Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Sept 16, 1985 to Sept 20, 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

No analytical monitoring

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

(Tested length of 3.0 +/- 0.5 cm slightly higher than recommended length of 2.0 +/- 1.0 cm. No evidence the concentrations were satisfactorily maintained)

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Stock solution of 1000 mg/L dilution water prepared by dispersion in ultrasonic bath; test solutions prepared by dilution of stock solution in dilution water.
- Evidence of undissolved material (e.g. precipitate, surface film, etc): The test solutions of 2.5, 4.0, 6.4 and 10 mg/L showed a Tyndall effect, the intesity of which increased with increasing concentrations. Precipitates were observed on the bottom of the test aquarium in the 2.5, 4.0, 6.3 and 10 mg/L exposure concentrations 48 h after preparation of the test solution.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish
- Strain: Hamilton & Buchanan
- Source: German bred; Distributor: Hugo Schmidt, D-4670 Lunen
- Length at study initiation (length definition, mean, range and SD): 3.0 +/- 0.5 cm

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

268 mg/L (reported as 15°dH)

Test temperature:

Control: 23.0-23.4°C
1.0 mg/L: 23.0-23.4°C
1.6 mg/L: 23.0-23.3°C
2.5 mg/L: 23.0-23.3°C
4.0 mg/L: 23.0-23.3°C
6.3 mg/L: 23.0-23.3°C
10.0 mg/L: 23.0-23.5°C

pH:

Control: 7.72-7.84
1.0 mg/L: 7.73-7.85
1.6 mg/L: 7.73-7.85
2.5 mg/L: 7.67-7.86
4.0 mg/L: 7.64-7.86
6.3 mg/L: 7.68-7.86
10.0 mg/L: 7.71-7.85

Dissolved oxygen:

Control: 7.56-7.82 mg/L
1.0 mg/L: 7.60-7.85 mg/L
1.6 mg/L: 7.56-7.87 mg/L
2.5 mg/L: 7.44-7.81 mg/L
4.0 mg/L: 7.22-7.74 mg/L
6.3 mg/L: 7.50-7.81 mg/L
10.0 mg/L: 7.57-7.78 mg/L

Nominal and measured concentrations:

Nominal:
Control
1.0 mg/L
1.6 mg/L
2.5 mg/L
4.0 mg/L
6.3 mg/L
10.0 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 15 L all glass, 10 L test solution
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: DIN 348 12 L 11
- Ca/Mg ratio: 4:1
- Intervals of water quality measurement: 24 h

OTHER TEST CONDITIONS
- Photoperiod: 12:12

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
mortality - minimum twice daily

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 0.6
- Test concentrations: Control, 1.0 mg/L, 1.6 mg/L, 2.5 mg/L, 4.0 mg/L, 6.3 mg/L, 10.0 mg/L
- Results used to determine the conditions for the definitive study: Range finder with 0, 0.01 mg/L, 0.1 mg/L, 1 mg/L, 10 mg/L, 100 mg/L

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

2.5 mg/L

Nominal / measured:

nominal

Conc. based on:

not specified

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

5.2 mg/L

Nominal / measured:

nominal

Conc. based on:

not specified

Basis for effect:

mortality (fish)

Remarks on result:

other: 95% CL 4.4-6.3 mg/L

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

10 mg/L

Nominal / measured:

nominal

Conc. based on:

not specified

Basis for effect:

mortality (fish)

Details on results:

Mortality occurred in the first 48 h. After this time, seemingly moribund organsims recovered. Within the first 48h the test solutions at concentrations of 2.5, 4.0, 6.3 and 10 mg/L showed a Tyndall effect. The intensity increased with increasing concentrations. Precipitates were observed on bottom of test aquarium in these four exposure concentrations 48 h after preparation of test solution. These observations suggest that mortality is most likely a physical and not a toxic effect due to undissolved particals in the water phase. The survival of five additional organisms to test termination added to the 10.0 mg/L solution after the precipitates were observed supports this assumption.

Reported statistics and error estimates:

LC50 values calculated using a computer program according to Litchfield and Wilcoxon (1949).

Sublethal observations / clinical signs:

Table: Mortality of fish

Conc. [mg/L]	Number of dead fish after				% Mortality after 96 h
	24 h	48 h	72 h	96 h
control	0	0	0	0	0
1.0	0	0	0	0	0
1.6	0	0	0	0	0
2.5	0	0	0	0	0
4.0	1	0	0	0	10
6.3	5	3	0	0	80
10.0	8	2			100

Validity criteria fulfilled:

no

Remarks:

No evidence that the concentration of the test substance was satisfactorily maintained.

Conclusions:

In a 96 h acute toxicity study according to OECD TG 203, the Zebrafish (Danio rerio), was exposed to MDEA-Esterquat C16-18 and C18 unsatd. at nominal concentrations of 0, 1.0, 1.6, 2.5, 4.0, 6.3 and 10 mg/L under static conditions. The nominal 96 h LC50 value based on mortality was 5.2 mg/L (95% C.I.: 4.4 to 6.3 mg/L).

Executive summary:

In a 96 h acute toxicity study according to OECD TG 203, the Zebrafish (Danio rerio), was exposed to MDEA-Esterquat

C16-18 and C18 unsatd. at nominal concentrations of 0, 1.0, 1.6, 2.5, 4.0, 6.3 and 10 mg/L under static conditions. The nominal 96 h LC50 value based on mortality was 5.2 mg/L (95% C.I.: 4.4 to 6.3 mg/L). Mortality occurred in the first 48 h. After this time, seemingly moribund organisms recovered. Within the first 48 h the test solutions at concentrations of 2.5, 4.0, 6.3, and 10 mg/L showed a Tyndall effect. The intensity increased with increasing concentrations. Precipitates were observed on the bottom of the test aquarium in the exposure concentrations of 2.5 to 10 mg/L 48 h after preparation of the test solution. These observations suggest that mortality is most likely a physical and not a toxic effect due to the undissolved particles in the water phase. 5 additional fish were added to the 10.0 mg/L solution after 48 h (the time the precipitates were observed). The animals survived until test termination which supports the assumption of physical effects.

This toxicity study is classified as reliable with restriction and satisfies the requirement for the OECD 203 Fish acute (Zebrafish) toxicity study.

Description of key information

Zebrafish (Danio rerio): 96 h LC50=5.2 mg/L (nominal; 95% C.I.: 4.4 to 6.3 mg/L); OECD Guideline 203; RL2, GLP

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

5.2 mg/L

Additional information

In a 96 h acute toxicity study according to OECD TG 203, the Zebra fish (Danio rerio), was exposed to MDEA-Esterquat C16-18 and C18 unsatd. at nominal concentrations of 0, 1.0, 1.6, 2.5, 4.0, 6.3 and 10 mg/L under static conditions. The nominal 96 h LC50 value based on mortality was 5.2 mg/L (95% C.I.: 4.4 to 6.3 mg/L). Mortality occurred in the first 48 h. After this time, seemingly moribund organisms recovered. Within the first 48 h the test solutions at concentrations of 2.5, 4.0, 6.3, and 10 mg/L showed a Tyndall effect. The intensity increased with increasing concentrations. Precipitates were observed on the bottom of the test aquarium in the exposure concentrations of 2.5 to 10 mg/L 48 h after preparation of the test solution. These observations suggest that mortality is most likely a physical and not a toxic effect due to the undissolved particles in the water phase. 5 additional fish were added to the 10.0 mg/L solution after 48 h (the time the precipitates were observed). The animals survived until test termination which supports the assumption of physical effects.

Similar results were obtained with the closely related read-across substance MDIPA EsterquatC16-18 and C18 unsatd and MDIPA Esterquat C18 unsatd.:

In a 96-h acute toxicity study according to OECD guideline 203, adopted 17 July 1992, Carp (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758 were exposed to MDIPA Esterquat C18 unsatd. (100% a.i)at nominal concentrations of 0 (control), 0.10, 0.32,1.0, 3.2 and 10 mg/L under semi-static conditions in the presence of4 mg humic acid per litre (i.e. 2-4 mg dissolved organic carbon per litre). 

Measured test item concentrations were in agreement with nominal (90-93%). These concentrations remained stable during both refreshment periods (87-90% of initial). Given these results, effect parameters can be based on the nominal test concentrations.

No mortality or other clinical effect was observed at any of the test concentrations and the control during the 96-hour test period.The 96-h LC50 was >10 mg a.i./L. 

The 96–hr-acute toxicity of MDIPA-Esterquat C16-18 and C18 unsatd. to eggs of Danio rerio was studied under semi-static conditions according to guideline OECD guideline 236 (2013). Eggs were exposed to control and test chemical at analytically determined geometric mean concentrations of 0, 0.986, 1.90, 4.15, 8.05, and 16.0 mg/L under semi-static conditions with daily renewal. Analytics and all observations were made daily.

After 96 hours, the number of coagulated embryos in the 0.986, 1.90, 4.15, 8.05, and 16.0 mg/L test substance treatments was 0, 1, 0, 3, and 13 respectively, out of an initial 20 embryos.

None of the embryos in the control or test substance treatments lacked somites throughout the test, with the exception of two embryos in the 8.05 mg/L test substance treatment at 24 hours, and all embryos in the control and test substance treatments exhibited detached tails after 96 hours.

Out of an initial 24 embryos, one embryo had no visible heartbeat in the control at 48 hours. Two embryos in the 8.05 mg/L treatment and eight embryos in the 16.0 mg/L treatment lacked heartbeats after 48 hours; three embryos in the 16.0 mg/L lacked heartbeats after 72 hours; and one embryo lacked a heartbeat in the 8.05 mg/L treatment after 96 hours

The hatching rate after 96 hours was 96% in the control and 100, 90, 95, 55, and 25% in the 0.986, 1.90, 4.15, 8.05, and 16.0 mg/L test treatments, respectively.

The 96-hour LC50 was estimated to be 11.7 mg/L with 95% confidence limits of 9.91 and 13.8 mg/L.