Good Cosmetic Ingredient NOAEL Data

Dimethyl Isosorbide

INCI: DIMETHYL ISOSORBIDE

CAS Number
5306-85-4
Function
Solvent, Viscosity Controlling, Penetration Enhancer
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR published 2023 Final Report on Dimethyl Isosorbide assessing it as used in cosmetics. No FDA-specific concentration restrictions.

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
low
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Dimethyl Isosorbide. 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
NOAEL 375 mg/kg bw/day oral rat oral REACH

Expert Verdict

Bio-renewable solvent and penetration-enhancing delivery vehicle with CIR 2023 safe-as-used assessment and no EU or US regulatory restrictions. Not classified as hazardous under CLP; non-sensitizing and non-irritating in cosmetic use.

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Concern Level: Low

Regulatory Flags

cir-safe-2023 no-sccs-opinion bio-renewable penetration-enhancer not-readily-biodegradable clp-non-classified

Frequently Asked Questions

Is Dimethyl Isosorbide safe in cosmetics?

Bio-renewable solvent and penetration-enhancing delivery vehicle with CIR 2023 safe-as-used assessment and no EU or US regulatory restrictions. Not classified as hazardous under CLP; non-sensitizing and non-irritating in cosmetic use. The EU classifies Dimethyl Isosorbide as "permitted". Safety rating: GOOD. 1 toxicological study endpoint(s) are available in our database.

Is Dimethyl Isosorbide allowed in the EU?

Dimethyl Isosorbide EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Dimethyl Isosorbide do in cosmetics?

Dimethyl Isosorbide functions as: Solvent, Viscosity Controlling, Penetration Enhancer. It is classified as a cosmetic ingredient in our database. CAS number: 5306-85-4.

What is the Margin of Safety for Dimethyl Isosorbide?

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 Dimethyl Isosorbide?

The NOAEL (No Observed Adverse Effect Level) for Dimethyl Isosorbide is 375 mg/kg bw/day based on a oral study via oral route in rat. Source: REACH.

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