Is Arnica Montana Flower Extract safe in cosmetics?
Arnica Montana Flower Extract has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted.
Arnica Montana Flower Extract
Also known as: Arnica montana, ext., Arnica ext., Arnica flower ext., Arnica montana, extract, EXTRACT, ARNICA, MONTANA (+2 more)
INCI: ARNICA MONTANA FLOWER EXTRACT
Arnica Montana Flower Extract (CAS 68990-11-4) is a cosmetic cosmetic ingredient functioning as Anti-inflammatory; anti-ecchymotic (bruising and swelling reduction). EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 68990-11-4 →
Auto-generated CPSR Part A draft with source citations
Function
Anti-inflammatory; anti-ecchymotic (bruising and swelling reduction)
Safety Rating
MODERATE
Regulatory Status
EU EU Status
permitted
US 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 multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Arnica Montana Flower Extract.
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
Additional Ingredient Properties
7 property records from structured ingredient metadata.
acne
{"cas_number": "68990-11-4", "anti_acne_mechanism": "anti_inflammatory", "comedogenicity_rating_0_to_5": "1", "acne_type_efficacy": "inflammatory", "sebum_reduction_pct_clinical": "0-5", "prescription_required_usa": "No", "otc_drug_monograph_category": "No", "max_otc_concentration_pct": "No limit", "japan_quasi_drug_anti_acne": "No", "korea_functional_cosmetic_acne": "No", "eu_cosmetic_restriction…
allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "botanical", "cross_reactivity_group": "compositae-group", "patch_test_frequency_pct": "1.2", "sensitization_rate": "moderate", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "IVDK; ESSCA; NACDG"}
anti_aging
{"anti_aging_claim": "anti-inflammatory, antioxidant-protection", "mechanism_of_action": "Bioactive phytochemicals, antioxidant compounds", "target_skin_layer": "epidermis", "collagen_stimulation": "No", "elastin_protection": "No", "wrinkle_reduction_pct": "5-10", "clinical_study_duration_weeks": "8", "sample_size": "25", "double_blind": "No", "placebo_controlled": "Yes", "published_journal": "Phy…
anti_pollution
{"cas_number": "68990-11-4", "ingredient_class": "antioxidant_pollution_shield", "primary_mechanism": "free_radical_scavenging", "pollution_types_targeted": "PM2_5", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulati…
depigmentation
{"cas_number": "68990-11-4", "ingredient_class": "anti_inflammatory_brightener", "primary_mechanism_of_action": "Reduces inflammation-induced hyperpigmentation", "secondary_mechanisms": "Variable", "molecular_target": "other", "tyrosinase_inhibition_IC50_uM": "varies", "tyrosinase_inhibition_type": "competitive", "melanin_reduction_pct_in_vitro": "25-45", "melanin_reduction_pct_clinical": "15-30",…
pregnancy_detail
{"pregnancy_safe": "avoid", "breastfeeding_safe": "avoid", "trimester_restriction": "first", "risk_category": "not-rated", "reason": "Emmenagogue properties; uterine stimulant", "alternative_ingredient": "Calendula Extract", "source": "herbal literature"}
solubility_hlb
{"water_soluble": "yes", "oil_soluble": "partial", "soluble_in": "water, propylene glycol, ethanol", "insoluble_in": "oils", "log_p": "-1.1", "appearance": "amber liquid", "source": "Symrise"}
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Deodorizer
Fragrance
Humectant
Softener and conditioner
Expert Verdict
Expert safety assessment and concern-level summary for Arnica Montana Flower Extract.
Regulatory Flags
sensitizer
asteraceae-cross-reactivity
ames-test-positive
cir-data-gaps
contact-allergen
patch-test-positive
sesquiterpene-lactones
helenalin
herbal-extract
ema-assessed
Known Synonyms
Arnica montana, ext.
Arnica ext.
Arnica flower ext.
Arnica montana, extract
EXTRACT, ARNICA, MONTANA
EINECS No.: 273-579-2
Arnica montana
Chemical Function
Deodorizer
Softener and conditioner
Fragrance
Humectant
Regulatory Lists
Europe; Personal care - liniment
Canada; pharmaceutical
Canada; pharmaceutical
Canada; pharmaceutical
Canada; pharmaceutical
Europe; Personal care - body oil
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA count match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Adverse Event Associations
56
Frequently Asked Questions
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.
Is Arnica Montana Flower Extract used outside cosmetics?
Arnica Montana Flower Extract also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Arnica Montana Flower Extract compliance across multiple jurisdictions:
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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