Moderate Cosmetic Ingredient Sensitization Data

Arnica Montana Flower Extract

INCI: ARNICA MONTANA FLOWER EXTRACT

CAS Number
68990-11-4
Function
Anti-inflammatory; anti-ecchymotic (bruising and swelling reduction)
Safety Rating
MODERATE

Regulatory Status

🇪🇺 EU Status permitted
🇺🇸 US Status permitted
US Notes Permitted in cosmetics under general FDCA provisions. No specific FDA concentration restrictions. Listed in 21 CFR 172.510 as a natural flavoring substance (flowers only, alcoholic beverages only) — food classification does not extend to cosmetic use. CIR Expert Panel (2001): found not toxic, not irritating, not sensitizing, not phototoxic at cosmetic use concentrations; positive bacterial mutagenicity (Ames) flagged with request for additional mammalian genotoxicity, repeat-dose dermal, reproductive/developmental, and inhalation toxicity data — these gaps were never formally closed. Under MoCRA, the positive Ames result should be proactively documented in product safety substantiation files.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Arnica Montana Flower Extract based on clinical patch test studies and IFRA standards.

Sensitization Rate
moderate
Allergen Class
botanical
EU Allergen Listed
no
Patch Test Positive Rate
1.2%
Cross-reactivity Group
compositae-group
Reaction Type
contact-dermatitis

Source: IVDK; ESSCA; NACDG

Expert Verdict

Arnica Montana Flower Extract (CAS 68990-11-4) is permitted in the EU under Regulation (EC) No 1223/2009 with no concentration restrictions. CIR (2001) assessed as not toxic, not irritating, not sensitizing, and not phototoxic at cosmetic use concentrations; however, positive bacterial mutagenicity in Ames test remains unresolved. Safe at 0.1–1.0% standardized extract for most users, but primary concern is allergic contact dermatitis from sesquiterpene lactones in Asteraceae-sensitive individuals; cross-reactivity risk must be explicitly addressed in cosmetic product safety reports.

⚠️
Concern Level: Moderate

Regulatory Flags

sensitizer asteraceae-cross-reactivity ames-test-positive cir-data-gaps contact-allergen patch-test-positive sesquiterpene-lactones helenalin herbal-extract ema-assessed

Frequently Asked Questions

Is Arnica Montana Flower Extract safe in cosmetics?

Arnica Montana Flower Extract (CAS 68990-11-4) is permitted in the EU under Regulation (EC) No 1223/2009 with no concentration restrictions. CIR (2001) assessed as not toxic, not irritating, not sensitizing, and not phototoxic at cosmetic use concentrations; however, positive bacterial mutagenicity in Ames test remains unresolved. Safe at 0.1–1.0% standardized extract for most users, but primary concern is allergic contact dermatitis from sesquiterpene lactones in Asteraceae-sensitive individuals; cross-reactivity risk must be explicitly addressed in cosmetic product safety reports. The EU classifies Arnica Montana Flower Extract as "permitted". Safety rating: MODERATE.

Is Arnica Montana Flower Extract allowed in the EU?

Arnica Montana Flower Extract EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Arnica Montana Flower Extract do in cosmetics?

Arnica Montana Flower Extract functions as: Anti-inflammatory; anti-ecchymotic (bruising and swelling reduction). It is classified as a cosmetic ingredient in our database. CAS number: 68990-11-4.

What is the Margin of Safety for Arnica Montana Flower Extract?

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.

Compliance Tools

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Substance Compliance
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MoS Calculator
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