Didodecyl 3,3'-thiodipropionate

Specific investigations: other studies

Administrative data

Endpoint:

specific investigations: other studies

Type of information:

experimental study

Adequacy of study:

other information

Study period:

1990-07-18 to 1990-07-18

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Most parts of the study performed under GLP. Stability experiment well reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Practical Guidelines for Mutagenicity and Hydrolysis Data requested by SCF".Appendix 2: "Hydrolysis data" Issued by The Commission of the European Communities.

GLP compliance:

yes (incl. QA statement)

Type of method:

in vitro

Endpoint addressed:

not applicable

Test material

Test material information

Constituent 1

Reference substance name:

Didodecyl 3,3'-thiodipropionate

EC Number:

204-614-1

EC Name:

Didodecyl 3,3'-thiodipropionate

Cas Number:

123-28-4

Molecular formula:

C30H58O4S

IUPAC Name:

didodecyl 3,3'-sulfanediyldipropanoate

Details on test material:

Product designation : IRGANOX PS 800
Identification : Batch no. 568
Purity : 96 %

Administration / exposure

Analytical verification of doses or concentrations:

yes

Details on study design:

Simulated gastric fluid (Medium 1)
700 mL of hydrochloric acid are diluted to 1000 mL with distilled water. The resulting pH value is 1.19.

Simulated intestinal fluid (Medium 2)
6.8 g of KH2PO4 are dissolved in 250 mL of water, 190 mL of 0.2 N NaOH and 400 mL of water are added. 10.0 g of pancreatin (Fluka, pig pancreas) are added, mixed, and the pH is adjusted to a value of 7.50 with 42 mL of 0.2 N NaOH. This solution is diluted with water to 1000 mL.
Simulated saliva (Medium 3)
4.2 g of sodium bicarbonate (NaHC03), 0.5 g of sodium chloride (NaCl) and 0.72 g of potassium carbonate (K2CO3) are dissolved in 1 liter of distilled water. The resulting solution has a pH value of 9.0.

In each case 15.0 - 17.0 mg of the test substacne are weighed into a 100 mL round bottom flask. 50 mL of the respective media (heated up to 37°C) are added. The test mixtures are kept at 37°C with stirring for at most 240 min. The mixtures are then quantitatively transferred to 100 ml volumetric flasks using tetrahydrofuran and adjusted to the mark with tetrahydrofuran. The resulting solutions are analysed by liquid chromatography (detection limit of 4 mg/L).

Examinations

Examinations:

Concentration and chemical stability in gastric fluid simulants. The stability study was not performed under GLP.

Positive control:

none

Results and discussion

Details on results:

The solubility of the test item in gastric fluid simulants is lower than the limit of detection of 4 mg/L. In order to get an estimate of an eventual decomposition of the test substance during contact with the media at 37°C (in presence of undissolved material) the test mixtures were analysed in a non-GLP part of the study:
Recovery after 240 minutes at 37°C (determined for 0.150 g/L):
In medium 1 (pH 1.2) : >90%
In medium 2 (pH 7.5) : >90%
In medium 3 (pH 9.0) : >90%