Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
dissociation constant
Data waiving:
study technically not feasible
Justification for data waiving:
other:
Cross-reference
Reason / purpose for cross-reference:
data waiving: supporting information
Reference
Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 24 June 2019 to 03 July 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 105 (Water Solubility)
Deviations:
yes
Remarks:
As per study director deviation is seen to have no relevant effect on the solubility value.
Qualifier:
according to guideline
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
yes
Remarks:
As per study director deviation is seen to have no relevant effect on the solubility value.
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
yes
Remarks:
As per study director deviation is seen to have no relevant effect on the solubility value.
GLP compliance:
yes (incl. QA statement)
Type of method:
flask method
Key result
Water solubility:
ca. 10.2 mg/L
Conc. based on:
other: saturation mass concentrations of the test substance using TOC - determination.
Temp.:
20 °C
pH:
ca. 6.01
Details on results:
The water solubility of the test item was determined using the shake flask method. The saturation mass concentrations of the test substance were determined using TOC - determination.
The results showed no tendency to increase and met all validity criteria, therefore the study is considered to be valid. Corresponding to the analyses the water solubility was determined to be 10.2 mg/L at a temperature of 20 ± 0.7 °C.
Conclusions:
Under the study conditions, the water solubility of the test substance was determined to be 10.2 mg/L at 20.0 ± 0.7°C.
Executive summary:

A study was conducted to determined the water solubility of the test substance using the shake flask method according to the OECD Guideline 105 and EU Method A.6, in compliance with GLP. Under the study conditions, the water solubility of the test substance was determined to be 10.2 mg/L at 20.0 ± 0.7°C (Wohr, 2019).

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion