positive control):

The test is validated with regard to the sensitivity of the organisms by simulating a toxic effect on the swimming ability in dependence of the concentration in control experiments with the reference substance potassium dichromate. The sensitivity is considered adequate when the following range is
obtained:
EC50 (24 h): 0.6 - 2.1 mg/L
Determined EC50 (24 h) in the performed validation experiment: 1.1 mg/L
As a consequence of the obtained result in this control experiment the test system is regarded as valid.

Reported statistics and error estimates:

No statistical calculations were necessary because all Daphnia were immobilised within 24 hours and the EC50 value was below the lowest tested concentration of 1 mg/L of the test item.

Nominal concentrations of the test substance were not verified as no specific analytical method was available. Therefore the test substance was determined by Total Organic Carbon (TOC) analysis at the concentrations 16, 32, 64, 128 mg/L (and control) at 0, 24 and 48 h. The TOC content of the stock solution was 692.2 mg/L (69%).The retrieval rate in the tested concentrations was between 86%and 103% of the TOC content of the stock solution. While measuring TC the samples were stirred by magnetic stirrer.

The TOC determination showed that there was no loss of test substance during the course of the test (48 hours).

The test substance Varisoft 3696 had a negative influence on the swimming ability of the crustacean Daphnia magna:

 

Vessel No.	Nominal concentration, mg/L	Number of immobilized daphnia		Cumulative frequency, %
		1 day	2 day	1 day	2 day
1-5	0	0	0	0	0
6-10	1	25	-	100	-
11-15	2	25	-	100	-
16-20	4	25	-	100	-
21-25	8	25	-	100	-
26-30	16	25	-	100	-
31-35	32	25	-	100	-
36-40	64	25	-	100	-
41-45	128	25	-	100	-

 

Validity criteria fulfilled:

yes

Conclusions:

The test substance had a negative influence on the swimming ability of the crustacean Daphnia magna. All Daphnia were immobilised within 24 hours, the NOEC (EC0 in this study) and EC50 values were below the lowest tested concentration of 1 mg/L.

Executive summary:

In the static test performed according to the OECD Guideline for the Testing of Chemicals No. 202 (April 13, 2004) the effects of oleic-acid based IQAC, DES quaternised on immobilization of Daphnia magna were investigated.

The following nominal concentrations of the test substance were tested: 1; 2; 4; 8; 16; 32; 64 and 128 mg test mat. per litre. Effects on immobilization were determined after 24 and 48 hours.

Nominal concentrations of the test substance were not verified as no specific analytical method was available. Therefore the test substance was determined by Total Organic Carbon (TOC) analysis at the concentrations 16, 32, 64, 128 mg/L (and control) at 0, 24 and 48 h. The TOC content of the stock solution was 692.2 mg/L (69 %). The retrieval rate in the tested concentrations was between 86 % and 103% of the TOC content of the stock solution. The TOC determination showed that there was no loss of test substance during the course of the test (48 hours).

The test substance had a negative influence on the swimming ability of the crustacean Daphnia magna. All Daphnia were immobilised within 24 hours, the NOEC (EC0 in this study) and EC50 values were below the lowest tested concentration of 1 mg/L of Varisoft 3696.

This study is classified as reliable without restriction and satisfies the guideline requirements for an acute toxicity study with invertebrates.

Results Synopsis

Test organism Age: <24 h

Test Type: static

24 h-EC50: <1.0 mg/L, nominal concentration

Endpoint(s) Effected: immobilisation

Reference 4

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

migrated 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:

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

Remarks:

scientifically acceptable study, that satisfies basic scientific requirements, however not all data are reported

Qualifier:

according to guideline

Guideline:

other: DIN 38 412 Part 11

GLP compliance:

not specified

Analytical monitoring:

not specified

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Age at study initiation : <= 24 h
no feeding during the test

Test type:

static

Water media type:

freshwater

Total exposure duration:

24 h

Nominal and measured concentrations:

control, 0.001, 0.005, 0.01, 0.05, 0.1, 0.5, 1.0 mg/L (nominal)

Details on test conditions:

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water, filtered through charcoal

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 450 - <= 900 µg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EC0

Effect conc.:

90 µg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

24 h

Dose descriptor:

EC100

Effect conc.:

900 µg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

- Mortality of control: None

Effect concentrations:

24 h EC50 = 0.5 — 1 mg test mat./ L (nominal)
24 h EC0 = 0.1 mg/ test mat L(nominal)
24 h EC100 = 1 mg test mat test mat /L (nominal)
24 h EC50 = 0.90 mg act.ingr / L(nominal)
24 h EC0 = 0.09 mg/ act.ingr L(nominal)
24 h EC100 = 0.9 mg/ act.ingr.L (nominal)

The test material contains isopropanol. The toxicity of isopropanol against Daphnia magna more than 10 000 times lower than the toxicity of the test material. Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself.

Executive summary:

The 24–hr-acute toxicity of the partially unsaturated IQAC, DMS quaternised to Daphnia magna was studied under static conditions.  Daphnids were exposed to nominal concentrations of 0, 0.001, 0.005, 0.01, 0.05, 0.1, 0.5, 1.0 mg test mat. /L for 24 hr according to DIN 38 412 Part 11.  Mortality/immobilization were observed.  The 24 – hour EC₅₀was 0.45 – 0.9 mg a.i../L.  The 24 – hr EC0 based on mortality/immobilization/sublethal was 0.09 mg a.i. /L.

The test material contains isopropanol. The toxicity of isopropanol against Daphnia magna more than 10 000 times lower than the toxicity of the test material. Therefore it can be concluded in a first approach, neglecting additive effects, that the observed effect values can be attributed to the active ingredient itself.
This study is classified scientifically acceptable, that satisfies basic scientific requirements, however not all data are reported.

Results Synopsis

Test Organism Age (e.g. 1^st instar): Daphnia magna
Test Type: static

24 h EC₅₀: 0.45 - 0.9 mg a.i. /L
24 h EC₀:  0.09 mg a.i./L
24h EC100₀:  0.9 mg a.i./L

Endpoint(s) Effected: mortality, mobility 

Description of key information

The mean of the lower limit of the 48h EC50, 145 μg/L of partially unsaturated IQAC, DMS quaternised and the 48h EC 50 of 65 μg/L is used as a realistic 48h EC50.

The realistic 48h EC50 is calculated to be 105 μg/L.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

105 µg/L

Additional information

The 48 –hr-acute toxicity of Oleic-acid based IQAC, DMS quaternised to Daphnia magna was studied under static conditions. Daphnids were exposed for 48 hr. The 48 – hour EC50was 87 µg/l (48 hour EC50 = 65 µg/l based on a. i. -content of 75%), the 24h EC50 was 270 µg/L. Further information is available from the read across substance partially unsaturated IQAC, DMS quaternised (CAS 86088-85-9). The 24h EC50 is determined to be between 450 and 900μg/L. In a third test , the 24h EC50 is determined to be <1000 µg/l.

The difference between the three test results is a factor of more than 10. Taking into account that the only difference of the registration substance, oleic-acid based IQAC, and the read across substance, partially unsaturated IQAC, DMS quaternised is the chain-length distribution and the number and location of the C=C double bonds (see 1.1.2), this difference cannot be explained by the difference in fatty acid chains.

According to REACH Endpoint specific Guidance R.7b, pp24, it is not recommended to compare 24h EC50 values to 48h EC50 values.

Therefore the 24h EC50 were extrapolated to 48h EC50. Assuming the same slope of the dose-response curve for the acute tests (3.1 based on the nominal concentrations), the results of the 48h exposure of daphnids are calculated to be 145 – 290 μg/L and <322 μg/L respectively. The mean of the lower limit of the definite extrapolated 48h EC50, 145μg/L, and the 48h EC 50 of 65μg/L (based on 75% a.i. content) is used as a realistic 48h EC50. The realistic 48h EC50 is calculated to be 105μg/L.

 

Justification for read-across:

The structural similarities between the source and the target substances presented above are the basis for the read-across hypothesis. Adequate, reliable and available scientific information indicates that the source and target substances have similar physicochemical properties, ecotoxicological and toxicity profiles and thus support the read-across hypothesis.

Both substances are UVCB substances, produced by a similar process resulting in main constituents of the same structure, varying in the degree of saturation and chain length (C16 and C18 and mainly C18, for source and target substance, respectively). Given the underlying identical generic structure (outlined in chapter 1 and 2), similar absorption following oral or dermal uptake and the same metabolic patterns are expected for source and target substance. The findings from toxicokinetic data confirm that the discussed IQAC source and target substances are only poorly absorbed after oral application and rapidly excreted. There was no tendency for accumulation of the substance in the body of the test animals.

In conclusion the results obtained from source substance (partially unsaturated IQAC, DMS quaternised) are considered a reliable source to cover endpoints of the target substance (oleic-acid based IQAC, DMS quaternised). Beyond, the dose descriptors obtained from these studies performed on the source substance are considered as an appropriate starting point for deriving the respective PNECs.

A more detailed justification for read-across is outlined in a separate document:

“Justification for read-across - toxicological information”, is attached to the endpoint summary acute toxicity and provided in chapter 13 of Technical dossier.