Good Surfactant NOAEL Data

PEG-40 Hydrogenated Castor Oil

INCI: PEG-40 HYDROGENATED CASTOR OIL

CAS Number
61788-85-0
Function
Surfactant, solubilizer
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR Expert Panel (1997, re-reviewed 2014) concluded safe at up to 100% when formulated non-irritating. FDA no restriction. Not for application to broken or damaged skin due to systemic absorption risk in burn-treatment studies.

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

2 study endpoints found for PEG-40 Hydrogenated Castor Oil. 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 oral REACH
NOAEL 1250 mg/kg bw/day oral dog oral REACH

Expert Verdict

CAS 61788-85-0. EU: Permitted, no restrictions. US: CIR-affirmed safe up to 100%; FDA no restriction. 1,4-dioxane impurity possible from ethoxylation -- controllable via purification.

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Concern Level: Low

Regulatory Flags

ethoxylation-byproduct-risk dioxane-impurity-potential avoid-damaged-skin penetration-enhancer cir-safe eu_children_restricted ifra_fragrance

Frequently Asked Questions

Is PEG-40 Hydrogenated Castor Oil safe in cosmetics?

CAS 61788-85-0. EU: Permitted, no restrictions. US: CIR-affirmed safe up to 100%; FDA no restriction. 1,4-dioxane impurity possible from ethoxylation -- controllable via purification. The EU classifies PEG-40 Hydrogenated Castor Oil as "permitted". Safety rating: GOOD. 2 toxicological study endpoint(s) are available in our database.

Is PEG-40 Hydrogenated Castor Oil allowed in the EU?

PEG-40 Hydrogenated Castor Oil EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does PEG-40 Hydrogenated Castor Oil do in cosmetics?

PEG-40 Hydrogenated Castor Oil functions as: Surfactant, solubilizer. It is classified as a Surfactant in our database. CAS number: 61788-85-0.

What is the Margin of Safety for PEG-40 Hydrogenated Castor Oil?

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 PEG-40 Hydrogenated Castor Oil?

The NOAEL (No Observed Adverse Effect Level) for PEG-40 Hydrogenated Castor Oil is 5000 mg/kg bw/day based on a oral study via oral route in rat. A total of 2 study endpoints are available. Source: REACH.

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