Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
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
Guideline:
EU Method A.6 (Water Solubility)
Version / remarks:
March 04, 2016
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Version / remarks:
July 27, 1995
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Version / remarks:
March 1998
Deviations:
no
GLP compliance:
yes
Type of method:
column elution method

Test material

Constituent 1
Chemical structure
Reference substance name:
2-acetyl-3-(4-hexadecoxyphenyl)-1,4-benzoquinone
EC Number:
947-565-8
Molecular formula:
C30 H42 O4
IUPAC Name:
2-acetyl-3-(4-hexadecoxyphenyl)-1,4-benzoquinone

Results and discussion

Water solubility
Water solubility:
0.001 mg/L
Conc. based on:
test mat.
Temp.:
20.2 °C
pH:
>= 6.8 - <= 6.9
Details on results:
The water solubility was performed twice because the results of the first measurements 12 and 24 mL/h gave a maximum difference (MD) >30%. It was considered that undissolved system was not yet in equilibrium. Detailed results are archived in the raw data.

The coefficient of variation (CV) (n = 10) was ≤ 30% at both flow rates. It demonstrated that the system was equilibrated at all flow rates.
The maximum difference (MD) on the mean values of the samples at both flow rates was also ≤ 30%. Based on this, the water solubility of the test item is given as the mean value of these measurements.
The turbidity of the eluates was < 0.2 NTU. According to this, no undissolved particles were detected in the eluates.
Small responses were detected in the samples from the blank column. It was considered to derive from carry-over in the analytical system since similar responses were found in the analytical blanks. The maximum contribution to the highest test item sample was 3.7%. It was considered that it has no significant effect on the results of the test samples.

Applicant's summary and conclusion

Conclusions:
The column elution method was applied for the determination of the water solubility of V134434.
The water solubility of the test item at 20°C was 0.000799 mg/L.
The pH of the aqueous samples was 6.8 and 6.9.