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.
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
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.
US NotesAllowed - no specific prohibition or restriction on tea tree leaf as a cosmetic ingredient
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Melaleuca Alternifolia (Tea Tree) Leaf.
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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
AbrasiveAstringentBiocideDeodorizerFlavouring and nutrientFragranceHumectantPharmaceuticalSoftener 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.
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 285-377-1Tea tree ext.
Chemical Function
AbrasiveBiocideAstringentDeodorizerHumectantSoftener and conditioner
Regulatory Lists
Europe; Personal careEurope; Personal careEurope; 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.
Compliance Tools
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