4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate

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:

19 February 2018 to 05 March 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Principles of method if other than guideline:

Limit test based on the outcome of the acute daphnia test and lemna test according to the threshold approach as indicated in the REACH guidance

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Analytical samples were taken in 24 h intervals from fresh and aged test solutions. For each sampling also a retain sample was taken.
All samples were stored deep frozen until they were transferred to the analytical laboratory.
Samples were thawed to ambient temperature, mixed with 10 mL acetonitrile and shaken well using a Vortex-Mixer. The samples were then diluted with acetonitrile/test medium (1:1. v/v) prior to analysis by HPLC-MS/MS.
Analytical samples were analysed at t = 0 h fresh, t = 24 h fresh and aged, t = 48 h fresh and aged, t = 72 h fresh and aged and t = 96 h aged from control and 0.500 mg/L.

Vehicle:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Strain: Danio rerio Hamilton (Cypriniformes: Cyprinidae)
- Source: own stock breeding originating from from the University of Heidelberg (Germany)
- Length at study end: 23 ± 1 mm
- Weight at study end: 0.09 ± 0.02 g
- Method of breeding: in holding water (reconstituted water) at pH 6.0 – 8.5 and dissolved oxygen >60 % of the air saturation; hardness 140 - 250 mg/L (as CaCO3) at 21-25 °C

ACCLIMATION
- Acclimation period: not indicated - Acclimation conditions: same as test
- Type and amount of food during acclimation: fish flake food (TetraMin) and protein-enriched pellet food (Caviar)
- Feeding frequency during acclimation: at least once per day
- Health during acclimation (any mortality observed): not reported

FEEDING DURING TEST : none

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

232 mg CaCO3/L

Test temperature:

22.8-23.3 °C

pH:

7.24-7.55

Dissolved oxygen:

70-106% of saturation

Salinity:

NA

Conductivity:

680 µS/cm

Nominal and measured concentrations:

Nominal: 0 and 0.5 mg/L
Measured:in controls: ND; at 0.5 mg/L fresh 92-117 % of nominal; aged 90-102 % of nominal

Details on test conditions:

TEST SYSTEM
- Test vessel: 2 L glass bottles containing 1 L of test solution were used
- Aeration: none
- Renewal rate of test solution (frequency): every 24 hours
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: < 0.63 g/L (based on weight at study end)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Ca/Mg ratio: 4/1
- Na/K ratio: 10/1
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 16/8

EFFECT PARAMETERS MEASURED: mortality and signs of toxicity at 0, 4, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS
Limit test based on the outcome of the acute daphnia test and lemna test according to the threshold approach as indicated in the REACH guidance

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

0.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: no signs of toxicity

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 0.5 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

No sublethal effects were observed in the control and at 0.5 mg/L

Reported statistics and error estimates:

NA

Sublethal observations / clinical signs:

% mortality of fish in the test

Test item concentration [mg/L]	Control	0.500
Time [h]	Mortality [%]
0 4	0 0	0 0
24	0	0
48	0	0
72	0	0
96	0	0

Validity criteria fulfilled:

yes

Conclusions:

The LC50 of the substance in fish is >0.5 mg/L

Executive summary:

In a semi-static test with renewal every 24 hours, fish (Danio rerio) were exposed to the substance at nominal concentrations of 0 and 0.5 mg/L (measured 90 -117 % of nominal) during 96 hours. No signs of toxicity and mortality were observed. The LC50 is >0.5 mg/L

Description of key information

In a semi-static test with renewal every 24 hours, fish (Danio rerio) were exposed to the substance at nominal concentrations of 0 and 0.5 mg/L (measured 90 -117 % of nominal) during 96 hours. No signs of toxicity and mortality were observed. The LC50 is >0.5 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.5 mg/L