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Physical & Chemical properties

Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
26 August 2020 to 04 September 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
24.45 mg/L
Conc. based on:
element
Remarks:
Aluminium
Incubation duration:
72 h
Temp.:
20 °C
pH:
8
Details on results:
The solubility of the test substance was found to be 2.89 mg/L for 24 hours, 3.40 mg/L for 48 hours and 3.21 mg/L for 72 hours respectively in terms of Aluminium content and the solubility of the test substance was found to be 22.32 mg/L for 24 hours, 26.25 mg/L for 48 hours and 24.79 mg/L for 72 hours respectively, based on the 12.30% of Aluminium content in the test item which are within the limit of concentration measured in the last two conical flasks (48 hours and 72 hours) as they do not differ by more than 15%.

Table 1. Determination of precision (% RSD) and accuracy (% recovery)




































































































































































Sample Code



Conc. of Sample for Aluminium (ppb)



Sample Volume  Taken (mL)



Final Sample Volume  (mL)



Dilution Factor



Conc. Obtained for Aluminium (ppb)



Conc. Obtained for Aluminium (mg/L)



Nominal Conc. for Aluminium (mg/L)



Recovery (%)



Mean Recovery (%)



SD (±)



RSD (%)



Control 1



LLOQ



3.0



50.0



1.0



-



-



-



-



-



-



-



ACC 1 R1



38.67



3.0



50.0



1.0



644.50



0.64



0.69



93.41



91.73



1.25



1.36



ACC 1 R2



38.35



3.0



50.0



1.0



639.17



0.64



0.69



92.63



ACC 1 R3



37.45



3.0



50.0



1.0



624.17



0.62



0.70



90.46



ACC 1 R4



37.62



3.0



50.0



1.0



627.00



0.63



0.70



90.87



ACC 1 R5



37.78



3.0



50.0



1.0



629.67



0.63



0.70



91.26



Control 2



LLOQ



3.0



50.0



1.0



-



-



-



-



-



-



-



ACC2 R1



44.72



3.0



50.0



10.0



7453.33



7.45



6.93



107.55



94.97



11.37



11.97



ACC2 R2



44.60



3.0



50.0



10.0



7433.33



7.43



6.94



107.26



ACC2 R3



35.85



3.0



50.0



10.0



5975.00



5.98



6.99



86.22



ACC2 R4



35.77



3.0



50.0



10.0



5961.67



5.96



6.97



86.03



ACC2 R5



36.50



3.0



50.0



10.0



6083.33



6.08



7.02



87.78



 


Table 2. Determination of water solubility of ultramarine violet pigment violet 15 CI 77007 (24, 48 and 72 hours)




































































Sample Code



Conc. of Sample for Aluminium (ppb)



Dilution Factor



Conc. Obtained for Aluminium (ppb)



Conc. Obtained for Aluminium (mg/L)



Mean Conc.


Obtained for


Aluminium (mg/L)



24-Hours



Sample 1 24 hours



57.21



50.0



2860.50



2.86



2.89



Sample 2 24 hours



58.21



50.0



2910.50



2.91



48-Hours



Sample 1 48 hours



67.73



50.0



3386.50



3.39



3.40



Sample 2 48 hours



68.10



50.0



3405.00



3.41



72-Hours



Sample 1 72 hours



64.83



50.0



3241.50



3.24



3.21



Sample 2 72 hours



63.52



50.0



3176.00



3.18



 


Table 3. Mean water solubility of ultramarine violet pigment violet 15 CI 77007


































Hours



Aluminium Water Solubility (mg/L)



24 hours



2.89



48 hours



3.40



72 hours



3.21



Average



3.16



SD (±)



0.26



(%) RSD



8.00


Conclusions:
The solubility of the test substance in water was determined to be 24.45 mg/L at 20ºC, based on the aluminium content determination of 3.17 mg/L in water and 12.95% of aluminium content in the test item.
Executive summary:

The water solubility determination of the test item was performed in accordance with OECD TG 105 under GLP conditions. In a preliminary test, the solubility of test item was determined to be ≥10-2 g/L, hence the shake flask method was chosen to determine the solubility in the main test. The water solubility of the test substance was assessed by the quantification of aluminium content in the test item. Aluminium content in obtained samples was determined by Inductively coupled plasma mass spectrometry (ICP-MS). Then, the solubility of the test substance in water was determined based on 12.95% content of aluminium in the test substance. The validation of the analytical method was done based on SANCO/3029/99, rev 4.0 and all parameters assessed were within the acceptability criteria. The mean solubility of the test item was determined to be 3.17 mg/L in terms of aluminium content with 4.49% RSD. The mean total solubility of the test substance was determined to be 24.45 mg/L at 20ºC with 8.14% RSD, based on the 12.95% of aluminium content in the test item. The pH was found to be 8.0.

Description of key information

Key study: Test method OECD 105. GLP study. The solubility of the test item in distilled water at pH 8 was determined to be 24.45 mg/L at 20ºC.

Key value for chemical safety assessment

Water solubility:
24.45 mg/L
at the temperature of:
20 °C

Additional information