NOAEL Studies Cosmetic Ingredient

PABA NOAEL Studies

CAS: 150-13-0

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

IARC Monographs 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
IARC Monographs IARC carcinogenicity classification 3 IARC group - - 1987 IARC Monographs {"additional_info":"volume_publication_year=1987","evaluation_year":1987,"source_table":"iarc_classifications","volume":"16, Sup 7"}
IARC Monographs IARC carcinogenicity classification 3 IARC group - - 1987 IARC Monographs {"additional_info":"volume_publication_year=1987","evaluation_year":1987,"source_table":"iarc_classifications","volume":"16, Sup 7"}
IARC Monographs IARC carcinogenicity classification 3 IARC group - - 1987 IARC Monographs {"additional_info":"volume_publication_year=1987","evaluation_year":1987,"source_table":"iarc_classifications","volume":"16, Sup 7"}
NTP_ICE_adme_parameters 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_adme_parameters Clint 0 uL/min/10^6 cells Human - - Measured; httk, Human Hepatic Intrinsic Clearance sheet=Data; excel_row=2504; Record_ID=adme_parameters_865; Data_Type=Measured; DTXSID=DTXSID6024466; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=0.0; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_adme_parameters Fu 0.766 fraction Human - - Measured; httk, Human Plasma Fraction Unbound sheet=Data; excel_row=2503; Record_ID=adme_parameters_865; Data_Type=Measured; DTXSID=DTXSID6024466; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.766; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_cancer 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_cancer IARC group 3 unitless - - - WOE; IARC Carcinogenicity sheet=Data; excel_row=6967; Record_ID=cancer_7072; Data_Type=WOE; Formulation_Name=4-Aminobenzoic acid; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/34; http://publications.iarc.fr/139; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_endocrine 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_endocrine Model Score 0 unitless - - - ARPathway2016; AR Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=3608; RecordID=ARPathway2016_879; DatasetName=ARPathway2016; DTXSID=DTXSID6024466; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization 33 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_skin_sensitization CD86, EC150 >200 ug/mL - Dermal - In Vitro; CE_USENSE2018; U-SENS sheet=Data_invitro; excel_row=8646; Record_ID=skin_sensitization_invitro_2392; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=U-SENS; Endpoint=CD86, EC150; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=200; Reported_Response_Unit=ug/mL; Response=200; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization CV75 >1000 ug/mL - Dermal - In Vitro; CE_hCLAT2018; h-CLAT sheet=Data_invitro; excel_row=2290; Record_ID=skin_sensitization_invitro_561; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=h-CLAT; Endpoint=CV75; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=1000; Reported_Response_Unit=ug/mL; Response=1000; Response_Unit=ug/mL; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Cys 1 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5594; Record_ID=skin_sensitization_invitro_1312; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=1; Reported_Response_Unit=%; Response=1; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Cys 1.4 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5552; Record_ID=skin_sensitization_invitro_1302; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=1.4; Reported_Response_Unit=%; Response=1.4; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Cys 3.9 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5529; Record_ID=skin_sensitization_invitro_1296; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=3.9; Reported_Response_Unit=%; Response=3.9; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Cys 4.6 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5543; Record_ID=skin_sensitization_invitro_1300; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=4.5999999999999996; Reported_Response_Unit=%; Response=4.6; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Cys 5.9 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5515; Record_ID=skin_sensitization_invitro_1294; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=5.9; Reported_Response_Unit=%; Response=5.9; Response_Unit=%; Reference=Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Cys 10.6 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5535; Record_ID=skin_sensitization_invitro_1298; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=10.6; Reported_Response_Unit=%; Response=10.6; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Cys 10.7 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5525; Record_ID=skin_sensitization_invitro_1295; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=10.7; Reported_Response_Unit=%; Response=10.7; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys 0 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5558; Record_ID=skin_sensitization_invitro_1304; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0; Reported_Response_Unit=%; Response=0; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys 0.1 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5541; Record_ID=skin_sensitization_invitro_1300; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0.1; Reported_Response_Unit=%; Response=0.1; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys 0.4 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5522; Record_ID=skin_sensitization_invitro_1295; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0.4; Reported_Response_Unit=%; Response=0.4; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys 0.5 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5513; Record_ID=skin_sensitization_invitro_1294; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0.5; Reported_Response_Unit=%; Response=0.5; Response_Unit=%; Reference=Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys 0.6 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5533; Record_ID=skin_sensitization_invitro_1298; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0.6; Reported_Response_Unit=%; Response=0.6; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys 0.7 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5550; Record_ID=skin_sensitization_invitro_1302; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0.7; Reported_Response_Unit=%; Response=0.7; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys 0.9 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5528; Record_ID=skin_sensitization_invitro_1296; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0.9; Reported_Response_Unit=%; Response=0.9; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys + Cys 0.35 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5588; Record_ID=skin_sensitization_invitro_1310; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=0.35; Reported_Response_Unit=%; Response=0.35; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys + Cys 0.45 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5562; Record_ID=skin_sensitization_invitro_1304; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=0.45; Reported_Response_Unit=%; Response=0.45; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys + Cys 1.05 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5554; Record_ID=skin_sensitization_invitro_1302; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=1.05; Reported_Response_Unit=%; Response=1.05; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys + Cys 2.3 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5570; Record_ID=skin_sensitization_invitro_1306; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=2.2999999999999998; Reported_Response_Unit=%; Response=2.3; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys + Cys 2.35 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5546; Record_ID=skin_sensitization_invitro_1300; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=2.35; Reported_Response_Unit=%; Response=2.35; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys + Cys 2.4 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5530; Record_ID=skin_sensitization_invitro_1296; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=2.4; Reported_Response_Unit=%; Response=2.4; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys + Cys 3.2 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5518; Record_ID=skin_sensitization_invitro_1294; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=3.2; Reported_Response_Unit=%; Response=3.2; Response_Unit=%; Reference=Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys + Cys 5.55 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5526; Record_ID=skin_sensitization_invitro_1295; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=5.55; Reported_Response_Unit=%; Response=5.55; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Depletion Lys + Cys 5.6 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=5537; Record_ID=skin_sensitization_invitro_1298; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=5.6; Reported_Response_Unit=%; Response=5.6; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization EC1.5 >2000 uM - Dermal - In Vitro; CE_KeratinoSense2018; KeratinoSens sheet=Data_invitro; excel_row=5228; Record_ID=skin_sensitization_invitro_1221; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=KeratinoSens; Endpoint=EC1.5; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=2000; Reported_Response_Unit=uM; Response=2000; Response_Unit=uM; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Joint Research Centre of the European Union 2014|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization IC50 >2400 uM - Dermal - In Vitro; Urbisch_SkinSensitization2020; LuSens sheet=Data_invitro; excel_row=7642; Record_ID=skin_sensitization_invitro_1810; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=LuSens; Endpoint=IC50; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=2400; Reported_Response_Unit=uM; Response=2400; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Imax 1.107 ratio - Dermal - In Vitro; Urbisch_SkinSensitization2020; LuSens sheet=Data_invitro; excel_row=7544; Record_ID=skin_sensitization_invitro_1810; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=LuSens; Endpoint=Imax; Reported_Response=1.106609205; Reported_Response_Unit=Unitless; Response=1.107; Response_Unit=Ratio; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Imax 1.21 ratio - Dermal - In Vitro; CE_KeratinoSense2018; KeratinoSens sheet=Data_invitro; excel_row=5233; Record_ID=skin_sensitization_invitro_1221; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.21; Reported_Response_Unit=Unitless; Response=1.21; Response_Unit=Ratio; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Joint Research Centre of the European Union 2014|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Imax 1.23 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=5234; Record_ID=skin_sensitization_invitro_1222; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.23; Reported_Response_Unit=Unitless; Response=1.23; Response_Unit=Ratio; Reference=Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Incidence of positive responses 0 % Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=5607; Record_ID=skin_sensitization_invivo_1297; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=25.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Induction dose per skin area 15520 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=5605; Record_ID=skin_sensitization_invivo_1297; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=25.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=15520; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
NTP_ICE_skin_sensitization Relative reliability score 1 unitless Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=5610; Record_ID=skin_sensitization_invivo_1297; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=25.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6024466; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=1; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Basketter et al. 1994; 8045461; 10.1016/0278-6915(94)90112-0|Basketter et al. 1999; 10654593; 10.1016/S0278-6915(99)00112-x|Gerberick et al. 2000; 10684384; 10.1053/ajcd.2000.0003|Schneider and Akkan 2004; 15135206; 10.1016/j.yrtph.2004.02.002; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6024466; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6024466
SCCS_vision_codex 16 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS_vision_codex NOAEL =0.1 % rat oral 51-year NOAEL study {"citation":"Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0","dose":"1 mg x 32.0/0.320 = 100 mg/kg/d).","effect":"showed that PABA might accumulate in tissues and blood, but only to a relatively limited extent. Plasma aspartate aminotransferase activities in rats given 0.5% and 1% PABA were significantly lower (p<0.05) than that of control rats at week 2, but not at week 1 or 4. 1% PABA in the drinking water, significantly decreased t- butylhydroperoxide-induced lipid peroxidation in the liver (p<0.05) but not in the kidney. Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0.1% PABA in drinking water (According to Sprague Dawley – Ace Animals, Inc http://WWW.aceanimals.com) daily intake 10 – 12 ml/100 g bw/d. From the paper, the body weight at the end of the experiment was 320 g. This would correspond to a water intake of 10 x 3.2 = 32.0 ml, weight 320 g; 1 mg x 32.0/0.320 = 100 mg/kg/d). Humans A case report regarding a 51-year-old man admitted to the hospital with a seven-day history of progressive myalgias, generalized weakness and fever. The man had been trea","page":17,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_002"}
SCCS_vision_codex NOAEL =0.1 % rat oral 51-year NOAEL study {"citation":"Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0","dose":"1 mg x 32.0/0.320 = 100 mg/kg/d).","effect":"showed that PABA might accumulate in tissues and blood, but only to a relatively limited extent. Plasma aspartate aminotransferase activities in rats given 0.5% and 1% PABA were significantly lower (p<0.05) than that of control rats at week 2, but not at week 1 or 4. 1% PABA in the drinking water, significantly decreased t- butylhydroperoxide-induced lipid peroxidation in the liver (p<0.05) but not in the kidney. Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0.1% PABA in drinking water (According to Sprague Dawley – Ace Animals, Inc http://WWW.aceanimals.com) daily intake 10 – 12 ml/100 g bw/d. From the paper, the body weight at the end of the experiment was 320 g. This would correspond to a water intake of 10 x 3.2 = 32.0 ml, weight 320 g; 1 mg x 32.0/0.320 = 100 mg/kg/d). Humans A case report regarding a 51-year-old man admitted to the hospital with a seven-day history of progressive myalgias, generalized weakness and fever. The man had been trea","page":17,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_002"}
SCCS_vision_codex NOAEL =0.1 % rat oral 51-year NOAEL study {"citation":"Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0","dose":"1 mg x 32.0/0.320 = 100 mg/kg/d).","effect":"showed that PABA might accumulate in tissues and blood, but only to a relatively limited extent. Plasma aspartate aminotransferase activities in rats given 0.5% and 1% PABA were significantly lower (p<0.05) than that of control rats at week 2, but not at week 1 or 4. 1% PABA in the drinking water, significantly decreased t- butylhydroperoxide-induced lipid peroxidation in the liver (p<0.05) but not in the kidney. Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0.1% PABA in drinking water (According to Sprague Dawley – Ace Animals, Inc http://WWW.aceanimals.com) daily intake 10 – 12 ml/100 g bw/d. From the paper, the body weight at the end of the experiment was 320 g. This would correspond to a water intake of 10 x 3.2 = 32.0 ml, weight 320 g; 1 mg x 32.0/0.320 = 100 mg/kg/d). Humans A case report regarding a 51-year-old man admitted to the hospital with a seven-day history of progressive myalgias, generalized weakness and fever. The man had been trea","page":17,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_002"}
SCCS_vision_codex NOAEL =0.1 % rat oral 51-year NOAEL study {"citation":"Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0","dose":"1 mg x 32.0/0.320 = 100 mg/kg/d).","effect":"showed that PABA might accumulate in tissues and blood, but only to a relatively limited extent. Plasma aspartate aminotransferase activities in rats given 0.5% and 1% PABA were significantly lower (p<0.05) than that of control rats at week 2, but not at week 1 or 4. 1% PABA in the drinking water, significantly decreased t- butylhydroperoxide-induced lipid peroxidation in the liver (p<0.05) but not in the kidney. Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0.1% PABA in drinking water (According to Sprague Dawley – Ace Animals, Inc http://WWW.aceanimals.com) daily intake 10 – 12 ml/100 g bw/d. From the paper, the body weight at the end of the experiment was 320 g. This would correspond to a water intake of 10 x 3.2 = 32.0 ml, weight 320 g; 1 mg x 32.0/0.320 = 100 mg/kg/d). Humans A case report regarding a 51-year-old man admitted to the hospital with a seven-day history of progressive myalgias, generalized weakness and fever. The man had been trea","page":17,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_002"}
SCCS_vision_codex NOAEL =1 % rat oral 5 weeks NOAEL study {"citation":"Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals","dose":"SCCP/1008/06 Opinion on 4-Aminobenzoic acid (PABA) ____________________________________________________________________________________________ 17 Rats are resistant to oral administered PABA and tolerate 1.4 g/kg bw for about a month.","effect":"SCCP/1008/06 Opinion on 4-Aminobenzoic acid (PABA) ____________________________________________________________________________________________ 17 Rats are resistant to oral administered PABA and tolerate 1.4 g/kg bw for about a month. All rats survived and the gain in body weight for all 3 groups was the same. The autopsies on all of the animals were negative. NOAEL is larger than 1.4 g/kg body weight. Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals (sex not given) (5 weeks old at start of study, weight 150 g) Test substance: PABA as potassium salt (High grade, Sigma Chemical Co., St. Louis, MO, USA) Batch: / Purity: / Dose levels: 0, 0.1, 0.5, and 1% PABA in deionised water Route: Oral, in drinking water Exposure period: 4 week Experime","page":17,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_001"}
SCCS_vision_codex NOAEL =1 % rat oral 5 weeks NOAEL study {"citation":"Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals","dose":"SCCP/1008/06 Opinion on 4-Aminobenzoic acid (PABA) ____________________________________________________________________________________________ 17 Rats are resistant to oral administered PABA and tolerate 1.4 g/kg bw for about a month.","effect":"SCCP/1008/06 Opinion on 4-Aminobenzoic acid (PABA) ____________________________________________________________________________________________ 17 Rats are resistant to oral administered PABA and tolerate 1.4 g/kg bw for about a month. All rats survived and the gain in body weight for all 3 groups was the same. The autopsies on all of the animals were negative. NOAEL is larger than 1.4 g/kg body weight. Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals (sex not given) (5 weeks old at start of study, weight 150 g) Test substance: PABA as potassium salt (High grade, Sigma Chemical Co., St. Louis, MO, USA) Batch: / Purity: / Dose levels: 0, 0.1, 0.5, and 1% PABA in deionised water Route: Oral, in drinking water Exposure period: 4 week Experime","page":17,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_001"}
SCCS_vision_codex NOAEL =1 % rat oral 5 weeks NOAEL study {"citation":"Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals","dose":"SCCP/1008/06 Opinion on 4-Aminobenzoic acid (PABA) ____________________________________________________________________________________________ 17 Rats are resistant to oral administered PABA and tolerate 1.4 g/kg bw for about a month.","effect":"SCCP/1008/06 Opinion on 4-Aminobenzoic acid (PABA) ____________________________________________________________________________________________ 17 Rats are resistant to oral administered PABA and tolerate 1.4 g/kg bw for about a month. All rats survived and the gain in body weight for all 3 groups was the same. The autopsies on all of the animals were negative. NOAEL is larger than 1.4 g/kg body weight. Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals (sex not given) (5 weeks old at start of study, weight 150 g) Test substance: PABA as potassium salt (High grade, Sigma Chemical Co., St. Louis, MO, USA) Batch: / Purity: / Dose levels: 0, 0.1, 0.5, and 1% PABA in deionised water Route: Oral, in drinking water Exposure period: 4 week Experime","page":17,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_001"}
SCCS_vision_codex NOAEL =1 % rat oral 5 weeks NOAEL study {"citation":"Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals","dose":"SCCP/1008/06 Opinion on 4-Aminobenzoic acid (PABA) ____________________________________________________________________________________________ 17 Rats are resistant to oral administered PABA and tolerate 1.4 g/kg bw for about a month.","effect":"SCCP/1008/06 Opinion on 4-Aminobenzoic acid (PABA) ____________________________________________________________________________________________ 17 Rats are resistant to oral administered PABA and tolerate 1.4 g/kg bw for about a month. All rats survived and the gain in body weight for all 3 groups was the same. The autopsies on all of the animals were negative. NOAEL is larger than 1.4 g/kg body weight. Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals (sex not given) (5 weeks old at start of study, weight 150 g) Test substance: PABA as potassium salt (High grade, Sigma Chemical Co., St. Louis, MO, USA) Batch: / Purity: / Dose levels: 0, 0.1, 0.5, and 1% PABA in deionised water Route: Oral, in drinking water Exposure period: 4 week Experime","page":17,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_001"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral 2 weeks repeated dose toxicity {"dose":"Only few studies have investigated the repeated dose toxicity of PABA, a NOEL based on the transient effect on plasma aspartate aminotransferase activities after 2 weeks was 100 mg/kg bw/d.","effect":"g or preventing the radiation from reaching the vulnerable, living skin tissue. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The safety has only been considered for dermal exposure PABA has low acute oral toxicity, more than 2 g/kg bw in rodents. Applications of 5% PABA in sunscreen formulation on human skin have shown that irritation is negligible. Only few studies have investigated the repeated dose toxicity of PABA, a NOEL based on the transient effect on plasma aspartate aminotransferase activities after 2 weeks was 100 mg/kg bw/d. In two patients who were administered PABA orally for about four weeks (12 g/day) signs of hepatic injury were observed (LOAEL = 200 mg/kg bw/d). PABA did not induce mutations in bacteria, but induced an increased incidence of chromosome damage to CHO cells. PABA did not induce tumours in a skin painting study with Swiss mice. PABA has been tested for reproductive toxicity in rats and Drosophila melan","page":47,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral 2 weeks repeated dose toxicity {"dose":"Only few studies have investigated the repeated dose toxicity of PABA, a NOEL based on the transient effect on plasma aspartate aminotransferase activities after 2 weeks was 100 mg/kg bw/d.","effect":"g or preventing the radiation from reaching the vulnerable, living skin tissue. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The safety has only been considered for dermal exposure PABA has low acute oral toxicity, more than 2 g/kg bw in rodents. Applications of 5% PABA in sunscreen formulation on human skin have shown that irritation is negligible. Only few studies have investigated the repeated dose toxicity of PABA, a NOEL based on the transient effect on plasma aspartate aminotransferase activities after 2 weeks was 100 mg/kg bw/d. In two patients who were administered PABA orally for about four weeks (12 g/day) signs of hepatic injury were observed (LOAEL = 200 mg/kg bw/d). PABA did not induce mutations in bacteria, but induced an increased incidence of chromosome damage to CHO cells. PABA did not induce tumours in a skin painting study with Swiss mice. PABA has been tested for reproductive toxicity in rats and Drosophila melan","page":47,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral 2 weeks repeated dose toxicity {"dose":"Only few studies have investigated the repeated dose toxicity of PABA, a NOEL based on the transient effect on plasma aspartate aminotransferase activities after 2 weeks was 100 mg/kg bw/d.","effect":"g or preventing the radiation from reaching the vulnerable, living skin tissue. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The safety has only been considered for dermal exposure PABA has low acute oral toxicity, more than 2 g/kg bw in rodents. Applications of 5% PABA in sunscreen formulation on human skin have shown that irritation is negligible. Only few studies have investigated the repeated dose toxicity of PABA, a NOEL based on the transient effect on plasma aspartate aminotransferase activities after 2 weeks was 100 mg/kg bw/d. In two patients who were administered PABA orally for about four weeks (12 g/day) signs of hepatic injury were observed (LOAEL = 200 mg/kg bw/d). PABA did not induce mutations in bacteria, but induced an increased incidence of chromosome damage to CHO cells. PABA did not induce tumours in a skin painting study with Swiss mice. PABA has been tested for reproductive toxicity in rats and Drosophila melan","page":47,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_005"}
SCCS_vision_codex NOAEL =100 mg/kg bw/d rat oral 2 weeks repeated dose toxicity {"dose":"Only few studies have investigated the repeated dose toxicity of PABA, a NOEL based on the transient effect on plasma aspartate aminotransferase activities after 2 weeks was 100 mg/kg bw/d.","effect":"g or preventing the radiation from reaching the vulnerable, living skin tissue. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The safety has only been considered for dermal exposure PABA has low acute oral toxicity, more than 2 g/kg bw in rodents. Applications of 5% PABA in sunscreen formulation on human skin have shown that irritation is negligible. Only few studies have investigated the repeated dose toxicity of PABA, a NOEL based on the transient effect on plasma aspartate aminotransferase activities after 2 weeks was 100 mg/kg bw/d. In two patients who were administered PABA orally for about four weeks (12 g/day) signs of hepatic injury were observed (LOAEL = 200 mg/kg bw/d). PABA did not induce mutations in bacteria, but induced an increased incidence of chromosome damage to CHO cells. PABA did not induce tumours in a skin painting study with Swiss mice. PABA has been tested for reproductive toxicity in rats and Drosophila melan","page":47,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_005"}
SCCS_vision_codex NOAEL =108 - - oral 108 days NOAEL study {"citation":"Ref.: 29","dose":"No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA.","effect":"ography. Porphyrins were separated by thinlayer chromatography. Neither a simultaneous HCB-PABA (Prophylactic administration) nor PABA application after manifestation of the HCB-porphyria (therapeutic administration) influenced significantly the excretion of urinary porphyrins or precursors. In conclusion, PABA has not shown any effects on the excretion of urinary porphyrins or precursors. No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA. Ref.: 29","page":18,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_003"}
SCCS_vision_codex NOAEL =108 - - oral 108 days NOAEL study {"citation":"Ref.: 29","dose":"No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA.","effect":"ography. Porphyrins were separated by thinlayer chromatography. Neither a simultaneous HCB-PABA (Prophylactic administration) nor PABA application after manifestation of the HCB-porphyria (therapeutic administration) influenced significantly the excretion of urinary porphyrins or precursors. In conclusion, PABA has not shown any effects on the excretion of urinary porphyrins or precursors. No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA. Ref.: 29","page":18,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_003"}
SCCS_vision_codex NOAEL =108 - - oral 108 days NOAEL study {"citation":"Ref.: 29","dose":"No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA.","effect":"ography. Porphyrins were separated by thinlayer chromatography. Neither a simultaneous HCB-PABA (Prophylactic administration) nor PABA application after manifestation of the HCB-porphyria (therapeutic administration) influenced significantly the excretion of urinary porphyrins or precursors. In conclusion, PABA has not shown any effects on the excretion of urinary porphyrins or precursors. No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA. Ref.: 29","page":18,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_003"}
SCCS_vision_codex NOAEL =108 - - oral 108 days NOAEL study {"citation":"Ref.: 29","dose":"No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA.","effect":"ography. Porphyrins were separated by thinlayer chromatography. Neither a simultaneous HCB-PABA (Prophylactic administration) nor PABA application after manifestation of the HCB-porphyria (therapeutic administration) influenced significantly the excretion of urinary porphyrins or precursors. In conclusion, PABA has not shown any effects on the excretion of urinary porphyrins or precursors. No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA. Ref.: 29","page":18,"pdf":"sccp_o_058.pdf","row_type":"noael_study","study_id":"sccp_o_058_noael_003"}
ToxValDB_ECHA_IUCLID 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL >=1200 mg/kg bw/day Rat oral chronic; 108 days chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead7de4b0a7c65d1c470c; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/7095/7/6/2?documentUUID=2ff1de7d-7a75-41c5-89d9-7e3a25652645; YEAR=2016; ORIGINAL_YEAR=2016; STUDY_GROUP=ECHA IUCLID:15839933: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_5e3ce39d9a151e738e14a6ee5f2eeb6b
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =10.58 mg/m3 Human inhalation - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15629717:-:--; 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_81b47b85fefc7ed055987bd887f58c47
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 0.1 % rat oral 51-year - SOURCE_SUBDIR=sccp_o_058; REPORT_TITLE=Opinion on 4-Aminobenzoic acid (PABA) COLIPA n° S1; OPINION_NUMBER=SCCP/1008/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=0.1; DOSE=1 mg x 32.0/0.320 = 100 mg/kg/d).; EFFECT=showed that PABA might accumulate in tissues and blood, but only to a relatively limited extent. Plasma aspartate aminotransferase activities in rats given 0.5% and 1% PABA were significantly lower (p<0.05) than that of control rats at week 2, but not at week 1 or 4. 1% PABA in the drinking water, significantly decreased t- butylhydroperoxide-induced lipid peroxidation in the liver (p<0.05) but not in the kidney. Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0.1% PABA in drinking water (According to Sprague Dawley – Ace Animals, Inc http://WWW.aceanimals.com) daily intake 10 – 12 ml/100 g bw/d. From the paper, the body weight at the end of the experiment was 320 g. This would correspond to a water intake of 10 x 3.2 = 32.0 ml, weight 320 g; 1 mg x 32.0/0.320 = 100 mg/kg/d). Humans A case report regarding a 51-year-old man admitted to the hospital with a seven-day history of progressive myalgias, generalized weakness and fever. The man had been trea; CITATION=Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0; CITATION_NUMBERS=[26]; REFERENCE=Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0; DETAILS_JSON={"cas_number":"150-13-0","citation":"Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0","dose":"1 mg x 32.0/0.320 = 100 mg/kg/d).","duration":"51-year","effect":"showed that PABA might accumulate in tissues and blood, but only to a relatively limited extent. Plasma aspartate aminotransferase activities in rats given 0.5% and 1% PABA were significantly lower (p<0.05) than that of control rats at week 2, but not at week 1 or 4. 1% PABA in the drinking water, significantly decreased t- butylhydroperoxide-induced lipid peroxidation in the liver (p<0.05) but not in the kidney. Ref.: 26 Comment Based on the effect on the effect on plasma aspartate aminotransferase activities, a NOEL could be equal to 0.1% PABA in drinking water (According to Sprague Dawley – Ace Animals, Inc http://WWW.aceanimals.com) daily intake 10 – 12 ml/100 g bw/d. From the paper, the body weight at the end of the experiment was 320 g. This would correspond to a water intake of 10 x 3.2 = 32.0 ml, weight 320 g; 1 mg x 32.0/0.320 = 100 mg/kg/d). Humans A case report regarding a 51-year-old man admitted to the hospital with a seven-day history of progressive myalgias, generalized weakness and fever. The man had been trea","endpoint":"","ingredient":"Primary name","loael_value":"","noael_unit":"%","noael_value":"0.1","page":17,"route":"oral","species":"rat","study_id":"sccp_o_058_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 1 % rat oral 5 weeks - SOURCE_SUBDIR=sccp_o_058; REPORT_TITLE=Opinion on 4-Aminobenzoic acid (PABA) COLIPA n° S1; OPINION_NUMBER=SCCP/1008/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=1; DOSE=SCCP/1008/06 Opinion on 4-Aminobenzoic acid (PABA) ____________________________________________________________________________________________ 17 Rats are resistant to oral administered PABA and tolerate 1.4 g/kg bw for about a month.; EFFECT=SCCP/1008/06 Opinion on 4-Aminobenzoic acid (PABA) ____________________________________________________________________________________________ 17 Rats are resistant to oral administered PABA and tolerate 1.4 g/kg bw for about a month. All rats survived and the gain in body weight for all 3 groups was the same. The autopsies on all of the animals were negative. NOAEL is larger than 1.4 g/kg body weight. Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals (sex not given) (5 weeks old at start of study, weight 150 g) Test substance: PABA as potassium salt (High grade, Sigma Chemical Co., St. Louis, MO, USA) Batch: / Purity: / Dose levels: 0, 0.1, 0.5, and 1% PABA in deionised water Route: Oral, in drinking water Exposure period: 4 week Experime; CITATION=Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals; CITATION_NUMBERS=[13,12]; REFERENCE=Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals; DETAILS_JSON={"cas_number":"150-13-0","citation":"Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals","dose":"SCCP/1008/06 Opinion on 4-Aminobenzoic acid (PABA) ____________________________________________________________________________________________ 17 Rats are resistant to oral administered PABA and tolerate 1.4 g/kg bw for about a month.","duration":"5 weeks","effect":"SCCP/1008/06 Opinion on 4-Aminobenzoic acid (PABA) ____________________________________________________________________________________________ 17 Rats are resistant to oral administered PABA and tolerate 1.4 g/kg bw for about a month. All rats survived and the gain in body weight for all 3 groups was the same. The autopsies on all of the animals were negative. NOAEL is larger than 1.4 g/kg body weight. Ref.: 13 Determination of accumulation of PABA in blood, liver, and kidney and the overt toxicity of PABA in rats Guideline: / Species/strain: Sprague-Dawley rats Group size: 12 animals (sex not given) (5 weeks old at start of study, weight 150 g) Test substance: PABA as potassium salt (High grade, Sigma Chemical Co., St. Louis, MO, USA) Batch: / Purity: / Dose levels: 0, 0.1, 0.5, and 1% PABA in deionised water Route: Oral, in drinking water Exposure period: 4 week Experime","endpoint":"","ingredient":"Primary name","loael_value":"","noael_unit":"%","noael_value":"1","page":17,"route":"oral","species":"rat","study_id":"sccp_o_058_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 108 - - oral 108 days - SOURCE_SUBDIR=sccp_o_058; REPORT_TITLE=Opinion on 4-Aminobenzoic acid (PABA) COLIPA n° S1; OPINION_NUMBER=SCCP/1008/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=unclear:ography. Porphyrins were separated by thinlayer chromatography. Neither a simultaneous HCB-PABA (Prophylactic administration) nor PABA application after manifestation of the HCB-porphyria (therapeutic administration) influenced significantly the excretion of urinary porphyrins or precursors. In conclusion, PABA has not shown any effects on the excretion of urinary porphyrins or precursors. No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA. Ref.: 29; DOSE=No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA.; EFFECT=ography. Porphyrins were separated by thinlayer chromatography. Neither a simultaneous HCB-PABA (Prophylactic administration) nor PABA application after manifestation of the HCB-porphyria (therapeutic administration) influenced significantly the excretion of urinary porphyrins or precursors. In conclusion, PABA has not shown any effects on the excretion of urinary porphyrins or precursors. No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA. Ref.: 29; CITATION=Ref.: 29; CITATION_NUMBERS=[29]; REFERENCE=Ref.: 29; DETAILS_JSON={"cas_number":"150-13-0","citation":"Ref.: 29","dose":"No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA.","duration":"108 days","effect":"ography. Porphyrins were separated by thinlayer chromatography. Neither a simultaneous HCB-PABA (Prophylactic administration) nor PABA application after manifestation of the HCB-porphyria (therapeutic administration) influenced significantly the excretion of urinary porphyrins or precursors. In conclusion, PABA has not shown any effects on the excretion of urinary porphyrins or precursors. No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA. Ref.: 29","endpoint":"","ingredient":"Primary name","loael_value":"","noael_unit":"","noael_value":"unclear:ography. Porphyrins were separated by thinlayer chromatography. Neither a simultaneous HCB-PABA (Prophylactic administration) nor PABA application after manifestation of the HCB-porphyria (therapeutic administration) influenced significantly the excretion of urinary porphyrins or precursors. In conclusion, PABA has not shown any effects on the excretion of urinary porphyrins or precursors. No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA. Ref.: 29","page":18,"route":"oral","species":"","study_id":"sccp_o_058_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies - 108 - - oral 108 days - SOURCE_SUBDIR=sccp_o_058; REPORT_TITLE=Opinion on 4-Aminobenzoic acid (PABA) COLIPA n° S1; OPINION_NUMBER=SCCP/1008/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=unclear:Porphyrins were separated by thinlayer chromatography. Neither a simultaneous HCB-PABA (Prophylactic administration) nor PABA application after manifestation of the HCB-porphyria (therapeutic administration) influenced significantly the excretion of urinary porphyrins or precursors. In conclusion, PABA has not shown any effects on the excretion of urinary porphyrins or precursors. No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA. Ref.: 29; DOSE=No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA.; EFFECT=Porphyrins were separated by thinlayer chromatography. Neither a simultaneous HCB-PABA (Prophylactic administration) nor PABA application after manifestation of the HCB-porphyria (therapeutic administration) influenced significantly the excretion of urinary porphyrins or precursors. In conclusion, PABA has not shown any effects on the excretion of urinary porphyrins or precursors. No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA. Ref.: 29; CITATION=Ref.: 29; CITATION_NUMBERS=[29]; REFERENCE=Ref.: 29; DETAILS_JSON={"cas_number":"150-13-0","citation":"Ref.: 29","dose":"No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA.","duration":"108 days","effect":"Porphyrins were separated by thinlayer chromatography. Neither a simultaneous HCB-PABA (Prophylactic administration) nor PABA application after manifestation of the HCB-porphyria (therapeutic administration) influenced significantly the excretion of urinary porphyrins or precursors. In conclusion, PABA has not shown any effects on the excretion of urinary porphyrins or precursors. No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA. Ref.: 29","endpoint":"","ingredient":"Primary name","loael_value":"","noael_unit":"","noael_value":"unclear:Porphyrins were separated by thinlayer chromatography. Neither a simultaneous HCB-PABA (Prophylactic administration) nor PABA application after manifestation of the HCB-porphyria (therapeutic administration) influenced significantly the excretion of urinary porphyrins or precursors. In conclusion, PABA has not shown any effects on the excretion of urinary porphyrins or precursors. No toxic sign were described after 108 days of oral administration of 1.2 g/kg bw of PABA, administered as potassium salt, and NOEL or NOAEL could be stated as equal or larger than 1.2 g/kg bw of PABA. Ref.: 29","page":18,"route":"oral","species":"","study_id":"sccp_o_058_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies repeated dose toxicity 100 mg/kg bw/d rat oral 2 weeks repeated dose toxicity SOURCE_SUBDIR=sccp_o_058; REPORT_TITLE=Opinion on 4-Aminobenzoic acid (PABA) COLIPA n° S1; OPINION_NUMBER=SCCP/1008/06; COMMITTEE=SCCP; REPORT_DATE=20 June 2006; VALUE_TEXT=100; DOSE=Only few studies have investigated the repeated dose toxicity of PABA, a NOEL based on the transient effect on plasma aspartate aminotransferase activities after 2 weeks was 100 mg/kg bw/d.; LOAEL_VALUE=200 mg/kg bw/d; EFFECT=g or preventing the radiation from reaching the vulnerable, living skin tissue. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The safety has only been considered for dermal exposure PABA has low acute oral toxicity, more than 2 g/kg bw in rodents. Applications of 5% PABA in sunscreen formulation on human skin have shown that irritation is negligible. Only few studies have investigated the repeated dose toxicity of PABA, a NOEL based on the transient effect on plasma aspartate aminotransferase activities after 2 weeks was 100 mg/kg bw/d. In two patients who were administered PABA orally for about four weeks (12 g/day) signs of hepatic injury were observed (LOAEL = 200 mg/kg bw/d). PABA did not induce mutations in bacteria, but induced an increased incidence of chromosome damage to CHO cells. PABA did not induce tumours in a skin painting study with Swiss mice. PABA has been tested for reproductive toxicity in rats and Drosophila melan; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"150-13-0","citation":"","dose":"Only few studies have investigated the repeated dose toxicity of PABA, a NOEL based on the transient effect on plasma aspartate aminotransferase activities after 2 weeks was 100 mg/kg bw/d.","duration":"2 weeks","effect":"g or preventing the radiation from reaching the vulnerable, living skin tissue. 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Not applicable 3.3.14. Discussion The safety has only been considered for dermal exposure PABA has low acute oral toxicity, more than 2 g/kg bw in rodents. Applications of 5% PABA in sunscreen formulation on human skin have shown that irritation is negligible. Only few studies have investigated the repeated dose toxicity of PABA, a NOEL based on the transient effect on plasma aspartate aminotransferase activities after 2 weeks was 100 mg/kg bw/d. In two patients who were administered PABA orally for about four weeks (12 g/day) signs of hepatic injury were observed (LOAEL = 200 mg/kg bw/d). PABA did not induce mutations in bacteria, but induced an increased incidence of chromosome damage to CHO cells. PABA did not induce tumours in a skin painting study with Swiss mice. PABA has been tested for reproductive toxicity in rats and Drosophila melan","endpoint":"repeated dose toxicity","ingredient":"Primary name","loael_value":"200 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"100","page":47,"route":"oral","species":"rat","study_id":"sccp_o_058_noael_005"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier TL2TJE8QTX UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H7NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"TL2TJE8QTX"}
openFDA substances FDA UNII substance identifier TL2TJE8QTX UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H7NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"TL2TJE8QTX"}
openFDA substances FDA UNII substance identifier TL2TJE8QTX UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H7NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"TL2TJE8QTX"}
openFDA substances FDA UNII substance identifier TL2TJE8QTX UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H7NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"TL2TJE8QTX"}