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EC number: 237-865-0 | CAS number: 14025-21-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to soil macroorganisms except arthropods: short-term
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2018-10-11 to 2018-10-26 with the definitive exposure time from 2018-10-11 to 2018-10-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See Chapter 13 for Read Across Justification - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
- Version / remarks:
- 1984
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and application of test substrate:
- The respective test item amount was weighed out for a stock solution (nominal: 4440 mg/200 mL, actual: 4440.3 mg/200 mL) and dispersed in demineralised water. The stock solution was further diluted to the respective application solutions. The application solution and additional demineralised water were added to the artificial soil to adjust the humidity of the artificial soil to a moisture of 54 % of the WHCmax. Subsequently, the test medium was thoroughly mixed to ensure a homogenous distribution and about 555 g SDW were filled into each test vessel.
- Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: Eisenia fetida (Annelida, Lumbricidae)
- Source: Breeding stock culture maintained at the test facility
- Age at test initiation (mean and range, SD): Adult
- Weight at test initiation (mean and range, SD): 0.47 +/- 0.04 g
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:
- no
- Total exposure duration:
- 14 d
- Test temperature:
- 18 - 22 °C
- pH:
- Test item concentration
[mg/kg SDW]
pH-value
day 0 day 14
Control 6.31 5.75
10 6.37 5.75
31.6 6.29 5.75
100 6.30 5.79
316 6.34 5.81
1000 6.34 5.78 - Moisture:
- Test item concentration
[mg/kg SDW]
Moisture [%] of DW
[g /100 g SDW]
day 0 day 14
Control 24.8 23.5
10 24.8 23.6
31.6 24.3 23.6
100 24.5 23.6
316 25.2 23.7
1000 25.1 24.0
- Details on test conditions:
- TEST SYSTEM
- Test containers Glass vessels (volume 1.5 L, used for preserving) were used. During the test, transparent and perforated lids enabled sufficient gas exchange and light input and prevented drying of the test substrate.
- Amount of soil or substrate: 555 g soil dry weight per replicate
- No. of organisms per container (treatment): 10 per replicate
- No. of replicates per treatment group: 4
- No. of replicates per control: 4
Artificial soil:
- Artificial soil consisted of the following components:
- 10 % Peat, air-dried and finely ground
- 20 % Kaolin, kaolinite content > 30 %
- 69 % Air-dried quartz sand (sand with > 50 % particles size of 0.05 to 0.2 mm)
- 0.40 % calcium carbonate (CaCO3) to adjust the pH to 6.0 ± 0.5
The soil moisture content and the WHCmax were determined prior to experimental starting.
Two days before earthworm insertion into the test vessels the artificial soil (17 kg) was pre-moistened with 1425 g deionised water to achieve a moisture of 27 % of the WHCmax of the artificial soil. The moistened soil was kept covered to prevent evaporative water losses prior to the start of exposure.
OTHER TEST CONDITIONS
- Photoperiod: 24 h
- Light intensity: 536 ± 77.9
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
The live weight of the earthworms was determined individually on the day of application (day 0) and on day 14.
The mean weight change was assessed on day 14 after application.
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: √10
- Justification for using less concentrations than requested by guideline:
- Range finding study
A preliminary range finding test was performed with 3 test item concentrations.
2 replicates without the addition of food with 10 earthworms each.
Range Finding Test (14 days): Mortality and Change of Live Weight
Concentration Mortality of adult earthworms Change of Live weight
[mg test item/kg SDW] [%] [%]
Control 0 -11
10 0 -10
100 0 -18
1000 50 -35 - Nominal and measured concentrations:
- Nominal: 10 – 31.6 – 100 – 316 – 1000 mg/kg soil dry weight
- Reference substance (positive control):
- yes
- Remarks:
- 2-Chloroacetamide
- Duration:
- 14 d
- Dose descriptor:
- LOEC
- 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:
- other: Mortality, behaviour, pathological symptoms
- Duration:
- 14 d
- Dose descriptor:
- LOEC
- Effect conc.:
- 1 000 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Change of body weight
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 316 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Change of body weight
- Duration:
- 14 d
- Dose descriptor:
- EC10
- Effect conc.:
- 430 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth
- Remarks on result:
- other: CI (95%) = 301 - 615 mg/kg soil DW
- Duration:
- 14 d
- Dose descriptor:
- other:
- Remarks:
- EC20
- Effect conc.:
- 634 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Change of body weight
- Remarks on result:
- other: CI (95%) = 441 - 921 mg/kg soil DW
- 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:
- other: Change of body weight
- Remarks on result:
- other: none
- Details on results:
- - Mortality at end of exposure period:
No statistically significant mortality was observed in all test item concentrations after 14 days of exposure. Consequently no LCx values were determined.
- Total mass of adults at beginning of test:
Control: 19.1 g
10 mg/kg soil DW: 19.0 g
31.6 mg/kg soil DW: 18.9 g
100 mg/kg soil DW: 19.0 g
316 mg/kg soil DW: 19.0 g
1000 mg/kg soil DW: 19.0 g
- Changes in body weight of live adults (% of initial weight) at end of exposure period:
In terms of body weight loss, the NOEC was determined to be 316 mg/kg soil dry weight and LOEC was determined to be 1000 mg/kg soil dry weight.
- Morphological abnormalities:
No pathological symptoms or changes in the earthworm behaviour were observed in the control as well as in the test item concentrations 10 to 316 mg/kg soil dry weight after 7 days of exposure. In the test item concentration 316 mg/kg soil dry weight after 14 days and
1000 mg/kg soil dry weight after 7 and 14 days significant pathological symptoms were observed. - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels:
NOEC and LC-Value after 14 d for the Reference Item 2-Chloroacetamide
LC-Value /
NOEC Concentration
[mg reference item/kg SDW] 95 % - Confidence Interval
[mg reference item/kg SDW]
NOEC 30 –
LC50 42.3 n.d.*
*) not determined due to mathematical reasons (3 reference item concentrations) - Reported statistics and error estimates:
- LC values No LCx values were determined since no statistically significant mortality occurred.
EC values The EC10/20/50 values were determined by Analysis of Variance and Test for Lack of Fit for the 3-param. normal CDF.
NOEC, LOEC and statistical analyses
The NOEC/LOEC for mortality was determined using a Multiple
Sequentially-rejective Fisher Test After Bonferroni-Holm for determination of statistically significant differences in mortality compared to the control. When running the test, a Qualitative Trend Analysis by Contrasts and a Tarone’s Test Procedure for signs of extra-binomial variance were done first.
Statistically significant differences in biomass compared to the control were determined using a Williams Multiple Sequential t-test Procedure. When running the test, a Shapiro-Wilk’s Test on Normal Distribution, a Levene’s Test on Variance Homogeneity (with Residuals) and Trend analysis by Contrasts (Monotonicity of Rate/Response) were done first. The alpha-value (acceptable probability of incorrectly concluding that there is a difference) is alpha = 0.05. - Validity criteria fulfilled:
- yes
- Conclusions:
- No statistically significant mortality was observed in all test item concentrations after 14 days of exposure. Therefore, the NOEC was determined to be ≥ 1000 mg/kg soil dry weight and LOEC was determined to be > 1000 mg/kg soil dry weight.
In terms of body weight loss, the NOEC was determined to be 316 mg/kg soil dry weight and LOEC was determined to be 1000 mg/kg soil dry weight. - Executive summary:
The acute effects ofEDTA-ZnK2(Batch:FC-C11530)on the earthwormEisenia fetidawere determined according to the OECD Guideline 207 at the test facility in 31157 Sarstedt, Germany from 2018-10-11 to 2018-10-26 with the definitive exposure time from 2018-10-11 to 2018-10-25. The study was conducted under static conditions for 14 days with the test item concentrations 10 – 31.6 – 100 – 316 and 1000 mg/kg soil dry weight mixed into artificial soil containing 10 % peat. Artificial soil without test item was used as control. 40 test organisms with an individual weight between 0.38 - 0.54 g, divided into four replicates, were tested per test item concentration and control.
No statistically significant mortality was observed in all test item concentrations after 14 days of exposure.Therefore, theNOEC was determined to be ≥ 1000 mg/kg soil dry weight and LOEC was determined to be > 1000 mg/kg soil dry weight. No LCxvalues were determined since nostatistically significantmortality was observed.
In terms of body weight loss, the NOEC was determined to be 316 mg/kg soil dry weight and LOEC was determined to be 1000 mg/kg soil dry weight.
All validity criteria of the test guideline were fulfilled.
Summary of all Effects
Effects
EDTA-ZnK2
[mg/kg soil dry weight]
LOEC
Mortality, behaviour, pathological symptoms
> 1000
NOEC
Mortality, behaviour, pathological symptoms
≥1000
LOEC
Change of body weight
1000
NOEC
Change of body weight
316
EC10body weight(confidence interval)
EC20body weight(confidence interval)
EC50body weight(confidence interval)
430 (301 – 615)
634 (441 – 921)
> 1000
Reference
Earthworm Mortality in [%] after 7 and 14 Days of Exposure
|
|
|
|
|
Mortality [%] |
|||||||||
Test item concentration [mg/kg SDW] |
Day 7 |
Day 14 |
||||||||||||
1 |
2 |
3 |
4 |
MV |
1 |
2 |
3 |
4 |
MV |
|||||
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
10 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
31.6 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
316 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||
1000 |
0 |
0 |
0 |
0 |
0 |
10 |
30 |
0 |
0 |
10 |
MV = mean value
Earthworm Behaviour and Pathological Symptoms after 7 and 14 Days of Exposure
Test item concentration [mg product/kg SDW] |
Effect |
Replicate |
|||
1 |
2 |
3 |
4 |
||
Day 7 |
|||||
Control |
A) |
10/10 |
10/10 |
10/10 |
10/10 |
3.16 |
A) |
10/10 |
10/10 |
10/10 |
10/10 |
10 |
A) |
10/10 |
10/10 |
10/10 |
10/10 |
31.6 |
A) |
10/10 |
10/10 |
10/10 |
10/10 |
100 |
A) |
10/10 |
10/10 |
10/10 |
10/10 |
316 |
A) |
10/10 |
10/10 |
10/10 |
10/10 |
1000 |
A) |
10/10 |
7/10 |
10/10 |
10/10 |
D) |
- |
3/10 |
- |
- |
|
|
Day 14 |
||||
Control |
A) |
10/10 |
10/10 |
10/10 |
10/10 |
3.16 |
A) |
10/10 |
10/10 |
10/10 |
10/10 |
10 |
A) |
10/10 |
10/10 |
10/10 |
10/10 |
31.6 |
A) |
10/10 |
10/10 |
10/10 |
10/10 |
100 |
A) |
10/10 |
10/10 |
10/10 |
10/10 |
316 |
A) D) |
10/10 - |
10/10 - |
9/10 1/10 |
8/10 2/10 |
1000 |
A) B,D,G) |
7/10 - |
4/10 - |
7/10 1/10 |
6/10 - |
D) |
2/10 |
3/10 |
2/10 |
4/10 |
|
H) |
1/10 |
3/10 |
- |
- |
A) no obvious pathological symptoms
B) no reaction to touching
D) spontaneous segmentation and separation
G) ulcer and skin bleedings
H) dead earthworm
Mean Live Weight and Mean Loss of Body Weight
|
Mean live weight |
|||
Test item concentration [mg product/kg SDW] |
Test start MV±SD [g/worm] |
Test end MV±SD [g/worm] |
Inhibition [%] |
Statistically significant vs. Control |
Control |
0.48 ± 0.03 |
0.41 ± 0.04 |
14.6 |
– |
10 |
0.47 ± 0.04 |
0.42 ± 0.04 |
10.6 |
No |
31.6 |
0.47 ± 0.05 |
0.41 ± 0.04 |
12.8 |
No |
100 |
0.47 ± 0.05 |
0.42 ± 0.05 |
10.6 |
No |
316 |
0.47 ± 0.04 |
0.40 ± 0.07 |
14.9 |
No |
1000 |
0.47 ± 0.04 |
0.29 ± 0.10 |
38.3 |
Yes |
MV = Mean value SD = Standard deviation
Description of key information
Only one acute toxicity study with earthworms is available for EDTA-H4 (Edwards, 2009). The EC50 was determined at 156 mg/kg soil dry weight.
This corresponds to 213 mg/kg soil dw EDTA-ZnNa2.
A short term earthworm study performed with EDTA-ZnK2 (CAS no 14689 -29 -3) according to OECD 207 resulted in no statistically significant mortality in all test item concentrations after 14 days of exposure.Therefore, the NOEC was determined to be ≥ 1000 mg/kg soil dry weight and LOEC was determined to be > 1000 mg/kg soil dry weight. No LCx values were determined since no statistically significant mortality was observed. In terms of body weight loss, the NOEC was determined to be 316 mg/kg soil dry weight and LOEC was determined to be 1000 mg/kg soil dry weight. All validity criteria of the test guideline were fulfilled.
Corrected for the difference in MW between EDTA-ZnK2 and EDTA-ZnNa2 this results in a NOEC of 316*399.6/431.8 = 292 mg/kg dw
Corrected for the active ingredient of 90.4% of EDTA-ZnK2 this results in a NOEC of 264 mg a.i./kg dw
Key value for chemical safety assessment
- Short-term EC50 or LC50 for soil macroorganisms:
- 264 mg/kg soil dw
Additional information
The hazard assessment of EDTA-ZnNa2 reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance. The substance is expected to have a low potential for adsorption based on its ionic structure under environmental relevant pH conditions and its low log Kow , the low log Kow also indicates that the substance will not be bioaccumulative. There are no further indications that the substance may be hazardous to the environment.
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