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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 228-794-6 | CAS number: 6359-10-0
- 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:
- key study
- Study period:
- 2018-02-15 to 2018-10-26
- 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:
- 13 April 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: 0.6, 1.3, 2.9, 6.4, 14.0 and 30.9 mg/L
- Sampling method: Analysis of test concentration and stability of the test item was performed at the beginning of the test (0 hour) and day 0 and at the end of the test (48 hours) from all test concentrations. 15 mL of samples were collected in duplicates from each group. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Stock solution was freshly prepared prior to exposure, by weighing required quantity of test item in a beaker; small volume of reconstituted water was added and mixed well using a glass rod. After test item was completely soluble, the test formulation was transferred into a measuring cylinder and the beaker was rinsed with reconstituted water and transferred again to the measuring cylinder. Rinsing process was repeated until the complete transfer of test contents. Stock solution prepared was kept on magnetic stirrer to maintain homogeneity. Test medium of chosen concentration was prepared by dilution of stock solution. - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Source: Environmental and Molecular Toxicology Division, Department of Zoology, Kamataka University, Karnataka, India.
- Age at study initiation: Less than 24 hours
- Feeding during test: No
ACCLIMATION
- Acclimation period: 48 h
- Acclimation conditions: same as test
- Type and amount of food: Daphnids were fed with live algal cells (Pseudokirchneriella subcapitata) of 2 mL per liter during the acclimatization.
- Feeding frequency: Daphnids was fed with live algal cells at the beginning and on Day 2 of acclimatization.
- Health during acclimation: No signs of stress - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 212 mg/L of CaCO3
- Test temperature:
- 20.1 - 20.9 °C
- pH:
- 7.46 - 7.91
- Dissolved oxygen:
- 6.25 - 6.84 mg/L
- Salinity:
- not applicable.
- Conductivity:
- no data.
- Nominal and measured concentrations:
- Nominal: 0.6, 1.3, 2.9, 6.4, 14.0 and 30.9 mg/L
Measured: 0.58, 1.35, 2.91, 6.67, 14.55 and 32.66 mg/L (after 48 hours) - Details on test conditions:
- TEST SYSTEM
- Test vessel: rectangular beaker
- Type: open
- Material, size: Glass, 100 mL
- Aeration: water was aerated prior to use for the test so that the dissolved oxygen concentration has reached saturation.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Culture medium different from test medium: No
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours of light and 8 hours dark.
EFFECT PARAMETERS MEASURED:
- Each test vessel was observed for immobilized Daphnids at 24 and 48 hours after the beginning of the test, in addition any abnormal behavior or appearance was recorded.
VEHICLE CONTROL PERFORMED: no
RANGE-FINDING STUDY
- Test concentrations: 0.01, 0.1, 1.0, 10.0, 50.0 and 100.0 mg/L
- Results used to determine the conditions for the definitive study: During the range finding study, no immobility was observed in control and in the tested concentrations of 0.01 and 0.1 mg/L during the 48 hour exposure period. In the tested concentrations of 1.0, 10.0, 50.0 and 100.0 mg/L during the 48 hour exposure period an immobilization of 10, 50, 100 and 100 % was observed. Based on the results of the range-finding study, the main study was conducted at concentrations of 0.6, 1.3, 2.9, 6.4, 14.0 and 30.9 mg/L of test item using a geometric factor of 2.2) - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 6.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % CI: 4.778 - 9.116
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- 1.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 0.6 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Behavioural abnormalities: Lethargy
- Mobility of control: 100 %
- Other adverse effects control: No
- Abnormal responses: Lethargy, localisation at the bottom of the beaker.
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
- Effect concentrations exceeding solubility of substance in test medium: No - Results with reference substance (positive control):
- - Results with reference substance valid?
Yes
- Relevant effect levels: 0.12, 0.24, 0.48, 0.96, 1.92 mg/L
- Limit test: No
- Dose-response test: Yes
- EC50: 0.57 mg/L - Reported statistics and error estimates:
- Data are analysed by statistical methods (Finney’s probit analysis) to calculate the EC50 with confidence limits.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In a short-term toxicity study in Daphnia magma according to OECD guideline 202, an EC50 of 6.6 mg/L (95 % CI: 4.778 to 9.116 mg/L) was determined.
- Executive summary:
The test item was evaluated for acute toxicity on Daphnia magma according to OECD guideline 202. Based on the results of a range finding study test item concentrations of 0.6, 1.3, 2.9, 6.4, 14.0 and 30.9 mg/L were tested along with untreated control and positive control (potassium dichromate). 5 Daphnids/dose were exposed to the test item by aqueous exposure (treatment) under static conditions. Signs of toxicity and immobility were recorded after 24 and 48 hours. No clinical signs of toxicity were observed in control and in the tested concentration of 0.6 mg/L during the 48 hour observation period. Immobilization and lethargy were observed in the tested concentrations of 1.3, 2.9, 6.4 and 14.0 mg/L during the 48 hour observation period. Percent immobility of 15, 25, 40 and 65 % were observed in the tested concentrations of 1.3, 2.9, 6.4 and 14.0 mg/L. 100 % immobilization was observed in the highest concentration of 30.9 mg/L after 48 hours.
Based on these results, an EC50(48 h) of 6.6 mg/L (95 % CI: 4.778 to 9.116 mg/L) was determined. The No Observed Effect Concentration (NOEC) and Lowest Observed Effect Concentration (LOEC) over the 48 hour exposure period were found to be 0.6 and 1.3 mg/L, respectively.
Reference
Table 1: Test concentration analysis in test media during main study (reconstituted water)
Day 0 (0 Hour) |
Day 2 (48 Hours) |
||||
Nominal concentration (mg/L) |
Conc. Obtained (mg/L) |
% Recovery |
Nominal concentration (mg/L) |
Conc. Obtained (mg/L) |
% Recovery |
0.0 |
- |
- |
0.0 |
- |
- |
0.60 |
0.57 |
94.17 |
0.60 |
0.58 |
95.84 |
1.30 |
1.29 |
98.85 |
1.30 |
1.35 |
103.85 |
2.90 |
2.84 |
97.76 |
2.90 |
2.91 |
100.18 |
6.40 |
6.43 |
100.47 |
6.40 |
6.67 |
104.22 |
14.00 |
14.28 |
102.00 |
14.00 |
14.55 |
103.93 |
30.90 |
31.64 |
102.40 |
30.90 |
32.66 |
105.68 |
Results reported that determined test concentrations at the 0 hour and stability at 48 hour were in the acceptable range of 20 % recovery to the nominal concentrations.
Description of key information
In a short-term toxicity study in Daphnia magma according to OECD guideline 202, an EC50 of 6.6 mg/L (95% CI: 4.778 to 9.116 mg/L) was determined.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 6.6 mg/L
Additional information
The test item was evaluated for acute toxicity on Daphnia magma according to OECD guideline 202. Based on the results of a range finding study test item concentrations of 0.6, 1.3, 2.9, 6.4, 14.0 and 30.9 mg/L were tested along with untreated control and positive control (potassium dichromate). 5 Daphnids/dose were exposed to the test item by aqueous exposure (treatment) under static conditions. Signs of toxicity and immobility were recorded after 24 and 48 hours. No clinical signs of toxicity were observed in control and in the tested concentration of 0.6 mg/L during the 48 hour observation period. Immobilization and lethargy were observed in the tested concentrations of 1.3, 2.9, 6.4 and 14.0 mg/L during the 48 hour observation period. For immobility a percent of 15, 25, 40 and 65 % were observed in the tested concentrations of 1.3, 2.9, 6.4 and 14.0 mg/L. 100 % immobilization was observed in the highest concentration of 30.9 mg/L after 48 hours.
Based on these results, an EC50(48 h) of 6.6 mg/L (95 % CI: 4.778 to 9.116 mg/L) was determined. The No Observed Effect Concentration (NOEC) and Lowest Observed Effect Concentration (LOEC) over the 48 hour exposure period were found to be 0.6 and 1.3 mg/L, respectively.
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.