NOAEL Studies Cosmetic Ingredient

Mentha Piperita Oil NOAEL Studies

INCI: MENTHA PIPERITA OIL

CAS: 8006-90-4

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

Back to parent ingredient page
CIR_vision_codex 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR_vision_codex NOAEL =40 mg/kg/d rat - - NOAEL study {"citation":"100; 40; 1","dose":"Brain lesions (specifically, cyst-like spaces in the cerebellum) were observed in all dose groups, but these results were classified as significant only for animals of the 100 mg/kg/d dose group.","effect":"s were within normal range, and there were no significant differences in absolute and relative organ weights. Brain lesions (specifically, cyst-like spaces in the cerebellum) were observed in all dose groups, but these results were classified as significant only for animals of the 100 mg/kg/d dose group. No other lesions of encepha- lopathy were observed. Nephropathy (hyaline droplet forma- tion) was observed only in male rats of the 100 mg/kg/d dose group, and there was no evidence of epithelial degeneration. The no-observed-adverse-effect level (NOAEL) for Mentha Piperita (Peppermint) Oil was 40 mg/kg/d in this study. Genotoxicity Studies In Vitro M piperita (Peppermint) Oil. The mutagenic potential of Mentha Piperita (Peppermint) Oil was investigated using the Salmo- nella/mammalian microsome test.1 The following Salmonella typhimurium strains were used: TA1535, TA100, TA1537, and TA98. The sample tested contained 38.1% menthol, 33.7% menthone, and 1.7% pulegone; the remaining components were not identified. Mentha Piperita (Peppermint) Oil, tested at doses Johnson et al. 127S","page":11,"pdf":"PRS741.pdf","row_type":"noael_study","study_id":"PRS741_noael_001"}
CIR_vision_codex NOAEL =40 mg/kg/d rat - - NOAEL study {"citation":"100; 40; 1","dose":"Brain lesions (specifically, cyst-like spaces in the cerebellum) were observed in all dose groups, but these results were classified as significant only for animals of the 100 mg/kg/d dose group.","effect":"s were within normal range, and there were no significant differences in absolute and relative organ weights. Brain lesions (specifically, cyst-like spaces in the cerebellum) were observed in all dose groups, but these results were classified as significant only for animals of the 100 mg/kg/d dose group. No other lesions of encepha- lopathy were observed. Nephropathy (hyaline droplet forma- tion) was observed only in male rats of the 100 mg/kg/d dose group, and there was no evidence of epithelial degeneration. The no-observed-adverse-effect level (NOAEL) for Mentha Piperita (Peppermint) Oil was 40 mg/kg/d in this study. Genotoxicity Studies In Vitro M piperita (Peppermint) Oil. The mutagenic potential of Mentha Piperita (Peppermint) Oil was investigated using the Salmo- nella/mammalian microsome test.1 The following Salmonella typhimurium strains were used: TA1535, TA100, TA1537, and TA98. The sample tested contained 38.1% menthol, 33.7% menthone, and 1.7% pulegone; the remaining components were not identified. Mentha Piperita (Peppermint) Oil, tested at doses Johnson et al. 127S","page":11,"pdf":"PRS741.pdf","row_type":"noael_study","study_id":"PRS741_noael_001"}
CIR_vision_codex NOAEL =40 mg/kg/d rat - - NOAEL study {"citation":"100; 40; 1","dose":"Brain lesions (specifically, cyst-like spaces in the cerebellum) were observed in all dose groups, but these results were classified as significant only for animals of the 100 mg/kg/d dose group.","effect":"s were within normal range, and there were no significant differences in absolute and relative organ weights. Brain lesions (specifically, cyst-like spaces in the cerebellum) were observed in all dose groups, but these results were classified as significant only for animals of the 100 mg/kg/d dose group. No other lesions of encepha- lopathy were observed. Nephropathy (hyaline droplet forma- tion) was observed only in male rats of the 100 mg/kg/d dose group, and there was no evidence of epithelial degeneration. The no-observed-adverse-effect level (NOAEL) for Mentha Piperita (Peppermint) Oil was 40 mg/kg/d in this study. Genotoxicity Studies In Vitro M piperita (Peppermint) Oil. The mutagenic potential of Mentha Piperita (Peppermint) Oil was investigated using the Salmo- nella/mammalian microsome test.1 The following Salmonella typhimurium strains were used: TA1535, TA100, TA1537, and TA98. The sample tested contained 38.1% menthol, 33.7% menthone, and 1.7% pulegone; the remaining components were not identified. Mentha Piperita (Peppermint) Oil, tested at doses Johnson et al. 127S","page":11,"pdf":"PRS741.pdf","row_type":"noael_study","study_id":"PRS741_noael_001"}
CIR_vision_codex NOAEL =40 mg/kg/d rat - - NOAEL study {"citation":"100; 40; 1","dose":"Brain lesions (specifically, cyst-like spaces in the cerebellum) were observed in all dose groups, but these results were classified as significant only for animals of the 100 mg/kg/d dose group.","effect":"s were within normal range, and there were no significant differences in absolute and relative organ weights. Brain lesions (specifically, cyst-like spaces in the cerebellum) were observed in all dose groups, but these results were classified as significant only for animals of the 100 mg/kg/d dose group. No other lesions of encepha- lopathy were observed. Nephropathy (hyaline droplet forma- tion) was observed only in male rats of the 100 mg/kg/d dose group, and there was no evidence of epithelial degeneration. The no-observed-adverse-effect level (NOAEL) for Mentha Piperita (Peppermint) Oil was 40 mg/kg/d in this study. Genotoxicity Studies In Vitro M piperita (Peppermint) Oil. The mutagenic potential of Mentha Piperita (Peppermint) Oil was investigated using the Salmo- nella/mammalian microsome test.1 The following Salmonella typhimurium strains were used: TA1535, TA100, TA1537, and TA98. The sample tested contained 38.1% menthol, 33.7% menthone, and 1.7% pulegone; the remaining components were not identified. Mentha Piperita (Peppermint) Oil, tested at doses Johnson et al. 127S","page":11,"pdf":"PRS741.pdf","row_type":"noael_study","study_id":"PRS741_noael_001"}
COSMOS_DB 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 100 mg/kg bw/day rat oral 28 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 500 mg/kg bw/day rat oral 35 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 125 mg/kg bw/day dog oral 35 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 747 mg/kg bw/day rat oral 1 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 75 mg/kg bw/day rat oral 28 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
NTP_ICE_endocrine 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_endocrine AC50 33.5252100339392 uM - - - ERPathway2016; ER Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=13002; RecordID=ERPathway2016_408; DatasetName=ERPathway2016; DTXSID=DTXSID6021113; Assay=ER Pathway Model, Antagonist; Endpoint=AC50; Response=33.5252100339392; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021113
NTP_ICE_endocrine ACC 67.2663767739755 uM - - - ERPathway2016; ER Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=13003; RecordID=ERPathway2016_408; DatasetName=ERPathway2016; DTXSID=DTXSID6021113; Assay=ER Pathway Model, Antagonist; Endpoint=ACC; Response=67.2663767739755; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021113
NTP_ICE_endocrine Model Score 0 unitless - - - ARPathway2016; AR Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=12998; RecordID=ARPathway2016_1596; DatasetName=ARPathway2016; DTXSID=DTXSID6021113; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021113
NTP_ICE_endocrine Model Score 0.00851 unitless - - - ERPathway2016; ER Pathway Model, Agonist sheet=Integrated_approaches; excel_row=13004; RecordID=ERPathway2016_408; DatasetName=ERPathway2016; DTXSID=DTXSID6021113; Assay=ER Pathway Model, Agonist; Endpoint=Model Score; Response=0.00851; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6021113
UnifiedCodex:CIR:beta.noael_studies 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:CIR:beta.noael_studies - 40 mg/kg/d rat - - - SOURCE_SUBDIR=PRS741; REPORT_TITLE=Amended Safety Assessment of Mentha piperita (Peppermint)–Derived Ingredients as Used in Cosmetics Wilbur Johnson*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks***,; OPINION_NUMBER=PRS741; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2023; VALUE_TEXT=40; DOSE=Brain lesions (specifically, cyst-like spaces in the cerebellum) were observed in all dose groups, but these results were classified as significant only for animals of the 100 mg/kg/d dose group.; EFFECT=s were within normal range, and there were no significant differences in absolute and relative organ weights. Brain lesions (specifically, cyst-like spaces in the cerebellum) were observed in all dose groups, but these results were classified as significant only for animals of the 100 mg/kg/d dose group. No other lesions of encepha- lopathy were observed. Nephropathy (hyaline droplet forma- tion) was observed only in male rats of the 100 mg/kg/d dose group, and there was no evidence of epithelial degeneration. The no-observed-adverse-effect level (NOAEL) for Mentha Piperita (Peppermint) Oil was 40 mg/kg/d in this study. Genotoxicity Studies In Vitro M piperita (Peppermint) Oil. The mutagenic potential of Mentha Piperita (Peppermint) Oil was investigated using the Salmo- nella/mammalian microsome test.1 The following Salmonella typhimurium strains were used: TA1535, TA100, TA1537, and TA98. The sample tested contained 38.1% menthol, 33.7% menthone, and 1.7% pulegone; the remaining components were not identified. Mentha Piperita (Peppermint) Oil, tested at doses Johnson et al. 127S; CITATION=100; 40; 1; CITATION_NUMBERS=[100,40,1]; REFERENCE=100; 40; 1; DETAILS_JSON={"cas_number":"8006-90-4","citation":"100; 40; 1","dose":"Brain lesions (specifically, cyst-like spaces in the cerebellum) were observed in all dose groups, but these results were classified as significant only for animals of the 100 mg/kg/d dose group.","duration":"","effect":"s were within normal range, and there were no significant differences in absolute and relative organ weights. Brain lesions (specifically, cyst-like spaces in the cerebellum) were observed in all dose groups, but these results were classified as significant only for animals of the 100 mg/kg/d dose group. No other lesions of encepha- lopathy were observed. Nephropathy (hyaline droplet forma- tion) was observed only in male rats of the 100 mg/kg/d dose group, and there was no evidence of epithelial degeneration. The no-observed-adverse-effect level (NOAEL) for Mentha Piperita (Peppermint) Oil was 40 mg/kg/d in this study. Genotoxicity Studies In Vitro M piperita (Peppermint) Oil. The mutagenic potential of Mentha Piperita (Peppermint) Oil was investigated using the Salmo- nella/mammalian microsome test.1 The following Salmonella typhimurium strains were used: TA1535, TA100, TA1537, and TA98. The sample tested contained 38.1% menthol, 33.7% menthone, and 1.7% pulegone; the remaining components were not identified. Mentha Piperita (Peppermint) Oil, tested at doses Johnson et al. 127S","endpoint":"","ingredient":"Mentha piperita (Peppermint)–Derived Ingredients","loael_value":"","noael_unit":"mg/kg/d","noael_value":"40","page":11,"route":"","species":"rat","study_id":"PRS741_noael_001"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier AV092KU4JH UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"AV092KU4JH"}
openFDA substances FDA UNII substance identifier AV092KU4JH UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"AV092KU4JH"}
openFDA substances FDA UNII substance identifier AV092KU4JH UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"AV092KU4JH"}
openFDA substances FDA UNII substance identifier AV092KU4JH UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"AV092KU4JH"}