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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 278-388-8 | CAS number: 76199-85-4
- 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://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_environmental-fate-and-pathways.png)
Biodegradation in soil
Administrative data
- Endpoint:
- biodegradation in soil: simulation testing
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- 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:
- biodegradation in water: ready biodegradability
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test)
- GLP compliance:
- yes
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge (adaptation not specified)
- Details on inoculum:
- - Source of inoculum: Chemicals Evaluation and Research Institute, Japan
- Culturing: Once a day, the supernatant solution was removed about one-third the total amount and synthetic waste water was refilled - Duration of test (contact time):
- 28 d
- Initial conc.:
- 100 mg/L
- Based on:
- test mat.
- Parameter followed for biodegradation estimation:
- O2 consumption
- Parameter followed for biodegradation estimation:
- DOC removal
- Parameter followed for biodegradation estimation:
- test mat. analysis
- Details on study design:
- TEST CONDITIONS
- Test volume: 300 ml
- Solubilising agent (type and concentration if used):
- Test temperature: 25 °C
- pH: 7.2 - 7.8 - Reference substance:
- aniline
- Parameter:
- % degradation (O2 consumption)
- Value:
- 0 - 10
- Sampling time:
- 28 d
- Details on results:
- Degradability based on DOC removal after 28 d: 0 - 10 %
Degradability based on residual test substance concentration after 28 d: 0 - 10 %
Suspended matter of the insoluble test substance was observed in test bottles. - Results with reference substance:
- - Degradability of aniline (based on BOD): 53 % at day 7
- Interpretation of results:
- under test conditions no biodegradation observed
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- biodegradation in water: ready biodegradability
- Type of information:
- (Q)SAR
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
- Principles of method if other than guideline:
- Estimation of results of OECD screening tests on ready biodegradation in water: CATALOGIC (v5.14.1.5); CATALOGIC 301C v.11.16
- GLP compliance:
- no
- Oxygen conditions:
- aerobic
- Inoculum or test system:
- activated sludge, domestic, non-adapted
- Duration of test (contact time):
- 28 d
- Parameter:
- half-life in days (QSAR/QSPR)
- Remarks on result:
- other: Primary half life: 2.71 days; Ultimate half life: 1y 0m 5d
- Parameter:
- probability of ready biodegradability (QSAR/QSPR)
- Remarks on result:
- not readily biodegradable based on QSAR/QSPR prediction
- Details on results:
- Model domain similarity:
- Parametric domain: 100%
- Structural domain: 100%
- Mechanistic domain: 100%
Predicted BOD value: 0.18 +/- 7.10E-3
Prediction: not ready degradable - Validity criteria fulfilled:
- yes
- Interpretation of results:
- not readily biodegradable
- Conclusions:
- The test substance is not readily biodegradable (according to OECD criteria)
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- additional information on environmental fate and behaviour
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 318
- GLP compliance:
- no
- Executive summary:
At any of the time points mentioned in the TG-318, the influence of Ca is critical. Regardless of pH, the pigment is unstable in 10 mM Ca, representing high water hardness. After 6h, the samples showed high dispersion stability in 0 mM Ca, intermediate stability in 1 mM and 10 mM Ca at pH values 4 and 9 and low stability 1 mM and 10 mM Ca at pH 7. After 24 hours the stability in 0 mM Ca remained high. For the samples in 1 and 10 mM Ca the stability was low.
At any of the time points mentioned in the TG-318, the influence of Ca is critical. Regardless of pH, the pigment is unstable in 10 mM Ca, representing high water hardness. After 6h, the samples showed high dispersion stability in 0 mM Ca, intermediate stability in 1 mM and 10 mM Ca at pH values 4 and 9 and low stability 1 mM and 10 mM Ca at pH 7. After 24 hours the stability in 0 mM Ca remained high. For the samples in 1 and 10 mM Ca the stability was low.
Table 1: full results of the dispersion stability in the presence of NOM
Ca(NO3)2 | Stability after 6h | Standard deviation | Stability after 15h | Standard deviation | Stability after 24h | Standard deviation | |
[mM] | [%] | [%] | [%] | [%] | [%] | [%] | |
|
|
|
| ||||
pH 4 | 0 | 103.9 | 1.0 | 105.3 | 0.9 | 99.7 | 7.1 |
pH 4 | 1 | 13.4 | 0.8 | 5.3 | 0.3 | 4.1 | 0.3 |
pH 4 | 10 | 14.8 | 2.7 | 4.8 | 0.9 | 3.3 | 0.6 |
. |
|
|
|
|
|
| |
pH 7 | 0 | 97.3 | 0.4 | 95.5 | 0.3 | 94.5 | 0.4 |
pH 7 | 1 | 7.0 | 4.2 | 2.9 | 1.5 | 1.8 | 0.6 |
pH 7 | 10 | 9.2 | 3.9 | 4.0 | 1.4 | 2.4 | 4.2 |
. |
|
|
|
|
|
| |
pH 9 | 0 | 99.6 | 0.6 | 99.5 | 0.7 | 98.5 | 0.8 |
pH 9 | 1 | 15.6 | 0.9 | 6.9 | 0.3 | 5.1 | 0.6 |
pH 9 | 10 | 13.9 | 4.5 | 7.5 | 1.9 | 5.7 | 1.8 |
To rationalize the observed dispersion stability, we finally checked the particle size distribution directly in the environmental medium. We applied the NanoDefine method of Analytical Ultracentrifugation. The centrifugation parameters are given in the methods section.
As required by TG318, paragraph 31, the tested nanomaterial was pre-wetted in ultrapure water and left in the form of wet-paste for 24 h. The TG318 requires this step “to insure the proper interaction of nanomaterial surface with ultrapure water.” We visually observed incomplete wetting, and so any ensuing measurement would have been incorrect. In accord with the NanoGenoTox dispersion protocol, a drop of ethanol was added, successfully transferred the powder into a paste, which was then further diluted as specified in the TG318
The observed size distributions confirm the moderate agglomeration at 1 mM Ca, pH7, with NOM. If the particles would have been significantly dissolved, no size distribution would be observable at all by this method, which relies on the detection of the movement of particles during centrifugal separation.
Additionally, the centrifugation methods include a determination of the remaining absorption after centrifugation, fully consistent with the conventional determination of the dissolved fraction after centrifugation as recommended by the TG-318. The remaining absorption was measured at ca. 0.21. This is a fraction of 10% of the initial absorption, but actually is close to the LOD of the built-in UV/Vis detector. Considering the LOD, between 0% and 10% of the sample may have been dissolved.
All evidence combined, the results after centrifugation confirm that at least 90% of the observed dispersion stability has to be attributed to the particles, not to dissolution.
Data source
Materials and methods
Results and discussion
- Transformation products:
- no
- Remarks:
- Since the substance is highly insoluble in water, simulation biodegradation tests in water and sediment are not proposed, since no relevant new findings are expected from such investigations.
Applicant's summary and conclusion
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)