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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:
2017-06-06 to 2017-08-09
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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:
2008
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
March 1998
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method
Remarks:
shake flask method
Key result
Water solubility:
>= 0.53 - <= 0.61 mg/L
Conc. based on:
act. ingr.
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 2.54 - <= 2.57
Remarks on result:
other: the water solubility of Blue Sema was determined to be 0.57 +/- 0.04 mg/L (95% confidence interval) .
Remarks:
The measured concentrations are constant within ± 15 % and thus within the range required by the guidelines.
Details on results:
The measured concentrations were constant within ± 15 % and thus within the range required by the guidelines.

Table 1: Results of the Method Validation

Measurement repeatability
(7 parallels)

CV% < 1 %

Repeatability of the Preparation (n=5)

< 3 %

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

100 %

Recovery from20X AAPmedium

99 %

Recovery from ultra-pure water

110 %

Accuracy(samples used for calibration)

≤ 5 %

Precision

≤ 7 %
(10 % at LOQ)

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

28 %
at the test conditions

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

58 %
at the test conditions

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

for at least 5 days at 5±3 °C

Table 3: Regression data

Analytical occasion

Constant

X Coefficient

R. Squared

June 20, 2017

0.0028

0.0943

0.9994

Table 3: Results of the determination of Blue Sema concentrations

Sampling time

Measured concentrationofBlue Sema(mg/L )

Measured pH

Test vessels

Mean withthe 95% confidence intervals

After 24h

0.57

0.55 ± 0.09

2.57

0.56

2.55

0.51

2.56

After 48h

0.53

0.54 ± 0.09

2.54

0.58

2.55

0.51

2.55


Table 4: Results of the determination of Blue Sema concentrations (continued)

Sampling time

Measured concentrationofBlue Sema(mg/L )

Measured pH

Test vessels

Mean withthe 95% confidence intervals

After 72h

0.60

0.61 ± 0.13

2.54

0.67

2.54

0.56

2.54

Solubility ofthe test item (mg/L)

0.57 ± 0.04

-

RSD%

9

-

Ultra-pure water

< LOQ

5.83

Conclusions:
The water solubility of the test item was determined to be 0.57 ± 0.04 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: 0.57 ± 0.04 mg/L (95% confidence interval).

 

Description of key information

The water solubility of Blue Sema was determined to be 0.57 ± 0.04 mg/L (95% confidence interval)  at 20 °C ± 1 °C using the shake-flask method for the performance 

Key value for chemical safety assessment

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

Additional information

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 0.57 ± 0.04 mg/L (95% confidence interval).