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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 500-195-7 | CAS number: 68131-39-5 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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- effects on growth of green algae
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03 May - 11 Jun 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- Version / remarks:
- 206, corrected 2011
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: all concentrations
- Sampling method: sampling at 0h (fresh solutions) and aftter 24, 48 and 72 h (aged solutions)
- Sample storage conditions before analysis: The samples were mixed with 10 mL acetonitrile and stored deep-frozen (= - 18 °C) until analysis. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution with a nominal concentration of 20 mg/L was prepared by adding the necessary amount of test item to a volumetric flask. Test medium was added and the solution was homogenised by stirring on a magnetic stirrer for 1 hour. The solution was observed to be slightly turbid. Test item concentrations were prepared by dilution with test medium. All dilutions were observed to be clear and transparent. - Test organisms (species):
- Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)
- Details on test organisms:
- TEST ORGANISM
- Strain: SAG 61.81
- Source (laboratory, culture collection): purchased from MBM Sciencebridge GmbH, Göttingen, Germany
- Method of cultivation: The algae are grown semi-continuously in sterile cultures in the laboratory. Old medium is periodically replaced by fresh mineral solution in order to keep the algae in an exponential growth state.
ACCLIMATION
- Acclimation period: 3 to 4 days
- Culturing media and conditions (same as test or not): same - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 22.4 – 23.3 °C
- pH:
- 7.65 -.8.38
- Nominal and measured concentrations:
- Nominal test item concentrations: 1.00, 0.500, 0.250, 0.125, 0.0625 mg/L
Geometric mean measured test item concentrations: 0.0400, 0.0300, 0.0100, 0.0125, 0.00563 mg/L (based on 2 representative constituents) - Details on test conditions:
- TEST SYSTEM
- Test vessel: Erlenmeyer flasks (glass), nominal volume 100 mL
- Type (delete if not applicable): covered by aluminium caps
- Fill volume: ~50 mL
- Initial cells density: 0.5 × E*4 cells/mL
- Control end cells density: 69.27 × E*4 cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes acc. to AAP-Medium (according to Annex 3 of OECD 201)
TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: no
- Intervals of water quality measurement: pH at test start and test end; temperature continously
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod:continous illumination
- Light intensity and quality: 95.0 µEm-2s-1 (mean light intensity)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: cell densities were determined by a fluorimeter at time points. 0, 24, 48 and 72 h
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.0100, 0.100, and 1.00 mg/L
- Results used to determine the conditions for the definitive study: EC50 (72h): >0.10 - < 1.0 mg/L - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 72 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.025 mg/L
- 95% CI:
- >= 0.021 - <= 0.024
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- other: based on two representative constituents
- Remarks:
- C13EO2 and C13EO3
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.031 mg/L
- 95% CI:
- >= 0.03 - <= 0.032
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- other: based on two representative constituents
- Remarks:
- C13EO2 and C13EO3
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.013 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- other: based on two representative constituents
- Remarks:
- C13EO2 and C13EO3
- Basis for effect:
- growth rate
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Observation of abnormalities (for algal test): At nominal test item concentration of 0.500 mg/L slender and bloated cells were observed. - Results with reference substance (positive control):
- - ErC50 (72 h): 1.55 mg/L (NOErC(72 h): 0.320 mg/L)
- Other: test performed Jan 2021 - Reported statistics and error estimates:
- The NOEC and LOEC were determined using a multiple comparison method (multiple Welch's t-test with Bonferroni-Holm adjustment, left sided, for growth rate, Jonckheere-Terpstra test, left sided, for yield). The EC10, 20, 50-values for growth rate were determined by Weibull analysis using maximum likelihood regression, the EC10, 20, 50-values for yield were determined by probit analysis using linear weighted regression.
- Validity criteria fulfilled:
- yes
- Remarks:
- please see table 1 at "Any other information on results incl. tables"
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 02 NOV - 26 NOV 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 201 (Alga, Growth Inhibition Test)
- GLP compliance:
- yes
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution was prepared with a nominal concentration of 2000 mg/L. Testconcentrations were prepared by dilution. - Test organisms (species):
- Skeletonema costatum
- Details on test organisms:
- TEST ORGANISM
- Strain: NIVA BAC1
- Age of inoculum (at test initiation): 3 d - Test type:
- static
- Water media type:
- saltwater
- Limit test:
- no
- Total exposure duration:
- 72 h
- Test temperature:
- 20.5 - 21.0 °C
- pH:
- 8.1 - 9.0
- Nominal and measured concentrations:
- Nominal test concentrations: 0, 0.10, 0.32, 1.00, 3.20 and 10.00 mg/L
- Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 mL, all-glass,
-Fill volume: 50 mL test medium
- Initial cells density: 4 x 10 exp. 4 algal cells/mL
- Control end cells density: 74.55 x 10 exp. 4 algal cells/mL
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 6
GROWTH MEDIUM
- Standard medium used: yes, ISO-medium formulated according to the International Standards "Water quality - Marine algal growth inhibition test"
OTHER TEST CONDITIONS
- Photoperiod: continuous illumination
- Light intensity and quality: 6000 - 8000 lux (TLD-lamps of 18 Watt, Philips, Spain)
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
- Determination of cell concentrations: counting chamber at 0 h, spectrophotometer at 24, 48 and 72 h
TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.1 - 1000 mg/L increasing by a factor 10
- Results used to determine the conditions for the definitive study: NOEC > 10 mg/L - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1 - 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.32 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- growth rate
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.3 mg/L
- 95% CI:
- >= 0.01 - <= 1.07
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Duration:
- 72 d
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.1 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- biomass
- Details on results:
- - Exponential growth in the control (for algal test): yes
- Results with reference substance (positive control):
- ErC50 (72 h): 3.2 - 5.6 mg/L (nominal)
- Validity criteria fulfilled:
- not applicable
Referenceopen allclose all
Table 1: Validity criteria for OECD 201 (2006)
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
The biomass in the control cultures should have increased exponentially by a factor of at least 16 within the 72-hour test period. |
125.95 |
yes |
The mean coefficient of variation for section-by-section specific growth rates (days 0-1, 1-2 and 2-3, for 72-hour tests) in the control cultures must not exceed 35% |
10% |
yes |
The coefficient of variation of average specific growth rates during the whole test period in replicate control cultures must not exceed 7% in tests with Pseudokirchneriella subcapitata and Desmodesmus subspicatus. For other less frequently tested species, the value should not exceed 10%. |
1.0% |
yes |
Table 2: Percentage inhibition of growth rate
Nominal Conc. |
% Inhibition of growth rate |
||
[mg/L] |
0 h – 24 h |
0 h – 48 h |
0 h – 72 h |
Control |
0.0 |
0.0 |
0.0 |
0.0625 |
-5.3 |
-0.3 |
-0.9 |
0.125 |
10.3 |
-1.7 |
0.0 |
0.250 |
32.4 |
11.8 |
5.8 |
0.500 |
103.6 |
64.9 |
40.0* |
1.00 |
310.6 |
208.9 |
141.2* |
* Statistically significant different to the control (left-sided, p=0.05)
Description of key information
EC50 (72 h): 0.0311 mg/L
EC10 (72 h): 0.0255 mg/L
Key value for chemical safety assessment
Additional information
The key study, investigating the toxicity of Alcohols, C12-15, branched and linear, ethoxylated to aquatic algae, was performed according to guideline OECD 201. In the GLP guideline study, green algae of the species Raphidocelis subcapitata, were exposed to nominal test substance concentrations of 0.0625, 0.125, 0.250, 0.500 and 1,.00 mg/L.. The test concentrations were analytically monitored by HPLC-MS/MS by analysing the concentration of two representative constituents. The time weighted mean concentrations were 0.00563, 0.0125, 0.0100, 0.0300and 0.0400 mg/L. Based on the algal growth an EC50 (72 h) of 0.0311 mg/L was determined. The EC10 (72 h) was 0.0255 mg/L.
A supporting study, conducted according to OECD GD 201, investigated the growth inhibition of the marine organism Skeletonema costatum. The determined EC50 (72 h) range was 1 – 3.2 mg/L (nominal (NOEC (72 h): 0.32 mg/L).
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.