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EC number: 824-774-1 | CAS number: 148124-40-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- 1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The results as observed/predicted for EDTA-FeNa are read across to EDTA-Fe(OH)K2 as in diluted form in the environment both EDTA complexes will have a similar structure and related fate.
2. ANALOGUE APPROACH JUSTIFICATION
It is therefore considered justified to use data/predictions as observed for EDTA-FeNa also for EDTA-Fe(OH)K2.
3. ANALOGUE APPROACH JUSTIFICATION
It is considered justified to use the results as observed/predicted for EDTA-FeNa for read across to EDTA-Fe(OH)K2 because in diluted form in the environment both EDTA complexes will have a similar structure and related fate.
4. DATA MATRIX
See chapter 13 for Read across document - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 207 (Earthworm, Acute Toxicity Tests)
- Version / remarks:
- 1984 version
- Deviations:
- no
- Principles of method if other than guideline:
- No
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- no
- Vehicle:
- no
- Remarks:
- Substance has a high water solubility
- Details on preparation and application of test substrate:
- The respective test item amount was weighed out for a stock solution (nominal: 2220 mg/100 mL, actual: 2220 mg/100 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 Eisenia fetida (Annelida, Lumbricidae)
Reason for the selection Eisenia fetida is suitable for this kind of study and is one of the recommended species according to the guideline.
Source Breeding stock culture maintained at the test facility
Breeding Organisms of the species Eisenia fetida are bred at the test facility in covered plastic vessels containing potting compost.
Breeding conditions Temperature of 20 ± 2°C in the dark
Feeding During breeding, the earthworms are fed with a litter of dried stinging nettle leaves and porridge oats. A sufficient amount of the food is provided depending on the feeding rate and the density of the earthworm population in the vessels. - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 14 d
- Test temperature:
- 18 - 23 °C
The room temperature increased to 23 °C for about 6 hours. Since adaptation of the soil to room temperature is very slow, this deviation is considered to have no impact on quality and integrity of the study. - pH:
- Control: Day 0 = 6.12; Day 14 = 5.74
316 mg/kg dw: Day 0 = 6.24; Day 14 = 5.73
Range: 5.70 - 6.32 - Moisture:
- Control: Day 0 = 24.6; Day 14 = 23.7
316 mg/kg dw: Day 0 = 23.3; Day 14 = 22.9
Range: 22.6 - 24.6 - Details on test conditions:
- The WHCmax, pH-value and the moisture content of the artificial soil were determined prior to the adaptation of the earthworms. At the start and the end of the test, the pH-value and moisture content of the test medium were analysed in the treatments and the control using mixed samples of all replicates.
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. - Nominal and measured concentrations:
- Nominal: 0, 3.16, 10, 31.6, 100, 316 mg/kg dw
- Reference substance (positive control):
- yes
- Remarks:
- 2-Chloroacetamide (SIGMA-ALDRICH)
- Key result
- Duration:
- 14 d
- Dose descriptor:
- LC50
- Effect conc.:
- 133 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Key result
- Duration:
- 14 d
- Dose descriptor:
- EC50
- Effect conc.:
- 129 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Body Weight
- Duration:
- 14 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 31.6 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- other: Mortality, behaviour, pathological symptoms
- Reported statistics and error estimates:
- LC values The LC10/20/50 values were determined by Probit analysis using linear max. likelihood regression.
For details, please refer to section 12.
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.
For details, please refer to section 12.
NOEC, LOEC and statistical The NOEC/LOEC for mortality was determined using Multiple
analyses Sequentially-rejective Fisher Test After Bonferroni-Holm. When running the test, a Qualitative Trend Analysis by Contrasts and Tarone’s Test Procedure were done first.
Statistically significant differences in biomass compared to the control were determined using a Multiple Sequentially-rejective Welsh-t-test After Bonferroni-Holm. When running the test, Shapiro-Wilk’s Test on Normal Distribution and Levene’s Test on Variance Homogeneity (with Residuals) were done first. The -value (acceptable probability of incorrectly concluding that there is a difference) is = 0.05.
For details, please refer to section 12. - Validity criteria fulfilled:
- yes
- Conclusions:
- A valid study performed under GLP conditions according to a standard guideline.
- Executive summary:
The acute effects of Dissolvine E-Fe-13 on the earthworm Eisenia fetida were determined according to OECD Guideline 207. The study was conducted under static conditions for 14 days with the test item concentrations 3.16 – 10 – 31.6 – 100 – 316 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 0.40 - 0.54 g, divided into four replicates, were tested per test item concentration and control.
A statistically significant mortality was observed in the test item concentrations 100 and 316 mg/kg soil dry weight after 14 days of exposure, whereas no mortalities were observed in the control and the test item concentrations 3.16 to 31.6 mg/kg soil dry weight. Consequently, the NOEC was determined to be 31.6 mg/kg soil dry weight and LOEC was determined to be 100 mg/kg soil dry weight. In terms of body weight loss, theNOEC was determined to be 31.6 mg/kg soil dry weight and LOEC was determined to be 100 mg/kg soil dry weight.
For all LC - and ECx- values please refer to Table 1.
All validity criteria of the test guideline were fulfilled.
Table1: Summary of all Effects
Effects
Dissolvine E-Fe-13
[mg/kg soil dry weight]
LOEC
Mortality, behaviour, pathological symptoms
100
NOEC
Mortality, behaviour, pathological symptoms
31.6
LOEC
Change of body weight
100
NOEC
Change of body weight
31.6
LC10mortality(confidence interval)
LC20mortality(confidence interval)
LC50mortality(confidence interval)
56.8 (7.84 - 95.9)
76.1 (18.3 – 123)
133 (70.1 - 262)
EC10body weight(confidence interval)
EC20body weight(confidence interval)
EC50body weight(confidence interval)
51.3 (38.3 – 68.7)
70.4 (52.9 – 93.8)
129 (88.3 – 185)
Reference
1.1 Definitive Test
1.1.1 Mortality
A statistically significant mortality was observed in the test item concentrations 100 mg/kg and 316 mg/kg soil dry weight, whereas no mortalities were observed in the control and the test item concentrations 3.16 to 31.6 mg/kg soil dry weight after 14 days of exposure (Table 2).For LC-values please refer to Table 1.
Table 2: 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 |
||||
3.16 |
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 |
10 |
0 |
2.50 |
0 |
10 |
10 |
0 |
5.00 |
||||
100 |
10 |
10 |
10 |
0 |
7.50 |
20 |
20 |
30 |
20 |
22.5 |
||||
316 |
80 |
70 |
50 |
60 |
65.0 |
100 |
90 |
100 |
90 |
95 |
||||
MV = mean value
1.1.2 Behaviour and Pathological Symptoms
No significant pathological symptoms or changes in the earthworm behaviour were observed in the control as well as in the test item concentrations 3.16 to 31.6 mg/kg soil dry weight after 7 and 14 days of exposure. In the test item concentration 100 mg/kg soil dry weight and 316 mg/kg soil dry weight, significant changes in earthworm behaviour were observed after 7 and 14 days (Table3).
Table3: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) D) H) |
10/10 - - |
10/10 - - |
9/10 - 1/10 |
10/10 - - |
A) no obvious pathological symptoms D) spontaneous segmentation and separationH) dead earthworm
Table 3: Earthworm Behaviour and Pathological Symptoms after 7 and 14 Days of Exposure
(continued)
Test item concentration [mg product/kg SDW] |
Effect |
Replicate |
|||||||||
1 |
2 |
3 |
4 |
||||||||
Day 7 |
|||||||||||
100 |
A) B) C) D) H) |
9/10 - - - 1/10 |
8/10 - - 1/10 1/10 |
6/10 2/10 1/10
1/10 |
9/10 1/10 -
|
||||||
316 |
A) B) C) D) H) |
- 2/10 -
8/10 |
1/10 1/10 - 1/10 7/10 |
- - 4/10 1/10 5/10 |
1/10 - 3/10 - 6/10 |
||||||
|
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) H) |
10/10 - |
9/10 1/10 |
9/10 1/10 |
10/10 - |
||||||
100 |
A) B,D) C,D) H) |
6/10 - 2/10 2/10 |
8/10 - - 2/10 |
6/10 1/10 - 3/10 |
8/10 - - 2/10 |
||||||
316 |
A) H) |
- 10/10 |
1/10 9/10 |
- 10/10 |
1/10 9/10 |
A) no obvious pathological symptoms
B) no reaction to touching
C) no negative phototactical reaction
D) Spontaneous segmentation and separation
H) dead earthworm
Live Weight of the Earthworms
The individual live weights of the earthworms at test start as well as the mean weights and standard deviations of the replicates of the control and the test item concentration are given in Table 8 toTable 13. The data for individual live weights of the earthworms on day 14 as well as the mean values and the standard deviations of the control and the test item concentration are given in Table 14 to Table19.
During the test, the biomass loss of the earthworms was below 20 % in the control (Table 4).
Table4: 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 |
0.43 ± 0.04 |
10.4 |
– |
|||||
3.16 |
0.48 ± 0.03 |
0.43 ± 0.04 |
10.4 |
No |
|||||
10 |
0.48 ± 0.03 |
0.44 ± 0.03 |
8.33 |
No |
|||||
31.6 |
0.48 ± 0.04 |
0.43 ± 0.05 |
10.4 |
No |
|||||
100 |
0.47 ± 0.04 |
0.36 ± 0.10 |
23.4 |
Yes |
|||||
316 |
0.48 ± 0.04 |
0.39 ± 0.04 |
18.8 |
Yes |
MV = Mean value SD = Standard deviation
Physical Data
The initial pH of the artificial soil was 5.97 measured on day - 8. Measurements of pH-values and moisture content of the test medium based on mixed samples of all replicates per test item treatment and control are given in Table 5. The environmental conditions throughout the study are summarized in Table 6.
Table 5: pH-Values, Moisture and WHCmaxof the Test Media
Test item concentration [mg product/kg SDW] |
pH-value
|
Moisture [%] of DW |
WHCmax [g /100 g SDW] |
||
day 0 |
day 14 |
day 0 |
day 14 |
|
|
Control |
6.12
|
5.74 |
24.6 |
23.7 |
48.2 |
3.16 |
6.32 |
5.74 |
23.9
|
23.1 |
|
10 |
6.18 |
5.77 |
23.5
|
22.8 |
|
31.6 |
6.19 |
5.71 |
23.3 |
22.7 |
|
100 |
6.29 |
5.70 |
23.5 |
22.6 |
|
316 |
6.24 |
5.73 |
23.3 |
22.9 |
Table 6: Environmental Conditions
|
Room temperature [°C] |
Photoperiod [h] |
Light intensity [lx] |
nominal |
20±2 |
24 |
400 - 800 |
actual |
18 – 23* |
503 ± 56.5 |
*) The room temperature increased to 23 °C for about 6 hours. Since adaptation of the soil to room temperature is very slow, this deviation is considered to have no impact on quality and integrity of the study.
Test of Reference Item
The acute toxicity of 2-Chloroacetamide on the earthworm Eisenia fetida fetida (Savigny) was determined over a period of two weeks from 2018-01-26 to 2018-02-09. The LC50value was in the range between 20 and 80 mg/kg SDW as recommended by the guideline (Table7).
Table7: NOEC and LC-Value after 14 d for the Reference Item2-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)
Description of key information
The ecotoxicity of EDTA-FeK/EDTA-FeNa are considered to be similar to the ecotoxicity of EDTA-Fe(OH)K2 as these substances will be tested in very diluted form in buffered matrices and under these conditions no significant effects of the additional OH or the difference between sodium and potassium are expected. The ecotoxicity test results as observed for EDTA-FeK/ EDTA-FeNa will therefore be read across to EDTA-Fe(OH)K2.
The acute effects of EDTA-FeNa on the earthworm Eisenia fetida were determined according to OECD Guideline 207. The study was conducted under static conditions for 14 days with the test item concentrations 3.16 – 10 – 31.6 – 100 – 316 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 0.40 - 0.54 g, divided into four replicates, were tested per test item concentration and control.
A statistically significant mortality was observed in the test item concentrations 100 and 316 mg/kg soil dry weight after 14 days of exposure, whereas no mortalities were observed in the control and the test item concentrations 3.16 to 31.6 mg/kg soil dry weight. Consequently, the NOEC was determined to be 31.6 mg/kg soil dry weight and LOEC was determined to be 100 mg/kg soil dry weight.
In terms of body weight loss, the NOEC was determined to be 31.6 mg/kg soil dry weight and LOEC was determined to be 100 mg/kg soil dry weight.
The LC50 for mortaility was 133 (70.1 - 262) mg/kg dw. The EC50 for body weight was 129 (88.3 - 185) mg/kg dw. As a worst-case these values observed for EDTA-FeNa will not be corrected for the MW difference.
One additional 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 204.6 mg/kg soil dw EDTA-FeK.
Key value for chemical safety assessment
- Short-term EC50 or LC50 for soil macroorganisms:
- 129 mg/kg soil dw
Additional information
The hazard assessment of EDTA-Fe(OH)K2 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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