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EC number: 500-241-6 | CAS number: 69011-36-5 1 - 2.5 moles ethoxylated
- 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
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- Nanomaterial pour density
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- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
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- 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
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- 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: long-term
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 May - 11 Jul 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 222 (Earthworm Reproduction Test (Eisenia fetida/Eisenia andrei))
- Version / remarks:
- 2016
- 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 end, the soil moisture deviated by more than 10 % from the initial value in the control and the treatment rates 62.5 to 1000 mg test item/kg SDW. The room temperature decreased to minimum 16 °C and increased to maximum 23 °C for in total about 44 h corresponding to 3.33 % of the definitive exposure time. These deviations are considered to have no impact on quality and integrity of the study.
- GLP compliance:
- yes
- Remarks:
- Staatliches Gewerbeaufsichtsamt Hildesheim, Germany
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: control and 62.5, 125, 250, 500, 1000 and 2000 mg test item/kg SDW (day 0, 55)
- Sampling method: pooled samples of all respective replicates - Vehicle:
- no
- Details on preparation and application of test substrate:
- - Method of mixing into soil: respective test item amount for each test item concentration was weighed out, dispersed in demineralised water (200 mL) and added to the artificial soil (2440 g SDW). test medium was thoroughly mixed to ensure a homogenous distribution.
- Test organisms (species):
- Eisenia fetida
- Animal group:
- annelids
- Details on test organisms:
- TEST ORGANISM
- Common name: earthworm
- Source: breeding stock culture maintained at the test facility
- Age at test initiation: 2-12 months, difference of age did not deviate by more than 1 month
- Weight at test initiation: 0.35 - 0.58 g
ACCLIMATION
- Acclimation period: 2 days - Study type:
- laboratory study
- Substrate type:
- artificial soil
- Limit test:
- no
- Total exposure duration:
- 8 wk
- Test temperature:
- 16 - 23°C
- pH:
- 6.23 - 6.80
- Moisture:
- 19.4 - 25.6% of dry weight
- Details on test conditions:
- TEST SYSTEM
- Test container: round plastic boxes (diameter: 15 cm, bottom surface area: 177 cm2 , height: 14 cm)
- Amount of soil or substrate: 610 g
- No. of organisms per container (treatment): 10
- No. of replicates per treatment group: 4
- No. of replicates per control: 8
SOURCE AND PROPERTIES OF SUBSTRATE (if soil)
- Composition (if artificial substrate): 5 % peat, air-dried and finely ground, 20 % kaolin (kaolinite content > 30 %), 74 % air-dried quartz sand (sand with > 50 % particle size of 0.05 - 0.2 mm), 0.25 % calcium carbonate (CaCO3) to achieve a pH of 6.0 ± 0.5)
- Maximum water holding capacity: 27%
- Pretreatment of soil: Two days before test start the artificial soil was pre-moistened with demineralised water to achieve a moisture content corresponding to 27 % of the WHCmax of the artificial soil.
- Storage: The moistened soil was kept covered to prevent evaporative water losses.
OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h dark
- Light intensity: 400 - 800 lux
EFFECT PARAMETERS MEASURED: day 0 and 28: body weight, day 28: mortality and morphological changes of the adult, day 56: number of offspring (juveniles)
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study
- Test concentrations: 1, 10, 100, 1000 mg/kg SDW
- Results used to determine the conditions for the definitive study: Mortality after 14 days: 0% (control), 0% (1 mg/kg SDW), 0% (10 mg/kg SDW), 0% (100 mg/kg SDW), 5% (1000 mg/kg SDW) - Nominal and measured concentrations:
- Nominal concentrations: 0 (control), 62.5, 125, 250, 500, 1000, 2000 mg/kg SDW
Mean mesured concentrations: day 0: < LOQ (control), 64.1, 120, 229, 507, 1014, 1913 mg/kg SDW, day 7: 1629 mg/kg SDW (2000 mg/kg SDW), day 55: < LOQ (control), < LOQ, 24.8, 47.1, 88.5, 241 mg/kg SDW (2000 mg/kg SDW not determined) - Reference substance (positive control):
- yes
- Remarks:
- Carbendazim
- Duration:
- 56 d
- Dose descriptor:
- EC10
- Effect conc.:
- 122 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Remarks on result:
- other: 95% confidence limits: 155 - 129 mg/kg soil dw
- Duration:
- 56 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 125 mg/kg soil dw
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- reproduction
- Details on results:
- - Mortality at end of exposure period:
6.25 (control), 2.5, 0, 2.5, 0, 15, 100%
- Total mass of adults at beginning of test: 610 g
- Changes in body weight of live adults (% of initial weight) at end of exposure period: 12.3 (control), 7.63, 7.10, 2.13, 8.25, 2.78, - % - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: LOEC: 1 mg/kg SDW - Validity criteria fulfilled:
- yes
- Remarks:
- For further details, refer to "Any other information on results incl. tables"
Reference
Table 1: Mortality of Adult Earthwormsin [%]after 28 Days of Exposure
Application rate |
Replicate |
||||||||
[mg test item/kg SDW] |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
Mean |
Control |
0 |
0 |
0 |
10 |
30 |
0 |
0 |
10 |
6.25 |
62.5 |
10 |
0 |
0 |
0 |
- |
2.5 |
|||
125 |
0 |
0 |
0 |
0 |
0 |
||||
250 |
0 |
0 |
0 |
10 |
2.5 |
||||
500 |
0 |
0 |
0 |
0 |
0 |
||||
1000 |
30 |
10 |
20 |
0 |
15 |
||||
2000# |
100 |
100 |
100 |
100 |
100 |
#) 100 % mortality on day 7
Table 2: Body Weight Changes of the Adult Earthworms
Application rate [mgtestitem/kg SDW] |
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 |
0.46 |
0.51 |
0.05 |
10.9 |
0.06 ± 0.01 |
12.3 ± 2.61 |
– |
2 |
0.45 |
0.51 |
0.06 |
13.3 |
||||
3 |
0.46 |
0.50 |
0.04 |
8.7 |
||||
4 |
0.46 |
0.52 |
0.06 |
13.0 |
||||
5 |
0.45 |
0.49 |
0.04 |
8.9 |
||||
6 |
0.45 |
0.52 |
0.07 |
15.6 |
||||
7 |
0.46 |
0.52 |
0.06 |
13.0 |
||||
8 |
0.46 |
0.53 |
0.07 |
15.2 |
||||
62.5 |
1 |
0.45 |
0.46 |
0.01 |
2.2 |
0.04 ± 0.02 |
7.63 ± 5.15 |
No |
2 |
0.46 |
0.52 |
0.06 |
13.0 |
||||
3 |
0.45 |
0.47 |
0.02 |
4.4 |
||||
4 |
0.46 |
0.51 |
0.05 |
10.9 |
||||
125 |
1 |
0.46 |
0.48 |
0.02 |
4.3 |
0.03 ± 0.02 |
7.10 ± 3.38 |
No |
2 |
0.46 |
0.48 |
0.02 |
4.3 |
||||
3 |
0.45 |
0.50 |
0.05 |
11.1 |
||||
4 |
0.46 |
0.50 |
0.04 |
8.7 |
||||
250 |
1 |
0.45 |
0.41 |
-0.04 |
-8.9 |
0.01 ± 0.04 |
2.13 ± 9.32 |
No |
2 |
0.45 |
0.44 |
-0.01 |
-2.2 |
||||
3 |
0.46 |
0.50 |
0.04 |
8.7 |
||||
4 |
0.46 |
0.51 |
0.05 |
10.9 |
||||
500 |
1 |
0.45 |
0.48 |
0.03 |
6.7 |
0.04 ± 0.02 |
8.25 ± 4.82 |
No |
2 |
0.46 |
0.47 |
0.01 |
2.2 |
||||
3 |
0.46 |
0.52 |
0.06 |
13.0 |
||||
4 |
0.45 |
0.50 |
0.05 |
11.1 |
||||
1000 |
1 |
0.46 |
0.41 |
-0.05 |
-10.9 |
0.01 ± 0.04 |
2.78 ± 9.54 |
Yes |
2 |
0.45 |
0.50 |
0.05 |
11.1 |
||||
3 |
0.46 |
0.49 |
0.03 |
6.5 |
||||
4 |
0.45 |
0.47 |
0.02 |
4.4 |
||||
2000 |
1 |
0.45 |
# |
# |
# |
# |
# |
# |
2 |
0.46 |
# |
# |
# |
||||
3 |
0.46 |
# |
# |
# |
||||
4 |
0.45 |
# |
# |
# |
#) not determinable due to 100 % mortality
SD = Standard deviation
Sig. = Statistical Significance (Step-down Jonckheere-Terpstra Test Procedure, α = 0.05) compared to control
Table 3: Reproduction Rate (Number of Juveniles after 8 Weeks)
Application rate [mg test item/kgsoildry weight] |
Replicate |
Number of juveniles |
Mean ± SD |
CV [%] |
[%] of control |
Sig. |
Control |
1 |
131 |
124 ± 16.9 |
13.7 |
- |
- |
2 |
140 |
|||||
3 |
128 |
|||||
4 |
135 |
|||||
5 |
87 |
|||||
6 |
119 |
|||||
7 |
136 |
|||||
8 |
119 |
|||||
62.5 |
1 |
126 |
123 ± 13.1 |
10.7 |
99.2 |
No |
2 |
128 |
|||||
3 |
134 |
|||||
4 |
104 |
|||||
125 |
1 |
123 |
119 ± 11.2 |
9.37 |
96.0 |
No |
2 |
103 |
|||||
3 |
120 |
|||||
4 |
129 |
|||||
250 |
1 |
44 |
59 ± 11.1 |
18.9 |
47.6 |
Yes |
2 |
67 |
|||||
3 |
68 |
|||||
4 |
58 |
|||||
500 |
1 |
53 |
22 ± 21.9 |
99.5 |
17.7 |
Yes |
2 |
4 |
|||||
3 |
19 |
|||||
4 |
10 |
|||||
1000 |
1 |
0 |
0 ± 0 |
0 |
0 |
Yes |
SD = Standard deviation
CV = Coefficient of variation
Sig. = Statistical Significance (William’s Multiple Sequential t-test Procedure, α = 0.05) compared to the control
Table 4: Validity criteria for OECD 222.
Criterion from the guideline to be satisfied in the controls |
Outcome |
Validity criterion fulfilled |
Each replicate (containing 10 adults) to have produced ≥ 30 juveniles by the end of the test. |
124 |
yes |
The coefficient of variation of reproduction is ≤ 30%. |
13.7% |
yes |
Adult mortality over the initial 4 weeks of the test is ≤ 10%. |
6.25% |
yes |
Description of key information
NOEC (56 d): 125 mg/kg soil dw (OECD 222)
Key value for chemical safety assessment
- Long-term EC10, LC10 or NOEC for soil macroorganisms:
- 125 mg/kg soil dw
Additional information
One long-term study investigating the toxicity of Isotridecanol, ethoxylated on earthworms is available. The study was conducted with Eisenia fetida using artificial soil as test substrate (OECD 222). Earthworms were exposed to nominal concentrations of 62.5, 125, 250, 500, 1000, 2000 mg/kg soil dw. The test concentrations were analytically verified by LC MS/MS at days 0, 7 and 55. At day 28 of the study the mortality, body weight and morphological changes of adult worms was determined. No mortalities or differences in earthworm biomass occurred at test substance concentrations 62.5- 500 mg/kg soil dw. At the test item concentrations 1000 mg/kg and 2000 mg/kg 15 % and 100 % mortality occurred, respectively. At 1000 mg/kg the earthworm weight was significantly reduced compared to the control. The offspring was counted at day 56. No statistically significant differences in earthworm reproduction were observed at 62.5 and 125 mg/kg soil dw compared to the control. At test concentrations 250 to 1000 mg/kg soil dw the earthworm reproduction was statistically significantly reduced.
Based on the reproduction rate a NOEC 56 d of 125 mg/kg soil dw (nominal) was recorded.
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