Propanamide, N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)thio]-2-hydroxy-2-methyl-

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

bis(N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfanyl]-2-hydroxy-2-methylpropanamide)

EC Number:

618-533-8

Cas Number:

90356-78-8

Molecular formula:

C18H14F4N2O2S

IUPAC Name:

bis(N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfanyl]-2-hydroxy-2-methylpropanamide)

Test material form:

solid: crystalline

Details on test material:

Test item: B-SulphenylCAS number: 90356-78-8Batch number: 235100NPhysical state: Solid, crystalline substanceColour: Creamy whiteActive ingredient content: ca. 99%Storage: At a temperature of 15 to 30 °C, protected from light and moisture

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

yes

Details on test solutions:

Preparation of stock solution: The preparation of stock and test solutions was based on the preliminary non GLP range finding test. The stock solution was prepared by measuring 50.23 mg of test item into 1 000 ml Elendt M4 growth medium. The suspension was stirred for 24 hours in dark. After stirring the suspension was filtered through a 0.2 μm WhatmanTM ME24 (Mixed cellulose ester) filter. The first 100 ml filtrate was disposed. The concentration of the test item in the filtrate (stock solution) was determined by UHPLC. The measured value was 5.08 mg/L.Preparation of test solutions:Seven dilution levels were prepared by mixing appropriate volume of Elendt M4 medium and stock solution of the test item. The maximum separation factor between of test vessels was 2.0.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

Test species: Daphnia magna Straus;< 24 hours neonates;Origin: National Institute of Environmental Health;Culture conditions: The test species is maintained in Elendt M4 medium with culture conditions at 21±1 °C and a light/dark cycle of 16/8 hours with light intensities of less than 1000 Lux. The cultures are fed with centrifugalized green alga (Pseudokirchneriella subcapitata) cells daily at weekdays.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

The temperature of thermostat was recorded daily and registered continuously by Extech datalogger. The temperature inside the thermostat at the test vessels was measured and registered continuously by Extech SD200 thermometer and datalogger.

pH:

The pH was measured at the beginning and at the end of the test. At the beginning of the test the concentration of test item was measured from the remaining test solutions of the concurrent test vessels at each dilution levels. At the end of the test the concentration of test item was measured from pooled replicates.

Dissolved oxygen:

The dissolved oxygen was measured at the beginning and at the end of the test. At the beginning of the test thedissolved oxygen was measured from the remaining test solutions of the concurrent test vessels at each dilution levels. At the end of the test the dissolved oxygen was measured in each test vessel.

Nominal and measured concentrations:

In the test the following nominal concentrations were applied: 0.42; 0.85; 1.27; 1.69; 2.54; 3.39 and 5.08 mg/L. The following actual concentrations were calculated from the measured values in the test: 0.24; 0.59; 1.10; 1.45; 2.40; 3.37 and 4.84 mg test item/L.

Details on test conditions:

The test was maintained under static conditions for a period of 48 hours. At the start of the study each test vessels contained 50 ml of test solutions and five young daphnids. In the test four replicates total of 20 animals at each test concentration level were investigated. The test vessels were covered with plastic lids and were kept in thermostat at 21 ± 1 °C with a 16/8 hours light/dark cycle. Each control vessels containing five young daphnids in Elendt M4 medium were prepared in four replicates and kept under the same static conditions. The number of immobilised and abnormally behaved daphnids was recorded after 24 and 48h. A daphnia is considered to be immobile if it is not able to swim within 15 seconds after a gentle agitation of the test vessel. The daphnids were not fed during the test.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC10

Effect conc.:

1.77 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

2.5 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In this Daphnia sp., Acute Immobilisation Test for B-sulphenyl the results indicated that the test item is hazardous to the aquatic environment and classified into the second acute toxic hazardous category [GHS Acute aquatic hazard Category Acute II. – 48 hr EC50 (for Crustacea) > 1 mg/L but ≤ 10 mg/L].