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Physical & Chemical properties

Water solubility

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Administrative data

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Reference
Endpoint:
water solubility
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
From January 28th to March 18th, 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Justification for type of information:
REPORTING FORMAT FOR THE ANALOGUE APPROACH
The usage of information on Direct Blue 199 Na/NH4, which has the same main component and with a different counter ion, can be considered as suitable and appropriated because the difference in salification is expected to not influence the characteristics related to the specific end-point.
The impurity profile does not impact on the read across proposed. Details on the approach followed are included in the document attached to the IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
adopted 27th July 1995
Deviations:
yes
Remarks:
deviation from methods has no negative impact on the study results
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
deviation from methods has no negative impact on the study results
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Water solubility:
133.41 g/L
Temp.:
20 °C
pH:
4.77 - 4.84
Remarks on result:
other: average of 1st and 2nd determination of two vessels
Details on results:
Because concentrations in the two last vessels (2nd and 3rd day) do not differ by more than 15 %, the individual results from last two vessels could be averaged.
Average of 2nd and 3rd day: 133.41 g/l (SD 2.51)

Results of the 1st determination of the test substance solubility in water by flask method.

Day pH of saturated solution Concentration in water
(g/l)
1st 4.77 86.19
2nd 4.81 136.10
3rd 4.84 142.60

Results of the 2nddetermination of the test substance solubility in water by flask method.

Day pH of saturated solution 1st measurement* (g/l) 2nd measurement* (g/l) Average of 1st and 2nd measurement (g/l)
1st 4.82 87.78 87.03 87.40
2nd 4.77 127.31 127.01 127.16
3rd 4.79 127.63 127.90 127.76

*Samples for 1st and 2nd measurement were taken from one flask for each day.

Results of 1st and 2nd determination of the test substance solubility in water by flask method.

Day 1stdeterminationt (g/l) 2nddeterminationt (g/l) Average of 1stand 2nddetermination (g/l) Standard Deviation
1st 86.19 87.40 86.80 0.86
2nd 136.10 127.16 131.63 6.32
3rd 142.60 127.76 135.18 10.49
Conclusions:
Water solubility: 133.41 g/l at 20 °C and pH ca 4.8
Executive summary:

Water solubility test was performed for the test substance. Flask method was used. Test was performed according to the Method A.6., Water Solubility, Council Regulation (EC) No.440/2008, Published in O.J. L 142, 2008. 

The concentration of the test substance in the aqueous solution was determined by the gravimetric method.

One deviation occurred during the study: in preliminary test the initial amount of the substance was increased to 1.00 g on the basis of analytical experience. Water volumes have been increased at the same rate. The reason for the increase of the test substance amount and water volume was an expectation of high water solubility. This deviation from methods has no negative impact on the study results.

Because concentrations in the two last vessels (2nd and 3rd day) do not differ by more than 15 %, the individual results from last two vessels could be averaged: 133.41 g/l (SD 2.51).

Conclusion

Water solubility: 133.41 g/l at 20 °C and pH ca 4.8

Description of key information

133.41 g/l at 20 °C and pH ca 4.8

Key value for chemical safety assessment

Water solubility:
133.41 g/L
at the temperature of:
20 °C

Additional information

Flask method - OECD 105