Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September 12-29, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Batch No.: UGe-RS Kilo 1
Color: Yellow
Odor: Not specific
Storage conditions: room temperature
Solubility and stability: Very good solubility in water, stable in solution at least 2 days
Expiring date: 12.12.2018
Correction factor: 1.07
Specific details on test material used for the study:
Test Item name: Yellow LF 6911
Batch No. UGe-RS Kilo 1
Purity 93.3 % (organic part excluding water and salts not containing similar chromophore)
Expiry date 12 December 2018
Storage room temperature

Results and discussion

Water solubility
Key result
Water solubility:
380.2 g/L
Conc. based on:
test mat.
Loading of aqueous phase:
125 g/L
Incubation duration:
24 - 72 h
Temp.:
20 °C
pH:
6.9 - 7.7

Any other information on results incl. tables

Results of the determination of water solubility of Yellow LF 6911

Sampling time

Measured concentrationoftest item,g/L

Measured pH

Test vessels

Mean

After 24h

355.6

361.1

6.9

381.7

6.9

345.9

6.9

After 48h

361.5

390.3

7.0

407.0

7.0

402.5

7.1

After 72h

395.6

389.1

7.1

404.8

7.1

367.0

7.1

Mean with confidence interval (95 %)

380.2 ± 17.95

-

RSD %

6

-

 

Applicant's summary and conclusion

Conclusions:
In conclusion the water solubility of Yellow LF 6911 was determined to be 380.2 ± 17.95 g/L (95% confidence interval) at 20 °C ± 1 °C using the flask method for the performance of the main test
Executive summary:

The purpose of the study was to evaluate the solubility of test item in water at 20 ± 0.5 °C. The test item is dissolved in water at a temperature somewhat above the test temperature. When saturation is achieved the mixture is 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, which must not contain any undissolved particles, is determined by a suitable analytical method.

The water solubility of Yellow LF 6911 was determined to be 380.2 ± 17.95 g/L (95% confidence interval) at 20 °C ± 0.5 °C using the flask method for the performance of the main test