Registration Dossier
Registration Dossier
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EC number: 274-987-3 | CAS number: 70892-38-5
Water solubility
Administrative data
Link to relevant study record(s)
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 July - 23 August, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- July 27, 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- March 2014
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- March 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- flask method
- Specific details on test material used for the study:
- Expiry date April 26, 2021
- Key result
- Water solubility:
- >= 0.39 - <= 0.43 mg/L
- Conc. based on:
- element (dissolved fraction)
- Loading of aqueous phase:
- 5 000 mg/L
- Incubation duration:
- 24 h
- Temp.:
- 20 °C
- pH:
- >= 5.94 - <= 5.99
- Key result
- Water solubility:
- >= 0.41 - <= 0.43 mg/L
- Conc. based on:
- act. ingr. (dissolved fraction)
- Loading of aqueous phase:
- 5 000 mg/L
- Incubation duration:
- 48 h
- Temp.:
- 20 °C
- pH:
- >= 6.01 - <= 6.07
- Key result
- Water solubility:
- >= 0.39 - <= 0.43 mg/L
- Conc. based on:
- act. ingr. (dissolved fraction)
- Loading of aqueous phase:
- 5 000 mg/L
- Incubation duration:
- 72 h
- Temp.:
- 20 °C
- pH:
- >= 5.99 - <= 6.03
- Details on results:
- Calibration
The calibration solutions were prepared in 0.2 – 20 µg/mL range.
The calibration samples were analysed by spectrophotometric method with three replicates from each.
Concentration of Leuco Sulphur Green 16 was calculated with the help of the calibration equation
Results of the measured concentrations are constant within ± 15 % and thus within the range required by the guidelines. - Conclusions:
- In conclusion the water solubility of the test item was determined to be 0.41 ± 0.02 mg/L (95% confidence interval) at 20 ± 1 °C using the shake-flask method for the performance.
- Executive summary:
The water solubility of the test item was assessed according to OECD Guideline 105, EU Method A.6 and US EPA OPPTS 830.7840 under GLP conditions. The solubility of the test item is below 10 E-2 g/L, so the column elution method should be applied according to the guideline. However, column elution method is not feasible with this test item, because coating of the support material is not possible due to the low solubility of the test item in any solvent. Therefore, the shake-flask method was applied. In result, the water solubility of the test item was determined to be 0.41 ± 0.02 mg/L (95% confidence interval) at 20 °C +/- 1 °C.
Reference
Description of key information
The water solubility was determined to be 0.41 ± 0.02 mg/L (95% confidence interval) at 20 °C ± 1 °C using the shake-flask method.
Key value for chemical safety assessment
- Water solubility:
- 0.41 mg/L
- at the temperature of:
- 20 °C
Additional information
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