NOAEL Studies Cosmetic Ingredient

2-Ethylbutyric Acid NOAEL Studies

INCI: 2-ETHYLBUTYRIC ACID

CAS: 88-09-5

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 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB LOAEL 150 mg/kg bw/day rat oral 6-15 Gestation day Developmental PAFA; FUNDAM APPL TOXICOL 22:251-265
COSMOS DB NOAEL 150 mg/kg bw/day rat oral 10 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 310 mg/kg bw/day rat oral 90 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA 18 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 =200 mg/kg bw/day Rat oral: gavage 10 days reproduction toxicity EFSA AFC - 2004 - OutputID 2025 - no adverse effect observed at single/highest dose - Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) on a request from the Commission related to Flavouring Group Evaluation 6 (FGE.06): Straight- and branched-chain aliphatic unsaturated primary alcohols, aldehydes, carboxylic acids, and esters from chemical groups 1 and 4 (Commission Regulation (EC) No 1565/2000 of 18 July 2000) - doi:10.2903/j.efsa.2004.108
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:15614571:-:--; 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_e2319ef9283d3edd95d5e8e08132c094
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:15614572:-:--; 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_78eb0f6dcf1c13ecd9600837f05e3689
EFSA NOAEL =200 mg/kg bw/day Rat oral short-term; 10 days reproduction developmental LONG_REF=EFSA AFC (2004). Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) on a request from the Commission related to Flavouring Group Evaluation 6 (FGE.06): Straight- and branched-chain aliphatic unsaturated primary alcohols, aldehydes, carboxylic acids, and esters from chemical groups 1 and 4 (Commission Regulation (EC) No 1565/2000 of 18 July 2000). doi:10.2903/j.efsa.2004.108.; TITLE=Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) on a request from the Commission related to Flavouring Group Evaluation 6 (FGE.06): Straight- and branched-chain aliphatic unsaturated primary alcohols, aldehydes, carboxylic acids, and esters from chemical groups 1 and 4 (Commission Regulation (EC) No 1565/2000 of 18 July 2000); AUTHOR=EFSA AFC; DOI=doi:10.2903/j.efsa.2004.108; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2004; ORIGINAL_YEAR=2004; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA_dup_-_15614576_15614577_15614580: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_abd04fa24f8ad52c0c6bdea2c8d24fe9
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:15614575:-:--; 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_b8133cb1e652112f08194421f05ec1fa
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_-_15614573_15614574:-:--; 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_7c70ef2b69941eeacd47016805e61050
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_-_15614568_15614569:-:--; 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_47227ebe711e549a2ec088cc8ff98695
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:15614570:-:--; 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_0258d34c8add7c485a077fb702e54be6
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_-_15614568_15614569:-:--; 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_09028fbd2b3228492751e2685d425ea4
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_-_15614573_15614574:-:--; 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_4b6c5f3459f14c3b6838b6afd715d5bf
NTP ICE acute oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE acute oral LD50 =2200 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM ChemIDplus TEST (undated); record_id=acute_oral_11101; row=4725; data_type=In Vivo; mixture=Chemical; chemical_name=2-Ethylbutyric acid; preferred_name=2-Ethylbutyric acid; dtxsid=DTXSID2041418; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2041418; source_file=acute_oral.xlsx
ECHA 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA NOAEL =10 mg/kg bw/day Rat oral subchronic; 42 days subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf40e4b0a7c65d1cd35f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24720/7/6/2?documentUUID=e8cdaa77-0ef3-4ad9-bc86-9edbf4e8628e; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID:15849968:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_a4c798abb35a2c0728ecca000e24bc56
ECHA NOAEL =50 mg/kg bw/day Rat oral subchronic (developmental); 39 days reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf40e4b0a7c65d1cd35f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24720/7/6/2?documentUUID=e8cdaa77-0ef3-4ad9-bc86-9edbf4e8628e; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15840219_15848955: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_7e0781a591603bc68c23abaa36de2066
ECHA NOAEL =250 mg/kg bw/day Rat oral subchronic (developmental); 39 days reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf40e4b0a7c65d1cd35f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24720/7/6/2?documentUUID=e8cdaa77-0ef3-4ad9-bc86-9edbf4e8628e; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15840219_15848955:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_5b3c5929641ac0b08d794cae00c2c1aa
ECHA NOAEL =300 mg/kg bw/day Rat oral short-term; 14 days short-term QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cc0be4b0a7c65d228aa8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24720/7/6/2?documentUUID=e8cdaa77-0ef3-4ad9-bc86-9edbf4e8628e; YEAR=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ECHA IUCLID:15849969:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_55216ba1a0fc06d5c00d86a8105010e5
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier IDY8B990KE UNII - - - chemical -