Good Cosmetic Ingredient NOAEL Data

Hydrogenated Mineral Oil

INCI: HYDROGENATED MINERAL OIL

CAS Number
64742-54-7
Function
Emollient, skin conditioning agent, occlusive
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted โ€” white mineral oil is FDA-approved (21 CFR ยง172.878 for food; 21 CFR ยง178.3620(a) for indirect food contact); no CIR restriction

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

Safety Data

Margin of Safety (MoS)
adequate
Dermal Absorption
negligible
Sensitization
none

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Hydrogenated Mineral 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 >=150 mg/kg bw/day dermal code:3543 dermal REACH
NOAEL >2000 mg/kg bw/day dermal rat dermal REACH
NOAEL 1.5 mg/kg bw/day oral rat oral REACH
NOAEL ca.1000 mg/kg bw/day dermal code:3484 dermal REACH
NOAEL >10 other oral rat oral REACH
LOEL 2 other oral rat oral REACH
LOEL 0.2 other oral rat oral REACH
NOAEL ca.0.2 other oral rat oral REACH
LOAEL ca.2 other oral rat oral REACH
NOAEL >=150 mg/kg bw/day dermal code:3543 dermal REACH

Expert Verdict

MOSH/MOAH contamination is the primary concern; CPSR must include full refining history documentation, IP346 test certificate, and PAH specification. For lip products: Cosmetics Europe recommends only fractions with established ADI values

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Concern Level: Low

Regulatory Flags

plant-oil eu_banned_cosmetics eu_cosing_listed

Frequently Asked Questions

Is Hydrogenated Mineral Oil safe in cosmetics?

MOSH/MOAH contamination is the primary concern; CPSR must include full refining history documentation, IP346 test certificate, and PAH specification. For lip products: Cosmetics Europe recommends only fractions with established ADI values The EU classifies Hydrogenated Mineral Oil as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database.

Is Hydrogenated Mineral Oil allowed in the EU?

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

What does Hydrogenated Mineral Oil do in cosmetics?

Hydrogenated Mineral Oil functions as: Emollient, skin conditioning agent, occlusive. It is classified as a cosmetic ingredient in our database. CAS number: 64742-54-7.

What is the Margin of Safety for Hydrogenated Mineral 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 Hydrogenated Mineral Oil?

The NOAEL (No Observed Adverse Effect Level) for Hydrogenated Mineral Oil is >=150 mg/kg bw/day based on a dermal study via dermal route in code:3543. A total of 10 study endpoints are available. Source: REACH.

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