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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 August 2015-17 November 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant study in accordance with EC A.6 and OECD 105.

Data source

Referenceopen allclose all

Reference Type:
other: study amendment
Title:
Unnamed
Year:
2021
Report date:
2021
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:
5-[(S)-4-Carboxy-4-(1,3-dioxo-1,3-dihydro-isoindol-2-yl)-butyrylamino]-2-nitro-benzoic acid
EC Number:
926-197-1
Cas Number:
2561176-48-3
Molecular formula:
C20 H15 N3 O9
IUPAC Name:
5-[(S)-4-Carboxy-4-(1,3-dioxo-1,3-dihydro-isoindol-2-yl)-butyrylamino]-2-nitro-benzoic acid
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name (as cited in study report): P-Glupa-C
- Appearance: yellow powder
- Storage conditions: at room temperature

Results and discussion

Water solubility
Water solubility:
1.63 g/L
Temp.:
20 °C
pH:
2.4 - 2.5
Remarks on result:
other: The substance seems not stable in water.
Details on results:
The concentration analysed after 24, 48 and 72 hours of stirring was 0.977 g/L, 0.772 g/L and 0.654 g/L, resp. A decrease in concentration was observed over time indicating degradation. The pH of the aqueous samples was 2.6-2.7. The maximum difference of 40% did not meet the criterion of = 15% .

The concentration analysed after 3, 6 and 16 hours of stirring was 1.65 g/L, 1.62 g/L and 1.05 g/L, resp. The pH of the aqueous samples was 2.4-2.5. The 16-hour measurement was significantly lower than the 3- and 6-hour measurements (maximum difference > 15%). Based on this, the water solubility of the test substance was given as the mean value of the 3- and 6-hour measurements. A maximum difference of 2.2% was calculated over the 3- and 6-hour measurements.

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

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): decomposes
In a GLP-compliant study in accordance with EC A.6, OECD 105 and OPPTS 830.7840 using the flask method, a decrease in concentration with stirring time was measured indicating degradation. The water solubility of the substance at 20°C was reported as 1.63 g/L, which is the mean of the concentration analysed after 3 and 6 hours of stirring.