Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Version / remarks:
-
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method A.3 (Relative Density)
Version / remarks:
-
Deviations:
no
GLP compliance:
no
Type of method:
pycnometer method

Test material

Constituent 1
Chemical structure
Reference substance name:
Pyrrolidine, 1-[2-[2-nitro-4-(phenylmethoxy)phenyl]ethenyl]-
Cas Number:
99474-22-3
Molecular formula:
C19H20N2O3
IUPAC Name:
Pyrrolidine, 1-[2-[2-nitro-4-(phenylmethoxy)phenyl]ethenyl]-
Specific details on test material used for the study:
- Analytical purity: > 98.4%
 - Lot/batch No.: 0159115
 - Expiration date of the lot/batch: 21/02/2018

Results and discussion

Densityopen allclose all
Key result
Type:
density
Density:
>= 1.248 - <= 1.26 g/cm³
Temp.:
20 °C
Key result
Type:
relative density
Density:
ca. 1.254 g/cm³
Temp.:
20 °C

Any other information on results incl. tables

Calculated Values

First Determination

 

 

 

Error rel.

Error abs.

Temperature

20.0

°C

 

 

0.1

Density of water

0.998203

g/cm3

 

2.00%

0.0002

Volume of Pycnometer

25.5888

cm3

 

 

 

Density of

Replacement Liquid

0.7892

 

 

 

 

Density of Test Substance

1.2596

g/cm3

 

0.0384%

0.0005

Second Determination

 

 

 

Error rel.

Error abs.

Temperature

20.4

°C

 

 

0.1

Density of water

0.998098

g/cm3

 

2.00%

0.0002

Temperature in °C

20.2

20.4

20.0

20.0

20.0

Volume of Pycnometer

25.5923

cm3

 

 

 

Density of

Replacement Liquid

0.7891

 

 

 

 

Density of Test Substance

1.2477

g/cm3

 

0.0382%

0.0005

rel. = relative; abs. = absolute

Presentation of Results

Results of the single determinations with the respective error as well as the mean value and its standard deviation are presented in the following tables:

Results of Single Determinations

Determination

Density in g/cm3

Error ofDeterm. in g/cm3

1

1.2596

0.0005

2

1.2477

0.0005

As the third determination confirmed the result of the first determination, the result of the second determination was not used for the calculation of the mean value.

Results – Mean Values

Parameter

Value

Unit

Standard Deviation

Relative Standard Deviation

Volume of Pycnometer

25.59

cm3

0.0025

0.01%

Density of Test Substance

1.2536

g/cm3

0.0084

0.67%

Density of Test Substance

1253.6

kg/m3

8.4

0.67%

Relative Density of Test Substance

1.2536

 

0.0084

0.67%

Final Result

Using the pycnometer method, a density of 1.2536 ± 0.0005g/cm3at 20 ± 0.4 °Cwas measured.This valueisthe mean of two independent determinations with the maximum error of a single determination.Standard deviation was 0.0084 g/cm3, showing good correlation of the two determinations

Applicant's summary and conclusion

Conclusions:
Using the pycnometer method, a density of 1.2536 ± 0.0005g/cm3 at 20 ± 0.4 °C was measured. This value is the mean of two independent determinations with the maximum error of a single determination.
Standard deviation was 0.0084 g/cm3, showing good correlation of the two determinations.
Executive summary:

The density of the test item was determined with a not-GLP compliant study following the standard guideline OECD TG 109. Using the pycnometer method, a density of 1.2536 ± 0.0005g/cm3 at 20 ± 0.4 °C was measured. This value is the mean of two independent determinations with the maximum error of a single determination.

Standard deviation was 0.0084 g/cm3, showing good correlation of the two determinations.

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