NOAEL Studies Cosmetic Ingredient

Methyl Amyl Ketone NOAEL Studies

INCI: METHYL AMYL KETONE (SYNONYM: 2-HEPTANONE)

CAS: 110-43-0

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

COSMOS_DB 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 100 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 =20 mg/kg bw/day Rat oral: gavage 91 days subchronic EFSA FEEDAP - 2015 - OutputID 2700 - organ weights - nephrotoxicity - Safety and efficacy of saturated and unsaturated aliphatic secondary alcohols, ketones and esters with esters containing secondary alcohols belonging to chemical group 5 when used as flavourings for all animal species - doi:10.2903/j.efsa.2015.4268
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =20 mg/kg bw/day Rat oral: gavage 91 days subchronic EFSA FEEDAP - 2015 - OutputID 2700 - organ weights - nephrotoxicity - Safety and efficacy of saturated and unsaturated aliphatic secondary alcohols, ketones and esters with esters containing secondary alcohols belonging to chemical group 5 when used as flavourings for all animal species - doi:10.2903/j.efsa.2015.4268
NTP_ICE_acute_inhalation 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_inhalation LC50 >16.7 mg/L - Inhalation Duration=4 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=2841; Record_ID=acute_inhalation_3635; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID5021916; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=16.7; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10230/7/3/3/?documentUUID=0c28182b-ed8d-47f6-9918-edba860c39aa; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021916
NTP_ICE_acute_inhalation LC50 range9 mg/L - Inhalation Duration=6 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=2842; Record_ID=acute_inhalation_2928; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID5021916; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=range; Response=>9 and 19<; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10230/7/3/3/?documentUUID=ba9fc706-59a4-4c11-b755-4e085e2cc665; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021916
NTP_ICE_acute_oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 =1670 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_919; row=8666; data_type=In Vivo; mixture=Chemical; chemical_name=2-Heptanone; preferred_name=2-Heptanone; dtxsid=DTXSID5021916; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021916; source_file=acute_oral.xlsx
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=2448; RecordID=ARPathway2016_545; DatasetName=ARPathway2016; DTXSID=DTXSID5021916; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021916
NTP_ICE_eye_irritation 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_eye_irritation EPA Classification 3 unitless Rabbit Ocular - In Vivo; Draize Eye Irritation/Corrosion Test sheet=Data; excel_row=1541; Record_ID=eye_irritation_220; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID5021916; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=3; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021916
NTP_ICE_eye_irritation Intensity 0.2 %/sec - Ocular - In Vitro; Vitrigel sheet=Data; excel_row=1538; Record_ID=eye_irritation_1326; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID5021916; Assay=Vitrigel; Endpoint=Intensity; Response=0.2; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021916
NTP_ICE_eye_irritation Lag time 50 s - Ocular - In Vitro; Vitrigel sheet=Data; excel_row=1537; Record_ID=eye_irritation_1326; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID5021916; Assay=Vitrigel; Endpoint=Lag time; Response=50; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021916
NTP_ICE_eye_irritation Plateau level 9 % - Ocular - In Vitro; Vitrigel sheet=Data; excel_row=1539; Record_ID=eye_irritation_1326; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID5021916; Assay=Vitrigel; Endpoint=Plateau level; Response=9; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021916
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=3436; Record_ID=skin_sensitization_invivo_869; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=4.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5021916; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Epstein 1974: report to RIFM|RIFM 1974; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Opdyke 1975; Not available; 10.1016/0015-6264(75)90246-1|Api et al. 2019; 31238147; 10.1016/j.fct.2019.110624; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021916
NTP_ICE_skin_sensitization Induction dose per skin area 2592 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=3435; Record_ID=skin_sensitization_invivo_869; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=4.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5021916; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=2592; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Epstein 1974: report to RIFM|RIFM 1974; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Opdyke 1975; Not available; 10.1016/0015-6264(75)90246-1|Api et al. 2019; 31238147; 10.1016/j.fct.2019.110624; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021916
NTP_ICE_skin_sensitization Relative reliability score 3 unitless Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=3446; Record_ID=skin_sensitization_invivo_869; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=4.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5021916; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=3; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Epstein 1974: report to RIFM|RIFM 1974; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Opdyke 1975; Not available; 10.1016/0015-6264(75)90246-1|Api et al. 2019; 31238147; 10.1016/j.fct.2019.110624; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021916
ToxValDB_DOE_Protective_Action_Criteria 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_DOE_Protective_Action_Criteria LEL =51373.2 mg/m3 Human inhalation - acute LONG_REF=U.S. Department of Energy (DOE) Protective Action Criteria (PAC). 2023. PAC Chemical Database. Updated 11 October 2023. Available: https://edms3.energy.gov/pac/ (Accessed November 16, 2023); TITLE=U.S. Department of Energy (DOE) Protective Action Criteria (PAC) Chemical Database; AUTHOR=U.S. Department of Energy; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65428efee4b045b9ff7cc432; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://edms3.energy.gov/pac/TeelDocs; YEAR=2012; ORIGINAL_YEAR=2012; STUDY_GROUP=DOE Protective Action Criteria:15517149:-:--; 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_a25d029a83d61e539debf6ddfb2621ad
ToxValDB_ECHA_IUCLID 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID LEL =18681.2 mg/m3 Rat inhalation - acute QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059759e4b063812d6fa6de; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/21836/7/3/3?documentUUID=8f2ad3d9-0483-4ba1-8ff7-cdac54e48c62; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=ECHA IUCLID:15796186:-:--; 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_92222b917c9ed41f3fa72a760c254914
ToxValDB_ECHA_IUCLID NOAEC =5604.35 mg/m3 Rat inhalation - developmental GUIDELINE=OECD Guideline 414 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d189e4b0a7c65d22f061; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/21836/7/9/3?documentUUID=4ca7f8cf-dabc-47d1-920f-1c68d5675978; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID:15821575:M/F:-fetal; 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_464c1768b283a2dd6a575240b249e4d1
ToxValDB_ECHA_IUCLID NOEC =4670.29 mg/m3 Rat inhalation - reproduction developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c892e4b0a7c65d2192c4; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/21836/7/9/2?documentUUID=4ca7f8cf-dabc-47d1-920f-1c68d5675978; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID:15856973:M/F:P0-; 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_b14a2ed5343694e9586cdbc0985950cd
ToxValDB_EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL =20 mg/kg bw/day Rat oral subchronic; 13 weeks subchronic LONG_REF=EFSA FEEDAP (2015). Safety and efficacy of saturated and unsaturated aliphatic secondary alcohols, ketones and esters with esters containing secondary alcohols belonging to chemical group 5 when used as flavourings for all animal species. doi:10.2903/j.efsa.2015.4268.; TITLE=Safety and efficacy of saturated and unsaturated aliphatic secondary alcohols, ketones and esters with esters containing secondary alcohols belonging to chemical group 5 when used as flavourings for all animal species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2015.4268; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2015; ORIGINAL_YEAR=2015; TOXICOLOGICAL_EFFECT=organ weight; TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=EFSA:15624170: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_ae0d968ddea641e608dc2b2674ae4f86
ToxValDB_EU_SCOEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EU_SCOEL NOAEL =1000 ppm Rat oral or inhalation chronic; 10 months chronic LONG_REF=Johnson, B.L., Setzer., J. S., Lewis, T.R. and Hornung, R. W. (1978). An electrodiagnostic study of the neurotoxicity of methyl n-amyl-ketone. Am. Ind. Hyg. Ass. J. 39, 866-872. Lynch, D.W., Lewis, T.R., Moorman, W.J., Plotnick, W.B. et al. (1981). Inhalation toxicity of methyl n-amylketone (2-heptanone) in rats and monkeys. Toxicol. App!. Pharmacol. 58, 341-352; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c985c4e4b02565fc7d39d9; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu; SUBSOURCE_URL=https://echa.europa.eu/documents/10162/35144386/006_heptan-2-one_oel_en.pdf; YEAR=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=irritation on the upper respiratory tract and systemic effects on the nervous system, liver and kidneys; STUDY_GROUP=EU SCOEL:15952431:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ea87a1b980e3b1568bb9e37d4b28411c
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =394.25 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:15632440:-:--; 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_435499e31c10a6ea1e429beb9abed360
ToxValDB_TX_TCEQ 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_TX_TCEQ NOAEL =32 ppm Human vapor acute; 1 min clinical LONG_REF=Cometto-Muniz, JE, WS Cain, MH Abraham, and JMR Gola. 1999.Chemosensory detectability of 1-butanol and 2-heptanone singly and in binary mixtures. Physiol Behav 67: 269-276; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c993f9e4b02565fc7d5aef; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.tceq.texas.gov; SUBSOURCE_URL=https://www.tceq.texas.gov/downloads/toxicology/dsd/final/mak.pdf; YEAR=2010 Accessible 2013; ORIGINAL_YEAR=2010 Accessible 2013; TOXICOLOGICAL_EFFECT=Eye irritation; STUDY_GROUP=TX TCEQ:15954535:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_ceb3f68af47e89cfc6349a228130ffe3
ToxValDB_TX_TCEQ NOAEL =4787.05 mg/m3 Monkey inhalation subchronic subchronic LONG_REF=Johnson, BL, JV Setzer, TR Lewis, and RW Hornung. 1979. An electrodiagnostic study of the neurotoxicity of methyl n-amyl ketone. Am Ind Hyg Assoc J 39:866-872; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c993f9e4b02565fc7d5aef; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.tceq.texas.gov; SUBSOURCE_URL=https://www.tceq.texas.gov/downloads/toxicology/dsd/final/mak.pdf; YEAR=2010 Accessible 2013; ORIGINAL_YEAR=2010 Accessible 2013; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=TX TCEQ:15954536:M:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_2a218fe48e9f126e3aacba65d10e46c5
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 89VVP1B008 UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H14O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"89VVP1B008"}
openFDA substances FDA UNII substance identifier 89VVP1B008 UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H14O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"89VVP1B008"}
openFDA substances FDA UNII substance identifier 89VVP1B008 UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H14O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"89VVP1B008"}
openFDA substances FDA UNII substance identifier 89VVP1B008 UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H14O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"89VVP1B008"}