CHOLECALCIFEROL
Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for CHOLECALCIFEROL. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | 0.625 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 0.01 mg/kg bw/day | oral | rat | Special Toxicology Study | COSMOS_DB |
| NOAEL | 2.7 mg/kg bw/day | oral | rat | Special Toxicology Study | COSMOS_DB |
| NOAEL | 0.495 mg/kg bw/day | oral | swine | Short Term Toxicity | COSMOS_DB |
| NOAEL | 0.063 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 0.019 mg/kg bw/day | oral | rabbit | Short Term Toxicity | COSMOS_DB |
| NOAEL | 0.25 mg/kg bw/day | oral | rabbit | Short Term Toxicity | COSMOS_DB |
| NOAEL | 0.00085 mg/kg bw/day | oral | swine | Special Toxicology Study | COSMOS_DB |
| NOAEL | 3 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 0.375 mg/kg bw/day | oral | cat | Short Term Toxicity | COSMOS_DB |
Expert Verdict
Cholecalciferol (Vitamin D3, CAS 67-97-0) is prohibited in EU cosmetic products under Annex II Entry 335 of Regulation (EC) 1223/2009 due to its classification as an active pharmaceutical ingredient. The compound carries GHS Acute Toxicity Category 2 (oral, dermal, inhalation), with a human dietary NOAEL of approximately 100 ug/day and an EFSA upper limit of 100 ug/day for adults; dermal NOAEL has not been established. In the US, cholecalciferol is referenced in OTC Monograph M016 (Skin Protectant) at restricted concentrations and requires drug classification when therapeutic claims are made.
Regulatory Flags
Frequently Asked Questions
Is CHOLECALCIFEROL safe in cosmetics?
Cholecalciferol (Vitamin D3, CAS 67-97-0) is prohibited in EU cosmetic products under Annex II Entry 335 of Regulation (EC) 1223/2009 due to its classification as an active pharmaceutical ingredient. The compound carries GHS Acute Toxicity Category 2 (oral, dermal, inhalation), with a human dietary NOAEL of approximately 100 ug/day and an EFSA upper limit of 100 ug/day for adults; dermal NOAEL has not been established. In the US, cholecalciferol is referenced in OTC Monograph M016 (Skin Protectant) at restricted concentrations and requires drug classification when therapeutic claims are made. The EU classifies CHOLECALCIFEROL as "prohibited". Safety rating: POOR. 10 toxicological study endpoint(s) are available in our database.
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.
What is the Margin of Safety for CHOLECALCIFEROL?
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.
What is the NOAEL for CHOLECALCIFEROL?
The NOAEL (No Observed Adverse Effect Level) for CHOLECALCIFEROL is 0.625 mg/kg bw/day based on a Short Term Toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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