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Amended Safety Assessment of Methylisothiazolinone as Used in Cosmetics
Christina L Burnett1, Ivan Boyer2, Wilma F Bergfeld3
11 Cosmetic Ingredient Review Scientific Analyst/Writer, Cosmetic Ingredient Review, Washington, DC, USA.
Abstract:
The Cosmetic Ingredient Review Expert Panel (Panel) reviewed the safety of methylisothiazolinone (MI), which functions as a preservative. The Panel reviewed relevant animal and human data provided in this safety assessment and in a previously published safety assessment of MI and concluded that MI is safe for use in rinse-off cosmetic products at concentrations up to 100 ppm and safe in leave-on cosmetic products when they are formulated to be nonsensitizing, which may be determined based on a quantitative risk assessment.
Insights
Methylisothiazolinone (MI) is safe as a cosmetic preservative. It is approved for rinse-off products up to 100 ppm and for leave-on products if formulated to be non-sensitizing.
Area of Science:
- Cosmetic Science
- Dermatology
- Toxicology
Background:
- Methylisothiazolinone (MI) is a widely used preservative in cosmetics.
- Previous safety assessments have informed its use.
- Concerns regarding skin sensitization necessitate ongoing review.
Purpose of the Study:
- To evaluate the safety of methylisothiazolinone (MI) in cosmetic products.
- To determine safe concentration limits for MI in different product types.
- To establish criteria for the safe use of MI in leave-on formulations.
Main Methods:
- Review of existing animal and human safety data for methylisothiazolinone (MI).
- Analysis of data from previous safety assessments.
- Consideration of quantitative risk assessment for non-sensitizing formulations.
Main Results:
- Methylisothiazolinone (MI) is deemed safe for rinse-off cosmetic products at concentrations up to 100 ppm.
- MI is considered safe for leave-on cosmetic products when formulated to be non-sensitizing.
- Quantitative risk assessment can determine acceptable non-sensitizing formulations.
Conclusions:
- The Cosmetic Ingredient Review Expert Panel concludes methylisothiazolinone (MI) is safe under specified conditions.
- Safe use of MI in rinse-off products is established up to 100 ppm.
- Safe use of MI in leave-on products depends on formulation to prevent sensitization.
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