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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 241-659-6 | CAS number: 17675-60-4
- 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
- Remarks:
- Daphnia magna
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 August 2017 to 19 Sept 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 16VL8189
- Expiration date of the lot/batch: 04 Feb 2018
- Purity test date: 05 Aug 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: ambient (=< 30 deg C), dark, dry
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No - Analytical monitoring:
- yes
- Details on sampling:
- Analytical data are required by the guidelines for verification of test item concentrations as well as the stability of the test item over the entire test period. Analytical samples were taken from all test item concentrations and control at test start and after 24 hours from fresh and aged solutions and after 48 hours from aged solutions. For each sampling also a retain sample was taken.
All samples were stored deep frozen until they were transferred to the analytical laboratory. - Vehicle:
- no
- Details on test solutions:
- Based on the results of a non GLP range-finding test, the following nominal concentrations were tested in the main test: 100, 50.0, 25.0, 12.5, 6.25 mg/L and control. The necessary amount of test item for preparing the stock solution S1 was weighed on a weighing scoop and transferred to a volumetric flask. Test medium (see Appendix B) was added up to the bench mark and the solution was treated with 10 minutes of ultrasonication. Afterwards the solution was clear and transparent. Lower test solutions were prepared by dilution of the appropriate solutions with test medium. The preparation procedure was repeated after 24 hours. ~ 50 mL of the prepared solutions were transferred to each test vessel
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Daphnia magna Straus, Clone V, was used as the test organism. The animals are continuously bred in the laboratory and were originally purchased in a healthy condition from the Federal Environment Agency in Berlin/Germany. Daphnia magna was bred as single culture (1 daphnid per 100 mL) in Elendt M4 medium. The pHvalue of the aerated water was within a range of 6.0 – 9.0. The dissolved oxygen was above 60 % saturation and the total hardness 140 - 250 mg/L (as CaCO3), corresponding to 7.8 - 14°dH. The animals were fed with single cell green algae (Desmodesmus subspicatus, formerly Scenedesmus subspicatus) at least three times a week.
The daphnids were reared at a temperature of 20 ± 2 °C in a climatic chamber with 16 hours of illumination and 8 hours of darkness. The medium was changed three times per week. A pipette was used to separate the young daphnids from the adults.
Freshly hatched daphnids less than 24 hours old were used for the test. The first brood progeny was not used - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- None
- Post exposure observation period:
- None
- Hardness:
- 13°dH (232 mg/L as CaCO3)
- Test temperature:
- 19.0 – 19.8 °C
- pH:
- 6.85 – 7.97
- Dissolved oxygen:
- >= 8.9 mg/L
- Salinity:
- Not applicable
- Conductivity:
- Not measured
- Nominal and measured concentrations:
- 100, 50.0, 25.0, 12.5, 6.25 mg/L and control.
- Details on test conditions:
- Test procedure: semi-static
Duration: 48 hours
Temperature: 19.0 – 19.8 °C
Oxygen concentration: >= 8.9 mg/L
pH-value: 6.85 – 7.97
Exposure to light: 16 hours photoperiod /8 hours darkness daily
Feeding: none
Test vessels: four 100 mL glass beakers per concentration, each filled with ~ 50 mL, one additional replicate for pysico - chemical measurements without test organisms
Loading: ~ 10 mL of test solution for each animal
Aeration: none
Number of animals: 20 per concentration in 4 replicates of 5
Biological Assessment
After 24 h and 48 h the immobilised daphnids were counted. All daphnids not able to swim within 15 seconds after gentle agitation of the test vessel were considered to be immobilised. If present, behavioural changes of daphnids were recorded at 24 and 48 hours after starting the test.
Physico- Chemical Assessment
The test temperature and the pH-value as well as the oxygen concentration of the test solutions were measured at all concentrations at t = 0 h fresh and t = 24 h from fresh test solutions and after t = 24 h and t = 48 h from aged test solutions in one separate replicate per test item concentration without test organisms - Reference substance (positive control):
- yes
- Key result
- Duration:
- 48 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 50 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- Validity Criteria of the Study
Control immobilisation
The percentage of immobilisation should be 10 %. In this study the control immobilisation was 0 %.
Oxygen concentration
The dissolved oxygen concentration at the end of the test should be 3 mg/L in all test units. In this test, the dissolved oxygen concentration at the end of the test was 8.9 mg/L.
Biological Results
After 24 hours of exposure no immobilisation was observed in the control and up to and including 100 mg/L. After 48 hours of exposure no immobilisation was observed in the control and all test item concentrations up to and including 50.0 mg/L. 30 % immobilisation was observed at 100 mg/L.
No behavioural changes could be observed after 24 hours. After 48 hours the daphnids were sluggish in the highest test item concentration of 100 mg/L.
Analytical Results
The measured content of A.I./test item was between 94 % and 98 % of nominal in the fresh samples with a mean initial concentration of 96 % of nominal. In the aged samples the measured content was between 92 % and 97 % of nominal with a mean measured concentration of 95 % of nominal. Therefore toxicological endpoints were evaluated using the nominal of the test item. - Results with reference substance (positive control):
- In order to check the validity of the results, the toxicity of the reference item potassium dichromate was tested at 1.00 and 2.00 mg/L with 20 test organisms per test concentration.
The results indicate an EC50 (24 h) of the reference item potassium dichromate around 1.00 mg/L. Since the results are in accordance with the requirements of the OECD guideline 202 and fall within the historical data generated with the reference item at the testing facility, the daphnids were suitable for the determination of the toxicological effects of the test item. - Reported statistics and error estimates:
- All toxicological endpoints were evaluated using nominal concentrations.
- Validity criteria fulfilled:
- yes
- Conclusions:
- According to the results of the test, the EC50 (48 h) for immobilisation was supposed to be > 100 mg/L (nominal). The corresponding NOEC (48 h) was 50.0 mg/L (nominal).
- Executive summary:
The acute toxicity of the test substance to aquatic invertebrates (Daphnia magna) was performed in accordance with OECD Guideline 202.
A semi-static main test with nominal concentrations of 100, 50.0, 25.0, 12.5 6.25 mg/L and control was performed using twenty organisms per test concentration (4 replicates of 5 animals each). The duration of the test was 48 hours.
Temperature, pH-value and oxygen concentration of the test solutions measured after 0, 24 hours fresh and 48 hours aged are reported. Hardness of the test water was measured on the day of application. Analytical samples taken at 0 hours (initial value) and 24 hours from fresh and 48 hours aged test solutions were analysed from control and 50.0 and 100 mg/L.
According to the results of the test, the EC50 (48 h) for immobilisation was supposed to be > 100 mg/L (nominal). The corresponding NOEC (48 h) was 50.0 mg/L (nominal).
Reference
Results of test: 48 hours – immobilised Daphnia
mg/L |
Control |
6.25 |
12.5 |
25.0 |
50.0 |
100 |
Group 1 |
0 |
0 |
0 |
0 |
0 |
0 |
Group 2 |
0 |
0 |
0 |
0 |
0 |
2 |
Group 3 |
0 |
0 |
0 |
0 |
0 |
3 |
Group 4 |
0 |
0 |
0 |
0 |
0 |
1 |
Ʃ |
0 |
0 |
0 |
0 |
0 |
6 |
% |
0 |
0 |
0 |
0 |
0 |
30 |
Description of key information
The acute toxicity of the test substance to aquatic invertebrates (Daphnia magna) was performed in accordance with OECD Guideline 202.
A semi-static main test with nominal concentrations of 100, 50.0, 25.0, 12.5 6.25 mg/L and control was performed using twenty organisms per test concentration (4 replicates of 5 animals each). The duration of the test was 48 hours.
Temperature, pH-value and oxygen concentration of the test solutions measured after 0, 24 hours fresh and 48 hours aged are reported. Hardness of the test water was measured on the day of application. Analytical samples taken at 0 hours (initial value) and 24 hours from fresh and 48 hours aged test solutions were analysed from control and 50.0 and 100 mg/L.
According to the results of the test, the EC50 (48 h) for immobilisation was supposed to be > 100 mg/L (nominal). The corresponding NOEC (48 h) was 50.0 mg/L (nominal).
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 100 mg/L
Additional information
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.