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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 247-161-5 | CAS number: 25646-71-3
- 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:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- Daphnids use for the test were not <24h; a mixture of juvenile and adult daphnids was exposed to the test item
- GLP compliance:
- no
- Analytical monitoring:
- no
- Vehicle:
- no
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Source: Carolina Biological Supply company, Burlington North carolina, USA
- Other: Adult Daphnia were transferred to a separate holding container. After one week, the large adults were removed, and the young Daphnia were maintained for an additional two weeks prior to testing; Culture medium was obtained by blending approximately 2 grams of alfalfa pellets with 3-4 dried brine shrimp per liter of water.
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Nominal and measured concentrations:
- Control, 0.3, 0.9 and 3.0 mg/L
- Details on test conditions:
- TEST SYSTEM
Test vessel:
- Type: open
- Material, size, headspace, fill volume: 15O-mL Griffin beakers, a final volume of 100-110 mL was used throughout the testing program
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
OTHER TEST CONDITIONS
- Adjustment of pH: 7.0 to 7.5
- Light intensity: flourescent lighting
EFFECT PARAMETERS MEASURED: Adult mortalities were recorded on a daily basis. Births observed during the experiment were noted but not enumerated, nor were mortalities among the newborn included in the daily record.
RANGE-FINDING STUDY: A pre-test was performed with the test item concentrations of 0, 0.18, 0.33, 0.58, 1.02 and 1.82 mg/L. After a test period of 96 h the EC50 was determined to be >1.8 mg/L. Based on these results the main test was performed with the test item concentration range of 0 - 3.0 mg/L. - Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- 0.3 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mortality
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 Dec 2017 - 23 Oct 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)
- Version / remarks:
- 2004
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: all test item concentrations and the control
- Sampling method: Samples were analysed on the day of sampling; 1.8 mL from the approximate centre of the test vessels; Samples were taken at various time points (t=0, 1, 2, 4, 8, 24 and 48 h)
- Sample storage conditions before analysis: Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 100 mg/L or 10 mg/L was stirred for 5-7 min with magnetic stirr. Afterwards the testitem was completely dissolve. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium. Test solutions were clear and colorless up to 4.6 mg/L and increasingly pink colored at 10 and 100 mg/L at the end of the preparation procedure. It was noted that the test solution of 100 mg/L prepared for the combined limit/range-finding test darkened already during the first minutes after preparation.
- Controls: Only medium - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Water flea
- Strain/clone: Straus, 1820
- Source: In-house laboratory culture with a known history
- Age of parental stock: More than two weeks old
- Feeding during test: No
- Food type: A suspension of fresh water algae
- Frequency: Daily
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES:
Daphnids originated from a healthy stock, 2nd to 5th brood, showing no signs of stress such as mortality >20%, presence of males, ephippia or discoloured animals and there was no delay in the production of the first brood.
Start of each batch: Approximately 250 newborn daphnids, i.e. less than 3 days old, were placed into 5 litres of medium in an all-glass culture vessel, renewal of culture: After 7 days of cultivation, half of the medium twice a week. - Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- CaCO3: 180 mg/L
- Test temperature:
- 20 °C
- pH:
- 8.0 - 8.1 (Control)
7.7 - 8.0 (Test item concentration) - Dissolved oxygen:
- 8.6 - 8.8 mg/L (Control)
8.3 - 8.9 mg/L (Test item concentration) - Nominal and measured concentrations:
- Control, 0.46, 1.0, 2.2, 4.6 and 10 mg/L (nominal)
- Details on test conditions:
- TEST SYSTEM
Test vessel
- Type: open
- Material, size, headspace, fill volume: 60 mL, all-glass
- Aeration: No aeration of the test solutions was applied.
- No. of organisms per vessel: 20 per concentration
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: The following salts (analytical grade) were added to tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands): CaCl2.2H2O: 211.5 mg/L; MgSO4.7H2O: 88.8 mg/L; NaHCO3: 46.7 mg/L; KCl: 4.2 mg/L
- Culture medium different from test medium: Yes, a different medium was used for the test
- Others: Detail composition of test medium is included in section "Any other information on material and methods inncl tables"
OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: A daily photoperiod of 16 h
- Introduction of daphnids: Within 1 h after preparation of the test solutions
EFFECT PARAMETERS MEASURED: Immobility (including mortality): At 24 h and at 48 h; pH and dissolved oxygen: At the beginning and at the end of the test, for all concentrations and the control; Temperature of medium: Continuously in a temperature control vessel, beginning at the start of the test.
RANGE-FINDING STUDY
- Test concentrations: 0.1, 1.0, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: One immobilised daphnid was observed in the control (5%) at the end of the test. No immobility was observed at the two lowest test concentrations of 0.10 and 1.0 mg/L, while all daphnids exposed to 10 and 100 mg/L were immobilised at the study end. Therefore, the expected EC50 was between nominally 1.0 and 10 mg/L. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 3.2 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- - Mortality of control: no mortality was observed
- Results with reference substance (positive control):
- The actual responses in this reference test with K2Cr2O7 are within the ranges of the expected responses at the different concentrations, i.e. the 48h EC50 was between 0.3 and 1.0 mg/L. Hence, the sensitivity of this batch of Daphnia magna was in agreement with the historical data.The 48h EC50 was 0.59 mg/L with a 95% confidence interval between 0.53 and 0.72 mg/L.
- Reported statistics and error estimates:
- The 24h-EC50-value was calculated from the weibits of the percentages of affected daphnids and the logarithms of the corresponding test item concentrations using the maximum likelihood estimation method. The 48h-EC50 could not be determined using a regression method. This was because there was no concentration between the highest concentration (A) at which 0% immobility and the lowest concentration (B) at which 100% immobility occurred. Instead, the EC50 was calculated as (AB)½, with A and B being limits of the 95% confidence interval. ToxRat Professional v 3.2.1 (ToxRat Solutions® GmbH, Germany) was used to perform the analysis.
Referenceopen allclose all
Biological Results:
Mortality after 96 h: Control: 7.5 %; 0.3 mg/L: 50%, 0.9 mg/L: 63.6 %; 3 mg/L: 61.5 %
Table 1: Number of Introduced Daphnids and Incidence of Immobility in the Final Test
Time (h) |
Replicate |
Test substance |
|||||
Control |
0.46 |
1.0 |
2.2 |
4.6 |
10 |
||
0 |
A |
5 |
5 |
5 |
5 |
5 |
5 |
B |
5 |
5 |
5 |
5 |
5 |
5 |
|
C |
5 |
5 |
5 |
5 |
5 |
5 |
|
D |
5 |
5 |
5 |
5 |
5 |
5 |
|
Total introduced |
20 |
20 |
20 |
20 |
20 |
20 |
|
24 |
A |
0 |
0 |
0 |
0 |
4 |
5 |
B |
0 |
0 |
0 |
0 |
5 |
5 |
|
C |
0 |
0 |
0 |
0 |
5 |
5 |
|
D |
0 |
0 |
0 |
0 |
5 |
5 |
|
Total immobilised |
0 |
0 |
0 |
0 |
19 |
20 |
|
Effect % |
0 |
0 |
0 |
0 |
95 |
100 |
|
|
|
|
|
|
|
||
48 |
A |
0 |
0 |
0 |
0 |
5 |
5 |
B |
0 |
0 |
0 |
0 |
5 |
5 |
|
C |
0 |
0 |
0 |
0 |
5 |
5 |
|
D |
0 |
0 |
0 |
0 |
5 |
5 |
|
Total immobilised |
0 |
0 |
0 |
0 |
20 |
20 |
|
Effect % |
0 |
0 |
0 |
0 |
100 |
100 |
Table 2: Final Full Test: Test Samples (based on the hydrolysis product)
Time of sampling |
Date of sampling |
Date of |
Concentration |
Relative to nominal |
Relative to initial |
|
Nominal |
Analyzed |
|||||
0 |
16 Oct 2018 |
23 Oct 2018 |
0 |
n.d. |
n.a. |
|
|
|
|
0.46 |
0.561 |
122 |
|
|
|
|
1.0 |
1.21 |
121 |
|
|
|
|
2.2 |
2.60 |
118 |
|
|
|
|
4.6 |
5.21 |
113 |
|
|
|
|
10 |
11.4 |
114 |
|
48 |
18 Oct 2018 |
23 Oct 2018 |
0 |
n.d. |
n.a. |
n.a. |
|
|
|
0.46 |
0.511 |
111 |
91 |
|
|
|
1.0 |
1.15 |
115 |
95 |
|
|
|
2.2 |
2.49 |
113 |
96 |
|
|
|
4.6 |
5.04 |
109 |
97 |
|
|
|
10 |
11.4 |
114 |
100 |
1) Samples were stored in the freezer (≤ -15°C) until the day of analysis.
n.d. Not detected.
n.a. Not applicable.
Table 3: Effect Parameters
Parameter |
Test substance Nominal conc. (mg/L) |
95%-confidence interval |
24h-EC50 |
3.5 |
3.1-3.9 |
48h-EC50 |
3.2 |
2.2-4.6 |
Table 4: pH and Oxygen Concentrations (mg/L) During the Final Test
Test substance Nominal conc. (mg/L) |
Start (t=0 h) |
End (t=48 h) |
||
O2 |
pH |
O2 |
pH |
|
Control |
8.8 |
8.0 |
8.6 |
8.1 |
0.46 |
8.8 |
7.9 |
8.5 |
8.0 |
1.0 |
8.9 |
7.9 |
8.3 |
8.0 |
2.2 |
8.9 |
7.9 |
8.4 |
8.0 |
4.6 |
8.7 |
7.8 |
8.4 |
7.9 |
10 |
8.5 |
7.7 |
8.4 |
7.9 |
Table 5: Validity criteria for OECD 202
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. |
no daphnids became immobilised or showed other signs of disease or stress |
yes |
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels. |
the dissolved oxygen concentration at the end of the test was ≥3 mg/L in control and test vessels |
yes |
Description of key information
EC50 (48h) 3.2 mg/L (Daphnia magna, OECD 202, nominal)
Key value for chemical safety assessment
Additional information
One key study is available, in which the short term toxicity to invertebrates was investigated according to GLP and OECD guideline 202 (Migchielsen, 2018b). The test was performed with a test item concentration of 0.46, 1.0, 2.2, 4.6 and 10 mg/L (nominal) in a static test system with the test organism Daphnia magna. The initial measured content of the test item ranged between 113 and 122% and the aged measured content ranged between 109 and 115% of nominal. Therefore the results are given based on nominal concentrations. The EC50 (48 h) was determined to be 3.2 mg/L.
One additional study is available on the short-term toxicity of the test item to aquatic invertebrates (National Association of Photographic Manufacturers, 1977). The study was performed with the freshwater species Daphnia magna in a static test design. Daphnids were exposed to 0, 0.3, 0.9 and 3.0 mg/L of the test substance for a 96 h period. The LC50 (96 h) of the test item was determined to be 0.3 mg/L. However, the study was considered to be not reliable since the test design differs much from the OECD standrads (e.g. instead of neonates a mixture of juvenile and adults test organisms were used) .
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.