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EC number: 201-161-1 | CAS number: 78-95-5
- 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:
- 2021-03-02 to 2021-03-26
- 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:
- 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Analytical monitoring:
- yes
- Details on sampling:
- - Sampling method: At the start, samples were taken after preparation of each concentration level and the control and analyzed. At the end of the renewal (24 hours) and the exposure (48 hours), samples of the old media were taken from the test vessels.
- Sampling schedule: at the start of exposure and at the renewal of the test solutions (0 and 24 hours) as well as in the 24-hours old media at the renewal and at the end of the exposure (24 and
48 hours) - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test solutions were prepared using a stock solution. For the stock solution 10.0 mg test item/L were freshly prepared with dilution water. For preparation the density was taken into account. The solution was agitated until the solution was visually clear (approx. 1 minute).
- Controls: Dilution water without test item incubated under the same conditions as the test groups. In addition, a reference test with potassium dichromate was separately conducted as an acute immobilization test in Elendt M4 medium under static conditions with a test duration of 24 hours once per month in order to prove the validity of the test system and test conditions at the test facility.
- Test concentration separation factor: 2.2
- Evidence of undissolved material: no - Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
- Common name: water flea
- Age at study initiation: less than 24 hours old
- Stage and instar at study initiation: juvenile, no first brood progeny
- Method of breeding: In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 +/- 2 °C, 16 hours illumination, light intensity of max. 1500 lux; Elendt M4, according to OECD 202; daphnids were fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus (algae cultured at the test facility).
- Source: continuous laboratory cultures; originally obtained from Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), 14195 Berlin, Germany
- Feeding during test: no
ACCLIMATION
Acclimatization was not necessary, because the composition of the dilution water is equivalent to the culture medium.
METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES, INCLUDING CULTURING CONDITIONS:
Juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded. The juveniles born within the following period were used for the test. No first brood progeny was used for the test. - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
- Post exposure observation period:
- none
- Test temperature:
- 18 - 22 °C, constant within ± 1 °C
- pH:
- 6.57-8.88 (treatments)
- Dissolved oxygen:
- 8.32 - 9.33 mg/L
- Salinity:
- not applicable
- Conductivity:
- not specified
- Nominal and measured concentrations:
- nominal: 1.76, 0.800, 0.364, 0.165, 0.0750, 0 (negative control) mg/L; Measured: 1.59, 0.728, 0.338, 0.152, 0.0637, < LOQ (negative control) mg/L (geom. mean measured)
- Details on test conditions:
- TEST SYSTEM
- Test vessel: flasks
- Type: closed
- Material, size, headspace, fill volume: Sealed glass flasks (4.5 (ID) x 9.5 (H) cm) with screw were used and filled up to the top with the test solutions.
- Volume of solution: approximately 130 mL
- Aeration: no
- Renewal rate of test solution: after 24 hours of exposure
- No. of organisms per vessel: 5
- No. of vessels per concentration: 4
- No. of vessels per control: 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to OECD 202
OTHER TEST CONDITIONS
- Adjustment of pH:no
- Photoperiod: 16/8 hours light/dark cycle
- Light intensity: diffuse light, light intensity of max. 1500 lx
EFFECT PARAMETERS MEASURED: immobility of daphnids after 24 and 48 hours
RANGE-FINDING STUDY
- Test concentrations: 10, 1 and 0.1 mg/L along with a negative control
- Results used to determine the conditions for the definitive study: yes - Duration:
- 48 h
- Dose descriptor:
- EC100
- Effect conc.:
- 0.728 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 24 h
- Dose descriptor:
- EC100
- Effect conc.:
- > 1.59 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 0.369 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % Confidence Limits: 0.338 – 0.728 mg/L
- Duration:
- 24 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.817 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % Confidence Limits: 0.366 – 1.58 mg/L
- Duration:
- 48 h
- Dose descriptor:
- EC10
- Effect conc.:
- 0.346 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % Confidence Limits: 0.190 – 0.671 mg/L
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 1.16 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95 % Confidence Limits: 0.749 – 1.59 mg/L
- Details on results:
- - Behavioural abnormalities: no
- Observations on body length and weight: not reported
- Other biological observations: none
- Mortality of control: no
- Other adverse effects control: no
- Immobilisation of control: no
- Abnormal responses: no
- Any observations 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: EC40 (24 h) = 1.94 mg/L (nominal) (CL: 1.00 - 4.00 mg/L) - Reported statistics and error estimates:
- EC10/50 values were determined using sigmoidal dose-response regression. 95 % confidence limits for the EC10 / 50-values after 24 hours and for the EC10-values after 48 hours were calculated from the standard error and the t-distribution. The confidence limits for the EC50-values after 48 hours was estimated empirically from the observed immobilization rates.
- Validity criteria fulfilled:
- yes
- Conclusions:
- In an Acute Immobilisation Test with Daphnia magna according to OECD 202 the 48 hour EC50 of the test item was determined to be 0.369 mg/L (95% CL: 0.338 – 0.728) based on geom. mean measured concentrations.
- Executive summary:
The effects of the test item to aquatic invertebrates were assessed in an Acute Immobilisation Test with Daphnia magna according to OECD 202. The study was conducted under semi-static conditions in closed test vessels without headspace over a period of 48 hours. Five concentrations of the test item (nominal: 0.0750 to 1.76 mg/L) prepared from a stock solution of 10.0 mg test item/L in a geometric series with a separation factor of 2.2 were tested. Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration level and the control. The concentrations of the test item were analytically verified via GC-MS in the fresh media at the start of the exposure and at the renewal of the test solutions (0 and 24 hours) and in the 24-hours old media at the renewal and at the end of the test (24 and 48 hours) in all concentration levels and the control. The measured concentrations of the test item in the fresh media were in the range of 94 to 106 % of the nominal values at the start of the exposure (0 hours) and at the renewal (24 hours). The measured concentrations of the test item in the old media at the renewal and at the end of the test (24 and 48 hours) were in the range of 72 to 94 % of the nominal values. Therefore, biological results are based on geom. mean measured concentrations. All validity criteria of the guideline were fulfilled. As a result, the 48 hour EC50 of the test item was determined to be 0.369 mg/L (95 % CL: 0.338 – 0.728 mg/L).
Reference
Table 1: Immobilization Rates after 24 and 48 hours of Exposure (n = 20, divided into 4 replicates with 5 daphnids each)
Geometric mean measured concentration of the test item [mg/L] | IMMOBILIZATION [%] | |||||||||
24 hours | 48 hours | |||||||||
Replicates | Replicates | |||||||||
1 | 2 | 3 | 4 | MV | 1 | 2 | 3 | 4 | MV | |
1.59 | 80 | 80 | 100 | 80 | 85 | 100 | 100 | 100 | 100 | 100 |
0.728 | 0 | 0 | 20 | 0 | 5 | 100 | 100 | 100 | 100 | 100 |
0.338 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 20 | 0 | 5 |
0.152 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
0.0637 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Table 2: Measured Concentrations of the Test Item during the Definitive Test
Sampling sate | Fresh media, 0 hours | Old media, 24 hours | ||
Nominal concentration of the test item [mg/L] | Meas. Conc. [mg/L] | % | Meas. Conc. [mg/L] | % |
1.760 | 1.68 | 95 | 1.46 | 83 |
0.800 | 0.776 | 97 | 0.64 | 80 |
0.364 | 0.375 | 103 | 0.286 | 78 |
0.1.65 | 0.175 | 106 | 0.129 | 78 |
0.075 | 0.0746 | 99 | 0.0583 | 78 |
Control | < LOQ | < LOQ | ||
QC | 112% | 99%1) |
Meas. conc.= measured concentration of the
test item, dilution factors taken into account
% = percent of the nominal concentration of the test item
LOQ = limit of quantification of the analytical method (1.5 μg/L of the
test item)
1) = QC for Old media (24 hours) and Fresh media (24 hours)
QC = Procedural recovery on 10 x LOQ-level, % recovery calculated to
weighed amount of the test item, mean value 104 %
Description of key information
In an Acute Immobilisation Test with Daphnia magna according to OECD 202 the 48 hour EC50 of the substance was determined to be 0.369 mg/L (95 % CL: 0.338 – 0.728) based on geom. mean measured concentrations (reference 6.1.3-1).
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Dose descriptor:
- EC50
- Effect concentration:
- 0.369 mg/L
Additional information
The effects of the test item to aquatic invertebrates were assessed in an Acute Immobilisation Test with Daphnia magna according to OECD 202. The study was conducted under semi-static conditions in closed test vessels without headspace over a period of 48 hours. Five concentrations of the test item (nominal: 0.0750 to 1.76 mg/L) prepared from a stock solution of 10.0 mg test item/L in a geometric series with a separation factor of 2.2 were tested. Twenty daphnids (divided into 4 replicates with 5 daphnids each) were exposed to each concentration level and the control. The concentrations of the test item were analytically verified via GC-MS in the fresh media at the start of the exposure and at the renewal of the test solutions (0 and 24 hours) and in the 24-hours old media at the renewal and at the end of the test (24 and 48 hours) in all concentration levels and the control. The measured concentrations of the test item in the fresh media were in the range of 94 to 106 % of the nominal values at the start of the exposure (0 hours) and at the renewal (24 hours). The measured concentrations of the test item in the old media at the renewal and at the end of the test (24 and 48 hours) were in the range of 72 to 94 % of the nominal values. Therefore, biological results are based on geom. mean measured concentrations. All validity criteria of the guideline were fulfilled. As a result, the 48 hour EC50 of the test item was determined to be 0.369 mg/L (95 % CL: 0.338 – 0.728 mg/L).
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