Poor Preservative NOAEL Data SCCS/CIR Reviewed Sensitization Data

Methylisothiazolinone

INCI: METHYLISOTHIAZOLINONE

CAS Number
2682-20-4
Function
preservative
Safety Rating
POOR

Regulatory Status

🇪🇺 EU Status restricted
EU Max Conc. 0.0015% in rinse-off cosmetics only; banned in all leave-on cosmetics
🇺🇸 US Status permitted
US Notes Still permitted in leave-on products in the US, Canada, and Australia — no federal ban. Sensitization rate 6–12% in clinical dermatitis populations. Industry self-restriction strongly recommended for all leave-on products globally. Decline in usage has produced measurable population-level reduction in sensitization rates in EU-compliant markets.

For full compliance data across 55 jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
moderate
Sensitization
high

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

6 study endpoints found for Methylisothiazolinone. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.

Endpoint Value Route Species Study Type Source
LOAEL 75 ppm oral rat Subchronic COSMOS_DB
NOAEL 19 mg/kg bw/day oral rat oral REACH
NOAEL 28.6 mg/kg bw/day oral rat oral REACH
NOAEL 30.09 mg/kg bw/day oral rat oral REACH
NOAEL 40.6 mg/kg bw/day oral dog oral REACH
NOEL 30 ppm oral rat oral REACH

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

cir
Verdict: unknown
NOAEL: 1500 ppm (oral)
cir
Verdict: unknown
NOAEL: 30 mg/kg/d (oral)
cir
Verdict: unknown
NOAEL: 28.6 mg/kg bw/d (not specified)
cir
Verdict: unknown
NOAEL: 30.09 mg/kg bw/d (oral)
cir
Verdict: unknown
NOAEL: 10 mg/kg/d (oral)

Sensitization Profile

Contact sensitization data for Methylisothiazolinone based on clinical patch test studies and IFRA standards.

Sensitization Rate
very-high
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
11.5%
Cross-reactivity Group
isothiazolinone-group
Reaction Type
contact-dermatitis

Source: NACDG 2021-22; ESSCA 2019/20

Expert Verdict

HIGH CONCERN — contraindicated for sensitive-skin formulations. Methylisothiazolinone triggered a documented epidemic of contact allergy in Europe in the 2010s with sensitization rates of 6–12% in dermatitis populations. EU banned from all leave-on cosmetics in 2016; still permitted in rinse-off at ≤0.0015% only. Remains permitted in leave-on products in US, Canada, and Australia — formulators should avoid in all leave-on applications globally regardless of local regulation. Sensitization rate for phenoxyethanol (preferred alternative) is 0.3–1% — 6–40x lower. Avoiding MI in leave-on products reduces both individual sensitization risk and population-level allergen burden.

⚠️
Concern Level: High

Regulatory Flags

preservative eu-banned-leave-on contact-allergen high-sensitization potent-sensitizer rinse-off-only-eu 6-12pct-sensitization-rate pandemic-allergen avoid-leave-on us-permitted-leave-on endocrine_disruptor eu_children_restricted epa_safer_alternative ifra_fragrance eu_cosing_listed

Frequently Asked Questions

Is Methylisothiazolinone safe in cosmetics?

HIGH CONCERN — contraindicated for sensitive-skin formulations. Methylisothiazolinone triggered a documented epidemic of contact allergy in Europe in the 2010s with sensitization rates of 6–12% in dermatitis populations. EU banned from all leave-on cosmetics in 2016; still permitted in rinse-off at ≤0.0015% only. Remains permitted in leave-on products in US, Canada, and Australia — formulators should avoid in all leave-on applications globally regardless of local regulation. Sensitization rate for phenoxyethanol (preferred alternative) is 0.3–1% — 6–40x lower. Avoiding MI in leave-on products reduces both individual sensitization risk and population-level allergen burden. The EU classifies Methylisothiazolinone as "restricted". Safety rating: POOR. 6 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is Methylisothiazolinone allowed in the EU?

Methylisothiazolinone EU regulatory status: restricted. Maximum allowed concentration: 0.0015% in rinse-off cosmetics only; banned in all leave-on cosmetics. This is based on EU Regulation 1223/2009 and its amendments.

What does Methylisothiazolinone do in cosmetics?

Methylisothiazolinone functions as: preservative. It is classified as a Preservative in our database. CAS number: 2682-20-4.

What is the Margin of Safety for Methylisothiazolinone?

not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.

What is the NOAEL for Methylisothiazolinone?

The NOAEL (No Observed Adverse Effect Level) for Methylisothiazolinone is 75 ppm based on a Subchronic study via oral route in rat. A total of 6 study endpoints are available. Source: COSMOS_DB.

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