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_REACH_reach_study_results_dossiers_23-05-2023.zip 36 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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_REACH_reach_study_results_dossiers_23-05-2023.zip 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
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
ToxValDB_ECHA_IUCLID 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID 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
ToxValDB_ECHA_IUCLID 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
ToxValDB_ECHA_IUCLID 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
ToxValDB_ECHA_IUCLID 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