Opinion of the Scientific Committee on Consumer safety (SCCS) - Opinion on the safety of the use of Methylisothiazolinone (MI) (P94), in cosmetic products (sensitisation only)

Regul Toxicol Pharmacol. 2016 Apr:76:211-2. doi: 10.1016/j.yrtph.2016.01.001. Epub 2016 Jan 11.

Abstract

The information provided does not support the safe use of MI as a preservative in rinse-off cosmetic products up to a concentration limit of 100 ppm from the view of induction of contact allergy. For rinse-off cosmetic products, a concentration of 15 ppm (0.0015%) MI is considered safe for the consumer from the point of view of induction of contact allergy. The information provided does not support the safe use of MI as a preservative in leave-on hair cosmetic products up to a concentration limit of 100 ppm from the point of view of induction of contact allergy. The concerns and opinions raised in SCCS Opinion SCCS/1521/13 (12 December 2013 with revision 27 March 2014) remain. The results of the recent Scandinavian study do not support safety of MI in rinse-off products at either 100 ppm or at 50 ppm for elicitation or induction.

Keywords: CAS 2682-20-4; EC 220-239-6; Methylisothiazolinone (MI) (P94); Regulation 1223/2009; SCCS; Scientific opinion; Sensitisation.

MeSH terms

  • Animals
  • Consumer Product Safety*
  • Cosmetics / adverse effects*
  • Cosmetics / analysis
  • Dermatitis, Allergic Contact / etiology*
  • Dose-Response Relationship, Drug
  • Humans
  • Preservatives, Pharmaceutical / adverse effects*
  • Preservatives, Pharmaceutical / analysis
  • Risk Assessment
  • Risk Factors
  • Thiazoles / adverse effects*
  • Thiazoles / analysis
  • Toxicity Tests

Substances

  • Cosmetics
  • Preservatives, Pharmaceutical
  • Thiazoles
  • 2-methyl-4-isothiazolin-3-one