clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine

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:

26 Jul - 21 Jul, 2000

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:

1993

Deviations:

no

Remarks:

stated in the report. According to the current OECD guideline: fish length is higher than the recommended range of maximum 3 cm, environmental parameters not measured in each test vessel. These deviations have no impact on the outcome of the study.

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Water samples were collected from each replicate test chamber at approximately 0 and 96 hours to measure concentrations of the test substance. The samples were collected from mid-depth in each test chamber, placed in glass scintillation vials and analyzed immediately.

Vehicle:

no

Details on test solutions:

A primary stock solution was prepared by dissolving the test material in dilution water at a concentration of 120 mg a.i./L. The primary stock was mixed and sonicated overnight. The resultant solution appeared clear and colorless. 50 L aliquots of this test solution were distributed into each of three replicate test chambers for the definitive test.

Test organisms (species):

Lepomis macrochirus

Details on test organisms:

All fish used in the test were from the same source and year class. The bluegill were held for approximately 15 weeks prior to the test. The fish were acclimated to test conditions for approximately 54 hours prior to test initiation.
During the holding period, the bluegill were fed daily a commercially-prepared diet and live brine shrimp nauplii (Artemia sp.). The fish were not fed during the acclimation period (at least two days prior to the test) or during the test.
The test organisms were transferred to the test chambers within 30 minutes of preparation.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

128 mg/L

Test temperature:

21.0 to 22.0°C

pH:

7.8 to 8.5

Dissolved oxygen:

7.6 to 8.4 mg/L

Salinity:

Not applicable

Conductivity:

330 µmhos/cm

Nominal and measured concentrations:

Nominal: 201 mg a.i./L
Mean measured: 117 mg a.i./L

Details on test conditions:

The water used for culturing and testing was freshwater obtained from a well approximately 40 m deep located on the Wildlife International, Ltd. site. The well water is characterized as moderately-hard water.
Test chambers were 19 L glass aquaria containing 15 L of test solution. The depth of water in a representative test chamber was approximately 18.2 cm.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 117 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Details on results:

Bluegill in the negative control group appeared normal and healthy throughout the test, with no mortalities or overt signs of toxicity observed. Similarly, all bluegill in the treatment group appeared normal and healthy throughout the test, with no mortalities or overt signs of toxicity observed.

Sublethal observations / clinical signs:

Please refer to "overall remark/ attached background material" field for result tables.

Validity criteria for OECD 203 (2019)

Criterion from the guideline	Outcome	Validity criterion fulfilled
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test	0%	Yes
The dissolved oxygen concentration must have been at least 60 per cent of the air saturation value throughout the test	Ranged between 7.6 to 8.4 mg/L (5.2 mg/L = 60%)	Yes
There must be evidence that the concentration of the substance being tested has been satisfactorily maintained, and preferably it should be at least 80% of the nominal concentration throughout the test. If the deviation from the nominal concentration is greater than 20%, results should be based on the measured concentration.	The measured values were greater than 80 % of the nominal value in all aquaria over the whole test period	Yes

Validity criteria fulfilled:

not specified

Remarks:

in the report. Valid according to the current guideline, for further details please refer to “Any other information on results incl. tables”

Conclusions:

The present guideline study was conducted in compliance with GLP. Under the test conditions used, the LC50 96h for Lepomis macrochirus was > 117 mg a.s./L.

Description of key information

From short-term key study, the 96-hour LC50 for fish exposed to the present test material was > 117 mg a.s./L in freshwater.

From short-term supportive study, the 96-hour LC50 for fish exposed to the present test material was > 100 mg a.s./L for in saltwater.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Dose descriptor:

LC50

Effect concentration:

> 117 mg/L

Marine water fish

Marine water fish

Dose descriptor:

LC50

Remarks:

supportive study

Effect concentration:

> 100 mg/L

Additional information

Four GLP-studies are available for short-term toxicity testing in fish and one of them was identified as key study.

In the key study (2000), the acute toxicity of clothianidin to fish was investigated in a 96-hours static test with the bluegill sunfish (Lepomis macrochirus) according to guideline OECD 203. Ten fish per replicate and three replicate per concentration were exposed for 96 hours under static conditions to a limit nominal concentration of 120 mg as/L, alongside with a control. The 96-hour LC₅₀was determined to be > 117 mg as/L. based on mean measured concentration values. Based on this study, the LC₅₀for bluegill sunfish exposed to clothianidin in the freshwater was > 117 mg as/L.

There are three additional studies available, conducted with Oncorhynchus mykiss (rainbow trout),Cyprinodon variegatus (sheepshead minnow) and Lepomis macrochirus (bluegill); the resulting LC₅₀values were > 100 mg a.s./L. These studies were considered suitable for supporting purpose.

 

In the first supporting study (2000), the acute toxicity of test material to rainbow trout was determined in a 96-h-static limit test according to guideline OECD 203.The 96-hour LC50of the technical active ingredient was determined to be > 100 mg as/L based on the nominal concentration.

 

In the second supporting study (1999), the acute toxicity of test material to sheepshead minnow was determined in a 96-h-static limit test according to OPPTS 850.1075 guideline.The 96-hour LC50of the technical active ingredient was determined to be > 100 mg a.s./L, based on the nominal concentration. Based on this study, the LC₅₀for sheepshead minnow exposed to clothianidin in the saltwater was > 100 mg as/L.

In the third supporting study (2000), the acute toxicity of test material to bluegill sunfish was determined in a 96-h-static limit test according to OECD 203 guideline.The 96-hour LC50of the technical active ingredient was determined to be > 100 mg a.s./L, based on the nominal concentration.