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EC number: 246-618-6 | CAS number: 25103-54-2
- 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 fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24th November 2017 - 2nd March 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 203 (Fish, Acute Toxicity Test)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Analytical monitoring:
- yes
- Details on sampling:
- - Concentrations: All test concentrations and the control
- Sampling method: 2.0 mL from the approximate centre of the test vessels taken at the start of the test and after 72 hours from freshly prepared solutions and at the first renewal (24 hours) and end of the test for 24-hour old solutions
- Sample storage conditions before analysis: None, samples were analysed on the day of sampling - Vehicle:
- no
- Details on test solutions:
- PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test solutions were individually prepared loading rates. A three-day period of magnetic stirring was applied to accelerate dissolution of the test item in medium. The obtained mixtures were allowed to settle for a period of approximately one hour. Thereafter, the aqueous Water Accommodated Fractions (WAFs) were collected through glass wool and used as test concentrations.
- Controls: Test medium without test item
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): None
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): All test solutions were clear and colorless at the end of the preparation procedure. - Test organisms (species):
- Cyprinus carpio
- Details on test organisms:
- TEST ORGANISM
- Common name: Carp (Cyprinus carpio, Teleostei, Cyprinidae) Linnaeus, 1758
- Source: Zodiac, proefacc, "De Haar Vissen", Wageningen University and Research Centre, The Netherlands
- Length at study initiation (length definition, mean, range and SD): 2.3 ± 0.1 cm
- Weight at study initiation (mean and range, SD): 0.20 ± 0.04 g
- Characteristics: F1 from a single parent-pair bred in UV-treated water
ACCLIMATION
- Acclimation period: At least 12 days after delivery
- Acclimation conditions (same as test or not): Same as test (adjusted ISO medium)
- Type and amount of food during acclimation: Fed with pelleted fish food
- Feeding frequency during acclimation: Daily
- Health during acclimation (any mortality observed): In the batch of fish used for the test, mortality during the seven days prior to the start of the test was less than 5%.
FEEDING DURING TEST
- No feeding from 24 hours prior to the test and during the total test period - Test type:
- semi-static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 96 h
- Hardness:
- 180 mg CaCO3/L
- Test temperature:
- 21 - 22°C
- pH:
- 7.4 - 7.9
- Dissolved oxygen:
- 6.5 - 9.7 mg/L
- Salinity:
- Not applicable
- Nominal and measured concentrations:
- Nominal: 4.6, 10, 22, 46, 100 mg/L
Measured (test start): 0.027, 0.10, 0.15, 0.11, 0.092 mg/L
Measured (72 hours, fresh): 0.069, 0.13, 0.19, 0.50, 0.32 mg/L
Measured (24 hours, aged): 0.017, 0.059, 0.11, 0.067, 0.053 mg/L
Measured (96 hours aged): 0.048, 0.10, 0.14, 0.47, 0.22 mg/L
Mean measured: 0.039, 0.097, 0.15, 0.28, 0.17 mg/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 3.2 litre vessels
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: All-glass, silanised (to prevent adsorption of the test item to glass), containing 3 litres of test solution
- Aeration: None
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution: Daily renewal
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): Not applicable
- Biomass loading rate: 0.47 g fish/L
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Adjusted ISO medium
- Culture medium different from test medium: No
- Intervals of water quality measurement: Dissolved oxygen, pH and temperature measured daily in all vessels with surviving fish
OTHER TEST CONDITIONS
- Adjustment of pH: None
- Photoperiod: 16 hours
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality assessed at 2 1/4, 24, 48, 72 and 96 hours
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2.2
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study : Yes
- Test concentrations: 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: Yes. The result of the full test were not in line with the results of the range-finding test, as in the latter all fish exposed to the highest group did not survive the exposure. The reason behind this is unknown. However, all average exposure concentrations tested in the full test were above the water solubility of the test item and some of them were higher than the highest concentration measured in the range-finding test. Therefore it is justified to base the effect of the test item on the results of the full test. - Reference substance (positive control):
- yes
- Remarks:
- pentachlorophenol
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- > 0.28 mg/L
- Nominal / measured:
- meas. (geom. mean)
- Conc. based on:
- test mat.
- Basis for effect:
- mortality (fish)
- Remarks on result:
- other: LC50 was above the limit of solubility of the test item
- Results with reference substance (positive control):
- Tested at concentrations of 0.1, 0.22 and 0.46 mg/L, 13 - 17 February 2017
96-hour LC50: 0.32 mg/L (95% confidence interval: 0.22 - 0.46 mg/L)
Historical range: 0. 1 - 0.46 mg/L (April 1988 - present) - Reported statistics and error estimates:
- No LC50 could be calculated because the test item proved to be non-toxic (LC50 > maximum soluble concentration).
- Sublethal observations / clinical signs:
Table 1 Incidence of Mortality and Total Mortality During the Final Test
Test item Average Exposure Concentration (mg/L)
Initial
number
of fishCumulative mortality
Total
Mortality
(%)2¼h
24h
48h
72h
96h
Control
7
0
0
0
0
0
0
0.039
7
0
0
0
0
0
0
0.097
7
0
0
0
0
0
0
0.15
7
0
0
0
0
0
0
0.28
7
0
0
0
0
0
0
0.17
7
0
0
0
0
0
0
Table 2 Average Exposure Concentration Versus Nominal Concentration of the Final Test
Test item
Loading rate (mg/L)
Measured concentration (mg/L)
Average Exposure
Concentration (mg/L)t=0h (fresh)
t=24h (old)
t=72h (fresh)
t=96 (old)
4.6
0.027
0.017
0.069
0.048
0.039
10
0.10
0.059
0.13
0.10
0.097
22
0.15
0.11
0.19
0.14
0.15
46
0.11
0.067
0.50
0.47
0.28
100
0.092
0.053
0.32
0.22
0.17
Table 3 Incidence of Mortality and Total Mortality During the Range-Finding Test
Test item
WAF loading rate (mg/L)Initial
number
of fishCumulative mortality
Total
Mortality (%)2¼h
24h
48h
72h
96h
1.0
3
0
0
0
0
0
0
10
3
0
0
0
0
0
0
100
3
0
3
3
3
3
100
Table 4 Average Exposure Concentration Versus Nominal Loading rates of the Range-Finding Test
Test item
WAF Loading rate (mg/L)
Measured concentration (mg/L)
Average exposure
concentrations (mg/L)t=0h
t=24h
t=96
1.0
0.041
0.016
0.010
0.016
10
0.19
0.12
0.074
0.11
100
0.20
0.14
0.12
0.14
- Validity criteria fulfilled:
- yes
- Remarks:
- No mortality observed in control at end of test; test conditions maintained constant throughout the test; dissolved oxygen >60% air saturation throughout test; results based on mean measured as deviated from nominal by >20%
- Conclusions:
- The 96-hour LC50 value for the test item was determined to be >0.28 mg/L (based on measured concentrations), considered to be the limit of solubility for the test item in test medium.
- Executive summary:
Tobor-Kaplon (2018) is a GLP-compliant study following OECD guideline 203, with Cyprinus carpio. Following the OECD guidance on difficult to test substances the test solutions were individually prepared as water accommodated fractions (WAF) at loading rates of 4.6, 10, 22, 46 and 100 mg/L. Tests solutions were renewed daily and after 24 hours of exposure the measured
test item concentrations were at the level of 58 – 76% of initial. A similar decrease was observed in the 24-hour old solutions at the end of the test (69 – 75% of initial in old solutions), except for the WAF prepared at a loading rate of 46 mg/L, which was at 95% of initial. Mean measured concentrations were determined to be 0.039, 0.097, 0.15, 0.28 and 0.17 mg/L and results were reported based on these mean measured concentrations. 7 fish were tested per test concentration and for the untreated control and mortality was assessed after 2 1/4, 24, 48, 72 and 96 hours. All validity criteria for the study were met. The 96 -hour LC50 was determined to be >0.28 mg/L (based on measured concentrations), considered to be the limit of solubility for the test item in test medium.
The results of the full test were not in line with the results of the range-finding test, as in the latter all fish exposed to the highest group did not survive the exposure. The reason behind this is unknown. However, all average exposure concentrations tested in the full test were above the water solubility of the test item and some of them were higher than the highest concentration measured in the range-finding test. Therefore it is justified to base the effect of the test item on the results of the full test.
Reference
Description of key information
The 96-hour LC50 value for the test item was determined to be >0.28 mg/L (based on measured concentrations), considered to be the limit of solubility for the test item in test medium.
Key value for chemical safety assessment
Additional information
Tobor-Kaplon (2018) is a GLP-compliant study following OECD guideline 203, with Cyprinus carpio. Following the OECD guidance on difficult to test substances the test solutions were individually prepared as water accommodated fractions (WAF) at loading rates of 4.6, 10, 22, 46 and 100 mg/L. Tests solutions were renewed daily and after 24 hours of exposure the measured test item concentrations were at the level of 58 – 76% of initial. A similar decrease was observed in the 24-hour old solutions at the end of the test (69 – 75% of initial in old solutions), except for the WAF prepared at a loading rate of 46 mg/L, which was at 95% of initial.Mean measured concentrations were determined to be 0.039, 0.097, 0.15, 0.28 and 0.17 mg/L and results were reported based on these mean measured concentrations. 7 fish were tested per test concentration and for the untreated control and mortality was assessed after 2 1/4, 24, 48, 72 and 96 hours. All validity criteria for the study were met. The 96 -hour LC50 was determined to be >0.28 mg/L (based on measured concentrations), considered to be the limit of solubility for the test item in test medium.
The results of the full test were not in line with the results of the range-finding test, as in the latter all fish exposed to the highest group did not survive the exposure. The reason behind this is unknown. However, all average exposure concentrations tested in the full test were above the water solubility of the test item and some of them were higher than the highest concentration measured in the range-finding test. Therefore it is justified to base the effect of the test item on the results of the full test.
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