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EC number: 700-493-9 | CAS number: 1228180-58-2
- 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
Hydrolysis
Administrative data
- Endpoint:
- hydrolysis
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13-Oct-2010 to 08-Mar-2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 111 (Hydrolysis as a Function of pH)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method C.7 (Degradation: Abiotic Degradation: Hydrolysis as a Function of pH)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Acid Yellow RN 2903
- IUPAC Name:
- Acid Yellow RN 2903
- Details on test material:
- Identification: Acid Yellow RN 2903
Batch Number: Vers. Kilo 6, 26.05.2009
Purity: 65.7 %
Expiry Date: August 01, 2015
Storage Conditions: At room temperature at about 20 °C
Constituent 1
- Radiolabelling:
- no
Study design
- Analytical monitoring:
- yes
- Estimation method (if used):
- Not used.
Duration of testopen allclose all
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 442 508 other: peak area counts
- Duration:
- 120 h
- pH:
- 4
- Temp.:
- 50 °C
- Initial conc. measured:
- 460 905 other: peak area counts
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 448 418 other: peak area counts
- Duration:
- 120 h
- pH:
- 7
- Temp.:
- 50 °C
- Initial conc. measured:
- 450 415 other: peak area counts
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 462 890 other: peak area counts
- Duration:
- 120 h
- pH:
- 9
- Temp.:
- 50 °C
- Initial conc. measured:
- 467 983 other: peak area counts
- Number of replicates:
- Duplicate aliquots (A and B) of sample solution were measured.
- Positive controls:
- not specified
- Negative controls:
- not specified
- Statistical methods:
- Not specified.
Results and discussion
- Transformation products:
- not specified
Total recovery of test substance (in %)open allclose all
- % Recovery:
- 98
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 96
- pH:
- 4
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 100
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 101
- pH:
- 7
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 101
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
- % Recovery:
- 102
- pH:
- 9
- Temp.:
- 50 °C
- Duration:
- 120 h
Dissipation DT50 of parent compoundopen allclose all
- pH:
- 4
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 7
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- pH:
- 9
- Temp.:
- 25 °C
- DT50:
- > 1 yr
- Other kinetic parameters:
- None.
- Details on results:
- At pH4, 7 and 9 there was less than 10% hydrolysis after 5 days at 50°C, equivalent to a half-life greater than 1 year at 25°C.
Any other information on results incl. tables
A typical chromatogram of a standard solution is given in the attached Figure 1. Typical chromatograms of the test solutions after an incubation time of 5 days are given in the attached Figure 2 to Figure 4. The calibration curve of Acid Yellow RN 2903 is shown in the attached Figure 5. The calibration data are given in the attached Table 2. The r2 fit was 0.9990 (optimum 1.0000). This reflects the suitability of the HPLC-system within the range of 0.4758 µg/mL to 23.79 µg/mL of test item.
The results of the tests at pH 4.0, pH 7.0 and pH 9.0 showed no significant degradation of Acid Yellow RN 2903 at 50 °C.
Table 1 Results of the Preliminary Test of Acid Yellow RN 2903
|
pH 4 |
pH 7 |
pH 9 |
|||
|
P1 |
P2 |
P3 |
P4 |
P5 |
P6 |
InitialPeak Areameasured |
442508 |
460905 |
448418 |
450415 |
462890 |
467983 |
Peak Area measured after 2.40 hours incubation |
451426 |
446639 |
444230 |
464684 |
459652 |
466317 |
Peak Areameasured after 120.0 hours incubation |
435365 |
442071 |
448506 |
454383 |
466285 |
476743 |
Hydrolysis after 120.0 hours [%] |
2 |
4 |
0 |
-1 |
-1 |
-2 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- yes
- Conclusions:
- The degradation of Acid Yellow RN 2903 was less than 10% after 5 days at 50 °C and pH 4, 7 and 9. Acid Yellow RN 2903 was considered to be hydrolytically stable, and no further testing was necessary.
- Executive summary:
The hydrolysis determination of Acid Yellow RN 2903 at different pH values was based on the OECD Guideline No. 111, “Hydrolysis as a Function of pH”; adoptedApril 13, 2004.
The results of the tests at pH 4.0, pH 7.0 and pH 9.0 showed no significant degradation of Acid Yellow RN 2903 at 50 °C. The degradation of Acid Yellow RN 2903 was less than 10% after 5 days. These results are summarized in the table below.
pH
Hydrolysis after 5 days, 50 °C
[%]4.0
< 10
7.0
< 10
9.0
< 10
According to theEECDirective 92/69, Section C.7 it can be concluded, that the estimated half-life time is higher than one year under representative environmental conditions (25 °C). Therefore, Acid Yellow RN 2903 is considered to be hydrolytically stable, and no further testing was necessary.
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