2,2,6,6-Tetramethylpiperidin-4-yl dodecanoate

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2012

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non GLP, less reporting detail than normally in an OECD 111 study.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Objective of study:

other: hydrolysis in stomach acid

Principles of method if other than guideline:

The stability towards hydrolysis at pH 1.2 and pH 4 was investigated in an adaption of OECD guideline 111.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2,2,6,6-tetramethylpiperidin-4-yl dodecanoate

EC Number:

700-503-1

Cas Number:

101238-01-1

Molecular formula:

C21 H41 N O2

IUPAC Name:

2,2,6,6-tetramethylpiperidin-4-yl dodecanoate

Test material form:

other: slightly viscous liquid

Details on test material:

Expiry date: August 2012
Purity: >94%

Radiolabelling:

no

Administration / exposure

Details on study design:

Buffer pH 1.2 : 3.73 g KCl and 134.0 mL 1N HCl diluted to 1 L with dionized water
Buffer pH 4: 5.88 g citric acid, 3.49 g NaCl and 20.6 mL 1 N NaOH diluted to 1 L with dionized water

Analytical Method: Capillary gas chromatography: Determination of loss of the parent substance.
Tested linear range: 0.1 mg/L – 100 mg/L

0.444 mg (pH 1.2 A), 0.570 mg (pH 1.2 B and C) or 0.509 mg (pH
4.0 A and B) were dissolved in 500 mL of the respective buffer by sonication for 30 min at RT. 15 mL portions of these solutions were filled up in 20 mL brown glass test tubes, seald with ground-in stoppers and stored at 40 °C (pH 1.2) and 70°C (pH 4.0). After defined time intervals test tubes were cooled down to room temperature and 1.5 mL dichloromethane were added. The mixtures were shaken well and then the organic layer was analyzed.

Test item concentration: 0.66 mg/L

Details on dosing and sampling:

For pH 1.2 eight time points between 2.5 and 99h were examined.
For pH 4, eight time points between 1.7 and 232 h were examined.

Results and discussion

Preliminary studies:

The half-life at pH 1.2 at 40°C was 22.8h (mean of 3 experiments).
No significant hydrolysis ( < 10%) was observed at pH 4 at 70°C during ten days.

Metabolite characterisation studies

Metabolites identified:

not measured

Any other information on results incl. tables

The half-live of the substance at pH 1.2 and 40°C was determined in three independet experiments to be 22.7, 23.6 and 22.2 h, resulting in an average of 22.8h.

At pH 4, less than 10% hydrolysis was observed during 10 days.