4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline)

Toxicity to soil macroorganisms except arthropods

Link to relevant study record(s)

Reference

Endpoint:

toxicity to soil macroorganisms except arthropods: short-term

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 Nov 2016 - 18 April 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Also in accordance with GLP principles.

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

yes

Details on preparation and application of test substrate:

- Method of mixing into soil (if used): A defined amount of test substance was dissolved in solvent to give the test substance/solvent stock solution. An aliquot of this solution was then separately added to a certain amount of silica sand and the solvent allowed to evaporate off prior to incorporation into formulated artificial soil with deionised reverse osmosis water. These were mixed by a mixer to give the test concentration of 1000 mg/kg. The nominal moisture content was adjusted with deionized water to 40-60% by mass of the total water-holding capacity. The test medium preparation process of the blank control group was the same, but without the solvent and the test substance. The test medium preparation process of the solvent control group was the same, but without the test substance.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Acetone
- Evaporation of vehicle before use: yes

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Earthworm
- Source: Jiang Su province Jurong Stock Farm
- Weight at test initiation (mean and range, SD): 300 - 600 mg

ACCLIMATION
- Acclimation period: 24h
- Acclimation conditions (same as test or not): same as test

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

yes

Total exposure duration:

14 d

Test temperature:

20.1 - 20.3 °C

pH:

6.25 - 6.35 at initiation
6.24 - 6.33 at termination

Moisture:

25.14 - 26.38 % at initiation
24.37 - 26.10 % at the termination

Details on test conditions:

TEST SYSTEM
- Test container (material, size): 1L breathable glas bottle with cover
- Amount of soil or substrate: 750g wet weight
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
- No. of replicates per vehicle control: 4

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Artificial soil

OTHER TEST CONDITIONS
- Photoperiod: continuous illumination
- Light intensity: 592 - 622 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality on Days 7 and 14, average body weight in surviving earthworms

VEHICLE CONTROL PERFORMED: yes

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Since no effects were recorded in the Range-finder, only one limit concentration was tested.
- Range finding study
- Test concentrations: 0, 10, 100, 1000 mg/kg + solvent control
- Results used to determine the conditions for the definitive study: No mortality in any condition. Therefore, a limit test was run at 1000 mg/kg only.

Reference substance (positive control):

yes

Remarks:

Chloroacetamide routinely tested once a year (last test Oct 2016)

Duration:

14 d

Dose descriptor:

EC50

Effect conc.:

> 1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

NOEC

Effect conc.:

1 000 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality

Remarks on result:

other: Highest dose tested

Details on results:

No mortality was recorded in the controls or in the treatment at days 7 and 14.

The average body weight decreased over the 14-day exposure in each group due to the fact that earthworms were not fed during the test. The weight decreases were similar in the different groups (blank control: 12.25%, solvent control: 11.64%, treatment: 11.57%).

Results with reference substance (positive control):

Five concentrations tested: 3.75, 7.50, 15, 30 and 60 mg/kg dry soil weight
14-day LC50 21.4 mg/kg dry soil weight.

Historical range (2009-2015): 3.1 - 30.3 mg/kg

Validity criteria fulfilled:

yes

Conclusions:

The 7- and 14-day LC50s for the test substance were > 1000 mg/kg dry soil weight.

Executive summary:

Following the OECD TG 207 and GLP principles, the acute toxicity of the test substance to Eisenia fetida was determined in a 14 -day test in artifical soil.

Based on the results of a range-finding test, it was decided to perform a limit test with one blank control group, one solvent control group and one treatement group which had each four repiclates of 10 worms. The nominal concentration of the treatment group was 1000 mg/kg dry artifical soil weight. The number of dead earthworms were determined after 7 and 14 days exposure.

The mortality of the earthworms in both the blank control group and the solvent control group was 0% (< 10%, test valid). Similarly, 0% mortality was observed in the treatment group exposed to 1000 mg/kg dry soil weight.

Under the tested condtions, the 7- and 14 -day LC50s for the test substance were > 1000 mg/kg dry soil weight.

Description of key information

OECD 207 study with Eisenia fetida showed that the EC50 / NOEC was > 1000 mg/kg soil dw.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

1 000 mg/kg soil dw

Additional information

Following the OECD TG 207 and GLP principles, the acute toxicity of the test substance to Eisenia fetida was determined in a 14 -day test in artificial soil.

Based on the results of a range-finding test, it was decided to perform a limit test with one blank control group, one solvent control group and one treatment group which had each four replicates of 10 worms. The nominal concentration of the treatment group was 1000 mg/kg dry artificial soil weight. The number of dead earthworms were determined after 7 and 14 days exposure.

The mortality of the earthworms in both the blank control group and the solvent control group was 0% (< 10%, test valid). Similarly, 0% mortality was observed in the treatment group exposed to 1000 mg/kg dry soil weight.

Under the tested conditions, the 7- and 14 -day LC50s for the test substance were > 1000 mg/kg dry soil weight.