3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxylic acid

Short-term toxicity to fish

Administrative data

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: GLP guideline study with analytical monitoring

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 (control), 120 mg/L
- Sampling method: Samples for analytical determination of the concentration were taken within 30 minutes before insertion of the test organisms (start of exposure), and at the end of the exposure after approx. 96 hours. Water samples were taken from the middle of the test vessel using a glass pipette and were transported to the analytical laboratory in glass ampoules.
- Sample storage conditions before analysis: The transport to the Analytical Laboratory was done on the day of sampling.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The test solution (120 mg/L) was prepared by weighing the test substance and mixing with the correct volume of test water. All test solutions were visibly clear over the entire exposure period. The test concentration at 120 mg/L was clear and slightly colored pink.
- Controls: yes, 0 mg/L

Test organisms

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebrafish (Danio rerio)
- Strain: Danio rerio
- Source: ZF Biolabs, Tres Cantos, Spain
- Age at study initiation (mean and range, SD): Approx. 13 months
- Length at study initiation (length definition, mean, range and SD): 3.3 cm (3.1 – 3.5 cm)
- Weight at study initiation (mean and range, SD): 0.39 g (0.32 – 0.45 g)
- Food type: Commercial fish diet “Tetramin“, supplier Tetra-Werke, Melle, Germany, ad libitum, additionally generally on workdays live brine shrimp (Artemia nauplii).


ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): 16 hours light, 8 hours dark, Oxygen content: > 80% saturation, Temperature: Approx. 23°C
- Type and amount of food: Commercial fish diet “Tetramin“, supplier Tetra-Werke, Melle, Germany, ad libitum, additionally generally on workdays live brine shrimp (Artemia nauplii).
- Health during acclimation (any mortality observed): All test animals were healthy at test initiation and showed no signs of sickness, injury, or other abnormalities. Mortality: <5 %

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

Hardness:

1 mmol/L = 100 mg/L CaCO3

Test temperature:

24°C

pH:

7.5 – 8.5

Dissolved oxygen:

8,5-8,9 mg/L; Oxygen content: > 80% saturation

Nominal and measured concentrations:

nominal concentrations: 0 (control), 120 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass aquaria
- Material, size, headspace, fill volume: Glass aquaria (30 cm long, 22 cm wide, 24 cm high), 10 L
- Aeration: Slight
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The water used for housing and test purposes is non-chlorinated charcoal filtered tap water (Frankenthal, Germany) mixed with deionized water and aerated to achieve the following water characteristics:
- Ca content: approx. 40 mg/L; Mg content: approx. 5 mg/L
- Conductivity: approx. 250 μS/cm (at 25°C)
- Intervals of water quality measurement: Temperature, oxygen content and pH-value were measured in each test vessel within 1 hour after start of exposure and after 24, 48, 72 and 96 hours.
- Total hardness: Approx. 1 mmol/L = 100 mg/L CaCO3
- Acid capacity: Approx. 2.5 mmol/L
- pH-value: Generally 7.5 – 8.5

OTHER TEST CONDITIONS
- Adjustment of pH: The initial pH of 6.7 was adjusted to pH 8.2.
- Photoperiod: 16 hours light, 8 hours darkness
- Light intensity: Approx. 75 - 446 Lux (the light intensity is determined in regular intervals at the surface of the aquaria)

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 3

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Effect concentrations 4

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

>= 120 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Applicant's summary and conclusion

Validity criteria fulfilled:

yes