NOAEL Studies Antioxidant

BHA NOAEL Studies

CAS: 25013-16-5

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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CIR Safety Assessment 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment NOAEL =100 mg/kg bw/d rat oral - oral toxicity 125); 300); 210), p.6
CIR Safety Assessment NOAEL =420 mg/kg/d rat oral 13 wk reproductive toxicity 100; 500; 13, p.10
CIR Safety Assessment NOAEL =220 mg/kg/d rat oral 13 wk reproductive toxicity 100; 500; 13, p.10
COSMOS DB 30 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB NOAEL 50 mg/kg bw/day swine oral 110 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 60 mg/kg bw/day dog oral 180 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 100 mg/kg bw/day dog oral 365 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 120 mg/kg bw/day hamster oral 5 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 125 mg/kg bw/day rat oral 728 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 150 mg/kg bw/day mouse oral 14 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 200 mg/kg bw/day rabbit oral 13 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 225 mg/kg bw/day mouse oral 10 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 237 mg/kg bw/day dog oral 180 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 250 mg/kg bw/day dog oral 180 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 300 mg/kg bw/day mouse oral 1 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 325 mg/kg bw/day dog oral 180 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 375 mg/kg bw/day rat oral 14 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 400 mg/kg bw/day swine oral 110 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 500 mg/kg bw/day rat oral 728 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 600 mg/kg bw/day rat oral 770 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 662 mg/kg bw/day house shrew oral 560 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 750 mg/kg bw/day mouse oral 728 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 840 mg/kg bw/day syrian hamster oral 225 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 956 mg/kg bw/day rat oral 728 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 974 mg/kg bw/day rat oral 728 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1000 mg/kg bw/day rat oral 32 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1041 mg/kg bw/day rat oral 728 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1125 mg/kg bw/day mouse oral 10 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1180 mg/kg bw/day rat oral 14 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1200 mg/kg bw/day hamster oral 140 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1375 mg/kg bw/day rat oral 728 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1500 mg/kg bw/day mouse oral 21 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2000 mg/kg bw/day rat oral 90 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2400 mg/kg bw/day hamster oral 28 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
California Proposition 65 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
California Proposition 65 California Proposition 65 NSRL AB4000 ug/day - - 1990-01-01 No significant risk level -
California Proposition 65 California Proposition 65 listing ABcancer listing type - - 1990-01-01 California Proposition 65 listing -
EFSA 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA NOAEL =100 mg/kg bw/day Rat oral: unspecified - reproduction toxicity EFSA ANS - 2011 - OutputID 488 - development - developmental - Scientific Opinion on the re-evaluation of butylated hydroxyanisole BHA (E 320) as a food additive - doi:10.2903/j.efsa.2011.2392
EFSA ADI =1 mg/kg bw/day Consumers - - ADI EFSA ANS - 2011 - OutputID 488 - Consumers - Scientific Opinion on the re-evaluation of butylated hydroxyanisole BHA (E 320) as a food additive - doi:10.2903/j.efsa.2011.2392
EFSA NOAEL =100 mg/kg bw/day Rat oral - developmental LONG_REF=EFSA ANS (2011). Scientific Opinion on the re-evaluation of butylated hydroxyanisole BHA (E 320) as a food additive. doi:10.2903/j.efsa.2011.2392.; TITLE=Scientific Opinion on the re-evaluation of butylated hydroxyanisole BHA (E 320) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2011.2392; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2011; ORIGINAL_YEAR=2011; TOXICOLOGICAL_EFFECT=development; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=EFSA_dup_-_15614341_15614342_15614343:-:--; 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_f4860a914ce41c83c6db2710fbad625e
IARC Monographs 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
IARC Monographs IARC carcinogenicity classification 2B IARC group - - 1987 IARC Monographs -
NTP ICE cancer 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE cancer IARC group 2 unitless - - - WOE; IARC Carcinogenicity sheet=Data; excel_row=7430; Record_ID=cancer_837; Data_Type=WOE; Formulation_Name=Butylated hydroxyanisole; Mixture=Chemical; DTXSID=DTXSID7020215; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=2B; Response_Unit=Unitless; URL=http://publications.iarc.fr/58; http://publications.iarc.fr/139; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7020215; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID7020215
NTP ICE endocrine 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE endocrine NOEL 500 mg/kg bw/day Rat Oral Treatment_Duration=10 days; Age_at_First_Dose=PND 51; Age_Ovariectomized_or_Castrated=PND 42; Time_Elapsed_Between_Surgery_and_Treatment=8 days; Time_Elapsed_Between_Last_Dose_and_Necropsy=18 to 36 hours; Number_of_Doses_Tested=8 In Vivo; Hershberger-Agonist sheet=Data_invivo; excel_row=1836; Record_ID=endocrine_invivo_788; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID7020215; Assay=Hershberger-Agonist; Endpoint=NOEL; Response=500; Response_Unit=mg/kg/day; Species=Rat; Reported_Strain=Sprague-Dawley; Strain=Sprague-Dawley; Sex=Male (castrated); Route=Oral; Reference_Hormone=Testosterone propionate; Reference_Hormone_Dose=0.4; Reference_Hormone_Dose_Units=mg/kg/day; Reference_Hormone_Route=Subcutaneous; Additional_Information=Browne et al. 2018 unique record identifier 156; Reference=Kang et al. 2005; 16023279; 10.1016/j.tox.2005.05.027|Browne et al. 2018; 30205136; 10.1016/j.reprotox.2018.08.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7020215; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID7020215
SCCS Opinion 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =0.0029 mg/kg bw/d - - - NOAEL study p.45
SCCS Opinion NOAEL =0.079 mg/kg bw/d - oral - dermal absorption p.45
SCCS Opinion NOAEL =0.082 mg/kg bw/d - oral - dermal absorption p.45
SCCS Opinion NOAEL =50 mg/kg bw/d rat oral 4 weeks repeated dose toxicity Ref.: Miyakawa et al, p.22
SCCS Opinion NOAEL =55 mg/kg bw/d rat oral 104 wk NOAEL study p.60
SCCS Opinion NOAEL =200 mg/kg bw/day rat - developmental reproductive toxicity Ref.: Hansen et al, p.24
SCCS Opinion NOAEL =400 mg/kg bw/day rabbit oral 7 to day reproductive toxicity p.24
ToxValDB ECOTOX 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB ECOTOX LOEL =500 mg/kg bw/day Mouse oral acute; 1 days acute LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15607592_15607593:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=0a9b557befd14cc3f3710b072e45e203
ToxValDB ECOTOX NOEL =0.75 % w/v Mouse oral short-term; 8.0833 days short-term LONG_REF=Toxicol. Appl. Pharmacol.87(3): 389-392 Ketterman,A.J., S.M. Pond, and C.E. Becker The Effects of Differential Induction of Cytochrome P-450, Carboxylesterase and Glutathione S-Transferase Activities on Malathion Toxicity in Mice 1987; TITLE=The Effects of Differential Induction of Cytochrome P-450, Carboxylesterase and Glutathione S-Transferase Activities on Malathion Toxicity in Mice; AUTHOR=Ketterman,A.J., S.M. Pond, and C.E. Becker; DOI=10.1016/0041-008x(87)90243-2; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=88919; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1987; ORIGINAL_YEAR=1987; TOXICOLOGICAL_EFFECT=Enzyme(s): Acetylcholinesterase|Enzyme(s): Cytochrome P-450|Enzyme(s): Malathion carboxylesterase; TOXICOLOGICAL_EFFECT_CATEGORY=enzyme activity|neurotransmitter; STUDY_GROUP=ECOTOX_dup_EPA ORD_15595130_15596728:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=290206b7fb741beb64a2e9506b0c1ba8
ToxValDB ECOTOX NOEL =2 % Rat oral subchronic; 56 days subchronic LONG_REF=Toxicol. Appl. Pharmacol.99(1): 37-49 Shibata,M.A., M. Yamada, H. Tanaka, M. Kagawa, and S. Fukushima Changes in Urine Composition, Bladder Epithelial Morphology, and DNA Synthesis in Male F344 Rats in Response to Ingestion of Bladder Tumor Promoters 1989; TITLE=Changes in Urine Composition, Bladder Epithelial Morphology, and DNA Synthesis in Male F344 Rats in Response to Ingestion of Bladder Tumor Promoters; AUTHOR=Shibata,M.A., M. Yamada, H. Tanaka, M. Kagawa, and S. Fukushima; DOI=10.1016/0041-008x(89)90109-9; QUALITY=Control type: Multiple entries; EXTERNAL_SOURCE_ID=106692; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1989; ORIGINAL_YEAR=1989; TOXICOLOGICAL_EFFECT=Biochemistry: Phosphorus content|Physiology: Osmolality; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|urinalysis; STUDY_GROUP=ECOTOX_dup_EPA ORD_15606152_15606153:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=9e32b962490f3ab16295ff87c645719c
ToxValDB ECOTOX NOEL =100 mg/kg bw/day Mouse oral acute; 1 days acute LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15607592_15607593:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=37769999adf9ad5df3f5d820fc2dd8ba
WHO/JECFA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
WHO/JECFA ADI <=0.5 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afb36e4b0d99f5a87a669; 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/1910; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=WHO JECFA ADI:15715345:-:--; 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_40ef5fb290354b51ced1628598a40bd2
Regulatory source 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source oral toxicity 100 mg/kg bw/d rat oral - oral toxicity p.6
Regulatory source reproductive toxicity 420 mg/kg/d rat oral 13 wk reproductive toxicity p.10
Regulatory source reproductive toxicity 220 mg/kg/d rat oral 13 wk reproductive toxicity p.10
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier REK4960K2U UNII - - - mixture -