Stearic acid, monoester with propane-1,2-diol

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Type of information:

other: weight of evidence assessment based on hydrolysis products and structural analogues

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: based on expert group reviews

Justification for type of information:

Limited data are available for Stearic acid, monoester with propane-1,2-diol (PGMS). The toxicokinetic properties of PGMS is assessed in the present weight of evidence analysis based on existing data on PGMS and the relevant hydrolysis products: propane-1,2-diol (EFSA 2018b), fatty acids in general and fatty acid salts (EFSA 2017 and CIR 2019).

In general, data on propane-1,2-diol esters of fatty acids (EFSA 2018a), fatty acids (EFSA 2017) and fatty acids and salts of fatty acids (CIR 2019) and propane-1,2-diol (EFSA 2018b) will be used in the weight of evidence approach:

CIR (2015): Cosmetic Ingredient Review. Safety assessment of propylene glycol esters as used in cosmetics. Final amended report, 2015.
CIR (2019): Cosmetic Ingredient Review. Safety assessment of fatty acids & fatty acids salts as used in cosmetics. Tentative report for public comment, January 4, 2019.
EFSA (2017). Re-evaluation of fatty acids (E 570) as a food additive EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS). EFSA Journal 2017;15(5):4785
EFSA (2018a). Re-evaluation of propane-1,2-diol esters of fatty acids (E 477) as a food additive, EFSA Journal 2018; 16 (12), Scientific Opinion Adopted 7 November 2018.
EFSA (2018b). Re-evaluation of propane-1,2-diol (E 1520) as a food additive, EFSA Journal 2018; 16 (4), Scientific Opinion Adopted 13 March 2018.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2022

Report date:

2022

Materials and methods

Test material

Test material information

1

Reference substance name:

Stearic acid, monoester with propane-1,2-diol

EC Number:

215-354-3

EC Name:

Stearic acid, monoester with propane-1,2-diol

Cas Number:

1323-39-3

Molecular formula:

C21H42O3

IUPAC Name:

2-hydroxypropyl stearate

Test material form:

solid: pellets

Results and discussion

Toxicokinetic / pharmacokinetic studies

Details on absorption:

Stearic acid, monoester with propane-1,2-diol is hydrolysed by pancreatic lipase in the intestine and is readily absorbed.

Details on distribution in tissues:

The main products by hydrolysis of Stearic acid, monoester with propane-1,2-diol is propane-1,2-diol and stearic acid. Propane-1,2-diol is readily absorbed from the gastrointestinal tract and systemically distributed and primarily metabolised in the liver.

Details on excretion:

Stearic acid, monoester with propane-1,2-diol is excreted in the urine and feces, however, a significant proportion is utilized and excreted as CO2

Metabolite characterisation studies

Details on metabolites:

The main products by hydrolysis of PGMS is propane-1,2-diol and stearic acid.

Propane-1,2-diol is readily absorbed from the gastrointestinal tract and is expected to be widely distributed to organs and tissues (EFSA 2018b). Propane-1,2-diol is primarily metabolized via oxidation to lactic acid and pyruvic acid.

After absorption from the gastrointestinal tract, fatty acids (e.g. stearic acid) are either metabolized or incorporated into chylomicrons, which enter the systemic circulation. Ultimately, fatty acids are either incorporated into triglycerides and phospholipids and stored or catabolized via the beta-oxidation pathway and the tricarboxylic acid cycle to carbon dioxide which is finally excreted via exhalation.

Applicant's summary and conclusion

Conclusions:

Based on the studies available for Stearic acid, monoester with propane-1,2-diol , the relevant hydrolysis products and the components of the UVCB substance, it is concluded that the compoundStearic acid, monoester with propane-1,2-diol is partially hydrolysed e.g. by pancreatic lipase into propane-1,2-diol and stearic acid. These substances are then readily absorbed from the intestine, systemically distributed and primarily metabolised in the liver or used as precursors in biogenesis similar to those obtained from intake of a regular diet

Executive summary:

Limited data are available on the toxicokinetics of the UVCB substance, Stearic acid, monoester with propane-1,2-diol (PGMS). However, several data exists on the toxicokinetics of the hydrolytic products: propane-1,2-diol (E 1520) and certain fatty acids (E 570). The overall conclusion of the toxicokinetics of PGMS is, that in the gastrointestinal tract the substance is partially hydrolysed e.g. by pancreatic lipase into propane-1,2-diol and stearic acid. These substances are then readily absorbed from the intestine, systemically distributed and primarily metabolised in the liver or used as precursors in biogenesis similar to those obtained from intake of a regular diet.