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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 807-015-9 | CAS number: 126437-91-0
- 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Tetradecyltrimethylammonium oxalate
- IUPAC Name:
- Tetradecyltrimethylammonium oxalate
- Reference substance name:
- 154858-16-9
- Cas Number:
- 154858-16-9
- IUPAC Name:
- 154858-16-9
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Constituent 2
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 5.12 - 12.8 - 32.0 - 80.0 - 200 - 500 µg/L
- Sampling method: All test concentrations above LOQ and the control were analytically verified by photometer in the fresh media (at 0 hours) and old media (after 48 hours) as specified below.
Sampling from freshly prepared media was carried out immediately after homogenisation. Samples of the old media were taken directly from the test vessels.
- Sample storage conditions before analysis: All samples were stored at 7±2°C before preparation and before analysis, if necessary.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Stock solution: 50 mg/L, prepared with dilution water
Dispersion treatment: Agitation
Test concentrations: 500-200-80.0-32.0- 12.8-5.12 µg/L
In the stock solution of 50 mg/L a slight turbidity was observed at test start.
In all tested concentration levels the test item was clearly dissolved throughout exposure.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna (STRAUS)
- Strain: Clone 5
- Source: Institut für Wasser-, Boden- Lufthygiene (WaBoLu)
- Age at study initiation: 2 to 24 h
- Method of breeding: In 2-3 L glass vessels with appr. 1.8 L culture medium, at 21 °C, in an incubator, 16 h illumination, illumination strength max. 20 µEmol x m-2 x s-1
- Feeding during test: No feeding
ACCLIMATION
- Acclimation period: 2 h
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: No feeding
DILUTION WATER:
Dilution water according to EC 92/69 L383A C.2
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- no
Test conditions
- Hardness:
- Dilution water at test start: 244 mg CaCO3/l
- Test temperature:
- 21±1°C
- pH:
- 7.51-7.80
- Dissolved oxygen:
- 8.08-8.52 mg/l
- Salinity:
- not measured, freshwater
- Nominal and measured concentrations:
- please refer to "Any other information on material and methods"
- Details on test conditions:
- Test vessels: Glass beakers (5 cm ID x 8 cm H), 50 ml
Volume of the study medium: 20 ml
Number of study organisms per concentration and control: 20 animals, divided into 4 (2*) parallel samples, each with 5 (10*) animals
Number of animals per test vessel: 5 (10*)
Number of parallel samples per concentration: 4 (2*)
Photoperiod: 16/8 h light/dark cycle
*) The information in brackets refer to the test of the reference item
TEST DESCRIPTION
A static preliminary range finding tests was conducted with 6 concentrations of the test item ranging from 0.5 to 50 000 µg/L, set up in a geometric series with a factor of 10 (NON-GLP-state ).
Based on the results of the preliminary test the definitive test was performed with 6 concentrations ranging from 5.12 to 500 µg/L in a geometric series with a factor of 2.5 under static conditions to enable the determination of immobilisation after 24 and 48 hours.
2 to 24 h old daphnids were used for the definitive test. They were obtained by removing the mother animals twice within 22 h. The daphnids were acclimated to the dilution water ca. 2 h before the test started. The daphnids were not fed during the study.
Control replicates with dilution water (test medium without test item) were tested under the same conditions as the test groups.
20 daphnids divided into 4 (2*) groups with 5 (10*) animals per test vessel were used. All test beakers were placed in an incubator (light/dark cycle 16/8 for 48 h at 20 ± 1 °C constant). In the definitive test the immobilisation of the daphnids was observed after 24 and 48 hours of exposure. Water parameters were measured at begin and end of the study.
The reference item was tested in five concentrations within the concentration range 0.58 to 5.8 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 29.3 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 37.9 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 12.8 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 32 µg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Mortality of control: 0 %
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No - Results with reference substance (positive control):
- The percentage immobility for the reference item was determined after 24 h. The EC100-value was determined directly from the test results. The EC10 and EC50- with 95 % confidence interval (CI) was determined in a probability network by interpolation according to standard procedures.
EC-values after 24 h of the reference item in mg/L:
EC10 : 0.96
EC50 : 1.73 (CI 1.47- 2.03)
EC100 : 5.80
The EC50-value of the reference item potassium dichromate after 24 h is within the prescribed concentration range of 1.0 - 2.5 mg/L of quality criteria according to AQS: DIN Guideline 38412 L 30. - Reported statistics and error estimates:
- The No Observed Effect Concentration (NOEC) for immobilisation (<10 %) of 12.8 µg/L was determined directly from the test results obtained.
The concentration-effect-relationships after 24 and 48 h of exposure are graphically illustrated in a probability network. The 24 and 48 h EC10and EC50-values were calculated by probit analysis.
Any other information on results incl. tables
Percentage of Daphnids Incapable of Swimming after 24 and 48 h of Exposure (n = 20)
Nominal |
IMMOBILIZATION [%] |
|||||||||
Test Item Concentration |
24 h |
48 h |
||||||||
[µg/L] |
Replicates |
Replicates |
||||||||
|
1 |
2 |
3 |
4 |
MV |
1 |
2 |
3 |
4 |
MV |
500 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
100 |
200 |
80 |
100 |
100 |
100 |
95 |
100 |
100 |
100 |
100 |
100 |
80.0 |
60 |
40 |
20 |
60 |
45 |
100 |
100 |
100 |
100 |
100 |
32.0 |
0 |
0 |
20 |
0 |
5 |
0 |
20 |
40 |
20 |
20 |
12.8 |
0 |
0 |
20 |
0 |
5 |
0 |
20 |
20 |
0 |
10 |
5.12 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the nominal concentrations of the test item the 48-h EC50 for Daphnia magna was calculated to be 37.9 µg/L (95 % confidence limits: 34.7 – 41.4 µg/L). The NOEC after 48 h was 12.8 µg/L. The LOEC after 48 h was 32.0 µg/L.
- Executive summary:
The Acute lmmobilisation (EC50) of the test item, to Daphnia magna (STRAUS) was determined according to OECD Guideline 202 (1999, Draft) and EC Directive 92/69/EC Method C.2 (1992) from 2003-03-10 to 2003-03-12 at DR.U.NOACK-LABORATORIEN, D-31157 Sarstedt, Germany. The study was conducted under static conditions with 6 concentrations ranging from 5.12 to 500 µg/L in a geometric series with a factor of 2.5 over a duration of 48 hours. 20 test organisms were exposed to each test concentration and control. The test concentration levels of 12.8 to 500 µg/L of the test item and the control were analytically verified via photometer after 0 h (new media) and 48 h (old media). Recovery rates of the test item were > 80 %. All results are given based on the nominal test item concentrations. Details of the analytical results are given in part 9. The EC10 and
EC50-values were calculated by probit analysis according to WEBER (1986). A reference test was carried out with potassium dichromate as reference item. The EC50-value of the reference item at 1. 73 mg/L after 24 h was within the prescribed concentration range of 1.0 to 2.5 mg/L according to AQS, DIN Guideline 38412 L 30. Water quality parameters of pH-value and dissolved oxygen concentration measured at 0 h and 48 h were determined to be within the acceptable limits. The validity criteria of the test guideline were fulfilled.
EC10, EC50- (with Confidence Interval), EC100 -Values, NOEC and LOEC (based on nominal concentrations)
Test
Nominal Test Item Concentration
Duration
[µg/L]
[h]
EC10
24
40.1
48
29.3
EC50
24
81.9
48
37.9
95 % confidence interval
24
67.1-99-9
48
34.7-41.4
EC100
24
500
48
80.0
NOEC
48
12.8
LOEC
48
32.0
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.