Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides

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:

Jan 12, 1993 - Feb 19, 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 207 (Earthworm, Acute Toxicity Tests)

Deviations:

yes

Remarks:

(one control worm at 616 mg greater than recommended 600 mg weight at test initiation. This is not expected to have an effect on results)

GLP compliance:

yes

Specific details on test material used for the study:

- Substance type: quaternized ammonium compound
- Storage condition of test material: room temperature in the dark
- Other: Test material was supplied to the laboratory as a 4.74% active aqueous dispersion of E4429.01.
- Physical state: solid (E4429.01)

Analytical monitoring:

not required

Vehicle:

no

Details on preparation and application of test substrate:

- Method of mixing into soil (if used): mechanical mixer

Test organisms (species):

Eisenia fetida

Animal group:

annelids

Details on test organisms:

TEST ORGANISM
- Common name: Earthworm
- Source: NIAC-proefdierbedrijf, Millseweg 1, Beer (N-B), Netherlands
- Age at test initiation (mean and range, SD): adults
- Weight at test initiation (range):
Control 0.317-0.616 g
2.20 mg a.i./kg - 0.321-0.569 g
4.74 mg a.i./kg - 0.305-0.599 g
10.2 mg a.i./kg - 0.311-0.548 g
22.0 mg a.i./kg - 0.314-0.484 g
47.4 mg a.i./kg - 0.305-0.548g

Study type:

laboratory study

Substrate type:

artificial soil

Limit test:

no

Total exposure duration:

14 d

Post exposure observation period:

Not applicable

Test temperature:

20 +/- 1 C

pH:

Control - test initiation: 6.0; test termination: 6.3
47.4 mg active ingr./kg - test initiation: 6.0; test termination: 6.5

Moisture:

Control - test initiation: 53.7%; test termination: 51.6%

Details on test conditions:

TEST SYSTEM
- Test container (material, size): glass, 1 L
- Amount of soil or substrate: 750 g (wet weight) test medium
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 4

SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): sphagnum peat (no visible plant materials):kaolin clay:sand at 1:2:7 based on dry weight. The components were mixed with distilled water and calcium carbonate to bring the pH to 6.0 +/- 0.5.

OTHER TEST CONDITIONS
- Photoperiod: continuous
- Light intensity: 10-11 µmol s-2 m-2

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality, appearance and behavior at 7 and 14 days

VEHICLE CONTROL PERFORMED: no vehicle used

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Range finding study
- Test concentrations: 0, 10, 100, 1000 mg dispersion/kg dry soil or 0, 0.47, 4.74, 47.4 mg a.i./kg dry soil
- Results used to determine the conditions for the definitive study: Mortality NOEC at 14 days was >47.4 mg a.i./kg dry soil. Appearance and behavior NOEC at 14 days was 4.74 mg a.i./kg dry soil. Weight NOEC at 14 days was 4.74 mg a.i./kg dry soil.

Nominal and measured concentrations:

Nominal based on dispersion supplied as test substance: 0, 46.4, 100, 215, 464, 1000 mg dispersion/kg dry soil
Nominal based on 4.74% a.i. in dispersion: 0, 2.20, 4.74, 10.2, 22.0, 47.4 mg a.i./kg dry soil

Reference substance (positive control):

no

Duration:

14 d

Dose descriptor:

LC0

Effect conc.:

> 47.4 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

LC50

Effect conc.:

> 47.4 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

14 d

Dose descriptor:

LC100

Effect conc.:

> 47.4 mg/kg soil dw

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality

Details on results:

- Mortality at end of exposure period: no mortality in all concentrations at 14 days
- Changes in body weight of live adults (% of initial weight) at end of exposure period:
Control - loss of 8.0%
2.20 mg a.i./kg - loss of 6.0%
4.74 mg a.i./kg - loss of 4.6%
10.2 mg a.i./kg - loss of 3.1%
22.0 mg a.i./kg - loss of 4.0%
47.4 mg a.i./kg - loss of 5.6%
- Other biological observations: At 14 days, earthworms in 47.4 mg a.i./kg were slower than control worms.

In a 14-day acute toxicity study, earthworms (Eisenia fetida)were exposed to MDEA-Esterquat at 0, 2.20, 4.74, 10.2, 22.0, 47.4 mg a.i./kg dry soil (artifical soil). The experiment was carried out according to OECD TG 207. The 14 day LC50 value was determined to be >47.4 mg a.i./kg soil dry weight (nominal). The 14 d EC50 was >47.4 mg a.i./kg dry soil. The 14 d NOEC and LOEC, based on appearance and behaviour was >47.4 mg a.i./kg dry soil. No compound related toxicity effects were noted.

Validity criteria fulfilled:

yes

Remarks:

(control mortality <10% at the end of the test)

Conclusions:

In a 14-day acute toxicity study, earthworms (Eisenia fetida) were exposed to MDEA-Esterquat C16-18 and C18 unsatd. at 0, 2.20, 4.74, 10.2, 22.0, 47.4 mg a.i./kg dry soil (artifical soil). The experiment was carried out according to OECD TG 207. The 14 day LC50 value was determined to be >47.4 mg a.i./kg soil dry weight (nominal). The 14 d EC50 was >47.4 mg a.i./kg dry soil. The 14 d NOEC and LOEC, based on appearance and behaviour was >47.4 mg a.i./kg dry soil. No compound related toxicity effects were noted.

Executive summary:

In a 14-day acute toxicity study, earthworms (Eisenia fetida) were exposed to MDEA-Esterquat C16-18 and C18 unsatd.  at 0, 2.20, 4.74, 10.2, 22.0, 47.4 mg a.i./kg dry soil (artifical soil). The experiment was carried out according to OECD TG 207. The 14 day LC50 value was determined to be >47.4 mg a.i./kg soil dry weight (nominal). The 14 d EC50 was >47.4 mg a.i./kg dry soil. The 14 d NOEC and LOEC, based on appearance and behaviour was >47.4 mg a.i./kg dry soil. No compound related toxicity effects were noted.

This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with earthworms.

Description of key information

Eisenia fetida
14 d LC50>47.4 mg a.i./kg dry soil 
14 d EC50>47.4 mg a.i./kg dry soil
14d-NOEC and LOEC, based on appearance and behavior: > 47.4 mg act. ingr./kg dry soil (nominal each)

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:

47.4 mg/kg soil dw

Additional information

In a 14-day acute toxicity study, earthworms (Eisenia fetida) were exposed to MDEA-Esterquat C16-18 and C18 unsatd. at 0, 2.20, 4.74, 10.2, 22.0, 47.4 mg a.i./kg dry soil (artifical soil). The experiment was carried out according to OECD TG 207. The 14 day LC50 value was determined to be >47.4 mg a.i./kg soil dry weight (nominal). The 14 d EC50 was >47.4 mg a.i./kg dry soil. The 14 d NOEC and LOEC, based on appearance and behaviour was >47.4 mg a.i./kg dry soil. No compound related toxicity effects were noted.

According to REACH regulation (Annex X 9.4.4 column II), short- and long-term toxicity testing with soil macroorganisms except arthropods does not need to be conducted.Testing shall be proposed if the results of the safety assessment indicates the need. The direct and indirect exposure of soil compartments is unlikely as the substance is readily biodegradable. The biodegradability of the substance is proved in a number of tests conducted under different conditions (aerobic, anaerobic) and in different environmental conditions (water, soil).