Good Preservative NOAEL Data SCCS/CIR Reviewed Sensitization Data

METHYLISOTHIAZOLINONE (MIT)

INCI: METHYLISOTHIAZOLINONE

CAS Number
2682-20-4
Function
Preservative (broad-spectrum biocide)
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status restricted
US Notes New Drug Application (NDA) required

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
moderate
Sensitization
moderate

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

6 study endpoints found for METHYLISOTHIAZOLINONE (MIT). 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 (MIT) 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

Preservative with good safety profile but restricted in US due to NDA requirements and known sensitization potential in specific applications.

โš ๏ธ
Concern Level: Moderate

Regulatory Flags

eu_children_restricted epa_safer_alternative ifra_fragrance eu_cosing_listed

Frequently Asked Questions

Is METHYLISOTHIAZOLINONE (MIT) safe in cosmetics?

Preservative with good safety profile but restricted in US due to NDA requirements and known sensitization potential in specific applications. The EU classifies METHYLISOTHIAZOLINONE (MIT) as "permitted". Safety rating: GOOD. 6 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by cir.

Is METHYLISOTHIAZOLINONE (MIT) allowed in the EU?

METHYLISOTHIAZOLINONE (MIT) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does METHYLISOTHIAZOLINONE (MIT) do in cosmetics?

METHYLISOTHIAZOLINONE (MIT) functions as: Preservative (broad-spectrum biocide). It is classified as a Preservative in our database. CAS number: 2682-20-4.

What is the Margin of Safety for METHYLISOTHIAZOLINONE (MIT)?

adequate 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 (MIT)?

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

๐Ÿ“ฑ

Is METHYLISOTHIAZOLINONE (MIT) in Your Products?

Scan any product label with Piro โ€” our free ingredient scanner. Point your camera at the ingredients list and get instant safety scores for every ingredient.

Try Piro Free โ†’

Analyze Your Full Ingredient List

Paste any INCI list into the Decoder for instant safety analysis, or calculate the Margin of Safety for METHYLISOTHIAZOLINONE (MIT) in your formulation.