Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Qualifier:
according to
Guideline:
OECD Guideline 105 (Water Solubility)
GLP compliance:
yes
Type of method:
flask method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Batch 44034
Description: Cream to light grey powder
Expiry date: 30 November 2019
Storage conditions: Controlled room temperature (15-25 ºC, below 70 RH%).
Specific details on test material used for the study:
Storage conditions: Controlled room temperature (15-25 ºC, below 70 RH%).

Results and discussion

Water solubility
Key result
Water solubility:
17.7 other: mg/mL
Conc. based on:
test mat.
Incubation duration:
>= 24 - <= 72 h
Temp.:
20 °C
pH:
>= 5.51 - <= 5.84

Applicant's summary and conclusion

Conclusions:
In conclusion, the water solubility of Sodium [(6-hydroxy-4-methyl-2-oxo-2H-1-benzopyran-7-yl)oxy]acetate was determined to be 17.7 ± 0.28 mg/mL (95% confidence interval) at 20 °C ± 0.5°C using the shake-flask method.
Executive summary:

pH of the samples varied in the range of 5.51 – 5.84.

Samples were analysed with the above HPLC method.

Based on the measured concentrations the test mixtures were homogeneous.