Registration Dossier

Administrative data

Endpoint:
water solubility
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 Aug 2017 to 30 Jan 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:
OECD Guideline 105 (Water Solubility)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method A.6 (Water Solubility)
Deviations:
not specified
Qualifier:
according to
Guideline:
EPA OPPTS 830.7840 (Water Solubility)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Remarks:
Health Care Inspectorate of the Ministry of Health, Welfare and Sport; Utrecht, The Netherlands
Type of method:
column elution method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Water solubility
Key result
Water solubility:
< 0.026 mg/L
Conc. based on:
test mat.
Temp.:
20 °C
pH:
>= 7.1 - <= 7.6

Applicant's summary and conclusion