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EC number: - | CAS number: -
- 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:
- 09 - 11 Mar 2020
- 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:
- April 2004
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 2017
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Version / remarks:
- April 1996
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- National Institute of Pharmacy and Nutrition, Budapest, Hungary (date of issue: 03 August 2018)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control and 100 mg/L
- Sampling method: Duplicate samples were taken (2 x ~15 mL from three replicates) at the beginning and at the end of the renewal periods from the control and at the applied test concentration level.
- Sample storage conditions before analysis: Samples were frozen and kept approximately at -20 °C at the Test Facility. One set of the samples was sent to the Test Site for analysis and one set was retained as a back-up at the Test Facility. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Because the test item is a UVCB with very poor solubility, test solution was prepared using a saturated solution method according to the Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, OECD No. 23. A saturated test item solution (nominal loading rate of 100.0 mg/L) was prepared by dispersing/dissolving the amount of test item into the test medium (ISO Medium) two days before the start of the experiment. This solution was shaken for about 24 hours at approximately 30°C and then equilibrated for about 24 hours at approximately 20°C. The non-dissolved test material was removed by filtration through a fine (0.22 µm) filter to give the appropriate WAF solution. The maximum amount of test material in the medium was exposed applying this procedure. Prior to treatment of each renewal period, test item solution was prepared by the method described above. The test solution was prepared just before introduction of the Daphnia (start of the treatments). - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Age at study initiation (mean and range, SD): < 24 h
- Stage and instar at study initiation: juveniles
- Method of breeding: The Daphnia are bred in Ecotoxicological Laboratory of Charles River Laboratories Hungary Kft.
- Source: István Szent University, 2100 Gödöllő, Páter Károly u. 1, Hungary
- Feeding during test : No
ACCLIMATION
- Acclimation period: None
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 244 mg/L as CaCO3
- Test temperature:
- 20.5 – 20.8 °C
- pH:
- 7.78 – 7.89
- Dissolved oxygen:
- 7.1 – 8.7 mg/L
- Nominal and measured concentrations:
- - nominal concentration: 100 mg/L nominal loading rate WAF
- mean measured concentration 0 h new: 0.256 mg/L
- mean measured concentration 24 h new: 0.256 mg/L
- mean measured concentrtaion 24 h old: 0.181 mg/L
- mean measured concentration 48 h old: 0.178 mg/L
- geometric mean: 0.214 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass beakers
- Volume of solution: 50 mL
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): 24 h
- 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 water according to guideline
- Culture medium different from test medium: No
- Intervals of water quality measurement: water temperature, the oxygen concentrations and pH of the control and the test solution were measured at the beginning and at the end of the renewal periods
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light/ 8 hours darkness
EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- mobility was checked every 24 hours
RANGE-FINDING STUDY
- Test concentrations: 0.1, 1, 10, 100 mg/L nominal loading rate WAF
- Results used to determine the conditions for the definitive study: no significant toxicity was found in any of the test concentrations - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate is tested at least twice a year
- Duration:
- 48 h
- Dose descriptor:
- EL50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOELR
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Remarks:
- WAF
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.214 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.214 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- The biological results are mainly related nominal loading rate WAF, but expressed as both the nominal loading rate WAF and measured geometric mean test item concentration.
- Results with reference substance (positive control):
- - Last test with potassium dichromate (05 - 06 Mar 2020): The 24 h EC50: 0.87 mg/L, (95 % confidence limits: 0.70 – 0.99 mg/L)
- Reported statistics and error estimates:
- No statistical analysis was performed because of the lack of toxic effects.
- Validity criteria fulfilled:
- yes
- Remarks:
- See table 2 at "any other information on results incl. tables".
Reference
Table 1:Number and percentage of immobilised daphnids
Test Group |
|
Number of treated daphnids |
Number of immobilised daphnids |
|||
|
24 hours |
48 hours |
||||
|
number |
percent |
number |
percent |
||
Control |
|
20 |
0 |
0 |
0 |
0 |
100.0 mg/L nominal loading rate |
|
20 |
0 |
0 |
0 |
0 |
Table 2: Validity criteria
Criterion from the guideline |
Outcome |
Validity criterion fulfilled |
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized. |
0% |
Yes |
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels. |
≥7.1 mg/L |
Yes |
Description of key information
Daphnia magna: 48-hour EC50 > 0.214 mg/L (geom. mean meas.) (OECD 202, 2004)
Daphnia magna: 48-hour NOEC >= 0.214 mg/L (geom. mean meas.) (OECD 202, 2004)
Key value for chemical safety assessment
Additional information
The acute toxicity of Glycerides, C16-18 (even numbered) mono- and di- and their citrates (EC 701-358-7) to aquatic invertebrates was studied in a 48 hour semi-static limit test according to OECD guideline 202. Daphnids were exposed to a nominal loading rate of 100 mg/L (WAF). Analytical measurement resulted in measured concentrations of 0.256 mg/L at the start of the renewal period and a geometric mean concentration of 0.214 mg/L. The effect parameters were measured after 24 and 48 hours. No immobilisation was observed in the replicates of the test concentration and control at any time of the test period. Therefore the EC50 value after 48 h was determined to be > 0.214 mg/L. The result is based on the geometric mean measured test concentrations of the test substance.
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