Octocrylene
INCI: OCTOCRYLENE
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
3 study endpoints found for Octocrylene. 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 | 2250 ppm | oral | rat | Subchronic | COSMOS_DB |
| LOAEL | 4500 ppm | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 2250 ppm | oral | rat | oral | REACH |
SCCS NOAEL Values
NOAEL/LOAEL values cited in official SCCS opinions for Octocrylene.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 153 mg/kg/day | 534 mg/kg/day | Oral | Rat | Extended one-generation reproductive (EOGRTS, OECD 443) (~10 weeks premating + gestation + lactation (GLP)) | 50 | SCCS/1627/21 (2021) |
| 175 mg/kg/day | - | Oral | Rat (Wistar) | Subchronic (90-day, OECD 407) (90 days (dietary)) | 50 | SCCS/1627/21 (2021) |
Sensitization Profile
Contact sensitization data for Octocrylene based on clinical patch test studies and IFRA standards.
Source: ESSCA
Dermal Penetration Profile
Skin absorption and penetration characteristics of Octocrylene, relevant to systemic exposure and MoS calculations.
Source: SCCS/1627/21
Expert Verdict
Octocrylene is a dual-function UV filter and avobenzone photostabilizer critical to many US sunscreen formulations, but it hydrolyzes to benzophenone over shelf life—a potential endocrine disruptor and suspected carcinogen that bio-accumulates in fatty tissue. Systemic absorption is confirmed; SCCS safety reassessment is ongoing through 2025–2026; FDA approval status remains in limbo pending additional safety data. Alternatives such as bemotrizinol (Tinosorb S) can stabilize avobenzone without this benzophenone degradation risk.
Regulatory Flags
Frequently Asked Questions
Is Octocrylene safe in cosmetics?
Octocrylene is a dual-function UV filter and avobenzone photostabilizer critical to many US sunscreen formulations, but it hydrolyzes to benzophenone over shelf life—a potential endocrine disruptor and suspected carcinogen that bio-accumulates in fatty tissue. Systemic absorption is confirmed; SCCS safety reassessment is ongoing through 2025–2026; FDA approval status remains in limbo pending additional safety data. Alternatives such as bemotrizinol (Tinosorb S) can stabilize avobenzone without this benzophenone degradation risk. The EU classifies Octocrylene as "permitted". Safety rating: MODERATE. 3 toxicological study endpoint(s) are available in our database.
Is Octocrylene allowed in the EU?
Octocrylene EU regulatory status: permitted. Maximum allowed concentration: 10%. This is based on EU Regulation 1223/2009 and its amendments.
What does Octocrylene do in cosmetics?
Octocrylene functions as: Oil-soluble UVB and short-wave UVA UV filter; triplet-state quencher and radical scavenger that photostabilizes avobenzone by accepting triplet energy and dissipating it harmlessly; peak absorption ~303 nm; may hydrolyze to benzophenone as a degradation product over product shelf life. It is classified as a Active Ingredient in our database. CAS number: 6197-30-4.
What is the Margin of Safety for Octocrylene?
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 Octocrylene?
The NOAEL (No Observed Adverse Effect Level) for Octocrylene is 2250 ppm based on a Subchronic study via oral route in rat. A total of 3 study endpoints are available. Source: COSMOS_DB.
Compliance Tools
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