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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 246-885-9 | CAS number: 25354-97-6
- 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 aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019-10-09 to 2019-10-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP compliant
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- adopted 13. April 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP Certificate: Statement of GLP Compliance from Staatliches Gewerbeaufsichtsamt Hildesheim, Germany, dated 03.01.2017
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: all concentration levels and the control were analytically verified
- Sampling method: samples were taken in the fresh media at the start of the exposure and at the renewal of the test solutions (0 and 24 hours) after preparation of the test item concentrations as well as in 24-hours old media at the renewal and at the end of the exposure (24 and 48 hours), samples of the 24-hours old media were taken directly from the test vessels
- Sample storage conditions before analysis: at room temperature until the start of the analysis, if necessary - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preparation of saturated solution with a nominal concentration of 1.00 mg/L 4 days prior to start of exposure as well as 4 days prior to the renewal of the test solutions in a glass flask filled with the appropraite amount of dilution water (ISO Test Water acc. to guideline). The test item (density of 0.8779 g/cm3 taken into account) placed by pipette onto the water surface, bottle closed with a screw cap, then slow stirring procedure was applied (gentle stirring to avoid formation of emulsion carried out for 72 ± 1 hour with a magnetic stirrer at 30 ± 1 °C). After completion of stirring, dispersion was allowed to stand for at least 24 hours at 20 ± 1 °C for separation of undissolved test item. Thereafter, clear water phase removed by siphoning from the bottom of the glass flask and centrifuged at 17000 g for 20 minutes at 20 ± 1 °C. Mixing regime selected based on observations during preliminary testing. This saturated solution was used as highest test concentration level and as stock solution for preparation of further dilutions.
- Evidence of undissolved material: No, the saturated test item solution checked via laser beam (Tyndall effect) for undissolved test item (formation of an emulsion). The Tyndall effect was negative.
- Other relevant information: none - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Strain/clone: Daphnia magna STRAUS, obtained from continuous laboratory cultures
- Age at study initiation: less than 24 hours old
- Stage and instar at study initiation: to achieve this juvenile daphnids were removed from culture vessels at the latest 24 hours before start of exposure and discarded, juveniles born within the following period were used for the test, no first brood progeny was used
- Method of breeding: in glass vessels (2-3 l capacity) with approximately 1.8L culture medium (Elendt M4 acc. to guideline), feeding at least 5 times per week ad libitum with a mix of unicellular green algae (e.g. Pseudokirchneriella and Desmodesmus subspicatus)
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), Berlin, Germany
- Feeding during test : none
ACCLIMATION
- Acclimation period: at least 2 hours in dilution water
- Acclimation conditions: same as test
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 273 mg CaCO3/L
- Test temperature:
- 19.0 - 20°C
- pH:
- 7.15 - 7.85
- Dissolved oxygen:
- 7.16 - 8.57 mg/L
- Conductivity:
- 649 - 668 µS/cm
- Nominal and measured concentrations:
- Nominal: 6.25, 12.5, 25.0, 50.0, 100% saturated solution (test concentrations based on results of non-GLP preliminary range finding test)
Measured (geometric mean): 20.0, 52.4, 112, 203, 448 µg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: beaker, loosely covered with watch glasses
- Material: glass, (4 (id) x 7 (h) cm), 50 mL capacity
- Volume of solution: 20 mL
- Aeration: no
- Renewal rate of test solution (frequency): 1 renewal after 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO Test Water (according to guideline OECD 202, Annex 3)
- Culture medium different from test medium: yes, Elendt M4
- Intervals of water quality measurement: prior to start of exposure (0 hours) and renewal of test solutions (24 hours) ), the water quality parameters (i.e. pH value, dissolved oxygen concentration, temperature, conductivity and total hardness) of the dilution water were measured.
At the start of the exposure and at the renewal (0 and 24 hours), the water quality parameters of the fresh media (i.e. pH value, dissolved oxygen concentration) were measured in one additional replicate per concentration level and control. At the renewal and at the end of the exposure (24 and 48 hours), the water quality parameters of the old media were measured in one appropriate replicate (containing daphnids) per concentration level and control. The replicate with the highest immobilization rate per concentration level and control was measured.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8 hours light/dark cycle
- Light intensity: diffuse light, light intensity of max. 1500 lx
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobilization determined in all groups after 24 and 48 hours (an animal considered immobile, if not able to swim in the water phase within 15 s after gentle agitation of the test vesel), determination of other adverse, sub-lethal effects (e.g. discolouration, abnormal behaviour, etc.)
RANGE-FINDING STUDY
- Test concentrations: control, 10 and 100% saturated solution
- Results used to determine the conditions for the definitive study: 90% immobile daphnids at 100% saturated solution (geometric mean measured concentration: 735 µg/l), 0% immoblie daphnids at 10% saturated solution (geometric mean measured concentration: 69 µg/l), 0% immobile daphnids at control - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 448 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 302 µg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- EC50-value (with Confidence Limits) of the Reference Item Potassium dichromate based on nominal concentrations mg/L, (0 - 24 hours)
EC50 = 2.03 mg/L (valid range: 0.6-2.4 mg/L)
confidence limits: 1-4 mg/L - Reported statistics and error estimates:
- After 48 hours only 0 and 100% mortality occurred. Therefore the EC50-values were calculated by straight line regression. The concentrations enclosed to the EC50 - values were chosen as lower and upper confidence limits. All calculations were carried out from the best-fit values with the software GraphPad Prism.
All data were computer-processed and rounded for presentation. Consequently, minor variations may occur from the original figures if manual calculations based on the original figures are made subsequently. Calculations were made using the following software:
- Excel, MICROSOFT CORPORATION
- GraphPad Prism, Version 5.03, GraphPad Software, Inc. - Validity criteria fulfilled:
- yes
- Remarks:
- control group: no daphnids immobilized or showed any signs of disease or stress, dissolved O2 concentration in the 24-hours old media was ≥ 7.16 mg/L) in all concentration levels and the control.
- Conclusions:
- Based on the geometric mean measured concentrations of the test item 2-hexyldecanoic acid, the 48 hours EC50 for Daphnia magna was 302 µg/L (confidence limits: 203 – 448 µg/L).
- Executive summary:
In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item 2-hexyldeccanoic acid were determined according to OECD 202 (2004).
The study was conducted under semi-static conditions over a period of 48 hours with a saturated solution of the test item and a further four dilution levels in a geometric series with a separation factor of 2 (nominal concentrations 6.25 to 100% of the saturated solution, corresponding to the geometric mean measured concentrations 20.0 – 52.4 – 112 – 203 – 448 µg/L).
The test item is a colorless liquid with a water solubility of 71 µg/L (ECHA factsheet, QSAR calculation). A saturated solution of the test item was prepared before the start of the exposure (day 0) and before the renewal of the test solutions (day 1). The saturated solution was used as the highest concentration level and as the stock solution for the preparation of all further tested concentration levels.
The tested concentration levels were colorless and visually clear throughout the exposure period. A negative Tyndall effect was observed in the saturated solution. The test solutions were colourless and clear. Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration level and the untreated control.
The test item concentrations were analytically verified via LC-MS/MS in the fresh media at the start of the exposure and at the renewal of the test solutions (0 and 24 hours) as well as in the old media at the renewal and at the end of the test (24 and 48 hours) in all tested concentration levels and the control.
The measured concentrations of the test item in the old media (24 and 48 hours)were in the range of < LOQ to 117% of the initially measured concentrations.
Based on the geometric mean measured concentrations of the test item 2-hexyldecanoic acid, the 48 hours EC50 for Daphnia magna was 302 µg/L (confidence limits: 203 – 448 µg/L).
Reference
Table 2: Measured Concentrations of the Test Item Isocarb 16 during the Definitive Test
Sampling date | Fresh media 0 hours |
Old media, 24 hours | Fresh media, 24 hours | Old media, 48 hours | Geometric mean measured test item concentration/µg/L | ||
Percentage of the saturated solution/% | Isocarb 16 | ||||||
Meas. conc./µg/L | Meas. conc./µg/L | % | Meas. conc./µg/L | Meas. conc./µg/L | % | ||
100 | 547 | 568 | 104 | 333 | 391 | 117 | 448 |
50.0 | 224 | 258 | 115 | 164 | 178 | 109 | 203 |
25.0 | 137 | 141 | 103 | 92.8 | 87.5 | 94 | 112 |
12.5 |
65.1 |
55.8 |
86 |
50 .8 |
40.9 |
81 |
52.4 |
6.25 |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
20 |
Control |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
< LOQ |
|
Table 3: EC10-, EC50- and EC100-Values
Effect concentrations |
Test duration/hours |
2 -hexyldecanoic acid Geometric mean measured concentration of the test item/µg/L |
EC10 (with confidence limits |
24 |
> 448 |
48 |
203 < EC10 < 448 |
|
EC50 (with confidence limits |
24 |
> 448 |
48 |
302 (203 -448)* |
|
EC100 |
24 |
> 448 |
48 |
448 |
*= determined via straight line regression due to no partial response
Table 4: Immobilization Rates after 24 and 48 hours of Exposure in the Definitive Test
(n = 20, divided into 4 replicates with 5 daphnids each)
Geometric mean measured test item concentration/µg/L |
Immobilization/% | |||||||||
24 hours | 48 hours | |||||||||
Replicates | Replicates | |||||||||
1 | 2 | 3 | 4 | MV | 1 | 2 | 3 | 4 | MV | |
448 | 0 | 0 | 20 | 0 | 5 | 100 | 100 | 100 | 100 | 100 |
203 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
112 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
52.4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
20.0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Control | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Table 5: Absolute Numbers of immobile Daphnids after 24 and 48 hours of Exposure in the Definitive Test
(n = 20, divided into 4 replicates with 5 daphnids each)
Geometric mean measured test item concentration/µg/L |
Number of immobile daphnids/total number of daphnids | |||||||||
24 hours | 48 hours | |||||||||
Replicates | Replicates | |||||||||
1 | 2 | 3 | 4 | Sum | 1 | 2 | 3 | 4 | Sum | |
448 | 0/5 | 0/5 | 1/5 | 0/5 | 1/20 | 5/5 | 5/5 | 5/5 | 5/5 | 20/20 |
203 | 0/5 | 0/5 | 0/5 | 0/5 | 0/20 | 0/5 | 0/5 | 0/5 | 0/5 | 0/20 |
112 | 0/5 | 0/5 | 0/5 | 0/5 | 0/20 | 0/5 | 0/5 | 0/5 | 0/5 | 0/20 |
52.4 | 0/5 | 0/5 | 0/5 | 0/5 | 0/20 | 0/5 | 0/5 | 0/5 | 0/5 | 0/20 |
20.0 | 0/5 | 0/5 | 0/5 | 0/5 | 0/20 | 0/5 | 0/5 | 0/5 | 0/5 | 0/20 |
Control | 0/5 | 0/5 | 0/5 | 0/5 | 0/20 | 0/5 | 0/5 | 0/5 | 0/5 | 0/20 |
Description of key information
In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item 2-hexyldeccanoic acid were determined according to OECD 202 (2004). The study was conducted under semi-static conditions over a period of 48 hours with a saturated solution of the test item and a further four dilution levels in a geometric series with a separation factor of 2 (nominal concentrations 6.25 to 100% of the saturated solution, corresponding to the geometric mean measured concentrations 20.0 – 52.4 – 112 – 203 – 448 µg/L). Based on the geometric mean measured concentrations of the test item 2-hexyldecanoic acid, the 48 hours EC50 for Daphnia magna was 302 µg/L (confidence limits: 203 – 448 µg/L).
In addition, a reliable calculated value from ECOSAR 2.0 is available. The calculated daphnid 48 hour LC50 was 0.29 mg/L for the substance.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- 0.32 mg/L
Additional information
In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item 2-hexyldeccanoic acid were determined according to OECD 202 (2004).
The study was conducted under semi-static conditions over a period of 48 hours with a saturated solution of the test item and a further four dilution levels in a geometric series with a separation factor of 2 (nominal concentrations 6.25 to 100% of the saturated solution, corresponding to the geometric mean measured concentrations 20.0 – 52.4 – 112 – 203 – 448 µg/L).
The test item is a colorless liquid with a water solubility of 71 µg/L (ECHA factsheet, QSAR calculation). A saturated solution of the test item was prepared before the start of the exposure (day 0) and before the renewal of the test solutions (day 1). The saturated solution was used as the highest concentration level and as the stock solution for the preparation of all further tested concentration levels.
In addition, the ECOSAR 2.0,model calculated a daphnid 48 hour LC50 was 0.29 mg/L for the substance.
In toxicity studies with linear C16 acid, no toxicity to daphnids was observed at the level of water solubility.
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.