NOAEL Studies
Active Ingredient
Salicylic Acid NOAEL Studies
INCI: SALICYLIC ACID
CAS: 69-72-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 75 | mg/kg bw/day | rat | oral | 8-14 Gestation day | Developmental | SCCNFP; Tanaka S. et a. Studies on teratogenic effects of salicylic acid and aspirin in rats as related to fetal distribution.Congenital Abnormalities. 1973, 13: 73-84. |
NTP_ICE_acute_inhalation 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | LC50 | >0.9 | mg/L | - | Inhalation | Duration=1 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=3993; Record_ID=acute_inhalation_3008; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=0.9; Response_Unit=mg/L; Reference=ChemIDplus; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID7026368 |
NTP_ICE_adme_parameters 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_adme_parameters | Fu | 0.4 | fraction | Rat | - | - | Measured; httk, Rat Plasma Fraction Unbound | sheet=Data; excel_row=2889; Record_ID=adme_parameters_2112; Data_Type=Measured; DTXSID=DTXSID7026368; Assay=httk, Rat Plasma Fraction Unbound; Endpoint=Fu; Response=0.4; Response_Unit=Unitless Fraction; Species=Rat; Reference=httk2.3.1, Pearce 2017; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID7026368 |
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=14180; RecordID=ARPathway2016_1499; DatasetName=ARPathway2016; DTXSID=DTXSID7026368; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
NTP_ICE_skin_sensitization 52 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | CD54, EC200 | 608.88 | ug/mL | - | Dermal | - | In Vitro; CE_hCLAT2018; h-CLAT | sheet=Data_invitro; excel_row=2152; Record_ID=skin_sensitization_invitro_532; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=h-CLAT; Endpoint=CD54, EC200; Reported_Response=608.88; Reported_Response_Unit=ug/mL; Response=608.88; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | CD54, EC200 | 715.6 | ug/mL | - | Dermal | - | In Vitro; hCLAT2015; h-CLAT | sheet=Data_invitro; excel_row=3238; Record_ID=skin_sensitization_invitro_751; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=h-CLAT; Endpoint=CD54, EC200; Reported_Response=715.6; Reported_Response_Unit=ug/mL; Response=715.6; Response_Unit=ug/mL; Reference=Sakaguchi et al. 2010; 20510347; 10.1016/j.tiv.2010.05.012|h-CLAT RingTrial EC values for NICEATM (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | CD54, EC200 | 9 | ug/mL | - | Dermal | - | In Vitro; hCLAT2015; h-CLAT | sheet=Data_invitro; excel_row=3240; Record_ID=skin_sensitization_invitro_749; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=h-CLAT; Endpoint=CD54, EC200; Reported_Response=9; Reported_Response_Unit=ug/mL; Response=9; Response_Unit=ug/mL; Reference=Sakaguchi et al. 2010; 20510347; 10.1016/j.tiv.2010.05.012|h-CLAT RingTrial EC values for NICEATM (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | CD54, EC200 | 394.4 | ug/mL | - | Dermal | - | In Vitro; hCLAT2015; h-CLAT | sheet=Data_invitro; excel_row=3244; Record_ID=skin_sensitization_invitro_753; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=h-CLAT; Endpoint=CD54, EC200; Reported_Response=394.4; Reported_Response_Unit=ug/mL; Response=394.4; Response_Unit=ug/mL; Reference=Sakaguchi et al. 2010; 20510347; 10.1016/j.tiv.2010.05.012|h-CLAT RingTrial EC values for NICEATM (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | CD54, EC200 | 608.9 | ug/mL | - | Dermal | - | In Vitro; hCLAT2015; h-CLAT | sheet=Data_invitro; excel_row=3253; Record_ID=skin_sensitization_invitro_755; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=h-CLAT; Endpoint=CD54, EC200; Reported_Response=608.9; Reported_Response_Unit=ug/mL; Response=608.9; Response_Unit=ug/mL; Reference=Sakaguchi et al. 2010; 20510347; 10.1016/j.tiv.2010.05.012|h-CLAT RingTrial EC values for NICEATM (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | CD86, EC150 | >966.854 | ug/mL | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; U-SENS | sheet=Data_invitro; excel_row=8191; Record_ID=skin_sensitization_invitro_2214; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=U-SENS; Endpoint=CD86, EC150; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=7000; Reported_Response_Unit=uM; Conversion_Factor_Value=138.122; Conversion_Factor_Source=EPA Dashboard; Converted_Response_Modifier=>; Converted_Response=966.854; Converted_Response_Unit=ug/mL; Response=966.854; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | CD86, EC150 | >200 | ug/mL | - | Dermal | - | In Vitro; CE_USENSE2018; U-SENS | sheet=Data_invitro; excel_row=8483; Record_ID=skin_sensitization_invitro_2332; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID7026368; 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/DTXSID7026368 |
| NTP_ICE_skin_sensitization | CV75 | >1000 | ug/mL | - | Dermal | - | In Vitro; CE_hCLAT2018; h-CLAT | sheet=Data_invitro; excel_row=2154; Record_ID=skin_sensitization_invitro_532; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=h-CLAT; Endpoint=CV75; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=1000; Reported_Response_Unit=ug/mL; Response=1000; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | CV75 | 974 | ug/mL | - | Dermal | - | In Vitro; hCLAT2015; h-CLAT | sheet=Data_invitro; excel_row=3217; Record_ID=skin_sensitization_invitro_746; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=h-CLAT; Endpoint=CV75; Reported_Response=974; Reported_Response_Unit=ug/mL; Response=974; Response_Unit=ug/mL; Reference=Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Depletion Cys | 8.7 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1100; Record_ID=skin_sensitization_invitro_299; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=8.6999999999999993; Reported_Response_Unit=%; Response=8.7; Response_Unit=%; Reference=Bauch et al. 2011; 21669280; 10.1016/j.tiv.2011.05.030|Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Depletion Cys | 3.5 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1108; Record_ID=skin_sensitization_invitro_301; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=3.5; Reported_Response_Unit=%; Response=3.5; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Depletion Cys | 5.2 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1113; Record_ID=skin_sensitization_invitro_302; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=5.2; Reported_Response_Unit=%; Response=5.2; Response_Unit=%; Reference=Jaworska 2011; 23670904; 10.1002/jat.2869; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Depletion Lys | 1 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1098; Record_ID=skin_sensitization_invitro_299; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=1; Reported_Response_Unit=%; Response=1; Response_Unit=%; Reference=Bauch et al. 2011; 21669280; 10.1016/j.tiv.2011.05.030|Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Depletion Lys | 0.1 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1112; Record_ID=skin_sensitization_invitro_302; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0.1; Reported_Response_Unit=%; Response=0.1; Response_Unit=%; Reference=Jaworska 2011; 23670904; 10.1002/jat.2869; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Depletion Lys | 21.1 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1118; Record_ID=skin_sensitization_invitro_304; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=21.1; Reported_Response_Unit=%; Response=21.1; Response_Unit=%; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 4.85 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1102; Record_ID=skin_sensitization_invitro_299; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=4.8499999999999996; Reported_Response_Unit=%; Response=4.85; Response_Unit=%; Reference=Bauch et al. 2011; 21669280; 10.1016/j.tiv.2011.05.030|Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 2.65 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1114; Record_ID=skin_sensitization_invitro_302; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=2.65; Reported_Response_Unit=%; Response=2.65; Response_Unit=%; Reference=Jaworska 2011; 23670904; 10.1002/jat.2869; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 12.3 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1122; Record_ID=skin_sensitization_invitro_304; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=12.3; Reported_Response_Unit=%; Response=12.3; Response_Unit=%; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | EC1.5 | >2000 | uM | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6540; Record_ID=skin_sensitization_invitro_1547; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=EC1.5; Response_Modifier=>; Reported_Response=No induction; Reported_Response_Unit=Unitless; Conversion_Factor=Text to numeric; Conversion_Factor_Value=No induction assumed >2000 uM; Conversion_Factor_Source=Manually calculated; Converted_Response_Modifier=>; Converted_Response=2000; Converted_Response_Unit=uM; Response=2000; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | EC3 | >2000 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=6567; Record_ID=skin_sensitization_invitro_1550; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=EC3; 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; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | EC3 | 12.2 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13608; Record_ID=skin_sensitization_invivo_3840; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=LLNA; Endpoint=EC3; Response=12.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 1992; 1459374; 10.1016/0272-0590(92)90183-i; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | EC3 | 12.2 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13608; Record_ID=skin_sensitization_invivo_3840; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=LLNA; Endpoint=EC3; Response=12.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 1992; 1459374; 10.1016/0272-0590(92)90183-i; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | EC3 | 12.2 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13608; Record_ID=skin_sensitization_invivo_3840; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=LLNA; Endpoint=EC3; Response=12.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 1992; 1459374; 10.1016/0272-0590(92)90183-i; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | EC3 | 12.2 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13608; Record_ID=skin_sensitization_invivo_3840; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=LLNA; Endpoint=EC3; Response=12.2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 1992; 1459374; 10.1016/0272-0590(92)90183-i; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | IC50 | >3000 | uM | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; LuSens | sheet=Data_invitro; excel_row=7639; Record_ID=skin_sensitization_invitro_1807; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=LuSens; Endpoint=IC50; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=3000; Reported_Response_Unit=uM; Response=3000; 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/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.034 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6612; Record_ID=skin_sensitization_invitro_1559; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.034; Reported_Response_Unit=Unitless; Response=1.034; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.1 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6614; Record_ID=skin_sensitization_invitro_1554; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.1000000000000001; Reported_Response_Unit=Unitless; Response=1.1; Response_Unit=Ratio; Reference=Emter et al. 2010; 20307559; 10.1016/j.taap.2010.03.009|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.107 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6616; Record_ID=skin_sensitization_invitro_1561; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.107; Reported_Response_Unit=Unitless; Response=1.107; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.109 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6617; Record_ID=skin_sensitization_invitro_1557; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.109; Reported_Response_Unit=Unitless; Response=1.109; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.117 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6618; Record_ID=skin_sensitization_invitro_1556; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.117; Reported_Response_Unit=Unitless; Response=1.117; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.21 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6619; Record_ID=skin_sensitization_invitro_1552; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.21; Reported_Response_Unit=Unitless; Response=1.21; Response_Unit=Ratio; Reference=Bauch et al. 2011; 21669280; 10.1016/j.tiv.2011.05.030|Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.125 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6620; Record_ID=skin_sensitization_invitro_1566; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.125; Reported_Response_Unit=Unitless; Response=1.125; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.25 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6621; Record_ID=skin_sensitization_invitro_1549; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.25; Reported_Response_Unit=Unitless; Response=1.25; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.13 | ratio | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=6622; Record_ID=skin_sensitization_invitro_1550; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.1299999999999999; Reported_Response_Unit=Unitless; Response=1.13; Response_Unit=Ratio; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.282 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6623; Record_ID=skin_sensitization_invitro_1551; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.282; Reported_Response_Unit=Unitless; Response=1.282; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.143 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6624; Record_ID=skin_sensitization_invitro_1558; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.143; Reported_Response_Unit=Unitless; Response=1.143; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.296 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6625; Record_ID=skin_sensitization_invitro_1568; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.296; Reported_Response_Unit=Unitless; Response=1.296; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.197 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6626; Record_ID=skin_sensitization_invitro_1562; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.1970000000000001; Reported_Response_Unit=Unitless; Response=1.197; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.297 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6627; Record_ID=skin_sensitization_invitro_1555; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.2969999999999999; Reported_Response_Unit=Unitless; Response=1.297; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.202 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6628; Record_ID=skin_sensitization_invitro_1547; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.202; Reported_Response_Unit=Unitless; Response=1.202; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.3 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6629; Record_ID=skin_sensitization_invitro_1565; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.3; Reported_Response_Unit=Unitless; Response=1.3; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.207 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6630; Record_ID=skin_sensitization_invitro_1553; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.2070000000000001; Reported_Response_Unit=Unitless; Response=1.207; Response_Unit=Ratio; Reference=Bauch et al. 2011; 21669280; 10.1016/j.tiv.2011.05.030|Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.4 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6633; Record_ID=skin_sensitization_invitro_1563; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.4; Reported_Response_Unit=Unitless; Response=1.4; Response_Unit=Ratio; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.408 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6634; Record_ID=skin_sensitization_invitro_1548; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.4079999999999999; Reported_Response_Unit=Unitless; Response=1.408; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.46 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6636; Record_ID=skin_sensitization_invitro_1570; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.46; Reported_Response_Unit=Unitless; Response=1.46; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.489 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6638; Record_ID=skin_sensitization_invitro_1560; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.4890000000000001; Reported_Response_Unit=Unitless; Response=1.489; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 1.49 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6640; Record_ID=skin_sensitization_invitro_1564; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.49; Reported_Response_Unit=Unitless; Response=1.49; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Imax | 0.8004 | ratio | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; LuSens | sheet=Data_invitro; excel_row=7541; Record_ID=skin_sensitization_invitro_1807; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=LuSens; Endpoint=Imax; Reported_Response=0.800440799; Reported_Response_Unit=Unitless; Response=0.8004; 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/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Incidence of positive responses | 0 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=9670; Record_ID=skin_sensitization_invivo_2146; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7026368; 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|Gad et al. (1986; 3715870; 10.1016/0041-008X(86)90419-9|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|ICCVAM 2009; Not available; https://ntp.niehs.nih.gov/iccvam/docs/immunotox_docs/llna-ps/llnaperfstds.pdf|Basketter et al. 2014; 24407057; 10.1097/der.0000000000000003; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Induction dose per skin area | 12410 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=9668; Record_ID=skin_sensitization_invivo_2146; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=12410; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Kligman 1966; 5924294; 10.1038/jid.1966.160|Gad et al. (1986; 3715870; 10.1016/0041-008X(86)90419-9|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|ICCVAM 2009; Not available; https://ntp.niehs.nih.gov/iccvam/docs/immunotox_docs/llna-ps/llnaperfstds.pdf|Basketter et al. 2014; 24407057; 10.1097/der.0000000000000003; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Max stimulation index | 2.5 | ratio | Mouse | Dermal | - | In Vivo; LLNA2013; LLNA | sheet=Data_invivo; excel_row=12865; Record_ID=skin_sensitization_invivo_490; Data_Type=In Vivo; Internal_Data_Source=LLNA2013; Mixture=Chemical; DTXSID=DTXSID7026368; Assay=LLNA; Endpoint=Max stimulation index; Response=2.5; Response_Unit=Ratio; Species=Mouse; Route=Dermal; Reference=ICCVAM 2009; Not available; https://ntp.niehs.nih.gov/iccvam/docs/immunotox_docs/llna-ps/llnaperfstds.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
| NTP_ICE_skin_sensitization | Relative reliability score | 1 | unitless | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=9674; Record_ID=skin_sensitization_invivo_2146; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7026368; 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|Gad et al. (1986; 3715870; 10.1016/0041-008X(86)90419-9|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|ICCVAM 2009; Not available; https://ntp.niehs.nih.gov/iccvam/docs/immunotox_docs/llna-ps/llnaperfstds.pdf|Basketter et al. 2014; 24407057; 10.1097/der.0000000000000003; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7026368 |
SCCNFP_vision_codex 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =80 | mg/kg/day | rat | oral | - | developmental toxicity | {"citation":"Ref. : 115 2","dose":"However, there was no evidence of systemic or maternal toxicity, and no adverse effects on offspring survival or growth in the mid-dose group (80 mg/kg/day) and in the low-dose group (20 mg/kg/day).","effect":"sumption. These signs were generally associated with prolonged parturition and difficulty in delivery. A significant increase in mean gestation length was noted with acetylsalicylic acid. Corresponding adverse effects on offspring survival for the affected dams were noted. However, there was no evidence of systemic or maternal toxicity, and no adverse effects on offspring survival or growth in the mid-dose group (80 mg/kg/day) and in the low-dose group (20 mg/kg/day). Under the experimental conditions adopted, the NOAEL (No-Observable-Adverse-Effect-Level) of sodium salicylate has been found to be 80 mg/kg/day when administered orally to mated rats corresponding approximately to 69 mg/kg/day of salicylic acid. Ref. : 115 2.6.1 Two-generation reproduction toxicity No data are available 2.6.2 Teratogenicity Numerous studies concerning fetotoxic and teratogenic potential of acetylsalicylic acid and salicylic acid have been performed in animals. When these compounds were administered by oral or by parenteral route at various time dur","page":18,"pdf":"out170_en.pdf","row_type":"noael_study","study_id":"out170_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =75 | mg/kg | rat | oral | - | dermal absorption | {"dose":"I x A = 0.05 mg Systemic exposure dose (SED) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % D...","effect":"I x A = 0.05 mg Systemic exposure dose (SED) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.","page":28,"pdf":"out170_en.pdf","row_type":"noael_study","study_id":"out170_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =2 | % | rat | oral | - | dermal absorption | {"dose":"s / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall...","effect":"s / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.","page":28,"pdf":"out170_en.pdf","row_type":"noael_study","study_id":"out170_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =80 | mg/kg/day | rat | oral | - | developmental toxicity | {"citation":"Ref. : 115 2","dose":"However, there was no evidence of systemic or maternal toxicity, and no adverse effects on offspring survival or growth in the mid-dose group (80 mg/kg/day) and in the low-dose group (20 mg/kg/day).","effect":"sumption. These signs were generally associated with prolonged parturition and difficulty in delivery. A significant increase in mean gestation length was noted with acetylsalicylic acid. Corresponding adverse effects on offspring survival for the affected dams were noted. However, there was no evidence of systemic or maternal toxicity, and no adverse effects on offspring survival or growth in the mid-dose group (80 mg/kg/day) and in the low-dose group (20 mg/kg/day). Under the experimental conditions adopted, the NOAEL (No-Observable-Adverse-Effect-Level) of sodium salicylate has been found to be 80 mg/kg/day when administered orally to mated rats corresponding approximately to 69 mg/kg/day of salicylic acid. Ref. : 115 2.6.1 Two-generation reproduction toxicity No data are available 2.6.2 Teratogenicity Numerous studies concerning fetotoxic and teratogenic potential of acetylsalicylic acid and salicylic acid have been performed in animals. When these compounds were administered by oral or by parenteral route at various time dur","page":18,"pdf":"out170_en.pdf","row_type":"noael_study","study_id":"out170_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =75 | mg/kg | rat | oral | - | dermal absorption | {"dose":"I x A = 0.05 mg Systemic exposure dose (SED) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % D...","effect":"I x A = 0.05 mg Systemic exposure dose (SED) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.","page":28,"pdf":"out170_en.pdf","row_type":"noael_study","study_id":"out170_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =2 | % | rat | oral | - | dermal absorption | {"dose":"s / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall...","effect":"s / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.","page":28,"pdf":"out170_en.pdf","row_type":"noael_study","study_id":"out170_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =80 | mg/kg/day | rat | oral | - | developmental toxicity | {"citation":"Ref. : 115 2","dose":"However, there was no evidence of systemic or maternal toxicity, and no adverse effects on offspring survival or growth in the mid-dose group (80 mg/kg/day) and in the low-dose group (20 mg/kg/day).","effect":"sumption. These signs were generally associated with prolonged parturition and difficulty in delivery. A significant increase in mean gestation length was noted with acetylsalicylic acid. Corresponding adverse effects on offspring survival for the affected dams were noted. However, there was no evidence of systemic or maternal toxicity, and no adverse effects on offspring survival or growth in the mid-dose group (80 mg/kg/day) and in the low-dose group (20 mg/kg/day). Under the experimental conditions adopted, the NOAEL (No-Observable-Adverse-Effect-Level) of sodium salicylate has been found to be 80 mg/kg/day when administered orally to mated rats corresponding approximately to 69 mg/kg/day of salicylic acid. Ref. : 115 2.6.1 Two-generation reproduction toxicity No data are available 2.6.2 Teratogenicity Numerous studies concerning fetotoxic and teratogenic potential of acetylsalicylic acid and salicylic acid have been performed in animals. When these compounds were administered by oral or by parenteral route at various time dur","page":18,"pdf":"out170_en.pdf","row_type":"noael_study","study_id":"out170_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =75 | mg/kg | rat | oral | - | dermal absorption | {"dose":"I x A = 0.05 mg Systemic exposure dose (SED) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % D...","effect":"I x A = 0.05 mg Systemic exposure dose (SED) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.","page":28,"pdf":"out170_en.pdf","row_type":"noael_study","study_id":"out170_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =2 | % | rat | oral | - | dermal absorption | {"dose":"s / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall...","effect":"s / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.","page":28,"pdf":"out170_en.pdf","row_type":"noael_study","study_id":"out170_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =80 | mg/kg/day | rat | oral | - | developmental toxicity | {"citation":"Ref. : 115 2","dose":"However, there was no evidence of systemic or maternal toxicity, and no adverse effects on offspring survival or growth in the mid-dose group (80 mg/kg/day) and in the low-dose group (20 mg/kg/day).","effect":"sumption. These signs were generally associated with prolonged parturition and difficulty in delivery. A significant increase in mean gestation length was noted with acetylsalicylic acid. Corresponding adverse effects on offspring survival for the affected dams were noted. However, there was no evidence of systemic or maternal toxicity, and no adverse effects on offspring survival or growth in the mid-dose group (80 mg/kg/day) and in the low-dose group (20 mg/kg/day). Under the experimental conditions adopted, the NOAEL (No-Observable-Adverse-Effect-Level) of sodium salicylate has been found to be 80 mg/kg/day when administered orally to mated rats corresponding approximately to 69 mg/kg/day of salicylic acid. Ref. : 115 2.6.1 Two-generation reproduction toxicity No data are available 2.6.2 Teratogenicity Numerous studies concerning fetotoxic and teratogenic potential of acetylsalicylic acid and salicylic acid have been performed in animals. When these compounds were administered by oral or by parenteral route at various time dur","page":18,"pdf":"out170_en.pdf","row_type":"noael_study","study_id":"out170_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =75 | mg/kg | rat | oral | - | dermal absorption | {"dose":"I x A = 0.05 mg Systemic exposure dose (SED) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % D...","effect":"I x A = 0.05 mg Systemic exposure dose (SED) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.","page":28,"pdf":"out170_en.pdf","row_type":"noael_study","study_id":"out170_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =2 | % | rat | oral | - | dermal absorption | {"dose":"s / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall...","effect":"s / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.","page":28,"pdf":"out170_en.pdf","row_type":"noael_study","study_id":"out170_en_noael_005"} |
SCCS_vision_codex 96 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =0.1 | % | rat | oral | developmental | reproductive toxicity | {"dose":"Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.","effect":"n rats and are summarised in table 9. Table 9. Reproductive and developmental animal studies with salicylic acid. Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at par","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_001"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg/day | rat | oral | - | reproductive toxicity | {"dose":"& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.","effect":"& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Kos","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_002"} |
| SCCS_vision_codex | NOAEL | =5.3 | % | rat | dermal | developmental | developmental toxicity | {"dose":"days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","effect":"days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_003"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg | rat | oral | developmental | developmental toxicity | {"dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg and the NOAEL (development): 75 mg/kg were identified. Taken from RAC (March 2016) The results of the studies demonstrated that salicylic acid has an embryo-/foetotoxic effect in rats with dose-dependent growth delays, fetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaw","page":33,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_006"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/day | mouse | - | Developmental | reproductive toxicity | {"dose":"2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS.","effect":"ess. Reproductive toxicity SCCS concludes that there is insufficient evidence that salicylic acid has an adverse effect on sexual function and fertility. Developmental Toxicity SCCS agrees that salicylic acid can be considered as a developmental toxicant. Harmonised classification of salicylic acid was recently published in regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS. Mutagenicity / genotoxicity The genotoxicity of salicylic acid was investigated with valid genotoxicity tests for in vitro gene mutations, in both bacterial and mammalian test system. Although no valid in vitro test results on chromosomal aberrations were provided, the in vivo chromosomal aberration and sister chromatid exchange tests in mice showed no mutagenic activity of salicylic acid. Based on the submitted studies and available literature, the","page":53,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_012"} |
| SCCS_vision_codex | NOAEL | =9 | - | - | - | - | reproductive toxicity | {"effect":"Table 9. Reproductive a: group | NOAEL 75 mg/ | kg/day","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_014"} |
| SCCS_vision_codex | NOAEL | =22 | - | - | - | - | NOAEL study | {"dose":"The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","effect":"Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","page":50,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_016"} |
| SCCS_vision_codex | NOAEL | =195 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 51: Scenario 1 | Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level | 0.384 | 195","page":51,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_019"} |
| SCCS_vision_codex | NOAEL | =50 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 51: SCCS 2016 Notes of guidance Approach | SCCS Guidance 9th revision*; deterministic additive; maximum % level | 1.50 | 50","page":51,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_020"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/d | - | dermal | - | NOAEL study | {"dose":"The MoS in Table 8 is calculated based on a NOAEL of 75 mg/kg bw/d and it is below the safe level of 100.","effect":"2 Toothpaste3 2.16 0.5 0.0108 0.00648 11574 Mouthwash3 32.54 0.5 0.1627 0.0976 768 Aggregate 2.67 1.67 45 1. According to values as derived in Tables 3A and 3B in the SCCS notes of guidance (11th revision) (2021). These are common values for all product types, as set by the SCCS in this model. 2. Total dermal external exposure x 60% dermal penetration (SCCS 2017) 3. No dermal penetration applied to lipstick, toothpaste and mouthwash; SCCS default 100% absorption used. The MoS in Table 8 is calculated based on a NOAEL of 75 mg/kg bw/d and it is below the safe level of 100. In accordance with a tiered approach, a probabilistic exposure assessment (see chapter 3.3.2.2) was presented by the Applicant.3.3.2.2 Probabilistic aggregate exposure assessment: Scenario 2.","page":21,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_001"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg/day | rat | oral | developmental | reproductive toxicity | {"dose":"Reproductive and developmental animal studies with salicylic acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%.","effect":"__________________________ 35 Table 18. Reproductive and developmental animal studies with salicylic acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%. 0.4 %: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2 %: growth retardation, skeletal abnormalities. 0.1 % and 0.06 % no significant adverse effects. NOAEL approx. 75 mg/kg/day Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26 % fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturitio","page":35,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_002"} |
| SCCS_vision_codex | NOAEL | =5.3 | % | rat | dermal | developmental | developmental toxicity | {"dose":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","effect":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub-cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity","page":35,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_004"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","effect":"malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973a (Former opinion and new applicant’s dossier) Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7","page":35,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_005"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg bw/day and the NOAEL (development): 75 mg/kg bw/day were identified. Taken from RAC (March 2016, former Opinion) The results of the studies demonstrated that salicylic acid has an embryo-/fetotoxic effect in rats with dose-dependent growth delays, foetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the","page":37,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_007"} |
| SCCS_vision_codex | NOAEL | =2018 | - | human | oral | developmental | reproductive toxicity | {"effect":"ibed and is assessed to be of high quality. The study provides strong evidence of adverse effects of acetylsalicylic acid on male sexual development leading to congenital cryptorchidism. Labib, 2018: These authors published a kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrating no evidence of a health risk from developmental toxicity. Briefly, they performed a safety reassessment in which margins of safety (MoS) were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with acetylsalicylic acid, rapidly converted to salicylic acid in plasma, human salicylic acid plasma levels from oral exposure to acetylsalicylic acid and human dermal exposure to salicylic acid-containing cosmetic products. In addition, they performed a literature review and showed that there are no adverse developmental effects despite extensive human clinical oral use of acetylsalicylic acid up to the maximum recommended therapeutic doses. The pl","page":45,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_010"} |
| SCCS_vision_codex | NOAEL | =60 | % | - | oral | developmental | developmental toxicity | {"dose":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","effect":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is in agreement with the previous SCCNFP Opinion (2002), the previous SCCS Opinion (SCCS/1601/2018) and it is also supported by Tanaka et al. (1973b). Because of the evidence for rapid and almost complete absorption of salicylic acid from the oral route, the SCCS has not applied any adjustment for bioavailability to this NOAEL value. Details of the calculation of systemic exposure dose (SED) are given in the Tables presented in section 3.3.2. A generic maximal value for skin penetration of salicylic acid of 60% (see section 3.2.1) has been used for all products in these calculations where dermal absorption needs to be factored in to calculate a systemic exposure dose (SED). For lipstick and oral care products, a worst-case value of 100% absorption is used for passage across the oral mucosa. The SCCS considers that for this case, the p","page":50,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_012"} |
| SCCS_vision_codex | NOAEL | =21 | - | - | - | - | NOAEL study | {"dose":"For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived","effect":"Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic: For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived","page":50,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_016"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg/day | rat | oral | developmental | reproductive toxicity | {"dose":"Reproductive and developmental animal studies with Salicylic Acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%.","effect":"and are summarised in Table 24. Table 30. Reproductive and developmental animal studies with Salicylic Acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%. 0.4 %: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2 %: growth retardation, skeletal abnormalities. 0.1 % and 0.06 % no significant adverse effects. NOAEL approx. 75 mg/kg/day Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26 % fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturitio","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_001"} |
| SCCS_vision_codex | NOAEL | =5.3 | % | rat | dermal | developmental | developmental toxicity | {"dose":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","effect":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub-cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_003"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/day | rat | - | developmental | developmental toxicity | {"dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","effect":"malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_004"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg bw/day and the NOAEL (development): 75 mg/kg bw/day were identified. Taken from RAC (March 2016, former Opinion) The results of the studies demonstrated that salicylic acid has an embryo-/fetotoxic effect in rats with dose-dependent growth delays, foetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further","page":48,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_006"} |
| SCCS_vision_codex | NOAEL | =2018 | - | human | oral | developmental | reproductive toxicity | {"effect":"ibed and is assessed to be of high quality. The study provides strong evidence of adverse effects of acetylsalicylic acid on male sexual development leading to congenital cryptorchidism. Labib, 2018: These authors published a kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrating no evidence of a health risk from developmental toxicity. Briefly, they performed a safety reassessment in which margins of safety (MoS) were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with acetylsalicylic acid, rapidly converted to salicylic acid in plasma, human salicylic acid plasma levels from oral exposure to acetylsalicylic acid and human dermal exposure to salicylic acid-containing cosmetic products. In addition, they performed a literature review and showed that there are no adverse developmental effects despite extensive human clinical oral use of acetylsalicylic acid up to the maximum recommended therapeutic doses. The pl","page":56,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_009"} |
| SCCS_vision_codex | NOAEL | =60 | % | - | oral | developmental | developmental toxicity | {"dose":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","effect":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is in agreement with the previous SCCNFP Opinion (2002), the previous SCCS Opinion (SCCS/1601/2018) and it is also supported by Tanaka et al. (1973b). Because of the evidence for rapid and almost complete absorption of salicylic acid from the oral route, the SCCS has not applied any adjustment for bioavailability to this NOAEL value. Details of the calculation of systemic exposure dose (SED) are given in the Tables presented in section 3.3.2.6. A generic maximal value for skin penetration of salicylic acid of 60% (see section 3.2.1) has been used for all products in these calculations where dermal absorption needs to be factored in to calculate a systemic exposure dose (SED). For oral care products, a worst-case value of 100% absorption is used for passage across the oral mucosa.","page":61,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_011"} |
| SCCS_vision_codex | NOAEL | =30 | - | - | - | developmental | reproductive toxicity | {"effect":"Table 30. Reproductive and developmental animal studies with Salicylic Acid: NOAEL approx. 75","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_013"} |
| SCCS_vision_codex | NOAEL | =0.1 | % | rat | oral | developmental | reproductive toxicity | {"dose":"Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.","effect":"n rats and are summarised in table 9. Table 9. Reproductive and developmental animal studies with salicylic acid. Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at par","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_001"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg/day | rat | oral | - | reproductive toxicity | {"dose":"& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.","effect":"& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Kos","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_002"} |
| SCCS_vision_codex | NOAEL | =5.3 | % | rat | dermal | developmental | developmental toxicity | {"dose":"days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","effect":"days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_003"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg | rat | oral | developmental | developmental toxicity | {"dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg and the NOAEL (development): 75 mg/kg were identified. Taken from RAC (March 2016) The results of the studies demonstrated that salicylic acid has an embryo-/foetotoxic effect in rats with dose-dependent growth delays, fetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaw","page":33,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_006"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/day | mouse | - | Developmental | reproductive toxicity | {"dose":"2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS.","effect":"ess. Reproductive toxicity SCCS concludes that there is insufficient evidence that salicylic acid has an adverse effect on sexual function and fertility. Developmental Toxicity SCCS agrees that salicylic acid can be considered as a developmental toxicant. Harmonised classification of salicylic acid was recently published in regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS. Mutagenicity / genotoxicity The genotoxicity of salicylic acid was investigated with valid genotoxicity tests for in vitro gene mutations, in both bacterial and mammalian test system. Although no valid in vitro test results on chromosomal aberrations were provided, the in vivo chromosomal aberration and sister chromatid exchange tests in mice showed no mutagenic activity of salicylic acid. Based on the submitted studies and available literature, the","page":53,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_012"} |
| SCCS_vision_codex | NOAEL | =9 | - | - | - | - | reproductive toxicity | {"effect":"Table 9. Reproductive a: group | NOAEL 75 mg/ | kg/day","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_014"} |
| SCCS_vision_codex | NOAEL | =22 | - | - | - | - | NOAEL study | {"dose":"The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","effect":"Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","page":50,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_016"} |
| SCCS_vision_codex | NOAEL | =195 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 51: Scenario 1 | Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level | 0.384 | 195","page":51,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_019"} |
| SCCS_vision_codex | NOAEL | =50 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 51: SCCS 2016 Notes of guidance Approach | SCCS Guidance 9th revision*; deterministic additive; maximum % level | 1.50 | 50","page":51,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_020"} |
| SCCS_vision_codex | NOAEL | =0.1 | % | rat | oral | developmental | reproductive toxicity | {"dose":"Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.","effect":"n rats and are summarised in table 9. Table 9. Reproductive and developmental animal studies with salicylic acid. Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at par","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_001"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg/day | rat | oral | - | reproductive toxicity | {"dose":"& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.","effect":"& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Kos","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_002"} |
| SCCS_vision_codex | NOAEL | =5.3 | % | rat | dermal | developmental | developmental toxicity | {"dose":"days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","effect":"days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_003"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg | rat | oral | developmental | developmental toxicity | {"dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg and the NOAEL (development): 75 mg/kg were identified. Taken from RAC (March 2016) The results of the studies demonstrated that salicylic acid has an embryo-/foetotoxic effect in rats with dose-dependent growth delays, fetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaw","page":33,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_006"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/day | mouse | - | Developmental | reproductive toxicity | {"dose":"2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS.","effect":"ess. Reproductive toxicity SCCS concludes that there is insufficient evidence that salicylic acid has an adverse effect on sexual function and fertility. Developmental Toxicity SCCS agrees that salicylic acid can be considered as a developmental toxicant. Harmonised classification of salicylic acid was recently published in regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS. Mutagenicity / genotoxicity The genotoxicity of salicylic acid was investigated with valid genotoxicity tests for in vitro gene mutations, in both bacterial and mammalian test system. Although no valid in vitro test results on chromosomal aberrations were provided, the in vivo chromosomal aberration and sister chromatid exchange tests in mice showed no mutagenic activity of salicylic acid. Based on the submitted studies and available literature, the","page":53,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_012"} |
| SCCS_vision_codex | NOAEL | =9 | - | - | - | - | reproductive toxicity | {"effect":"Table 9. Reproductive a: group | NOAEL 75 mg/ | kg/day","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_014"} |
| SCCS_vision_codex | NOAEL | =22 | - | - | - | - | NOAEL study | {"dose":"The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","effect":"Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","page":50,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_016"} |
| SCCS_vision_codex | NOAEL | =195 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 51: Scenario 1 | Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level | 0.384 | 195","page":51,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_019"} |
| SCCS_vision_codex | NOAEL | =50 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 51: SCCS 2016 Notes of guidance Approach | SCCS Guidance 9th revision*; deterministic additive; maximum % level | 1.50 | 50","page":51,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_020"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/d | - | dermal | - | NOAEL study | {"dose":"The MoS in Table 8 is calculated based on a NOAEL of 75 mg/kg bw/d and it is below the safe level of 100.","effect":"2 Toothpaste3 2.16 0.5 0.0108 0.00648 11574 Mouthwash3 32.54 0.5 0.1627 0.0976 768 Aggregate 2.67 1.67 45 1. According to values as derived in Tables 3A and 3B in the SCCS notes of guidance (11th revision) (2021). These are common values for all product types, as set by the SCCS in this model. 2. Total dermal external exposure x 60% dermal penetration (SCCS 2017) 3. No dermal penetration applied to lipstick, toothpaste and mouthwash; SCCS default 100% absorption used. The MoS in Table 8 is calculated based on a NOAEL of 75 mg/kg bw/d and it is below the safe level of 100. In accordance with a tiered approach, a probabilistic exposure assessment (see chapter 3.3.2.2) was presented by the Applicant.3.3.2.2 Probabilistic aggregate exposure assessment: Scenario 2.","page":21,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_001"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg/day | rat | oral | developmental | reproductive toxicity | {"dose":"Reproductive and developmental animal studies with salicylic acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%.","effect":"__________________________ 35 Table 18. Reproductive and developmental animal studies with salicylic acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%. 0.4 %: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2 %: growth retardation, skeletal abnormalities. 0.1 % and 0.06 % no significant adverse effects. NOAEL approx. 75 mg/kg/day Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26 % fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturitio","page":35,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_002"} |
| SCCS_vision_codex | NOAEL | =5.3 | % | rat | dermal | developmental | developmental toxicity | {"dose":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","effect":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub-cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity","page":35,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_004"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","effect":"malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973a (Former opinion and new applicant’s dossier) Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7","page":35,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_005"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg bw/day and the NOAEL (development): 75 mg/kg bw/day were identified. Taken from RAC (March 2016, former Opinion) The results of the studies demonstrated that salicylic acid has an embryo-/fetotoxic effect in rats with dose-dependent growth delays, foetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the","page":37,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_007"} |
| SCCS_vision_codex | NOAEL | =2018 | - | human | oral | developmental | reproductive toxicity | {"effect":"ibed and is assessed to be of high quality. The study provides strong evidence of adverse effects of acetylsalicylic acid on male sexual development leading to congenital cryptorchidism. Labib, 2018: These authors published a kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrating no evidence of a health risk from developmental toxicity. Briefly, they performed a safety reassessment in which margins of safety (MoS) were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with acetylsalicylic acid, rapidly converted to salicylic acid in plasma, human salicylic acid plasma levels from oral exposure to acetylsalicylic acid and human dermal exposure to salicylic acid-containing cosmetic products. In addition, they performed a literature review and showed that there are no adverse developmental effects despite extensive human clinical oral use of acetylsalicylic acid up to the maximum recommended therapeutic doses. The pl","page":45,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_010"} |
| SCCS_vision_codex | NOAEL | =60 | % | - | oral | developmental | developmental toxicity | {"dose":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","effect":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is in agreement with the previous SCCNFP Opinion (2002), the previous SCCS Opinion (SCCS/1601/2018) and it is also supported by Tanaka et al. (1973b). Because of the evidence for rapid and almost complete absorption of salicylic acid from the oral route, the SCCS has not applied any adjustment for bioavailability to this NOAEL value. Details of the calculation of systemic exposure dose (SED) are given in the Tables presented in section 3.3.2. A generic maximal value for skin penetration of salicylic acid of 60% (see section 3.2.1) has been used for all products in these calculations where dermal absorption needs to be factored in to calculate a systemic exposure dose (SED). For lipstick and oral care products, a worst-case value of 100% absorption is used for passage across the oral mucosa. The SCCS considers that for this case, the p","page":50,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_012"} |
| SCCS_vision_codex | NOAEL | =21 | - | - | - | - | NOAEL study | {"dose":"For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived","effect":"Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic: For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived","page":50,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_016"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/d | - | dermal | - | NOAEL study | {"dose":"The MoS in Table 8 is calculated based on a NOAEL of 75 mg/kg bw/d and it is below the safe level of 100.","effect":"2 Toothpaste3 2.16 0.5 0.0108 0.00648 11574 Mouthwash3 32.54 0.5 0.1627 0.0976 768 Aggregate 2.67 1.67 45 1. According to values as derived in Tables 3A and 3B in the SCCS notes of guidance (11th revision) (2021). These are common values for all product types, as set by the SCCS in this model. 2. Total dermal external exposure x 60% dermal penetration (SCCS 2017) 3. No dermal penetration applied to lipstick, toothpaste and mouthwash; SCCS default 100% absorption used. The MoS in Table 8 is calculated based on a NOAEL of 75 mg/kg bw/d and it is below the safe level of 100. In accordance with a tiered approach, a probabilistic exposure assessment (see chapter 3.3.2.2) was presented by the Applicant.3.3.2.2 Probabilistic aggregate exposure assessment: Scenario 2.","page":21,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_001"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg/day | rat | oral | developmental | reproductive toxicity | {"dose":"Reproductive and developmental animal studies with salicylic acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%.","effect":"__________________________ 35 Table 18. Reproductive and developmental animal studies with salicylic acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%. 0.4 %: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2 %: growth retardation, skeletal abnormalities. 0.1 % and 0.06 % no significant adverse effects. NOAEL approx. 75 mg/kg/day Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26 % fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturitio","page":35,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_002"} |
| SCCS_vision_codex | NOAEL | =5.3 | % | rat | dermal | developmental | developmental toxicity | {"dose":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","effect":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub-cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity","page":35,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_004"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","effect":"malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973a (Former opinion and new applicant’s dossier) Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7","page":35,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_005"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg bw/day and the NOAEL (development): 75 mg/kg bw/day were identified. Taken from RAC (March 2016, former Opinion) The results of the studies demonstrated that salicylic acid has an embryo-/fetotoxic effect in rats with dose-dependent growth delays, foetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the","page":37,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_007"} |
| SCCS_vision_codex | NOAEL | =2018 | - | human | oral | developmental | reproductive toxicity | {"effect":"ibed and is assessed to be of high quality. The study provides strong evidence of adverse effects of acetylsalicylic acid on male sexual development leading to congenital cryptorchidism. Labib, 2018: These authors published a kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrating no evidence of a health risk from developmental toxicity. Briefly, they performed a safety reassessment in which margins of safety (MoS) were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with acetylsalicylic acid, rapidly converted to salicylic acid in plasma, human salicylic acid plasma levels from oral exposure to acetylsalicylic acid and human dermal exposure to salicylic acid-containing cosmetic products. In addition, they performed a literature review and showed that there are no adverse developmental effects despite extensive human clinical oral use of acetylsalicylic acid up to the maximum recommended therapeutic doses. The pl","page":45,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_010"} |
| SCCS_vision_codex | NOAEL | =60 | % | - | oral | developmental | developmental toxicity | {"dose":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","effect":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is in agreement with the previous SCCNFP Opinion (2002), the previous SCCS Opinion (SCCS/1601/2018) and it is also supported by Tanaka et al. (1973b). Because of the evidence for rapid and almost complete absorption of salicylic acid from the oral route, the SCCS has not applied any adjustment for bioavailability to this NOAEL value. Details of the calculation of systemic exposure dose (SED) are given in the Tables presented in section 3.3.2. A generic maximal value for skin penetration of salicylic acid of 60% (see section 3.2.1) has been used for all products in these calculations where dermal absorption needs to be factored in to calculate a systemic exposure dose (SED). For lipstick and oral care products, a worst-case value of 100% absorption is used for passage across the oral mucosa. The SCCS considers that for this case, the p","page":50,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_012"} |
| SCCS_vision_codex | NOAEL | =21 | - | - | - | - | NOAEL study | {"dose":"For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived","effect":"Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic: For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived","page":50,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_016"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg/day | rat | oral | developmental | reproductive toxicity | {"dose":"Reproductive and developmental animal studies with Salicylic Acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%.","effect":"and are summarised in Table 24. Table 30. Reproductive and developmental animal studies with Salicylic Acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%. 0.4 %: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2 %: growth retardation, skeletal abnormalities. 0.1 % and 0.06 % no significant adverse effects. NOAEL approx. 75 mg/kg/day Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26 % fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturitio","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_001"} |
| SCCS_vision_codex | NOAEL | =5.3 | % | rat | dermal | developmental | developmental toxicity | {"dose":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","effect":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub-cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_003"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/day | rat | - | developmental | developmental toxicity | {"dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","effect":"malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_004"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg bw/day and the NOAEL (development): 75 mg/kg bw/day were identified. Taken from RAC (March 2016, former Opinion) The results of the studies demonstrated that salicylic acid has an embryo-/fetotoxic effect in rats with dose-dependent growth delays, foetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further","page":48,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_006"} |
| SCCS_vision_codex | NOAEL | =2018 | - | human | oral | developmental | reproductive toxicity | {"effect":"ibed and is assessed to be of high quality. The study provides strong evidence of adverse effects of acetylsalicylic acid on male sexual development leading to congenital cryptorchidism. Labib, 2018: These authors published a kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrating no evidence of a health risk from developmental toxicity. Briefly, they performed a safety reassessment in which margins of safety (MoS) were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with acetylsalicylic acid, rapidly converted to salicylic acid in plasma, human salicylic acid plasma levels from oral exposure to acetylsalicylic acid and human dermal exposure to salicylic acid-containing cosmetic products. In addition, they performed a literature review and showed that there are no adverse developmental effects despite extensive human clinical oral use of acetylsalicylic acid up to the maximum recommended therapeutic doses. The pl","page":56,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_009"} |
| SCCS_vision_codex | NOAEL | =60 | % | - | oral | developmental | developmental toxicity | {"dose":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","effect":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is in agreement with the previous SCCNFP Opinion (2002), the previous SCCS Opinion (SCCS/1601/2018) and it is also supported by Tanaka et al. (1973b). Because of the evidence for rapid and almost complete absorption of salicylic acid from the oral route, the SCCS has not applied any adjustment for bioavailability to this NOAEL value. Details of the calculation of systemic exposure dose (SED) are given in the Tables presented in section 3.3.2.6. A generic maximal value for skin penetration of salicylic acid of 60% (see section 3.2.1) has been used for all products in these calculations where dermal absorption needs to be factored in to calculate a systemic exposure dose (SED). For oral care products, a worst-case value of 100% absorption is used for passage across the oral mucosa.","page":61,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_011"} |
| SCCS_vision_codex | NOAEL | =30 | - | - | - | developmental | reproductive toxicity | {"effect":"Table 30. Reproductive and developmental animal studies with Salicylic Acid: NOAEL approx. 75","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_013"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg/day | rat | oral | developmental | reproductive toxicity | {"dose":"Reproductive and developmental animal studies with Salicylic Acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%.","effect":"and are summarised in Table 24. Table 30. Reproductive and developmental animal studies with Salicylic Acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%. 0.4 %: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2 %: growth retardation, skeletal abnormalities. 0.1 % and 0.06 % no significant adverse effects. NOAEL approx. 75 mg/kg/day Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26 % fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturitio","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_001"} |
| SCCS_vision_codex | NOAEL | =5.3 | % | rat | dermal | developmental | developmental toxicity | {"dose":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","effect":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub-cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_003"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/day | rat | - | developmental | developmental toxicity | {"dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","effect":"malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_004"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg bw/day and the NOAEL (development): 75 mg/kg bw/day were identified. Taken from RAC (March 2016, former Opinion) The results of the studies demonstrated that salicylic acid has an embryo-/fetotoxic effect in rats with dose-dependent growth delays, foetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further","page":48,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_006"} |
| SCCS_vision_codex | NOAEL | =2018 | - | human | oral | developmental | reproductive toxicity | {"effect":"ibed and is assessed to be of high quality. The study provides strong evidence of adverse effects of acetylsalicylic acid on male sexual development leading to congenital cryptorchidism. Labib, 2018: These authors published a kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrating no evidence of a health risk from developmental toxicity. Briefly, they performed a safety reassessment in which margins of safety (MoS) were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with acetylsalicylic acid, rapidly converted to salicylic acid in plasma, human salicylic acid plasma levels from oral exposure to acetylsalicylic acid and human dermal exposure to salicylic acid-containing cosmetic products. In addition, they performed a literature review and showed that there are no adverse developmental effects despite extensive human clinical oral use of acetylsalicylic acid up to the maximum recommended therapeutic doses. The pl","page":56,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_009"} |
| SCCS_vision_codex | NOAEL | =60 | % | - | oral | developmental | developmental toxicity | {"dose":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","effect":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is in agreement with the previous SCCNFP Opinion (2002), the previous SCCS Opinion (SCCS/1601/2018) and it is also supported by Tanaka et al. (1973b). Because of the evidence for rapid and almost complete absorption of salicylic acid from the oral route, the SCCS has not applied any adjustment for bioavailability to this NOAEL value. Details of the calculation of systemic exposure dose (SED) are given in the Tables presented in section 3.3.2.6. A generic maximal value for skin penetration of salicylic acid of 60% (see section 3.2.1) has been used for all products in these calculations where dermal absorption needs to be factored in to calculate a systemic exposure dose (SED). For oral care products, a worst-case value of 100% absorption is used for passage across the oral mucosa.","page":61,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_011"} |
| SCCS_vision_codex | NOAEL | =30 | - | - | - | developmental | reproductive toxicity | {"effect":"Table 30. Reproductive and developmental animal studies with Salicylic Acid: NOAEL approx. 75","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_013"} |
| SCCS_vision_codex | NOAEL | =0.1 | % | rat | oral | developmental | reproductive toxicity | {"dose":"Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.","effect":"n rats and are summarised in table 9. Table 9. Reproductive and developmental animal studies with salicylic acid. Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at par","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_001"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg/day | rat | oral | - | reproductive toxicity | {"dose":"& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.","effect":"& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Kos","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_002"} |
| SCCS_vision_codex | NOAEL | =5.3 | % | rat | dermal | developmental | developmental toxicity | {"dose":"days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","effect":"days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_003"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg | rat | oral | developmental | developmental toxicity | {"dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg and the NOAEL (development): 75 mg/kg were identified. Taken from RAC (March 2016) The results of the studies demonstrated that salicylic acid has an embryo-/foetotoxic effect in rats with dose-dependent growth delays, fetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaw","page":33,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_006"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/day | mouse | - | Developmental | reproductive toxicity | {"dose":"2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS.","effect":"ess. Reproductive toxicity SCCS concludes that there is insufficient evidence that salicylic acid has an adverse effect on sexual function and fertility. Developmental Toxicity SCCS agrees that salicylic acid can be considered as a developmental toxicant. Harmonised classification of salicylic acid was recently published in regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS. Mutagenicity / genotoxicity The genotoxicity of salicylic acid was investigated with valid genotoxicity tests for in vitro gene mutations, in both bacterial and mammalian test system. Although no valid in vitro test results on chromosomal aberrations were provided, the in vivo chromosomal aberration and sister chromatid exchange tests in mice showed no mutagenic activity of salicylic acid. Based on the submitted studies and available literature, the","page":53,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_012"} |
| SCCS_vision_codex | NOAEL | =9 | - | - | - | - | reproductive toxicity | {"effect":"Table 9. Reproductive a: group | NOAEL 75 mg/ | kg/day","page":31,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_014"} |
| SCCS_vision_codex | NOAEL | =22 | - | - | - | - | NOAEL study | {"dose":"The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","effect":"Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","page":50,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_016"} |
| SCCS_vision_codex | NOAEL | =195 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 51: Scenario 1 | Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level | 0.384 | 195","page":51,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_019"} |
| SCCS_vision_codex | NOAEL | =50 | - | - | - | - | NOAEL study | {"effect":"Unlabeled table on page 51: SCCS 2016 Notes of guidance Approach | SCCS Guidance 9th revision*; deterministic additive; maximum % level | 1.50 | 50","page":51,"pdf":"sccs_o_223.pdf","row_type":"noael_study","study_id":"sccs_o_223_noael_020"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/d | - | dermal | - | NOAEL study | {"dose":"The MoS in Table 8 is calculated based on a NOAEL of 75 mg/kg bw/d and it is below the safe level of 100.","effect":"2 Toothpaste3 2.16 0.5 0.0108 0.00648 11574 Mouthwash3 32.54 0.5 0.1627 0.0976 768 Aggregate 2.67 1.67 45 1. According to values as derived in Tables 3A and 3B in the SCCS notes of guidance (11th revision) (2021). These are common values for all product types, as set by the SCCS in this model. 2. Total dermal external exposure x 60% dermal penetration (SCCS 2017) 3. No dermal penetration applied to lipstick, toothpaste and mouthwash; SCCS default 100% absorption used. The MoS in Table 8 is calculated based on a NOAEL of 75 mg/kg bw/d and it is below the safe level of 100. In accordance with a tiered approach, a probabilistic exposure assessment (see chapter 3.3.2.2) was presented by the Applicant.3.3.2.2 Probabilistic aggregate exposure assessment: Scenario 2.","page":21,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_001"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg/day | rat | oral | developmental | reproductive toxicity | {"dose":"Reproductive and developmental animal studies with salicylic acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%.","effect":"__________________________ 35 Table 18. Reproductive and developmental animal studies with salicylic acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%. 0.4 %: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2 %: growth retardation, skeletal abnormalities. 0.1 % and 0.06 % no significant adverse effects. NOAEL approx. 75 mg/kg/day Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26 % fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturitio","page":35,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_002"} |
| SCCS_vision_codex | NOAEL | =5.3 | % | rat | dermal | developmental | developmental toxicity | {"dose":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","effect":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub-cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity","page":35,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_004"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","effect":"malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973a (Former opinion and new applicant’s dossier) Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7","page":35,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_005"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg bw/day and the NOAEL (development): 75 mg/kg bw/day were identified. Taken from RAC (March 2016, former Opinion) The results of the studies demonstrated that salicylic acid has an embryo-/fetotoxic effect in rats with dose-dependent growth delays, foetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the","page":37,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_007"} |
| SCCS_vision_codex | NOAEL | =2018 | - | human | oral | developmental | reproductive toxicity | {"effect":"ibed and is assessed to be of high quality. The study provides strong evidence of adverse effects of acetylsalicylic acid on male sexual development leading to congenital cryptorchidism. Labib, 2018: These authors published a kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrating no evidence of a health risk from developmental toxicity. Briefly, they performed a safety reassessment in which margins of safety (MoS) were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with acetylsalicylic acid, rapidly converted to salicylic acid in plasma, human salicylic acid plasma levels from oral exposure to acetylsalicylic acid and human dermal exposure to salicylic acid-containing cosmetic products. In addition, they performed a literature review and showed that there are no adverse developmental effects despite extensive human clinical oral use of acetylsalicylic acid up to the maximum recommended therapeutic doses. The pl","page":45,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_010"} |
| SCCS_vision_codex | NOAEL | =60 | % | - | oral | developmental | developmental toxicity | {"dose":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","effect":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is in agreement with the previous SCCNFP Opinion (2002), the previous SCCS Opinion (SCCS/1601/2018) and it is also supported by Tanaka et al. (1973b). Because of the evidence for rapid and almost complete absorption of salicylic acid from the oral route, the SCCS has not applied any adjustment for bioavailability to this NOAEL value. Details of the calculation of systemic exposure dose (SED) are given in the Tables presented in section 3.3.2. A generic maximal value for skin penetration of salicylic acid of 60% (see section 3.2.1) has been used for all products in these calculations where dermal absorption needs to be factored in to calculate a systemic exposure dose (SED). For lipstick and oral care products, a worst-case value of 100% absorption is used for passage across the oral mucosa. The SCCS considers that for this case, the p","page":50,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_012"} |
| SCCS_vision_codex | NOAEL | =21 | - | - | - | - | NOAEL study | {"dose":"For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived","effect":"Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic: For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived","page":50,"pdf":"sccs_o_268.pdf","row_type":"noael_study","study_id":"sccs_o_268_noael_016"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg/day | rat | oral | developmental | reproductive toxicity | {"dose":"Reproductive and developmental animal studies with Salicylic Acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%.","effect":"and are summarised in Table 24. Table 30. Reproductive and developmental animal studies with Salicylic Acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%. 0.4 %: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2 %: growth retardation, skeletal abnormalities. 0.1 % and 0.06 % no significant adverse effects. NOAEL approx. 75 mg/kg/day Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26 % fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturitio","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_001"} |
| SCCS_vision_codex | NOAEL | =5.3 | % | rat | dermal | developmental | developmental toxicity | {"dose":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","effect":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub-cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_003"} |
| SCCS_vision_codex | NOAEL | =75 | mg/kg bw/day | rat | - | developmental | developmental toxicity | {"dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","effect":"malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_004"} |
| SCCS_vision_codex | NOAEL | =150 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | {"dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg bw/day and the NOAEL (development): 75 mg/kg bw/day were identified. Taken from RAC (March 2016, former Opinion) The results of the studies demonstrated that salicylic acid has an embryo-/fetotoxic effect in rats with dose-dependent growth delays, foetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further","page":48,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_006"} |
| SCCS_vision_codex | NOAEL | =2018 | - | human | oral | developmental | reproductive toxicity | {"effect":"ibed and is assessed to be of high quality. The study provides strong evidence of adverse effects of acetylsalicylic acid on male sexual development leading to congenital cryptorchidism. Labib, 2018: These authors published a kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrating no evidence of a health risk from developmental toxicity. Briefly, they performed a safety reassessment in which margins of safety (MoS) were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with acetylsalicylic acid, rapidly converted to salicylic acid in plasma, human salicylic acid plasma levels from oral exposure to acetylsalicylic acid and human dermal exposure to salicylic acid-containing cosmetic products. In addition, they performed a literature review and showed that there are no adverse developmental effects despite extensive human clinical oral use of acetylsalicylic acid up to the maximum recommended therapeutic doses. The pl","page":56,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_009"} |
| SCCS_vision_codex | NOAEL | =60 | % | - | oral | developmental | developmental toxicity | {"dose":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","effect":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is in agreement with the previous SCCNFP Opinion (2002), the previous SCCS Opinion (SCCS/1601/2018) and it is also supported by Tanaka et al. (1973b). Because of the evidence for rapid and almost complete absorption of salicylic acid from the oral route, the SCCS has not applied any adjustment for bioavailability to this NOAEL value. Details of the calculation of systemic exposure dose (SED) are given in the Tables presented in section 3.3.2.6. A generic maximal value for skin penetration of salicylic acid of 60% (see section 3.2.1) has been used for all products in these calculations where dermal absorption needs to be factored in to calculate a systemic exposure dose (SED). For oral care products, a worst-case value of 100% absorption is used for passage across the oral mucosa.","page":61,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_011"} |
| SCCS_vision_codex | NOAEL | =30 | - | - | - | developmental | reproductive toxicity | {"effect":"Table 30. Reproductive and developmental animal studies with Salicylic Acid: NOAEL approx. 75","page":46,"pdf":"sccs_o_297.pdf","row_type":"noael_study","study_id":"sccs_o_297_noael_013"} |
ToxValDB_ECHA_IUCLID 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | NOAEL | =100 | mg/kg bw/day | Mouse | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab47e4b0a7c65d1b98f0; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23278/7/9/2?documentUUID=da8d09a8-236b-4588-8c8b-906fd051ede5; YEAR=1980; ORIGINAL_YEAR=1980; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15855596_15857571:M/F:P0-; 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_d570a0657147ca2f2b69420394f82963 |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL local | =5 | 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_dup_-_15634603_15634604:-:--; 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_765c00009980c59efc8a30cf6cc056bd |
UnifiedCodex:SCCNFP:beta.noael_studies 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 75 | mg/kg | rat | oral | - | - | SOURCE_SUBDIR=out170_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING SALICYLIC ACID; OPINION_NUMBER=SCCNFP/0522/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=75; DOSE=No observed adverse effect level (75 mg/kg) NOAEL | (rat oral teratogenicity study) | = | 75 mg/kg bw; EFFECT=Overall SED / NOAEL block: No observed adverse effect level (75 mg/kg) NOAEL | (rat oral teratogenicity study) | = | 75 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"No observed adverse effect level (75 mg/kg) NOAEL | (rat oral teratogenicity study) | = | 75 mg/kg bw","duration":"","effect":"Overall SED / NOAEL block: No observed adverse effect level (75 mg/kg) NOAEL | (rat oral teratogenicity study) | = | 75 mg/kg bw","endpoint":"","ingredient":"Salicylic acid","loael_value":"","noael_unit":"mg/kg","noael_value":"75","page":28,"route":"oral","species":"rat","study_id":"out170_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 75 | mg/kg | rat | oral | - | dermal absorption | SOURCE_SUBDIR=out170_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING SALICYLIC ACID; OPINION_NUMBER=SCCNFP/0522/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=75; DOSE=I x A = 0.05 mg Systemic exposure dose (SED) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % D...; EFFECT=I x A = 0.05 mg Systemic exposure dose (SED) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"I x A = 0.05 mg Systemic exposure dose (SED) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % D...","duration":"","effect":"I x A = 0.05 mg Systemic exposure dose (SED) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.","endpoint":"dermal absorption","ingredient":"Salicylic acid","loael_value":"","noael_unit":"mg/kg","noael_value":"75","page":28,"route":"oral","species":"rat","study_id":"out170_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | =75 | mg/kg bw | rat | oral | - | dermal absorption | SOURCE_SUBDIR=out170_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING SALICYLIC ACID; OPINION_NUMBER=SCCNFP/0522/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT== 75; DOSE=) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 m...; EFFECT=) I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":") I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 m...","duration":"","effect":") I x A / 60 kg = 0.01 mg/kg bw (All other remaining cosmetic products / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.","endpoint":"dermal absorption","ingredient":"Salicylic acid","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 75","page":28,"route":"oral","species":"rat","study_id":"out170_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 2 | % | rat | oral | - | dermal absorption | SOURCE_SUBDIR=out170_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING SALICYLIC ACID; OPINION_NUMBER=SCCNFP/0522/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=2.0; DOSE=s / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall...; EFFECT=s / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"s / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall...","duration":"","effect":"s / Salicylic acid as a preservative) Based on an exposure of 12 g, containing at maximum 0.5 % Maximum amount of ingredient applied I (mg) = 60 mg Typical body weight of human = 60 kg Maximum absorption through the skin A (%) = 20 % Dermal absorption per treatment I x A = 12 mg Systemic exposure dose (SED) I x A / 60 kg = 0.20 mg/kg bw Overall SED 0.11 + 0.16 + 0.03 + 0.05 + 0.01 + 0.20 = 0.56 mg/kg bw No observed adverse effect level (75 mg/kg) NOAEL = 75 mg/kg bw (rat oral teratogenicity study) Margin of Safety NOAEL / SED = 133 2.13 Opinion On the bases of the information provided for consideration, the SCCNFP considers that salicylic acid is safe for “other uses” than as a preservative, at a concentration up to 2.0 % for the leave on and rinse-off cosmetic products and at a concentration up to 3.0 % for the cosmetic rinse-off hair products.","endpoint":"dermal absorption","ingredient":"Salicylic acid","loael_value":"","noael_unit":"%","noael_value":"2.0","page":28,"route":"oral","species":"rat","study_id":"out170_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 80 | mg/kg/day | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=out170_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING SALICYLIC ACID; OPINION_NUMBER=SCCNFP/0522/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=80; DOSE=However, there was no evidence of systemic or maternal toxicity, and no adverse effects on offspring survival or growth in the mid-dose group (80 mg/kg/day) and in the low-dose group (20 mg/kg/day).; EFFECT=sumption. These signs were generally associated with prolonged parturition and difficulty in delivery. A significant increase in mean gestation length was noted with acetylsalicylic acid. Corresponding adverse effects on offspring survival for the affected dams were noted. However, there was no evidence of systemic or maternal toxicity, and no adverse effects on offspring survival or growth in the mid-dose group (80 mg/kg/day) and in the low-dose group (20 mg/kg/day). Under the experimental conditions adopted, the NOAEL (No-Observable-Adverse-Effect-Level) of sodium salicylate has been found to be 80 mg/kg/day when administered orally to mated rats corresponding approximately to 69 mg/kg/day of salicylic acid. Ref. : 115 2.6.1 Two-generation reproduction toxicity No data are available 2.6.2 Teratogenicity Numerous studies concerning fetotoxic and teratogenic potential of acetylsalicylic acid and salicylic acid have been performed in animals. When these compounds were administered by oral or by parenteral route at various time dur; CITATION=Ref. : 115 2; CITATION_NUMBERS=[115,2]; REFERENCE=Ref. : 115 2; DETAILS_JSON={"cas_number":"69-72-7","citation":"Ref. : 115 2","dose":"However, there was no evidence of systemic or maternal toxicity, and no adverse effects on offspring survival or growth in the mid-dose group (80 mg/kg/day) and in the low-dose group (20 mg/kg/day).","duration":"","effect":"sumption. These signs were generally associated with prolonged parturition and difficulty in delivery. A significant increase in mean gestation length was noted with acetylsalicylic acid. Corresponding adverse effects on offspring survival for the affected dams were noted. However, there was no evidence of systemic or maternal toxicity, and no adverse effects on offspring survival or growth in the mid-dose group (80 mg/kg/day) and in the low-dose group (20 mg/kg/day). Under the experimental conditions adopted, the NOAEL (No-Observable-Adverse-Effect-Level) of sodium salicylate has been found to be 80 mg/kg/day when administered orally to mated rats corresponding approximately to 69 mg/kg/day of salicylic acid. Ref. : 115 2.6.1 Two-generation reproduction toxicity No data are available 2.6.2 Teratogenicity Numerous studies concerning fetotoxic and teratogenic potential of acetylsalicylic acid and salicylic acid have been performed in animals. When these compounds were administered by oral or by parenteral route at various time dur","endpoint":"developmental toxicity","ingredient":"Salicylic acid","loael_value":"","noael_unit":"mg/kg/day","noael_value":"80","page":18,"route":"oral","species":"rat","study_id":"out170_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | reproductive toxicity | 80 | mg/kg/day | rat | oral | 200 days | reproductive toxicity | SOURCE_SUBDIR=out170_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING SALICYLIC ACID; OPINION_NUMBER=SCCNFP/0522/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=80; DOSE=200 days, showed no significant toxic effects compared to the control group at this dose level. - In humans, toxic effects were reported when 10 g or more of salicylates are given orally in single dose or divided doses within a period of 12 to 24 hours.; EFFECT=200 days, showed no significant toxic effects compared to the control group at this dose level. - In humans, toxic effects were reported when 10 g or more of salicylates are given orally in single dose or divided doses within a period of 12 to 24 hours. Children are more sensitive than adults to salicylates. Reye’s syndrome in children is associated with the ingestion of acetylsalicylic acid - Numerous reproductive studies have been performed with acetylsalicylic acid or salicylic acid in various animal species. A NOAEL of sodium salicylate administered orally to mated rats has been established to 80 mg/kg/day corresponding to 69 mg/kg/day of salicylic acid. The results also showed that following oral administration salicylic acid is not teratogenic nor embryotoxic up to 75 mg/kg/day in rodents and up to 100 mg/kg/day in Monkey. Above these dose levels, foetal malformations (skeletal malformations, cleft lip, growth retardation), resorptions and perinatal death were recorded with the compounds salicylic acid or acetylsalicylic ac; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"200 days, showed no significant toxic effects compared to the control group at this dose level. - In humans, toxic effects were reported when 10 g or more of salicylates are given orally in single dose or divided doses within a period of 12 to 24 hours.","duration":"200 days","effect":"200 days, showed no significant toxic effects compared to the control group at this dose level. - In humans, toxic effects were reported when 10 g or more of salicylates are given orally in single dose or divided doses within a period of 12 to 24 hours. Children are more sensitive than adults to salicylates. Reye’s syndrome in children is associated with the ingestion of acetylsalicylic acid - Numerous reproductive studies have been performed with acetylsalicylic acid or salicylic acid in various animal species. A NOAEL of sodium salicylate administered orally to mated rats has been established to 80 mg/kg/day corresponding to 69 mg/kg/day of salicylic acid. The results also showed that following oral administration salicylic acid is not teratogenic nor embryotoxic up to 75 mg/kg/day in rodents and up to 100 mg/kg/day in Monkey. Above these dose levels, foetal malformations (skeletal malformations, cleft lip, growth retardation), resorptions and perinatal death were recorded with the compounds salicylic acid or acetylsalicylic ac","endpoint":"reproductive toxicity","ingredient":"Salicylic acid","loael_value":"","noael_unit":"mg/kg/day","noael_value":"80","page":26,"route":"oral","species":"rat","study_id":"out170_en_noael_002"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 37 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 75 | mg/kg/day | human | - | - | - | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=SCCS/1601/18 Final Opinion Opinion on salicylic acid (CAS 69-72-7) - Submission I - Corrigendum of 20-21 June 2019 ___________________________________________________________________________________________ 51 acid Risk Assessment Scenario Basis for exposure assessment Aggregate Systemic Exposure Dose (mg/kg/day) Margin of Safety (using a NOAEL...; EFFECT=SCCS/1601/18 Final Opinion Opinion on salicylic acid (CAS 69-72-7) - Submission I - Corrigendum of 20-21 June 2019 ___________________________________________________________________________________________ 51 acid Risk Assessment Scenario Basis for exposure assessment Aggregate Systemic Exposure Dose (mg/kg/day) Margin of Safety (using a NOAEL of 75 mg/kg/day) Scenario 1 Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level 0.384 195 SCCS 2016 Notes of guidance Approach SCCS Guidance 9th revision*; deterministic additive; maximum % level 1.50 50 * Assumes everybody in the population uses all the products each day, and all products contain salicylic acid, aggregate exposure is calculated on the basis of deterministic additive methods. Applicant’s Analysis In the Applicant’s dossier, evidence is presented to show that human and; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"SCCS/1601/18 Final Opinion Opinion on salicylic acid (CAS 69-72-7) - Submission I - Corrigendum of 20-21 June 2019 ___________________________________________________________________________________________ 51 acid Risk Assessment Scenario Basis for exposure assessment Aggregate Systemic Exposure Dose (mg/kg/day) Margin of Safety (using a NOAEL...","duration":"","effect":"SCCS/1601/18 Final Opinion Opinion on salicylic acid (CAS 69-72-7) - Submission I - Corrigendum of 20-21 June 2019 ___________________________________________________________________________________________ 51 acid Risk Assessment Scenario Basis for exposure assessment Aggregate Systemic Exposure Dose (mg/kg/day) Margin of Safety (using a NOAEL of 75 mg/kg/day) Scenario 1 Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level 0.384 195 SCCS 2016 Notes of guidance Approach SCCS Guidance 9th revision*; deterministic additive; maximum % level 1.50 50 * Assumes everybody in the population uses all the products each day, and all products contain salicylic acid, aggregate exposure is calculated on the basis of deterministic additive methods. Applicant’s Analysis In the Applicant’s dossier, evidence is presented to show that human and","endpoint":"","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":51,"route":"","species":"human","study_id":"sccs_o_223_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 22 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=unclear:Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal; DOSE=The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal; EFFECT=Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","duration":"","effect":"Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","endpoint":"","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"","noael_value":"unclear:Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: The toxicologica | l POD (75 | mg/kg/d | ay) is ta | ken in | this case as | the NOAEL fro | m the pivotal","page":50,"route":"","species":"","study_id":"sccs_o_223_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 22 | - | human | oral | - | - | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=unclear:Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: bioavailability i | n humans | , the oral | NOAEL o | f 75 | mg/kg/day i | s defined as N | OAELsys. The; DOSE=MOS for aggregate systemic exposure to cosmetic products containing salicylic: bioavailability i | n humans | , the oral | NOAEL o | f 75 | mg/kg/day i | s defined as N | OAELsys.; EFFECT=Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: bioavailability i | n humans | , the oral | NOAEL o | f 75 | mg/kg/day i | s defined as N | OAELsys. The; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"MOS for aggregate systemic exposure to cosmetic products containing salicylic: bioavailability i | n humans | , the oral | NOAEL o | f 75 | mg/kg/day i | s defined as N | OAELsys.","duration":"","effect":"Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: bioavailability i | n humans | , the oral | NOAEL o | f 75 | mg/kg/day i | s defined as N | OAELsys. The","endpoint":"","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"","noael_value":"unclear:Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic: bioavailability i | n humans | , the oral | NOAEL o | f 75 | mg/kg/day i | s defined as N | OAELsys. The","page":50,"route":"oral","species":"human","study_id":"sccs_o_223_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 75 | mg/kg/day | - | - | - | - | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=Risk Assessment Scenario | Basis for exposure assessment | Aggregate Systemic Exposure Dose (mg/kg/day) | Margin of Safety (using a NOAEL of 75 mg/kg/day); EFFECT=Unlabeled table on page 51: Risk Assessment Scenario | Basis for exposure assessment | Aggregate Systemic Exposure Dose (mg/kg/day) | Margin of Safety (using a NOAEL of 75 mg/kg/day); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"Risk Assessment Scenario | Basis for exposure assessment | Aggregate Systemic Exposure Dose (mg/kg/day) | Margin of Safety (using a NOAEL of 75 mg/kg/day)","duration":"","effect":"Unlabeled table on page 51: Risk Assessment Scenario | Basis for exposure assessment | Aggregate Systemic Exposure Dose (mg/kg/day) | Margin of Safety (using a NOAEL of 75 mg/kg/day)","endpoint":"","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":51,"route":"","species":"","study_id":"sccs_o_223_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 195 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=195; EFFECT=Unlabeled table on page 51: Scenario 1 | Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level | 0.384 | 195; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 51: Scenario 1 | Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level | 0.384 | 195","endpoint":"","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"","noael_value":"195","page":51,"route":"","species":"","study_id":"sccs_o_223_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=50; EFFECT=Unlabeled table on page 51: SCCS 2016 Notes of guidance Approach | SCCS Guidance 9th revision*; deterministic additive; maximum % level | 1.50 | 50; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 51: SCCS 2016 Notes of guidance Approach | SCCS Guidance 9th revision*; deterministic additive; maximum % level | 1.50 | 50","endpoint":"","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"","noael_value":"50","page":51,"route":"","species":"","study_id":"sccs_o_223_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 75 | mg/kg bw/d | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=75; DOSE=The MoS in Table 8 is calculated based on a NOAEL of 75 mg/kg bw/d and it is below the safe level of 100.; EFFECT=2 Toothpaste3 2.16 0.5 0.0108 0.00648 11574 Mouthwash3 32.54 0.5 0.1627 0.0976 768 Aggregate 2.67 1.67 45 1. According to values as derived in Tables 3A and 3B in the SCCS notes of guidance (11th revision) (2021). These are common values for all product types, as set by the SCCS in this model. 2. Total dermal external exposure x 60% dermal penetration (SCCS 2017) 3. No dermal penetration applied to lipstick, toothpaste and mouthwash; SCCS default 100% absorption used. The MoS in Table 8 is calculated based on a NOAEL of 75 mg/kg bw/d and it is below the safe level of 100. In accordance with a tiered approach, a probabilistic exposure assessment (see chapter 3.3.2.2) was presented by the Applicant.3.3.2.2 Probabilistic aggregate exposure assessment: Scenario 2.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"The MoS in Table 8 is calculated based on a NOAEL of 75 mg/kg bw/d and it is below the safe level of 100.","duration":"","effect":"2 Toothpaste3 2.16 0.5 0.0108 0.00648 11574 Mouthwash3 32.54 0.5 0.1627 0.0976 768 Aggregate 2.67 1.67 45 1. According to values as derived in Tables 3A and 3B in the SCCS notes of guidance (11th revision) (2021). These are common values for all product types, as set by the SCCS in this model. 2. Total dermal external exposure x 60% dermal penetration (SCCS 2017) 3. No dermal penetration applied to lipstick, toothpaste and mouthwash; SCCS default 100% absorption used. The MoS in Table 8 is calculated based on a NOAEL of 75 mg/kg bw/d and it is below the safe level of 100. In accordance with a tiered approach, a probabilistic exposure assessment (see chapter 3.3.2.2) was presented by the Applicant.3.3.2.2 Probabilistic aggregate exposure assessment: Scenario 2.","endpoint":"","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"75","page":21,"route":"dermal","species":"","study_id":"sccs_o_268_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 75 | mg/kg/day | - | - | - | - | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=75; DOSE=MoS for aggregate systemic exposure to cosmetic products containing salicylic acid, calculated by the SCCS Risk Assessment Scenario Basis for exposure assessment Aggregate Systemic Exposure Dose (SED) (mg/kg/day) Margin of Safety (using a NOAEL of 75 mg/kg/day) Probabilistic Assessment for adults 18-94:; EFFECT=rs that for this case, the probabilistic approach Scenario 2A, presented in Table 12, section 3.3.2, can be used in the safety assessment of salicylic acid. The outcomes for aggregate exposures from the different risk assessment approaches are summarised in Table 21. Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic acid, calculated by the SCCS Risk Assessment Scenario Basis for exposure assessment Aggregate Systemic Exposure Dose (SED) (mg/kg/day) Margin of Safety (using a NOAEL of 75 mg/kg/day) Probabilistic Assessment for adults 18-94: Scenario 2A (Table 12); uses maximum salicylic acid concentrations in all product categories. Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level 0.45 167 Maximum use levels of salicylic acid and associated worst case deterministic aggregate assessment - Scenario 1A According to SCCS notes of guidance (11th revision) (2021); deterministic approach 1.67 45; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"MoS for aggregate systemic exposure to cosmetic products containing salicylic acid, calculated by the SCCS Risk Assessment Scenario Basis for exposure assessment Aggregate Systemic Exposure Dose (SED) (mg/kg/day) Margin of Safety (using a NOAEL of 75 mg/kg/day) Probabilistic Assessment for adults 18-94:","duration":"","effect":"rs that for this case, the probabilistic approach Scenario 2A, presented in Table 12, section 3.3.2, can be used in the safety assessment of salicylic acid. The outcomes for aggregate exposures from the different risk assessment approaches are summarised in Table 21. Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic acid, calculated by the SCCS Risk Assessment Scenario Basis for exposure assessment Aggregate Systemic Exposure Dose (SED) (mg/kg/day) Margin of Safety (using a NOAEL of 75 mg/kg/day) Probabilistic Assessment for adults 18-94: Scenario 2A (Table 12); uses maximum salicylic acid concentrations in all product categories. Crème Care and Cosmetics model; probabilistic habits & practices; maximum % level 0.45 167 Maximum use levels of salicylic acid and associated worst case deterministic aggregate assessment - Scenario 1A According to SCCS notes of guidance (11th revision) (2021); deterministic approach 1.67 45","endpoint":"","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":50,"route":"","species":"","study_id":"sccs_o_268_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 75 | mg/kg | - | - | - | - | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=75; DOSE=Reprodu: as a no observed | adv | erse effect lev | el (NOAEL) | of | 75 mg/kg b | w/day relating | to the most; EFFECT=Table 18. Reprodu: as a no observed | adv | erse effect lev | el (NOAEL) | of | 75 mg/kg b | w/day relating | to the most; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"Reprodu: as a no observed | adv | erse effect lev | el (NOAEL) | of | 75 mg/kg b | w/day relating | to the most","duration":"","effect":"Table 18. Reprodu: as a no observed | adv | erse effect lev | el (NOAEL) | of | 75 mg/kg b | w/day relating | to the most","endpoint":"","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg","noael_value":"75","page":35,"route":"","species":"","study_id":"sccs_o_268_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 21 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=unclear:Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic: For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived; DOSE=For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived; EFFECT=Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic: For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived","duration":"","effect":"Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic: For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived","endpoint":"","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"","noael_value":"unclear:Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic: For MoS calc | ulation, SCC | S has used | the developm | ent | al NOAEL o | f 75 | mg/kg bw/ | day derived","page":50,"route":"","species":"","study_id":"sccs_o_268_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 21 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=unclear:Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic: adjustment f | or bioavailabi | lity to this | NOAEL value.; EFFECT=Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic: adjustment f | or bioavailabi | lity to this | NOAEL value.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"","duration":"","effect":"Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic: adjustment f | or bioavailabi | lity to this | NOAEL value.","endpoint":"","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"","noael_value":"unclear:Table 21: MoS for aggregate systemic exposure to cosmetic products containing salicylic: adjustment f | or bioavailabi | lity to this | NOAEL value.","page":50,"route":"","species":"","study_id":"sccs_o_268_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 5.3 | % | rat | dermal | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=5.3; DOSE=days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.; EFFECT=days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","duration":"developmental","effect":"days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"%","noael_value":"5.3","page":31,"route":"dermal","species":"rat","study_id":"sccs_o_223_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 75 | mg/kg/day | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.; EFFECT=malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973 a Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7 ± 0.6, 77.4 ± 1.0, 165 ± 2.1, 205.9 ± 18.9 mg/; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","duration":"developmental","effect":"malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973 a Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7 ± 0.6, 77.4 ± 1.0, 165 ± 2.1, 205.9 ± 18.9 mg/","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":31,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 75 | mg/kg/day | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.; EFFECT=, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973 a Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7 ± 0.6, 77.4 ± 1.0, 165 ± 2.1, 205.9 ± 18.9 mg/kg bw/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","duration":"developmental","effect":", 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973 a Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7 ± 0.6, 77.4 ± 1.0, 165 ± 2.1, 205.9 ± 18.9 mg/kg bw/d","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":31,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 150 | mg/kg | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=150; DOSE=pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.; EFFECT=pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg and the NOAEL (development): 75 mg/kg were identified. Taken from RAC (March 2016) The results of the studies demonstrated that salicylic acid has an embryo-/foetotoxic effect in rats with dose-dependent growth delays, fetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","duration":"developmental","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg and the NOAEL (development): 75 mg/kg were identified. Taken from RAC (March 2016) The results of the studies demonstrated that salicylic acid has an embryo-/foetotoxic effect in rats with dose-dependent growth delays, fetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaw","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg","noael_value":"150","page":33,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 150 | mg/kg | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=150; DOSE=ely, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.; EFFECT=ely, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg and the NOAEL (development): 75 mg/kg were identified. Taken from RAC (March 2016) The results of the studies demonstrated that salicylic acid has an embryo-/foetotoxic effect in rats with dose-dependent growth delays, fetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaway (1982) in which teratogenicity of; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"ely, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","duration":"developmental","effect":"ely, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg and the NOAEL (development): 75 mg/kg were identified. Taken from RAC (March 2016) The results of the studies demonstrated that salicylic acid has an embryo-/foetotoxic effect in rats with dose-dependent growth delays, fetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaway (1982) in which teratogenicity of","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg","noael_value":"150","page":33,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 0.1 | % | rabbit | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=0.1; DOSE=For MoS calculation, SCCS uses the developmental NOAEL of 0.1% (75 mg/kg bw/day) derived from Tanaka et al.; EFFECT=monkey studies and a negative rabbit study), human epidemiology and medical experience, the RAC considered classification of salicylic acid as Repr. 2; H361d (Suspected of damaging the unborn child) to be justified. SCCS comments SCCS agrees with RAC that salicylic acid is a developmental toxicant. Harmonised classification of salicylic acid was recently published in Regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child). For MoS calculation, SCCS uses the developmental NOAEL of 0.1% (75 mg/kg bw/day) derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is also in agreement with the previous SCCNFP Opinion (2002) and is also supported by Tanaka et al. (1973b). 3.3.7 Mutagenicity / genotoxicity 3.3.7.1 Mutagenicity / genotoxicity in vitro From SCCNFP/0522/01/2002 Studies have been performed in order to assess the mutagenic/genotoxic potential of salicylic acid and acetylsal; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"For MoS calculation, SCCS uses the developmental NOAEL of 0.1% (75 mg/kg bw/day) derived from Tanaka et al.","duration":"developmental","effect":"monkey studies and a negative rabbit study), human epidemiology and medical experience, the RAC considered classification of salicylic acid as Repr. 2; H361d (Suspected of damaging the unborn child) to be justified. SCCS comments SCCS agrees with RAC that salicylic acid is a developmental toxicant. Harmonised classification of salicylic acid was recently published in Regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child). For MoS calculation, SCCS uses the developmental NOAEL of 0.1% (75 mg/kg bw/day) derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is also in agreement with the previous SCCNFP Opinion (2002) and is also supported by Tanaka et al. (1973b). 3.3.7 Mutagenicity / genotoxicity 3.3.7.1 Mutagenicity / genotoxicity in vitro From SCCNFP/0522/01/2002 Studies have been performed in order to assess the mutagenic/genotoxic potential of salicylic acid and acetylsal","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"%","noael_value":"0.1","page":34,"route":"","species":"rabbit","study_id":"sccs_o_223_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 75 | mg/kg/day | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) The Margin of Safety is calculated by dividing the toxicological Point of Departure, POD, (in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure.; EFFECT=tic uses, it was not possible to include them in the aggregated exposure scenarios. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) The Margin of Safety is calculated by dividing the toxicological Point of Departure, POD, (in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure. The MOS's were updated by the SCCS to include a skin penetration of 60% in all calculations of systemic exposure dose. The toxicological POD (75 mg/kg/day) is taken in this case as the NOAEL from the pivotal developmental study by Tanaka et al., 1973a, for the most sensitive toxic endpoint observed in the rat as the most sensitive species. Due to the evidence for high (100%) oral bioavailability in humans, the oral NOAEL of 75 mg/kg/day is defined as NOAELsys. The outcomes for aggregate exposures from the different risk assessment approaches are summarised in Table 22. Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) The Margin of Safety is calculated by dividing the toxicological Point of Departure, POD, (in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure.","duration":"developmental","effect":"tic uses, it was not possible to include them in the aggregated exposure scenarios. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) The Margin of Safety is calculated by dividing the toxicological Point of Departure, POD, (in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure. The MOS's were updated by the SCCS to include a skin penetration of 60% in all calculations of systemic exposure dose. The toxicological POD (75 mg/kg/day) is taken in this case as the NOAEL from the pivotal developmental study by Tanaka et al., 1973a, for the most sensitive toxic endpoint observed in the rat as the most sensitive species. Due to the evidence for high (100%) oral bioavailability in humans, the oral NOAEL of 75 mg/kg/day is defined as NOAELsys. The outcomes for aggregate exposures from the different risk assessment approaches are summarised in Table 22. Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":50,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 75 | mg/kg/day | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure.; EFFECT=in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure. The MOS's were updated by the SCCS to include a skin penetration of 60% in all calculations of systemic exposure dose. The toxicological POD (75 mg/kg/day) is taken in this case as the NOAEL from the pivotal developmental study by Tanaka et al., 1973a, for the most sensitive toxic endpoint observed in the rat as the most sensitive species. Due to the evidence for high (100%) oral bioavailability in humans, the oral NOAEL of 75 mg/kg/day is defined as NOAELsys. The outcomes for aggregate exposures from the different risk assessment approaches are summarised in Table 22. Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure.","duration":"developmental","effect":"in mg/kg/day) by an estimate of the systemic exposure dose (in mg/kg/day) following dermal exposure. The MOS's were updated by the SCCS to include a skin penetration of 60% in all calculations of systemic exposure dose. The toxicological POD (75 mg/kg/day) is taken in this case as the NOAEL from the pivotal developmental study by Tanaka et al., 1973a, for the most sensitive toxic endpoint observed in the rat as the most sensitive species. Due to the evidence for high (100%) oral bioavailability in humans, the oral NOAEL of 75 mg/kg/day is defined as NOAELsys. The outcomes for aggregate exposures from the different risk assessment approaches are summarised in Table 22. Table 22. MOS for aggregate systemic exposure to cosmetic products containing salicylic","endpoint":"developmental toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":50,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 5.3 | % | rat | dermal | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=5.3; DOSE=, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.; EFFECT=, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub-cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals.","duration":"developmental","effect":", days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub-cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity","endpoint":"developmental toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"%","noael_value":"5.3","page":35,"route":"dermal","species":"rat","study_id":"sccs_o_268_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 75 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=75; DOSE=The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.; EFFECT=malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973a (Former opinion and new applicant’s dossier) Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","duration":"developmental","effect":"malformations. Koshakji & Schulert, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973a (Former opinion and new applicant’s dossier) Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7","endpoint":"developmental toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"75","page":35,"route":"oral","species":"rat","study_id":"sccs_o_268_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 75 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=75; DOSE=The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.; EFFECT=, 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973a (Former opinion and new applicant’s dossier) Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7 ± 0.6,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species.","duration":"developmental","effect":", 1973 *From this review, Tanaka et al 1973a is the pivotal study yielding the lowest NOAEL for the risk assessment. Following review of the available toxicology data, the pivotal study (for deriving the point of departure (POD) as a toxicological benchmark for the safety evaluation of salicylic acid) remains the same in this dossier as was concluded by the SCCNFP in 2002, namely the developmental toxicity study on salicylic acid by Tanaka et al., 1973a. The POD is expressed as a no observed adverse effect level (NOAEL) of 75 mg/kg bw/day relating to the most sensitive toxic endpoint i.e. teratogenicity in the rat as the most sensitive species. Tanaka et al., 1973a (Former opinion and new applicant’s dossier) Guideline/method: Equivalent to OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: Rat/Wistar Group size: 20 females per dose Test substance: Test substance: salicylic acid; 0.5% in CMC (carboxymethyl cellulose); No other data Batch: Dose levels: 0.06%, 0.1%, 0.2% and 0.4% in the diet (50.7 ± 0.6,","endpoint":"developmental toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"75","page":35,"route":"oral","species":"rat","study_id":"sccs_o_268_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 150 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=150; DOSE=pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.; EFFECT=pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg bw/day and the NOAEL (development): 75 mg/kg bw/day were identified. Taken from RAC (March 2016, former Opinion) The results of the studies demonstrated that salicylic acid has an embryo-/fetotoxic effect in rats with dose-dependent growth delays, foetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","duration":"developmental","effect":"pring were 0%, 5.0% and 0% respectively, for the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg bw/day and the NOAEL (development): 75 mg/kg bw/day were identified. Taken from RAC (March 2016, former Opinion) The results of the studies demonstrated that salicylic acid has an embryo-/fetotoxic effect in rats with dose-dependent growth delays, foetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the","endpoint":"developmental toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"150","page":37,"route":"oral","species":"rat","study_id":"sccs_o_268_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 150 | mg/kg bw/day | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=150; DOSE=r the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.; EFFECT=r the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg bw/day and the NOAEL (development): 75 mg/kg bw/day were identified. Taken from RAC (March 2016, former Opinion) The results of the studies demonstrated that salicylic acid has an embryo-/fetotoxic effect in rats with dose-dependent growth delays, foetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaway (1982) in w; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"r the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group.","duration":"developmental","effect":"r the 75 mg/kg group and 13.7%, 17.2% and 79.2% respectively, for the 150 mg/kg group. Under the conditions of the present experiment, salicylic acid administered by gavage is embryotoxic in the rats and induces malformations at maternally toxic doses. The teratogenic effect of salicylic acid may be considered as possibly due to direct action of the agent on the foetus, since a relative distribution of the agent was found in the foetus through the placental barrier. The NOAEL (maternal): 150 mg/kg bw/day and the NOAEL (development): 75 mg/kg bw/day were identified. Taken from RAC (March 2016, former Opinion) The results of the studies demonstrated that salicylic acid has an embryo-/fetotoxic effect in rats with dose-dependent growth delays, foetal death and malformations. Early developmental effects were clearly seen in the absence of maternal effects. The teratogenicity of salicylic acid may be attributable to a direct action of the compound. This finding is further supported by the mechanistic study of Greenaway (1982) in w","endpoint":"developmental toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"150","page":37,"route":"oral","species":"rat","study_id":"sccs_o_268_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 75 | mg/kg bw/day | - | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=75; DOSE=For MoS calculations, the SCCS will use the developmental toxicity NOAEL of 75 mg/kg bw/day derived from Tanaka et al.; EFFECT=the RAC considered classification of salicylic acid as Repr. 2; H361d (Suspected of damaging the unborn child) to be justified. SCCS comments The SCCS maintains its previous opinion (SCCS/1601/18) and agrees with RAC that salicylic acid is a developmental toxicant. Harmonised classification of salicylic acid has recently been published in Regulation 2018/1480, where it has been classified as Repr. 2 (H361d Suspected of damaging the unborn child). For MoS calculations, the SCCS will use the developmental toxicity NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is also in agreement with the previous SCCNFP Opinion (2002) and supported by Tanaka et al. (1973b). 3.5.6 Mutagenicity / genotoxicity A range of studies have been performed to assess the mutagenic/genotoxic potential of salicylic acid. These studies were assessed and commented upon by the SCCS in the previous Opinion (SCCS/1601/18); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"For MoS calculations, the SCCS will use the developmental toxicity NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","duration":"developmental","effect":"the RAC considered classification of salicylic acid as Repr. 2; H361d (Suspected of damaging the unborn child) to be justified. SCCS comments The SCCS maintains its previous opinion (SCCS/1601/18) and agrees with RAC that salicylic acid is a developmental toxicant. Harmonised classification of salicylic acid has recently been published in Regulation 2018/1480, where it has been classified as Repr. 2 (H361d Suspected of damaging the unborn child). For MoS calculations, the SCCS will use the developmental toxicity NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is also in agreement with the previous SCCNFP Opinion (2002) and supported by Tanaka et al. (1973b). 3.5.6 Mutagenicity / genotoxicity A range of studies have been performed to assess the mutagenic/genotoxic potential of salicylic acid. These studies were assessed and commented upon by the SCCS in the previous Opinion (SCCS/1601/18)","endpoint":"developmental toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"75","page":38,"route":"","species":"","study_id":"sccs_o_268_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 75 | mg/kg bw/day | - | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=75; DOSE=For MoS calculation, SCCS has used the developmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.; EFFECT=d. More specific studies using salicylic acid need to be performed to conclude on the ED properties of salicylic acid. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) According to the Applicant, salicylic acid can be used in 17 product categories (the standard 17 product types of cosmetic products that could lead to exposure by different routes – dermal and oral (but not by inhalation) – therefore, aggregated exposure must be taken into consideration. For MoS calculation, SCCS has used the developmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is in agreement with the previous SCCNFP Opinion (2002), the previous SCCS Opinion (SCCS/1601/2018) and it is also supported by Tanaka et al. (1973b). Because of the evidence for rapid and almost complete absorption of salicylic acid from the oral route, the SCCS has not applied any adjustment for bioavailability to this NOAEL value.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"For MoS calculation, SCCS has used the developmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","duration":"developmental","effect":"d. More specific studies using salicylic acid need to be performed to conclude on the ED properties of salicylic acid. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MoS) According to the Applicant, salicylic acid can be used in 17 product categories (the standard 17 product types of cosmetic products that could lead to exposure by different routes – dermal and oral (but not by inhalation) – therefore, aggregated exposure must be taken into consideration. For MoS calculation, SCCS has used the developmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is in agreement with the previous SCCNFP Opinion (2002), the previous SCCS Opinion (SCCS/1601/2018) and it is also supported by Tanaka et al. (1973b). Because of the evidence for rapid and almost complete absorption of salicylic acid from the oral route, the SCCS has not applied any adjustment for bioavailability to this NOAEL value.","endpoint":"developmental toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"75","page":50,"route":"oral","species":"","study_id":"sccs_o_268_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 60 | % | - | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=60; DOSE=pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.; EFFECT=pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is in agreement with the previous SCCNFP Opinion (2002), the previous SCCS Opinion (SCCS/1601/2018) and it is also supported by Tanaka et al. (1973b). Because of the evidence for rapid and almost complete absorption of salicylic acid from the oral route, the SCCS has not applied any adjustment for bioavailability to this NOAEL value. Details of the calculation of systemic exposure dose (SED) are given in the Tables presented in section 3.3.2. A generic maximal value for skin penetration of salicylic acid of 60% (see section 3.2.1) has been used for all products in these calculations where dermal absorption needs to be factored in to calculate a systemic exposure dose (SED). For lipstick and oral care products, a worst-case value of 100% absorption is used for passage across the oral mucosa. The SCCS considers that for this case, the p; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","duration":"developmental","effect":"pmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is in agreement with the previous SCCNFP Opinion (2002), the previous SCCS Opinion (SCCS/1601/2018) and it is also supported by Tanaka et al. (1973b). Because of the evidence for rapid and almost complete absorption of salicylic acid from the oral route, the SCCS has not applied any adjustment for bioavailability to this NOAEL value. Details of the calculation of systemic exposure dose (SED) are given in the Tables presented in section 3.3.2. A generic maximal value for skin penetration of salicylic acid of 60% (see section 3.2.1) has been used for all products in these calculations where dermal absorption needs to be factored in to calculate a systemic exposure dose (SED). For lipstick and oral care products, a worst-case value of 100% absorption is used for passage across the oral mucosa. The SCCS considers that for this case, the p","endpoint":"developmental toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"%","noael_value":"60","page":50,"route":"oral","species":"","study_id":"sccs_o_268_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 0.1 | % | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=0.1; DOSE=Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.; EFFECT=n rats and are summarised in table 9. Table 9. Reproductive and developmental animal studies with salicylic acid. Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at par; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.","duration":"developmental","effect":"n rats and are summarised in table 9. Table 9. Reproductive and developmental animal studies with salicylic acid. Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at par","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"%","noael_value":"0.1","page":31,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 75 | mg/kg/day | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.; EFFECT=& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Kos; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%.","duration":"","effect":"& 0.4 % in diet (50 to 200 mg/kg/day) Maternal mortality 0%. 0.4%: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2%: growth retardation, skeletal abnormalities. 0.1% and 0.06% no significant adverse effects. NOAEL 0.1% (approx. 75 mg/kg/day) Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8- 14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26% fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub- cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Kos","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":31,"route":"oral","species":"rat","study_id":"sccs_o_223_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 75 | mg/kg bw/day | mouse | - | Developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=75; DOSE=2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS.; EFFECT=ess. Reproductive toxicity SCCS concludes that there is insufficient evidence that salicylic acid has an adverse effect on sexual function and fertility. Developmental Toxicity SCCS agrees that salicylic acid can be considered as a developmental toxicant. Harmonised classification of salicylic acid was recently published in regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS. Mutagenicity / genotoxicity The genotoxicity of salicylic acid was investigated with valid genotoxicity tests for in vitro gene mutations, in both bacterial and mammalian test system. Although no valid in vitro test results on chromosomal aberrations were provided, the in vivo chromosomal aberration and sister chromatid exchange tests in mice showed no mutagenic activity of salicylic acid. Based on the submitted studies and available literature, the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS.","duration":"Developmental","effect":"ess. Reproductive toxicity SCCS concludes that there is insufficient evidence that salicylic acid has an adverse effect on sexual function and fertility. Developmental Toxicity SCCS agrees that salicylic acid can be considered as a developmental toxicant. Harmonised classification of salicylic acid was recently published in regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child).As the developmental effects are the most sensitive effects after repeated exposure to SA, the NOAEL of 75 mg/kg bw/day has been used for the calculation of the MoS. Mutagenicity / genotoxicity The genotoxicity of salicylic acid was investigated with valid genotoxicity tests for in vitro gene mutations, in both bacterial and mammalian test system. Although no valid in vitro test results on chromosomal aberrations were provided, the in vivo chromosomal aberration and sister chromatid exchange tests in mice showed no mutagenic activity of salicylic acid. Based on the submitted studies and available literature, the","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"75","page":53,"route":"","species":"mouse","study_id":"sccs_o_223_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 0.1 | % | - | - | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=0.1; EFFECT=Table 9. Reproductive a: NOAEL 0.1%; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"","duration":"","effect":"Table 9. Reproductive a: NOAEL 0.1%","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"%","noael_value":"0.1","page":31,"route":"","species":"","study_id":"sccs_o_223_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 9 | - | - | - | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=unclear:Table 9. Reproductive a: group | NOAEL 75 mg/ | kg/day; EFFECT=Table 9. Reproductive a: group | NOAEL 75 mg/ | kg/day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"","duration":"","effect":"Table 9. Reproductive a: group | NOAEL 75 mg/ | kg/day","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"","noael_value":"unclear:Table 9. Reproductive a: group | NOAEL 75 mg/ | kg/day","page":31,"route":"","species":"","study_id":"sccs_o_223_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 9 | - | - | - | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_223; REPORT_TITLE=Final Opinion Corrigendum of 20-21 June 2019 Scientific Committee on Consumer Safety SCCS OPINION ON salicylic acid (CAS 69-72-7); OPINION_NUMBER=SCCS/1601/18; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2018; VALUE_TEXT=unclear:Table 9. Reproductive a: *From this review, T | ana | ka et al 1 | 97 | 3a is th | e piv | ot | al | study yieldin | g the lowest NOAEL | for the risk; EFFECT=Table 9. Reproductive a: *From this review, T | ana | ka et al 1 | 97 | 3a is th | e piv | ot | al | study yieldin | g the lowest NOAEL | for the risk; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"","duration":"","effect":"Table 9. Reproductive a: *From this review, T | ana | ka et al 1 | 97 | 3a is th | e piv | ot | al | study yieldin | g the lowest NOAEL | for the risk","endpoint":"reproductive toxicity","ingredient":"codes ............................................... 8","loael_value":"","noael_unit":"","noael_value":"unclear:Table 9. Reproductive a: *From this review, T | ana | ka et al 1 | 97 | 3a is th | e piv | ot | al | study yieldin | g the lowest NOAEL | for the risk","page":31,"route":"","species":"","study_id":"sccs_o_223_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 75 | mg/kg/day | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=75; DOSE=Reproductive and developmental animal studies with salicylic acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%.; EFFECT=__________________________ 35 Table 18. Reproductive and developmental animal studies with salicylic acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%. 0.4 %: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2 %: growth retardation, skeletal abnormalities. 0.1 % and 0.06 % no significant adverse effects. NOAEL approx. 75 mg/kg/day Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26 % fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturitio; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"Reproductive and developmental animal studies with salicylic acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%.","duration":"developmental","effect":"__________________________ 35 Table 18. Reproductive and developmental animal studies with salicylic acid Species Test article Route of exposure Dosage Results Reference Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 0.06, 0.1, 0.2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%. 0.4 %: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2 %: growth retardation, skeletal abnormalities. 0.1 % and 0.06 % no significant adverse effects. NOAEL approx. 75 mg/kg/day Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26 % fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturitio","endpoint":"reproductive toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":35,"route":"oral","species":"rat","study_id":"sccs_o_268_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 75 | mg/kg/day | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=75; DOSE=2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%.; EFFECT=2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%. 0.4 %: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2 %: growth retardation, skeletal abnormalities. 0.1 % and 0.06 % no significant adverse effects. NOAEL approx. 75 mg/kg/day Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26 % fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub-cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Kosh; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%.","duration":"","effect":"2 & 0.4 % in diet (50 to 200 mg/kg/ day) Maternal mortality 0%. 0.4 %: body weight loss, toxic symptoms, 71% neonatal mortality and growth retardation in foetuses. 0.2 %: growth retardation, skeletal abnormalities. 0.1 % and 0.06 % no significant adverse effects. NOAEL approx. 75 mg/kg/day Tanaka et al 1973a* Wistar Rat 20 per group Salicylic acid Oral, days 8-14 of gestation 75, 150 or 300 mg/kg once daily 300 mg/kg/day: 3 dams died; 100% fetal mortality. 150 mg/kg/day: 26 % fetal mortality, reproductive effects. NOAEL 75 mg/kg/day Tanaka et al 1973b* Sprague Dawley Rat n = 10 Salicylic acid Oral, 10 mg/kg twice daily, days 20 &21 of gestation 20 mg/kg/day Increase in time of onset of parturition; duration of parturition increased in one animal; increased bleeding at parturition in 4 animals. No fetal deaths. Waltman et al., 1973 Sprague Dawley Rat n = 17 Salicylic acid Sub-cutaneous dose on day 9 of gestation 380 mg/kg/day Marked maternal weight loss; decreased fetal weight; 46.6% resorption rate, 5.3% fetal malformations. Kosh","endpoint":"reproductive toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":35,"route":"oral","species":"rat","study_id":"sccs_o_268_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 2018 | - | human | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=unclear:ibed and is assessed to be of high quality. The study provides strong evidence of adverse effects of acetylsalicylic acid on male sexual development leading to congenital cryptorchidism. Labib, 2018: These authors published a kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrating no evidence of a health risk from developmental toxicity. Briefly, they performed a safety reassessment in which margins of safety (MoS) were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with acetylsalicylic acid, rapidly converted to salicylic acid in plasma, human salicylic acid plasma levels from oral exposure to acetylsalicylic acid and human dermal exposure to salicylic acid-containing cosmetic products. In addition, they performed a literature review and showed that there are no adverse developmental effects despite extensive human clinical oral use of acetylsalicylic acid up to the maximum recommended therapeutic doses. The pl; EFFECT=ibed and is assessed to be of high quality. The study provides strong evidence of adverse effects of acetylsalicylic acid on male sexual development leading to congenital cryptorchidism. Labib, 2018: These authors published a kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrating no evidence of a health risk from developmental toxicity. Briefly, they performed a safety reassessment in which margins of safety (MoS) were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with acetylsalicylic acid, rapidly converted to salicylic acid in plasma, human salicylic acid plasma levels from oral exposure to acetylsalicylic acid and human dermal exposure to salicylic acid-containing cosmetic products. In addition, they performed a literature review and showed that there are no adverse developmental effects despite extensive human clinical oral use of acetylsalicylic acid up to the maximum recommended therapeutic doses. The pl; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"","duration":"developmental","effect":"ibed and is assessed to be of high quality. The study provides strong evidence of adverse effects of acetylsalicylic acid on male sexual development leading to congenital cryptorchidism. Labib, 2018: These authors published a kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrating no evidence of a health risk from developmental toxicity. Briefly, they performed a safety reassessment in which margins of safety (MoS) were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with acetylsalicylic acid, rapidly converted to salicylic acid in plasma, human salicylic acid plasma levels from oral exposure to acetylsalicylic acid and human dermal exposure to salicylic acid-containing cosmetic products. In addition, they performed a literature review and showed that there are no adverse developmental effects despite extensive human clinical oral use of acetylsalicylic acid up to the maximum recommended therapeutic doses. The pl","endpoint":"reproductive toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"","noael_value":"unclear:ibed and is assessed to be of high quality. The study provides strong evidence of adverse effects of acetylsalicylic acid on male sexual development leading to congenital cryptorchidism. Labib, 2018: These authors published a kinetic-based safety assessment of consumer exposure to salicylic acid from cosmetic products demonstrating no evidence of a health risk from developmental toxicity. Briefly, they performed a safety reassessment in which margins of safety (MoS) were calculated based on literature data on the NOAEL plasma exposure levels from animal reproductive toxicity studies with acetylsalicylic acid, rapidly converted to salicylic acid in plasma, human salicylic acid plasma levels from oral exposure to acetylsalicylic acid and human dermal exposure to salicylic acid-containing cosmetic products. In addition, they performed a literature review and showed that there are no adverse developmental effects despite extensive human clinical oral use of acetylsalicylic acid up to the maximum recommended therapeutic doses. The pl","page":45,"route":"oral","species":"human","study_id":"sccs_o_268_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 75 | mg/kg bw/day | - | - | Developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_268; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on salicylic acid (CAS No. 69-72-7, EC No. 200-712-3); OPINION_NUMBER=SCCS/1646/22; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=7 June 2023; VALUE_TEXT=75; DOSE=For MoS calculation, the SCCS has used the developmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.; EFFECT=ly available data, the SCCS considers that salicylic acid should not be regarded as a reproductive toxicant for the fertility endpoints. Developmental Toxicity As mentioned in the previous Opinion, SCCS maintains its opinion and agrees with RAC that salicylic acid is a developmental toxicant. Harmonised classification of salicylic acid was recently published in Regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child). For MoS calculation, the SCCS has used the developmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is also in agreement with the previous SCCNFP Opinion (2002) and also supported by Tanaka et al. (1973b). Mutagenicity / genotoxicity The SCCS comments are based on available, i.e. currently and previously submitted data on mutagenicity testing of salicylic acid. The genotoxicity of salicylic acid was investigated with valid genotoxi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"69-72-7","citation":"","dose":"For MoS calculation, the SCCS has used the developmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al.","duration":"Developmental","effect":"ly available data, the SCCS considers that salicylic acid should not be regarded as a reproductive toxicant for the fertility endpoints. Developmental Toxicity As mentioned in the previous Opinion, SCCS maintains its opinion and agrees with RAC that salicylic acid is a developmental toxicant. Harmonised classification of salicylic acid was recently published in Regulation 2018/1480 and is classified as Repr. 2 (H361d Suspected of damaging the unborn child). For MoS calculation, the SCCS has used the developmental NOAEL of 75 mg/kg bw/day derived from Tanaka et al. (1973a). The developmental effects observed in this study are the most sensitive effects after repeated exposure to salicylic acid. This is also in agreement with the previous SCCNFP Opinion (2002) and also supported by Tanaka et al. (1973b). Mutagenicity / genotoxicity The SCCS comments are based on available, i.e. currently and previously submitted data on mutagenicity testing of salicylic acid. The genotoxicity of salicylic acid was investigated with valid genotoxi","endpoint":"reproductive toxicity","ingredient":"for purposes other than inhibiting","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"75","page":53,"route":"","species":"","study_id":"sccs_o_268_noael_014"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | O414PZ4LPZ | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"O414PZ4LPZ"} |
| openFDA substances | FDA UNII substance identifier | O414PZ4LPZ | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"O414PZ4LPZ"} |
| openFDA substances | FDA UNII substance identifier | O414PZ4LPZ | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"O414PZ4LPZ"} |
| openFDA substances | FDA UNII substance identifier | O414PZ4LPZ | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"O414PZ4LPZ"} |