Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021-04-12 to 2021-04-16
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: fresh media at 0 and 72 h and aged media at 24 and 96 h (limit concentration: 1.5 mg/L)
- Sampling method: Samples were taken directly from the test vessels. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: WAF acc. to OECD guidance document No. 23 (2018). A WAF with a nominal loading rate of 5 mg/L was prepared. This dispersion was shaken for 24 hours with 20 rpm at room temperature. After completion of shaking and a separation phase
of at least 1 hour standing at room temperature, the WAF was removed by siphoning from the middle of the glass flask. Undissolved particles were removed by membrane filtration (membrane filter 0.45 μm, RC, Macherey-Nagel). The filter was saturated in order to avoid adsorption during the filtration. The first 25 mL of the filtrate were discarded. The filtration was interrupted for 10 minutes to allow adsorption and saturation of the filter material with dissolved test item. Thereafter, the filtration was continued. The next 25 mL were discarded. During filtration, the filter was always kept covered. No presence of undissolved test item during the test was observed. The limit loading of the test item was prepared out of the WSF (nominal loading 5.00 mg/L) by dilution and tested in a limit test with a nominal loading of 1.50 mg/L.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no - Test organisms (species):
- Danio rerio (previous name: Brachydanio rerio)
- Details on test organisms:
- TEST ORGANISM
- Common name: zebrafish
- Source: originally obtained from Umweltbundesamt, Berlin, Germany
- Age at study initiation (mean and range, SD): Juvenile
ACCLIMATION
- Acclimation period: 9 days
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: commercial fish food, Sera Vipan; SERA GmbH, Germany, 4% of the fish body weight.
- Feeding frequency during acclimation: three times per week
- Health during acclimation (any mortality observed): no mortality observed. No disease treatments were administered throughout holding and testing.
FEEDING DURING TEST (as applicable) : no - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 96 h
- Test temperature:
- 23.0 - 24.2°C
- pH:
- 7.6 - 7.8
- Dissolved oxygen:
- 94 - 100%
- Conductivity:
- 150 μS/cm
- Nominal and measured concentrations:
- Nominal loading rate: 1.5 mg/L
Geometric mean measured concentration: 1.10 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: aquaria
- Material, size, headspace, fill volume: glass, 3 L, 2.5 L fill volume
- Aeration: gentle aeration
- Renewal rate of test solution (frequency/flow rate): every 24 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.132 g fish per liter test solution
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water of local origin was used for holding. The water was filtered on activated charcoal and aerated for at least 24 h to remove chlorine.
- Total organic carbon: < 2 mg/L
- Chlorine: < 0.01 mg/L
- Alkalinity: 0.6 mmol/L
- Intervals of water quality measurement: daily
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: light / dark cycle: 16 / 8 h
- Light intensity: 540 – 1000 Lux
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality and symptoms of intoxciation after 2 ± 0.5 h and 5 ± 1 h after the start of the exposure. On days 1-4 of the test, all vessels with living fish were inspected twice per day.
- Reference substance (positive control):
- no
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 1.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Duration:
- 96 h
- Dose descriptor:
- LL50
- Effect conc.:
- > 1.1 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Details on results:
- - Mortality of control:
no
- Sublethal observations / clinical signs:
Table 1: Measured Concentrations of the Test Item Isotridecanol, ethoxylated (2EO) during the Definitive Test
0 h
fresh medium
24 h
old medium
72 h
fresh medium
96 h
old medium
Geometric mean
measured
test item
concentration
[mg/L]
Nominal concentration [mg/L]
Measured conc. [mg/L]
[%]
Measured conc. [mg/L]
[%]
Measured conc. [mg/L]
[%]
Measured conc. [mg/L]
[%]
1.50
1.27
85
1.01
68
1.31
88
0.861
57
1.10
Control
< LOQ
< LOQ
< LOQ
< LOQ
< LOQ
Table 2: Validity criteria for OECD 203.
Criterion from the guideline
Outcome
Validity criterion fulfilled
The mortality in the control(s) should not exceed 10% (or one fish if less than ten are used) at the end of the test
0%
yes
The dissolved oxygen concentration must have been at least 60 per cent of the air
saturation value throughout the test
≥ 94%
yes
There must be evidence that the concentration of the substance being tested has been satisfactorily maintained, and preferably it should be at least 80% of the
nominal concentration throughout the test. If the deviation from the nominal
concentration is greater than 20%, results should be based on the measured concentration.
WAF prepared
yes
- Validity criteria fulfilled:
- yes
- Remarks:
- Please refer to table 2 at "Any other information on results incl. tables"
Reference
Description of key information
LL50 (96h) > 1.1 mg/L (geom. mean measured, OECD 203)
Key value for chemical safety assessment
Additional information
The acute toxicity of Isotridecanol, ethoxylated, < 2.5 EO to fish was investigated in a study following OECD 203 (GLP). Fish of the species Danio rerio were exposed to a nominal loading rate of 1.5 mg/L. The study was set up in a semi-static test design with a daily renewal of the test medium. The test concentration was analytically verified by LC-MS/MS. Mortality was not observed. At the end of the 96 hour exposure period a LL50 > 1.1 mg/L (geom. mean measured) was determined.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.