Moderate Cosmetic Ingredient NOAEL Data

Ergocalciferol

INCI: ERGOCALCIFEROL

CAS Number
50-14-6
Function
Skin Conditioning
Safety Rating
MODERATE

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes Primarily regulated as drug substance; no specific FDA restriction on cosmetic use; drug claims would trigger drug classification

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Ergocalciferol. 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 299 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 76 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 2.9 mg/kg bw/day oral rat Developmental COSMOS_DB
NOAEL 50 mg/kg bw/day oral gerbil Special Toxicology Study COSMOS_DB
NOAEL 4 mg/kg bw/day oral rat Short Term Toxicity COSMOS_DB
NOAEL 100 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB
NOAEL 0.825 mg/kg bw/day oral horse Short Term Toxicity COSMOS_DB
NOAEL 7.5 mg/kg bw/day oral rat Special Toxicology Study COSMOS_DB

Expert Verdict

Significant data gaps for cosmetic risk assessment: no CIR monograph, no SCCS opinion, no dermal absorption data, no sensitization data. Systemic toxicity (hypercalcemia) well-characterized at high oral doses but not expected at cosmetic use levels.

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Concern Level: Moderate

Regulatory Flags

fda_food_additive

Frequently Asked Questions

Is Ergocalciferol safe in cosmetics?

Significant data gaps for cosmetic risk assessment: no CIR monograph, no SCCS opinion, no dermal absorption data, no sensitization data. Systemic toxicity (hypercalcemia) well-characterized at high oral doses but not expected at cosmetic use levels. The EU classifies Ergocalciferol as "permitted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database.

Is Ergocalciferol allowed in the EU?

Ergocalciferol EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Ergocalciferol do in cosmetics?

Ergocalciferol functions as: Skin Conditioning. It is classified as a cosmetic ingredient in our database. CAS number: 50-14-6.

What is the Margin of Safety for Ergocalciferol?

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 Ergocalciferol?

The NOAEL (No Observed Adverse Effect Level) for Ergocalciferol 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.

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