Moderate Cosmetic Ingredient NOAEL Data

Pentaerythrityl Rosinates

INCI: PENTAERYTHRITYL ROSINATE

CAS Number
8050-26-8
Function
Skin conditioning – emollient; viscosity increasing – nonaqueous; film forming
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes FDA permitted for cosmetic use; also direct food additive in chewing gum base (21 CFR 172.615) and indirect food additive (21 CFR 175.105, 175.300, 176.170, 176.210, 178.3120, 178.3870)

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Pentaerythrityl Rosinates. 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

CIR determined insufficient data. Missing genotoxicity assays (≥1 mammalian), dermal absorption study, and chemical properties including structure and impurities. Formulations at 7–9.6% were non-irritating and non-sensitizing in HRIPT, but genotoxicity and impurity data gaps remain unresolved.

⚠️
Concern Level: Moderate

Regulatory Flags

potential-allergen

Frequently Asked Questions

Is Pentaerythrityl Rosinates safe in cosmetics?

CIR determined insufficient data. Missing genotoxicity assays (≥1 mammalian), dermal absorption study, and chemical properties including structure and impurities. Formulations at 7–9.6% were non-irritating and non-sensitizing in HRIPT, but genotoxicity and impurity data gaps remain unresolved. The EU classifies Pentaerythrityl Rosinates as "permitted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is Pentaerythrityl Rosinates allowed in the EU?

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

What does Pentaerythrityl Rosinates do in cosmetics?

Pentaerythrityl Rosinates functions as: Skin conditioning – emollient; viscosity increasing – nonaqueous; film forming. It is classified as a cosmetic ingredient in our database. CAS number: 8050-26-8.

What is the Margin of Safety for Pentaerythrityl Rosinates?

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 Pentaerythrityl Rosinates?

The NOAEL (No Observed Adverse Effect Level) for Pentaerythrityl Rosinates 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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