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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:
2017-04-06 to 2017-05-17
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reference:
Composition 0
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
July 27, 1995
Deviations:
no
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
2014
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
March 1998
Deviations:
no
GLP compliance:
yes (incl. certificate)
Other quality assurance:
ISO/IEC 17025 (General requirements for the competence of testing and calibration laboratories)
Type of method:
flask method
Test material information:
Composition 1
Key result
Water solubility:
0.35 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
3.33 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 3.18 - <= 3.26
Details on results:
The calibration solutions were prepared in 0.1 – 10 µg/mL range.
The calibration samples were analysed by spectrophotometric method with three replicates from each.
Concentration of Leuco Sulfur Red 14 was calculated with the help of the calibration equation.

Results of the test and measured concentrations of Leuco Sulfur Red 14 are presented in the following table. The measured concentrations are constant within ± 15 % and thus within the range required by the guidelines.

Results of the Method Validation

Measurement repeatability
(7 parallels)

CV% < 2 %

Repeatability of the Preparation (n=5)

< 5 %

Linear range

0.1 - 10 µg/mL

Correlation coefficients

≥ 0.999

Limit of Quantification

0.1 µg/mL

Limit of Detection

0.05 µg/mL

Recovery from ISO medium

92 %

Recovery from20X AAPmedium

94 %

Recovery from ultra-pure water

97 %

Accuracy

≤ 6 %

Precision

≤ 9 %

Stability of the test item inISO mediumat the temperature 18-22°C for 2 days

Stable at the test conditions

Stability of the test item in20X AAPmediumat the temperature 22-26°C for 7 days

78 %
at the test conditions

Stock solution stability (1 mg/mL) , after dissolution, dye complexation and color development

for at least 3 days at 5±3 °C

Results of the determination of Leuco Sulfur Red 14 concentrations

Sampling time

Measured concentrationofLeuco Sulfur Red 14(mg/L )

Measured pH

Test vessels

Mean withthe 95% confidence intervals

After 24h

0.37

0.36 ± 0.02

3.25

0.36

3.26

0.35

3.25

After 48h

0.35

0.34 ± 0.04

3.18

0.35

3.18

0.32

3.18

Results of the determination of Leuco Sulfur Red 14 concentrations (continued)

Sampling time

Measured concentrationofLeuco Sulfur Red 14(mg/L )

Measured pH

Test vessels

Mean withthe 95% confidence intervals

After 72h

0.36

0.35 ± 0.03

3.18

0.33

3.20

0.35

3.19

Solubility ofthe test item (mg/L)

0.35 ± 0.01

-

RSD%

4

-

Ultra-pure water

< LOQ

6.51

Conclusions:
The water solubility of Leuco Sulfur Red 14 was determined to be 0.35 +/- 0.01 mg/L (95% confidence interval) at 20 °C ± 1 °C using the shake-flask method.

Executive summary:

The solubility of the test item in water was measured according to OECD Guideline 105 (shake-flask method), EU Method A.6 and US EPA OPPTS 830.7840 and in compliance with GLP principles. The substance was dissolved in water at a temperature somewhat above the test temperature of 20 ± 1 °C. When saturation was achieved the mixture was cooled and kept at the test temperature, stirring as long as necessary to reach equilibrium. Subsequently, the mass concentration of the substance in the aqueous solution was determined by a suitable analytical method. In result, the water solubility of the test item was determined to be 0.35 +/- 0.01 mg/L (95% confidence interval)  at 20 °C ± 1 °C using the shake-flask method for the performance.

 

 

Description of key information

The solubility of the test item in water was measured to be 0.35 +/- 0.01 mg/L (95% confidence interval)  at 20 °C ± 1 °C.

Key value for chemical safety assessment

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

Additional information

The solubility of the test item in water was measured according to OECD Guideline 105 (shake-flask method) and in compliance with GLP principles. The substance was dissolved in water at a temperature somewhat above the test temperature of 20 ± 1 °C. When saturation was achieved the mixture was cooled and kept at the test temperature, stirring as long as necessary to reach equilibrium. Subsequently, the mass concentration of the substance in the aqueous solution was determined by a suitable analytical method. In result, the water solubility of the test item was determined to be 0.35 +/- 0.01 mg/L (95% confidence interval)  at 20 °C ± 1 °C using the shake-flask method for the performance.