Tetradecan-1-ol, propoxylated, esters with propionic acid

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Type of information:

other: Endpoint Expert Assessment

Adequacy of study:

key study

Study period:

March 2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference 1

Reference Type:

other: Endpoint Expert Assessment

Title:

Unnamed

Year:

2018

Report date:

2018

Reference 2

Reference Type:

publication

Title:

An evaluation of the safety of PPG-2 myristyl ether propionate.

Author:

Bernard BK, Harris JE, Fischer JE.

Year:

1998

Bibliographic source:

Food Additives & Contaminants. May-Jun;15(4):427-36.

Materials and methods

Objective of study:

toxicokinetics

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

Principle of test: Assessment of the available experimental data on toxicokinetics for PPG-2 myristyl ether propionate.
- Short description of test conditions: The assessment has been made with reference to the available experimental data on the substance including physical-chemical and toxicological information.
- Parameters analysed / observed: n/a.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (2 mol PO)

Molecular formula:

C23H46O4

IUPAC Name:

1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (2 mol PO)

Constituent 2

Reference substance name:

1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (1 mol PO)

Molecular formula:

C23H46O4

IUPAC Name:

1-(1-tetradecoxypropan-2-yloxy)propan-2-yl propanoate (1 mol PO)

Constituent 3

Reference substance name:

Tetradecyl propionate

EC Number:

228-300-9

EC Name:

Tetradecyl propionate

Cas Number:

6221-95-0

Molecular formula:

C17H34O2

IUPAC Name:

tetradecyl propanoate

Constituent 4

Reference substance name:

PG-2 Tetradecan-1-ol

IUPAC Name:

PG-2 Tetradecan-1-ol

Test material form:

liquid

Applicant's summary and conclusion

Conclusions:

The absence of specific toxicokinetics data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolisation and excretion of PPG-2 myristyl ether propionate. However, it was possible to use existing data on the physical, chemical and toxicological properties of the substance, as well as data available for various fatty alcohol ethoxylates, to determine the likely toxicokinetics behaviour of PPG-2 myristyl ether propionate.
PPG-2 myristyl ether propionate is expected to be well-absorbed following exposure via the oral route considering its high lipophilicity. Available animal data on the substance do not allow confirmation that absorption occurs following oral exposure. PPG-2 myristyl ether propionate is not expected to be available as a vapour due to its low vapour pressure and therefore no absorption via inhalation is expected. Absorption via the dermal route can be expected to be very limited and slow due to the substance being highly insoluble in water and lipophilic.
There are no available animal data providing evidence of distribution of PPG-2 myristyl ether propionate in cells and fatty tissues; however, it is expected that the substance will be well-distributed in any tissue or organ due to its lipophilicity.
No data is available on the metabolisation and excretion of PPG-2 myristyl ether propionate. However the alkyl chain of the constituents of the substance are expected to be rapidly metabolised as CO2 and thus eliminated, while the propoxylated groups are expected to be rapidly eliminated unchanged in the urine.

Executive summary:

An assessment has been performed to evaluate the toxicokinetics behaviour of PPG-2 myristyl ether propionate based on experimental data on the substance and considering adsorption, distribution, metabolism and excretion.

The absence of specific toxicokinetics data from animal testing means that it is not possible to make firm conclusions concerning the absorption, distribution, metabolisation and excretion of PPG-2 myristyl ether propionate. However, it was possible to use existing data on the physical, chemical and toxicological properties of the substance, as well as data available for various fatty alcohol ethoxylates, to determine the likely toxicokinetics behaviour of PPG-2 myristyl ether propionate.

PPG-2 myristyl ether propionate is expected to be well-absorbed following exposure via the oral route considering its high lipophilicity. Available animal data on the substance do not allow confirmation that absorption occurs following oral exposure. PPG-2 myristyl ether propionate is not expected to be available as a vapour due to its low vapour pressure and therefore no absorption via inhalation is expected. Absorption via the dermal route can be expected to be very limited and slow due to the substance being highly insoluble in water and lipophilic.

There are no available animal data providing evidence of distribution of PPG-2 myristyl ether propionate in cells and fatty tissues; however, it is expected that the substance will be well-distributed in any tissue or organ due to its lipophilicity.

No data is available on the metabolisation and excretion of PPG-2 myristyl ether propionate. However the alkyl chain of the constituents of the substance are expected to be rapidly metabolised as CO2 and thus eliminated, while the propoxylated groups are expected to be rapidly eliminated unchanged in the urine.

It is not considered justified to perform animal studies on this substance to further investigate its toxicokinetics behaviour.