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EC number: 500-233-2 | CAS number: 68891-29-2 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
- 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
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 October - 05 December 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- Version / remarks:
- adopted July 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Samples (5 mL) were taken from the control and test concentration prior to organism addition, on Day 0 (organism addition) and on Days 3, 11, 18, 25 and 28 post-hatch for analysis.
- Sampling method: The samples were taken using an air displacement pipette fitted with a plastic pipette tip into 20 mL glass scintillation vials containing 5 mL of methanol - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: ca 4092 mg of test substance was dissolved in 11 L of treated mains water to give a 125 mg a.i./mL stock solution. The stock solution was prepared and replaced daily throughout the duration of the test. - Test organisms (species):
- Pimephales promelas
- Details on test organisms:
- TEST ORGANISM
- Common name: fathead minnow
- Source: eggs used in this study were obtained from an in-house laboratory breeding system
METHOD FOR PREPARATION AND COLLECTION OF FERTILIZED EGGS
- Numbers of parental fish (i.e. of females used to provide required number of eggs): Viable fish eggs were obtained from breeding groups of Pimephales promelas. Prior to initiation of the test, the stage of development was established.
- Method of collection of fertilised eggs: < 24 hours prior to testing, collected in glass scintillation vials containing dilution water
POST-HATCH FEEDING
- Type/source of feed: brine shrimp (Artemia salinis) nauplii, freshly cultured during the test
- Amount given: initially the larvae were fed approximately 24-hour old brine shrimp. From Day 7 post-hatch onwards the larvae were fed approximately 48-hour old brine shrimp. - Test type:
- flow-through
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 28 d
- Test temperature:
- 24.1 - 25.1°C
- pH:
- 6.85 - 7.86
- Dissolved oxygen:
- 88.4 - 103.6% ASV
- Nominal and measured concentrations:
- Nominal test substance concentration: 25 mg a.i./L
Mean measured test concentration: 11.2 mg/L - Details on test conditions:
- TEST SYSTEM
- Emybro cups (if used, type/material, size, fill volume): 17 cm long glass cylinders (6.5 cm internal diameter) with a 0.5 - 1.0 mm non-reactive mesh attached to one end (bottom).
- Test vessel: 3 L glass aquaria
- Fill volume: 2.5 L
- Type of flow-through (e.g. peristaltic or proportional diluter): the stock solution was dosed at a rate of 7 ± 10% mL/minute to a diluent flow rate of 28 ± 10% mL/minute through an in-line mixer
- Renewal rate of test solution (frequency/flow rate): five total replacements within 24 h
- No. of fertilized eggs/embryos per vessel: 20
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The dilution water was treated mains water (municipal water treated via activated carbon particulate filter and ultraviolet irradiation).
- Intervals of water quality measurement: weekly measurement of pH and dissolved oxygen, daily measurement of temperature
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16-hour light:8 hour dark period with an approximate 30 minute dawn:dusk transition period.
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : On Day 28 post-hatch the total numbers of surviving larvae were counted and individual total fish length and wet weight of all remaining fish were determined.
RANGE-FINDING STUDY
- Test concentrations: 0.25, 2.5, 25 mg a.i./L
- Results used to determine the conditions for the definitive study: 100% post hatch survival
POST-HATCH DETAILS
- Begin of post-hatch period: day 6 - Reference substance (positive control):
- no
- Duration:
- 28 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 11.2 mg/L
- Nominal / measured:
- meas. (arithm. mean)
- Conc. based on:
- act. ingr.
- Basis for effect:
- other: time-to-hatch, hatching success, normal larvae at hatch, post-hatch survival and growth
- Remarks on result:
- other: Concentration based on eight representative constituents
- Details on results:
- - Post-hatch survival: 91% in controls and treatment, respectively
- Days to hatch or time to release of young: First egg hatch occurred between Day 3s and 4 and completion of hatching occurred between Days 4 and 6 (post-egg addition) in the test concentration and the control vessels.
- Numbers hatched: control 96%, treatment 90%
- Observations on body length and weight of young and/or exposed parents at one or more time periods: The mean fish total length in the control and test concentration groups was 19.5 and 19.6 mm, respectively.
The mean fish wet weight in the control and test concentration groups was 67.3 and 62.0 mg, respectively.
- Type of and number with morphological abnormalities: 3 larvae of the control with bent spine and 1 larvae of the test concentration was observed to be underdeveloped. These observations were not concentration specific.
- Type of and number with behavioural abnormalities: none
- Type and number of developmental effects: none
- Type and magnitude of hormonal changes: none
- Reported statistics and error estimates:
- Statistical analysis of the data was performed using the CETIS program v 1.8.6.8.
The Lowest Observed Effect Concentration (LOEC) is defined as the lowest tested concentration at which the chemical is observed to have a statistically significant effect compared to the control. The No Observed Effect Concentration (NOEC) is the test concentration immediately below the LOEC.
To confirm no significant effects were observed between the control and test concentration, statistical analysis was conducted for the hatching success, post-hatch survival and growth (wet weight and length) endpoints.
Each NOEC and LOEC analysis included Bartletts Equality of Variance test and Shapiro-Wilks Test to evaluate homogeneity and normality of the data, respectively. In addition, Grubbs Extreme Value test was also included to determine the presence of outliers. The data were not transformed prior to analysis.
To determine the NOEC and LOEC values, the number of hatched larvae and the number of larvae surviving at 28 days post-hatch data for the test concentration were compared to the control using the Fisher Exact Test. The Day 28 length and wet weight data for the test concentration were compared to the control using the Equal Variance t Two-Sample Test. All data were shown to be homogenous and normally distributed. No statistical outliers were detected in the data sets.
Given that no statistically significant effects were observed between the control and test substance group and that the test was conducted using a single test concentration, the ECx values could not be calculated. - Validity criteria fulfilled:
- yes
- Remarks:
- Please refer to table 3 at "Any other infrmation on results incl. tables"
Reference
Table 1: Biological results
Measured concentration [mg/L]
|
Vessel number |
Number of eggs added at start of test
|
Number of hatched larvae
|
Number of normal larvae at hatch
|
Number of larvae surviving at 28 days post-hatch |
Mean Total length of fish [mm] at 28 days post-hatch |
Mean Wet weight of fish [mg] at 28 days post-hatch |
Control |
V1 |
20 |
20 |
18 |
15 |
20.4 |
76.1 |
V2 |
20 |
19 |
19 |
19 |
19.0 |
60.6 |
|
V3 |
20 |
19 |
19 |
18 |
19.6 |
69.4 |
|
V4 |
20 |
19 |
19 |
18 |
19.0. |
63.2 |
|
11.2 |
V1 |
20 |
20 |
20 |
20 |
18.9 |
53.7 |
V2 |
20 |
16 |
16 |
13 |
20.6 |
73.1 |
|
V3 |
20 |
19 |
19 |
17 |
20.0 |
56.7 |
|
V4 |
20 |
17 |
17 |
16 |
19.0 |
64.6 |
Table 2: Analysis of test media per constituent during the definitive test
Constituent analysed |
Measured concentration [mg/L] |
|||||||
Day 0 |
Day 11 (post-hatch) |
Day 18 (post-hatch) |
Day 25 (post-hatsch) |
Day 28 (post-hatch) |
||||
Ammonium octyl sulfate |
0.612 |
0.739 |
0.462 |
0.496 |
0.181 |
|||
1-Octanol, ethoxylated (1 EO), sulfated, ammonium salt |
1.35 |
1.14 |
0.796 |
0.766 |
0.459 |
|||
1-Octanol, ethoxylated (2 EO), sulfated, ammonium salt |
1.52 |
1.42 |
1.39 |
1.51 |
1.10 |
|||
1-Octanol, ethoxylated (3 EO), sulfated, ammonium salt |
1.41 |
1.37 |
1.21 |
1.29 |
1.02 |
|||
Ammonium decyl sulfate |
0.286 |
0.235 |
0.233 |
0.304 |
0.0750 |
|||
1-Decanol, ethoxylated (1 EO), sulfated, ammonium salt |
0.439 |
0.426 |
0.352 |
0.448 |
0.244 |
|||
1-Decanol, ethoxylated (2 EO), sulfated, ammonium salt |
1.31 |
1.27 |
1.02 |
0.890 |
0.626 |
|||
1-Decanol, ethoxylated (3 EO), sulfated, ammonium salt |
1.21 |
1.16 |
0.821 |
0.663 |
0.486 |
|||
Sum of constituents |
8.14 |
7.76 |
6.28 |
6.37 |
4.19 |
|||
Test substance concentrationa |
13.9 |
13.3 |
10.7 |
10.9 |
7.16 |
|||
a= Calculated based on sum of the measured concentrations of each constituent x 1.71 (correction factor based on measured constituents representing 58.4% of total test substance)
Table 2: Validity criteria for OECD 210
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The dissolved oxygen concentration should be >60% of the air saturation value throughout the test. |
88.4 - 103.6% |
yes |
The water temperature should not differ by more than ± 1.5 °C between test chambers or between successive days at any time during the test, and should be within the temperature ranges specified for the test species (Annex 2). |
≤1°C |
yes |
The analytical measure of the test concentrations is compulsory. |
Analytical monitoring by LC-MS/MS |
yes |
Overall survival of fertilised eggs and post-hatch success in the controls and, where relevant, in the solvent controls should be greater than or equal to the limits defined in Annex 2. |
The mean hatching success of embryos in the control group was 96% which was in excess of the validity criterion of ≥70%. The mean post-hatch survival in the control group was 91% which was greater than the validity criterion of ≥75%. |
yes |
Description of key information
NOEC (28 d): 11.2 mg/L (mean measured, OECD 210, Pimephales promelas)
Key value for chemical safety assessment
Additional information
The assessment is based on the data currently available. New studies, based on the category review and the final decisions issued for some of the category substances, which are also relevant for this assessment, are currently being conducted. The hazard assessment with respect to aquatic toxicity will be updated once all ongoing studies have been finalised.
The chronic toxicity of the substance to fish was tested in a GLP guideline study conducted according to OECD 210. The test was conducted as a limit test under flow-through conditions. Fertilised eggs of the freshwater fish species Pimephales promelas were exposed to a nominal limit test item concentration of 25 mg a.i./L. The substance concentrations of the UVCB substance was analytically verified by targeting eight different constituents in the LC-MS/MS analysis. The overall mean measured concentration was 11.2 mg/L. No effects on hatching success, post-hatch survival, final fish length and final fish wet weight were observed. The determined NOEC was 11.2 mg/L.
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