ethyl 2-[[(1R,2S,5R)-5-methyl-2-propan-2-ylcyclohexanecarbonyl]amino]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:

2015

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:

The study was conducted using a full range of concentrations as toxicity was observed at the threshold level.

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

Water samples were taken from the control and all surviving test groups at 0 and 72 hours from fresh media, and at 24 and 96 hours from old media for quantitative analysis.

Vehicle:

no

Details on test solutions:

The test solution were prepared using a prlonged stir method. An initial loading rate of 100 mg/L was stirred for a period of 24 hours prior to the removal of any undissolved test item by filtration through a 0.2 micrometer Sartorius Sartopore filter.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

Fish were obtained from Brow Well Fisheries Limited and maintained in house from the 7th October 2015. Fish were maintained in a glass fibre tank with single pass water renewal system. Fish were acclimatised to the test conditions from the 19th October to 26 October 2015.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

Total hardness of approximately 140 mg/L as CaCO3.

Test temperature:

The water temperature was controlled at approximately at 13 °C.

pH:

pH was recorded daily it ranged from 7.5-8.1

Dissolved oxygen:

The dissolved oxygen content of was greater or equal to 9.2 mg O2/L

Nominal and measured concentrations:

Nominal concentrations of 1, 3.2, 10, 32, and 100 mg/L were used. The test solution was renewed daily.

Details on test conditions:

25-30 litre glass exposure vessels containing 20 litres of test media was used for each test concentration and control. The test vessels were covered to reduce evaporation and maintained at approximately 13 °C in a temperature-controlled room with a photoperiod of 16 hours light and 8 hours darkness with a 20-minute dawn and dusk transition periods for a period of 96 hours. Test vessel were aerated via narrow bore glass tubes. The fish received no food during exposure. a semi static test regime was employed involving a daily renewal of the test preparation to prevent a build-up of nitrogenous waste products.

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

5.7 mg/L

Nominal / measured:

nominal

Basis for effect:

mortality (fish)

Details on results:

Analysis of freshly prepared test preparations at 0 and 72 hours showed measured test concentrations to be near nominal. There was no significant change in the measured concentrations at 24 and 96 hours. The results are therefore based on nominal test concentrations.

Validity criteria fulfilled:

yes

Conclusions:

The 96 h LC50 was determined to be 5.7 mg/L.

Executive summary:

The short-term toxicity of the test item to fish was determined following the methods in the OECD 203 guidelines. The test system was a semi-static daily renewal system. The concentration of the test solution was verified analytically at 0 and 72 hours for the fresh media and 24 and 96 hours for the old media. The study found the LC50 of the test item to O. mykiss to be 5.7 mg/L.

Description of key information

The study found the 96h LC50 of the test item to O. mykis to be 5.7 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

5.7 mg/L

Additional information

The short term toxicity of the test item to fish was determined following the methods in the OECD 203 guidelines. The test system was a semi-static daily renewal system. The concentration of the test solution was verified analytically at 0 and 72 hours for the fresh media and 24 and 96 hours for the old media. The study found the 96 h LC50 of the test item to O. mykis to be 5.7 mg/L.