Moderate Cosmetic Ingredient NOAEL Data

Melaleuca Alternifolia Leaf Extract

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

INCI: MELALEUCA ALTERNIFOLIA LEAF EXTRACT

Melaleuca Alternifolia Leaf Extract (CAS 85085-48-9) is a cosmetic cosmetic ingredient functioning as Skin conditioning, fragrance, antimicrobial, antifungal, antioxidant. Reported NOAEL =45 mg/kg bw/day in Rat (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: restricted, max 0.1% leave-on face cream; 1.0% rinse-off shower gel; 2.0% shampoo; sprays prohibited. 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, fragrance, antimicrobial, antifungal, antioxidant
Safety Rating
MODERATE

Chemistry & Identifiers

EC Number
285-377-1

Regulatory Status

EU EU Status restricted
EU Max Conc. 0.1% leave-on face cream; 1.0% rinse-off shower gel; 2.0% shampoo; sprays prohibited
US US Status permitted
US Notes CIR assessed safe in 2021 when formulated to be non-sensitizing. 724 VCRP registrations for Leaf Oil. CIR covers all 8 Melaleuca alternifolia-derived ingredients.

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 Leaf Extract.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

1 study endpoint found for Melaleuca Alternifolia Leaf Extract. 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 Leaf Extract.

Regulatory Flags

Allergen Endocrine Disruptor Restricted

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Melaleuca Alternifolia Leaf Extract 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 Leaf Extract safe in cosmetics?

Melaleuca Alternifolia Leaf Extract 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 Leaf Extract allowed in the EU?

Melaleuca Alternifolia Leaf Extract EU regulatory status: restricted. Maximum allowed concentration: 0.1% leave-on face cream; 1.0% rinse-off shower gel; 2.0% shampoo; sprays prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Melaleuca Alternifolia Leaf Extract do in cosmetics?

Melaleuca Alternifolia Leaf Extract functions as: Skin conditioning, fragrance, antimicrobial, antifungal, antioxidant. It is classified as a cosmetic ingredient in our database. CAS number: 85085-48-9.

What is the NOAEL for Melaleuca Alternifolia Leaf Extract?

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

Is Melaleuca Alternifolia Leaf Extract used outside cosmetics?

Melaleuca Alternifolia Leaf Extract 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 Leaf Extract have different safety status in cosmetics vs industrial chemicals?

Melaleuca Alternifolia Leaf Extract is classified GHS Danger (H226, H302, H304, H315, H317, H319, H411) in the chemicals database but is restricted in EU cosmetics at max 0.1% leave-on face cream; 1.0% rinse-off shower gel; 2.0% shampoo; sprays prohibited.

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