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EC number: 226-214-6 | CAS number: 5328-37-0
- 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
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- February 2018
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: AD16081001
- Expiration date of the batch: 2019-08-09
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: Stable under ambient conditions - Analytical monitoring:
- yes
- Details on sampling:
- Eight replicate samples (2 mL per replicate) were taken from the test solution (100 mg/L) and from the control at the start and at the end of the test.
- Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
The test solution used in the test was prepared by mechanical dispersion without using of any solubilising agent.
- Method: The test solution used in the test was prepared by mechanical dispersion. 0.0501 g of test item was dissolved in 501 mL dilution water (ISO Medium) in order to obtain the concentration of 100 mg/L. The test solution was prepared just before introduction of Daphnia (start of the experiment).
- Controls: Blank control (test water only), positive control (with Potassium dichromate)
- Introduction of Individuals: Twenty Daphnia per test group, divided into four replicates (glass beaker) of five animals, each replicates in ~40 mL test medium.
- Evidence of undissolved material: No - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Strain/clone: Straus
- Source: Laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection) 2100 Gödöllő, Kotlán S. u. 3. Hungary
- Age at test start: Less than 24 hours old
- Feeding during test: no
ACCLIMATION
- Acclimation period: no, breeding conditions same as test conditions - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Post exposure observation period:
- No
- Hardness:
- 249 mg/L (as CaCO3)
- Test temperature:
- 19.7 – 21.0 °C
- pH:
- 8.06– 8.29
- Dissolved oxygen:
- 7.37 – 7.51 mg/L
- Salinity:
- Not applicable
- Conductivity:
- Not specified
- Nominal and measured concentrations:
- Nominal: 100 mg/L
Measured mean: 114 mg/L at the start of the test (114 % of the nominal value), 97.7 mg/L at the end of the test (98 % of the nominal value) - Details on test conditions:
- TEST SYSTEM
- Test vessel: Glass beakers
- Material, fill volume: glass, 40 mL medium
- Aeration: No
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control: 4
TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: ISO medium, according to OECD 202
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light (artificial illumination) and 8 hours darkness
- Light intensity: 895 lux
EFFECT PARAMETERS MEASURED
- Visual observation of immobility or mortality after 24 and 48 h of exposure
PRELIMINARY EXPERIMENT
A non-GLP preliminary test was performed at the nominal concentration of 100 mg/L in order to check the toxicity of the test item on the daphnids. Ten daphnids (divided into two replicates) in the test concentration and control were exposed for 48 hours (respectively). In the preliminary test no immobility or any sub-lethal effect was detected in the treated test concentration and in the control group during the 48-h exposure period. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate (K2Cr2O7)
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EL10
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- other: EC20
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- In this 48-hour acute toxicity test on Daphnia magna, the obtained results showed that the test item had no significant toxic effects on the mobility of the daphnids up to the limit concentration of 100 mg/L. The 48h-EC50 was determined to be greater than 100 mg/L. All validity criteria were met. The results are based on the nominal test item concentration.
- Results with reference substance (positive control):
- The 24h EC50 was determined to be 1.41 mg/L (95% conf. limits: 1.19 – 1.68 mg/L).
- Reported statistics and error estimates:
- A limit test was performed and no immobility was observed in the treated group, therefore, statistical analysis was not performed. The NOEC, LOEC and ECx values of the test item were determined directly from the raw data.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In an Acute Immobilisation Test with Daphnia magna according to OECD TG 202 and EU Method C.2 the 48-h EC50 of the test item was determined to be > 100 mg/L.
- Executive summary:
The acute immobilisation of the test item to Daphnia magna was determined in compliance with OECD TG 202 and EU Method C.2. A limit test was performed in which the test animals (5 animals per vessel) were exposed for 48 hours to aqueous test media containing the test item at the nominal concentration of 100 mg/L (4 replicates), a blank control containing test water only (4 replicates) and a positive control with potassium dichromate as reference item (last study: 2018 -02 -28 to 2018 -03 -01). The test item concentration was verified by LC-MS/MS analysis to be ± 20 % of the nominal concentration and hence results are based on nominal concentrations. There was no immobilisation observed in the twenty daphnids exposed to the test item treated group and there was no immobilization observed in the the blank control. Accordingly, the 48-h NOEC was determined as 100 mg/L (nominal) and the 48-h LOEC, EC10, EC20 and EC50 values were determined to be higher than 100 mg/L (nominal, directly from the raw data).The 24h EC50 for the reference substance potsassium dichtomate was determined to be 1.41 mg/L, confirming the suitability of the test system. All validity criteria of the guidelines were fulfilled.
Reference
Table 1: Immobilization of the test animals
Nominal concentration |
Number of |
Number of immobilised |
% of immobilised |
||
24 h |
48 h |
24 h |
48 h |
||
Control |
20 |
0 |
0 |
0 |
0 |
100 |
20 |
0 |
0 |
0 |
0 |
Table 2: Concentration of Test Item measured in the Test Solutions
Nominal concentration mg/L | Start (June 06, 2018) | End (June 08, 2018) | ||
Concentration (mg/L) | % of the nominal | Concentration (mg/L) | % of the nominal | |
Control | not detected | - | not detected | - |
100 | 97.4 | 97 | 99.8 | 100 |
125 | 125 | 99.9 | 100 | |
122 | 122 | 96.7 | 97 | |
118 | 118 | 97.1 | 97 | |
118 | 118 | 96.2 | 96 | |
111 | 111 | 97.9 | 98 | |
113 | 113 | 96.6 | 97 | |
110 | 110 | 97.6 | 98 | |
Mean: | 114 | 114 | 97.7 | 98 |
RSD: | 8 | 8 | 1 | 1 |
Description of key information
In an Acute Immobilisation Test with Daphnia magna according to OECD TG 202 and EU Method C.2 the 48-h EC50 of the test item was determined to be > 100 mg/L.
Key value for chemical safety assessment
Additional information
Key study
The acute immobilisation of the test item to Daphnia magna was determined in compliance with OECD TG 202 and EU Method C.2. A limit test was performed in which the test animals (5 animals per vessel) were exposed for 48 hours to aqueous test media containing the test item at the nominal concentration of 100 mg/L (4 replicates), a blank control containing test water only (4 replicates) and a positive control with potassium dichromate as reference item. The test item concentration was verified by LC-MS/MS analysis to be ± 20 % of the nominal concentration and hence results are based on nominal concentrations. There was no immobilisation observed in the twenty daphnids exposed to the test item treated group and there was no immobilization observed in the blank control. Accordingly, the 48-h NOEC was determined as 100 mg/L (nominal) and the 48-h LOEC, EC10, EC20 and EC50 values were determined to be higher than 100 mg/L (nominal, directly from the raw data). The 24h EC50 for the reference substance potassium dichtomate was determined to be 1.41 mg/L, confirming the suitability of the test system. All validity criteria of the guidelines were fulfilled (Toxi-Coop ZRT, 2018).
Supporting study
The short-term toxicity of the test item to daphnids was calculated using ECOSAR v1.11 class-specific estimation for Aldehydes (Mono). The test item falls in the applicability domain of the model. In result, the 48-h LC50 was calculated to be 12217.028 mg/L (SCC GmbH, 2018).
Disclaimer: In accordance with Article 13 and taking into account the conditions set out in Annex XI of Regulation (EC) No 1907/2006, information on intrinsic properties of substances might be generated by alternative methods other than tests if the (Q)SAR model has been proven to be valid, the substance falls in the applicability domain of the model, results are sufficient for the classification and labeling and/or risk assessment and the applied method is reliably and adequately documented. These criteria are considered to be fulfilled and, hence, the result to be suitable for classification and labelling purposes and/or risk assessment.
Conclusion
Based on results of a GLP-compliant guideline study (Toxi-Coop ZRT, 2018) the 48-h EC50 is considered to be > 100 mg/L (nominal). This result is supported by an ECOSAR estimation (SCC GmbH, 2018) since the calculated 48-h EC50 of the test item was even higher (48-h LC50 = 12217.028mg/L).
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