Reactive Blue F08-0170

Water solubility

Administrative data

Endpoint:

water solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 December 2010 - 07 January 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with recognised study guidelines and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 105 (Water Solubility)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 830.7840 (Water Solubility)

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method A.6 (Water Solubility)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of method:

flask method

Test material

Test material information

Constituent 1

Details on test material:

Name: Reactive Blue F08-0170

Results and discussion

Water solubility

Water solubility 1

Water solubility:

> 145.02 g/L

Temp.:

20 °C

Remarks on result:

other: +/- 9.70 g/L (95% confidence interval) based on Component 1. pH values are tabulised below.

Water solubility 2

Water solubility:

> 139.6 g/L

Temp.:

20 °C

Remarks on result:

other: +/-2.13 g/L (95% confidence interval) based on Component 2. pH values are tabulised below.

Water solubility 3

Water solubility:

> 129.92 g/L

Temp.:

20 °C

Remarks on result:

other: +/-10.54 g/L (95% confidence interval) based on Component 3. pH values are tabulised below.

Water solubility 4

Water solubility:

> 122.35 g/L

Temp.:

20 °C

Remarks on result:

other: +/-9.24 g/L (95% confidence interval) based on Component 4. pH values are tabulised below.

Details on results:

Water Solubility

Measured concentrations of Reactive Blue F08-0170 are summarised in Table 3-6 below. The repeatability of the determination was <15%, and thus within the range required by the guidelines.

The study was supplemented with a sample preparation trial in order to justify the saturation of the water solubility samples.

4.00 g Reactive Blue F08-0170 was weighed into a stoppered Erlenmeyer flasks. After the addition of 20 ml water, the flasks were agitated at 30°C. Passing 1 day the flasks were removed and re-equilibrated at 20°C for 24 hours. The samples were centrifuged and filtered (0.45 µm membrane filter) and diluted with Acetonitrile : Water = 1 : 9 mixture. The concentration of the sample was determined by HPLC.
The result were higher than the concentrations measured during the main test.

Any other information on results incl. tables

Measured concentrations of Reactive Blue F08-0170are summarised in Table 3-6 below. The repeatability of the determination was <15%, and thus within the range required by the guidelines.

 

Table 3. Results of the determination of Reactive Blue F08-0170 (Component 1) concentrations

Measured concentration after 24 hours (g/l)	Measured concentration after 48 hours (g/l)	Measured concentration after 72 hours (g/l)	Solubility ofthe test item (g/l)
142.6	149.1	142.8	145.02 ± 9.70
149.0	145.1	141.2
143.2	152.7	139.5
Mean: 144.9	Mean: 149.0	Mean: 141.2

 

Table 4. Results of the determination of Reactive Blue F08-0170 (Component 2) concentrations

Measured concentration after 24 hours (µg/ml)	Measured concentration after 48 hours (µg/ml)	Measured concentration after 72 hours (µg/ml)	Solubility ofthe test item (µg/ml)
138.3	140.1	138.0	139.60 ± 2.13
144.7	137.6	138.0
138.0	141.8	139.9
Mean: 140.3	Mean: 139.8	Mean: 138.7

 

Table 5. Results of the determination of Reactive Blue F08-0170 (Component 3) concentrations

Measured concentration after 24 hours (µg/ml)	Measured concentration after 48 hours (µg/ml)	Measured concentration after 72 hours (µg/ml)	Solubility ofthe test item (µg/ml)
130.9	124.5	130.3	129.92 ± 10.54
134.6	123.0	132.8
129.7	127.7	135.7
Mean: 131.7	Mean: 125.1	Mean: 133.0

 

Table 6. Results of the determination of Reactive Blue F08-0170 (Component 4) concentrations

Measured concentration after 24 hours (µg/ml)	Measured concentration after 48 hours (µg/ml)	Measured concentration after 72 hours (µg/ml)	Solubility ofthe test item (µg/ml)
121.5	117.6	123.2	122.35 ± 9.24
125.9	117.1	126.1
120.8	120.7	128.3
Mean: 122.7	Mean: 118.5	Mean: 125.9

 

Table 7. Measured pH values

Measured pH values after 24 hours	Measured pH values after 48 hours	Measured pH values after 72 hours
5.28	5.22	5.19
5.25	5.21	5.17
5.25	5.18	5.15

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): very soluble (> 10000 mg/L)
The water solubility of Reactive Blue F08-0170 was determined to be:

- higher than 145.02 +/- 9.70 g/L (95% confidence interval) based on Component 1,
- higher than 139.60 +/- 2.13 g/L (95% confidence interval) based on Component 2,
- higher than 129.92 +/- 10.54 g/L (95% confidence interval) based on Component 3,
- higher than 122.35 +/- 9.24 g/L (95% confidence interval) based on Component 4

at 20°C ± 1°C using the shake-flask method for the performance of the main test.

Executive summary:

 In conclusion, the water solubility of Reactive Blue F08-0170 was determined to be:

- higher than 145.02 ± 9.70 g/L (95% confidence interval) based on Component 1,
- higher than 139.60 ± 2.13 g/L (95% confidence interval) based on Component 2,
- higher than 129.92 ± 10.54 g/L (95% confidence interval) based on Component 3,
- higher than 122.35 ± 9.24 g/L (95% confidence interval) based on Component 4
at 20°C ± 1°C using the shake-flask method for the performance of the main test.

The various components of the substance are considered to be very soluble in water.