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
8 study endpoints found for Homosalate. 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 | 50 mg/kg bw/day | oral | dog | oral | REACH |
| NOAEL | 1180 mg/kg bw/day | dermal | code:3484 | dermal | REACH |
| NOAEL | 50 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 250 mg/kg bw/day | oral | dog | oral | REACH |
| NOAEL | 50 mg/kg bw/day | oral | rat | oral | REACH |
| NOAEL | 300 mg/kg bw/day | oral | rat | oral | REACH |
| LOAEL | =60 mg/kg/day | oral | rat | reproductive | SCCS |
| NOAELadj | =10 mg/kg/day | oral | rat | reproductive | SCCS |
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Homosalate.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 300 mg/kg/day | 750 mg/kg/day | Oral | Rat (Wistar RccHan) | Combined repeated dose + reproductive screening (OECD 422) (28 days) | 100 | SCCS/1622/20 (2021) |
| 10 mg/kg/day | 60 mg/kg/day | Oral | Rat (Wistar) | Combined repeated dose + reproductive screening (OECD 422) (28 days) | 100 | SCCS/1638/21 (2021) |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Homosalate, relevant to systemic exposure and MoS calculations.
Source: SCCS/1564/15
Expert Verdict
UVB filter with declining regulatory standing in both EU and US. EU SCCS 2021 endocrine disruption concern triggered restriction from 10% to 7.34% in face products only, effective January 2025 with product withdrawals by July 2025. US permits up to 15% but FDA maintains regulatory limbo status with final GRASE determination pending. Systemic absorption confirmed in FDA PK studies. Not a primary performance filter due to UVB-only spectrum and limited coverage. Increasing restriction in EU and unresolved FDA status make homosalate a higher-risk choice for new formulation development.
Regulatory Flags
Frequently Asked Questions
Is Homosalate safe in cosmetics?
UVB filter with declining regulatory standing in both EU and US. EU SCCS 2021 endocrine disruption concern triggered restriction from 10% to 7.34% in face products only, effective January 2025 with product withdrawals by July 2025. US permits up to 15% but FDA maintains regulatory limbo status with final GRASE determination pending. Systemic absorption confirmed in FDA PK studies. Not a primary performance filter due to UVB-only spectrum and limited coverage. Increasing restriction in EU and unresolved FDA status make homosalate a higher-risk choice for new formulation development. The EU classifies Homosalate as "restricted". Safety rating: MODERATE. 8 toxicological study endpoint(s) are available in our database.
Is Homosalate allowed in the EU?
Homosalate EU regulatory status: restricted. Maximum allowed concentration: 7.34%. This is based on EU Regulation 1223/2009 and its amendments.
What does Homosalate do in cosmetics?
Homosalate functions as: Oil-soluble UVB UV filter; peak absorption ~306 nm; used as SPF booster in combination formulations; UVB-only spectrum with no UVA coverage. It is classified as a Active Ingredient in our database. CAS number: 118-56-9.
What is the Margin of Safety for Homosalate?
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 Homosalate?
The NOAEL (No Observed Adverse Effect Level) for Homosalate is 50 mg/kg bw/day based on a oral study via oral route in dog. A total of 8 study endpoints are available. Source: REACH.
Compliance Tools
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