Tea Tree Oil (CAS 68647-73-4) is a cosmetic active ingredient functioning as Antimicrobial; antifungal; anti-inflammatory. NOAEL 14 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; 5 safety opinions reviewed (sccs). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
US NotesUS FDA has not restricted cosmetic use. CIR Expert Panel concluded eight Melaleuca alternifolia-derived ingredients safe in cosmetics when formulated to be non-sensitizing (final report 2021). FDA 2019 final rule excludes TTO from OTC antiseptic rub eligibility. No GRAS status for cosmetic use; FEMA GRAS only for food flavoring.
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Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Tea Tree Oil.
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Toxicological Studies
10 study endpoints found for Tea Tree 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
=0.117 mg/kg bw/day
oral
rat
NOAEL study
SCCS_vision_codex
NOAEL
=0.117 mg/kg bw/day
oral
rat
NOAEL study
SCCS_vision_codex
NOAEL
=0.117 mg/kg bw/day
oral
rat
NOAEL study
SCCS_vision_codex
NOAEL
=0.117 mg/kg bw/day
oral
rat
NOAEL study
SCCS_vision_codex
NOAEL
=20 mg/kg bw/day
-
-
developmental toxicity
SCCS_vision_codex
NOAEL
=20 mg/kg bw/d
oral
rat
reproductive toxicity
SCCS_vision_codex
NOAEL
=20 mg/kg bw/day
-
-
developmental toxicity
SCCS_vision_codex
NOAEL
=20 mg/kg bw/d
oral
rat
reproductive toxicity
SCCS_vision_codex
NOAEL
=20 mg/kg bw/day
-
-
developmental toxicity
SCCS_vision_codex
NOAEL
=20 mg/kg bw/d
oral
rat
reproductive toxicity
SCCS_vision_codex
Safety Opinions
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
sccsSCCS/1681/2530 October 2025
Verdict: unknown
NOAEL: 25 mg/kg bw/d (not specified)
Max Concentration: 2% in general
sccsSCCS/1681/2530 October 2025
Verdict: unknown
NOAEL: 25 mg/kg bw/d (not specified)
Max Concentration: 0.001% in leave-on
sccsSCCS/1681/2530 October 2025
Verdict: unknown
NOAEL: 25 mg/kg bw/d (not specified)
Max Concentration: 0.0002% in leave-on
sccsSCCS/1681/2530 October 2025
Verdict: unknown
NOAEL: 25 mg/kg bw/d (not specified)
Max Concentration: 2% in leave-on
sccsSCCS/1681/2530 October 2025
Verdict: unknown
NOAEL: 25 mg/kg bw/d (not specified)
Max Concentration: 0.1% in leave-on
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Tea Tree Oil across SCCS product categories, with measured dermal absorption where available.
Sensitization Profile
Contact sensitization data for Tea Tree 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
EPA ToxValDB — Toxicity Values
1 toxicity value from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
Endpoint
Value
Species
Route
Duration
Source
LD50
=1900 mg/kg
Rat
oral
-
TEST
HRIPT Human Patch Test Studies
1 human repeat insult patch test aggregated from dermatological literature.
Test Type
N
Sensitized
Dose µg/cm²
NESIL µg/cm²
Potency
HMT
-
0
675
-
-
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (1)
Jurisdiction
Status
Max %
Product Type
AU
restricted
-
all
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Aggregated DA Values (5 records across 5 sources)
Type
DA %
Method
Skin Model
SCCS Ref
measured
20.41
method=measured
-
-
default
12.84
method=default
-
-
measured
5.0
method=measured
-
-
measured
2.5
method=measured
-
-
measured
1.25
method=measured
-
-
Additional Ingredient Properties
1 property record from structured ingredient metadata.
AntioxidantFragranceBiocideFlavouring and nutrient
Regulatory Lists
Canada; Personal care; Substances in PCP - Canada (4/2014)Canada; consumer_product; Substances in Products - Canada (4/2014)children; Europe; Personal carechildren; Europe; Personal care - hair styling and care - shampooEurope; Personal care - hair styling and care - shampoo-dandruffEurope; Personal careEurope; Personal careEurope; Personal careEurope; Personal careactive_ingredient; Europe; PesticidesCanada; consumer_product; Substances in Products - Canada (4/2014)inert_ingredient; non_food_use; PesticidesEurope; Personal care - body oilIFRA TransparencyCanada; pharmaceuticalCanada; pharmaceuticalfood_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Australian Status
AICIS status:listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCEChEMBL / DrugCentral / FAERSDB_PHARMA count match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Tea Tree Oil has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by sccs.
Is Tea Tree Oil allowed in the EU?
Tea Tree Oil EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Tea Tree Oil do in cosmetics?
Tea Tree Oil functions as: Antimicrobial; antifungal; anti-inflammatory. It is classified as a Active Ingredient in our database. CAS number: 68647-73-4.
What is the NOAEL for Tea Tree Oil?
The NOAEL (No Observed Adverse Effect Level) for Tea Tree Oil is =0.117 mg/kg bw/day based on a NOAEL study study via oral route in rat. A total of 10 study endpoints are available. Source: SCCS_vision_codex.
Is Tea Tree Oil used outside cosmetics?
Tea Tree Oil also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
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