Registration Dossier

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November - December 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: no guideline reported
Principles of method if other than guideline:
Colour - visual
Aspect - visual
Odour - organoleptic
GLP compliance:
yes (incl. certificate)
Remarks:
This study has been performed in compliance with Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986, issued by the Federal Department of the Interior and the Intercantonal Office for the Control of Medicaments, Switzerlan

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: bulk

Results and discussion

Physical state at 20°C and 1013 hPa:
solid
Form / colour / odour
Key result
Form:
crystalline
Colour:
white to beige
Odour:
sweetish
Substance type:
organic

Applicant's summary and conclusion

Conclusions:
Colour: white to beige
Aspect: crystalline powder
Odour: a slightly sweet odour
Executive summary:

Property

Substance

Method

Result

Colour

P.201025

visual

White to beige

Aspect

P.201025

Visual

Crystalline powder

Odour

P.201025

organoleptic

A slightly sweet odour