NOAEL Studies Cosmetic Ingredient

Isovaleric Acid NOAEL Studies

INCI: ISOVALERIC ACID

CAS: 503-74-2

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 2500 mg/kg bw/day rat oral 90 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA 16 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA NOAEL =50 mg/kg bw/day Rat oral: gavage 730 days chronic/long term toxicity EFSA FEEDAP - 2012 - OutputID 615 - body weight - systemic - Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species - doi:10.2903/j.efsa.2012.2927
EFSA NOAEL =125 mg/kg bw/day Rat oral: gavage 90 days subchronic EFSA FEEDAP - 2012 - OutputID 615 - gross pathology - systemic - Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species - doi:10.2903/j.efsa.2012.2927
EFSA NOAEL >219 mg/kg bw/day Rat oral: unspecified 90 days subchronic EFSA FEEDAP - 2012 - OutputID 615 - no adverse effect observed at single/highest dose - Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species - doi:10.2903/j.efsa.2012.2927
EFSA NOAEL >300 mg/kg bw/day Rat oral: feed 90 days subchronic EFSA FEEDAP - 2012 - OutputID 615 - no adverse effect observed at single/highest dose - Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species - doi:10.2903/j.efsa.2012.2927
EFSA NOAEL =340 mg/kg bw/day Rat oral: drinking water 90 days subchronic EFSA FEEDAP - 2012 - OutputID 615 - haematology - hemopoietic - Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species - doi:10.2903/j.efsa.2012.2927
EFSA NOAEL >1000 mg/kg bw/day Rat oral: gavage 119 days chronic/long term toxicity EFSA FEEDAP - 2012 - OutputID 615 - no adverse effect observed at single/highest dose - Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species - doi:10.2903/j.efsa.2012.2927
EFSA NOAEL >1450 mg/kg bw/day Rat oral: drinking water 90 days subchronic EFSA FEEDAP - 2012 - OutputID 615 - no adverse effect observed at single/highest dose - Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species - doi:10.2903/j.efsa.2012.2927
EFSA NOAEL >2500 mg/kg bw/day Rat oral: feed 90 days subchronic EFSA FEEDAP - 2012 - OutputID 615 - no adverse effect observed at single/highest dose - Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species - doi:10.2903/j.efsa.2012.2927
EFSA NOAEL =50 mg/kg bw/day Rat oral chronic; 2 years chronic LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species. doi:10.2903/j.efsa.2012.2927.; TITLE=Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2927; 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=body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=EFSA:15614555:-:--; 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_8b67357d3481a31c69e59a3dd324769c
EFSA NOAEL =125 mg/kg bw/day Rat oral subchronic; 90 days subchronic LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species. doi:10.2903/j.efsa.2012.2927.; TITLE=Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2927; 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=gross pathology; TOXICOLOGICAL_EFFECT_CATEGORY=gross pathology; STUDY_GROUP=EFSA:15614556:-:--; 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_044ba3b797460339070f792d1b8a2f65
EFSA NOAEL >219 mg/kg bw/day Rat oral subchronic; 90 days subchronic LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species. doi:10.2903/j.efsa.2012.2927.; TITLE=Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2927; 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=no effects; STUDY_GROUP=EFSA:15614559:-:--; 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_a1d2f9c85425d87300b590af4163773f
EFSA NOAEL >300 mg/kg bw/day Rat oral subchronic; 90 days subchronic LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species. doi:10.2903/j.efsa.2012.2927.; TITLE=Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2927; 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=no effects; STUDY_GROUP=EFSA_dup_-_15614557_15614558:-:--; 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_d4e7385a90ca483d7cfe062cd4e1d2be
EFSA NOAEL =340 mg/kg bw/day Rat oral subchronic; 90 days subchronic LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species. doi:10.2903/j.efsa.2012.2927.; TITLE=Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2927; 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=hematological; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=EFSA_dup_-_15614552_15614553:-:--; 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_69be32a57295958885cce65b288d113e
EFSA NOAEL >1000 mg/kg bw/day Rat oral chronic; 17 weeks chronic LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species. doi:10.2903/j.efsa.2012.2927.; TITLE=Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2927; 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=no effects; STUDY_GROUP=EFSA:15614554:-:--; 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_7b97fc4a95814f08f0dead378b504341
EFSA NOAEL >1450 mg/kg bw/day Rat oral subchronic; 90 days subchronic LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species. doi:10.2903/j.efsa.2012.2927.; TITLE=Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2927; 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=no effects; STUDY_GROUP=EFSA_dup_-_15614552_15614553:-:--; 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_e366f092dc8ee970d7e731daccfe5331
EFSA NOAEL >2500 mg/kg bw/day Rat oral subchronic; 90 days subchronic LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species. doi:10.2903/j.efsa.2012.2927.; TITLE=Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as flavourings for all animal species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2927; 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=no effects; STUDY_GROUP=EFSA_dup_-_15614557_15614558:-:--; 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_a4235bc5510a4d4c794c9b8e51a2907b
NTP ICE acute oral 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE acute oral LD50 =2000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_6787; row=8975; data_type=In Vivo; mixture=Chemical; chemical_name=Isovaleric acid; preferred_name=Isovaleric acid; dtxsid=DTXSID5029182; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5029182; source_file=acute_oral.xlsx
NTP ICE acute oral LD50 =2500 mg/kg bw Rat oral acute Rat Acute Oral Toxicity ECHA ChemProp (undated); record_id=acute_oral_6788; row=8974; data_type=In Vivo; mixture=Chemical; chemical_name=Isovaleric acid; preferred_name=Isovaleric acid; dtxsid=DTXSID5029182; url=https://echa.europa.eu/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5029182; source_file=acute_oral.xlsx
NTP ICE acute oral LD50 <3200 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_6789; row=8977; data_type=In Vivo; mixture=Chemical; chemical_name=Isovaleric acid; preferred_name=Isovaleric acid; dtxsid=DTXSID5029182; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5029182; source_file=acute_oral.xlsx
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=7582; Record_ID=skin_sensitization_invivo_1725; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=1.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5029182; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Epstein 1977: report to RIFM|RIFM 1977; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Anonymous 1979; Not available; 10.1016/S0015-6264(79)80063-2; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5029182
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=7580; Record_ID=skin_sensitization_invivo_1725; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=1.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5029182; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=675; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Epstein 1977: report to RIFM|RIFM 1977; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Anonymous 1979; Not available; 10.1016/S0015-6264(79)80063-2; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5029182
NTP ICE skin sensitization Relative reliability score 3 unitless Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=7586; Record_ID=skin_sensitization_invivo_1725; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=1.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5029182; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=3; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Epstein 1977: report to RIFM|RIFM 1977; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Anonymous 1979; Not available; 10.1016/S0015-6264(79)80063-2; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5029182
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 1BR7X184L5 UNII - - - chemical -