Registration Dossier
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EC number: 279-356-6 | CAS number: 79953-85-8
- 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:
- data waiving: supporting information
- Remarks:
- dispersion stability
Reference
see endpoint study record in chapter 5.6
- Reason / purpose:
- data waiving: supporting information
- Remarks:
- dispersion stability
Reference
The study of Pigment Yellow 128 according to the mentioned guideline was not possible due to its insufficient wetting with water.
→ Details refer to the endpoint 5.7
The OECD TG 318 on Dispersion Stability of Nanomaterials in Simulated Environmental Media is the first nano-specific test guideline, published 2017. Here we applied it to an organic pigment in order to map the ranges of stability in different media of surface water.
→ The study record maintained at the endpoint 5.7
- Reason / purpose:
- data waiving: supporting information
- Remarks:
- dispersion stability
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:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to
- Guideline:
- other: OECD 318
- GLP compliance:
- no
- Executive summary:
The study is technically not feasible.
The preparation of a stock solution was not successful. The resulting suspension is heterogeneous with most of the pigment accumulated in a foam-like upper phase. It is an indication that the pigment is too hydrophobic and thus it is not sufficiently wetted by water. This makes it impossible to perform all other steps in accordance to the guideline TG-318. Thus the evaluation of the stability of Pigment Yellow 128 in simulated environmental media is not possible.
- Reason / purpose:
- data waiving: supporting information
- Remarks:
- logKow
Reference
Estimated based on solubility ratio:
log Pow= <0 at 23°C
The Log Pow was determined following the ETAD guideline ETAD-299 based on the water solubility method OECD 105.
The test substance is almost insoluble in water as well as in n-Octanol therefore it is not possible to determine the log Pow experimentally by the shake flask method nor by HPLC method.
- Reason / purpose:
- data waiving: supporting information
- Remarks:
- logKow
Reference
- Endpoint:
- partition coefficient
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2011
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Qualifier:
- according to
- Guideline:
- other: based on the ETAD guideline ETAD-229, which in turn is based in part on the water solubility method (shaken flask) OECD 105.
- Principles of method if other than guideline:
- calculation based on solubility ratio
- GLP compliance:
- no
- Type of method:
- estimation method (solubility ratio)
- 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
- Details on results:
- The solubilities of the pigment at 23°C are recorded below:
Solubility in water: <25 µg/L
Solubility in n-octanol: <25 µg/L
The solubility is lower the detection limit of 25 µg/L. - Conclusions:
- The partition coefficient of test substance was estimated to be log Pow= <0 at 23°C
Estimation based on individual solubilities:
Pow= C(n-octanol) / C(water)= <25 µg/L / <25 µg/L = <1
log Pow= <0
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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