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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 305-644-9 | CAS number: 94891-43-7
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_ecotoxicological-information.png)
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:
- 2018-04-25 to 2018-04-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
- EC Number:
- 305-644-9
- EC Name:
- Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
- Cas Number:
- 94891-43-7
- Molecular formula:
- C32 H16 N8 Ni . C8 H11 N O6 S2 . 2 Na
- IUPAC Name:
- Nickel, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)sulfonyl]ethyl hydrogen sulfate monosodium salt, sodium salts
- Test material form:
- solid: particulate/powder
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Determination of the test item
The limit concentration and the control were analytically verified via HPLC-DAD in the fresh media at the start of the exposure (0 hours) and in the old media at the end of the exposure (48 hours).
Sampling for the analytical monitoring
At the start of the exposure (0 hours), samples of the fresh media (control and limit concentration) were taken after preparation of the limit concentration and analyzed.
At the end of the exposure (48 hours), samples of the old media (control and limit concentration) were taken directly from the test vessels.
Criteria for the analytical monitoring (target)
Recoveries of the test item should be within ± 20% of the nominal or initially measured concentrations.
Test solutions
- Vehicle:
- no
- Details on test solutions:
- Limit concentration
A limit concentration of 100 mg/L of the test item was tested.
The limit concentration was selected based on the results of a non-GLP preliminary range finding test.
Preparation of the limit concentration
A limit concentration (100 mg/L of the test item were weighed out) was freshly prepared with dilution water prior to the start of the exposure (at 0 hours). The limit concentration was mixed thoroughly by manual agitation.
Control
Dilution water without test item incubated under the same conditions as the test group.
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Test system
Daphnia magna STRAUS (Clone 5).
Reason for the selection of the test system
Daphnia magna is the preferred species in accordance with the test guideline and is bred at the test facility.
Origin
Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), 14195 Berlin, Germany
Breeder
Noack Laboratorien GmbH, Käthe-Paulus-Str. 1, 31157 Sarstedt, Germany
Culture
In glass vessels (2 - 3 L capacity) with approximately 1.8 L culture medium, at 20 +/- 2 °C, in an incubator, 16 hours illumination, light intensity of max. 1500 lx
Culture medium
Elendt M4, according to OECD 202, Annex 3 (2004) is used.
Composition of the Culture Medium Elendt M4 according to OECD 202, Annex 3 (2004)
Component Concentration [mg/L]
CaCl2 x 2 H2O 294
MgSO4 x 7 H2O 123
KCl 5.80
NaHCO3 64.8
Na2SiO3 x 5 H2O 7.47
NaNO3 0.274
KH2PO4 0.143
K2HPO4 0.184
Na2EDTA x 2 H2O 2.50
FeSO4 x 7 H2O 0.996
H3BO3 2.86
MnCl2 x 4 H2O 0.361
LiCl 0.306
SrCl2 x 6 H2O 0.152
RbCl 0.0710
NaBr 0.0160
Na2MoO4 x 2 H2O 0.0615
CuCl x 2 H2O 0.0168
ZnCl2 0.0130
CoCl2 x 6 H2O 0.0100
KI 0.00325
Na2SeO3 0.00219
NH4VO3 0.000575
Thiaminhydrochloride 0.075
Cyanocobalamin 0.0010
Biotin 0.00075
pH 8.2 +/- 0.8
Feeding of the culture stocks
The daphnids were fed at least 5 times per week ad libitum with a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata and Desmodesmus subspicatus. The algae were cultured at the test facility.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- yes
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- Dilution water
0 hours:Total hardness [mg CaCO3/L]: 249 - Test temperature:
- 18 - 22°C, constant within ± 1°C
20 °C - pH:
- Water Quality Parameters in fresh Media at the Start of the Exposure (0 hours)
(measured in one additional replicate (without daphnids) of the limit concentration and the control)
Nominal test item concentration
[mg/L] pH-value Dissolved O2 concentration [mg/L]
100 7.85 8.93
Control 7.95 8.90
Water Quality Parameters in old Media at the End of the Exposure (48 hours)
(measured in one replicate (replicate with the highest immobilization rate, containing daphnids) of the limit concentration and the control)
Nominal test item concentration
[mg/L] pH-value Dissolved O2 concentration [mg/L] Replicate number
100 7.32 8.21 4
Control 7.27 8.39 4
Water Quality Parameters of the Dilution Water at the Start of the Exposure (0 hours)
Dilution water dated: pH-value Dissolved O2 concentration [mg/L] Temperature [°C] Conductivity [µS/cm] Total hardness [mg CaCO3/L]
2018-04-25 7.75 8.84 20.2 619 249 - Dissolved oxygen:
- see above
- Conductivity:
- See above
- Details on test conditions:
- Test vessels
Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity, loosely covered with watch glasses
Test volume
20 mL
Dilution water
Same composition as the culture medium
Number of daphnids and replicates
20 daphnids, divided into 4 replicates, each with 5 daphnids, were used for the limit concentration and control.
Age of the daphnids at the start of the exposure
Less than 24 hours old daphnids from a healthy stock were used
for the study. Juvenile daphnids were removed from the culture vessels at the latest 24 hours before the start of the exposure and discarded. The juveniles born within the following period of max. 24 hours preceding the exposure were used for the test. No first brood progeny was used for the test.
Acclimatization
Acclimatization of the daphnids was not necessary, because the composition of the dilution water was equivalent to the culture medium.
Application
20 g test solution per replicate was weighed out into each test vessel. This corresponds to 20 mL per test vessel. The daphnids were inserted with a small amount of dilution water by a pipette.
Test temperature (target)
18 - 22 °C, constant within ± 1 °C
Illumination (target)
Diffuse light, light intensity of max. 1500 lx
Photoperiod (target)
16/8 hours light/dark cycle
Feeding
The daphnids were not fed during the study. - Reference substance (positive control):
- yes
- Remarks:
- Potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- other: EC10/50/100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- other: EC10/50/100
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Results with reference substance (positive control):
- Test of the Reference Item
The percentage of immobility for the reference item potassium dichromate (SIGMA-ALDRICH, batch number MKBV0900V, purity 99.0%, CAS RN 7778-50-9) was determined after 24 hours from 2018 05-03 to 2018-05-04.
EC50-Value (with 95% Confidence Limits) of the Reference Item Potassium dichromate
based on nominal concentrations mg/L, (0 - 24 hours)
Current Study Valid Range
EC50 2.07 mg/L
0.6 - 2.4 mg/L, acc. to AQS P 9/2 (02/2000); clone 5
0.6 - 2.1 mg/L, acc. to OECD 202 (2004); clone A
95% confidence limits 1.00 - 4.00 mg/L
- Reported statistics and error estimates:
- Methods of evaluation
The EC10 / 50 / 100-values after 24 and 48 hours for the test item were empirically derived from the observation data. Since no effects on Daphnia magna were observed in the limit concentration of the test item, no calculations were made. All effect concentrations (EC10 / 50 / 100) given were based on the nominal concentration of the test item.
EC-values and statistical analyses for reference item
An EC50-value was calculated for the reference item by sigmoidal dose-response regression. The respective 95 % confidence limits for the EC50 were empirically derived from the observation data as follows: The highest concentration level without any effect (EC0) and the lowest concentration level causing 100% immobilization (EC100) were used as 95% confidence limits, since calculation was not possible by the software.All calculations were carried out from the best-fit values with the software GraphPad Prism.
Software
All data were computer-processed and rounded for presentation. Consequently, minor variations may occur from the original figures if manual calculations based on the original figures are made subsequently. Calculations were made using the following software:
- GraphPad Prism, GRAPHPAD SOFTWARE, INC.
- SigmaPlot, SPSS INC.
- Excel, MICROSOFT CORPORATION
Any other information on results incl. tables
Measured Exposure Concentrations during the Definitive Test
The concentration of the test item Reactive Blue 38 was analytically verified via HPLC-DAD in the fresh media at the start of the exposure (0 hours) and in the old media at the end of the exposure (48 hours) in the limit concentration and in the control.
The measured concentration of the test item in fresh media at the start of the exposure (0 hours) was 94% of the nominal value of the limit concentration. At the end of the exposure period (48 hours), the measured test item concentration in the old media was 92% of the nominal value of the limit concentration. Since the measured concentration of the test item Reactive Blue 38 did remainstable within ± 20% of the nominal concentration throughout the exposure period, the nominal concentration was used for evaluation.
Measured Concentrations of the Test Itemduring the Definitive Test
Sampling date |
Fresh Media, |
Old Media, |
||
Nominal test item concentration [mg/L] |
ReactiveBlue 38 |
|||
Meas. conc. [mg/L] |
% |
Meas. conc. [mg/L] |
% |
|
100 |
94.0 |
94 |
92.0 |
92 |
Control |
< LOQ |
< LOQ |
Meas. conc.= measured concentration of the test item, mean value of 2 injections, dilution factors taken into account
% = percent of the nominal concentration of the test item
LOQ = limit of quantification of the analytical method (0.350 mg/L of the test item)
Preliminary Range Finding Test (non-GLP)
A non-GLP preliminary range finding test was conducted at the test facility under static conditions over a period of 48 hours with three nominal test item concentrations of 1, 10 and 100 mg/L prepared with dilution water (Table2). The preliminary range finding test was conducted under diffuse light conditions (light intensity of max. 1500 lx, 16/8 hours light/dark cycle).
A stock solution of 100 mg/L was freshly prepared prior to the start of the exposure (0 hours) as specified in section4.2for the definitive test and further diluted to the concentration levels 1 and 10 mg/L. All concentration levelswere visually clear throughout the exposure period andwere concentration-related turquoise-blue coloured.
In the range finding test, two replicates per concentration level and control, each with ten daphnids, were tested. The results are presented inTable15andTable 16.
Immobilization Rates in the non-GLP Preliminary Range Finding Test
(n = 20, divided into 2 replicates with 10 daphnids each)
Nominal test item concentration [mg/L] |
IMMOBILIZATION [%] |
||||||||||||
24 hours |
48 hours |
||||||||||||
Replicates |
Replicates |
||||||||||||
1 |
2 |
MV |
1 |
2 |
MV |
||||||||
100 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||
10 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||
1 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||
Control |
0 |
0 |
0 |
0 |
0 |
0 |
MeasuredConcentrations ofReactiveBlue 38during the non-GLPPreliminary Range Finding Test
Analytical system: HPLC-DAD
Sampling date |
Start of the exposure, 0 hours |
End of the Exposure, 48 hours |
||
Nominal test item concentration [mg/L] |
ReactiveBlue 38 |
|||
Meas. conc. [mg/L] |
% |
Meas. conc. [mg/L] |
% |
|
100 |
98.7 |
99 |
96.1 |
97 |
10 |
9.69 |
97 |
9.32 |
96 |
1 |
0.920 |
92 |
0.861 |
94 |
Control |
< 0.02501) |
< 0.02501) |
Meas. conc. = measured concentration of the test item, singledeterminations, dilution factors taken into account
% = percent of the nominal concentration of the test item
1) = lowest calibration level (0.0250 mg/L of the test item)
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- In the limit concentration of 100 mg/L of the test item Reactive Blue 38, no effects on Daphnia magna were observed.
Based on the nominal concentrations of the test item Reactive Blue 38, the 48 hours-EC10 / 50 / 100 for Daphnia magna was > 100 mg/L. - Executive summary:
In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item Reactive Blue 38 were determined at the test facility according to OECD 202 (2004) from 2018-04-25 to 2018-04-27.
A concentration of 100 mg/L was tested in a limit test under static conditions over a period of 48 hours.The limit concentration of 100 mg test item/Lwas blue and visually clearly dissolved throughout the exposure, while the control was colourless and visually clear throughout the exposure.
Twenty daphnids, divided into 4 replicates with 5 daphnids each, were exposed to the limit concentration and the control.
The concentration of the test item ReactiveBlue 38 was analytically verified via HPLC-DAD in the fresh media at the start of the exposure (0 hours) and in the old media at the end of the exposure (48 hours) in the limit concentration and in the control.
The measured concentration of the test item in fresh media at the start of the exposure (0 hours) was 94% of the nominal value of the limit concentration. At the end of the exposure period (48 hours), the measured test item concentration in the old media was 92% of the nominal value of the limit concentration. Since the measured concentration of the test item Reactive Blue 38 remained stable within ± 20% of the nominal concentration throughout the exposure period, the nominal concentration was used for evaluation.
The effect concentrations given in are based on the nominal concentration of the test item Reactive Blue 38.
No effects were found at the limit concentration of 100 mg/L of the test item in Elendt M4 medium.
The validity criteria of the test guideline were fulfilled.
EC10 / 50 / 100-Values
(based on the nominal concentration of the test item)
Effect concentrations
Test
duration
[hours]
Reactive Blue38
Nominal concentration of the test item
[mg/L]
EC10 / 50 / 100
24
> 100
48
> 100
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)