Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 January 2011 to 26 January 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to EU & OECD test guidance in compliance with GLP and reported with a valid GLP certificate

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Principles of method if other than guideline:
The guideline specifies that the test item in excess should be added to water however the physical properties of Reactive Orange F08-0314 do not permit this. Due to the high solubility, five times the visually estimated quantity cannot be stirred. The study method therefore deviates from the guideline but is considered scientifically valid.
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method

Test material

Constituent 1
Details on test material:
Name: Reactive Orange F08-0314

Results and discussion

Water solubility
Water solubility:
> 417 g/L
Temp.:
20 °C
pH:
> 5.02 - < 5.05
Details on results:
Calibration: Six concentration levels were used: 0.2, 0.5, 1, 2, 5 and 10 µg/ml. The calibration graph was calculated applying linear regression.

Results of the Shake Flask Method: pH of the samples varied in the range of 5.02 – 5.05. Samples were analysed with the HPLC method. Based on the measured concentrations the test mixtures were homogeneous and the whole amount of the added test substance was dissolved.

Justification Measurement: Into a single flask 12.0 g Reactive Orange F08-0314 was weighed. After addition of 20 ml water, the mixture was agitated at 30 °C for three days. After the re-equilibration at 20 °C for 24 hours the sample was centrifuged, filtered, diluted and analysed by HPLC like the other samples.

Concentration measured for this sample was 463 mg/ml.

Any other information on results incl. tables

Table 1: Summary of Standard Curve Parameters

Date

Intercept

Slope

Correlation Coefficient.

24 January 2011

419

19196.4

1.000

25 January 2011

-11

19229.5

1.000

26 January 2011

111

18552.5

1.000

 

Table 2: Results of the determination of Reactive Orange F08-0314 concentrations

Equilibration at 30°C

pH

Measured concentration [g/l]

Mean
[g/l]

[%] of theoretical concentration

24 hours

5.05

411

409

98

5.05

406

5.04

410

48 hours

5.03

405

409

98

5.04

414

5.03

408

72 hours

5.03

417

416

100

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): very soluble (> 10000 mg/L)
As the measured concentrations correspond to the total dissolution of the test substance, and also based on the justification measurement, water solubility of Reactive Orange F08-0314 is higher than 417 g/l at 20 °C.
Executive summary:

Study performed to Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Part A, A.6 Water Solubility and Organisation for Economic Co-operation and Development (OECD), OECD Guidelines for Testing of Chemicals, Guideline No. 105, "Water Solubility", adopted July 27, 1995. This study is compliant with the Principles of Good Laboratory Practice (GLP) and reported with a valid GLP certificate.

 

The purpose of this study was to determine the water solubility of Reactive Orange F08-0314 which is specified by the saturation mass concentration of the test item in water at 20 ±1°C.

As the expected water solubility was above 10-2 g/l, the flask method was applied.

Water solubility of Reactive Orange F08-0314 is higher than 417 g/lat 20°C.