Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16 March 2017
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Appearance was determined by visual observation, direct and under a microscope. No guideline was followed but sufficient details were given in the study report.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-bis(2-hydroxyethyl)glycine
EC Number:
205-755-1
EC Name:
N,N-bis(2-hydroxyethyl)glycine
Cas Number:
150-25-4
Molecular formula:
C6H13NO4
IUPAC Name:
N,N-bis(2-hydroxyethyl)glycine
impurity 1
Chemical structure
Reference substance name:
N-(2-hydroxyethyl)ethylenediaminetriacetic acid
EC Number:
205-759-3
EC Name:
N-(2-hydroxyethyl)ethylenediaminetriacetic acid
Cas Number:
150-39-0
Molecular formula:
C10H18N2O7
IUPAC Name:
N-{2-[bis(carboxymethyl)amino]ethyl}-N-(2-hydroxyethyl)glycine
impurity 2
Reference substance name:
Not specified
IUPAC Name:
Not specified
impurity 3
Chemical structure
Reference substance name:
Water
EC Number:
231-791-2
EC Name:
Water
Cas Number:
7732-18-5
Molecular formula:
H2O
IUPAC Name:
Dihydrogen oxide
Test material form:
solid: crystalline
Details on test material:
Appearance: white crystalline powder
Storage conditions: at room temperature protected from light

Results and discussion

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

Any other information on results incl. tables

The substance as received at the test facility was observed to be a medium, white crystalline powder with clusters. At 32x magnification under a microscope, the particles appeared to be irregular shaped crystals. Many of the larger particles were rectangular in shape, whilst the smaller particles were irregular in shape. At 400x magnification, the sample was observed to be made up of single crystalline particles.  

Applicant's summary and conclusion

Conclusions:
The substance is a white powder.
Executive summary:

The substance was visually observed to be a white solid powder. Under a microscope, the substance was observed to be made up of single crystalline particles.