NOAEL Studies Active Ingredient

Tea Tree Oil NOAEL Studies

INCI: MELALEUCA ALTERNIFOLIA LEAF OIL

CAS: 68647-73-4

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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NTP ICE skin sensitization 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE skin sensitization Incidence of positive responses 0 % Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=9586; Record_ID=skin_sensitization_invivo_2126; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=1.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID60100611; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Epstein 1981: report to RIFM|Anonymous 1988; Not available; 10.1016/0278-6915(88)90204-9; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID60100611
NTP ICE skin sensitization Induction dose per skin area 675 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=9584; Record_ID=skin_sensitization_invivo_2126; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=1.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID60100611; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=675; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Epstein 1981: report to RIFM|Anonymous 1988; Not available; 10.1016/0278-6915(88)90204-9; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID60100611
NTP ICE skin sensitization Relative reliability score 3 unitless Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=9588; Record_ID=skin_sensitization_invivo_2126; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=1.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID60100611; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=3; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Epstein 1981: report to RIFM|Anonymous 1988; Not available; 10.1016/0278-6915(88)90204-9; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID60100611
SCCS Opinion 38 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =400 mg/kg bw/day rat oral 28-days repeated dose toxicity Ref.: 35 Terpinen-4-ol (max, p.28
SCCS Opinion NOAEL =15 % rat oral 28-days NOAEL study Ref.: 35 Terpinen-4-ol (max, p.28
SCCS Opinion NOAEL =300 mg/kg bw/day rat oral 28-days NOAEL study p.28
SCCS Opinion NOAEL =60 mg/kg bw/day rat - - NOAEL study Ref.: 86 p-Cymene (max, p.29
SCCS Opinion NOAEL =75 mg/kg bw/day rat oral 20 weeks NOAEL study Ref.: 87 α-Terpineol (max, p.29
SCCS Opinion NOAEL =500 mg/kg bw/day rat oral 20 weeks NOAEL study p.29
SCCS Opinion NOAEL =250 mg/kg bw/day rat oral 28 days repeated dose toxicity Ref.: 88 Terpinolene (max, p.29
SCCS Opinion NOAEL =5 % rat - 28-day repeated dose toxicity Ref.: 88 Terpinolene (max, p.29
SCCS Opinion NOAEL =40 % - - - NOAEL study p.30
SCCS Opinion NOAEL =4.5 % - - - NOAEL study p.30
SCCS Opinion NOAEL =6 % - - - NOAEL study p.30
SCCS Opinion NOAEL =100 % - - - NOAEL study p.30
SCCS Opinion NOAEL =510 mg/kg bw/day - - - NOAEL study p.30
SCCS Opinion NOAEL =49.5 % - - - repeated dose toxicity p.30
SCCS Opinion NOAEL =117 mg/kg bw/day - oral 28 days repeated dose toxicity p.30
SCCS Opinion NOAEL =30 mg/kg rat oral - reproductive toxicity p.33
SCCS Opinion NOAEL =333 mg/kg bw/day rat oral - reproductive toxicity p.33
SCCS Opinion NOAEL =30 mg/kg bw/d human oral 10 years reproductive toxicity p.33
SCCS Opinion NOAEL =117 mg/kg bw/d mouse - - repeated dose toxicity p.35
SCCS Opinion NOAEL =60 mg/kg bw/d - - - repeated dose toxicity p.35
SCCS Opinion NOAEL =333 mg/kg - - - reproductive toxicity p.35
SCCS Opinion NOAEL =3 - - - - NOAEL study p.28
SCCS Opinion NOAEL =30 - - - - NOAEL study p.30
SCCS Opinion NOAEL =400 - - - - NOAEL study p.30
SCCS Opinion NOAEL =300 - - - - NOAEL study p.30
SCCS Opinion NOAEL =60 - - - - NOAEL study p.30
SCCS Opinion NOAEL =500 - - - - NOAEL study p.30
SCCS Opinion NOAEL =250 - - - - NOAEL study p.30
SCCS Opinion NOAEL =10000 μg/cm2 human - 442D sensitisation p.47
SCCS Opinion NOAEL =45 mg/kg bw/day rat oral 28 days repeated dose toxicity p.53
SCCS Opinion NOAEL =62.5 mg/kg bw/day - - - NOAEL study p.53
SCCS Opinion NOAEL =30 mg/kg bw/day rat oral 8 weeks NOAEL study p.54
SCCS Opinion NOAEL =25 mg/kg bw/day - - 28 days repeated dose toxicity p.55
SCCS Opinion NOAEL =25 mg/kg bw/d rat - Developmental reproductive toxicity p.56
SCCS Opinion NOAEL =20 mg/kg bw/day - - developmental developmental toxicity p.59
SCCS Opinion NOAEL =20 mg/kg bw/d rat oral developmental reproductive toxicity p.71
SCCS Opinion NOAEL =0.117 mg/kg bw/day rat oral - NOAEL study p.71
SCCS Opinion NOAEL =70 % rat oral - NOAEL study p.71
Regulatory source 40 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 15 % rat oral 28-days - p.28
Regulatory source - 300 mg/kg bw/day rat oral 28-days - p.28
Regulatory source - 60 mg/kg bw/day rat - - - p.29
Regulatory source - 75 mg/kg bw/day rat oral 20 weeks - p.29
Regulatory source - 500 mg/kg bw/day rat oral 20 weeks - p.29
Regulatory source - 5 % - - - - p.30
Regulatory source - 40 % - - - - p.30
Regulatory source - 4.5 % - - - - p.30
Regulatory source - 6 % - - - - p.30
Regulatory source - 75 mg/kg bw/day - - - - p.30
Regulatory source - =100 % - - - - p.30
Regulatory source - 510 mg/kg bw/day - - - - p.30
Regulatory source - 3 - - - - - p.28
Regulatory source - 3 - rat - - - p.28
Regulatory source - 30 - - - - - p.30
Regulatory source - 400 - - - - - p.30
Regulatory source - 300 - - - - - p.30
Regulatory source - 60 - - - - - p.30
Regulatory source - 75 - - - - - p.30
Regulatory source - 500 - - - - - p.30
Regulatory source - 250 - - - - - p.30
Regulatory source repeated dose toxicity 400 mg/kg bw/day rat oral 28-days repeated dose toxicity p.28
Regulatory source repeated dose toxicity 250 mg/kg bw/day rat oral 28 days repeated dose toxicity p.29
Regulatory source repeated dose toxicity 250 mg/kg bw/day rat - 28-day repeated dose toxicity p.29
Regulatory source repeated dose toxicity 5 % rat - 28-day repeated dose toxicity p.29
Regulatory source repeated dose toxicity 49.5 % - - - repeated dose toxicity p.30
Regulatory source repeated dose toxicity 49.5 % - oral 28 days repeated dose toxicity p.30
Regulatory source repeated dose toxicity 40 % - oral 28 days repeated dose toxicity p.30
Regulatory source repeated dose toxicity =100 % - oral 28 days repeated dose toxicity p.30
Regulatory source repeated dose toxicity 117 mg/kg bw/day - oral 28 days repeated dose toxicity p.30
Regulatory source repeated dose toxicity 117 mg/kg bw/d mouse - - repeated dose toxicity p.35
Regulatory source repeated dose toxicity 117 mg/kg bw/d - - - repeated dose toxicity p.35
Regulatory source repeated dose toxicity 60 mg/kg bw/d - - - repeated dose toxicity p.35
Regulatory source reproductive toxicity 60 mg/kg bw/day rat oral - reproductive toxicity p.33
Regulatory source reproductive toxicity 30 mg/kg rat oral - reproductive toxicity p.33
Regulatory source reproductive toxicity 333 mg/kg bw/day rat oral - reproductive toxicity p.33
Regulatory source reproductive toxicity 333 mg/kg bw/day human oral 10 years reproductive toxicity p.33
Regulatory source reproductive toxicity 30 mg/kg bw/d human oral 10 years reproductive toxicity p.33
Regulatory source reproductive toxicity 333 mg/kg - - - reproductive toxicity p.35
Regulatory source reproductive toxicity 30 mg/kg bw/d - - - reproductive toxicity p.35
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier VIF565UC2G UNII - - - structurallyDiverse -