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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
- 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:
- December 16 2020 to December 18 2020
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
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:
- copper(II) 3,3',3'',3'''-(29H,31H-phthalocyanine-2(or 3),9(or 10),16(or 17),23(or 24)-tetrayltetrasulfonyl)tetrapropane-1-sulfonate and its amides with (2-hydroxypropyl)amine, sodium salts
- Molecular formula:
- Cannot be adequately assigned
- IUPAC Name:
- copper(II) 3,3',3'',3'''-(29H,31H-phthalocyanine-2(or 3),9(or 10),16(or 17),23(or 24)-tetrayltetrasulfonyl)tetrapropane-1-sulfonate and its amides with (2-hydroxypropyl)amine, sodium salts
- Test material form:
- solid: particulate/powder
- Details on test material:
- Molecular formula: C50H52CuN10Na2O20S8 (main component)
Molecular weight: 1479.02 (main component)
Purity of test item: 93.1%
Impurity
Water: 6.5%
EDTA-4Na: 0.4%
Supplier: FUJIFILM Corporation
Lot number: M-002P
Storage conditions: Store in the dark at room temperature.
Constituent 1
- Specific details on test material used for the study:
- Not specified
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- The test solutions were collected at the start and end of the exposure period.
The collected test solutions (the analytical sample) were used as the high-performance liquid
chromatography (HPLC) analytical samples without treatment or after appropriate dilution with dechlorinated tap water.
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- The test sample (50.0 mg) was precisely weighed by an electronic analytical balance. It
was dissolved and filled up to 50 mL with ultrapure water to obtain 931 mg/L solution of
the test item (operated by study No.: 99428). The solution was diluted with dechlorinated
tap water to prepare 46.6 mg/L standard solution.
The concentration of the test item in each HPLC analytical sample was determined on
the basis of a comparison of the peak area on the chromatogram of the HPLC analytical
sample with that of a standard solution.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Species: Daphnia magna Clone A
Reason for selection of species: Species recommended in the test guideline
Supplier: The University of Sheffield, UK
Date of supply: July 9, 1990
Acclimation: Young daphnids produced by parents that were cultured in this test facility were used. The parents to obtain young daphnids were bred in the same quality of water (dechlorinated tap water), water temperature (20±1 °C) and photoperiod (16-hour light/8-hour dark) as used in the study. The parent animals used for the test were same lot and their age and survival rate were 20-day old and 100%, respectively. Chlorella vulgaris of 0.1-0.2 mgC (Organic carbon content)/day per Daphnia was fed to the parents once a day.
Selection of young daphnia: Less than 24-hour-old daphnids
Allocation: Random sampling
Confirmation of reproducibility of test system: A 48-hour acute immobilization study of a reference substance with the test organisms was periodically conducted.
Study design
- Test type:
- static
- Water media type:
- not specified
- Limit test:
- yes
- Total exposure duration:
- 48 h
- Remarks on exposure duration:
- As required by study guideline.
- Post exposure observation period:
- Not specified
Test conditions
- Hardness:
- 14 CaCo3 mg/L
- Test temperature:
- 19.9-20.0°C
- pH:
- 7.9-8.0
- Dissolved oxygen:
- 8.3-8.6 mg/L
- Conductivity:
- 7.4 mS/m at 25 °C
- Nominal and measured concentrations:
- Nominal concentration was 99.8 mg/L and measured concentration was 101 mg/L.
- Details on test conditions:
- Type of test: Static regime (no renewal of test solution)
Exposure duration: 48 hours
Test concentration : 100 mg /L (upper limit concentration of test guideline) as limit test
The test concentration was decided from the results of the preliminary study.
Control: Dilution water without the test item
Replicate: 4 replicates/test level
Number of organism: 20 daphnids/test level (5 daphnids/test vessel)
Volume of test solution: 400 mL/test level (1 00 mL/test vessel)
Temperature of test solution: 20±1°C
Dissolved oxygen concentration: ≥ 3 mg/L without aeration
pH adjustment: No adjustment
Lighting condition: Room light, 16-hour light/8-hour dark
Feeding: No feeding - Reference substance (positive control):
- not specified
Results and discussion
Effect concentrationsopen allclose all
- Key result
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 ng/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Key result
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- The 24-hour and 48-hour EC50s of the test item for Daphnia magna were both> 100 mg/L.
- Results with reference substance (positive control):
- Not specified
- Reported statistics and error estimates:
- Not specified
Any other information on results incl. tables
In the exposure level, neither immobilization nor abnormalities of behavior or appearance were observed.
In the control, no abnormal response (discolor of body, trapping at the surface of the water and so on) was observed during exposure, which met the criterion for the validity of the test (i.e. not more than 10%).
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The 24-hour and 48-hour EC50s of the test item for Daphnia magna were both> 100 mg/L.
- Executive summary:
A 48-hour acute immobilisation study in Daphnia magna was carried out in accordance with OECD test guideline 202, in compliance with GLP. This study was conducted as a limit test in order to confirm the effect of the test item on the test organisms at the upper limit concentration of the test guideline. As a result, no adverse effect were found in the definitive study. Therefore, it was determined that the test item had no adverse acute effect on the test organisms at the upper limit concentration of the test guideline.
The concentrations of the test item in the test solution during exposure were kept within the range of 80-120% of the nominal concentration. The environmental conditions were within the suitable range. Therefore, it is concluded that this study complied with the applied test guidelines.The 24-hour and 48-hour EC50s of the test item for Daphnia magna were both > 100 mg/L.
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.