3-((C12-18)-acylamino)-N-(2-((2-hydroxyethyl)amino)-2-oxoethyl)-N,N-dimethyl-1-propanaminium chloride

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, OECD guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Details on sampling:

Preparation of the test substance
• dilution water was the same as that used for the test
• a stock solution (100 mg/L) was prepared 40 minutes before the start of the test, dissolving test
substance into dilution water
• this stock solution was submitted to magnetic stirring for 10 minutes.
• pH was not adjusted.

Vehicle:

no

Details on test solutions:

Identity and concentration of auxiliary solvent for dispersal: none

Test organisms (species):

Daphnia magna

Details on test organisms:

Species and scientific name:
freshwater microcrustacea, "Daphnia magna".
Justification for the choice of species:
this species can be easily bred in laboratory by acyclic parthenogenesis and is recommended by the International Standards. Daphnia magna is very sensitive to the toxic effects of chemical substances.

Supplier:
Société d’Ecotoxicologie et de Physico-Chimie (ZAC de Milieux - F - 42160 AndrézieuxBouthéon).
Age:
less than 24 hours old at the start of the main test;
Number:
• Preliminary test:
control group: 20 Daphnia,
treated groups (5): 100 Daphnia,
•Maintest:
control group: 20 Daphnia,
treated groups (5): 100 Daphnia.

• 1 litre of dilution water contained 200 ml demineralized water by the mineral stock solution, and 800 ml natural water (Volvic)

Acclimatization (7 days)
• containers : covered glass vessels of 2- litre capacity;
• volume of dilution water used for breeding: varying between 1 to 1.5 litres, aerated;
• pH of breeding water remained between 7.73 and 8.21;
• temperature of breeding water remained between 19.3 °C and 21.7 °C;
• lighting: artificial, 12 hours out of 24.

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

260 mg CaCO3/L

Test temperature:

20.5 °C

pH:

7.85

Nominal and measured concentrations:

Preliminary test
0 / 1.25 / 6.25 / 12.5 / 62.5 / 125.0 mg/L

Main test
0 / 1 / 1.8 / 3.2 / 5.6 / 10 mg/L

Details on test conditions:

20 Daphnia were used per group for the main test

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

other: EC30

Effect conc.:

5.6 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 3.2 - < 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Validity criteria fulfilled:

yes

Conclusions:

Results, within 48 hours of exposure (nominal concentrations):
- EC3O -48 hours (tested concentration): 5.6 mg/L
- Highest tested concentration inducing no significant immobilization: 3.2 mg/L
- Lowest tested concentration inducing 100% immobilization: 10.0 mg/L

All taken together, the LC50 is calculated as an average 6.9 mg/l

Executive summary:

 

ACUTE TOXICITY IN DAPHNIA - STATIC SYSTEM - Daphnia magna

Compliance with: OECD Guideline No. 202 (1984) and EEC Directive 92/69 - Method C.2 (1992).

METHOD :The Daphnia (Daphnia magna) were exposed to the test substance for 48 hours.

A preliminary test (phase I) was performed using nominal concentrations of 0 (control), 1.25, 6.25, 12.5, 62.5 and 125.0 mg of test substance per litre of test medium (20 Daphnia per concentration, excepted at 12.5 mg/L where 15 Daphnia were tested).

A main test (phase II) has been then performed using nominal concentrations of 0 (control), 1, 1.8, 3.2, 5.6 and 10 mg of test substance per litre of test medium (20 daphnia per concentration).

The percentage of immobilization was noted approximately 24 and 48 hours after the start of the test.

Measurements of pH, dissolved oxygen and temperature were performed at the start of the test for each test medium and for the control one, then at the end of the test.

Each medium was once sampled (at the beginning and at the end of the test).

The frozen samples were transmitted to the analytical testing facility at the end of the test, in order to have test substance concentration levels determined: although it was tried to decrease the limit of quantification, it was not possible to quantify the test item in aqueous solutions since an interferent peak occurs at 220 nm. The results are therefore based on nominal concentrations.

The quality criteria for the test as notified in the OECD and EEC protocols relative to the dissolved oxygen concentration, the degree of immobilization of Daphnia in the control medium, their absence from the surface and the pH value variation per concentration, were respected.

RESULTS : Taking into account the results obtained under our experimental conditions, these ones may be expressed as follows:

EC 50, for Daphnia magna, at 24 and 48 hours of exposure (nominal concentrations):

 

 

Method	24 hours	48 hours
Range of concentrations within which the EC (I) 50 falls (mg/L)	>10	3.2 -10.0

 

Results, within 48 hours of exposure (nominal concentrations):

- EC3O - 48 hours (tested concentration): 5.6 mg/1

- Highest tested concentration inducing no significant immobilization: 3.2 mg/L

- Lowest tested concentration inducing 100% immobilization: 10.0 mg/1

 

EC50 -48 hours, for Daphnia magna (nominal concentration):

Included between 3.2 mg/L and 10.0 mg/L

 

By graphical estimation: EC50-48 hours = 6.9 mg/L

Description of key information

Results, within 48 hours of exposure (nominal concentrations):
- EC3O -48 hours (tested concentration): 5.6 mg/L
- Highest tested concentration inducing no significant immobilization: 3.2 mg/L
- Lowest tested concentration inducing 100% immobilization: 10.0 mg/L

All taken together, the LC50 is calculated as an average 6.9 mg/l

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

LC50

Effect concentration:

6.9 mg/L