Registration Dossier

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
other: visual observation
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: No guideline followed but evaluation was performed by trained personnel at a GLP facility.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Referenceopen allclose all

Reference Type:
other: NOTOX substance information sheet
Title:
Unnamed
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Visual evaluation of the substance upon arrival at GLP test facility performed by trained personnel and during the particle size distribution test.


GLP compliance:
yes (incl. QA statement)
Remarks:
observation during particle size distribution test

Test material

Constituent 1
Chemical structure
Reference substance name:
2,5-anhydro-4-{[4-(4-{4-[({1-[(2S,3S)- 2-(benzyloxy)pentan-3-yl]hydrazino}carbonyl)amino]phenyl}piperazin1-yl)phenoxy]methyl}-1,3,4-trideoxy-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-
EC Number:
701-059-1
Cas Number:
345217-03-0
Molecular formula:
C43H50F2N8O4
IUPAC Name:
2,5-anhydro-4-{[4-(4-{4-[({1-[(2S,3S)- 2-(benzyloxy)pentan-3-yl]hydrazino}carbonyl)amino]phenyl}piperazin1-yl)phenoxy]methyl}-1,3,4-trideoxy-2-(2,4-difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): PAZ-D
- Physical state: white powder
- Hygroscopic

Results and discussion

Physical state at 20°C and 1013 hPa:
solid
Form / colour / odour
Form:
powder
Colour:
white
Odour:
other: not determined
Substance type:
organic

Applicant's summary and conclusion

Conclusions:
The appearance of the substance has been determined by visual observation directly and under a microscope with 100x and 400x magnification at GLP test facility. The substance is a fine/medium, white powder. It is made up of single crystalline particles.