Good Emollient NOAEL Data SCCS/CIR Reviewed Sensitization Data

Melaleuca Alternifolia (Tea Tree) Leaf Oil

INCI: MELALEUCA ALTERNIFOLIA LEAF OIL

CAS Number
68647-73-4
Function
Emollient
Safety Rating
GOOD

Regulatory Status

๐Ÿ‡ช๐Ÿ‡บ EU Status permitted
๐Ÿ‡บ๐Ÿ‡ธ US Status permitted
US Notes CIR: SQ - Final Report Available from CIR 09/2021

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 Melaleuca Alternifolia (Tea Tree) 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).

sccs SCCS/1681/25 30 October 2025
Verdict: unknown
NOAEL: 25 mg/kg bw/d (not specified)
Max Concentration: 2% in general
sccs SCCS/1681/25 30 October 2025
Verdict: unknown
NOAEL: 25 mg/kg bw/d (not specified)
Max Concentration: 0.001% in leave-on
sccs SCCS/1681/25 30 October 2025
Verdict: unknown
NOAEL: 25 mg/kg bw/d (not specified)
Max Concentration: 0.0002% in leave-on
sccs SCCS/1681/25 30 October 2025
Verdict: unknown
NOAEL: 25 mg/kg bw/d (not specified)
Max Concentration: 2% in leave-on
sccs SCCS/1681/25 30 October 2025
Verdict: unknown
NOAEL: 25 mg/kg bw/d (not specified)
Max Concentration: 0.1% in leave-on

Sensitization Profile

Contact sensitization data for Melaleuca Alternifolia (Tea Tree) Leaf Oil based on clinical patch test studies and IFRA standards.

Sensitization Rate
moderate
Allergen Class
fragrance
EU Allergen Listed
no
Patch Test Positive Rate
1.1%
Cross-reactivity Group
terpene-hydroperoxide-group
Reaction Type
contact-dermatitis
IFRA Restricted

Source: IVDK

Expert Verdict

Good safety profile with established use in cosmetics; generally considered safe for topical application.

โš ๏ธ
Concern Level: Low

Regulatory Flags

eu_children_restricted ifra_fragrance fda_food_additive

Frequently Asked Questions

Is Melaleuca Alternifolia (Tea Tree) Leaf Oil safe in cosmetics?

Good safety profile with established use in cosmetics; generally considered safe for topical application. The EU classifies Melaleuca Alternifolia (Tea Tree) Leaf Oil as "permitted". Safety rating: GOOD. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.

Is Melaleuca Alternifolia (Tea Tree) Leaf Oil allowed in the EU?

Melaleuca Alternifolia (Tea Tree) Leaf Oil EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.

What does Melaleuca Alternifolia (Tea Tree) Leaf Oil do in cosmetics?

Melaleuca Alternifolia (Tea Tree) 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 Melaleuca Alternifolia (Tea Tree) 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 Melaleuca Alternifolia (Tea Tree) Leaf Oil?

The NOAEL (No Observed Adverse Effect Level) for Melaleuca Alternifolia (Tea Tree) 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.

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