Registration Dossier

Physical & Chemical properties

Density

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
density
Remarks:
density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14-04-2017 – 14-04-2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Experimental test result performed using standard test guidelines
Qualifier:
according to
Guideline:
OECD Guideline 109 (Density of Liquids and Solids)
Principles of method if other than guideline:
Test methods: Pour density and tapped density of powders” recommended in The International Pharmacopoeia, Fourth Edition, 2014
Pour Density: It is the ratio of known weight of test item and its volume in graduated glass cylinder.
Tap Density: It is the difference between the volume of test item measured before & after tapping in the graduated glass cylinder.
GLP compliance:
no
Type of method:
pycnometer method
Key result
Type:
pour density
Density:
0.421 g/cm³
Temp.:
29.1 °C
Key result
Type:
tap density
Density:
0.541 g/cm³
Temp.:
29.1 °C

FOR SOLIDS:
By Pour Density and Tapped Density Method:

Method Details

Observations

Remarks if,

any

Guideline

OECD 109

1stReading

2ndReading

 

 

 

 

 

 

 

-

Method

Test methods: Pour density and tapped density of powders” recommended in

The International

Pharmacopoeia, Fourth

Edition, 2014

-

 

Principle of method

 

Pour Density:It is the ratio of known weight of test item and its volume in graduated glass cylinder.

Tap Density:It is the

difference between the

volume of test item

measured before & after

tapping in the graduated

glass cylinder.

-

 

Test temperature

(°C)

-

28.6°C

29.7°C

Atmospheric

pressure (in hPa)

 

968.8

968.5

Weight of test

item(m)

 

 

20.005

20.001

Volume of measuring

cylinder; readability

in g

 

50 ml;1 ml

50 ml;1 ml

Volume of test item without tapping (V)

 

48

47

Volume of test item after tapping ( V1)

After 10 tapping

44

45

 

After 50 tapping

40

40

After 100 tapping

36

38

After 250 tapping

36

38

After 500 tapping

-

-

After 750 Tapping

-

-

*ρat=density of air at 27°C and 760 mm Hg pressure= 0.001168 g/cm³
**Density of water referred from the Table 1 of the IS method.

CALCULATIONS:

Parameters

Details

Calculated values

Average

Density

1st Calculation

2nd Calculation

Pour Density of test Item

(g/cm³)

=m

  V

0.4167

0.4255

0.4211

Tap density of test Item

(g/cm³)

=m

  V1

0.5556

0.5263

0.5410

Conclusions:
The density of test item 4-(phenylazo)benzene-1,3-diamine (CAS No. 495-54-5) was determined following OECD Guideline 109 and according to the The International Pharmacopoeia, Fourth Edition, 2014 using bulk density apparatus. The mean pour density and tapped density of test item was found to be 0.4211 g/cm³ and 0.5410 g/cm³at 29.1°C and 968.6 hPa.
Executive summary:

The density of Test item 4-(phenylazo)benzene-1,3-diamine (CAS No. 495-54-5 ) was determined following OECD guideline 109 and according to the method recommended in the International Pharmacopoeia, fourth Edition, 2014.The mean pour density and tapped density of the test item was found to be 0.4211 g/cm³ and 0.5410 g/cm³at 29.1°C

and 968.6 hPa.

Description of key information

The density of test item 4-(phenylazo)benzene-1,3-diamine (CAS No. 495-54-5) was determined following OECD Guideline 109 and according to the The International Pharmacopoeia, Fourth Edition, 2014 using bulk density apparatus. The mean pour density and tapped density of test item was found to be 0.4211 g/cm³ and 0.5410 g/cm³at 29.1°C and 968.6 hPa.

Key value for chemical safety assessment

Relative density at 20C:
0.421

Additional information

The density of Test item 4-(phenylazo)benzene-1,3-diamine (CAS No. 495-54-5 ) was determined following OECD guideline 109 and according to the method recommended in the International Pharmacopoeia, fourth Edition, 2014.The mean pour density and tapped density of the test item was found to be 0.4211 g/cm³ and 0.5410 g/cm³at 29.1°C and 968.6 hPa.

Supporting data from reliable handbook source (SAX handbook) the density of 4-(Phenylazo)benzene-1,3-diamine is determined as 1.139.

As the data from lab has K1 reliability and the test was performed using OECD guidelines, thus pour density value is considered as key value for the chemical safety assessment.