NOAEL Studies Cosmetic Ingredient

Ibuprofen NOAEL Studies

INCI: IBUPROFEN

CAS: 15687-27-1 [^1_9]

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

ECHA 16 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA LOAEL 60 mg/kg bw/day rat oral: feed - carcinogenicity: oral dossier=dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6z; document=f4b7501f-8112-4399-bec2-6c8b0d9f1297_dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6d; document_key=f4b7501f-8112-4399-bec2-6c8b0d9f1297/dd4aeb78-87b9-46b7-84c6-9bd89e424103; document_subtype=Carcinogenicity; literature=Name=Unnamed; ReferenceYear=1977; ReportDate=1977-09-26; basis=histopathology: non-neoplastic; key_result=false; entry_uuid=25dc6c33-339c-469f-b3c9-0107a6bc3192
ECHA LOAEL 180 mg/kg bw/day rat oral: gavage - sub-chronic toxicity: oral dossier=dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6z; document=d863a700-955a-4650-a403-7811b9550583_dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6d; document_key=d863a700-955a-4650-a403-7811b9550583/dd4aeb78-87b9-46b7-84c6-9bd89e424103; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=1969; basis=body weight and weight gain; key_result=false; entry_uuid=2cc306bd-1b35-40f1-9e15-4069980416d5
ECHA NOAEL >120 mg/kg bw/day rat oral: feed - carcinogenicity: oral dossier=dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6z; document=f4b7501f-8112-4399-bec2-6c8b0d9f1297_dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6d; document_key=f4b7501f-8112-4399-bec2-6c8b0d9f1297/dd4aeb78-87b9-46b7-84c6-9bd89e424103; document_subtype=Carcinogenicity; literature=Name=Unnamed; ReferenceYear=1977; ReportDate=1977-09-26; basis=other:; key_result=true; entry_uuid=f144e77c-befc-40ef-a391-aa9397d29e0c
ECHA NOAEL 20 mg/kg bw/day rat oral: feed - carcinogenicity: oral dossier=dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6z; document=f4b7501f-8112-4399-bec2-6c8b0d9f1297_dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6d; document_key=f4b7501f-8112-4399-bec2-6c8b0d9f1297/dd4aeb78-87b9-46b7-84c6-9bd89e424103; document_subtype=Carcinogenicity; literature=Name=Unnamed; ReferenceYear=1977; ReportDate=1977-09-26; basis=other:; key_result=false; entry_uuid=2b1a6f5f-24e8-4494-971c-de2928afe514
ECHA NOAEL 40 mg/kg bw/day monkey oral: gavage - chronic toxicity: oral dossier=dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6z; document=93669e16-0831-4852-a3df-50d32203e9ea_dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6d; document_key=93669e16-0831-4852-a3df-50d32203e9ea/dd4aeb78-87b9-46b7-84c6-9bd89e424103; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=1982; ReportDate=1982-01-07; basis=gross pathology; key_result=true; entry_uuid=9bdb095d-870f-425c-bb8d-9bf465992a11
ECHA NOAEL 7.5 mg/kg bw/day rat oral: gavage - developmental toxicity dossier=dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6z; document=adb0ee0e-5230-4dd9-a6a3-c32b0311f93f_dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6d; document_key=adb0ee0e-5230-4dd9-a6a3-c32b0311f93f/dd4aeb78-87b9-46b7-84c6-9bd89e424103; document_subtype=DevelopmentalToxicityTeratogenicity; literature=Name=Unnamed; ReferenceYear=1969; basis=histopathology: non-neoplastic; key_result=true; entry_uuid=dab46c97-7baf-4abe-bb4a-f63e5e83e2f1
ECHA NOAEL 180 mg/kg bw/day rat oral: gavage - developmental toxicity dossier=dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6z; document=adb0ee0e-5230-4dd9-a6a3-c32b0311f93f_dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6d; document_key=adb0ee0e-5230-4dd9-a6a3-c32b0311f93f/dd4aeb78-87b9-46b7-84c6-9bd89e424103; document_subtype=DevelopmentalToxicityTeratogenicity; literature=Name=Unnamed; ReferenceYear=1969; basis=other:; key_result=false; entry_uuid=6979f1c8-59de-48fa-9f47-53ea6fb19aa0
ECHA NOAEL 300 mg/kg bw/day mouse oral: feed - carcinogenicity: oral dossier=dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6z; document=b9d99727-6498-485f-9f43-220ac05df1a6_dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6d; document_key=b9d99727-6498-485f-9f43-220ac05df1a6/dd4aeb78-87b9-46b7-84c6-9bd89e424103; document_subtype=Carcinogenicity; literature=Name=Unnamed; ReferenceYear=1976; ReportDate=1976-09-16; basis=histopathology: neoplastic; key_result=true; entry_uuid=0fe9c064-1fbe-4e02-a3de-3983a1b6fe86
ECHA NOAEL 100 mg/kg bw/day monkey oral: capsule - short-term repeated dose toxicity: oral dossier=dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6z; document=9e6a1a43-3e7e-419a-9eac-ea8dca11c726_dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6d; document_key=9e6a1a43-3e7e-419a-9eac-ea8dca11c726/dd4aeb78-87b9-46b7-84c6-9bd89e424103; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=1977; ReportDate=1977-06-23; basis=other:; key_result=true; entry_uuid=218be7a7-8230-45c8-b8a3-0fb74e0d42e0
ECHA NOAEL 255 mg/kg bw/day rat oral: gavage - developmental toxicity dossier=dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6z; document=f7152812-5df2-4f56-a3c4-4f6a0d82fcdd_dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6d; document_key=f7152812-5df2-4f56-a3c4-4f6a0d82fcdd/dd4aeb78-87b9-46b7-84c6-9bd89e424103; document_subtype=DevelopmentalToxicityTeratogenicity; literature=Name=Unnamed; ReferenceYear=2011; basis=other:; key_result=false; entry_uuid=605dd5fb-c746-47f7-b96e-457cd584e7b3
ECHA NOAEL 60 mg/kg bw/day rat oral: gavage - sub-chronic toxicity: oral dossier=dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6z; document=d863a700-955a-4650-a403-7811b9550583_dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6d; document_key=d863a700-955a-4650-a403-7811b9550583/dd4aeb78-87b9-46b7-84c6-9bd89e424103; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=1969; basis=other:; key_result=true; entry_uuid=97c24920-01eb-4cd8-9092-b0a2219bfda6
ECHA NOAEL 25.5 mg/kg bw/day rat oral: gavage - developmental toxicity dossier=dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6z; document=ad6db5a3-56f1-4d55-a42b-cae454102d56_dd4aeb78-87b9-46b7-84c6-9bd89e424103.i6d; document_key=ad6db5a3-56f1-4d55-a42b-cae454102d56/dd4aeb78-87b9-46b7-84c6-9bd89e424103; document_subtype=DevelopmentalToxicityTeratogenicity; literature=Name=Unnamed; ReferenceYear=2005; basis=body weight and weight gain; key_result=false; entry_uuid=7435670f-c5d3-4689-a534-70427e819f23
ECHA LEL >=5 mg/kg bw/day Dog oral short-term; 28 days short-term STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61ff4e4b096bca877f71c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=b29f49f9-fec6-440b-8efb-3d73066fea18; TOXICOLOGICAL_EFFECT=diarrhea; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15851168_15851169_15853456_15853457_15853459: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_9daca57b6ad0f7e65c6a65be7211bab6
ECHA LEL >=15 mg/kg bw/day Dog oral short-term; 28 days short-term STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6209ce4b096bca8782014; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=b29f49f9-fec6-440b-8efb-3d73066fea18; TOXICOLOGICAL_EFFECT=abnormal feces composition|abnormality of the gastrointestinal tract|infusion site swelling|injection site inflammation|kidney inflammation; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15851168_15851169_15853456_15853457_15853459: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_3e974dc3d10503bd53377b2f6b39e1b8
ECHA NOAEL =1 mg/kg bw/day Dog oral short-term; 28 days short-term STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61ff4e4b096bca877f71c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=b29f49f9-fec6-440b-8efb-3d73066fea18; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15851168_15851169_15853456_15853457_15853459: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_89cb1a451d5fb7f6681b8013d2d06ebe
ECHA NOEL <=45 mg/kg bw/day Dog oral short-term; 28 days short-term STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6209ce4b096bca8782014; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=b29f49f9-fec6-440b-8efb-3d73066fea18; TOXICOLOGICAL_EFFECT=no abnormal phenotype detected; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15851168_15851169_15853456_15853457_15853459: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_50ecbf25619da1003af0c2c28aaa5e33
NTP ICE adme parameters 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE adme parameters Clint 10.12 uL/min/10^6 cells Human - - Measured; httk, Human Hepatic Intrinsic Clearance sheet=Data; excel_row=1935; Record_ID=adme_parameters_459; Data_Type=Measured; DTXSID=DTXSID5020732; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=10.12; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wood 2017; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5020732
NTP ICE adme parameters Clint 5.9 uL/min/10^6 cells Rat - - Measured; httk, Rat Hepatic Intrinsic Clearance sheet=Data; excel_row=1938; Record_ID=adme_parameters_459; Data_Type=Measured; DTXSID=DTXSID5020732; Assay=httk, Rat Hepatic Intrinsic Clearance; Endpoint=Clint; Response=5.9; Response_Unit=ul/min/10^6 cells; Species=Rat; Reference=httk2.3.1, Honda 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5020732
NTP ICE adme parameters Fu 0.01 fraction Human - - Measured; httk, Human Plasma Fraction Unbound sheet=Data; excel_row=1936; Record_ID=adme_parameters_459; Data_Type=Measured; DTXSID=DTXSID5020732; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.01; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Obach 1999; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5020732
NTP ICE adme parameters Fu 0.023 fraction Rat - - Measured; httk, Rat Plasma Fraction Unbound sheet=Data; excel_row=1937; Record_ID=adme_parameters_459; Data_Type=Measured; DTXSID=DTXSID5020732; Assay=httk, Rat Plasma Fraction Unbound; Endpoint=Fu; Response=0.023; Response_Unit=Unitless Fraction; Species=Rat; Reference=httk2.3.1, Wood 2017; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5020732