Registration Dossier

Administrative data

Endpoint:
melting point/freezing point
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study according to international accepted guidelines but not GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 102 (Melting point / Melting Range)
Version / remarks:
ASTM E 537-12
Deviations:
no
GLP compliance:
no
Type of method:
thermal analysis
Remarks:
differential scanning calorimetry

Test material

Constituent 1
Chemical structure
Reference substance name:
(8R,9S,10R,13S,14S,17R)-17-ethynyl-10,13-dimethyl-1,2,4,7,8,9,10,11,12,13,14,15,16,17,-tetradecahydrospiro[cyclopenta[a]phenanthrene-3,2´-[1,3]dioxolan]-17-ol
EC Number:
610-527-3
Cas Number:
50407-76-6
Molecular formula:
C23H32O3
IUPAC Name:
(8R,9S,10R,13S,14S,17R)-17-ethynyl-10,13-dimethyl-1,2,4,7,8,9,10,11,12,13,14,15,16,17,-tetradecahydrospiro[cyclopenta[a]phenanthrene-3,2´-[1,3]dioxolan]-17-ol
Test material form:
solid: crystalline
Details on test material:
Test item: Ethisterone-ketal
Batch No.: 252123N
Physical state: crystalline powder
Colour: almost white
Storage: at 15-30°C, protected from light and wet

Results and discussion

Melting / freezing point
Melting / freezing pt.:
257 °C
Atm. press.:
100.1
Decomposition:
yes
Decomp. temp.:
> 245
Sublimation:
no

Applicant's summary and conclusion