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Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

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Reference
Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-03-12 to 2010-03-29
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, according to the OECD 207 technical guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
Version / remarks:
and ISO 11268-1 (1997)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Details on sampling:
No analytical monitoring
Vehicle:
yes
Details on preparation and application of test substrate:
- Method of mixing into soil (if used):
The test item amount (i.e. 2400 mg) for the limit concentration was weighed out and mixed thoroughly with quartz sand (10 g per replicate). The treated quartz sand was given to the artificial soil. Demineralised water (439 g) was added to adjust the humidity of the artificial soil to a moisture of 54 % of the maximum water holding capacity.
Subsequently, the test medium was thoroughly mixed to ensure a homogenous distribution and about 555 g soil dry weight were filled to each test vessel.
- Controls: Artificial soil with the addition of quartz sand and moistened with demineralised water without test item was used as control medium.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Quartz sand
- Concentration of vehicle in test medium (stock solution and final test solution): 10 g per replicates
- Evaporation of vehicle before use: Not necessary
Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Earthworm Eisenia fetida Savigny 1826
- Source: Own breeding
- Weight at test initiation (mean and range, SD): 0.47 +/- 0.09


ACCLIMATION
- Acclimation period: 2 days
- Acclimation conditions (same as test or not): same as test
- Health during acclimation (any mortality observed): No mortality observed
Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
yes
Total exposure duration:
14 d
Post exposure observation period:
No
Test temperature:
18 - 22 °C
pH:
Nominal test item
concentration
[mg/kg soil dry weight]
pH-value

day 0 day 14
Control 5.93 6.51
1000 6.17 6.49
Moisture:
Nominal test item
concentration
[mg/kg soil dry weight] Moisture [%] of dry weight
day 0 day 14
Control 34.6 33.0
1000 33.9 32.7
Details on test conditions:
TEST SYSTEM
- Test container (material, size): Glass dishes, volume 1.5 L, covered with perforated plastic film
- Amount of soil or substrate: 555 g (dry weight)
- No. of organisms per container (treatment): 10 per replicate
- No. of replicates per treatment group: 4
- No. of replicates per control: 4



SOURCE AND PROPERTIES OF SUBSTRATE (if soil)

- Composition (if artificial substrate):
- Organic carbon (%): 10 % peat
- Maximum water holding capacity (in % dry weigth): 64
- Storage (condition, duration): under test conditions for 9 days



OTHER TEST CONDITIONS
- Photoperiod: 24 h
- Light intensity: 564 +/- 78 lx


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

The live weight of the earthworms was measured individually at the day of application (day 0) and at day 14.
Mortality, behaviour and morphological changes of the earthworms were recorded 7 and 14 days after application.


VEHICLE CONTROL PERFORMED: no


TEST CONCENTRATIONS
- Spacing factor for test concentrations: none
- Range finding study
Range Finding Test (14 d): Mortality and Change of Live Weight [%]
Concentration Mortality Change of Live weight
[mg test item/kg soil dry weight] [%] [%]
Control 0 2
10 0 0
100 0 4
1000 0 2
Nominal and measured concentrations:
Nominal: 1000 mg/kg soil DW
Reference substance (positive control):
yes
Remarks:
2-Chloroacetamide
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:
loss of body weight, other symptoms
Details on results:
- Mortality at end of exposure period: No mortality was seen at the test item concentration 1000 mg/kg soil DW after 14 days of exposure
- Changes in body weigth of live adults (% of initial weight) at end of exposure period:
During the test the biomass loss of the earthworms was below 20 % in the controls. After 14 days of exposure the earthworm biomass was not statistically significant different at the limit test item concentration of 1000 mg/kg soil dry weight compared to the control

- Behavioural abnormalities: No earthworm showed any symptoms or behavioural changes in the control as well as in the limit test item concentration of 1000 mg/kg soil dry weight
- Other biological observations: None
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Relevant effect levels:
NOEC and LC-Values after 14 d for 2-Chloroacetamide
LC-Values /
NOEC Concentration[mg/kg soil dry weight] 95% -Confidence Interval
[mg/kg soil dry weight]
LC50 47.5 42.7 - 52.8
NOEC 20.0 –

Reported statistics and error estimates:
A t-test was carried out for the determination of statistically significant differences compared to the control. A Normality Test and an Equal Equal Variance Test were conducted prior to the
t-test. P-values for both Normality and Equal Variance Test are 0.05. The -value (acceptable probability of incorrectly concluding that there is no difference) is =0.05.

Earthworm Mortality in [%] after 7 and 14 Days of Exposure

                                          Mortality [%]

Nominal

test item

concentration

Day 7

Day 14

[mg/kg soil dry weight]

1

2

3

4

MV

1

2

3

4

MV

Control

0

0

0

0

0

0

0

0

0

0

1000

0

0

0

0

0

0

0

0

0

0

Earthworm Behaviour and Pathological Symptoms after 7 and 14 Days of Exposure

Nominal

test item

concentration      

Effect

Day 7                               

Replicate

Day 14                   

Replicate

[mg/kg soil dry weight]

1

2

3

4

1

2

3

4

Control

a)

10/10

10/10

10/10

10/10

10/10

10/10

10/10

10/10

       1000

a)

10/10

10/10

10/10

10/10

10/10

10/10

10/10

10/10

Mean Biomass and Mean Loss of Body Weight

Mean live weight

Comparison versus Control

Nominal

test item

concentration

Test start

MV ± SD

Test end

MV ± SD

Test end

CV

Loss

Significance

[mg/kg soil dry weight]

[g/worm]

[g/worm]

[%]

[%]

Control

0.473 ± 0.09

0.446 ± 0.09

20.2

6

1000

0.473 ± 0.09

0.449 ± 0.09

22.3

5

No

Validity criteria fulfilled:
yes
Conclusions:
No mortality as well as no pathological symptoms or changes in the earthworm behaviour were observed at the limit test item concentration of 1000 mg/kg soil dry weight after 14 days of exposure to Flue Dust T. Compared to the control the biomass of earthworms exposed to Flue Dust T at the limit test item concentration of 1000 mg/kg soil dry weight was not statistically significantly reduced at test end.
Consequently, the No Observed Effect Concentration (NOEC) of Flue Dust T with respect to mortality, loss of body weight and other symptoms was determined to be at 1000 mg/kg soil dry weight.
Executive summary:

The acute effects of Flue Dust T(Batch: 12-2009) on the earthworm Eisenia fetidawere determined according to the OECD Guideline 207 and DIN ISO 11268-1 at Dr.U.Noack-Laboratorien in 31157 Sarstedt, Germany from March 12th to March 29th, 2010with the definitive exposure phase from March 12th to March 26th, 2010. The study was conducted with a limit test item concentration of 1000 mg/kg soil dry weight for 14 days. Artificial soil without test item was used as control. 40 test organisms with an initial individual weight between 0.3 - 0.6 g, divided into four replicates, were tested at the limit test item concentration and control in artificial soil containing 10 % peat.

No mortality as well as no pathological symptoms or changes in the earthworm behaviour were observed in the control and at the limit test item concentration of 1000 mg/kg soil dry weight after 7 and 14 days of exposure (Table 1). Compared to the control, the biomass of the earthworms at the limit test item concentration was not statistically significantly reduced at test end.

Consequently, the no observed effect concentration (NOEC) with respect to mortality, loss of biomass and other symptoms was determined to be at 1000 mg/kg soil dry weight (Table 1).

All validity criteria of the test guideline were fulfilled.

Summary of all Effects

Effects

Flue Dust T

[mg/kg soil dry weight]

LOEC

Mortality

> 1000

LOEC

Loss of body weight

> 1000

LOEC

Behaviour and pathological symptoms

> 1000

NOEC

Mortality, loss of body weight, other symptoms

1000

Flue Dust T did not induce effects on mortality and biomass of adult earthworms

at the nominal limit test item concentration of 1000 mg/kg soil dry weight.

Description of key information

The substance is not toxic to soil macroorganisms, due to a Klimisch 1 study result. The substance did not induce effects on mortality and biomass of adult earthworms at the nominal limit test item concentration of 1000 mg/kg soll dry weight.

Key value for chemical safety assessment

Short-term EC50 or LC50 for soil macroorganisms:
1 000 mg/kg soil dw

Additional information

The acute effects of Flue Dust T (Batch: 12-2009) an the earthworm Eisenia fetida were determined according to the OECD Guideline 207 and DIN ISO 11268-1. The study was conducted with a limit test item concentration of 1000 mg/kg soil dry weight for 14 days. Artificial soil without test item was used as control. 40 test organisms with an initial individual weight between 0.3 - 0.6 g, divided into four replicates, were tested at the limit test item concentration and control in artificial soil containing 10 % peat. No mortality as well as no pathological symptoms or changes in the earthworm behaviour were observed in the control and at the limit test item concentration of 1000 mg/kg soil dry weight after 7 and 14 days of exposure. Compared to the control, the biomass of the earthworms at the limit test item concentration was not statistically significantly reduced at test end. Consequently, the no observed effect concentration (NOEC) with respect to mortality, loss of biomass and other symptoms was determined to be at 1000 mg/kg soll dry weight.