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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 604-593-2 | CAS number: 147622-85-3
- 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
- Endpoint:
- short-term toxicity to aquatic invertebrates
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 09, 2001 - May 11, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Reliability 1
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- 1992
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- Version / remarks:
- 1992
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-[4-trans-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone
- EC Number:
- 604-593-2
- Cas Number:
- 147622-85-3
- Molecular formula:
- C18 H22 F2 O
- IUPAC Name:
- 4-[4-trans-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Remarks:
- The analysis of a saturated aqueous solution revealed that the water solubility of the test item was < 0.4 mg/L; so the actual test item concentrations could not be determined
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Macro nutrients (mg/L)
CaCI2 •2H20: 293.80
MgSO4•7H20: 123.30
NaHCO3: 64.80
KCI: 5.80
Na2SiO3•9H20: 10.00
NaNO3: 0.27
KH2PO4: 0.14
K2HPO4: 0.18
Trace elements (mg/L)
B: 0.5000
Fe: 0.2000
Mn: 0.1000
Li, Rb and Sr: 0.0500
Mo: 0.0250
Br: 0.0125
Cu and Zn: 0.0063
Co and I: 0.0025
Se: 0.0010
V: 0.0003
Macro nutrients (mg/L)
Na2EDTA • 2H20: 2.50
Vitamins (μg/L):
Thiamine: 75.00
B12: 1.00
Biotin: 0.75
- pH: 7.89
Preparation of the Test Item:
The test medium (reconstituted water and test material) was freshly prepared. Therefore, the calibrated flask with test material and reconstituted water, was treated in an ultrasonic device for 1 hour. Subsequently the preparation was aerated, and stirred with a magnetic stirrer for further 23 hours. After 24 hours, the preparation was given through a nutsch filter (pore size > 10 - < 16 µm. The filtrate of the test material preparation (water accommodated fraction) was used fort he study.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Species: Daphnia magna Straus
Culture conditions: The Daphnia magna were kept in reconstituted water in glass-vessels. The study was located in an air-conditioned room in the Institute of Toxicology. Lighting was controlled by a ti
mer to provide a 16 hours light - 8 hours dark regime.
Temperature and humidity in the experimental room was measured.
At the start of the experimental phase 5 Daphnia magna were introduced in each test vessel (25 mL, all-glass) containing 10 ml reconstituted water with or without test material. The vessels were open. The test media were freshly prepared before the introduction of the young Daphnia magna.
The Daphnia magna were not fed, and the test medium was not aerated during the test.
Feeding: The parental daphnids are fed with fresh water algae. once a week.
Age: Offspring less than 24 hours old were used for the study.
Acclimation period: same as test
Feeding during test: None
ACCLIMATION: not necessary
Acclimation conditions (same as test or not): same conditions as in test
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 21°C in all test vessels
- pH:
- pH at test start in all vessels: 7.78-7.93
pH at test end in all vessels: 7.52-7.70 - Dissolved oxygen:
- at test start in all vessels: 97.3-97.8%
at test end in all vessels: 96.8-97.5% - Nominal and measured concentrations:
- nominal: 100 mg/L
- Details on test conditions:
- EXPOSURE:
The study was performed in an air-conditioned room. For the study glass vessels containing 10 mL either reconstituted water (control group) or test medium (test item group) were used. Each
test vessel contained five daphnids. They were not fed and the media were not aerated during the exposure.
The test was performed as a static test in open vessels.
The duration of exposure was 48 hours. During the exposure period, the mobility of the daphnids was assessed daily, i.e. after 24 and 48 hours.
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ELENDT M4 medium according to guideline
- Culture medium different from test medium: no
- Intervals of water quality measurement: 48 h
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light/8 h dark
- Light intensity: not reported
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mobility
CONCENTRATIONS(S):
A solution of a nominal test item concentration of 100 mg/L was tested in the present study.
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hour EC50 for Daphnia magna exceeded the maximum solubility of the test material in reconstituted water (< 0.4 mg/L) and, thus, could not be determined in this test.
- Behavioural abnormalities: no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no - Results with reference substance (positive control):
- No positive control used in this study. The accuracy and reliability of the test method is demonstrated periodically as recommended by guidelines with potassium dichromate.
Any other information on results incl. tables
Study Design
The objective of this study was to determine the acute toxicity of the test material using Daphnia magna.
For this purpose, juvenile Daphnia magna were exposed to an aqueous test material solution over 48 hours, under defined conditions. The study comprised of four test vessels per concentration containing five Daphnia magna each, i.e. 20 Daphnia magna per concentration (test medium group) and control group.
Daphnia magna were exposed to a nominal test material concentration of 100 mg/L (limit test) in an open static system.
Results
After exposure of Daphnia magna o a nominal concentration of 100 mg/L for 48 hours, the following results were obtained:
Nominal concentration (mg/L) |
Daphnia magna immobilized/exposed |
|
24 h |
48 h |
|
0 |
0/20 |
0/20 |
100 |
0/20 |
0/20 |
Daphnia magna exposed to an aqueous preparation (water accommodated fraction) of the nominal concentration of 100 mg/L the test item were not affected.
The test material concentration in the aqueous test medium could not be determined with standard analytical methods due to its low water solubility (< 0.4 mg/L). The development of an analytical method with a sufficiently low detection and quantification limit is complex. Due to the absence of any adverse effects at the saturation
concentration, the study was performed without analytical concentration verification.
For the test material, the following nominal EC50 values for Daphnia magna were determined:
24 h EC50 > 100 mg/L
48 h EC50 > 100 mg/L
No effect on the mobility of the daphnia was observed at a nominal concentration of 100 mg/L.
Conclusion
An aqueous solution of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hour EC50 for Daphnia magna exceeded the maximum solubility of the test material in reconstituted water (< 0.4 mg/L) and, thus, could not be determined in this test.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- An aqueous solution (water accommodated fraction) of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hour EC50 for Daphnia magna exceeded the maximum solubility of the test material in reconstituted water (< 0.4 mg/L) and, thus, could not be determined in this test.
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 202. An aqueous solution (water accommodated fraction) of nominal 100 mg/L of the test item revealed no aquatic toxicity in the test system. The 48 hour EC50 for Daphnia magna exceeded the maximum solubility of the test material in reconstituted water (< 0.4 mg/L) and, thus, could not be determined in this test.
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.