Trimethyl Pentanyl Diisobutyrate

What Is It?

Trimethyl Pentanyl Diisobutyrate is a clear, water white liquid substance used primarily as a plasticizerMaterials that soften synthetic polymers by reducing brittleness and cracking. in nail polish.

Why Is It Used?

Trimethyl Pentanyl Diisobutyrate functions as a plasticizer. It imparts flexibility and durability to synthetic polymers such as those used in nail polish.

Scientific Facts

Trimethyl Pentanyl Diisobutyrate is an esterAn organic compound formed by the reaction of an acid with an alcohol.. This means that it is a compound formed between and acid and an alcoholAlcohols are a large class of important cosmetic ingredients but only ethanol needs to be denatured to prevent it from being redirected from cosmetic applications to alcoholic beverages.. Trimethyl Pentanyl Diisobutryate is stable in neutral and acidic solutions, and it is has been shown to biodegrade.

Safety Information

The Food and Drug Administration (FDA) includes Trimethyl Pentanyl Diisobutyrate (as 2,2,4-trimethyl-1,3-pentanediol diisobutryate) on its list of indirect food additives. It may be used in cellophane and as a plasticizer in food contact polymers. The safety studies available on Trimethyl Pentanyl Diisobutyrate have been reviewed as part of the Organization for Economic Cooperation and Development (OECD) Screening Information Data Set (SIDS) for High Production Volume (HPV) chemicals. The review concluded that Trimethyl Pentanyl Diisobutyrate had low potential risk and low priority for needing additional study.

FDA: Link to Code of Federal Regulations for 2,2,4-trimethyl-1,3-pentanediol diisobutyrate (Trimethyl Pentanyl Diisobutyrate)

Information summarized in the review completed for the OECD HPV program indicated that Trimethyl Pentanyl Diisobutyrate was not a mutagen. Some effects on the liver and kidney were observed following high oral doses. No effects on reproduction or development were reported.

Link to the OECD SIDS Summary:
http://cs3-hq.oecd.org/scripts/hpv/status/downloadfile.asp?casnum=684650…

Trimethyl Pentanyl Diisobutryate may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Regulation of the European UnionUnder the general provisions of the cosmetics regulation of the EU, ingredients appearing on the following function-specific annexes must comply with the listed restrictions and/or specifications: colorants (Annex IV), preservatives (Annex V), UV filters (Annex VI) and other ingredients with specific concentration limits and/or other restrictions (Annex III). Ingredients specifically prohibited from use in cosmetic products are listed in Annex II. Other ingredients listed in the EU cosmetic ingredient database (CosIng) may be used without restrictions..

Link to the EU Cosmetic Regulation:
http://europa.eu/legislation_summaries/consumers/product_labelling_and_p…

Resources

Link to the complete OECD SIDS report on Trimethyl Pentanyl Diisobutyrate http://www.chem.unep.ch/irptc/sids/oecdsids/6846500.pdf

Find out more about the regulation of Food Additives by the Food and Drug Administration

Food Ingredients and Packaging: http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm

Food Contact Substances: http://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/defaul…

Substances Generally Recognized As Safe (GRAS“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.): http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/default.htm

Search the Code of Federal Regulations http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

EU Cosmetics Inventory http://ec.europa.eu/consumers/cosmetics/cosing/