Calcium 1,4-bis(2-ethylhexyl) bis(2-sulphosuccinate)

Density

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

relative density

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 109 (Density of Liquids and Solids)

Principles of method if other than guideline:

The test is conducted in accordance with the procedure described in EU Regulation (EC) 440/2008, Annex Part A test A.3 and OECD Test Guideline 109.

The relative density of solids or liquids is the ratio between the mass of a volume of substance to be examined, determined at 20°C, and the mass of the same volume of water, determined at 4°C. The relative density has no dimension.

The density, ρ, of a substance is the quotient of the mass, m, and its volume, v.

The density, ρ, is given, in SI units, in kg/m3.

For solids or liquids, pycnometers of various shapes and with known volumes may be employed. The density is calculated from the difference in weight between the full and empty pycnometer and its known volume. The tests are run at a constant temperature, preferably 20°C, and at least two measurements are generally performed.

GLP compliance:

no

Type of method:

pycnometer method

Specific details on test material used for the study:

Batch FPAC1822263.
Substance tested is a 56%wt solution of calcium docusate in corn oil. Attempts were made to obtain neat/pure test material but the substance is extremely difficult to handle in the neat form. The form of the substance tested reflects how the substance will be supplied and placed on the market.

Key result

Type:

relative density

Density:

1.021

Temp.:

20 °C

Type:

density

Density:

1.021 g/cm³

Temp.:

20 °C

Conclusions:

Mean result from 3 runs:
Relative density = 1.021 @ 20°C
Density = 1.021 g.cm-3 @ 20°C

Executive summary:

The density of docusate calcium (56%w/w in corn oil) was determined in accordance with the pycnometer procedure described in EU Regulation (EC) 440/2008, Annex Part A test A.3 and OECD Test Guideline 109.

Mean result from 3 runs:

Relative density = 1.021 @ 20°C

Density = 1.021 g.cm-3 @ 20°C

Reference 2

Endpoint:

density

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

March to April 2010

Reliability:

1 (reliable without restriction)

Justification for type of information:

Data has been read across from a structurally similar substance (Sodium Docusate). See read-across justification documents in section 13 (to be updated to include calcium docusate divalent salt)

Qualifier:

according to guideline

Guideline:

EU Method A.3 (Relative Density)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 109 (Density of Liquids and Solids)

Deviations:

no

GLP compliance:

no

Type of method:

pycnometer method

Type:

density

Density:

1.146 g/cm³

Temp.:

27.4 °C

Four independent measurements were performed at 20.3 °C with following results:

1.1475; 1.1472; 1.1454; 1.1451 g·cm^-3

The mean value was : 1.146 ± 0.001 g·cm^-3

The density °C was determined to be of 1.146 ± 0.001 g·cm^-3 (=1146 kg/m^-3) and the relative density is 1.146 ± 0.001.

Executive summary:

The density of Docusate Soduium was determined accroding to EC A.3 and OECD 109 at 20.3°C using a helium pygnometer. The density °C was determined to be of 1.146 ± 0.001 g·cm^-3(=1146 kg/m^-3) and the relative density is 1.146 ± 0.001.

The relative density value of 1.146 for sodium docusate is used as a read-across supporting study for calcium docusate.

The obtained value is considered relevant and reliable.

Description of key information

The density of docusate calcium (56%w/w in corn oil) was determined in accordance with the pycnometer procedure described in EU Regulation (EC) 440/2008, Annex Part A test A.3 and OECD Test Guideline 109.

Mean result from 3 runs:

Relative density = 1.021 @ 20°C

Density = 1.021 g.cm-3 @ 20°C

Key value for chemical safety assessment

Relative density at 20C:

1.021

Additional information

The density of the read across substance Docusate Sodium was determined in a non-GLP Klimisch 1 key study (Holzschuh 2010) according to methods EC A.3 and OECD 109 at 20.3°C using a helium pygnometer. The density was determined to be of 1.146 ± 0.001 g·cm^-3 (=1146 kg*m^-3). The corresponding relative density is 1.146 ± 0.001.