Moderate Cosmetic Ingredient NOAEL Data

Melaleuca Alternifolia (Tea Tree) Leaf

Also known as: EINECS 285-377-1, Tea tree ext.

INCI: MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF

Melaleuca Alternifolia (Tea Tree) Leaf (CAS 85085-48-9) is a cosmetic cosmetic ingredient functioning as Skin conditioning - emollient (softens and smoothens the skin). Reported NOAEL =45 mg/kg bw/day in Rat (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: restricted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.

View industrial chemical safety profile for CAS 85085-48-9 →

Auto-generated CPSR Part A draft with source citations
Function
Skin conditioning - emollient (softens and smoothens the skin)
Safety Rating
MODERATE

Chemistry & Identifiers

EC Number
285-377-1

Regulatory Status

EU EU Status restricted
US US Status permitted
US Notes Allowed - no specific prohibition or restriction on tea tree leaf as a cosmetic ingredient

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Melaleuca Alternifolia (Tea Tree) Leaf.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Melaleuca Alternifolia (Tea Tree) Leaf. 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 =45 mg/kg bw/day oral Rat short-term ToxValDB_ECHA_IUCLID

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Abrasive Astringent Biocide Deodorizer Flavouring and nutrient Fragrance Humectant Pharmaceutical Softener and conditioner
Regulatory List Membership (1)
EU Regulated in Personal Care

Expert Verdict

Expert safety assessment and concern-level summary for Melaleuca Alternifolia (Tea Tree) Leaf.

Regulatory Flags

potential-allergen

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Melaleuca Alternifolia (Tea Tree) Leaf by CAS number or substance name.

Studies
1
Lowest NOAEL
45 mg/kg bw/day
Highest NOAEL
45 mg/kg bw/day
ToxValDB_ECHA_IUCLID

Known Synonyms

EINECS 285-377-1 Tea tree ext.

Chemical Function

Abrasive Biocide Astringent Deodorizer Humectant Softener and conditioner

Regulatory Lists

Europe; Personal care Europe; Personal care Europe; Personal care

Australian Status

AICIS status: listed

Frequently Asked Questions

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

Melaleuca Alternifolia (Tea Tree) Leaf has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. 1 toxicological study endpoint(s) are available in our database.

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

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

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

Melaleuca Alternifolia (Tea Tree) Leaf functions as: Skin conditioning - emollient (softens and smoothens the skin). It is classified as a cosmetic ingredient in our database. CAS number: 85085-48-9.

What is the NOAEL for Melaleuca Alternifolia (Tea Tree) Leaf?

The NOAEL (No Observed Adverse Effect Level) for Melaleuca Alternifolia (Tea Tree) Leaf is =45 mg/kg bw/day based on a short-term study via oral route in Rat. Source: ToxValDB_ECHA_IUCLID.

Is Melaleuca Alternifolia (Tea Tree) Leaf used outside cosmetics?

Melaleuca Alternifolia (Tea Tree) Leaf also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.

Does Melaleuca Alternifolia (Tea Tree) Leaf have different safety status in cosmetics vs industrial chemicals?

Melaleuca Alternifolia (Tea Tree) Leaf is classified GHS Danger (H226, H302, H304, H315, H317, H319, H411) in the chemicals database but is restricted in EU cosmetics.

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