Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
appearance / physical state / colour
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24.10.2016 (issue date of the certificate of analysis)
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15. - 17.11.2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose for cross-reference:
reference to same study
Qualifier:
according to guideline
Guideline:
EU Method A.3 (Relative Density)
Qualifier:
according to guideline
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
GLP compliance:
yes (incl. QA statement)
Other quality assurance:
other: not applicable
Type of method:
air comparison pycnometer (for solids)
Specific details on test material used for the study:
purity: 99.9% w/w
Dynamic viscosity of test material:
not specified
Key result
Type:
relative density
Density:
1.41
Temp.:
20 °C

Density of L-Tyrosine

Sample No. Determined sample volume (cm3) Weight test item (g) Temperature (°C) Density (g/cm*) Realtive Density ()
1 3.12931 4.4102 20.00 1.4093 1.4093
2 2.73689 3.8611 20.00 1.4108 1.4108
mean: 20.00 1.4101 1.4101
absolute deviation: 0.00 0.0015 0.0015
relative deviation: 0.00 0.11 0.11
Conclusions:
The mean relative density (D20/4) of L-Tyrosine was determined to be 1.4101 relating to the nominal density of water at 4°C (0.999972 g/cm3).
Executive summary:

The relative density (D20/4) of L-Tyrosine was determined according to EC method A.3 and OECD TG 109 and under GLP compliance. The density of the test item was determined two times with individualy prepared samples. The relative deviation between two measurements was </= 0.5% and the quality criteria of the measurement were therefore fulfilled.

The mean relative density (D20/4) of L-Tyrosine was determined to be 1.4101 relating to the nominal density of water at 4°C (0.999972 g/cm3).

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:
Test item related data in the study report are obtained from a certificate delivered by the sponsor. Methods are not specified.
GLP compliance:
not specified
Other quality assurance:
other: not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Tyrosine
EC Number:
200-460-4
EC Name:
Tyrosine
Cas Number:
60-18-4
Molecular formula:
C9H11NO3
IUPAC Name:
tyrosine
Specific details on test material used for the study:
purity: 99.9 w/w, Lot# 0011675004

Results and discussion

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

Applicant's summary and conclusion

Conclusions:
The sample is solid and white of color at room temperature (20˚C).
Executive summary:

The stated appearance of the test item L-Tyrosine (Lot# 0011675004, 99.9% pure) is based on the information of a certificate of analysis delivered by the sponsor. The used methods are nor specified.

The sample is a white solid at room temperature (20˚C)..