Good Cosmetic Ingredient NOAEL Data

Polysorbate 61

INCI: POLYSORBATE 61

CAS Number

9005-67-8

Function

Surfactant – Emulsifying, Wetting Agent

Safety Rating

GOOD

Regulatory Status

🇪🇺 EU Status permitted

🇺🇸 US Status permitted

US Notes Permitted for cosmetic use; CIR concluded safe when formulated to be nonirritating

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

Safety Data

Margin of Safety (MoS)

adequate

Dermal Absorption

low

Sensitization

low

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

8 study endpoints found for Polysorbate 61. 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	5000 mg/kg bw/day	oral	rat	Chronic	COSMOS_DB
NOAEL	15000 mg/kg bw/day	oral	mouse	Subchronic	COSMOS_DB
NOAEL	7500 mg/kg bw/day	oral	hamster	Chronic	COSMOS_DB
NOAEL	2500 mg/kg bw/day	oral	rat	Chronic	COSMOS_DB
NOAEL	15000 mg/kg bw/day	oral	mouse	Multigeneration Reproductive	COSMOS_DB
NOAEL	5000 mg/kg bw/day	oral	rat	Multigeneration Reproductive	COSMOS_DB
NOAEL	7693 mg/kg bw/day	oral	rat	Developmental	COSMOS_DB
dose_tested	7693 mg/kg bw/day	oral	rat	Developmental	COSMOS_DB

Expert Verdict

HLB 9.6 — W/O emulsifier range with established safety profile when formulated to be nonirritating.

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Concern Level: Low

Regulatory Flags

eu_children_restricted epa_safer_alternative ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Polysorbate 61 safe in cosmetics?

HLB 9.6 — W/O emulsifier range with established safety profile when formulated to be nonirritating. The EU classifies Polysorbate 61 as "permitted". Safety rating: GOOD. 8 toxicological study endpoint(s) are available in our database.

Is Polysorbate 61 allowed in the EU?

Polysorbate 61 EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Polysorbate 61 do in cosmetics?

Polysorbate 61 functions as: Surfactant – Emulsifying, Wetting Agent. It is classified as a cosmetic ingredient in our database. CAS number: 9005-67-8.

What is the Margin of Safety for Polysorbate 61?

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 Polysorbate 61?

The NOAEL (No Observed Adverse Effect Level) for Polysorbate 61 is 5000 mg/kg bw/day based on a Chronic study via oral route in rat. A total of 8 study endpoints are available. Source: COSMOS_DB.

Compliance Tools

Check Polysorbate 61 compliance across multiple jurisdictions:

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Ingredient Decoder

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82 Allergen Checker

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Substance Compliance

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MoS Calculator

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Heavy Metal Limits

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