4-bromo-α,α,α-trifluoro-m-toluidine

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

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:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 201 (Alga, Growth Inhibition Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-bromo-α,α,α-trifluoro-m-toluidine

EC Number:

206-885-1

EC Name:

4-bromo-α,α,α-trifluoro-m-toluidine

Cas Number:

393-36-2

Molecular formula:

C7H5BrF3N

IUPAC Name:

4-bromo-α,α,α-trifluoro-m-toluidine

Test material form:

solid: crystalline

Specific details on test material used for the study:

Test item: 4-Bromo-3-(trifluoromethyl)anilineCAS number: 393-36-2EC number: 206-885-1Molecular formula: C7H5BrF3NMolecular weight: 240.02 g/molManufacturer: Fuxin Jintelai FluorineBatch number 0002DC5 (D150702BC15001)Physical state: Solid, crystalline substanceColour: Light-brownOdour: CharacteristicStorage: in a cool, dry place

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

yes

Details on test solutions:

The preparation of stock and test solutions was based on the preliminary non GLP range finding test.For the stock solution 48.02 mg of test item was measured into 1 000 ml OECD medium. The suspension were stirred and ultrasonicated till complete dilution of test item. The stock solution was clear and colourless. The concentration of stock solutions was determined by validated HPLC method. The measured concentration was 48.555 mg/L.Seven test solutions of different concentration were prepared by mixing appropriate volume of OECD medium and stock solution of the test item. These concentrations were arranged in a geometric series with a maximum separation factor 2.0.

Test organisms

Test organisms (species):

Pseudokirchneriella subcapitata (previous names: Raphidocelis subcapitata, Selenastrum capricornutum)

Details on test organisms:

Test species: Pseudokirchneriella subcapitata(Korshikov) F.Hindák (formerly known as Selenastrum capricornutum)Source: UTEX The Culture Collcetion of Algae (USA)

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

72 h

Test conditions

Test temperature:

The temperature inside the incubator at the test vessels was measured and registered continuously by Extech SD200 thermometer and datalogger. Throughoutthe test the temperature was nearly constant.

pH:

At the beginning of the test the pH values were measured in the remaining test solution of the concurrent test vessels at each dilution level.At the end of the test the pH values were measured in each test vessel.The pH of test solutions was not adjusted at the beginning of the test.

Nominal and measured concentrations:

In the test the following nominal concentrations were applied: 48; 24; 12; 6.4; 3.2; 1.6 and 0.8 mg/L. The following concentrations were calculated from the measured values in the test: 42.893; 20.922; 10.163; 5.267; 2.842; 1.447 and 0.744 mg test item/L.

Details on test conditions:

Three replicates were prepared at every test, two at the abiotic control and six at the control level. The vessels contained 75 ml test media. The test vessels were closed with silicone stopper and kept in incubator. For the proper mass transfer of carbon dioxide glass tubes with filter were placed trough silicone stoppers. The test was maintained under static conditions for a period of 72 hours. The temperature during the test remained in the 21 ± 2 °C range.The vessels were shaken and illuminated continuously in the incubator. The vessels were placed randomly into the incubator and were repositioned daily after sampling. One of the vessels of abiotic controls was taken into the incubator with a completealuminium foil cover to check the stability of test item in the absence of light.

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

EC10

Effect conc.:

2.511 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 2

Duration:

72 h

Dose descriptor:

EC20

Effect conc.:

2.696 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

growth rate

Effect concentrations 3

Key result

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

3.088 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

growth rate

Details on results:

The ECx for specific growth rate and yield were determined by ToxRat® statistic software.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

According to the Council Regulation (EC) 440/2008 4-bromo-3-(trifluoromethyl)aniline is hazardous to the aquatic environment and classified into the second acute toxic hazardous category [GHS Acute aquatic hazard Category Acute II. – 72 hr EC50 (for algae or other aquatic plants) > 1 mg/L but ≤ 10 mg/L].