(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 - 22 Aug 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

2004

Deviations:

yes

Remarks:

Culture medium (M4-medium) differed from test medium (ISO-medium), no pre-test acclimation period was included. Switching from M4-medium (husbandry) to Dilution water (test) has been shown not to cause any detrimental effects for test daphnia.

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

2008

Deviations:

yes

Remarks:

Culture medium (M4-medium) differed from test medium (ISO-medium), no pre-test acclimation period was included. Switching from M4-medium (husbandry) to Dilution water (test) has been shown not to cause any detrimental effects for test daphnia.

GLP compliance:

yes (incl. QA statement)

Remarks:

Landesamt für Umwelt, Mainz, Germany

Test material

Test material information

Constituent 1

Reference substance name:

(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide

EC Number:

261-684-6

EC Name:

(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide

Cas Number:

59272-84-3

Molecular formula:

C21H42N2O3

IUPAC Name:

(carboxymethyl)dimethyl-3-[(1-oxotetradecyl)amino]propylammonium hydroxide

Test material form:

solid: particulate/powder

Sampling and analysis

Analytical monitoring:

yes

Remarks:

HPLC-UV

Details on sampling:

- Concentrations: all test item concentrations (0 h and 48 h)

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: stock solution concentration: 100.0 mg/L, lower treatments (4.6 / 10 / 22 / 46 mg/L) were prepared by dilution of this stock solution with dilution water.
- Differential loading: no
- Controls: dilution water only

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: Berlin
- Age at study initiation: < 24 h
- Method of breeding: similar to OECD 202 in M4-medium (recipe of ELENDT)
- Source: bred in the LAUS GmbH

METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES, INCLUDING CULTURING CONDITIONS:
- 22 hours before the start of the test, adult animals were separated from the young. 75 min. before test start, adults were caught with the help of a glass tube, and newborn daphnia (age < 24h) were sieved from the medium and immediately placed into a beaker containing dilution water. Animals which showed no apparent damage were used for the test. Daphnids were caught and lifted from the beaker, put on a small sieve, and the medium surrounding the animals was sucked off using absorbent paper. Immediately after that, the animals were put into the respective test solution.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Test temperature:

19.5° - 20.0°C

pH:

7.6 - 7.9

Dissolved oxygen:

8.2 - 8.7 mg/L

Nominal and measured concentrations:

Nominal concentrations: 0 (control), 4.6, 10, 22, 46 and 100mg/L
Measured concentrations: - (control), 4.8, 9.5, 16.4, 38.3 and 88.4 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass baekers (50 mL, tall shaped)
- Fill volume: 20 ± 5 mL
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO medium according to OECD 202
- Culture medium different from test medium: yes: Culture medium: M4-medium, test medium: ISO-medium

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: not reported
- Light intensity: not reported

EFFECT PARAMETERS MEASURED: number of immobilized daphnia (24 h and 48 h)

RANGE-FINDING STUDY : yes (non-GLP)
- Test concentrations: not reported
- Results used to determine the conditions for the definitive study: not reported

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

15.32 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95% confidence limits: not determined

Results with reference substance (positive control):

- Results with reference substance valid? yes
- EC50 (24 h): 1.98 mg/L

Reported statistics and error estimates:

- Performed with TOXRAT® PROFESSIONAL 3.3.0

Any other information on results incl. tables

Table 1: Further derived effect concentrations

 

Parameter	Value	95%-confidence interval
24h EC50	16.65 mg/L	not determinable*
48h EC50	15.32 mg/L	not determinable*
48h NOEC	9.5 mg/L	--
48h LOEC	16.4 mg/L	--

Table 2: Immobility of Daphnia maga in the test

 

Nominal Concentration in mg/L	Immobility 24 hours					Immobility 48 hours
	absolute				in %	absolute				in %
Blank control	0	0	0	0	0	0	0	0	0	0
4.6	0	0	0	0	0	0	0	0	0	0
10	0	0	0	0	0	0	0	0	0	0
22	5	0	4	0	45	5	2	5	3	75
46	5	5	5	5	100	5	5	5	5	100
100	5	5	5	5	100	5	5	5	5	100

Table 3: % of nominal concentration and geometric mean

 

Nominal Concentration Test Item	% of Nominal Concentration		Geometric Mean
mg/L	t = 0 h	t = 72 h	mg/L
Blank control	--	--	--
4.6	94	117	4.8
10	86	104	9.5
22	69	81	16.4
46	77	90	38.3
100	83	94	88.4

Table 4: Validity criteria for OECD 202.

Criterion from the guideline	Outcome	Validity criterion fulfilled
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized.	0%	yes
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.	8.2 - 8.7 mg/L	yes

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

Please refer to "Any other information on results and tables" for more details.