Glyceryl tris-12-hydroxystearate is a triester of glycerol and 12-hydroxystearic acid, a
hydroxy fatty acid that is formed from the hydrogenation of the predominant castor oil fatty acid.
Hydrogenation of castor oil results in a substance that is a waxy solid in nature which is also
known as castor wax. In addition to its use as a pesticide product inert ingredient, glyceryl tris12-hdyroxystearate is used as a component of speciality wax blends like crayons, lipsticks, and
stick deodorants.
Trihydroxystearin is used in cosmetic compositions.
Glyceryl tris-12-hydroxystearate is used as a component of speciality wax blends like
crayons, lipsticks, and stick deodorants as well as being used in pharmaceuticals as an excipient
in sustained release capsules. Other uses of glyceryl tris-12-hydroxystearate are as a thixotrophic
agent in paints, coatings, inks, adhesives, and sealants.
Glyceryl tris- 12-hydroxystearate is a triester of glycerol and 12-hydroxystearic acid, a
hydroxy fatty acid that is formed from the hydrogenation of the predominant castor oil fatty acid
(O'Shea, 205). The chemical structure of glyceryl tris-12-hydroxystearate corresponds to hlly
hydrogenated castor oil. Hydrogenation of castor oil results in a substance that is a waxy solid in
nature which is also known as castor wax. The hydrogenated form of castor oil has a wide array
of uses including cosmetic and pharmaceutical applications.
Glyceryl tris-12-hydroxystearate is a triglyceride that is similar to many other fats and oils
and is the fully hydrogenated form of the predominant castor oil fatty acid. Glyceryl tris-12-
hydroxystearate is not expected to be absorbed via any route of exposure and is of low concern
for human health effects. Glyceryl tris-12-hydroxystearate is also readily degraded in the
environment. Taking into consideration all available information on glyceryl tris- 12-hydroxystearate, it
has been determined that there is a reasonable certainty that no harm to any population subgroup
will result fi-om aggregate exposure to glyceryl tris- 12-hydroxystearate when considering dietary
exposure and all other non-occupational sources of pesticide exposure for which there is reliable
information. Therefore, it is recommended that the exemptions from the requirement of a
tolerance established for residues of glyceryl tris-12-hydroxystearate idon raw agricultural
commodities can be considered reassessed as safe under section 408(q) of the FFDCA.
Glyceryl tris-12-hydroxystearate is a hydrogenated form of castor oil. There is no readily
available toxicity data on glyceryl tris-12-hydroxystearate. Limited data are available on castor
oil; as part of the Joint FAOIWHO Expert Committee on Food Additives (JECFA) evaluation of
castor oil as a food additive, it was noted that while low doses of castor oil are absorbed by
humans, higher does are not absorbed and laxation is observed, consistent with its long history of
use as a laxative (JECFA, 1979). A structure activity relationship analysis of glyceryl tris-12-
hydroxystearate was conducted by the Office of Pollution Prevention and Toxics (OPPT)
Structure Activity Team. The OPPT assessment concluded that glyceryl tris-12-hydroxystearate
was poorly absorbed via all routes of exposure and is of low concern for human health effects,
with no identified health concerns (Appendix A).
Glyceryl tris-12-hydroxystearate is expected to be poorly absorbed by the gastrointestinal
(GI) tract (OPPT, 2004). While no pharmacokinetic data are available on glyceryl tris-12-
hydroxysterate, as an orally-administered laxative, castor oil is not absorbed in the GI tract and is
excreted unchanged in the feces. As part of its review of castor oil and derivatives as food
additives, the European Commission's Scientific Committee for Food noted that small doses of
castor oil are hydrolyzed and absorbed completely and can be stored and metabolized similar to
dietary fatty acids (SCF, 2003).
