Moderate Cosmetic Ingredient NOAEL Data

Pentaerythrityl Hydrogenated Rosinate

INCI: PENTAERYTHRITYL HYDROGENATED ROSINATE

CAS Number
64365-17-9
Function
Film forming; viscosity increasing – nonaqueous; skin conditioning – emollient
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA: permitted; hydrogenated rosin pentaerythritol esters have direct food additive status (21 CFR 172.615)

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Pentaerythrityl Hydrogenated Rosinate. 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
NOEL 3000 ppm oral rat oral REACH
NOEL 3000 ppm oral - oral REACH
NOAEL 18000 other oral rat oral REACH
NOAEL 18000 other oral - oral REACH
NOEL 500 other oral rat oral REACH
NOEL 500 other oral - oral REACH
NOEL 500 other oral rat oral REACH
NOEL 500 other oral - oral REACH
NOEL 10000 ppm oral rat oral REACH
NOEL 10000 ppm oral - oral REACH

Expert Verdict

Rosin derivative with colophony-related sensitization potential. CIR found data insufficient for parent compound (pentaerythrityl rosinate). Hydrogenation reduces sensitization vs. unmodified rosin but does not eliminate it. Missing genotoxicity assays, dermal absorption data, and impurity profiles.

⚠️
Concern Level: Moderate

Regulatory Flags

potential-allergen

Frequently Asked Questions

Is Pentaerythrityl Hydrogenated Rosinate safe in cosmetics?

Rosin derivative with colophony-related sensitization potential. CIR found data insufficient for parent compound (pentaerythrityl rosinate). Hydrogenation reduces sensitization vs. unmodified rosin but does not eliminate it. Missing genotoxicity assays, dermal absorption data, and impurity profiles. The EU classifies Pentaerythrityl Hydrogenated Rosinate as "permitted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is Pentaerythrityl Hydrogenated Rosinate allowed in the EU?

Pentaerythrityl Hydrogenated Rosinate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Pentaerythrityl Hydrogenated Rosinate do in cosmetics?

Pentaerythrityl Hydrogenated Rosinate functions as: Film forming; viscosity increasing – nonaqueous; skin conditioning – emollient. It is classified as a cosmetic ingredient in our database. CAS number: 64365-17-9.

What is the Margin of Safety for Pentaerythrityl Hydrogenated Rosinate?

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 Pentaerythrityl Hydrogenated Rosinate?

The NOAEL (No Observed Adverse Effect Level) for Pentaerythrityl Hydrogenated Rosinate is 3000 ppm based on a oral study via oral route in rat. A total of 10 study endpoints are available. Source: REACH.

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