NOAEL Studies Cosmetic Ingredient

Gamma-Undecalactone NOAEL Studies

INCI: GAMMA-UNDECALACTONE

CAS: 104-67-6

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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COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 14 mg/kg bw/day rat oral 90 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =112 mg/kg bw/day Rat oral: gavage 730 days chronic/long term toxicity EFSA FEEDAP - 2012 - OutputID 616 - mortality - systemic - Scientific Opinion on the safety and efficacy of primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones (chemical group 9) when used as flavourings for all animal species - doi:10.2903/j.efsa.2012.2928
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =112 mg/kg bw/day Rat oral: gavage 730 days chronic/long term toxicity EFSA FEEDAP - 2012 - OutputID 616 - mortality - systemic - Scientific Opinion on the safety and efficacy of primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones (chemical group 9) when used as flavourings for all animal species - doi:10.2903/j.efsa.2012.2928
NTP_ICE_acute_oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 =18500 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM ChemIDplus TEST (undated); record_id=acute_oral_384; row=7597; data_type=In Vivo; mixture=Chemical; chemical_name=5-Heptyldihydro-2(3H)-furanone; preferred_name=5-Heptyldihydro-2(3H)-furanone; dtxsid=DTXSID4034287; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4034287; source_file=acute_oral.xlsx
NTP_ICE_adme_parameters 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_adme_parameters Clint 9.47 uL/min/10^6 cells Human - - Measured; httk, Human Hepatic Intrinsic Clearance sheet=Data; excel_row=1779; Record_ID=adme_parameters_243; Data_Type=Measured; DTXSID=DTXSID4034287; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=9.47; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4034287
NTP_ICE_adme_parameters Fu 0.069 fraction Human - - Measured; httk, Human Plasma Fraction Unbound sheet=Data; excel_row=1778; Record_ID=adme_parameters_243; Data_Type=Measured; DTXSID=DTXSID4034287; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.069; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4034287
NTP_ICE_endocrine 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_endocrine Model Score 0 unitless - - - ARPathway2016; AR Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=4344; RecordID=ARPathway2016_451; DatasetName=ARPathway2016; DTXSID=DTXSID4034287; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4034287
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=2706; Record_ID=skin_sensitization_invivo_722; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=2.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID4034287; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Kligman 1971: report to RIFM|Opdyke 1975; Not available; 10.1016/0015-6264(75)90282-5; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4034287
NTP_ICE_skin_sensitization Induction dose per skin area 1296 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=2704; Record_ID=skin_sensitization_invivo_722; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=2.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID4034287; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=1296; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Kligman 1971: report to RIFM|Opdyke 1975; Not available; 10.1016/0015-6264(75)90282-5; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4034287
NTP_ICE_skin_sensitization Relative reliability score 3 unitless Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=2709; Record_ID=skin_sensitization_invivo_722; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=2.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID4034287; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=3; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Kligman 1971: report to RIFM|Opdyke 1975; Not available; 10.1016/0015-6264(75)90282-5; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4034287
ToxValDB_EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL =112 mg/kg bw/day Rat oral chronic; 2 years chronic LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones (chemical group 9) when used as flavourings for all animal species. doi:10.2903/j.efsa.2012.2928.; TITLE=Scientific Opinion on the safety and efficacy of primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones (chemical group 9) when used as flavourings for all animal species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2928; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=mortality; TOXICOLOGICAL_EFFECT_CATEGORY=mortality/survival; STUDY_GROUP=EFSA:15614730:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_3e4e69f1ae49de841e770d226b6758c8
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =19 mg/m3 Human inhalation - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15635638:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_5e3ef516aa1be4d5cdbb1b45521d8d94
ToxValDB_WHO_JECFA_ADI 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_WHO_JECFA_ADI ADI <=1.25 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afe5ae4b0d99f5a87ff34; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/; SUBSOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/1729; YEAR=1997; ORIGINAL_YEAR=1997; STUDY_GROUP=WHO JECFA ADI:15715553:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_85bd2e6b39520e417188d7fa5f0bea72
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier QB1T0AG2YL UNII - - - chemical {"approval_status":null,"molecular_formula":"C11H20O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"QB1T0AG2YL"}
openFDA substances FDA UNII substance identifier QB1T0AG2YL UNII - - - chemical {"approval_status":null,"molecular_formula":"C11H20O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"QB1T0AG2YL"}
openFDA substances FDA UNII substance identifier QB1T0AG2YL UNII - - - chemical {"approval_status":null,"molecular_formula":"C11H20O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"QB1T0AG2YL"}
openFDA substances FDA UNII substance identifier QB1T0AG2YL UNII - - - chemical {"approval_status":null,"molecular_formula":"C11H20O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"QB1T0AG2YL"}