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EC number: 279-576-2 | CAS number: 80858-47-5
- 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:
- 08 July 2016 - 16 August 2016
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: • Guidance document on aquatic toxicity testing of difficult items and mixtures, OECD series on testing and assessment number 23, December 14, 2000
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- Samples for possible analysis were taken from all test concentrations and the control at the start and the end of both 24-hour renewal periods.
The glass wool used for the preparation of the saturated solution (SS) was retained for possible analysis of the residue.
Volume 2.0 mL from the approximate centre of the test vessels
Storage Samples were stored in a freezer (<= -15°C) until analysis.
At the end of both refreshment periods, samples were taken from one of the replicates of each concentration. - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: saturated solution
The batch of Phenafleur tested was a clear colourless liquid with a purity of 98.51%. The test item was not completely soluble in test medium at the loading rate initially prepared. No correction was made for the composition of the test item.
Preparation of test solutions started with a loading rate of 100 mg/L applying three days of magnetic stirring in closed vessels to reach the maximum solubility of the test item in the test medium. The resulting aqueous mixture was left to stabilize for approximately 1 hour whereafter the clear and colourless Saturated Solution (SS) was siphoned out through glass wool. The SS was used as the highest test concentration for the combined limit range-finding test and as a stock solution for the final test. All lower test concentrations were prepared by subsequent dilutions of the SS in test medium.
- Controls: ISO-medium without test item
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): no - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: Daphnia magna (Straus, 1820)
- Source: In-house laboratory culture with a known history; at least third generation, obtained by acyclical parthenogenesis under specified breeding conditions. 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.
- Age at study initiation: young daphnids with an age of < 24 hours, from parental daphnids of more than two weeks old.
- Method of breeding: start of each batch with newborn daphnids, i.e. less than 3 days old, by placing a bout 250 of them into 5 litres of medium (M7) in an all-glass culture vessel. Renewal of the cultures: after 7 days of cultivation half of the medium twice a week.
- Feeding during test: no
ACCLIMATION
- Acclimation period: no - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Hardness:
- 180 mg CaCO3/L
- Test temperature:
- 20-21°C
- pH:
- in fresh solutions: 7.6
in used solutions: 7.6-7.7 - Dissolved oxygen:
- in fresh solutions: 8.9-9.2
in used solutions: 8.4-9.1 - Nominal and measured concentrations:
- Based on the results of the combined limit/range-finding test, EC50 was expected to range between concentrations obtained in 1.0 and 10% of a saturated solution (SS) at 100 mg/L.
Therefore the following test concentrations were assigned to the definitive test:
Test concentrations: 0.46, 1.0, 2.2, 4.6, 10 and 22% of an SS prepared at a loading rate of 100 mg/L
Mean measured test concentrations:
* first renewal period: 0.097, 0.21, 0.47, 0.97, 2.5 and 5.6 mg/L (all concentrations remained stable, i.e. 81-101% of initial)
* second renewal period: 0.095, 0.21, 0.47, 0.98, 2.4 and 5.2 mg/L (all concentrations remained stable, i.e. 100-102% of initial)
EC50 values were expressed in terms of mean initial measured concentrations. - Details on test conditions:
- TEST SYSTEM
- Test vessel: 60 mL, all-glass, air-tight closed
- Fill-volume: 60 mL
- Aeration: no
- Renewal rate of test solution (frequency): after 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Other: intgroduction of daphnids within 35 minutes after preparation of the test solutions
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium (prepared in RO water)
- Culture medium different from test medium: yes (M7)
- Intervals of water quality measurement: pH and dissolved oxygen at the start and the end of both renewal periods, for all concentrations and the control. Temperature continuously.
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mobility at 24 and 48 hours
RANGE-FINDING STUDY
- Test concentrations: 1.0, 10 and 100% of an SS prepared at a loading rate of 100 mg/L
- Results used to determine the conditions for the definitive study: yes - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (July 2016)
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.39 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% CI: 0.34-0.44 mg/L
- Details on results:
- - Behavioural abnormalities: none reported
- Other biological observations: none reported
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none reported
- Effect concentrations exceeding solubility of substance in test medium: no
Individual pH, temperature and dissolved oxygen values remained within acceptable limits throughout the duration of the study (pH: 6.0-8.5, not varying by more than 1.5 unit; temperature: 18-22°C, constant within 2°C; oxygen: >=3 mg/L at the end of the test). - Results with reference substance (positive control):
- - Results with reference substance valid? yes
- Relevant effect levels: 48-h EC50
- Dose-response test: yes (0.10-1.8 mg potassium dichromate/L)
- 48-h EC50: 0.39 (95% CI: 0.33-0.44)
- Other: The historical ranges for the 48h-EC50 lie between 0.28 and 0.90 mg/L. The observed 48h-EC50 corresponds with this range. - Reported statistics and error estimates:
- The 48h-EC50-value was calculated from the weibits of the percentages of affected daphnids and the logarithms of the corresponding test item concentrations (mean initial) using the maximum likelihood estimation method.
ToxRat Professional v 3.2.1 (ToxRat Solutions® GmbH, Germany) was used to perform the analyses.
An overview of the statistics is attached under 'Illustration'. - Validity criteria fulfilled:
- yes
- Remarks:
- 1) In the control, no daphnids became immobilised or showed other signs of disease or stress. 2) The oxygen concentration at the end of the test was ≥3 mg/L in control and test vessels.
- Conclusions:
- The 48h-EC50 value in Daphnia magna was 0.39 mg/L (95% confidence interval between 0.34 and 0.44 mg/L) based on mean initial measured concentrations.
- Executive summary:
A study was performed to assess the acute toxicity of the substance to Daphnia magna. The study was conducted in accordance with OECD Guideline for Testing of Chemicals No. 202 and GLP under semi-static conditions. An initial range-finding test performed at 1, 10 and 100 mg/l, showed toxicity starting at 10 mg/l after 24 h and starting at 1 mg/l after 48 h. Based on these results, the following nominal concentrations were tested in the definitive test: 0.46, 1.0, 2.2, 4.6, 10 and 22% of a saturated solution prepared at a loading rate of 100 mg/L using dilution. Dilution can be done because the substance is a mono-constituent and the toxicity is below 1 mg/l (OECD guidance 23, 2000). For each concentration and a control group, twenty Daphnia magna (less than 24 hours old) were exposed for 48 hours in air-tight closed vessels. The incidence of immobilisation was recorded for each test and control group at 24 hours and at 48 hours. Samples taken from all concentrations at the start and the end of both 24-hour renewal periods were analysed with a validated HPLC-UV method. nalysis of the samples taken at the start of the first renewal period showed measured concentrations of 0.097, 0.21, 0.47, 0.97, 2.5 and 5.6 mg/L in 0.46, 1.0, 2.2, 4.6, 10 and 22% of the SS at 100 mg/L, respectively. All concentrations remained stable (81-101% of initial) during the first 24-hour renewal period. Analysis of the samples taken at the start of the second renewal period showed measured concentrations of 0.095, 0.21, 0.47, 0.98, 2.4 and 5.2 mg/L. All concentrations remained stable (100-102% of initial) during the second 24-hour renewal period. Given this result, the EC50 values were expressed in terms of mean initial exposure concentrations.The mean initial measured concentrations corresponding with 0.46, 1.0, 2.2, 4.6, 10 and 22% of a saturated solution prepared at a loading rate of 100 mg/L were 0.096, 0.21, 0.47, 0.97, 2.4 and 5.4 mg/L. The 48h-EC50 value in Daphnia magna was 0.39 mg/L based on mean initial measured concentrations.
Reference
Table 1: Concentrations of the test item in test medium - final test
Time of sampling1 |
Percentage of SS2 |
Analysed concentration |
Relative to |
|
|
|
|
0 |
0 |
n.d. |
|
|
0.46 |
0.0972 |
|
|
1.0 |
0.212 |
|
|
2.2 |
0.469 |
|
|
4.6 |
0.974 |
|
|
10 |
2.46 |
|
|
22 |
5.61 |
|
|
|
|
|
24 (old) |
0 |
n.d. |
n.a. |
|
0.46 |
0.0810 |
83 |
|
1.0 |
0.208 |
98 |
|
2.2 |
0.381 |
81 |
|
4.6 |
0.943 |
97 |
|
10 |
2.42 |
98 |
|
22 |
5.68 |
101 |
|
|
|
|
24 (new) |
0 |
n.d. |
|
|
0.46 |
0.0949 |
|
|
1.0 |
0.211 |
|
|
2.2 |
0.467 |
|
|
4.6 |
0.975 |
|
|
10 |
2.42 |
|
|
22 |
5.17 |
|
|
|
|
|
48 (old) |
0 |
n.d. |
n.a. |
|
0.46 |
0.0971 |
102 |
|
1.0 |
0.212 |
100 |
|
2.2 |
0.473 |
101 |
|
4.6 |
0.991 |
102 |
|
10 |
2.41 |
100 |
|
22 |
5.20 |
101 |
|
|
|
|
1 Samples were stored in the freezer (≤ -15°C) until the day of analysis.
2 Percentage of a saturated solution prepared at a loading rate of 100 mg/L.
n.d. Not detected.
n.a. Not applicable.
Table 2: Exposure concentrations
Phenafleur %SS at 100 mg/L |
Measured concentration (mg/L) |
Mean initial concentration (mg/L) |
|
t=0h (fresh) |
t=24h (fresh) |
||
0.46 |
0.0972 |
0.0949 |
0.096 |
1.0 |
0.212 |
0.211 |
0.21 |
2.2 |
0.469 |
0.467 |
0.47 |
4.6 |
0.974 |
0.975 |
0.97 |
10 |
2.46 |
2.42 |
2.4 |
22 |
5.61 |
5.17 |
5.4 |
Table 3: Number of introduced daphnids and incidence of immobility in the final test
Time (h) |
Replicate |
Mean initial concentration Phenafleur (mg/L) |
||||||
Control |
0.096 |
0.21 |
0.47 |
0.97 |
2.4 |
5.4 |
||
0 |
A |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
B |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
C |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
D |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
Total introduced |
20 |
20 |
20 |
20 |
20 |
20 |
20 |
|
|
||||||||
24 |
A |
0 |
0 |
0 |
0 |
4 |
5 |
5 |
B |
0 |
0 |
0 |
0 |
5 |
5 |
5 |
|
C |
0 |
0 |
0 |
0 |
5 |
5 |
5 |
|
D |
0 |
0 |
0 |
0 |
4 |
5 |
5 |
|
Total immobilised |
0 |
0 |
0 |
0 |
18 |
20 |
20 |
|
Effect % |
0 |
0 |
0 |
0 |
90 |
100 |
100 |
|
|
|
|
|
|
|
|
||
48 |
A |
0 |
0 |
0 |
3 |
5 |
5 |
5 |
B |
0 |
0 |
0 |
4 |
5 |
5 |
5 |
|
C |
0 |
0 |
0 |
5 |
5 |
5 |
5 |
|
D |
0 |
1 |
0 |
4 |
5 |
5 |
5 |
|
Total immobilised |
0 |
1 |
0 |
16 |
20 |
20 |
20 |
|
Effect % |
0 |
5 |
0 |
80 |
100 |
100 |
100 |
Description of key information
A study was performed to assess the acute toxicity of the substance to Daphnia magna. The study was conducted in accordance with OECD Guideline for Testing of Chemicals No. 202 and GLP under semi-static conditions. An initial range-finding test performed at 1, 10 and 100 mg/l, showed toxicity starting at 10 mg/l after 24 h and starting at 1 mg/l after 48 h. Based on these results, the following nominal concentrations were tested in the definitive test: 0.46, 1.0, 2.2, 4.6, 10 and 22% of a saturated solution prepared at a loading rate of 100 mg/L using dilution. Dilution can be done because the substance is a mono-constituent and the toxicity is below 1 mg/l (OECD guidance 23, 2000). For each concentration and a control group, twenty Daphnia magna (less than 24 hours old) were exposed for 48 hours in air-tight closed vessels. The incidence of immobilisation was recorded for each test and control group at 24 hours and at 48 hours. Samples taken from all concentrations at the start and the end of both 24-hour renewal periods were analysed with a validated HPLC-UV method. nalysis of the samples taken at the start of the first renewal period showed measured concentrations of 0.097, 0.21, 0.47, 0.97, 2.5 and 5.6 mg/L in 0.46, 1.0, 2.2, 4.6, 10 and 22% of the SS at 100 mg/L, respectively. All concentrations remained stable (81-101% of initial) during the first 24-hour renewal period. Analysis of the samples taken at the start of the second renewal period showed measured concentrations of 0.095, 0.21, 0.47, 0.98, 2.4 and 5.2 mg/L. All concentrations remained stable (100-102% of initial) during the second 24-hour renewal period. Given this result, the EC50 values were expressed in terms of mean initial exposure concentrations.The mean initial measured concentrations corresponding with 0.46, 1.0, 2.2, 4.6, 10 and 22% of a saturated solution prepared at a loading rate of 100 mg/L were 0.096, 0.21, 0.47, 0.97, 2.4 and 5.4 mg/L. The 48h-EC50 value in Daphnia magna was 0.39 mg/L based on mean initial measured concentrations.
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 0.39 mg/L
Additional information
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