Poor Preservative Sensitization Data

Quaternium-15

Also known as: 3,5,7-Triazatricyclo(3.3.1.1(superscript 3,7))decane, 1-(3-chloro-2-propenyl)-, chloride, (Z)-, 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride, cis form, Hexamethylenetetramine cis-chloroallyl chloride, cis-N-(3-Chloroallyl) hexaminium chloride, cis-1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride (+1 more)

INCI: QUATERNIUM-15

Quaternium-15 (CAS 51229-78-8) is a cosmetic preservative functioning as Preservative (antimicrobial, biocide). EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 51229-78-8 →

Auto-generated CPSR Part A draft with source citations
Function
Preservative (antimicrobial, biocide)
Safety Rating
POOR

Chemistry & Identifiers

EC Number
426-020-3

Regulatory Status

EU EU Status prohibited
US US Status permitted
US Notes Permitted in the US; no federal ban. Consumer backlash driving brand self-restriction. Formaldehyde releaser — sensitization risk for formaldehyde-allergic individuals.

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

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Quaternium-15.

Calculate MoS for your specific formulation with the MoS Calculator.

Sensitization Profile

Contact sensitization data for Quaternium-15 based on clinical patch test studies and IFRA standards.

Sensitization Rate
moderate
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
1.5%
Cross-reactivity Group
formaldehyde-releaser-group
Reaction Type
contact-dermatitis

Source: ESSCA 2019/20; IVDK; FDA

EU CLP Annex VI Harmonized Classification

Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.

Signal Word
Warning
Pictograms
FlammableHealth HazardHarmful / IrritantEnvironmental Hazard
Hazard Class and Category
Flam. Sol. 2; Repr. 2; Acute Tox. 4 *; Skin Irrit. 2; Skin Sens. 1; Aquatic Chronic 2
Hazard Statements
  • H228 Flammable solid
  • H361d ***
  • H302 Harmful if swallowed
  • H315 Causes skin irritation
  • H317 May cause an allergic skin reaction
  • H411 Toxic to aquatic life with long lasting effects

Inserted via ATP: ATP01

Sensitization AOP Dashboard

Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.

DPRA Cys %
58.01%
DPRA Lys %
31.19%
KeratinoSens IC50
22.486 µM
hCLAT CV75
19.1 µg/mL
NESIL
3937 µg/cm²
GHS: 1B Human: positive

Source: DPRA: Cosmetics Europe; KS: Cosmetics Europe; hCLAT: Cosmetics Europe; HPPT: [603] Marzulli FN and Maguire HC (1983): http://www.worldcat.org/oclc/489755491

HRIPT Human Patch Test Studies

1 human repeat insult patch test aggregated from dermatological literature.

Test Type N Sensitized Dose µg/cm² NESIL µg/cm² Potency
HRIPT - 0 3937.01 - -

Endocrine Disruptor Evidence (Expanded)

Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.

Dose-Response Data Points
Endpoint Target Value Direction
ERα activation by released formaldehyde ERα (indirect) EC50/IC50: No direct in vitro EC50 reported; activity equivalent to HCHO released (~30–200 ppm); LOEC: not formally reported; NOEC: not established mixed weak agonist (high HCHO release rate)
Nrf2/ARE activation (pro-hapten via HCHO release) Nrf2/ARE innate immune / sensitization pathway EC50/IC50: EC1.5 reported in KeratinoSens; strong sensitizer in standard patch testing; LOEC: not formally quantified; NOEC: not established mixed sensitizer / hapten (HCHO release)
AR agonism/antagonism AR EC50/IC50: No published AR in vitro IC50/EC50; data gap; LOEC: not reported; NOEC: not reported mixed not assessed (strong skin sensitizer; no formal ER/AR in vitro data published)

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
Ceased manufacture
Substance Type
SUBSTANCE
SVHC Candidate
No
Hazard classification: Restricted (Annex XVII)

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex II — Prohibited
Ref: 1385
(EU) 2019/831

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

SA Saudi SFDA (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 1385
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)
India: Prohibited (GNRAS)
Additional Jurisdictional Restrictions (6)
Jurisdiction Status Max % Product Type
CN permitted_preservative 0.2 All cosmetics
AU restricted - preservatives
GCC banned - All cosmetics
BR banned - -
ID banned - All cosmetic products prohibited
ID banned 0% All cosmetic products

Additional Ingredient Properties

10 property records from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "cross_reactivity_group": "formaldehyde-releaser-group", "patch_test_frequency_pct": "1.5", "sensitization_rate": "moderate", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA 2019/20; IVDK; FDA"}
comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "3", "skin_type_suitability": "oily,combination", "acne_safe": "caution", "source": "Formaldehyde releaser"}
deodorant
{"cas_number": "51229-78-8", "ingredient_class": "antimicrobial_deodorant", "mechanism_of_action": "bacterial_growth_inhibition", "antiperspirant_efficacy_sweat_reduction_pct": "0", "deodorant_efficacy_hours": "24", "odor_reduction_pct": "60-80", "bacteriostatic": "yes", "bactericidal": "yes", "target_bacteria": "broad_spectrum", "microbiome_impact": "broad", "axillary_microbiome_effect": "varies …
ecotoxicity
{"biodegradable": "yes", "biodegradation_days": "14-28", "bioaccumulative": "no", "aquatic_toxicity_level": "moderate", "coral_reef_safe": "yes", "marine_toxicity": "moderate aquatic toxicity", "freshwater_toxicity": "releases formaldehyde", "endocrine_disruptor": "no", "persistent_organic_pollutant": "no", "microplastic": "no", "nano_particle": "no", "hawaii_banned": "no", "eu_restricted_environm…
pediatric_safety
{"safe_for_newborn_0_6m": "avoid", "safe_for_infant_6_12m": "avoid", "safe_for_toddler_1_3y": "caution", "safe_for_child_3_12y": "caution", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "0.0", "adult_max_concentration_pct": "0.2", "pediatric_dermal_absorption_factor": "higher", "immature_skin_barrier_risk": "moderate", "oral_ingestion_risk": "moderate", "eye_irritation_risk": "…
ph_stability
{"optimal_ph_min": "4.0", "optimal_ph_max": "8.0", "stable_ph_min": "3.5", "stable_ph_max": "9.0", "degrades_above_ph": "9.5", "degrades_below_ph": "3.0", "ph_dependent_function": "Formaldehyde releaser; preservative", "formulation_note": "Less common now", "source": "Formulation literature"}
pregnancy_detail
{"pregnancy_safe": "avoid", "breastfeeding_safe": "avoid", "trimester_restriction": "all", "risk_category": "not-rated", "reason": "Formaldehyde releaser", "alternative_ingredient": "Phenoxyethanol; Sodium Benzoate", "source": "ACOG; dermatology literature"}
preservative
{"preservative_class": "Formaldehyde donor", "antimicrobial_spectrum_bacteria_gp": "Yes", "antimicrobial_spectrum_bacteria_gn": "Yes", "antimicrobial_spectrum_yeast": "Yes", "antimicrobial_spectrum_mold": "Yes", "mic_staph_aureus_ppm": "250", "mic_e_coli_ppm": "300", "mic_pseudomonas_ppm": "380", "mic_candida_albicans_ppm": "500", "mic_aspergillus_niger_ppm": "900", "challenge_test_pass_concentrat…

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Preservative
Regulatory List Membership (2)
EU Banned in Cosmetics EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Quaternium-15.

Regulatory Flags

preservative eu-banned formaldehyde-releaser contact-allergen banned-eu us-permitted avoid eu_banned_cosmetics eu_cosing_listed

Known Synonyms

3,5,7-Triazatricyclo(3.3.1.1(superscript 3,7))decane, 1-(3-chloro-2-propenyl)-, chloride, (Z)- 1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride, cis form Hexamethylenetetramine cis-chloroallyl chloride cis-N-(3-Chloroallyl) hexaminium chloride cis-1-(3-Chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride UNII-LIT014L4RH

Chemical Function

Preservative

Regulatory Lists

fracking; water banned; Europe; Personal care banned; Europe; Personal care inert_ingredient; non_food_use; Pesticides active_ingredient; Europe; Pesticides Europe; Personal care - hair styling and care - shampoo-dandruff Canada; pharmaceutical Personal care - general moisturizing

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

ChEMBL ID
CHEMBL3181805
View full pharmaceutical profile →

Frequently Asked Questions

Is Quaternium-15 safe in cosmetics?

Quaternium-15 has a safety rating of "POOR" in our database. EU status: prohibited. US status: permitted.

Is Quaternium-15 allowed in the EU?

Quaternium-15 EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Quaternium-15 do in cosmetics?

Quaternium-15 functions as: Preservative (antimicrobial, biocide). It is classified as a Preservative in our database. CAS number: 51229-78-8.

Is Quaternium-15 used outside cosmetics?

Quaternium-15 also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does Quaternium-15 have different safety status in cosmetics vs industrial chemicals?

Quaternium-15 is prohibited in EU cosmetics but has active industrial GHS classifications (H228, H302, H311, H315, H317, H319, H361, H361d).

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