NOAEL Studies
Fragrance
Benzyl Salicylate NOAEL Studies
INCI: BENZYL SALICYLATE
CAS: 118-58-1
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
EFSA 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA | NOAEL | =5 | mg/kg bw/day | Rat | oral: unspecified | 91 days | subchronic | EFSA FEEDAP - 2012 - OutputID 607 - body weight - systemic - Scientific Opinion on the safety and efficacy of benzyl alcohols, aldehydes, acids, esters and acetals (chemical group 23) when used as flavourings for all animal species - doi:10.2903/j.efsa.2012.2785 |
| EFSA | NOAEL | =5 | mg/kg bw/day | Rat | oral: unspecified | 91 days | subchronic | EFSA FEEDAP - 2012 - OutputID 607 - body weight - systemic - Scientific Opinion on the safety and efficacy of benzyl alcohols, aldehydes, acids, esters and acetals (chemical group 23) when used as flavourings for all animal species - doi:10.2903/j.efsa.2012.2785 |
| EFSA | NOAEL | =5 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=EFSA FEEDAP (2012). Scientific Opinion on the safety and efficacy of benzyl alcohols, aldehydes, acids, esters and acetals (chemical group 23) when used as flavourings for all animal species. doi:10.2903/j.efsa.2012.2785.; TITLE=Scientific Opinion on the safety and efficacy of benzyl alcohols, aldehydes, acids, esters and acetals (chemical group 23) when used as flavourings for all animal species; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2012.2785; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=EFSA:15614201:-:--; 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_878fe799dcb39d5199e72b7d893f3c50 |
NTP ICE acute oral 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE acute oral | LD50 | =2227 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM ChemIDplus TEST (undated); record_id=acute_oral_1516; row=2624; data_type=In Vivo; mixture=Chemical; chemical_name=Benzyl salicylate; preferred_name=Benzyl salicylate; dtxsid=DTXSID1024598; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1024598; source_file=acute_oral.xlsx |
NTP ICE adme parameters 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE adme parameters | Clint | 841 | uL/min/10^6 cells | Human | - | - | Measured; httk, Human Hepatic Intrinsic Clearance | sheet=Data; excel_row=570; Record_ID=adme_parameters_898; Data_Type=Measured; DTXSID=DTXSID1024598; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=841.0; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE adme parameters | Fu | 3.35e-8 | fraction | Human | - | - | Measured; httk, Human Plasma Fraction Unbound | sheet=Data; excel_row=569; Record_ID=adme_parameters_898; Data_Type=Measured; DTXSID=DTXSID1024598; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=3.35e-08; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
NTP ICE endocrine 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE endocrine | AC50 | 53.9165290737662 | uM | - | - | - | ERPathway2016; ER Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=5448; RecordID=ERPathway2016_375; DatasetName=ERPathway2016; DTXSID=DTXSID1024598; Assay=ER Pathway Model, Antagonist; Endpoint=AC50; Response=53.9165290737662; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE endocrine | ACC | 42.9334269653505 | uM | - | - | - | ERPathway2016; ER Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=5449; RecordID=ERPathway2016_375; DatasetName=ERPathway2016; DTXSID=DTXSID1024598; Assay=ER Pathway Model, Antagonist; Endpoint=ACC; Response=42.9334269653505; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE endocrine | LOEL | 3.7 | mg/kg bw/day | Rat | Oral | Treatment_Duration=3 days; Age_at_First_Dose=PND 21; Time_Elapsed_Between_Last_Dose_and_Necropsy=24 hours; Number_of_Doses_Tested=5 | In Vivo; Uterotrophic-Agonist | sheet=Data_invivo; excel_row=767; Record_ID=endocrine_invivo_34; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Uterotrophic-Agonist; Endpoint=LOEL; Response=3.7; Response_Unit=mg/kg/day; Species=Rat; Reported_Strain=SD; Strain=Sprague-Dawley; Sex=Female; Route=Oral; Maximum_Dose=100; Maximum_Dose_Units=mg/kg/day; Reference_Hormone=Estradiol; Reference=Zhang et al. 2012; 22197706; 10.1016/j.toxlet.2011.12.004|Kleinstreuer et al. 2016; 26431337; 10.1289/ehp.1510183; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=5444; RecordID=ARPathway2016_648; DatasetName=ARPathway2016; DTXSID=DTXSID1024598; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE endocrine | Model Score | 0.013 | unitless | - | - | - | ERPathway2016; ER Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=5450; RecordID=ERPathway2016_375; DatasetName=ERPathway2016; DTXSID=DTXSID1024598; Assay=ER Pathway Model, Agonist; Endpoint=Model Score; Response=0.013; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE endocrine | Uterine weight increase vs control | 140 | % | Rat | Oral | Treatment_Duration=3 days; Age_at_First_Dose=PND 21; Time_Elapsed_Between_Last_Dose_and_Necropsy=24 hours; Number_of_Doses_Tested=5 | In Vivo; Uterotrophic-Agonist | sheet=Data_invivo; excel_row=2236; Record_ID=endocrine_invivo_34; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Uterotrophic-Agonist; Endpoint=Uterine weight increase vs control; Response=140; Response_Unit=%; Species=Rat; Reported_Strain=SD; Strain=Sprague-Dawley; Sex=Female; Route=Oral; Maximum_Dose=100; Maximum_Dose_Units=mg/kg/day; Reference_Hormone=Estradiol; Reference=Zhang et al. 2012; 22197706; 10.1016/j.toxlet.2011.12.004|Kleinstreuer et al. 2016; 26431337; 10.1289/ehp.1510183; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
NTP ICE skin irritation 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE skin irritation | Positive reaction | 0 | % | Human | Dermal | - | In Vivo; Four-hour Human Patch Test | sheet=Data_invivo; excel_row=402; Record_ID=skin_irritation_invivo_34; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Four-hour Human Patch Test; Endpoint=Positive reaction; Response=0; Response_Unit=%; Species=Human; Reference=Basketter et al. 2004; 15291823; 10.1111/j.0105-1873.2004.00385.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin irritation | Viability | 87.8 | % | - | Dermal | - | In Vitro; EpiDerm Irritation | sheet=Data_invitro; excel_row=979; Record_ID=skin_irritation_invitro_507; Data_Type=In Vitro; Formulation_Name=Benzyl salicylate; Concentration=99; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=EpiDerm Irritation; Endpoint=Viability; Response=87.8; Response_Unit=%; Reference=Kandarova et al. 2005; 16185104; 10.1177/026119290503300408; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin irritation | Viability | 93.74 | % | - | Dermal | - | In Vitro; EpiSkin Irritation | sheet=Data_invitro; excel_row=988; Record_ID=skin_irritation_invitro_503; Data_Type=In Vitro; Formulation_Name=Benzyl salicylate; Concentration=98; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=EpiSkin Irritation; Endpoint=Viability; Response=93.74; Response_Unit=%; Reference=Cotovio et al. 2005; 16185103; 10.1177/026119290503300403; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin irritation | Viability | 101 | % | - | Dermal | - | In Vitro; EpiDerm Irritation | sheet=Data_invitro; excel_row=981; Record_ID=skin_irritation_invitro_509; Data_Type=In Vitro; Formulation_Name=Benzyl salicylate; Concentration=99; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=EpiDerm Irritation; Endpoint=Viability; Response=101; Response_Unit=%; Reference=Kandarova et al. 2005; 16185104; 10.1177/026119290503300408; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin irritation | Viability | 103.2 | % | - | Dermal | - | In Vitro; EpiDerm Irritation | sheet=Data_invitro; excel_row=978; Record_ID=skin_irritation_invitro_511; Data_Type=In Vitro; Formulation_Name=Benzyl salicylate; Concentration=99; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=EpiDerm Irritation; Endpoint=Viability; Response=103.2; Response_Unit=%; Reference=Kandarova et al. 2005; 16185104; 10.1177/026119290503300408; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin irritation | Viability | 121.37 | % | - | Dermal | - | In Vitro; EpiSkin Irritation | sheet=Data_invitro; excel_row=980; Record_ID=skin_irritation_invitro_504; Data_Type=In Vitro; Formulation_Name=Benzyl salicylate; Concentration=98; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=EpiSkin Irritation; Endpoint=Viability; Response=121.37; Response_Unit=%; Reference=Cotovio et al. 2005; 16185103; 10.1177/026119290503300403; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin irritation | Viability (18 hours) | 115.7 | % | - | Dermal | - | In Vitro; Vitrolife-Skin Irritation | sheet=Data_invitro; excel_row=987; Record_ID=skin_irritation_invitro_202; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Vitrolife-Skin Irritation; Endpoint=Viability (18 hours); Response=115.7; Response_Unit=%; Reference=Morikawa et al. 2008; Not available; 10.11232/AATEX.13.11; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin irritation | Viability (42 hours) | 77 | % | - | Dermal | - | In Vitro; Vitrolife-Skin Irritation | sheet=Data_invitro; excel_row=982; Record_ID=skin_irritation_invitro_202; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Vitrolife-Skin Irritation; Endpoint=Viability (42 hours); Response=77; Response_Unit=%; Reference=Morikawa et al. 2008; Not available; 10.11232/AATEX.13.11; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
NTP ICE skin sensitization 27 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE skin sensitization | CD86, EC150 | 66.17 | ug/mL | - | Dermal | - | In Vitro; CE_USENSE2018; U-SENS | sheet=Data_invitro; excel_row=8659; Record_ID=skin_sensitization_invitro_2396; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=66.17; Reported_Response_Unit=ug/mL; Response=66.17; 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/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | CV75 | 38 | ug/mL | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; h-CLAT | sheet=Data_invitro; excel_row=1658; Record_ID=skin_sensitization_invitro_406; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=h-CLAT; Endpoint=CV75; Reported_Response=38; Reported_Response_Unit=ug/mL; Response=38; 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/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Concentration, 5% incidence of positive responses | 12.5 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4095; Record_ID=skin_sensitization_invivo_994; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Concentration, 5% incidence of positive responses; Response=12.5; Response_Unit=%; Species=Human; Route=Dermal; Reference=RIFM 1980; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Concentration, 5% incidence of positive responses | 25 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4110; Record_ID=skin_sensitization_invivo_998; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Concentration, 5% incidence of positive responses; Response=25; Response_Unit=%; Species=Human; Route=Dermal; Reference=RIFM 1979; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Concentration, one positive response | 10 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4091; Record_ID=skin_sensitization_invivo_994; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Concentration, one positive response; Response=10; Response_Unit=%; Species=Human; Route=Dermal; Reference=RIFM 1980; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Concentration, one positive response | 20 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4106; Record_ID=skin_sensitization_invivo_998; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Concentration, one positive response; Response=20; Response_Unit=%; Species=Human; Route=Dermal; Reference=RIFM 1979; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Depletion Cys | 3.8 | % | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; DPRA | sheet=Data_invitro; excel_row=103; Record_ID=skin_sensitization_invitro_28; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=3.8; Reported_Response_Unit=%; Response=3.8; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Depletion Lys | 1.5 | % | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; DPRA | sheet=Data_invitro; excel_row=160; Record_ID=skin_sensitization_invitro_28; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=1.5; Reported_Response_Unit=%; Response=1.5; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | EC1.5 | 8.422 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=4798; Record_ID=skin_sensitization_invitro_1108; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=8.4220000000000006; Reported_Response_Unit=uM; Response=8.422; 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/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | EC3 | 2.8 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13002; Record_ID=skin_sensitization_invivo_2951; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=LLNA; Endpoint=EC3; Response=2.8; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Kern et al. 2010; 20137736; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | EC3 | 2.9 | % | Mouse | Dermal | - | In Vivo; Urbisch_SkinSensitization2020; LLNA | sheet=Data_invivo; excel_row=12793; Record_ID=skin_sensitization_invivo_2802; Data_Type=In Vivo; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=LLNA; Endpoint=EC3; Response=2.9; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | EC3 | 40.88 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=4800; Record_ID=skin_sensitization_invitro_1108; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=KeratinoSens; Endpoint=EC3; Reported_Response=40.881999999999998; Reported_Response_Unit=uM; Response=40.88; 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/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | IC50 | 110.98 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=4802; Record_ID=skin_sensitization_invitro_1108; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=110.98; Reported_Response_Unit=uM; Response=110.98; 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/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Imax | 5.51 | ratio | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=4804; Record_ID=skin_sensitization_invitro_1108; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=5.51; Reported_Response_Unit=Unitless; Response=5.51; 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/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Incidence of positive responses | 0 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4094; Record_ID=skin_sensitization_invivo_996; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=30.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=RIFM 1975; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2008; 18406028; 10.1016/j.yrtph.2007.10.008|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Incidence of positive responses | 4 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4103; Record_ID=skin_sensitization_invivo_998; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=4; Response_Unit=%; Species=Human; Route=Dermal; Reference=RIFM 1979; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Incidence of positive responses | 8 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4088; Record_ID=skin_sensitization_invivo_994; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=8; Response_Unit=%; Species=Human; Route=Dermal; Reference=RIFM 1980; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Induction dose per skin area | 6200 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=4115; Record_ID=skin_sensitization_invivo_1000; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area; Response=6200; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=RIFM 1975; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2008; 18406028; 10.1016/j.yrtph.2007.10.008|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Induction dose per skin area | 13500 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4087; Record_ID=skin_sensitization_invivo_994; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=13500; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=RIFM 1980; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Induction dose per skin area | 17720 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=4122; Record_ID=skin_sensitization_invivo_1001; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=15.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area; Response=17720; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=RIFM 2004; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2008; 18406028; 10.1016/j.yrtph.2007.10.008|Basketter et al. 2014; 24407057; 10.1097/der.0000000000000003|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Induction dose per skin area | 19440 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4116; Record_ID=skin_sensitization_invivo_995; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=30.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=19440; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Kligman 1970: report to RIFM|RIFM 1970; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Opdyke 1973; Not available; 10.1016/0015-6264(73)90236-8|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Induction dose per skin area | 20250 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4092; Record_ID=skin_sensitization_invivo_996; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=30.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=20250; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=RIFM 1975; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2008; 18406028; 10.1016/j.yrtph.2007.10.008|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Induction dose per skin area, 5% incidence of positive responses | 8438 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4097; Record_ID=skin_sensitization_invivo_994; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Induction dose per skin area, 5% incidence of positive responses; Response=8438; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=RIFM 1980; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Induction dose per skin area, 5% incidence of positive responses | 16880 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4112; Record_ID=skin_sensitization_invivo_998; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Induction dose per skin area, 5% incidence of positive responses; Response=16880; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=RIFM 1979; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Induction dose per skin area, one positive response | 6750 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4093; Record_ID=skin_sensitization_invivo_994; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=20.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Induction dose per skin area, one positive response; Response=6750; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=RIFM 1980; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Relative reliability score | 3 | unitless | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=4090; Record_ID=skin_sensitization_invivo_995; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=30.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=3; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Kligman 1970: report to RIFM|RIFM 1970; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Opdyke 1973; Not available; 10.1016/0015-6264(73)90236-8|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
| NTP ICE skin sensitization | Relative reliability score | 4 | unitless | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=4113; Record_ID=skin_sensitization_invivo_999; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=5.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1024598; Assay=Human Repeat Insult Patch Test; Endpoint=Relative reliability score; Response=4; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=RIFM 1968; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066|Lapczynski et al. 2007; 18035470; 10.1016/j.fct.2007.09.036|Api et al. 2015; 25430073; 10.3109/15569527.2014.979425; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1024598; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1024598 |
SCCS Opinion 80 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS Opinion | NOAEL | =0 | - | rat | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: Salicylate when administere | d via the diet | to | Sprague Dawley rat | s for at least 9 | 0 consecutive","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_026"} |
| SCCS Opinion | NOAEL | =0 | - | rat | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: Salicylate when administere | d via the diet | to | Sprague Dawley rat | s for at least 9 | 0 consecutive","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_026"} |
| SCCS Opinion | NOAEL | =0 | - | rat | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: Salicylate when administere | d via the diet | to | Sprague Dawley rat | s for at least 9 | 0 consecutive","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_026"} |
| SCCS Opinion | NOAEL | =0 | - | rat | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: Salicylate when administere | d via the diet | to | Sprague Dawley rat | s for at least 9 | 0 consecutive","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_026"} |
| SCCS Opinion | NOAEL | =3.4 | - | - | oral | 28 days | NOAEL study | {"effect":"Table 21: Oral (gavage) re: 3.4.4.1 Repeated dos | e (28 days) | oral | / dermal / inhalatio | n toxicity","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_022"} |
| SCCS Opinion | NOAEL | =3.4 | - | - | oral | 28 days | NOAEL study | {"effect":"Table 21: Oral (gavage) re: 3.4.4.1 Repeated dos | e (28 days) | oral | / dermal / inhalatio | n toxicity","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_022"} |
| SCCS Opinion | NOAEL | =3.4 | - | - | oral | 28 days | NOAEL study | {"effect":"Table 21: Oral (gavage) re: 3.4.4.1 Repeated dos | e (28 days) | oral | / dermal / inhalatio | n toxicity","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_022"} |
| SCCS Opinion | NOAEL | =3.4 | - | - | oral | 28 days | NOAEL study | {"effect":"Table 21: Oral (gavage) re: 3.4.4.1 Repeated dos | e (28 days) | oral | / dermal / inhalatio | n toxicity","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_022"} |
| SCCS Opinion | NOAEL | =4 | mg/kg/day | - | oral | 28 days | repeated dose toxicity | {"dose":"Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study.","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 40 Table 21: Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study. EFSA (2019) also used this NOAEL to determine an ADI for benzyl alcohol in foods of 4 mg/kg/day. 3.4.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity 14 days range finding study mentioned in the reach dossier. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity • Oral route Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate it was requested to conduct additional toxicological studies: Sub-chronic toxicity study (90-day), oral route (Annex IX, Section 8.6.2.; test method: EU B.26./OECD TG 408","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_002"} |
| SCCS Opinion | NOAEL | =4 | mg/kg/day | - | oral | 28 days | repeated dose toxicity | {"dose":"Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study.","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 40 Table 21: Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study. EFSA (2019) also used this NOAEL to determine an ADI for benzyl alcohol in foods of 4 mg/kg/day. 3.4.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity 14 days range finding study mentioned in the reach dossier. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity • Oral route Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate it was requested to conduct additional toxicological studies: Sub-chronic toxicity study (90-day), oral route (Annex IX, Section 8.6.2.; test method: EU B.26./OECD TG 408","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_002"} |
| SCCS Opinion | NOAEL | =4 | mg/kg/day | - | oral | 28 days | repeated dose toxicity | {"dose":"Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study.","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 40 Table 21: Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study. EFSA (2019) also used this NOAEL to determine an ADI for benzyl alcohol in foods of 4 mg/kg/day. 3.4.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity 14 days range finding study mentioned in the reach dossier. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity • Oral route Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate it was requested to conduct additional toxicological studies: Sub-chronic toxicity study (90-day), oral route (Annex IX, Section 8.6.2.; test method: EU B.26./OECD TG 408","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_002"} |
| SCCS Opinion | NOAEL | =4 | mg/kg/day | - | oral | 28 days | repeated dose toxicity | {"dose":"Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study.","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 40 Table 21: Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study. EFSA (2019) also used this NOAEL to determine an ADI for benzyl alcohol in foods of 4 mg/kg/day. 3.4.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity 14 days range finding study mentioned in the reach dossier. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity • Oral route Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate it was requested to conduct additional toxicological studies: Sub-chronic toxicity study (90-day), oral route (Annex IX, Section 8.6.2.; test method: EU B.26./OECD TG 408","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_002"} |
| SCCS Opinion | NOAEL | =14 | - | - | oral | 14 days | NOAEL study | {"effect":"Table 21: Oral (gavage) re: 14 days range finding study | mentioned i | n the | reach dossier.","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_023"} |
| SCCS Opinion | NOAEL | =14 | - | - | oral | 14 days | NOAEL study | {"effect":"Table 21: Oral (gavage) re: 14 days range finding study | mentioned i | n the | reach dossier.","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_023"} |
| SCCS Opinion | NOAEL | =14 | - | - | oral | 14 days | NOAEL study | {"effect":"Table 21: Oral (gavage) re: 14 days range finding study | mentioned i | n the | reach dossier.","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_023"} |
| SCCS Opinion | NOAEL | =14 | - | - | oral | 14 days | NOAEL study | {"effect":"Table 21: Oral (gavage) re: 14 days range finding study | mentioned i | n the | reach dossier.","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_023"} |
| SCCS Opinion | NOAEL | =21 | - | - | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_019"} |
| SCCS Opinion | NOAEL | =21 | - | - | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_019"} |
| SCCS Opinion | NOAEL | =21 | - | - | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_019"} |
| SCCS Opinion | NOAEL | =21 | - | - | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_019"} |
| SCCS Opinion | NOAEL | =24 | - | - | dermal | - | NOAEL study | {"effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Product families | Product categories | Maximum conc | Dermal | Eproduct | Tier 1, | NOAEL | MOS","page":58,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_028"} |
| SCCS Opinion | NOAEL | =24 | - | - | dermal | - | NOAEL study | {"effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Product families | Product categories | Maximum conc | Dermal | Eproduct | Tier 1, | NOAEL | MOS","page":58,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_028"} |
| SCCS Opinion | NOAEL | =24 | - | - | dermal | - | NOAEL study | {"effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Product families | Product categories | Maximum conc | Dermal | Eproduct | Tier 1, | NOAEL | MOS","page":58,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_028"} |
| SCCS Opinion | NOAEL | =24 | - | - | dermal | - | NOAEL study | {"effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Product families | Product categories | Maximum conc | Dermal | Eproduct | Tier 1, | NOAEL | MOS","page":58,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_028"} |
| SCCS Opinion | NOAEL | =26 | - | rat | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: B.26./OECD TG 408) in rats | with the reg | ister | ed substance.","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_025"} |
| SCCS Opinion | NOAEL | =26 | - | rat | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: B.26./OECD TG 408) in rats | with the reg | ister | ed substance.","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_025"} |
| SCCS Opinion | NOAEL | =26 | - | rat | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: B.26./OECD TG 408) in rats | with the reg | ister | ed substance.","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_025"} |
| SCCS Opinion | NOAEL | =26 | - | rat | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: B.26./OECD TG 408) in rats | with the reg | ister | ed substance.","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_025"} |
| SCCS Opinion | NOAEL | =75 | mg/kg/day | - | - | - | NOAEL study | {"dose":"3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment.","effect":"potential. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment. However, as Benzyl Salicylate itself is not regarded as the main toxicant, but salicylic acid as the main hydrolysis product via all routes of exposure. Salicylic acid was reviewed recently by the SCCS in its opinion from SCCS/1646/22. The POD for salicylic acid was selected as a no observed adverse effect level (NOAEL) of 75 mg/kg/day","page":57,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_012"} |
| SCCS Opinion | NOAEL | =75 | mg/kg/day | - | - | - | NOAEL study | {"dose":"3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment.","effect":"potential. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment. However, as Benzyl Salicylate itself is not regarded as the main toxicant, but salicylic acid as the main hydrolysis product via all routes of exposure. Salicylic acid was reviewed recently by the SCCS in its opinion from SCCS/1646/22. The POD for salicylic acid was selected as a no observed adverse effect level (NOAEL) of 75 mg/kg/day","page":57,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_012"} |
| SCCS Opinion | NOAEL | =75 | mg/kg/day | - | - | - | NOAEL study | {"dose":"3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment.","effect":"potential. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment. However, as Benzyl Salicylate itself is not regarded as the main toxicant, but salicylic acid as the main hydrolysis product via all routes of exposure. Salicylic acid was reviewed recently by the SCCS in its opinion from SCCS/1646/22. The POD for salicylic acid was selected as a no observed adverse effect level (NOAEL) of 75 mg/kg/day","page":57,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_012"} |
| SCCS Opinion | NOAEL | =75 | mg/kg/day | - | - | - | NOAEL study | {"dose":"3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment.","effect":"potential. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment. However, as Benzyl Salicylate itself is not regarded as the main toxicant, but salicylic acid as the main hydrolysis product via all routes of exposure. Salicylic acid was reviewed recently by the SCCS in its opinion from SCCS/1646/22. The POD for salicylic acid was selected as a no observed adverse effect level (NOAEL) of 75 mg/kg/day","page":57,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_012"} |
| SCCS Opinion | NOAEL | =100 | - | - | oral | - | dermal absorption | {"dose":"Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297...","effect":"nt categories of ages have been considered by the SCCS. However, in view of the high values of the MoS for all product categories, even if specific scenario of exposure in children may lead to higher exposure (due to the difference of ratio in body surface and body weight depending of the ages) the MoS will still be above 100 and therefore these specific calculations are not included in the opinion. Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297 Hair conditioner 0.5 10.5 0.67 0.00035175 123 349680 Shampoo 0.5 10.5 1.51 0.00079275 123 155156 Hand wash soap Hand wash soap 0.5 10.5 3.33 0.00174825 123 70356 Leave on skin and hair products Body lotion 0.7 10.5 123.2 0.090552 123 1358 Face cream 0.5 10.5 24.14 0.0126735 123 9705 Hand crea","page":58,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_014"} |
| SCCS Opinion | NOAEL | =100 | - | - | oral | - | dermal absorption | {"dose":"Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297...","effect":"nt categories of ages have been considered by the SCCS. However, in view of the high values of the MoS for all product categories, even if specific scenario of exposure in children may lead to higher exposure (due to the difference of ratio in body surface and body weight depending of the ages) the MoS will still be above 100 and therefore these specific calculations are not included in the opinion. Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297 Hair conditioner 0.5 10.5 0.67 0.00035175 123 349680 Shampoo 0.5 10.5 1.51 0.00079275 123 155156 Hand wash soap Hand wash soap 0.5 10.5 3.33 0.00174825 123 70356 Leave on skin and hair products Body lotion 0.7 10.5 123.2 0.090552 123 1358 Face cream 0.5 10.5 24.14 0.0126735 123 9705 Hand crea","page":58,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_014"} |
| SCCS Opinion | NOAEL | =100 | - | - | oral | - | dermal absorption | {"dose":"Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297...","effect":"nt categories of ages have been considered by the SCCS. However, in view of the high values of the MoS for all product categories, even if specific scenario of exposure in children may lead to higher exposure (due to the difference of ratio in body surface and body weight depending of the ages) the MoS will still be above 100 and therefore these specific calculations are not included in the opinion. Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297 Hair conditioner 0.5 10.5 0.67 0.00035175 123 349680 Shampoo 0.5 10.5 1.51 0.00079275 123 155156 Hand wash soap Hand wash soap 0.5 10.5 3.33 0.00174825 123 70356 Leave on skin and hair products Body lotion 0.7 10.5 123.2 0.090552 123 1358 Face cream 0.5 10.5 24.14 0.0126735 123 9705 Hand crea","page":58,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_014"} |
| SCCS Opinion | NOAEL | =100 | - | - | oral | - | dermal absorption | {"dose":"Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297...","effect":"nt categories of ages have been considered by the SCCS. However, in view of the high values of the MoS for all product categories, even if specific scenario of exposure in children may lead to higher exposure (due to the difference of ratio in body surface and body weight depending of the ages) the MoS will still be above 100 and therefore these specific calculations are not included in the opinion. Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297 Hair conditioner 0.5 10.5 0.67 0.00035175 123 349680 Shampoo 0.5 10.5 1.51 0.00079275 123 155156 Hand wash soap Hand wash soap 0.5 10.5 3.33 0.00174825 123 70356 Leave on skin and hair products Body lotion 0.7 10.5 123.2 0.090552 123 1358 Face cream 0.5 10.5 24.14 0.0126735 123 9705 Hand crea","page":58,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_014"} |
| SCCS Opinion | NOAEL | =123 | - | - | - | - | NOAEL study | {"effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: fragrances | 4 | 10.5 | 4.67 | 0.019614 | 123 | 6271","page":58,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_029"} |
| SCCS Opinion | NOAEL | =123 | - | - | - | - | NOAEL study | {"effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: fragrances | 4 | 10.5 | 4.67 | 0.019614 | 123 | 6271","page":58,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_029"} |
| SCCS Opinion | NOAEL | =123 | - | - | - | - | NOAEL study | {"effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: fragrances | 4 | 10.5 | 4.67 | 0.019614 | 123 | 6271","page":58,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_029"} |
| SCCS Opinion | NOAEL | =123 | - | - | - | - | NOAEL study | {"effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: fragrances | 4 | 10.5 | 4.67 | 0.019614 | 123 | 6271","page":58,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_029"} |
| SCCS Opinion | NOAEL | =158 | mg/kg/day | rat | oral | Developmental | developmental toxicity | {"dose":"__________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","effect":"__________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: female Sprague-Dawley rats Group size: 4 groups of 25 female rats Test substance: Benzyl Salicylate Physical form: / Batch: / Purity: / Vehicle: not need (dietary study) Dose levels: 1000, 3000, and 4000 ppm equivalent to 72, 214 and 289 mg/kg Route: oral feed Administration: continuously Exposure period: From gestation Day 6 to through 21. GLP: Yes Study pe","page":44,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_008"} |
| SCCS Opinion | NOAEL | =158 | mg/kg/day | rat | oral | Developmental | developmental toxicity | {"dose":"__________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","effect":"__________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: female Sprague-Dawley rats Group size: 4 groups of 25 female rats Test substance: Benzyl Salicylate Physical form: / Batch: / Purity: / Vehicle: not need (dietary study) Dose levels: 1000, 3000, and 4000 ppm equivalent to 72, 214 and 289 mg/kg Route: oral feed Administration: continuously Exposure period: From gestation Day 6 to through 21. GLP: Yes Study pe","page":44,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_008"} |
| SCCS Opinion | NOAEL | =158 | mg/kg/day | rat | oral | Developmental | developmental toxicity | {"dose":"__________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","effect":"__________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: female Sprague-Dawley rats Group size: 4 groups of 25 female rats Test substance: Benzyl Salicylate Physical form: / Batch: / Purity: / Vehicle: not need (dietary study) Dose levels: 1000, 3000, and 4000 ppm equivalent to 72, 214 and 289 mg/kg Route: oral feed Administration: continuously Exposure period: From gestation Day 6 to through 21. GLP: Yes Study pe","page":44,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_008"} |
| SCCS Opinion | NOAEL | =158 | mg/kg/day | rat | oral | Developmental | developmental toxicity | {"dose":"__________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","effect":"__________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: female Sprague-Dawley rats Group size: 4 groups of 25 female rats Test substance: Benzyl Salicylate Physical form: / Batch: / Purity: / Vehicle: not need (dietary study) Dose levels: 1000, 3000, and 4000 ppm equivalent to 72, 214 and 289 mg/kg Route: oral feed Administration: continuously Exposure period: From gestation Day 6 to through 21. GLP: Yes Study pe","page":44,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_008"} |
| SCCS Opinion | NOAEL | =166 | mg/kg/day | rat | - | Developmental | developmental toxicity | {"dose":"204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (","page":44,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_007"} |
| SCCS Opinion | NOAEL | =166 | mg/kg/day | rat | - | Developmental | developmental toxicity | {"dose":"204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (","page":44,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_007"} |
| SCCS Opinion | NOAEL | =166 | mg/kg/day | rat | - | Developmental | developmental toxicity | {"dose":"204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (","page":44,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_007"} |
| SCCS Opinion | NOAEL | =166 | mg/kg/day | rat | - | Developmental | developmental toxicity | {"dose":"204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (","page":44,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_007"} |
| SCCS Opinion | NOAEL | =214 | mg/kg/day | rat | oral | - | genotoxicity | {"citation":"Ref: https://echa","dose":"Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for materna...","effect":"considered adverse because both have been noted to resolve postnatally and should not be used in risk assessment to set standards for exposure to chemical agents (Kimmel, et al., 2014). Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for maternal toxicity. Based on lower mean foetal body weights in the 4000 ppm group, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for embryo/foetal development when Benzyl Salicylate was administered orally (via the diet) to time-mated Crl:CD(SD) rats. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro Bacterial gene mutation tests Three Ames tests in Salmonella typhimurium were performed for Benzyl Salicylate in the presence and absence o","page":45,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_010"} |
| SCCS Opinion | NOAEL | =214 | mg/kg/day | rat | oral | - | genotoxicity | {"citation":"Ref: https://echa","dose":"Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for materna...","effect":"considered adverse because both have been noted to resolve postnatally and should not be used in risk assessment to set standards for exposure to chemical agents (Kimmel, et al., 2014). Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for maternal toxicity. Based on lower mean foetal body weights in the 4000 ppm group, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for embryo/foetal development when Benzyl Salicylate was administered orally (via the diet) to time-mated Crl:CD(SD) rats. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro Bacterial gene mutation tests Three Ames tests in Salmonella typhimurium were performed for Benzyl Salicylate in the presence and absence o","page":45,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_010"} |
| SCCS Opinion | NOAEL | =214 | mg/kg/day | rat | oral | - | genotoxicity | {"citation":"Ref: https://echa","dose":"Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for materna...","effect":"considered adverse because both have been noted to resolve postnatally and should not be used in risk assessment to set standards for exposure to chemical agents (Kimmel, et al., 2014). Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for maternal toxicity. Based on lower mean foetal body weights in the 4000 ppm group, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for embryo/foetal development when Benzyl Salicylate was administered orally (via the diet) to time-mated Crl:CD(SD) rats. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro Bacterial gene mutation tests Three Ames tests in Salmonella typhimurium were performed for Benzyl Salicylate in the presence and absence o","page":45,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_010"} |
| SCCS Opinion | NOAEL | =214 | mg/kg/day | rat | oral | - | genotoxicity | {"citation":"Ref: https://echa","dose":"Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for materna...","effect":"considered adverse because both have been noted to resolve postnatally and should not be used in risk assessment to set standards for exposure to chemical agents (Kimmel, et al., 2014). Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for maternal toxicity. Based on lower mean foetal body weights in the 4000 ppm group, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for embryo/foetal development when Benzyl Salicylate was administered orally (via the diet) to time-mated Crl:CD(SD) rats. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro Bacterial gene mutation tests Three Ames tests in Salmonella typhimurium were performed for Benzyl Salicylate in the presence and absence o","page":45,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_010"} |
| SCCS Opinion | NOAEL | =400 | mg/kg/day | - | oral | 28 days | repeated dose toxicity | {"dose":"Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study.","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 40 Table 21: Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study. EFSA (2019) also used this NOAEL to determine an ADI for benzyl alcohol in foods of 4 mg/kg/day. 3.4.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity 14 days range finding study mentioned in the reach dossier. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity • Oral route Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate it was requested","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_001"} |
| SCCS Opinion | NOAEL | =400 | mg/kg/d | - | oral | - | NOAEL study | {"dose":"The NOAEL from these stu | dies was reg | arde | d as 400 mg/kg/d | ay which was | subsequently","effect":"Table 21: Oral (gavage) re: The NOAEL from these stu | dies was reg | arde | d as 400 mg/kg/d | ay which was | subsequently","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_018"} |
| SCCS Opinion | NOAEL | =400 | mg/kg/day | - | oral | 28 days | repeated dose toxicity | {"dose":"Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study.","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 40 Table 21: Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study. EFSA (2019) also used this NOAEL to determine an ADI for benzyl alcohol in foods of 4 mg/kg/day. 3.4.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity 14 days range finding study mentioned in the reach dossier. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity • Oral route Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate it was requested","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_001"} |
| SCCS Opinion | NOAEL | =400 | mg/kg/d | - | oral | - | NOAEL study | {"dose":"The NOAEL from these stu | dies was reg | arde | d as 400 mg/kg/d | ay which was | subsequently","effect":"Table 21: Oral (gavage) re: The NOAEL from these stu | dies was reg | arde | d as 400 mg/kg/d | ay which was | subsequently","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_018"} |
| SCCS Opinion | NOAEL | =400 | mg/kg/day | - | oral | 28 days | repeated dose toxicity | {"dose":"Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study.","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 40 Table 21: Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study. EFSA (2019) also used this NOAEL to determine an ADI for benzyl alcohol in foods of 4 mg/kg/day. 3.4.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity 14 days range finding study mentioned in the reach dossier. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity • Oral route Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate it was requested","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_001"} |
| SCCS Opinion | NOAEL | =400 | mg/kg/d | - | oral | - | NOAEL study | {"dose":"The NOAEL from these stu | dies was reg | arde | d as 400 mg/kg/d | ay which was | subsequently","effect":"Table 21: Oral (gavage) re: The NOAEL from these stu | dies was reg | arde | d as 400 mg/kg/d | ay which was | subsequently","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_018"} |
| SCCS Opinion | NOAEL | =400 | mg/kg/day | - | oral | 28 days | repeated dose toxicity | {"dose":"Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study.","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 40 Table 21: Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study. EFSA (2019) also used this NOAEL to determine an ADI for benzyl alcohol in foods of 4 mg/kg/day. 3.4.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity 14 days range finding study mentioned in the reach dossier. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity • Oral route Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate it was requested","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_001"} |
| SCCS Opinion | NOAEL | =400 | mg/kg/d | - | oral | - | NOAEL study | {"dose":"The NOAEL from these stu | dies was reg | arde | d as 400 mg/kg/d | ay which was | subsequently","effect":"Table 21: Oral (gavage) re: The NOAEL from these stu | dies was reg | arde | d as 400 mg/kg/d | ay which was | subsequently","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_018"} |
| SCCS Opinion | NOAEL | =451 | - | - | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_020"} |
| SCCS Opinion | NOAEL | =451 | - | - | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_020"} |
| SCCS Opinion | NOAEL | =451 | - | - | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_020"} |
| SCCS Opinion | NOAEL | =451 | - | - | oral | - | NOAEL study | {"effect":"Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_020"} |
| SCCS Opinion | NOAEL | =2500 | ppm | rat | oral | - | reproductive toxicity | {"dose":"Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats.","effect":"observations or necropsy findings that could be attributed to F0 maternal administration of the test substance at any exposure concentration. Under the conditions of this screening study, no test substance-related effects were noted on reproductive performance in F0 males and females at any exposure concentration. Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats. Based on the lack of test substance-related effects at any dose level, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse-effect level (NOAEL) for F1 neonatal toxicity. The 2500 ppm dose level corresponded to actual consumption of 166 mg/kg/day for males during the pre-mating period and 158, 170, and 324 mg/kg/day for femal","page":43,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_004"} |
| SCCS Opinion | NOAEL | =2500 | ppm | rat | oral | - | reproductive toxicity | {"dose":"Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats.","effect":"observations or necropsy findings that could be attributed to F0 maternal administration of the test substance at any exposure concentration. Under the conditions of this screening study, no test substance-related effects were noted on reproductive performance in F0 males and females at any exposure concentration. Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats. Based on the lack of test substance-related effects at any dose level, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse-effect level (NOAEL) for F1 neonatal toxicity. The 2500 ppm dose level corresponded to actual consumption of 166 mg/kg/day for males during the pre-mating period and 158, 170, and 324 mg/kg/day for femal","page":43,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_004"} |
| SCCS Opinion | NOAEL | =2500 | ppm | rat | oral | - | reproductive toxicity | {"dose":"Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats.","effect":"observations or necropsy findings that could be attributed to F0 maternal administration of the test substance at any exposure concentration. Under the conditions of this screening study, no test substance-related effects were noted on reproductive performance in F0 males and females at any exposure concentration. Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats. Based on the lack of test substance-related effects at any dose level, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse-effect level (NOAEL) for F1 neonatal toxicity. The 2500 ppm dose level corresponded to actual consumption of 166 mg/kg/day for males during the pre-mating period and 158, 170, and 324 mg/kg/day for femal","page":43,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_004"} |
| SCCS Opinion | NOAEL | =2500 | ppm | rat | oral | - | reproductive toxicity | {"dose":"Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats.","effect":"observations or necropsy findings that could be attributed to F0 maternal administration of the test substance at any exposure concentration. Under the conditions of this screening study, no test substance-related effects were noted on reproductive performance in F0 males and females at any exposure concentration. Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats. Based on the lack of test substance-related effects at any dose level, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse-effect level (NOAEL) for F1 neonatal toxicity. The 2500 ppm dose level corresponded to actual consumption of 166 mg/kg/day for males during the pre-mating period and 158, 170, and 324 mg/kg/day for femal","page":43,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_004"} |
| SCCS Opinion | NOAEL | =3000 | ppm | rat | oral | 90 days | NOAEL study | {"citation":"Ref: https://echa","dose":"Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm.","effect":"g the study. Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm. Based on the results of this study, dietary administration of Benzyl Salicylate to Crl:CD(SD) rats at concentrations of 1500, 3000, and 6000 ppm for a minimum of 90 days resulted in adverse lower body weights, lower body weight gains, and decreased food efficiency for males and females at 6000 ppm. Therefore, the no-observed-effect level (NOEL) was considered to be 3000 ppm (equivalent to 177 and 204 mg/kg/day for males and females, respectively). Ref: https://echa.europa.eu/de/registration-dossier/-/registered-dossier/16100/7/6/1 • Inhalation route There are no specific repeat dose toxicity data by the inhalation route for Benzyl Salicylate. Given hydrolysis has been shown to occur via lung microsomes (Ozaki et al., 2015), it may be relevant to consider the benzyl alcohol data that is available. Also, there are data on acute inhalation for methyl sal","page":41,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_003"} |
| SCCS Opinion | NOAEL | =3000 | ppm | rat | oral | 90 days | NOAEL study | {"citation":"Ref: https://echa","dose":"Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm.","effect":"g the study. Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm. Based on the results of this study, dietary administration of Benzyl Salicylate to Crl:CD(SD) rats at concentrations of 1500, 3000, and 6000 ppm for a minimum of 90 days resulted in adverse lower body weights, lower body weight gains, and decreased food efficiency for males and females at 6000 ppm. Therefore, the no-observed-effect level (NOEL) was considered to be 3000 ppm (equivalent to 177 and 204 mg/kg/day for males and females, respectively). Ref: https://echa.europa.eu/de/registration-dossier/-/registered-dossier/16100/7/6/1 • Inhalation route There are no specific repeat dose toxicity data by the inhalation route for Benzyl Salicylate. Given hydrolysis has been shown to occur via lung microsomes (Ozaki et al., 2015), it may be relevant to consider the benzyl alcohol data that is available. Also, there are data on acute inhalation for methyl sal","page":41,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_003"} |
| SCCS Opinion | NOAEL | =3000 | ppm | rat | oral | 90 days | NOAEL study | {"citation":"Ref: https://echa","dose":"Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm.","effect":"g the study. Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm. Based on the results of this study, dietary administration of Benzyl Salicylate to Crl:CD(SD) rats at concentrations of 1500, 3000, and 6000 ppm for a minimum of 90 days resulted in adverse lower body weights, lower body weight gains, and decreased food efficiency for males and females at 6000 ppm. Therefore, the no-observed-effect level (NOEL) was considered to be 3000 ppm (equivalent to 177 and 204 mg/kg/day for males and females, respectively). Ref: https://echa.europa.eu/de/registration-dossier/-/registered-dossier/16100/7/6/1 • Inhalation route There are no specific repeat dose toxicity data by the inhalation route for Benzyl Salicylate. Given hydrolysis has been shown to occur via lung microsomes (Ozaki et al., 2015), it may be relevant to consider the benzyl alcohol data that is available. Also, there are data on acute inhalation for methyl sal","page":41,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_003"} |
| SCCS Opinion | NOAEL | =3000 | ppm | rat | oral | 90 days | NOAEL study | {"citation":"Ref: https://echa","dose":"Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm.","effect":"g the study. Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm. Based on the results of this study, dietary administration of Benzyl Salicylate to Crl:CD(SD) rats at concentrations of 1500, 3000, and 6000 ppm for a minimum of 90 days resulted in adverse lower body weights, lower body weight gains, and decreased food efficiency for males and females at 6000 ppm. Therefore, the no-observed-effect level (NOEL) was considered to be 3000 ppm (equivalent to 177 and 204 mg/kg/day for males and females, respectively). Ref: https://echa.europa.eu/de/registration-dossier/-/registered-dossier/16100/7/6/1 • Inhalation route There are no specific repeat dose toxicity data by the inhalation route for Benzyl Salicylate. Given hydrolysis has been shown to occur via lung microsomes (Ozaki et al., 2015), it may be relevant to consider the benzyl alcohol data that is available. Also, there are data on acute inhalation for methyl sal","page":41,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_003"} |
| SCCS Opinion | NOAEL | =4000 | ppm | rat | oral | Developmental | developmental toxicity | {"dose":"________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","effect":"________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: female Sprague-Dawley rats Group size: 4 groups of 25 female rats Test substance: Benzyl Salicylate Physical form: / Batch: / Purity: / Vehicle: not need (dietary study) Dose levels: 1000, 3000, and 4000 ppm equivalent to 72, 214 and 289 mg/kg Route: oral feed Administration: continuously Exposure period: From gestation Day 6 to through 21. GLP: Yes Study period:","page":44,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_009"} |
| SCCS Opinion | NOAEL | =4000 | ppm | rat | oral | Developmental | developmental toxicity | {"dose":"________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","effect":"________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: female Sprague-Dawley rats Group size: 4 groups of 25 female rats Test substance: Benzyl Salicylate Physical form: / Batch: / Purity: / Vehicle: not need (dietary study) Dose levels: 1000, 3000, and 4000 ppm equivalent to 72, 214 and 289 mg/kg Route: oral feed Administration: continuously Exposure period: From gestation Day 6 to through 21. GLP: Yes Study period:","page":44,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_009"} |
| SCCS Opinion | NOAEL | =4000 | ppm | rat | oral | Developmental | developmental toxicity | {"dose":"________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","effect":"________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: female Sprague-Dawley rats Group size: 4 groups of 25 female rats Test substance: Benzyl Salicylate Physical form: / Batch: / Purity: / Vehicle: not need (dietary study) Dose levels: 1000, 3000, and 4000 ppm equivalent to 72, 214 and 289 mg/kg Route: oral feed Administration: continuously Exposure period: From gestation Day 6 to through 21. GLP: Yes Study period:","page":44,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_009"} |
| SCCS Opinion | NOAEL | =4000 | ppm | rat | oral | Developmental | developmental toxicity | {"dose":"________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","effect":"________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: female Sprague-Dawley rats Group size: 4 groups of 25 female rats Test substance: Benzyl Salicylate Physical form: / Batch: / Purity: / Vehicle: not need (dietary study) Dose levels: 1000, 3000, and 4000 ppm equivalent to 72, 214 and 289 mg/kg Route: oral feed Administration: continuously Exposure period: From gestation Day 6 to through 21. GLP: Yes Study period:","page":44,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_009"} |
| SCCS Opinion | NOAEL | =6000 | ppm | - | oral | - | NOAEL study | {"dose":"Dose levels: | 1500, 3000, | and | 6000 ppm equivale | nt to 86, 177 a | nd 357","effect":"Table 21: Oral (gavage) re: Dose levels: | 1500, 3000, | and | 6000 ppm equivale | nt to 86, 177 a | nd 357","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_027"} |
| SCCS Opinion | NOAEL | =6000 | ppm | - | oral | - | NOAEL study | {"dose":"Dose levels: | 1500, 3000, | and | 6000 ppm equivale | nt to 86, 177 a | nd 357","effect":"Table 21: Oral (gavage) re: Dose levels: | 1500, 3000, | and | 6000 ppm equivale | nt to 86, 177 a | nd 357","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_027"} |
| SCCS Opinion | NOAEL | =6000 | ppm | - | oral | - | NOAEL study | {"dose":"Dose levels: | 1500, 3000, | and | 6000 ppm equivale | nt to 86, 177 a | nd 357","effect":"Table 21: Oral (gavage) re: Dose levels: | 1500, 3000, | and | 6000 ppm equivale | nt to 86, 177 a | nd 357","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_027"} |
| SCCS Opinion | NOAEL | =6000 | ppm | - | oral | - | NOAEL study | {"dose":"Dose levels: | 1500, 3000, | and | 6000 ppm equivale | nt to 86, 177 a | nd 357","effect":"Table 21: Oral (gavage) re: Dose levels: | 1500, 3000, | and | 6000 ppm equivale | nt to 86, 177 a | nd 357","page":40,"pdf":"sccs_o_277.pdf","row_type":"noael_study","study_id":"sccs_o_277_noael_027"} |
ToxValDB GESTIS DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB GESTIS DNEL | DNEL systemic | =7.8 | 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:15630076:-:--; 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_6135bad5014c064fdfe99abacc5c32ba |
ToxValDB Uterotrophic Hershberger DB 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB Uterotrophic Hershberger DB | LEL | =3.7 | mg/kg bw/day | Rat | oral | short-term; 3 days | uterotrophic | LONG_REF=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124 2106, https://doi.org/10.1289/ehp.1510183; TITLE=A Curated Database of Rodent Uterotrophic Bioactivity; AUTHOR=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124; DOI=10.1289/ehp.1510183; GUIDELINE=1; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759abc7e4b0a7c65d37b40c; RECORD_SOURCE_LEVEL=Extraction document; TOXICOLOGICAL_EFFECT=Active; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=Uterotrophic Hershberger DB:15713484:-:--; 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_f164c1155dcb466e330daee70aef317a |
| ToxValDB Uterotrophic Hershberger DB | LEL | =11.1 | mg/kg bw/day | Mouse | oral | short-term; 3 days | uterotrophic | LONG_REF=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124 2106, https://doi.org/10.1289/ehp.1510183; TITLE=A Curated Database of Rodent Uterotrophic Bioactivity; AUTHOR=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124; DOI=10.1289/ehp.1510183; GUIDELINE=0; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759abc7e4b0a7c65d37b40c; RECORD_SOURCE_LEVEL=Extraction document; TOXICOLOGICAL_EFFECT=Active; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=Uterotrophic Hershberger DB:15713520:-:--; 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_2b9853db701a21a0897220280e44b5e6 |
Regulatory source 47 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 0 | - | rat | oral | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=0 consecutive; EFFECT=Table 21: Oral (gavage) re: Salicylate when administere | d via the diet | to | Sprague Dawley rat | s for at least 9 | 0 consecutive; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 21: Oral (gavage) re: Salicylate when administere | d via the diet | to | Sprague Dawley rat | s for at least 9 | 0 consecutive","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"0 consecutive","page":40,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_026"} |
| Regulatory source | - | 3.4 | - | - | oral | 28 days | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=3.4.4.1 Repeated dos; EFFECT=Table 21: Oral (gavage) re: 3.4.4.1 Repeated dos | e (28 days) | oral | / dermal / inhalatio | n toxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"28 days","effect":"Table 21: Oral (gavage) re: 3.4.4.1 Repeated dos | e (28 days) | oral | / dermal / inhalatio | n toxicity","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"3.4.4.1 Repeated dos","page":40,"route":"oral","species":"","study_id":"sccs_o_277_noael_022"} |
| Regulatory source | - | 4 | mg/kg/day | - | oral | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=4; DOSE=Oral (gavage) re: determine an ADI for benzyl | alcohol in fo | ods | of 4 mg/kg/day.; EFFECT=Table 21: Oral (gavage) re: determine an ADI for benzyl | alcohol in fo | ods | of 4 mg/kg/day.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"Oral (gavage) re: determine an ADI for benzyl | alcohol in fo | ods | of 4 mg/kg/day.","duration":"","effect":"Table 21: Oral (gavage) re: determine an ADI for benzyl | alcohol in fo | ods | of 4 mg/kg/day.","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"4","page":40,"route":"oral","species":"","study_id":"sccs_o_277_noael_021"} |
| Regulatory source | - | 14 | - | - | oral | 14 days | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=14 days range finding study; EFFECT=Table 21: Oral (gavage) re: 14 days range finding study | mentioned i | n the | reach dossier.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"14 days","effect":"Table 21: Oral (gavage) re: 14 days range finding study | mentioned i | n the | reach dossier.","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"14 days range finding study","page":40,"route":"oral","species":"","study_id":"sccs_o_277_noael_023"} |
| Regulatory source | - | 21 | - | - | oral | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=unclear:Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to; EFFECT=Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"unclear:Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to","page":40,"route":"oral","species":"","study_id":"sccs_o_277_noael_019"} |
| Regulatory source | - | 24 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=unclear:Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Product families | Product categories | Maximum conc | Dermal | Eproduct | Tier 1, | NOAEL | MOS; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Product families | Product categories | Maximum conc | Dermal | Eproduct | Tier 1, | NOAEL | MOS; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Product families | Product categories | Maximum conc | Dermal | Eproduct | Tier 1, | NOAEL | MOS","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"unclear:Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Product families | Product categories | Maximum conc | Dermal | Eproduct | Tier 1, | NOAEL | MOS","page":58,"route":"dermal","species":"","study_id":"sccs_o_277_noael_028"} |
| Regulatory source | - | 26 | - | rat | oral | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=B.26./OECD TG 408) in rats; EFFECT=Table 21: Oral (gavage) re: B.26./OECD TG 408) in rats | with the reg | ister | ed substance.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 21: Oral (gavage) re: B.26./OECD TG 408) in rats | with the reg | ister | ed substance.","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"B.26./OECD TG 408) in rats","page":40,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_025"} |
| Regulatory source | - | 75 | mg/kg/day | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=75; DOSE=3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment.; EFFECT=potential. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment. However, as Benzyl Salicylate itself is not regarded as the main toxicant, but salicylic acid as the main hydrolysis product via all routes of exposure. Salicylic acid was reviewed recently by the SCCS in its opinion from SCCS/1646/22. The POD for salicylic acid was selected as a no observed adverse effect level (NOAEL) of 75 mg/kg/day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment.","duration":"","effect":"potential. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment. However, as Benzyl Salicylate itself is not regarded as the main toxicant, but salicylic acid as the main hydrolysis product via all routes of exposure. Salicylic acid was reviewed recently by the SCCS in its opinion from SCCS/1646/22. The POD for salicylic acid was selected as a no observed adverse effect level (NOAEL) of 75 mg/kg/day","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":57,"route":"","species":"","study_id":"sccs_o_277_noael_012"} |
| Regulatory source | - | 75 | mg/kg/day | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=75; DOSE=(INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment.; EFFECT=(INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment. However, as Benzyl Salicylate itself is not regarded as the main toxicant, but salicylic acid as the main hydrolysis product via all routes of exposure. Salicylic acid was reviewed recently by the SCCS in its opinion from SCCS/1646/22. The POD for salicylic acid was selected as a no observed adverse effect level (NOAEL) of 75 mg/kg/day; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"(INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment.","duration":"","effect":"(INCLUDING CALCULATION OF THE MOS) Selection of the Key study and the POD There are no repeat dose toxicity data for Benzyl Salicylate from before 11 March 2013 to use in a cosmetic safety assessment. However, as Benzyl Salicylate itself is not regarded as the main toxicant, but salicylic acid as the main hydrolysis product via all routes of exposure. Salicylic acid was reviewed recently by the SCCS in its opinion from SCCS/1646/22. The POD for salicylic acid was selected as a no observed adverse effect level (NOAEL) of 75 mg/kg/day","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"75","page":57,"route":"","species":"","study_id":"sccs_o_277_noael_013"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: fragrances | 4 | 10.5 | 4.67 | 0.019614 | 123 | 6271; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: fragrances | 4 | 10.5 | 4.67 | 0.019614 | 123 | 6271","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_029"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: products (except hand wash) | Shower gel | 1.3 | 10.5 | 2.79 | 0.00380835 | 123 | 32297; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: products (except hand wash) | Shower gel | 1.3 | 10.5 | 2.79 | 0.00380835 | 123 | 32297","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_030"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Hair conditioner | 0.5 | 10.5 | 0.67 | 0.00035175 | 123 | 349680; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Hair conditioner | 0.5 | 10.5 | 0.67 | 0.00035175 | 123 | 349680","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_031"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Shampoo | 0.5 | 10.5 | 1.51 | 0.00079275 | 123 | 155156; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Shampoo | 0.5 | 10.5 | 1.51 | 0.00079275 | 123 | 155156","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_032"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Hand wash soap | Hand wash soap | 0.5 | 10.5 | 3.33 | 0.00174825 | 123 | 70356; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Hand wash soap | Hand wash soap | 0.5 | 10.5 | 3.33 | 0.00174825 | 123 | 70356","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_033"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Leave on skin and hair products | Body lotion | 0.7 | 10.5 | 123.2 | 0.090552 | 123 | 1358; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Leave on skin and hair products | Body lotion | 0.7 | 10.5 | 123.2 | 0.090552 | 123 | 1358","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_034"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Face cream | 0.5 | 10.5 | 24.14 | 0.0126735 | 123 | 9705; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Face cream | 0.5 | 10.5 | 24.14 | 0.0126735 | 123 | 9705","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_035"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Hand cream | 0.5 | 10.5 | 32.7 | 0.0171675 | 123 | 7165; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Hand cream | 0.5 | 10.5 | 32.7 | 0.0171675 | 123 | 7165","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_036"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Deodorant non-spray | 0.5 | 10.5 | 22.08 | 0.011592 | 123 | 10611; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Deodorant non-spray | 0.5 | 10.5 | 22.08 | 0.011592 | 123 | 10611","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_037"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Hair styling* | 0.5 | 10.5 | 5.74 | 0.00386 | 123 | 31865; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Hair styling* | 0.5 | 10.5 | 5.74 | 0.00386 | 123 | 31865","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_038"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Face make-up products | Liquid foundation | 0.2 | 10.5 | 7.9 | 0.001659 | 123 | 74141; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Face make-up products | Liquid foundation | 0.2 | 10.5 | 7.9 | 0.001659 | 123 | 74141","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_039"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Make-up remover | 0.2 | 10.5 | 8.33 | 0.0017493 | 123 | 70314; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Make-up remover | 0.2 | 10.5 | 8.33 | 0.0017493 | 123 | 70314","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_040"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Eye make up | Eye make-up | 0.2 | 10.5 | 0.33 | 0.0000693 | 123 | 1774892; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Eye make up | Eye make-up | 0.2 | 10.5 | 0.33 | 0.0000693 | 123 | 1774892","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_041"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Mascara | 0.2 | 10.5 | 0.42 | 0.0000882 | 123 | 1394558; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Mascara | 0.2 | 10.5 | 0.42 | 0.0000882 | 123 | 1394558","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_042"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Eyeliner | 0.2 | 10.5 | 0.08 | 0.0000168 | 123 | 7321429; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Eyeliner | 0.2 | 10.5 | 0.08 | 0.0000168 | 123 | 7321429","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_043"} |
| Regulatory source | - | 123 | - | - | oral | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: oral care products | Toothpaste | 0.004 | 100 | 2.16 | 0.0000864 | 123 | 1423611; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: oral care products | Toothpaste | 0.004 | 100 | 2.16 | 0.0000864 | 123 | 1423611","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"oral","species":"","study_id":"sccs_o_277_noael_044"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Mouthwash | 0.004 | 100 | 32.54 | 0.0013016 | 123 | 94499; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Mouthwash | 0.004 | 100 | 32.54 | 0.0013016 | 123 | 94499","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_045"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Lip products | Lipstick, lip salve | 0.2 | 100 | 0.9 | 0.0018 | 123 | 68333; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Lip products | Lipstick, lip salve | 0.2 | 100 | 0.9 | 0.0018 | 123 | 68333","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_046"} |
| Regulatory source | - | 123 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=123; EFFECT=Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Mouthspray | 0.004 | 100 | 26.7 | 0.001066667 | 123 | 115313; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 24: Margins of Safety for consumer exposures to Benzyl Salicylate in cosmetic products: Mouthspray | 0.004 | 100 | 26.7 | 0.001066667 | 123 | 115313","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"123","page":58,"route":"","species":"","study_id":"sccs_o_277_noael_047"} |
| Regulatory source | - | 400 | mg/kg/d | - | oral | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=400; DOSE=The NOAEL from these stu | dies was reg | arde | d as 400 mg/kg/d | ay which was | subsequently; EFFECT=Table 21: Oral (gavage) re: The NOAEL from these stu | dies was reg | arde | d as 400 mg/kg/d | ay which was | subsequently; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"The NOAEL from these stu | dies was reg | arde | d as 400 mg/kg/d | ay which was | subsequently","duration":"","effect":"Table 21: Oral (gavage) re: The NOAEL from these stu | dies was reg | arde | d as 400 mg/kg/d | ay which was | subsequently","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"mg/kg/d","noael_value":"400","page":40,"route":"oral","species":"","study_id":"sccs_o_277_noael_018"} |
| Regulatory source | - | 451 | - | - | oral | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=confirmed in an OECD 451; EFFECT=Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"","effect":"Table 21: Oral (gavage) re: confirmed in an OECD 451 | carcinogeni | city | study. EFSA (2019 | ) also used th | is NOAEL to","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"confirmed in an OECD 451","page":40,"route":"oral","species":"","study_id":"sccs_o_277_noael_020"} |
| Regulatory source | - | 3000 | ppm | rat | oral | 90 days | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=3000; DOSE=Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm.; EFFECT=g the study. Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm. Based on the results of this study, dietary administration of Benzyl Salicylate to Crl:CD(SD) rats at concentrations of 1500, 3000, and 6000 ppm for a minimum of 90 days resulted in adverse lower body weights, lower body weight gains, and decreased food efficiency for males and females at 6000 ppm. Therefore, the no-observed-effect level (NOEL) was considered to be 3000 ppm (equivalent to 177 and 204 mg/kg/day for males and females, respectively). Ref: https://echa.europa.eu/de/registration-dossier/-/registered-dossier/16100/7/6/1 • Inhalation route There are no specific repeat dose toxicity data by the inhalation route for Benzyl Salicylate. Given hydrolysis has been shown to occur via lung microsomes (Ozaki et al., 2015), it may be relevant to consider the benzyl alcohol data that is available. Also, there are data on acute inhalation for methyl sal; CITATION=Ref: https://echa; CITATION_NUMBERS=[]; REFERENCE=Ref: https://echa; DETAILS_JSON={"cas_number":"118-58-1","citation":"Ref: https://echa","dose":"Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm.","duration":"90 days","effect":"g the study. Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm. Based on the results of this study, dietary administration of Benzyl Salicylate to Crl:CD(SD) rats at concentrations of 1500, 3000, and 6000 ppm for a minimum of 90 days resulted in adverse lower body weights, lower body weight gains, and decreased food efficiency for males and females at 6000 ppm. Therefore, the no-observed-effect level (NOEL) was considered to be 3000 ppm (equivalent to 177 and 204 mg/kg/day for males and females, respectively). Ref: https://echa.europa.eu/de/registration-dossier/-/registered-dossier/16100/7/6/1 • Inhalation route There are no specific repeat dose toxicity data by the inhalation route for Benzyl Salicylate. Given hydrolysis has been shown to occur via lung microsomes (Ozaki et al., 2015), it may be relevant to consider the benzyl alcohol data that is available. Also, there are data on acute inhalation for methyl sal","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"ppm","noael_value":"3000","page":41,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_003"} |
| Regulatory source | - | 6000 | ppm | - | oral | - | - | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=6000; DOSE=Dose levels: | 1500, 3000, | and | 6000 ppm equivale | nt to 86, 177 a | nd 357; EFFECT=Table 21: Oral (gavage) re: Dose levels: | 1500, 3000, | and | 6000 ppm equivale | nt to 86, 177 a | nd 357; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"Dose levels: | 1500, 3000, | and | 6000 ppm equivale | nt to 86, 177 a | nd 357","duration":"","effect":"Table 21: Oral (gavage) re: Dose levels: | 1500, 3000, | and | 6000 ppm equivale | nt to 86, 177 a | nd 357","endpoint":"","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"ppm","noael_value":"6000","page":40,"route":"oral","species":"","study_id":"sccs_o_277_noael_027"} |
| Regulatory source | dermal absorption | 100 | - | - | oral | - | dermal absorption | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=unclear:nt categories of ages have been considered by the SCCS. However, in view of the high values of the MoS for all product categories, even if specific scenario of exposure in children may lead to higher exposure (due to the difference of ratio in body surface and body weight depending of the ages) the MoS will still be above 100 and therefore these specific calculations are not included in the opinion. Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297 Hair conditioner 0.5 10.5 0.67 0.00035175 123 349680 Shampoo 0.5 10.5 1.51 0.00079275 123 155156 Hand wash soap Hand wash soap 0.5 10.5 3.33 0.00174825 123 70356 Leave on skin and hair products Body lotion 0.7 10.5 123.2 0.090552 123 1358 Face cream 0.5 10.5 24.14 0.0126735 123 9705 Hand crea; DOSE=Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297...; EFFECT=nt categories of ages have been considered by the SCCS. However, in view of the high values of the MoS for all product categories, even if specific scenario of exposure in children may lead to higher exposure (due to the difference of ratio in body surface and body weight depending of the ages) the MoS will still be above 100 and therefore these specific calculations are not included in the opinion. Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297 Hair conditioner 0.5 10.5 0.67 0.00035175 123 349680 Shampoo 0.5 10.5 1.51 0.00079275 123 155156 Hand wash soap Hand wash soap 0.5 10.5 3.33 0.00174825 123 70356 Leave on skin and hair products Body lotion 0.7 10.5 123.2 0.090552 123 1358 Face cream 0.5 10.5 24.14 0.0126735 123 9705 Hand crea; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297...","duration":"","effect":"nt categories of ages have been considered by the SCCS. However, in view of the high values of the MoS for all product categories, even if specific scenario of exposure in children may lead to higher exposure (due to the difference of ratio in body surface and body weight depending of the ages) the MoS will still be above 100 and therefore these specific calculations are not included in the opinion. Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297 Hair conditioner 0.5 10.5 0.67 0.00035175 123 349680 Shampoo 0.5 10.5 1.51 0.00079275 123 155156 Hand wash soap Hand wash soap 0.5 10.5 3.33 0.00174825 123 70356 Leave on skin and hair products Body lotion 0.7 10.5 123.2 0.090552 123 1358 Face cream 0.5 10.5 24.14 0.0126735 123 9705 Hand crea","endpoint":"dermal absorption","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"unclear:nt categories of ages have been considered by the SCCS. However, in view of the high values of the MoS for all product categories, even if specific scenario of exposure in children may lead to higher exposure (due to the difference of ratio in body surface and body weight depending of the ages) the MoS will still be above 100 and therefore these specific calculations are not included in the opinion. Product families Product categories Maximum conc BzS Dermal absorption Eproduct normalized Tier 1, dermal/oral SED NOAEL MOS (w/w %) (%) (mg/kg bw /d) (mg/kg bw /d) (mg/kg bw /d) Hydroalcoholic-based fragrances 4 10.5 4.67 0.019614 123 6271 Rinse-off skin & hair cleansing products (except hand wash) Shower gel 1.3 10.5 2.79 0.00380835 123 32297 Hair conditioner 0.5 10.5 0.67 0.00035175 123 349680 Shampoo 0.5 10.5 1.51 0.00079275 123 155156 Hand wash soap Hand wash soap 0.5 10.5 3.33 0.00174825 123 70356 Leave on skin and hair products Body lotion 0.7 10.5 123.2 0.090552 123 1358 Face cream 0.5 10.5 24.14 0.0126735 123 9705 Hand crea","page":58,"route":"oral","species":"","study_id":"sccs_o_277_noael_014"} |
| Regulatory source | developmental toxicity | 158 | mg/kg/day | rat | oral | Developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=158; DOSE=__________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.; EFFECT=__________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: female Sprague-Dawley rats Group size: 4 groups of 25 female rats Test substance: Benzyl Salicylate Physical form: / Batch: / Purity: / Vehicle: not need (dietary study) Dose levels: 1000, 3000, and 4000 ppm equivalent to 72, 214 and 289 mg/kg Route: oral feed Administration: continuously Exposure period: From gestation Day 6 to through 21. GLP: Yes Study pe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"__________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","duration":"Developmental","effect":"__________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: female Sprague-Dawley rats Group size: 4 groups of 25 female rats Test substance: Benzyl Salicylate Physical form: / Batch: / Purity: / Vehicle: not need (dietary study) Dose levels: 1000, 3000, and 4000 ppm equivalent to 72, 214 and 289 mg/kg Route: oral feed Administration: continuously Exposure period: From gestation Day 6 to through 21. GLP: Yes Study pe","endpoint":"developmental toxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"158","page":44,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_008"} |
| Regulatory source | developmental toxicity | 166 | mg/kg/day | rat | - | Developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=166; DOSE=204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.; EFFECT=SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","duration":"Developmental","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (","endpoint":"developmental toxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"166","page":44,"route":"","species":"rat","study_id":"sccs_o_277_noael_007"} |
| Regulatory source | developmental toxicity | 4000 | ppm | rat | oral | Developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=4000; DOSE=________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.; EFFECT=________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: female Sprague-Dawley rats Group size: 4 groups of 25 female rats Test substance: Benzyl Salicylate Physical form: / Batch: / Purity: / Vehicle: not need (dietary study) Dose levels: 1000, 3000, and 4000 ppm equivalent to 72, 214 and 289 mg/kg Route: oral feed Administration: continuously Exposure period: From gestation Day 6 to through 21. GLP: Yes Study period:; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats.","duration":"Developmental","effect":"________________________________ 44 SCCS comment The SCCS agrees that the NOAEL derived from this study should be 166 mg/kg/day for male rats and 158 mg/kg/day for female rats. 3.4.5.2 Developmental Toxicity The objectives of the following study were to determine the potential of the test substance to induce developmental toxicity after maternal exposure from implantation to expected parturition, to characterize maternal toxicity at the exposure levels tested and to determine a no-observed-adverse-effect level (NOAEL) for maternal and developmental toxicity. Guideline: OECD Guideline 414 (Prenatal Developmental Toxicity Study) Species/strain: female Sprague-Dawley rats Group size: 4 groups of 25 female rats Test substance: Benzyl Salicylate Physical form: / Batch: / Purity: / Vehicle: not need (dietary study) Dose levels: 1000, 3000, and 4000 ppm equivalent to 72, 214 and 289 mg/kg Route: oral feed Administration: continuously Exposure period: From gestation Day 6 to through 21. GLP: Yes Study period:","endpoint":"developmental toxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"ppm","noael_value":"4000","page":44,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_009"} |
| Regulatory source | genotoxicity | 214 | mg/kg/day | rat | oral | - | genotoxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=214; DOSE=Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for materna...; EFFECT=considered adverse because both have been noted to resolve postnatally and should not be used in risk assessment to set standards for exposure to chemical agents (Kimmel, et al., 2014). Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for maternal toxicity. Based on lower mean foetal body weights in the 4000 ppm group, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for embryo/foetal development when Benzyl Salicylate was administered orally (via the diet) to time-mated Crl:CD(SD) rats. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro Bacterial gene mutation tests Three Ames tests in Salmonella typhimurium were performed for Benzyl Salicylate in the presence and absence o; CITATION=Ref: https://echa; CITATION_NUMBERS=[]; REFERENCE=Ref: https://echa; DETAILS_JSON={"cas_number":"118-58-1","citation":"Ref: https://echa","dose":"Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for materna...","duration":"","effect":"considered adverse because both have been noted to resolve postnatally and should not be used in risk assessment to set standards for exposure to chemical agents (Kimmel, et al., 2014). Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for maternal toxicity. Based on lower mean foetal body weights in the 4000 ppm group, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for embryo/foetal development when Benzyl Salicylate was administered orally (via the diet) to time-mated Crl:CD(SD) rats. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro Bacterial gene mutation tests Three Ames tests in Salmonella typhimurium were performed for Benzyl Salicylate in the presence and absence o","endpoint":"genotoxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"214","page":45,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_010"} |
| Regulatory source | genotoxicity | 214 | mg/kg/day | rat | oral | - | genotoxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=214; DOSE=Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for materna...; EFFECT=al., 2014). Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for maternal toxicity. Based on lower mean foetal body weights in the 4000 ppm group, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for embryo/foetal development when Benzyl Salicylate was administered orally (via the diet) to time-mated Crl:CD(SD) rats. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro Bacterial gene mutation tests Three Ames tests in Salmonella typhimurium were performed for Benzyl Salicylate in the presence and absence of metabolic activation, using the following strains: TA98, TA100, TA1535, and TA1537, and/or TA97 (Zeiger et al., 1987; NTP (2018a,b)). Doses of 3.3 to 333 μg Benzyl Salicylat; CITATION=Ref: https://echa; CITATION_NUMBERS=[]; REFERENCE=Ref: https://echa; DETAILS_JSON={"cas_number":"118-58-1","citation":"Ref: https://echa","dose":"Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for materna...","duration":"","effect":"al., 2014). Ref: https://echa.europa.eu/de/registration-dossier/-/registered- dossier/16100/7/9/3/?documentUUID=59df934a-3aff-4c34-b016-61e23a9c1936 SCCS comment Based on adverse mean body weight loss, lower mean body weights and food consumption at 4000 ppm, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for maternal toxicity. Based on lower mean foetal body weights in the 4000 ppm group, a dosage level of 3000 ppm, equivalent to 214 mg/kg/day, was considered to be the NOAEL for embryo/foetal development when Benzyl Salicylate was administered orally (via the diet) to time-mated Crl:CD(SD) rats. 3.4.6 Mutagenicity / genotoxicity 3.4.6.1 Mutagenicity / genotoxicity in vitro Bacterial gene mutation tests Three Ames tests in Salmonella typhimurium were performed for Benzyl Salicylate in the presence and absence of metabolic activation, using the following strains: TA98, TA100, TA1535, and TA1537, and/or TA97 (Zeiger et al., 1987; NTP (2018a,b)). Doses of 3.3 to 333 μg Benzyl Salicylat","endpoint":"genotoxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"214","page":45,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_011"} |
| Regulatory source | repeated dose toxicity | 3.4 | - | - | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=3.4.4.2 Sub-chronic (; EFFECT=Table 21: Oral (gavage) re: 3.4.4.2 Sub-chronic ( | 90 days) ora | l / d | ermal / inhalation t | oxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"","duration":"Sub-chronic","effect":"Table 21: Oral (gavage) re: 3.4.4.2 Sub-chronic ( | 90 days) ora | l / d | ermal / inhalation t | oxicity","endpoint":"repeated dose toxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"","noael_value":"3.4.4.2 Sub-chronic (","page":40,"route":"oral","species":"","study_id":"sccs_o_277_noael_024"} |
| Regulatory source | repeated dose toxicity | 4 | mg/kg/day | - | oral | 28 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=4; DOSE=Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study.; EFFECT=SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 40 Table 21: Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study. EFSA (2019) also used this NOAEL to determine an ADI for benzyl alcohol in foods of 4 mg/kg/day. 3.4.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity 14 days range finding study mentioned in the reach dossier. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity • Oral route Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate it was requested to conduct additional toxicological studies: Sub-chronic toxicity study (90-day), oral route (Annex IX, Section 8.6.2.; test method: EU B.26./OECD TG 408; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study.","duration":"28 days","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 40 Table 21: Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study. EFSA (2019) also used this NOAEL to determine an ADI for benzyl alcohol in foods of 4 mg/kg/day. 3.4.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity 14 days range finding study mentioned in the reach dossier. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity • Oral route Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate it was requested to conduct additional toxicological studies: Sub-chronic toxicity study (90-day), oral route (Annex IX, Section 8.6.2.; test method: EU B.26./OECD TG 408","endpoint":"repeated dose toxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"4","page":40,"route":"oral","species":"","study_id":"sccs_o_277_noael_002"} |
| Regulatory source | repeated dose toxicity | 400 | mg/kg/day | - | oral | 28 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=400; DOSE=Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study.; EFFECT=SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 40 Table 21: Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study. EFSA (2019) also used this NOAEL to determine an ADI for benzyl alcohol in foods of 4 mg/kg/day. 3.4.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity 14 days range finding study mentioned in the reach dossier. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity • Oral route Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate it was requested; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study.","duration":"28 days","effect":"SCCS/1656/23 Final Opinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 40 Table 21: Oral (gavage) repeat dose studies in animals for benzyl alcohol The NOAEL from these studies was regarded as 400 mg/kg/day which was subsequently confirmed in an OECD 451 carcinogenicity study. EFSA (2019) also used this NOAEL to determine an ADI for benzyl alcohol in foods of 4 mg/kg/day. 3.4.4.1 Repeated dose (28 days) oral / dermal / inhalation toxicity 14 days range finding study mentioned in the reach dossier. 3.4.4.2 Sub-chronic (90 days) oral / dermal / inhalation toxicity • Oral route Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate it was requested","endpoint":"repeated dose toxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"400","page":40,"route":"oral","species":"","study_id":"sccs_o_277_noael_001"} |
| Regulatory source | reproductive toxicity | 166 | mg/kg/day | rat | oral | 90 days | reproductive toxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=166; DOSE=nt to 177 and 204 mg/kg/day for males and females, respectively).; EFFECT=nt to 177 and 204 mg/kg/day for males and females, respectively). This was derived from an oral 90 days study in rats performed after 2013 following a request from ECHA to comply with the Reach regulation. Reproductive toxicity Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate, additional toxicological studies were performed in 2019: - a Screening study for reproductive/developmental toxicity (Annex VIII, Sections 8.6.1 and 8.7.1.; test method: OECD TG 421) in rats, oral route leading to a NOAEL of 166 mg/kg/day for males and 158 mg/kg/day for females - a Pre-natal developmental toxicity study (Annex IX, Section 8.7.2.; test method: EU B.31./OECD 414) in a first species (rat or rabbit), oral route leading to a NOAEL of 214 mg/kg/day for maternal toxicity and for embryo/fetal development, when Benzyl Salicylate was administered orally (via the diet) to time-mated Crl:CD(SD) rats. Mutagenicity / genotoxicity Benzyl Salicylate was tested in 3 bacterial gene mutation tests with negative results. However, t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"nt to 177 and 204 mg/kg/day for males and females, respectively).","duration":"90 days","effect":"nt to 177 and 204 mg/kg/day for males and females, respectively). This was derived from an oral 90 days study in rats performed after 2013 following a request from ECHA to comply with the Reach regulation. Reproductive toxicity Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate, additional toxicological studies were performed in 2019: - a Screening study for reproductive/developmental toxicity (Annex VIII, Sections 8.6.1 and 8.7.1.; test method: OECD TG 421) in rats, oral route leading to a NOAEL of 166 mg/kg/day for males and 158 mg/kg/day for females - a Pre-natal developmental toxicity study (Annex IX, Section 8.7.2.; test method: EU B.31./OECD 414) in a first species (rat or rabbit), oral route leading to a NOAEL of 214 mg/kg/day for maternal toxicity and for embryo/fetal development, when Benzyl Salicylate was administered orally (via the diet) to time-mated Crl:CD(SD) rats. Mutagenicity / genotoxicity Benzyl Salicylate was tested in 3 bacterial gene mutation tests with negative results. However, t","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"166","page":61,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_016"} |
| Regulatory source | reproductive toxicity | 214 | mg/kg/day | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=214; DOSE=OECD TG 421) in rats, oral route leading to a NOAEL of 166 mg/kg/day for males and 158 mg/kg/day for females - a Pre-natal developmental toxicity study (Annex IX, Section 8.7.2.; test method:; EFFECT=ty Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate, additional toxicological studies were performed in 2019: - a Screening study for reproductive/developmental toxicity (Annex VIII, Sections 8.6.1 and 8.7.1.; test method: OECD TG 421) in rats, oral route leading to a NOAEL of 166 mg/kg/day for males and 158 mg/kg/day for females - a Pre-natal developmental toxicity study (Annex IX, Section 8.7.2.; test method: EU B.31./OECD 414) in a first species (rat or rabbit), oral route leading to a NOAEL of 214 mg/kg/day for maternal toxicity and for embryo/fetal development, when Benzyl Salicylate was administered orally (via the diet) to time-mated Crl:CD(SD) rats. Mutagenicity / genotoxicity Benzyl Salicylate was tested in 3 bacterial gene mutation tests with negative results. However, the SCCS noted that in the studies 1 strain combination recommended by the OECD TG 471 has not been represented (E. coli WP2 uvrA, or E. coli WP2 uvrA (pKM101), or S. typhimurium TA102). Benzyl Salicylate was tested in 2 mammal; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"OECD TG 421) in rats, oral route leading to a NOAEL of 166 mg/kg/day for males and 158 mg/kg/day for females - a Pre-natal developmental toxicity study (Annex IX, Section 8.7.2.; test method:","duration":"developmental","effect":"ty Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate, additional toxicological studies were performed in 2019: - a Screening study for reproductive/developmental toxicity (Annex VIII, Sections 8.6.1 and 8.7.1.; test method: OECD TG 421) in rats, oral route leading to a NOAEL of 166 mg/kg/day for males and 158 mg/kg/day for females - a Pre-natal developmental toxicity study (Annex IX, Section 8.7.2.; test method: EU B.31./OECD 414) in a first species (rat or rabbit), oral route leading to a NOAEL of 214 mg/kg/day for maternal toxicity and for embryo/fetal development, when Benzyl Salicylate was administered orally (via the diet) to time-mated Crl:CD(SD) rats. Mutagenicity / genotoxicity Benzyl Salicylate was tested in 3 bacterial gene mutation tests with negative results. However, the SCCS noted that in the studies 1 strain combination recommended by the OECD TG 471 has not been represented (E. coli WP2 uvrA, or E. coli WP2 uvrA (pKM101), or S. typhimurium TA102). Benzyl Salicylate was tested in 2 mammal","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"mg/kg/day","noael_value":"214","page":61,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_017"} |
| Regulatory source | reproductive toxicity | 2500 | ppm | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=2500; DOSE=Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats.; EFFECT=observations or necropsy findings that could be attributed to F0 maternal administration of the test substance at any exposure concentration. Under the conditions of this screening study, no test substance-related effects were noted on reproductive performance in F0 males and females at any exposure concentration. Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats. Based on the lack of test substance-related effects at any dose level, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse-effect level (NOAEL) for F1 neonatal toxicity. The 2500 ppm dose level corresponded to actual consumption of 166 mg/kg/day for males during the pre-mating period and 158, 170, and 324 mg/kg/day for femal; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats.","duration":"","effect":"observations or necropsy findings that could be attributed to F0 maternal administration of the test substance at any exposure concentration. Under the conditions of this screening study, no test substance-related effects were noted on reproductive performance in F0 males and females at any exposure concentration. Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats. Based on the lack of test substance-related effects at any dose level, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse-effect level (NOAEL) for F1 neonatal toxicity. The 2500 ppm dose level corresponded to actual consumption of 166 mg/kg/day for males during the pre-mating period and 158, 170, and 324 mg/kg/day for femal","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"ppm","noael_value":"2500","page":43,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_004"} |
| Regulatory source | reproductive toxicity | 2500 | ppm | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=2500; DOSE=Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats.; EFFECT=concentration. Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats. Based on the lack of test substance-related effects at any dose level, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse-effect level (NOAEL) for F1 neonatal toxicity. The 2500 ppm dose level corresponded to actual consumption of 166 mg/kg/day for males during the pre-mating period and 158, 170, and 324 mg/kg/day for females during pre-mating, gestation, and lactation, respectively. Ref: https://echa.europa.eu/de/registration-dossier/-/registered-dossier/16100/7/9/2; CITATION=Ref: https://echa; CITATION_NUMBERS=[]; REFERENCE=Ref: https://echa; DETAILS_JSON={"cas_number":"118-58-1","citation":"Ref: https://echa","dose":"Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats.","duration":"","effect":"concentration. Based on the lack of F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats. Based on the lack of test substance-related effects at any dose level, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse-effect level (NOAEL) for F1 neonatal toxicity. The 2500 ppm dose level corresponded to actual consumption of 166 mg/kg/day for males during the pre-mating period and 158, 170, and 324 mg/kg/day for females during pre-mating, gestation, and lactation, respectively. Ref: https://echa.europa.eu/de/registration-dossier/-/registered-dossier/16100/7/9/2","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"ppm","noael_value":"2500","page":43,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_005"} |
| Regulatory source | reproductive toxicity | 2500 | ppm | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=2500; DOSE=f F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats.; EFFECT=f F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats. Based on the lack of test substance-related effects at any dose level, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse-effect level (NOAEL) for F1 neonatal toxicity. The 2500 ppm dose level corresponded to actual consumption of 166 mg/kg/day for males during the pre-mating period and 158, 170, and 324 mg/kg/day for females during pre-mating, gestation, and lactation, respectively. Ref: https://echa.europa.eu/de/registration-dossier/-/registered-dossier/16100/7/9/2; CITATION=Ref: https://echa; CITATION_NUMBERS=[]; REFERENCE=Ref: https://echa; DETAILS_JSON={"cas_number":"118-58-1","citation":"Ref: https://echa","dose":"f F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats.","duration":"","effect":"f F0 parental toxicity at any exposure concentration, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse- effect level (NOAEL) for F0 systemic and reproductive toxicity of Benzyl Salicylate when administered in the diet to Crl:CD(SD) male and female rats. Based on the lack of test substance-related effects at any dose level, an exposure concentration of 2500 ppm (the highest dose level tested) was considered to be the no-observed-adverse-effect level (NOAEL) for F1 neonatal toxicity. The 2500 ppm dose level corresponded to actual consumption of 166 mg/kg/day for males during the pre-mating period and 158, 170, and 324 mg/kg/day for females during pre-mating, gestation, and lactation, respectively. Ref: https://echa.europa.eu/de/registration-dossier/-/registered-dossier/16100/7/9/2","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"ppm","noael_value":"2500","page":43,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_006"} |
| Regulatory source | reproductive toxicity | 3000 | ppm | rat | oral | 90 days | reproductive toxicity | SOURCE_SUBDIR=sccs_o_277; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9); OPINION_NUMBER=SCCS/1656/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=3000; DOSE=204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 61 Concerning benzyl alcohol, a summary of the repeat dose oral studies cited in the ECHA REACH registration dossier for benzyl alcohol (https://echa.europa.eu/re...; EFFECT=pinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 61 Concerning benzyl alcohol, a summary of the repeat dose oral studies cited in the ECHA REACH registration dossier for benzyl alcohol (https://echa.europa.eu/registration-dossier/- /registered-dossier/14748/7/6/2) has been provided to SCCS. A no-observed-effect level (NOEL) was of 3000 ppm (equivalent to 177 and 204 mg/kg/day for males and females, respectively). This was derived from an oral 90 days study in rats performed after 2013 following a request from ECHA to comply with the Reach regulation. Reproductive toxicity Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate, additional toxicological studies were performed in 2019: - a Screening study for reproductive/developmental toxicity (Annex VIII, Sections 8.6.1 and 8.7.1.; test method: OECD TG 421) in rat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"118-58-1","citation":"","dose":"204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 61 Concerning benzyl alcohol, a summary of the repeat dose oral studies cited in the ECHA REACH registration dossier for benzyl alcohol (https://echa.europa.eu/re...","duration":"90 days","effect":"pinion Opinion on Benzyl Salicylate (CAS No. 118-58-1, EC No. 204-262-9) _________________________________________________________________________________ ___________________________________________________________________________________________ 61 Concerning benzyl alcohol, a summary of the repeat dose oral studies cited in the ECHA REACH registration dossier for benzyl alcohol (https://echa.europa.eu/registration-dossier/- /registered-dossier/14748/7/6/2) has been provided to SCCS. A no-observed-effect level (NOEL) was of 3000 ppm (equivalent to 177 and 204 mg/kg/day for males and females, respectively). This was derived from an oral 90 days study in rats performed after 2013 following a request from ECHA to comply with the Reach regulation. Reproductive toxicity Following ECHA decision (CCH-D-2114379324-45-01/F) on Benzyl Salicylate, additional toxicological studies were performed in 2019: - a Screening study for reproductive/developmental toxicity (Annex VIII, Sections 8.6.1 and 8.7.1.; test method: OECD TG 421) in rat","endpoint":"reproductive toxicity","ingredient":"codes ............................................................. 9","loael_value":"","noael_unit":"ppm","noael_value":"3000","page":61,"route":"oral","species":"rat","study_id":"sccs_o_277_noael_015"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | WAO5MNK9TU | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H12O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"WAO5MNK9TU"} |
| openFDA substances | FDA UNII substance identifier | WAO5MNK9TU | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H12O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"WAO5MNK9TU"} |
| openFDA substances | FDA UNII substance identifier | WAO5MNK9TU | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H12O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"WAO5MNK9TU"} |
| openFDA substances | FDA UNII substance identifier | WAO5MNK9TU | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C14H12O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"WAO5MNK9TU"} |