Is CHOLECALCIFEROL safe in cosmetics?
CHOLECALCIFEROL has a safety rating of "POOR" in our database. EU status: prohibited. US status: restricted.
Poor
Active Ingredient
CHOLECALCIFEROL
Also known as: 9,10-Secocholesta-5,7,10(19)-trien-3-ol, (3.beta.,5Z,7E)-, CHOLECALCIFEROL; (VIT. D3), (3S,5Z,7E)-9,10-Secocholesta-5,7,10-trien-3-ol, Activated 7-dehydrocholesterol, Cholecalciferol, D3 (+14 more)
CHOLECALCIFEROL (CAS 67-97-0) is a cosmetic active ingredient functioning as Skin-conditioning agent; vitamin D receptor (VDR) activator in keratinocytes;. NOAEL 0.00015 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical and food safety data.
View industrial chemical safety profile for CAS 67-97-0 →
Auto-generated CPSR Part A draft with source citations
Function
Skin-conditioning agent; vitamin D receptor (VDR) activator in keratinocytes; keratinocyte differentiation regulator; barrier support; immune modulator
Safety Rating
POOR
Regulatory Status
EU EU Status
prohibited
US US Status
restricted
US Notes
Not categorically prohibited in US cosmetics. Referenced in FDA OTC Monograph M016 (Skin Protectant Drug Products) at 400 USP Units cholecalciferol combined with Vitamin A 10,000 USP Units in permitted combination products. Not listed as an approved sunscreen active under OTC Monograph M020. When intended for therapeutic purposes classified as a drug under the FD&C Act; as nutritional supplement regulated under DSHEA. Any cosmetic product making claims related to vitamin D's physiological functions would likely be regulated as a drug or drug-cosmetic combination.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for CHOLECALCIFEROL.
Calculate MoS for your specific formulation with the MoS Calculator.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for CHOLECALCIFEROL across SCCS product categories, with measured dermal absorption where available.
EPA ToxValDB — Toxicity Values
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LOEL | =54000 IU/kg diet | Dog | oral | short-term | ECOTOX |
| LOEL | =54000 IU/kg diet | Dog | oral | subchronic | ECOTOX |
| LOEL | =54000 IU/kg diet | Dog | oral | chronic | ECOTOX |
| LOEL | =1350 ug/kg diet | Dog | oral | chronic | ECOTOX |
| NOEL | =54000 IU/kg diet | Dog | oral | chronic | ECOTOX |
| LOEL | =0.0003 mg/org | Rat | oral | short-term | ECOTOX |
| NOEL | =0.0003 mg/org | Rat | oral | short-term | ECOTOX |
| LOEL | =12.5 mg/kg-day | Rat | injection | short-term | ECOTOX |
| LOEL | =20000 IU/kg | Rat | oral | chronic | ECOTOX |
| LOEL | =5000 IU/kg | Rat | oral | short-term | ECOTOX |
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Danger
Pictograms
Acute ToxicityHealth Hazard
Hazard Class and Category
Acute Tox. 2; Acute Tox. 2; Acute Tox. 2; STOT RE 1
Hazard Statements
- H330 Fatal if inhaled
- H310 Fatal in contact with skin
- H300 Fatal if swallowed
- H372 Causes damage to organs through prolonged or repeated exposure
Specific Concentration Limits / M-factors
inhalation: ATE = 0.05 mg/L dusts or mists; dermal: ATE = 50.0 mg/kg bw; oral: ATE = 35.0 mg/kg bw; STOT RE 1; H372: C ≥ 3.0%; STOT RE 2; H373: 0.3% ≤ C < 3.0%
Inserted via ATP: ATP13
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Confirmed
Evidence: High
(2024)
Health effects: Yes
Affected pathways: Steroidogenesis (hormonal)
Regulatory framework: BPR
Source list: I
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.
Additional Jurisdictional Restrictions (3)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CA | restricted | ≤25 μg/day average absorption | All cosmetics |
| CA | drug_classification | - | - |
| KR | prohibited | - | - |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
hair_care
{"hair_function": "scalp-care", "hair_type_suitability": "all", "curl_pattern_suitability": "all", "porosity_suitability": "all", "protein_sensitivity": "neutral", "moisture_protein_balance": "yes", "cg_method_approved": "not-a-silicone", "silicone_type": "not-a-sulfate", "sulfate_type": "no", "drying_alcohol": "no", "fatty_alcohol": "no", "heat_protectant": "yes", "color_safe": "neutral", "kerati…
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Biocide
Flavouring and nutrient
Pharmaceutical
Softener and conditioner
Regulatory List Membership (1)
FDA Substances Added to Food (EAFUS)
Expert Verdict
Expert safety assessment and concern-level summary for CHOLECALCIFEROL.
Regulatory Flags
eu-prohibited
annex-ii
no-sccs-opinion
no-cir-review
pharmaceutical-api
fda_food_additive
Known Synonyms
9,10-Secocholesta-5,7,10(19)-trien-3-ol, (3.beta.,5Z,7E)-
CHOLECALCIFEROL; (VIT. D3)
(3S,5Z,7E)-9,10-Secocholesta-5,7,10-trien-3-ol
Activated 7-dehydrocholesterol
Cholecalciferol, D3
Cholecalciferolum
Colecalcipherol
7-Dehydrocholesterol, irradiated
7-Dehydrocholestrol, activated
EINECS 200-673-2
Irradiated 7-dehydrocholesterol
NEO Dohyfral D3
Rampage
9,10-Seco(5Z,7E)-5,7,10(19)-cholestatrien-3-ol
D3-Vicotrat
Vi-de-3-hydrosol
EPA Pesticide Chemical Code 202901
Colecalciferolo
Colecalciferolum
Chemical Function
Softener and conditioner
Pharmaceutical
Biocide
Regulatory Lists
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Europe; Pesticides
active_ingredient; Australia
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
active_ingredient; Pesticides
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical and food safety data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA count match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Adverse Event Associations
17331
SOURCE
EFSA / FDA GRAS
food_additives
Food Safety Data
Same-CAS food additive or FDA GRAS records from the core public database.
Food Name
Vitamin D3 (Cholecalciferol)
Food Category
vitamins_minerals
Frequently Asked Questions
Is CHOLECALCIFEROL allowed in the EU?
CHOLECALCIFEROL EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.
What does CHOLECALCIFEROL do in cosmetics?
CHOLECALCIFEROL functions as: Skin-conditioning agent; vitamin D receptor (VDR) activator in keratinocytes; keratinocyte differentiation regulator; barrier support; immune modulator. It is classified as a Active Ingredient in our database. CAS number: 67-97-0.
Is CHOLECALCIFEROL used outside cosmetics?
CHOLECALCIFEROL also appears in pharmaceutical and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check CHOLECALCIFEROL compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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