Tea Tree Oil (Melaleuca Alternifolia Leaf 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 (Melaleuca Alternifolia Leaf 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 (Melaleuca Alternifolia Leaf Oil) based on clinical patch test studies and IFRA standards.
Source: IVDK
Expert Verdict
Good safety profile within approved limits. Restricted in EU at 1.25% concentration per Annex III.
Regulatory Flags
Frequently Asked Questions
Is Tea Tree Oil (Melaleuca Alternifolia Leaf Oil) safe in cosmetics?
Good safety profile within approved limits. Restricted in EU at 1.25% concentration per Annex III. The EU classifies Tea Tree Oil (Melaleuca Alternifolia Leaf Oil) as "restricted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.
Is Tea Tree Oil (Melaleuca Alternifolia Leaf Oil) allowed in the EU?
Tea Tree Oil (Melaleuca Alternifolia Leaf Oil) EU regulatory status: restricted. Maximum allowed concentration: 1.25%. This is based on EU Regulation 1223/2009 and its amendments.
What does Tea Tree Oil (Melaleuca Alternifolia Leaf Oil) do in cosmetics?
Tea Tree Oil (Melaleuca Alternifolia Leaf Oil) functions as: Emollient. It is classified as a Emollient in our database. CAS number: 68647-73-4.
What is the Margin of Safety for Tea Tree Oil (Melaleuca Alternifolia Leaf Oil)?
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 Tea Tree Oil (Melaleuca Alternifolia Leaf Oil)?
The NOAEL (No Observed Adverse Effect Level) for Tea Tree Oil (Melaleuca Alternifolia Leaf 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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