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Diss Factsheets

Ecotoxicological information

Toxicity to soil macroorganisms except arthropods

Administrative data

Endpoint:
toxicity to soil macroorganisms except arthropods: long-term
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2014-05-21 to 2014-07-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, no deficiencies

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
Deviations:
yes
Principles of method if other than guideline:
Food was provided on day 0 (test start) instead of day 1 due to good experience with this procedure. At test start and on day 28 the earthworms were washed with dechlorinated tap water instead of demineralised water. The soil moisture deviated by more than 10 % from the initial value in the control and all test item concentrations.
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
940-373-5
EC Number:
940-373-5
IUPAC Name:
940-373-5
Test material form:
other: waxy solid
Details on test material:
- Name of test material (as cited in study report): C18/C18 unsatd.-Glucamide
- Physical state: Yellowish waxy solid
- Analytical purity: 100 %
- Sum formula: C25H49NO6 (C18 unsatd.-Glucamide) and C25H51NO6 (C18 satd.-Glucamide)
- Molecular weight:
C18 unsatd.-Glucamide: 459.67 g/Mol
C18 satd.-Glucamide 461.68 g/Mol
- Storage condition of test material: Room temperature, protected from light, in original container.

Sampling and analysis

Analytical monitoring:
no

Test substrate

Vehicle:
no
Details on preparation and application of test substrate:
- Method of mixing into soil
The respective test item amount was weighed out for each test item concentration, demineralised water was added and stirred at 50 °C for one hour.
The spiking solutions and additional demineralised water were added to the artificial soil to adjust the humidity of the artificial soil to a moisture of 52 % of the maximum water holding capacity. Subsequently, the test medium was thoroughly mixed to ensure a homogenous distribution and about 600 g soil dry weight were filled into test vessels.

- Controls: Artificial soil moistened with demineralised water without test or reference item was used as control medium.
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): None
- Concentration of vehicle in test medium (stock solution and final test solution): None

Test organisms

Test organisms (species):
Eisenia fetida
Animal group:
annelids
Details on test organisms:
TEST ORGANISM
- Common name: Eisenia fetida, subspecies Eisenia fetida fetida
- Source: Own breeding
- Age at test initiation (mean and range, SD): synchronized earthworm culture, not deviating more than 1 month
- Weight at test initiation (mean and range, SD): 0.44


ACCLIMATION
- Acclimation period: 2 days prior to test start
- Acclimation conditions (same as test or not): same as test
- Health during acclimation (any mortality observed): healthy

Study design

Study type:
laboratory study
Substrate type:
artificial soil
Limit test:
no
Total exposure duration:
56 d
Remarks:
Removement of adults after 28 days

Test conditions

Test temperature:
18 – 22
pH:
Application rate
[mg test item/
kg soil
dry weight] pH-value
day 0 day 56
Control 6.59 6.42
62.5 6.58 6.45
125 6.64 6.45
250 6.54 6.52
500 6.46 6.55
1000 6.53 6.46
Moisture:
Application rate
[mg / kg soil
dry weight] Soil moisture [%]
day 0 day 56
Control 26.5 33.1*
62.5 26.8 32.1*
125 27.1 31.8*
250 26.7 32.0*
500 25.6 31.0*
1000 24.8 31.6*

Details on test conditions:
TEST SYSTEM
- Test container (material, size): round plastic boxes, ID: 15 cm, bottom surface area: 177 cm3, height: 14 cm, transparent and perforated lids enabled sufficient gas exchange and light penetration and prevented the test substrate from drying
- Amount of soil or substrate: 600 g DW
- No. of organisms per container (treatment): 10 (40)
- No. of replicates per treatment group: 4
- No. of replicates per control: 8



SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): 10 % peat, 20 % kaolin, 69 % air dried quartz sand, 0.40 % calcium carbonate
- Organic carbon (%): not determined
- Maximum water holding capacity (in % dry weigth): 53.3
- CEC: not determined
- Pretreatment of soil: none
- Storage (condition, duration): 8 days after preparation at test conditions in the dark



OTHER TEST CONDITIONS
- Photoperiod: 16 h light - 8 h dark
- Light intensity: 469 +/- 74 lx

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Adult mortality, biomass, behaviour and pathological symptoms after 28 days
Reproduction (Number of juveniles) after 56 days

VEHICLE CONTROL PERFORMED: No


Nominal and measured concentrations:
Nominal application rate: 62.5 – 125 – 250 – 500 – 1000 mg test item/kg soil dry weight
Reference substance (positive control):
yes
Remarks:
0.5 - 1 - 2 - 4 mg Carbendazim/ kg soil DW

Results and discussion

Effect concentrationsopen allclose all
Duration:
56 d
Dose descriptor:
NOEC
Effect conc.:
1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks:
mortality, body weight
Duration:
56 d
Dose descriptor:
LOEC
Effect conc.:
> 1 000 mg/kg soil dw
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks:
mortality, body weight
Details on results:
- Mortality at end of exposure period:
No mortality of adult earthworms was observed in the control as well as at all treatment rates after 28 days of exposure to the test item
- Changes in body weigth of live adults (% of initial weight) at end of exposure period:
At test start the earthworms had an individual weight of 0.32 - 0.55 g lying in the recommended range. The biomass of the adult earthworms increased throughout the first 28 days in all application rates with no statistically significant differences (ANOVA, α = 0.05) compared to the control.
- No. of offspring produced:
The mean number of juveniles in the control was 176. The average number of juveniles in the treated groups ranged between 138 and 166. Compared to the control the reproduction of the earthworms was not statistical significantly reduced at all treatment rates. The EC50 – value was not determined since no significant reduction of reproduction occurred. The coefficient of variation calculated for the reproduction of the control was 16.7 % and thus lower than 30 %.
- Behavioural abnormalities:
No pathological symptoms nor changes in the behaviour of the earthworms were observed in the control or in any of the application rates.
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- Relevant effect levels: 4 mg Carbendazim/kg soil DW
Reported statistics and error estimates:
One Way Analysis of Variance (ANOVA) was carried out for the determination of statistically significant differences compared to the control. A Normality Test and an Equal Variance Test were conducted prior to running the ANOVA. P-values for both Normality and Equal Variance Test are 0.05. The -value for ANOVA test (acceptable probability of incorrectly concluding that there is a difference) is  = 0.05. For the endpoint of reproduction the arithmetic mean and the variance (coefficient of variation) per treatment and control were calculated. EC50-value for reproduction was not calculated as no significant effects were observed.

Any other information on results incl. tables

Mortality of Adult Earthworms in [%] after 28 Days of Exposure

Application rate

Replicate

[mg test item/kg soil dry weight]

1

2

3

4

5

6

7

8

Mean

Control

0

0

0

0

0

0

0

0

0

62.5

0

0

0

0

0

0

0

0

0

125

0

0

0

0

0

0

0

0

0

250

0

0

0

0

0

0

0

0

0

500

0

0

0

0

0

0

0

0

0

1000

0

0

0

0

0

0

0

0

0

Earthworm Behaviour and Pathological Symptoms after 28 Days of Exposure

Application rate

Replicate

[mg test item/kg soil dry weight]

Observation parameter

1

2

3

4

5

6

7

8

Control

A

10/10

10/10

10/10

10/10

10/10

10/10

10/10

10/10

62.5

A

10/10

10/10

10/10

10/10

125

A

10/10

10/10

10/10

10/10

250

A

10/10

10/10

10/10

10/10

500

A

10/10

10/10

10/10

10/10

1000

A

10/10

10/10

10/10

10/10

Body Weight Changes of the Adult Earthworms

Application rates

[mg test item/kg soil dry weight]

Replicate

Mean body weights per replicate

Mean body weight change of earthworms

Test start

28 days

Per replicate

Mean ± SD

Sig.

[g]

[g]

[g]

[%]

[g]

[%]

Control

1

0.44

0.56

0.12

27.3

0.15 ± 0.03

34.4 ± 6.93

2

0.42

0.52

0.10

23.8

3

0.43

0.59

0.16

37.2

4

0.42

0.54

0.12

28.6

5

0.42

0.59

0.17

40.5

6

0.42

0.57

0.15

35.7

7

0.41

0.57

0.16

39.0

8

0.42

0.60

0.18

42.9

62.5

1

0.42

0.57

0.15

35.7

0.15 ± 0.01

35.3 ± 2.27

No

2

0.42

0.58

0.16

38.1

3

0.43

0.58

0.15

34.9

4

0.43

0.57

0.14

32.6

125

1

0.42

0.59

0.17

40.5

0.17 ± 0.01

39.8 ± 2.17

No

2

0.42

0.59

0.17

40.5

3

0.41

0.58

0.17

41.5

4

0.41

0.56

0.15

36.6

250

1

0.41

0.57

0.16

39.0

0.16 ± 0.02

38.4 ± 6.17

No

2

0.42

0.61

0.19

45.2

3

0.43

0.56

0.13

30.2

4

0.41

0.57

0.16

39.0

500

1

0.41

0.59

0.18

43.9

0.18 ± 0.01

44.0 ± 3.49

No

2

0.42

0.60

0.18

42.9

3

0.42

0.59

0.17

40.5

4

0.41

0.61

0.20

48.8

1000

1

0.42

0.55

0.13

31.0

0.18 ± 0.03

41.9 ± 7.44

No

2

0.41

0.59

0.18

43.9

3

0.42

0.61

0.19

45.2

4

0.42

0.62

0.20

47.6

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
Under the conditions of this study, C18/C18 unsatd.-Glucamide did not induce mortality, pathological symptoms or changes of the behaviour of adult earthworms after 28 days of exposure in all tested concentrations. The adult earthworm biomass increased in the control and in all application rates without any statistically significant differences. After 56 days of exposure the earthworm reproduction was not statistically significantly reduced in all test item concentrations.

Thus, the No Observed Effect Concentration (NOEC) for C18/C18 unsatd.-Glucamide summarizing the endpoints mortality and body weight and reproduction of Eisenia fetida fetida after 56 days of exposure in artificial soil was determined to be 1000 mg test item/kg soil dry weight.
Executive summary:

Effects of C18/C18 unsatd.-Glucamide (Batch no. SN119/13/3-8) on mortality, biomass and the reproductive potential of the earthworm species Eisenia fetida (Annelida, Lumbricidae) were determined according to the Guideline OECD 222 (2004) fromMay 21st to July 17th, 2014 with the definitive exposure phase from May 21st to July 15th/16th, 2014 at Dr.U.Noack-Laboratorien in 31157 Sarstedt, Germany. The study was conducted under static conditions over 56 days with the test item concentrations 62.5 – 125 – 250 – 500 – 1000 mg test item/kg soil dry weight, which were mixed into artificial soil containing 10 % peat and a control using untreated artificial soil. 80 test organisms were inserted into 8 control replicates and 40 test organisms were divided into 4 replicates for each treatment (10 earthworms per replicate). They had an individual body weight between 0.32 and 0.55 g at experimental starting.

 

After 28 days of exposure in soil, no earthworm mortalities as well as no pathological symptoms or changes in the behaviour of adult earthworms were observed in all treatments. Moreover, no statistically significant differences in earthworm body weights were observed at all test item concentrations compared to the control. After further four weeks the reproduction rate (average number of juveniles produced) was 176 in the control and ranged between 137 and 166 in the test item treatment rates. Compared to the control, no statistically significant reduction of reproduction was observed in all test item concentrations. Overall, the NOEC of the test item concerning mortality, biomass and reproduction of earthworms was determined to be 1000 mg test item/kg soil dry weight. The EC50- value for reproduction was not determined since no significant reduction of reproduction occured.

 

All validity criteria recommended by the test guidelines were fulfilled.


Summary of All Observed Effects in the Tested Application Rates

Effects

C18/C18 unsatd.-Glucamide

[mg test item/kg soil dry weight]

62.5

125

250

500

1000

Mortality1of adult earthworms          

No

No

No

No

No

Reduction of Body weight1                   

No

No

No

No

No

Reduced reproduction rate2

 (Number of juveniles)

No

No

No

No

No

Summary of all effects

No

No

No

No

No

NOEC and LOEC values

Endpoint

[mg test item/kg soil dry weight]

NOECmortality1,biomass1,reproduction2

1000

LOECmortality1,biomass1,reproduction2

>1000

1): after 28 days

2): after 56 days