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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:
- 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:
- 1996
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- National Institute of Pharmacy and Nutrition, Budapest, Hungary (issued: 2018-08-03)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: Control and 100 mg/L nominal loading rates WAFs
- Sampling method: Analytical measurements were performed at the applied test concentration levels at the beginning and end of each renewal period, from the control at the beginning and end of experiment. Duplicate samples were taken (2 x ~15 mL) from the applied test concentration level and from the control (three replicates) from the stock solution at the beginning of the renewal periods and from the test at the end of the renewal periods.
- 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, if required for any confirmatory analyses. - Vehicle:
- no
- Details on test solutions:
- -Method: The test item is poorly soluble in water, so test solutions were prepared using a saturated solution method (nominal loading rate of 100 mg/L, water accommodated fraction, WAF) according to the Guidance Document on Aqueous-Phase Aquatic Toxicity Testing of Difficult Test Chemicals, OECD No. 23. The saturated test item solution was prepared by dispersing/dissolving the amount of test item into the test medium (ISO-medium) two days before the start of the study. 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. Prior to treatment of each renewal period, test item solutions were prepared by the method described above. The test solutions were prepared just before introduction of the Daphnia (start of the treatments).
-Control: Yes, dilution water (ISO-medium) - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Age at study initiation (mean and range, SD): < 24 h
- Method of breeding: The Daphnia are bred in Ecotoxicological Laboratory of Charles River Laboratories Hungary Kft. The health of the stock animals is continuously monitored by visual daily checking. Abnormal behaviour or significant decrease of population is recorded.
- Source: István Szent University, 2100 Gödöllő, Páter Károly u. 1, Hungary
- Feeding during test : No
ACCLIMATION
- Acclimation period: No
- Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Hardness:
- 244 mg/L (as CaCO3)
- Test temperature:
- 20.4 – 20.8°C
- pH:
- 7.79 – 7.90
- Dissolved oxygen:
- 7.1 – 8.5 mg/L
- Nominal and measured concentrations:
- - Nominal concentrations: 100 mg/L WAF
- Measured concentration: 0.08 mg/L (geometric mean)
- Further deatils see table 1 under "any other information on results incl. tables" - Details on test conditions:
- TEST SYSTEM
- Test vessel: glass beakers
- Fill volume: approximately 40 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-medium according to OECD guideline 202
- Culture medium different from test medium: No
- Intervals of water quality measurement: The water temperature was measured daily; 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 h light and 8 h darkness
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Immobility of daphnids was observed every 24 hours
VEHICLE CONTROL PERFORMED: no
RANGE-FINDING STUDY
- Test concentrations: 0.1, 1, 10, 100 mg/L nominal loading rates WAFs
- Results used to determine the conditions for the definitive study: No toxic response was observed during the range-finding study. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 0.08 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 0.08 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: There were no effects at saturation with the test item.
- Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: The observed 24h EC50 value of the reference item was 0.82 mg/L, (95% confidence limits: 0.66 – 0.93 mg/L).
- Other: The experimental period of the last positive control study with reference item Potassium dichromate (Batch no.: A0345704) was 05 - 06 September 2019. - Reported statistics and error estimates:
- No statistical analysis was performed because of the lack of toxic effects.
- Validity criteria fulfilled:
- yes
- Remarks:
- See Table 3 at "any other information on results incl. tables"
Reference
Table 1:Calculation of exposure concentrations
Nominal Loading |
Measured concentrations |
Measured concentrations |
||
start |
end |
start |
end |
|
Control |
<LOQ* |
<LOQ* |
<LOQ* |
<LOQ* |
100.0 |
0.064 0.091 0.087 |
0.049 0.053 0.059 |
0.094 0.126 0.095 |
0.078 0.081 0.088 |
*LOQ = 0.038 mg/L sample concentration (counting with 50x enrichment and 1.05x dilution during the sample preparation)
Table 2:Number and percentage of immobile daphnids
Nominal Loading rate WAF mg/L |
Total number of animals |
Number of immobilized animals |
|||
24 h number |
24 h percent |
48 h number |
48 h percent |
||
Control |
20 |
0 |
0 |
0 |
0 |
100 |
20 |
0 |
0 |
0 |
0 |
Table 3: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
EC50 (48 h) > 0.08 mg/L (measured geom. mean)
Key value for chemical safety assessment
Additional information
There is one study available in which the short-term toxicity of Fatty acids, C16-18 (even numbered), esters with glycerol oligomers to aquatic invertebrates was assessed.
The GLP study was performed according to OECD 202 using Daphnia magna as test organism. A limit test with a nominal test concentration of 100 mg/L was conducted in a semi-static exposure regime. This test concentration was prepared as Water Accommodated Fraction (WAF). The test concentrations were analytically verified by GC-FID at the start and at the end of each renewal period. The test item concentration could be analytically quantified during the whole experiment, but the measured concentration was only slightly above the Limit of Quantification (LOQ = 0.038 mg/L). The corresponding measured geometric mean test item concentration was 0.08 mg/L. No effects were observed after 48 h. Therefore, an EC50 (48 h) of > 0.08 mg/L (measured geom. mean) was derived.
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