Diphenhydramine HCl

INCI: DIPHENHYDRAMINE HCL

CAS Number
147-24-0
Function
Skin-conditioning agent (pharmacologically active antihistamine)
Safety Rating
POOR

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status prohibited
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Permitted โ€” FDA permits as OTC active (antiemetic, sleep-aid, antihistamine); CIR deferred to FDA review

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Expert Verdict

Prohibited in EU and Canada for cosmetics due to pharmacological activity and systemic risk via dermal route; oral LD50 approximately 500 mg/kg in rats with GHS classifications for harmful ingestion, skin irritation, and eye irritation.

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Concern Level: High

Frequently Asked Questions

Is Diphenhydramine HCl safe in cosmetics?

Prohibited in EU and Canada for cosmetics due to pharmacological activity and systemic risk via dermal route; oral LD50 approximately 500 mg/kg in rats with GHS classifications for harmful ingestion, skin irritation, and eye irritation. The EU classifies Diphenhydramine HCl as "prohibited". Safety rating: POOR.

Is Diphenhydramine HCl allowed in the EU?

Diphenhydramine HCl EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Diphenhydramine HCl do in cosmetics?

Diphenhydramine HCl functions as: Skin-conditioning agent (pharmacologically active antihistamine). It is classified as a cosmetic ingredient in our database. CAS number: 147-24-0.

What is the Margin of Safety for Diphenhydramine HCl?

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.

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