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

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline, GLP study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Details on sampling:

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 notified chemical in aqueous solutions since an interferent peak occurs at 220 nm.
The results are therefore based on nominal concentrations.

Vehicle:

no

Details on test solutions:

Preparation of the test substance (at the start of the test):
no stock solution was prepared, the test substance beeing directly added into experimental water and manually dispersed with a spatula.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

Number (all the fish were issued from the same batch):
Preliminary test: control group: 10 rainbow trouts,
treated groups (5): 50 rainbow trouts.
Main test: control group: 10 rainbow trouts,
treated groups (5): 50 rainbow trouts.

Supplier (rearing):
“Pisciculture Font-Rome” (07 - Aubenas).
Size:
7.95 cm ranging from 6.5 to 10.0 cm (measurements made on ten fish taken at random at the end of the main test);

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

approx. 120 mg CaCO3/L

Test temperature:

The temperature of the water remained between 14.5 °C and 15.3 °C during the last 7 days of the acclimatization period;
The temperature of the water remained within 13.9 °C to 14.9 °C during the test;

pH:

The pH of water remained between 6.07 and 6.19 during the last 7 days of the acclimatization period;
The pH of the media remained between 6.31 to 7.10 during the test;

Dissolved oxygen:

at least 85% of the air saturation value; aeration was provided during the test by air bubbling in each medium.

Nominal and measured concentrations:

Test substance nominal concentration (mgIi)
0 / 0.6 / 1.0 / 1.7 / 2.9 / 5.0

Details on test conditions:

Test period (main test):
• containers:
tanks of 35 litre capacity; all these containers were covered;
• system:
static system (without renewal of test media during the test period);
• pH variation:
During the test (maximal deviation between the lowest and the highest pH measurement per concentration) : 0.68 unit;
• temperature variation:
Temperature variation in the media during the test (maximal deviation between the lowest and the highest temperature measurement per concentration) : 0.8 °C maximum;
• lighting:
artificial, 12 hours out of 24;
• dissolved oxygen concentration:
at least 85% of the air saturation value; aeration was provided during the test by air bubbling in each medium.

Diet
-Accimatization period:
Appropriate food for freshwater fish, at least 5 days.
Feeding was stopped 24 before the start of the test.
- Test period:
no food was provided during the test.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Duration:

24 h

Dose descriptor:

LC50

Effect conc.:

> 1.7 - < 5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 1.7 - < 5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

72 h

Dose descriptor:

LC50

Effect conc.:

> 1.7 - < 5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1.7 - < 5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

other: LC 80

Effect conc.:

2.9 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.5 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

yes

Conclusions:

96h-LC50, for fish in freshwater medium, Oncorhynchus mykiss (nominal concentration). Included between 1.7 and 5.0 mg/L
Thus, by graphic estimation LC50 - 96h = 2.5mg/l

Executive summary:

ACUTE TOXICITY IN FRESHWATER FISH - STATIC SYSTEM -

Oncorhynchus mykiss

Compliance with: OECD Guideline No. 203 (1992) and EEC Directive 92/69 - Method C.1 (1992).

METHOD: Freshwater fish (Oncorhynchus mykiss) were exposed to the test substance for 96 hours. The tests (phase I and phase II) were performed in a static system (without renewal of test media during the test period).

A preliminary test (phase I) was performed using the nominal concentrations of 0 (control), 1, 5, 10, 50, and 100 mg of test substance per litre of test medium (10 Oncorhynchus mykiss per group).

A main test (phase II) was then performed using the nominal concentrations of 0 (control), 0.6, 1.0, 1.7, 2.9, and 5.0 mg of test substance per litre of test medium (10 Oncorhynchus mykiss per group).

All death, morphological and behavioural abnormalities were recorded 3 hours 45 minutes and then 24, 48, 72 and 96 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 the control, then approximately 24, 48, 72 and 96 hours later. 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 notified chemical 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 variation of pH value per concentration and mortality in the control group were respected.

	24 hours	48 hours	72 hours	96 hours
range of concentration within which the LC50 falls (mg/L)	1.7 -5.0	1.7 -5.0	1.7 -5.0	1.7 -5.0

Within 96 hours of exposure

LC80 (tested concentration): 2.9 mg/L

Highest observed concentration inducing no significant mortality: 1.7 mg/L

Lowest observed concentration inducing 100% mortality: 5.0 mg/L

LC50- 96 hours, for fish in fresh water medium, Oncorhynchus mykiss (nominal concentration)

Included between 1.7 and 5.0 mg/L

By graphical estimation

LC50 -96 hours = 2.5 mg/L

Description of key information

96h-LC50, for fish in freshwater medium, Oncorhynchus mykiss (nominal concentration). Included between 1.7 and 5.0 mg/L
Thus, by graphic estimation LC50 - 96h = 2.5mg/l

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

2.5 mg/L