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Water solubility

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Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April 03 - May 03, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
July 27, 1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
March 2014
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
March 1998
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
2.81 mg/L
Conc. based on:
test mat.
Loading of aqueous phase:
3.33 g/L
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 6.71 - <= 6.84
Remarks on result:
other:
Remarks:
the water solubility of Yellow 22 was determined to be 2.81 +/- 0.16 mg/L
Details on results:
Result of Water Solubility Test
Results of the test and measured concentrations of Yellow 22 are presented in the following table. The measured concentrations are constant within ± 15 % and thus within the range required by the guidelines. The water solubility of Yellow 22 was determined to be 2.81 +/- 0.16 mg/L (95% confidence interval) at 20 °C ± 1 °C using the shake-flask method for the performance.



Validation Results

Yellow 22 in water was analysed by the previously validated spectrophotometric method.

Results of the Method Validation

Measurement repeatability

(8 parallels)       CV% < 1 %

Repeatability of the Preparation (n=5)       ~ 4 %

Linear range       0.1 - 20 µg/mL

Correlation coefficients       > 0.999

Limit of Quantification       0.1 µg/mL

Limit of Detection       0.1 µg/mL

Recovery from ISO medium       92 %

Recovery from 20X AAP medium       104 %

Recovery from ultra-pure water       100 %

Accuracy       ≤ 6 %

Precision       ≤ 6 %

(16 % at LOQ)

Stability of the test item in ISO medium at the temperature 18-22°C for 2 days       83 % at the test conditions

Stability of the test item in 20X AAP medium at the temperature 22-26°C for 7 days       50 % 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 Yellow 22 concentrations

Sampling time

Measured concentrationofYellow 22(mg/L )

Measured pH

Test vessels

Mean withthe 95% confidence intervals

After 24h

2.55

2.65 ± 0.22

6.84

2.72

6.84

2.69

6.84

After 48h

2.87

2.83 ± 0.67

6.81

3.08

6.79

2.55

6.75

Results of the determination of Yellow 22 concentrations (continued)

Sampling time

Measured concentrationofYellow 22(mg/L )

Measured pH

Test vessels

Mean withthe 95% confidence intervals

After 72h

2.79

2.95 ± 0.37

6.72

3.08

6.72

2.97

6.71

Solubility ofthe test item (mg/L)

2.81 ± 0.16

-

RSD%

7

-

Ultra-pure water

< LOQ

6.53

Conclusions:
The water solubility of the test item was determined to be 2.81 ± 0.16 mg/L (95% confidence interval) at 20 °C ± 1 °C using the shake-flask method for the performance.
Executive summary:

The water solubility of the test item was dertermined at 20 ± 1 °C

according to OECD TG 105 using the shake-flask method. The water solubility is 2.81 ± 0.16 mg/L (95% confidence interval).

Description of key information

The water solubility of Yellow 22 was determined to be 2.81 ± 0.16 mg/L (95% confidence interval)  at 20 °C ± 1 °C using the shake-flask method.  

Key value for chemical safety assessment

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

Additional information