Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Physical & Chemical properties

Density

Currently viewing:

Administrative data

Link to relevant study record(s)

Referenceopen allclose all

Endpoint:
relative density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 January 1999 to 4 May 1999.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results
Qualifier:
according to guideline
Guideline:
other: 92/69/EEC, A3 (Gas comparison: Pycnometer method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Date of inspection: 23/03/1998 Date of signature: 21/07/1998
Type of method:
pycnometer method
Type:
relative density
Density:
3.5 other: (corresponds to D4(20))
Temp.:
20 °C
Conclusions:
The relative density was determined to be 3.50 at 19.5 ± 0.5°C, using a gas comparison pycnometer, Method A3 of Commission Directive 92/69/EEC.
Executive summary:

The relative density was determined to be 3.50 at 19.5 ± 0.5°C, using a gas comparison pycnometer, Method A3 of Commission Directive 92/69/EEC.

Endpoint:
tap density
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Process was carried out in own analytical laboratory under internal quality procedure
Qualifier:
according to guideline
Guideline:
EPA OPPTS 830.7300 (Density / Relative Density / Bulk Density)
Deviations:
yes
Remarks:
internal procedure based on above standard
Principles of method if other than guideline:
The tapped density is an increased bulk density after mechanically tapping a container containing the powder sample. Tapped density is obtained by tapping a graduated measuring cylinder or vessel containing a powder sample. After observing the initial volume or weight, the measuring cylinder or vessel is mechanically tapped, and volume or weight readings are taken until little further volume or weight change is observed. The mechanical tapping is achieved by raising the cylinder or vessel and allowing it to drop under its own weight by a specified distance
The bulk specific gravity is calculated from the capacity and the mass of a sample filled by "Tap Denser".

At first the sample is pre-processed by a sieve of opening size 850μm, and, of these, the sample of approximately 50g is put in the measuring cylinder. Furthermore, this is set in The Tap Denser and is tapped 50 times in 25sec.

After tapping, the capacity and mass are measured, and specific gravity is calculated.

Bulk specific gravity (g/cm3) = Mass (g) / Capacity (cm3)
GLP compliance:
no
Type of method:
other: tap density method for powders
Type:
tap density
Density:
> 3.4 - < 3.6 g/cm³
Temp.:
20 °C
Conclusions:
Specific gravity of the Tofix-S is between 3.4 and 3.6 g/cm³
Endpoint:
density
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
other: Information provided by Toho Material
Qualifier:
no guideline available
Guideline:
other: Tap density method
Principles of method if other than guideline:
The tapped density is an increased bulk density after mechanically tapping a container containing the powder sample. Tapped density is obtained by tapping a graduated measuring cylinder or vessel containing a powder sample. After observing the initial volume or weight, the measuring cylinder or vessel is mechanically tapped, and volume or weight readings are taken until little further volume or weight change is observed.
GLP compliance:
not specified
Type of method:
other: Bulk specific gravity

Bulk specific gravity: 1.1~1.5g/cm3

Endpoint:
density
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
other: Information provided by Toho Material
Principles of method if other than guideline:
The tapped density is an increased bulk density after mechanically tapping a container containing the powder sample. Tapped density is obtained by tapping a graduated measuring cylinder or vessel containing a powder sample. After observing the initial volume or weight, the measuring cylinder or vessel is mechanically tapped, and volume or weight readings are taken until little further volume or weight change is observed.
GLP compliance:
not specified
Type of method:
other: Bulk specific gravity

Bulk specific gravity: 0.9~1.3g/cm3

Description of key information

The relative density was determined to be 3.50 at 19.5 ± 0.5°C, using a gas comparison pycnometer, Method A3 of Commission Directive 92/69/EEC. In another study the specific gravity of the substance (Tofix-S) was between 3.4 and 3.6 g/cm³.

The bulk specific gravity depends on the particle size of the manufactured material:

Tofix-SNR (Large Particle Size) = 1.1~1.5g/cm³

Tofix-SNR (Small Particle Size) = 0.9~1.3g/cm³

Key value for chemical safety assessment

Relative density at 20C:
3.5

Additional information

The relative density was determined to using a gas comparison pycnometer, Method A3 of Commission Directive 92/69/EEC.

The test described above meet the requirements of OECD Test Guidelines and are assigned to be reliability 1 data according to the scoring system of Klimisch et al (Klimischet al., 1997). This ranking was deemed appropriate because the studies were conducted at the GLP certified laboratory and were in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.