Registration Dossier
Registration Dossier
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EC number: 607-813-5 | CAS number: 25830-77-7
Water solubility
Administrative data
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 03 June 2016 to 11 November 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method A.6 (Water Solubility)
- Version / remarks:
- 2014
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- 1995
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 830.7840 (Water Solubility)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes
- Type of method:
- flask method
Test material
- Reference substance name:
- 2-[(3S)-2,6-dioxooxan-3-yl]isoindole-1,3-dione
- EC Number:
- 607-813-5
- Cas Number:
- 25830-77-7
- Molecular formula:
- C13 H9 N O5
- IUPAC Name:
- 2-[(3S)-2,6-dioxooxan-3-yl]isoindole-1,3-dione
- Test material form:
- solid
- Details on test material:
- - Appearance: white solid
- Storage conditions: in refrigerator (2-8°C) protected from light
Constituent 1
Results and discussion
Water solubilityopen allclose all
- Water solubility:
- 10.4 g/L
- Incubation duration:
- >= 24 - <= 72 h
- Temp.:
- 20 °C
- pH:
- >= 2.3 - <= 2.4
- Remarks on result:
- other: Main study 1 result
- Key result
- Water solubility:
- 8.2 g/L
- Incubation duration:
- >= 24 - <= 72 h
- Temp.:
- 20 °C
- pH:
- 2.4
- Remarks on result:
- other: Main study 2 result
- Details on results:
- Main study 1:
Concentrations analysed after 24, 48 and 72 hours of stirring: 10.7 g/L, 10.6 g/L and 9.96 g/L, resp. Maximum difference meets the criterion of ≤ 15% (i.e. 7.6%). No test substance was detected in the pretreated sample from the blank.
Main study 2:
Concentration analysed after 24, 48 and 72 hours of stirring: 8.12 g/L, 8.20 g/L and 8.29 g/L, resp. Maximum difference meets the criterion of ≤ 15% (i.e. 1.1%). The mean of the three concentrations was reported as the water solubility of the substance. A small peak at the retention time of the test item was detected in the pretreated sample from the blank water mixture. Its maximum contribution is 0.00029% based on peak area corrected for dilution factor.
Applicant's summary and conclusion
- Conclusions:
- The water solubility at 20°C was determined to be 8.2 g/L.
- Executive summary:
The water solubility of the substance was determined using the flask method in a GLP study according to EC A.6, OECD 105 and OPPTS 830.7840. Quantification was performed by UPLC. The pH of the aqueous samples was 2.4. From the measurements obtained after 24, 48 and 72 hours of stirring, the water solubility at 20°C was determined to be 8.2 g/L.
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