Registration Dossier

Administrative data

Endpoint:
surface tension
Type of information:
experimental study
Adequacy of study:
key study
Study period:
12 December 2017
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Determination of surface tension in an external laboratory
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method A.5 (Surface Tension)
Version / remarks:
The methods described are based on the OECD Test Guideline (1). The fundamental principles are given in reference (2). (1) OECD, Paris, 1981, Test Guideline 115, Decision of the Council C(81) 30 final. (2) R. Weissberger ed.: Technique of Organic Chemistry, Physical Methods of Organic Chemistry, 3rd ed., Interscience Publ., New York, 1959, Vol. I, Part I, Chapter XIV
Deviations:
no
Other quality assurance:
other: Certificate ISO 9001:2015
Remarks:
Measurement of surface tension was carried out in a non GLP but ISO 9001:2015 laboratory.
Type of method:
plate method

Test material

1
Reference substance name:
Ichthammol
EC Number:
232-439-0
EC Name:
Ichthammol
Cas Number:
8029-68-3
Molecular formula:
unspecified
IUPAC Name:
Ichthammol (UVCB substance)
Test material form:
liquid: viscous
Details on test material:
sample from a batch from regular production released for use as an active pharmaceutical ingredient in medicinal products.

Results and discussion

Surface tension
Key result
Surface tension:
31.5 mN/m
Temp.:
25 °C
Conc.:
100 other: %
Remarks on result:
other: Surface tension of the test substance was measured as delivered, i.e. it was not diluted or adapted otherwise.

Applicant's summary and conclusion