Tea Tree Oil
INCI: MELALEUCA ALTERNIFOLIA LEAF OIL
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 Tea Tree Oil. 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 | 30 mg/kg bw/day | - | - | - | SCCS_PDF_extraction |
| NOAEL | 25 mg/kg bw/day | - | - | reproductive | SCCS_PDF_extraction |
| NOAEL | 20 mg/kg bw/day | - | - | reproductive | SCCS_PDF_extraction |
| NOAEL | 20 mg/kg bw/day | oral | - | reproductive | SCCS_PDF_extraction |
| NOAEL | 30 mg/kg bw/day | oral | - | subchronic | SCCS_PDF_extraction |
| NOAEL | 30 mg/kg bw/day | - | rat | - | SCCS_PDF_extraction |
| NOAEL | 20 mg/kg bw/day | oral | rat | - | SCCS_PDF_extraction |
| NOAEL | 250 mg/kg bw/day | oral | - | reproductive | SCCS_PDF_extraction |
| NOAEL | 0.117 mg/kg bw/day | oral | rat | - | SCCS_PDF_extraction |
| NOAEL | 250 mg/kg bw/day | - | - | - | SCCS_PDF_extraction |
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
Sensitization Profile
Contact sensitization data for Tea Tree Oil based on clinical patch test studies and IFRA standards.
Source: IVDK
Expert Verdict
CAS 68647-73-4 (EC 285-377-1). EU: Not currently listed in Annexes of EC 1223/2009; SCCS/O/303 (Nov 2025) deems safe only at specific concentrations (2% shampoo, 1% shower gel, 1% face wash, 0.1% face cream) for adults only, no spray/aerosol formats. ECHA RAC classified as Repr. Cat 1B (H360) — potential Annex II prohibition pathway pending. US: FDA has not restricted cosmetic use; CIR Panel concludes safe when formulated to be non-sensitizing.
Regulatory Flags
Frequently Asked Questions
Is Tea Tree Oil safe in cosmetics?
CAS 68647-73-4 (EC 285-377-1). EU: Not currently listed in Annexes of EC 1223/2009; SCCS/O/303 (Nov 2025) deems safe only at specific concentrations (2% shampoo, 1% shower gel, 1% face wash, 0.1% face cream) for adults only, no spray/aerosol formats. ECHA RAC classified as Repr. Cat 1B (H360) — potential Annex II prohibition pathway pending. US: FDA has not restricted cosmetic use; CIR Panel concludes safe when formulated to be non-sensitizing. The EU classifies Tea Tree Oil as "permitted". Safety rating: MODERATE. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.
Is Tea Tree Oil allowed in the EU?
Tea Tree Oil EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Tea Tree Oil do in cosmetics?
Tea Tree Oil functions as: Antimicrobial; antifungal; anti-inflammatory. It is classified as a Active Ingredient in our database. CAS number: 68647-73-4.
What is the Margin of Safety for Tea Tree Oil?
adequate 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 Tea Tree Oil?
The NOAEL (No Observed Adverse Effect Level) for Tea Tree Oil is 30 mg/kg bw/day based on a toxicological study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_PDF_extraction.
Compliance Tools
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