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Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 - 12 Apr 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

1992

GLP compliance:

yes (incl. QA statement)

Remarks:

Staatsministerium für Umwelt und Landwirtschaft, Germany

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 and 100 mg/L
- Sample storage conditions before analysis: stored deep frozen (≤ -18 °C) at the test facility

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution was prepared by weighing 1000 mg test item and filling up to 5000 mL with test medium (= stock solution A, corresponding to a concentration of 100.0 mg test item/L). The test solutions of the chosen concentrations were prepared directly in the test vessels immediately before the transfer of the fish into the test vessels.
- Eluate: no
- Differential loading: no
- Controls: yes, test medium control

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: purchased from the fish farm „Forellenhof Trostadt“, Reurieth, Germany; held and bred in the testing facility under standardised laboratory conditions
- Age at study initiation (mean and range, SD):
- Length at study initiation (length definition, mean, range and SD): 4.8 ± 0.2 cm
- Weight at study initiation (mean and range, SD): 0.83 ± 0.2 g
- Feeding during test: none

ACCLIMATION
- Acclimation period: 62 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: fish food until 24 hours before the test was started
- Feeding frequency: daily
- Health during acclimation (any mortality observed): The mortality of the fish during the acclimatisation period was 0.3 %.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

200 mg/L CaCO3

Test temperature:

13.4 - 14.5 °C

pH:

7.60 - 7.93

Dissolved oxygen:

8.07 - 8.93 mg/L

Nominal and measured concentrations:

Nominal: 0 and 100 mg/L
Recoveries: 100.9% at 0 h and 97.5% at 96 h

Details on test conditions:

TEST SYSTEM
- Test vessel: stainless steel container
- Material, size, headspace, fill volume: stainless steel (approx. 25 L volume), fill volume 10 L, headspace: 15 L
- Aeration: yes
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.83 g fish/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water according to ISO 6341
- Conductivity of deionised water: 1.0 µS/cm
- Intervals of water quality measurement: pH, oxygen concentration and temperature daily

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light : 8 h dark, daily

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Number of dead fish in each test vessel (including abnormalities), 3, 6, 24, 48, 72 and 96 hours after start of exposure

Reference substance (positive control):

not required

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- No mortality was observed during the study
- Other adverse effects control: none
- Abnormal responses: No visible signs of abnormalities of the surviving test fish were observed at any time of inspection.

Reported statistics and error estimates:

Since a limit test was performed, it was not necessary to conduct a calculation or statistical evaluation.

Sublethal observations / clinical signs:

The measured concentrations of test item in the test solutions at 0 and 96 hours after application were 101 and 98 % of the nominal concentrations respectively. Therefore, all toxicity results are based on

the nominal concentrations.

Validity criteria fulfilled:

yes

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

Please refer to the analogue justification attached to chapter 13.

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: key, Source, Juckeland, 2013, Oncorhynchus mykiss 96h

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: key, Source, Juckeland, 2013, Oncorhynchus mykiss 96h

Description of key information

LC50 (96 h) > 100 mg/L (Oncorhynchus mykiss; OECD 203, read across)

Additional information

Experimental data on the acute toxicity of Reaction mass of dipotassium 2-(3,4-dimethyl-1H-pyrazol-1-yl) succinate and dipotassium 2-(4,5-dimethy-1H-pyrazol-1-yl) succinate to fish are not available.The assessment was therefore based on data available for the conjugate acid Reaction mass of 2-(3,4-dimethyl-1H-pyrazol-1-yl)succinic acid and 2-(4,5-dimethyl-1H-pyrazol-1-yl)succinic acid (CAS 2241455-89-8).

The acute toxicity of the source substance to fish was investigated in a limit test according to OECD Guideline 203 and GLP. The test organism Oncorhynchus mykiss was exposed to the test substance at a nominal concentration of 100 mg/L for 96 hours. Analytical monitoring determined recovery rates of 100.9% at 0 h and 97.5% at 96 h.No mortality or symptoms of intoxication were observed during the study. The determined LC50 (96 h) was > 100 mg/L (nominal).

Based on the available read-across data Reaction mass of dipotassium 2-(3,4-dimethyl-1H-pyrazol-1-yl) succinate and dipotassium 2-(4,5-dimethy-1H-pyrazol-1-yl) succinate is expected to be not acutely toxic to fish.