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EC number: 700-778-8 | CAS number: 1064076-86-3
- 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:
- Jan-Feb 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study has been performed according to OECD and/or EC guidelines and according to GLP principles
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N-cyclohexylcyclohexanaminium (2S)-4-fluoro-4-methyl-2-{[(1S)-2,2,2-trifluoro-1-{4'-methanesulfonyl-[1,1'-biphenyl]-4-yl}ethyl]amino}pentanoate
- EC Number:
- 700-778-8
- Cas Number:
- 1064076-86-3
- Molecular formula:
- C21H23F4NO4S.C12H23N
- IUPAC Name:
- N-cyclohexylcyclohexanaminium (2S)-4-fluoro-4-methyl-2-{[(1S)-2,2,2-trifluoro-1-{4'-methanesulfonyl-[1,1'-biphenyl]-4-yl}ethyl]amino}pentanoate
- Details on test material:
- Name of test material (as cited in study report): Wheat Solubles, Hydrolyzed
- Substance type: white powder
- Physical state: powder
- Analytical purity: 98.3% w/w (by HPLC)
- Lot/batch No.: 3141100578
- Expiration date of the lot/batch: 28 November 2012 (allocated by NOTOX, 1 year after receipt of the test substance)
- Stability under storage conditions: Stable
- Storage condition of test material: At room temperature protected from light desiccated
-Stability in water: Unknown
-Solubility in water: Not indicated
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- During the final test singular samples for possible analysis were taken from all test concentrations and the control according to the schedule below.
Frequency at t=0 h and t=48 h
Volume 2 ml from the approximate centre of the test vessels
Storage Samples were stored in a freezer until analysis.
At the end of the exposure period, the replicates were pooled at each concentration before sampling.
Additionally, reserve samples of 2 ml were taken for possible analysis. If not used, these samples were stored in a freezer for a maximum of three months after delivery of the draft report, pending on the decision of the sponsor for additional analysis.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Preparation of test solutions started with the highest test concentration of 100 mg/l. Magnetic stirring and treatment with ultrasonic waves were applied for a period of approximately 2 hours to accelerate the dissolving of the test substance in the test medium. The lower test concentrations were prepared by subsequent dilutions of the highest test concentration in test medium. The final test solutions were all clear and colourless.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- - Common name: Daphnia magna (Crustacea, Cladocera) (Straus, 1820)
- Source: In-house laboratory culture with a known history.
- Age at study initiation: < 24 hours
- Method of breeding: With newborn daphnids, i.e. less than 3 days old, by placing about 250 of them into 10 litres of medium in an all-glass culture vessel.
- Feeding during test: No
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- 180 mg/l expressed as CaCO3
- Test temperature:
- between 18.3 and 20.6°C
- pH:
- between 7.7 and 8.0
- Dissolved oxygen:
- between 8.9 and 9.8 mg/l
- Nominal and measured concentrations:
- Nominal: control and 10, 18, 32, 56 and 100 mg/l
Measured concentrations: Analysis of the samples taken at the start of the final test showed that measured concentrations based on the cation ranged between 111 and 118% relative to nominal. For the anion the measured concentrations ranged between 94 and 103% relative to nominal. During the exposure period the measured concentrations remained constant. All results were therefore based on the nominal test concentrations. - Details on test conditions:
- - Vessel type: open
- Material, size, headspace, fill volume: glass, 100 ml, normal headspace, 80 ml
- Aeration: no
- 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: Adjusted ISO medium: the following chemicals (analytical grade) are dissolved in tap water purified by Reverse Osmosis (RO-water, GEON Waterbehandeling, Berkel-Enschot, The Netherlands):
Macro salts:
CaCl2.2H2O : 211.5 mg/l
MgSO4.7H2O: 88.8 mg/l
NaHCO3 : 46.7 mg/l
KCl : 4.2 mg/l
The hardness: 180 mg/l expressed as CaCO3 and the pH: 7.7 ± 0.3 after aeration.
- Culture medium different from test medium: yes, for culturing M7 medium is used
OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours photoperiod daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : EC50 t=24, 48 h and NOEC
TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.8
- Test concentrations::control and 10, 18, 32, 56 and 100mg/l - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate (K2Cr2O7)
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 82 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Remarks on result:
- other: 95% confidence interval between 77 and 91 mg/l
- Duration:
- 48 h
- Dose descriptor:
- NOEC
- Effect conc.:
- 56 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- Behavioural abnormalities: no
- Immobility of control: no immobility was observed.
- Other adverse effects control: no - Results with reference substance (positive control):
- The 24h-EC50 was 0.53 mg/l with a 95% confidence interval between 0.47 and 0.62 mg/l.
The 48h-EC50 was 0.28 mg/l with a 95% confidence interval between 0.26 and 0.32 mg/l. - Reported statistics and error estimates:
- The EC50-value was calculated at 48 hours of exposure from the probits of the percentages of affected daphnids and the logarithms of the corresponding test substance concentrations using the maximum likelihood estimation method (Finney, D.J., 1971: Probit analysis, Cambridge University Press, Cambridge, U.K., 3rd edition).
Any other information on results incl. tables
Table 1 Acute immobilisation of daphnids after 24 and 48 hours in the final test
Concentration Biphenyl DCHA Salt (mg/l) |
Vessel number
|
Number Daphnia exposed |
Response at 24 h |
Response at 48 h |
||
number |
Total % |
number |
Total % |
|||
Control |
A B C D |
5 5 5 5 |
0 0 0 0 |
0 |
0 0 0 0 |
0 |
10 |
A B C D |
5 5 5 5 |
0 0 0 0 |
0 |
0 0 0 0 |
0 |
18 |
A B C D |
5 5 5 5 |
0 0 0 0 |
0 |
0 0 0 0 |
0 |
32 |
A B C D |
5 5 5 5 |
0 1 0 0 |
5 |
0 1 0 0 |
5 |
56 |
A B C D |
5 5 5 5 |
0 0 0 0 |
0 |
0 0 0 0 |
0 |
100 |
A B C D |
5 5 5 5 |
0 0 0 0 |
0 |
5 5 3 4 |
85 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- Biphenyl DCHA Salt did not induce acute immobilisation of Daphnia magna at 56 mg/l after 48 hours of exposure (NOEC).
The 48h-EC50 was 82 mg/l based on analytically confirmed nominal concentrations (95% confidence interval between 77 and 91 mg/l).
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