Final amended report on safety assessment on aminomethyl propanol and aminomethyl propanediol

Int J Toxicol. 2009 Nov-Dec;28(6 Suppl):141S-61S. doi: 10.1177/1091581809350932.

Abstract

Aminomethyl propanol and aminomethyl propanediol are substituted aliphatic alcohols that function as pH adjusters in cosmetic products at concentrations less than 10%; additionally, aminomethyl propanediol is a fragrance. Extensive oral toxicity data are reviewed, with fewer inhalation toxicity data. Dermal toxicity data are presented that demonstrate, for example, that a mascara with 1.92% aminomethyl propanediol does not cause dermal irritation or allergic contact sensitization, suggesting that the maximum reported use concentration of 2% in mascara would be safe. Although these ingredients are primary amines that are not substrates for N-nitrosation, they may contain secondary amines as impurities in finished products that may undergo N-nitrosation. These ingredients should not be included in cosmetic formulations containing N-nitrosating agents. The Cosmetic Ingredient Review Expert Panel concludes that aminomethyl propanol and aminomethyl propanediol are safe as cosmetic ingredients in the practices of use and concentrations as described in this safety assessment.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Cutaneous
  • Administration, Inhalation
  • Administration, Oral
  • Animals
  • Buffers
  • Consumer Product Safety*
  • Cosmetics / chemistry*
  • Cosmetics / toxicity
  • Emulsifying Agents / administration & dosage
  • Emulsifying Agents / pharmacokinetics
  • Emulsifying Agents / toxicity*
  • Humans
  • Hypersensitivity / etiology
  • Lethal Dose 50
  • Odorants
  • Propanolamines / administration & dosage
  • Propanolamines / pharmacokinetics
  • Propanolamines / toxicity*
  • Propylene Glycols / administration & dosage
  • Propylene Glycols / pharmacokinetics
  • Propylene Glycols / toxicity*
  • Toxicity Tests

Substances

  • Buffers
  • Cosmetics
  • Emulsifying Agents
  • Propanolamines
  • Propylene Glycols
  • 2-amino-2-methyl-1,3-propandiol
  • 2-amino-2-methyl-1-propanol