Excellent Cosmetic Ingredient NOAEL Data

Hydroxypropyl Methylcellulose (HPMC)

INCI: HYDROXYPROPYL METHYLCELLULOSE

CAS Number
9004-65-3
Function
Film forming, viscosity controlling, binding, stabilising, emulsion stabilising
Safety Rating
EXCELLENT

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted โ€“ FDA GRAS as food additive; CIR assessed safe in cosmetics

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

Safety Data

Margin of Safety (MoS)
not established
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Hydroxypropyl Methylcellulose (HPMC). 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 2004 mg/kg bw/day oral dog Subchronic COSMOS_DB
NOAEL 25000 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 7500 mg/kg bw/day oral rabbit Short Term Toxicity COSMOS_DB
NOAEL 3846 mg/kg bw/day oral dog Short Term Toxicity COSMOS_DB
NOAEL 40000 mg/kg bw/day oral mouse Short Term Toxicity COSMOS_DB
NOAEL 7700 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 6500 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 3000 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 8209 mg/kg bw/day oral rat Subchronic COSMOS_DB
NOAEL 8364 mg/kg bw/day oral rat Subchronic COSMOS_DB

Expert Verdict

Widely used pharmaceutical excipient with excellent safety profile; trace propylene oxide residuals possible.

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Concern Level: Low

Regulatory Flags

eu_children_restricted epa_safer_alternative fda_food_additive

Frequently Asked Questions

Is Hydroxypropyl Methylcellulose (HPMC) safe in cosmetics?

Widely used pharmaceutical excipient with excellent safety profile; trace propylene oxide residuals possible. The EU classifies Hydroxypropyl Methylcellulose (HPMC) as "permitted". Safety rating: EXCELLENT. 10 toxicological study endpoint(s) are available in our database.

Is Hydroxypropyl Methylcellulose (HPMC) allowed in the EU?

Hydroxypropyl Methylcellulose (HPMC) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Hydroxypropyl Methylcellulose (HPMC) do in cosmetics?

Hydroxypropyl Methylcellulose (HPMC) functions as: Film forming, viscosity controlling, binding, stabilising, emulsion stabilising. It is classified as a cosmetic ingredient in our database. CAS number: 9004-65-3.

What is the Margin of Safety for Hydroxypropyl Methylcellulose (HPMC)?

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 Hydroxypropyl Methylcellulose (HPMC)?

The NOAEL (No Observed Adverse Effect Level) for Hydroxypropyl Methylcellulose (HPMC) is 2004 mg/kg bw/day based on a Subchronic study via oral route in dog. A total of 10 study endpoints are available. Source: COSMOS_DB.

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