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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 217-588-1 | CAS number: 1897-45-6
- 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
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
- Endpoint:
- bioaccumulation in aquatic species: fish
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 Jul 1979 to 8 Sep 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Bluegill sunfish is exposed to 14C-labelled test substance for 30-d bioaccumulation phase and followed by a 14-d depuration phase at 22 ± 1 °C. BCF is calculated based on the concentraton of the substance in the test solution and organism in steady-state.
- GLP compliance:
- yes
- Radiolabelling:
- yes
- Details on sampling:
- SAMPLING
- Fish sampling schedule: At 1, 3, 7, 10, 14, 22 and 30 days of the bioaccunulation phase and at 1, 3, 7, 10 and 14 days of the depuration phase.
- Water sampling schedule: At 0, 1, 3, 7, 10, 14, 22 and 30 days of the bioaccunulation phase and 0, 1, 3, 7, 10 and 14 days of the depuration phase.
- Fish sampling method: On days 1, 3 and 10 of the bioaccumulation phase and 1, 7 and 10 of the depuration phase, three fish were removed from each of the test aquaria. The muscle tissue (fillet), defined as the edible portion including the bones, from each of these fish was combined. The viscera, including the head, guts and fins, from each of these fish were combined. Also included In the visceral section were the brain and all internal organs of the digestive, respiratory, circulatory, endocrine, reproductive and excretory systems. Each combined tissue sample was homogenized with dry ice in a mill. After sublimation of the dry ice duplicate subsamples of the homogenized fillet and visceral tissue were analyzed indirectly for radioactivity by total combustion analysis.
- Water sampling method: On each sampling day, a minimum 250 mL portion of water was removed from each aquarium using an 8 oz. polyethylene bottle. Water samples from the duplicate test aquaria were combined for each sampling day. Water samples from the duplicate control aquaria were combined for each sampling day. Duplicate 5 mL portions of each combined sample were transferred to separate liquid scintillation counting vials. A 15 mL portion of Aquasol-2was added to each vial, the vials were sealed, and the contents were mixed by manually shaking. - Vehicle:
- yes
- Remarks:
- ethanol
- Details on preparation of test solutions, spiked fish food or sediment:
- PREPARATION OF TEST MATERIAL
A 0.3173 g of the test substance was weighed and quantitatively transferred to a 250 mL round bottom flask using toluene. A total of 100 mL toluene was added to the flask and the tests substance was dissolved by mixing. A 4.78 milliCurie portion of uniformly ring labeled 14C-test substance with a specific activity of 31.4 milliCuries per millimole was added to the flask. The solution was mixed by magnetic stirring for 30 minutes, The solution was evaporated to dryness under reduced pressure. The resulting specific activity was calculated to be 29369 dpm/µg.
INTRODUCTION OF TEST MATERIAL
A concentrated working standard solution of the test material was prepared by dissolving 357.5 mg of the 14C-labelled test substance in 235 ml of ethanol to result in a concentration of 1.52 mg/mL. The test solution was prepared by diluting the concentrated working standard solution with ethanol to result in a concentration of 14C-labelled test substance of 11.97 mg/L. The test solution was transferred to the Mariott bottle of the test system and shielded from light by covering the Mariott bottle with aluninim foil, The test solution was prepared fresh at least every eight days. - Test organisms (species):
- Lepomis macrochirus
- Details on test organisms:
- TEST ORGANISM
- Common name: Bluegill sunfish
- Length at study initiation: 65 mm to 76 mm with a mean length of 69 mm
- Weight at study initiation: 4.4 g to 5.5 g with a mean weight of 4.9 g
ACCLIMATION
The test animals were held in culture tanks and observed for general health and suitability for a minimun of 14 days prior to testing. During
observation and acclimation , the test animals were held in culture tanks supplied with flowing well water.
- Well water temperature: 14°C to 21 °C
- Health during acclimation (any mortality observed): During the observation period , less than 10% mortality of the test animals was observed , thus indicating their suitability for testing. Based upon available documentation and behavior observations, the test animals were judged to be in excellent condition. During a 72 hour period, the test animals were gradually acclimated to the 22 °C test temperature.
FEEDING (holding, observation acclimation and test periods)
- Food type: Standard conmercial fish food
- Frequency: Daily - Route of exposure:
- aqueous
- Test type:
- flow-through
- Water / sediment media type:
- natural water: freshwater
- Total exposure / uptake duration:
- 30 d
- Total depuration duration:
- 14 d
- Test temperature:
- 22 ± 1 °C
- pH:
- Bioaccumulation: 8.0 - 8.6
Depuration: 7.9 - 8.2 - Dissolved oxygen:
- Bioaccumulation: 3.8 - 8.2 mg O2/L
Depuration: 5.2 - 7.2 mg O2/L - Details on test conditions:
- TEST SYSTEM
- Test vessel: 100 liter glass aguaria
- Fill volume: 70 liters of aerated well water
- Type of flow-through: Proportional diluter
- Flow rate: 500 mL per minute per aquarium
- No. of organisms per vessel: 120
- No. of vessels per concentration: 2
- No. of vessels per contro: 2
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Well water
- Dissolved oxygen: 9.3 mg O2/L
- Alkalinity: 380 mg/L as CaCO3
- pH: 7.7
- Hardness: 260 mg/L as CaCO3
- Water quality measurement: The water quality parameters of temperature, dissolved oxygen, pH and ammonia were measured throughout the study.
RANGE-FINDING
- Study desigh: 96- hour acute toxicity test of the substance to bluegill sunfish was performed.
- Results used to determine the conditions for the definitive study: Results of this study Indicated that the no mortality or abnormal behavior of the test animals was observed at concentration of 0.084 mg/L. Based upon this data, it was judged that the test concentration selected for the residue accunulation, distribution and depuration study should not exceed one-tenth of 0.084 mg/L. To minimize mortality of the test animals during the study, the nominal test concentration was selected to be 0.008 mg/L 14C-labelled test substsnace. - Nominal and measured concentrations:
- - Nominal concentration: 0.0080 mg/L
- Mean measured concentration: 0.0072 mg/L, see Table1 and Table 2 in 'Any other information on materials and methods incl. tables' - Reference substance (positive control):
- no
- Key result
- Conc. / dose:
- 0.007 mg/L
- Temp.:
- 22 °C
- pH:
- 8
- Type:
- BCF
- Value:
- 264 dimensionless
- Basis:
- whole body w.w.
- Time of plateau:
- 30 d
- Calculation basis:
- steady state
- Conc. / dose:
- 0.007 mg/L
- Temp.:
- 22 °C
- pH:
- 8
- Type:
- BCF
- Value:
- 76 dimensionless
- Basis:
- edible fraction
- Remarks:
- fillet
- Time of plateau:
- 30 d
- Calculation basis:
- steady state
- Conc. / dose:
- 0.007 mg/L
- Temp.:
- 22 °C
- pH:
- 8
- Type:
- BCF
- Value:
- 514 dimensionless
- Basis:
- non-edible fraction
- Remarks:
- visceral tissue
- Time of plateau:
- 30 d
- Calculation basis:
- steady state
- Elimination:
- yes
- Parameter:
- other: 80% of the accumulated 14C-residues were eliminated from the whole fish
- Depuration time (DT):
- 14 d
- Elimination:
- yes
- Parameter:
- other: 46% of the accumulated 14C-residues were eliminated from the fillet
- Depuration time (DT):
- 14 d
- Elimination:
- yes
- Parameter:
- other: 85% of the accumulated 14C-residues were eliminated from the visceral tissue
- Depuration time (DT):
- 14 d
- Details on results:
- An overview of the result is provided in Table 3 and Table 4 in 'Any other information on results incl. tables'.
After 30 days of exposure, the mean 14C-residues were 1.9 ppm in whole fish, 0.55 ppm in the fillet and 3.7 ppm in the viscera. The visceral tissue contained approximately 7 times the 14C- residues detected in the edible fillet tissue. The bioaccunulation factors were 264X, 76X and 514X for whole fish, fillet and visceral tissues , respectively. At the end of the 14 day depuration, 80%, 46% and 35% of the accumulated 14C-residues were eliminated from the whole fish, fillet and visceral tissues, respectively. - Validity criteria fulfilled:
- not specified
- Conclusions:
- Based on the findings, the corresponding bioconcentration factors were 264, 76, and 514 times the mean exposure concentration of 0.0072 mg/L14C-labelled test substance equivalents for the whole fish, fillet and visceral tissues, respectively. After 14 days of depuration 80.0% of the accumulated 14C-residues was eliminated from whole fish tissue, 45.5% was eliminated from the fillet and 85.4% was eliminated from the visceral tissue.
- Executive summary:
A study was conducted to evaluate the potential for accumulation, distribution and depuration of the 14C-labelled test substance residues in bluegill sunfish (Lepomis macrochirus) exposed to a nominal 14-C labelled test substance concentration of 0.0080 mg/L (the mean measured concentration was 0.0072 mg/L). The study was conducted without following a standard guideline but it was performed following an inhouse SOP and in compliance with GLP criteria. Four 100 litre glass aquaria (two for control and two for treatment) were used in this study with a flow through system. The temperature of the water in the aquaria was controlled by immersing the aquaria In a circulating water bath maintained at 22 ± 1 °C by the use of submersible heating elements. The bioaccumulation phase of the study was 30 days and the depuration phase of the study was 14 days. After 30 days exposure to 14C-labelled test substance in a flow through aquatic system, bluegill sunfish accumulated 1.9, 0.55 and 3.7 ppm 14C-labelled test substance equivalents in the whole fish, fillet and visceral tissues, respectively. The corresponding bioaccumulation factors were 264, 76, and 514 times the mean exposure concentration of 0.0072 mg/L 14C-labelled test substance equivalents for the whole fish, fillet and visceral tissues, respectively. After 14 days of depuration 80.0% of the accumulated, 14C-residues was eliminated from whole fish tissue, 45.5% was eliminated from the fillet and 85.4% was eliminated from the visceral tissue.
Reference
Table 3. Concentration (ppm) of 14C-residues as the test substance equivalents in blue gill sunfish during bioaccumulation.
Day |
Whole fish |
Fillet |
Viscera |
|||
|
Assay values |
Mean value |
Assay values |
Mean value |
Assay values |
Man value |
1 |
1.8 |
1.8 |
0.14 |
0.14 |
3.7 |
3.8 |
1.8 |
0.14 |
3.9 |
||||
3 |
1.4 |
1.8 |
0.20 |
0.20 |
1.9 |
1.9 |
2.1 |
0.19 |
1.8 |
||||
7 |
2.6 |
2.7 |
0.72 |
0.72 |
4.2 |
4.3 |
2.7 |
0.72 |
4.3 |
||||
10 |
2.5 |
2.5 |
0.50 |
0.51 |
5.1 |
5.4 |
2.5 |
0.51 |
5.6 |
||||
14 |
2.9 |
3.0 |
0.66 |
0.70 |
5.8 |
5.8 |
3.1 |
0.73 |
5.8 |
||||
22 |
2.4 |
2.4 |
0.53 |
0.53 |
4.2 |
4.3 |
2.4 |
0.52 |
4.4 |
||||
30 |
1.9 |
1.9 |
0.54 |
0.55 |
3.7 |
3.7 |
1.8 |
0.55 |
3.6 |
Table 4. Concentration (ppm) of 14C-residues as the test substance equivalents in blue gill sunfish during depuration.
Day |
Whole fish |
Fillet |
Viscera |
|||
|
Assay values |
Mean value |
Assay values |
Mean value |
Assay values |
Man value |
1 |
1.3 |
1.4 |
0.45 |
0.48 |
2.3 |
2.2 |
1.5 |
0.51 |
2.0 |
||||
3 |
0.79 |
0.81 |
0.34 |
0.35 |
1.2 |
1.2 |
0.83 |
0.35 |
1.2 |
||||
7 |
0.58 |
0.57 |
0.24 |
0.26 |
0.74 |
0.77 |
0.56 |
0.27 |
0.79 |
||||
10 |
0.49 |
0.48 |
0.25 |
0.26 |
0.75 |
0.75 |
0.47 |
0.26 |
0.74 |
||||
14 |
0.37 |
0.38 |
0.26 |
0.30 |
0.53 |
0.54 |
0.39 |
0.34 |
0.54 |
Description of key information
BCF = 264 in whole fish (bluegill sunfish), no guideline followed, Szalkowski 1980
Key value for chemical safety assessment
- BCF (aquatic species):
- 264 dimensionless
Additional information
A study was conducted to evaluate the potential for accumulation, distribution and depuration of the 14C-labelled test substance residues in bluegill sunfish (Lenomis macrochirus) exposed to a nominal 14-C labelled test substance concentration of 0.0080 mg/L (the mean measured concentration was 0.0072 mg/L). The study was conducted without following a standard guideline but it was performed following an inhouse SOP and in compliance with GLP criteria. Four 100 litre glass aquaria (two for control and two for treatment) were used in this study with a flow through system. The temperature of the water in the aquaria was controlled by immersing the aquaria In a circulating water bath maintained at 22 ± 1 °C by the use of submersible heating elements. The bioaccumulation phase of the study was 30 days and the depuration phase of the study was 14 days. After 30 days exposure to 14C-labelled test substance in a flow through aquatic system, bluegill sunfish accumulated 1.9, 0.55 and 3.7 ppm 14C-labelled test substance equivalents in the whole fish, fillet and visceral tissues, respectively. The corresponding bioaccumulation factors were 264, 76, and 514 times the mean exposure concentration of 0.0072 mg/L 14C-labelled test substance equivalents for the whole fish, fillet and visceral tissues, respectively. After 14 days of depuration 80.0% of the accumulated, 14C-residues was eliminated from whole fish tissue, 45.5% was eliminated from the fillet and 85.4% was eliminated from the visceral tissue.
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.