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EC number: 276-423-1 | CAS number: 72152-71-7
- 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
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:
- July 19, 2016 to September 05, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- OECD Guideline; EU Method; GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Disodium [6-hydroxy-5-[(2-hydroxy-5-sulphophenyl)azo]naphthalene-2-sulphonato(4-)]cuprate(2-)
- EC Number:
- 276-423-1
- EC Name:
- Disodium [6-hydroxy-5-[(2-hydroxy-5-sulphophenyl)azo]naphthalene-2-sulphonato(4-)]cuprate(2-)
- Cas Number:
- 72152-71-7
- Molecular formula:
- C16H8CuN2O8S2.2Na
- IUPAC Name:
- Cuprate(2-), [6-(hydroxy-kO)-5-[2-[2-(hydroxy-kO)-5-sulfophenyl]diazenyl-kN1]-2-naphthalenesulfonato(4-)]-, sodium
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- Duplicate samples from the freshly prepared test media of all test concentrations and the control were taken at the start of the test.
For the determination of the stability of the test item under the test conditions and of the maintenance of the test item concentrations during the test period, duplicate samples from the test media of all test concentrations and the control were collected at the end of the test (after 48 hours) by pouring together the contents of the test beakers of each treatment.
Additional samples of the control were taken
Test solutions
- Vehicle:
- no
- Details on test solutions:
- The test medium of the highest test concentration of nominal 100 mg test item/L was prepared by dissolving 80.4 mg test item into 804 mL test water by intense stirring for 10 minutes. Adequate volumes of this test medium were diluted with test water to prepare the test media.
The test media were prepared just before introduction of the Daphnia (= start of the test).
Test Concentrations: 100, 45.5, 20.7, 9.4 and 4.3 mg test item/L and a control
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- Species: Daphnia magna (Straus), clone 5
Age at Test Start: From 4.25 to 21.75 hours old
Sex: Female
Origin: The Daphnia introduced in the test were taken from ibacon's in house laboratory culture.
Breeding Conditions: The Daphnia were bred in the laboratories of ibacon under similar temperature and light conditions as used in the test. The cultivation of the parental Daphnia was performed in Elendt M4 medium (see 6.5). The test organisms were not first brood progeny. The Daphnia in the stock culture were fed at least on all working days with green algae (Desmodesmus subspicatus) freshly grown in the laboratories of ibacon.
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Hardness:
- Water Hardness: 2.5 mmol/L (= 250 mg/L) as Calcium Carbonate
- Test temperature:
- 21 °C at test start;
21 °C at test end - pH:
- 8.2 at test start;
8.1 at test end; and thus the pH-value did not vary by more than 1.5 units - Dissolved oxygen:
- 8.8 to 8.9 mg/L at test start;
8.6 to 8.7 mg/L at test end - Nominal and measured concentrations:
- 100, 45.5, 20.7, 9.4 and 4.3 mg test item/L and a control
- Details on test conditions:
- Test Environment: Controlled environment room
Measurement of pH, Dissolved
Oxygen and Water Temperature:
The water temperature, pH-values and dissolved oxygen concentrations were determined at test start and test end in each treatment group.
Water Temperature: 21 °C at test start;
21 °C at test end
pH-Values: 8.2 at test start;
8.1 at test end; and thus the pH-value did not vary by more than 1.5 units
Dissolved Oxygen Concentration: 8.8 to 8.9 mg/L at test start;
8.6 to 8.7 mg/L at test end
Light Regime: 16 h light : 8 h dark
Light Intensity: The light intensity was 550 to 830 lux (measured once during the test). - Reference substance (positive control):
- yes
- Remarks:
- For the evaluation of the quality of the Daphnia clone and the consistency of the experimental conditions, the reference item potassium dichromate is tested at least twice a year to demonstrate satisfactory test conditions.
Results and discussion
Effect concentrationsopen allclose all
- 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.:
- 45.5 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- LOEC
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat.
- Basis for effect:
- mobility
- Details on results:
- After 48 hours of exposure no immobilisation of the test animals was observed in the control and up to and including the test item concentration of 45.5 mg test item/L. At the concentration of 100 mg test item/L, six animals were immobile.
- Results with reference substance (positive control):
- In the most recent test with the reference item potassium dichromate the EC50 after 24 hours was determined to be 1.58 mg test item/L, indicating that the sensitivity of the Daphnia was consistent with the level proposed by the OECD 202 guideline (EC50-24 h between 0.6 and 2.1 mg potassium dichromate/L).
- Reported statistics and error estimates:
- Statistical Analysis: The 24-hour and 48-hour EC50, EC20 and EC10 and the 95 % confidence limits were calculated by probit analysis.
The NOEC and LOEC after 24 and 48 hours were determined directly from the raw data.
The software used to perform the statistical analysis was ToxRat Professional, Version 3.2.1, ToxRat Solutions GmbH.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- Control Immobilisation Rate was 0 % and furthermore no daphnid showed signs of disease or stress. Dissolved Oxygen Concentration was above or equal 8.6 mg O2/L in the control and test vessels at the end of the test.
- Conclusions:
- The toxic effect of the test item to Daphnia magna was assessed in a static concentration-response test. The 48-hour NOEC was determined to be 45.5 mg test item/L. The 48-hour LOEC was determined to be 100 mg test item/L and the 48-hour EC50 value was calculated to be > 100 mg test item/L. The 48-hour EC10 was calculated to be 86.7 mg test item/L.
- Executive summary:
Title:
Acute Toxicity to Daphnia magna in a Static 48-hour Immobilisation Test
Purpose:
The purpose of this study was to determine the influence of the test item on the mobility of Daphnia magna. Young Daphnia (< 24 hours old) were exposed in a static test to the test item for 48 hours, added to test water at a range of concentrations. Under otherwise identical test conditions, different concentrations of the test item result in different percentages of Daphnia being no longer capable of swimming at the end of the test.
The test method of application and the test species Daphnia magna are recommended by the test guidelines.
The purpose of the analytical part of this study was to verify the concentrations of the test item in the test medium.
Guidelines:
- Commission Regulation (EC) No 440/2008, Annex, Part C, C.2.: “Daphnia sp. Acute Immobilisation Test”, Official Journal of the European Union (EN), dated May 30, 2008
- OECD Guideline for Testing of Chemicals No. 202: “Daphnia sp., Acute Immobilisation Test” adopted April 13, 2004
- SANCO/3029/99 rev.4 11/07/00: Residues: Guidance for generating and reporting methods of analysis in support of pre-registration data requirements for Annex II (part A; Section 4) and Annex III (part A; Section 5) of directive 91/414
Material and Methods
Test Item:
batch no.:101115; purity: 92.1% w/w , according to certificate of analysis
Test Species:
Daphnia magna, clone 5;4.25to 21.75 hoursold
Source: The Daphnia introduced in the test were taken from ibacon’s in-house laboratory culture.
Test Design:
This study encompassed 6 treatment groups (5 dose rates of the test item and a control) each containing 20 individuals. The mobility of the daphnia was determined in a static 48-hour test by visual observation after 24 and 48 hours.
Endpoints:
Number of immobile organisms after 24 and 48 hours
Test Concentrations:
100, 45.5, 20.7, 9.4 and 4.3 mg test item/L and a control
Test Conditions:
Water temperature:21 °C; pH value:8.1to 8.2; dissolved oxygen concentration:8.6to 8.9mg/L; photoperiod: 16 h light – 8 h dark; light intensity:550 to 830 lux; and thus were within the ranges requested by guideline OECD 202
Results
Biological test results:
After 48 hours of exposure no immobilisation of the test animals was observed in the control and up to and including the test item concentration of 45.5mg test item/L. At the concentration of 100mg test item/L, six animals were immobile.
Table1. Summary of Biological Results
Nominal Concentration
% of immobilised Daphnia after
[mg test item/L]
24 hours
48 hours
Control
0
0
4.3
0
0
9.4
0
0
20.7
0
0
45.5
0
0
100
20
30
EC50[mg/L]:
> 100
> 100
95 % CI [mg/L]:
n.d.
n.d.
EC20[mg/L]:
100
94.2
95 % CI [mg/L]:
n.d.
n.d.
EC10[mg/L]:
91.5
86.7
95 % CI [mg/L]:
n.d.
n.d.
NOEC [mg/L]:
45.5
45.5
LOEC [mg/L]:
100
100
Values refer to nominal test concentrations
CI: Confidence interval
n.d.: not determinable
NOEC and LOEC values determined directly from raw dataAnalytical Results:
The quantification of the test item in the test samples was performed using liquid chromatography with UV detection.
At the start of the test 100 % of the nominal test concentrations were found (average of all test concentrations). After 48 hours test duration, 97 % of the nominal value was determined (average of all test concentrations). During the test the daphnids were exposed to a mean of 98 % of nominal. Therefore, all reported results refer to nominal concentrations.
Conclusion:
The toxic effect of the test item to Daphnia magna was assessed in a static concentration-response test. The 48-hour NOEC was determined to be45.5 mg test item/L. The 48-hour LOEC was determined to be 100 mg test item/Land the 48-hour EC50value was calculated to be> 100 mg test item/L. The 48-hour EC10was calculated to be 86.7 mg test item/L.
This study is classified as acceptable and satisfies the guideline requirements for an acute toxicity study with freshwater invertebrates.
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