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EC number: 946-789-3 | 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:
- From the 1st of February to the 3rd of February, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Deviations:
- yes
- Remarks:
- The temperature was kept at 23-24 °C (instead 18–22 °C), controlled at ±1 °C. This deviation had no influence
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.2 (Acute Toxicity for Daphnia)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Acid Brown 373
- IUPAC Name:
- Acid Brown 373
- Test material form:
- solid: particulate/powder
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
- Details on sampling:
- At the beginning of the test, as well as after 24 and 48 h of exposure.
Test solutions
- Vehicle:
- yes
- Details on test solutions:
- Elendt M4 medium
Test organisms
- Test organisms (species):
- Daphnia magna
- Details on test organisms:
- TEST ORGANISM
Daphnia magna (Straus, 1820) derived from a healthy stock and not first brood progeny
Age: less than 24 h
TEST SYSTEM
Breeding: parental and young Daphnia held in 4 L glass aquaria (3 L medium) at 20 ± 2 °C
Illumination: 16 h photoperiod a day, supplied by overhead white fluorescent tubes
Medium: continuously aerated Elendt M4 medium; prepared with ultra-pure water (conductivity <1.5 µS/cm)
Feed: Suspension of Desmodesmus subspicatus (green algae) in Elendt M4 medium with an optical density OD680 of about 15 units
Control of sensitivity: acute reference test with potassium dichromate conducted twice a year
Study design
- Test type:
- static
- Water media type:
- freshwater
- Limit test:
- no
- Total exposure duration:
- 48 h
Test conditions
- Test temperature:
- 20.3 - 20.6 °C
Determined in an additional flask without Daphnia at the beginning of the test and after 24 and 48 h of exposure. - pH:
- 6.5 - 7.0
Determined in the combined test solutions for each concentration at the beginning and after 48 h of exposure. - Dissolved oxygen:
- 7.6 - 8.2 mg/L
Determined in the combined test solutions for each concentration at the beginning and after 48 h of exposure. - Conductivity:
- 822 - 958 µS.cm-1
Determined in the combined test solutions for each concentration at the beginning of the exposure. - Nominal and measured concentrations:
- Based on the results of this non-GLP range finding test, the nominal test concentrations for the definitive test were
200 mg/L
100 mg/l test item,
corresponding to 121 and 60.4 mg/L, respectively, active ingredient.
The 200 mg/L test concentration was chosen in order to cover a broader concentration range, as the final purity of the test item was not yet known when the definitive test started. - Details on test conditions:
- Test vessel: 100 ml flasks, all-glass, with 50 ml of test medium, covered with a glass plate to avoid evaporation and contamination of the test solutions with dust
N. Daphia: 40 individuals per test concentration, 20 per vessel
Light: 16 h photoperiod a day, supplied by overhead white fluorescent tubes
Feed: the Daphnia are not fed during the test
All values apart from the temperature were within the acceptable range.
The temperature was kept at 23-24°C and therefore not within the required range of 18–22 °C, controlled at ±1°C. This deviation had no influence on the outcome of the test results since no mortality was observed in the blank control and all other validity criteria were fulfilled. - Reference substance (positive control):
- yes
- Remarks:
- potassium dichromate
Results and discussion
Effect concentrationsopen allclose all
- Duration:
- 24 h
- Dose descriptor:
- EC50
- Effect conc.:
- 103 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Duration:
- 48 h
- Dose descriptor:
- EC50
- Effect conc.:
- 103 mg/L
- Nominal / measured:
- meas. (initial)
- Conc. based on:
- act. ingr.
- Basis for effect:
- mobility
- Details on results:
- The concentrations o in the test medium were measured by photometry at the beginning and after 24 and 48 h of exposure. These analyses revealed that the concentrations of the test item did not correspond to 80-120% of the nominal concentrations throughout the test (ranging between 74 % and 91%), but that the concentrations were stable (within 80-120% of the initially measured concentrations). The measured concentrations of the active ingredient at the beginning of the test were 103 and 55.2 mg/L; and 89.8 and 53.3 mg/L (i.e. respectively 87 and 97% of the initial value) after 48 hours of exposure.
The effective concentrations ECx were assessed based on the initially measured concentrations of the active ingredient.
No significant effects (≤10% immobilization) were observed at the nominal concentrations of 60.4 and 121 mg/L active ingredient or in the blank controls, neither after 24 h of exposure nor after 48 h.
The NOEC values after 24 h and after 48 h of exposure were both 103 mg/l based on the measured concentrations of the active ingredient. - Results with reference substance (positive control):
- Acute reference test with potassium dichromate conducted twice a year.
The EC50 value for the control of sensitivity for 24 h of exposure with potassium dichromate was estimated to be 0.89 mg/L (data from 29 June 2016), which lies within the recommended range of 0.6–2.1 mg/L according to OECD Guideline 202. - Reported statistics and error estimates:
- Statistical analysis was performed with respect to the effect concentrations (including 95% confidence limits)
Any other information on results incl. tables
The effect concentration ECx is the concentration leading to immobilization of x % of the Daphnia after 24 or 48 h of exposure. Those individuals not able to swim within 15 s after gentle agitation of the test vessel were considered to be immobile (even if they were still able move their antennae). The effect concentration ErC50 and EyC50 were determined with ToxRat® Standard Version 2.10 (ToxRat® Solutions GmbH, Alsdorf, Germany).
The no observed effect concentration (NOEC) is the highest concentration tested for which the observed effect is not significantly different from the blank controls. Immobilization rates of <=10% are regarded as not biologically significant.
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Remarks:
- A test is considered valid if not more than 10% of the Daphnia in the control were immobilized, trapped at the surface of the water, or showed any signs of disease or stress. The dissolved oxygen concentration at the end of the test has to be ≥3 mg O2/L.
- Conclusions:
- EC50 Daphnia magna (24h): 103 mg/L
EC50 Daphnia magna (48h): 103 mg/L - Executive summary:
Method
The median effect concentration (EC50) and the no-effect concentration (NOEC) of the substance to Daphnia magna were investigated under static exposure conditions over a period of 48 h, following the guideline OECD 202. Since the test item proved to be only partially soluble in Daphnia medium, the test solutions were prepared as WSFs (water soluble fractions). The investigated concentrations were 300, 136, 62.0, 28.2 and 12.8 mg/L loading rate of the test item, corresponding to 219, 99.8, 45.3, 20.6 and 9.37 mg/L of the active ingredient.
40 individual Daphnia divided into 2 test vessels were expose to each concentration of the test item, and 60 Daphnia divided into 3 test vessels were used as blank controls. The test concentrations during the 48 h test period were measured by HPLC analysis, confirming that the test item was only partially soluble in Daphnia medium and that the concentrations of the test item were satisfactorily maintained over the whole 48 h test period. The effective concentrations ErCx/EyCx were assessed based on the geometric mean (GM) of the measured concentrations of the active ingredient.
Observations
No significant effects (≤ 10% immobilization) were observed at the nominal concentrations of 60.4 and 121 mg/L active ingredient or in the blank controls, neither after 24 h of exposure nor after 48 h.
Conclusion
The median effect concentrations (EC50) on Daphnia magna after 24 h as well as after 48 h of exposure were estimated to be >103 mg/L.
All validity criteria were fulfilled.
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