Registration Dossier
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EC number: 276-344-2 | CAS number: 72102-84-2
- 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

Adsorption / desorption
Administrative data
- Endpoint:
- adsorption / desorption: screening
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the physicochemical properties of the substance indicate that it can be expected to have a low potential for adsorption
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
see attached justification
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- additional information on environmental fate and behaviour
- Remarks:
- Dispersion stability in simulated environmental media
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 318
- GLP compliance:
- yes (incl. QA statement)
- Executive summary:
The dispersion stability of the pigment is high and depends especially on water hardness and pH. Only in very hard water with 10 mM Ca and/or under acidic conditions, the dispersion stability is low.
At any of the time points mentioned in the TG-318, the influence of Ca and pH is critical. Regardless of pH, the pigment is categorized at the 24h-sampling time as “unstable” in 10 mM Ca, representing high water hardness. The same “instable” categorization can be applied for any media at pH 4.
After 6h at pH 7 and higher and 0 or 1 mM Ca, the majority of the samples showed high dispersion stability. Only the sample at pH 7 and 1 mM Ca showed 88.3% stability which should therefore be rated as intermediate-high stability. At high Ca concentrations of 10 mM the stability was generally low regardless of the pH value.
In general two effects can be observed. A pH-dependent effect with low stability at low pH values and high stability at higher pH values and a Ca-dependent effects showing lower stability at higher Ca levels. Regarding the environmental relevance the substance is treated as high stability.
Ca(NO3)2 | Stability after 6h | Standard deviation | Stability after 15h | Standard deviation | Stability after 24h | Standard deviation | |
[mM] | [%] | [%] | [%] | [%] | [%] | [%] | |
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pH 4 | 0 | 14.1 | 0.4 | 8.0 | 0.6 | 6.3 | 0.6 |
pH 4 | 1 | 8.9 | 0.5 | 5.4 | 0.5 | 4.3 | 0.2 |
pH 4 | 10 | 8.3 | 0.5 | 4.8 | 0.3 | 3.8 | 0.2 |
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pH 7 | 0 | 99.8 | 0.1 | 99.3 | 0.2 | 98.0 | 0.6 |
pH 7 | 1 | 88.3 | 1.0 | 41.5 | 6.0 | 27.2 | 4.0 |
pH 7 | 10 | 7.5 | 0.1 | 4.2 | 0.2 | 3.1 | 0.2 |
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pH 9 | 0 | 96.1 | 0.9 | 93.8 | 2.0 | 91.8 | 2.1 |
pH 9 | 1 | 99.6 | 0.2 | 97.7 | 0.4 | 96.3 | 0.1 |
pH 9 | 10 | 7.7 | 1.0 | 4.6 | 0.6 | 4.0 | 0.6 |
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Principles of method if other than guideline:
- The partition coefficient was estimated based on the ratio of the solubilities in n-octanol and in water.
The individual solubilities were determined by the flask method based on the ETAD method which was developed by intensive cooperation with the ETAD (Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers) and is regarded as acceptable for pigments by authorities. - GLP compliance:
- no
- Type of method:
- flask method
- Partition coefficient type:
- octanol-water
- Analytical method:
- high-performance liquid chromatography
- Key result
- Type:
- log Pow
- Partition coefficient:
- 0
- Temp.:
- 23 °C
- Remarks on result:
- other: no data on pH value
- Details on results:
- 49 μg/L was found to be the detection limit (LOD) of the method, the quantification limit (LOQ) was defined as 2 times the detection limit; therefore LOQ is 98 μg/L.
- Conclusions:
- The partition coefficient of test substance was calculated to be log Pow=0 at 23 °C.
The concentration of the pigment in water and in n-octanol was determined by HPLC-UV measurements at two different wavelengths. At both wavelengths no pigment could be detected in water and n-octanol. Regarding calibration at 300 nm a lower limit of Detection LOD and Limit of Quantification LOQ was achieved, therefore these values were chosen for calculation.
Solvent | Average concentration at 300 nm |
water | < 98 μg/L |
n-octanol | < 98 μg/L |
The n-octanol/water partition coefficient can be approximated with the following equation:
Pow = (Cn-octanol/ Cwater) = 1.0
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Estimated based on individual solubilities:
log Pow= 0 at 23°C.
- Estimated based on fragment method:
log Pow= 0.5 at 25°C
The partition coefficient was estimated based on the ratio of the solubilities in n-octanol and in water.
The individual solubilities were determined by the flask method based on the ETAD method which was developed by intensive cooperation with the ETAD (Ecological and Toxicological Association of Dyes and Organic Pigments Manufacturers) and is regarded as acceptable for pigments by authorities. The concentration was quanitfied by HPLC with UV-Vis absorption.
In addition, a calculation based on fragment method using KOWWIN (v1.68) module of software EPI Suite v.4.11 yielded a log Pow value of 0.5.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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