A mixture of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid; dihydrogenated alkyl (C14-C18)amine

Solubility in organic solvents / fat solubility

Administrative data

Endpoint:

solubility in organic solvents / fat solubility

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study was conducted following good laboratory practices. However, since the substance was found to be miscible with standard fat, the main study could not be carried out according to the EEC guideline (EEC-Directive 84/449, Annex V, part A or OECD Guideline 116). Therefore an alternative test for the determination of the miscibility of test substance in standard fat was chosen.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1992

Materials and methods

Test guideline

Qualifier:

no guideline available

Deviations:

yes

Remarks:

An alternative test method was chosen because the test material was found in a preliminary test to be miscible in fat.

Principles of method if other than guideline:

The mass fraction of a test substance which forms a homogeneous phase with a liquid fat (oil) without giving rise to chemical reactions is defined as fat solubility. The maximum of such mass fraction is called the saturation mass fraction. In case the test substance is miscible with a liquid fat (oil), different ratios "test substance;o8q78d fat" are 9bserved.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

87787-81-3

EC Number:

618-070-1

Cas Number:

87787-81-3

IUPAC Name:

87787-81-3

Constituent 2

Reference substance name:

A mixture of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid; dihydrogenated alkyl (C14-C18)amine

EC Number:

413-800-3

EC Name:

A mixture of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid; dihydrogenated alkyl (C14-C18)amine

Cas Number:

87787-81-3

Molecular formula:

C44H79NO3

IUPAC Name:

2-(dioctadecylcarbamoyl)benzoic acid; 2-(ditetradecylcarbamoyl)benzoic acid; 2-[(propan-2-yloxy)carbonyl]benzoic acid; 2-[octadecyl(tetradecyl)carbamoyl]benzoic acid; 2-octadecyl-2,3-dihydro-1H-isoindole-1,3-dione; 2-tetradecyl-2,3-dihydro-1H-isoindole-1,3-dione; benzene-1,2-dicarboxylic acid; dioctadecylamine; ditetradecylamine; octadecyl(tetradecyl)amine

Constituent 3

Reference substance name:

reaction mass of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid dihydrogenated alkyl (C14-C18)amine

IUPAC Name:

reaction mass of: N,N-di(hydrogenated alkyl C14-C18)phthalamic acid dihydrogenated alkyl (C14-C18)amine

Constituent 4

Reference substance name:

Stepan TAB-2

IUPAC Name:

Stepan TAB-2

Details on test material:

Test substance was treated as 100% pure. Test substance is stable at 50 deg C and Stored at room temperature in the dark. Expiry date April 30, 1992. Test material batch number 198308.:

Results and discussion

Test substance stable:

yes

Details on results:

During the preliminary test Stepan TAB-2 was determined to be miscible with standard fat in at least a 1:1 (w/w) ratio at each observation.

Some turbidity was observed in the mixtures at some ratios at the first and third observation, which was probably due to a small decrease in temperature during shaking using a Vortex mixer. Turbidity arose during shaking. Before shaking the samples were clear. One clear (slight yellow) phase was observed at all ratios at the second and fourth observation. No phase separation was observed. The temperature of measurement was 37.0 +- 0.5 deg C.

Any other information on results incl. tables

No further details.

Applicant's summary and conclusion

Conclusions:

The test material (Stepan TAB-2) was determined to be miscible in standard fat HB 307.

Executive summary:

The fat solubility of Stepan TAB-2 was determined using an alternative test method compared to OECD Guideline No. 116. The test results show that Stepan TAB-2 is miscible in fat at a temperature of 37.0 +- 0.5 deg C.