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Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 June 2015-18 August 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP-compliant study in accordance with EC A.6 and OECD 105.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
(2008)
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

Constituent 1
Chemical structure
Reference substance name:
(2S)-2-(1,3-DIOXO-2,3-DIHYDRO-1H-ISOINDOL-2-YL)PENTANEDIOIC ACID
EC Number:
608-945-6
Cas Number:
340-90-9
Molecular formula:
C13H11NO6
IUPAC Name:
(2S)-2-(1,3-DIOXO-2,3-DIHYDRO-1H-ISOINDOL-2-YL)PENTANEDIOIC ACID
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name (as cited in study report): Phthalyl-L-Glu
- Appearance: white powder
- Storage conditions: room temperature

Results and discussion

Water solubility
Key result
Water solubility:
9.92 g/L
Temp.:
20 °C
pH:
2.3
Details on results:

The concentration analysed after 24, 48 and 72 hours of stirring was 9.75 g/L, 9.91 g/L and 10.1 g/L, resp. The maximum difference of 3.5% meets the criterion of = 15% . The reported water solubility is the mean of the concentrations analysed at t=24, 48 and 72 h.

The pH of the aqueous samples was 2.3.

No test substance was detected in the pretreated sample from the blank water mixture.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): soluble (1000-10000 mg/L)
In a GLP-compliant study in accordance with EC A.6, OECD 105 and OPPTS 830.7840 using the flask method, the water solubility of Phthalyl-L-Glu at 20°C has been determined as 9.92 g/L.