NOAEL Studies Cosmetic Ingredient

Ethyl Vanillin NOAEL Studies

INCI: ETHYL VANILLIN

CAS: 121-32-4

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

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COSMOS_DB 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB LOAEL 500 mg/kg bw/day rat oral 91 day Subchronic PAFA
COSMOS_DB NOAEL 505 mg/kg bw/day rat oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 545 mg/kg bw/day rat oral 14 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 1000 mg/kg bw/day rat oral 730 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 2500 mg/kg bw/day rat oral 365 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =500 mg/kg bw/day Rat - 98 days subchronic EFSA AFC - 2008 - OutputID 2243 - Flavouring Group Evaluation 52 (FGE.52): Consideration of hydroxy- and alkoxy substituted benzyl derivatives evaluated by JECFA (57th meeting) structurally related to benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters evaluated by EFSA in FGE.20 (2005) (Commission Regulation (EC) No 1565/2000 of 18 July 2000) - doi:10.2903/j.efsa.2008.637
NTP_ICE_endocrine 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_endocrine Model Score 0 unitless - - - ARPathway2016; AR Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=3130; RecordID=ARPathway2016_685; DatasetName=ARPathway2016; DTXSID=DTXSID5021968; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization 13 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_skin_sensitization CD86, EC150 >1163.232 ug/mL - Dermal - In Vitro; Urbisch_SkinSensitization2020; U-SENS sheet=Data_invitro; excel_row=8168; Record_ID=skin_sensitization_invitro_2191; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=U-SENS; Endpoint=CD86, EC150; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=7000; Reported_Response_Unit=uM; Conversion_Factor_Value=166.176; Conversion_Factor_Source=EPA Dashboard; Converted_Response_Modifier=>; Converted_Response=1163.232; Converted_Response_Unit=ug/mL; Response=1163.232; 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/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization CV75 569.5 ug/mL - Dermal - In Vitro; hCLAT2015; h-CLAT sheet=Data_invitro; excel_row=2576; Record_ID=skin_sensitization_invitro_616; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=h-CLAT; Endpoint=CV75; Reported_Response=569.5; Reported_Response_Unit=ug/mL; Response=569.5; Response_Unit=ug/mL; Reference=Ashikaga et al. 2010; 20822320; 10.1177/026119291003800403|Nukada et al. 2012; 22796097; 10.1016/j.tiv.2012.07.001|Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization Depletion Cys 1.1 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=449; Record_ID=skin_sensitization_invitro_136; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=1.1000000000000001; Reported_Response_Unit=%; Response=1.1; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization Depletion Lys 9.7 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=453; Record_ID=skin_sensitization_invitro_137; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=9.6999999999999993; Reported_Response_Unit=%; Response=9.7; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization Depletion Lys 45.1 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=447; Record_ID=skin_sensitization_invitro_136; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=45.1; Reported_Response_Unit=%; Response=45.1; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization Depletion Lys + Cys 5.4 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=459; Record_ID=skin_sensitization_invitro_137; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=5.4; Reported_Response_Unit=%; Response=5.4; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization Depletion Lys + Cys 23 % - Dermal - In Vitro; DPRA2015; DPRA sheet=Data_invitro; excel_row=451; Record_ID=skin_sensitization_invitro_136; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=23; Reported_Response_Unit=%; Response=23; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization EC1.5 161.7 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4906; Record_ID=skin_sensitization_invitro_1137; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=161.69999999999999; Reported_Response_Unit=uM; Response=161.7; Response_Unit=uM; Reference=Emter et al. 2010; 20307559; 10.1016/j.taap.2010.03.009|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization IC50 >2000 uM - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4909; Record_ID=skin_sensitization_invitro_1137; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=KeratinoSens; Endpoint=IC50; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=2000; Reported_Response_Unit=uM; Response=2000; Response_Unit=uM; Reference=Emter et al. 2010; 20307559; 10.1016/j.taap.2010.03.009|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization Imax 5.4 ratio - Dermal - In Vitro; KeratinoSens2015; KeratinoSens sheet=Data_invitro; excel_row=4911; Record_ID=skin_sensitization_invitro_1137; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=5.4; Reported_Response_Unit=Unitless; Response=5.4; Response_Unit=Ratio; Reference=Emter et al. 2010; 20307559; 10.1016/j.taap.2010.03.009|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization Incidence of positive responses 0 % Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=4239; Record_ID=skin_sensitization_invivo_1028; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=2.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Kligman 1970: report to RIFM|Opdyke 1975; Not available; 10.1016/0015-6264(75)90093-0; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization Induction dose per skin area 1296 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=4237; Record_ID=skin_sensitization_invivo_1028; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=2.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=1296; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Kligman 1970: report to RIFM|Opdyke 1975; Not available; 10.1016/0015-6264(75)90093-0; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
NTP_ICE_skin_sensitization Relative reliability score 3 unitless Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=4243; Record_ID=skin_sensitization_invivo_1028; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=2.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID5021968; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=3; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Kligman 1970: report to RIFM|Opdyke 1975; Not available; 10.1016/0015-6264(75)90093-0; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5021968; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5021968
ToxValDB_ECHA_IUCLID 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =500 mg/kg bw/day Rat oral - developmental GUIDELINE=OECD Guideline 414 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabc6e4b0a7c65d1bbbb2; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/13700/7/9/3?documentUUID=132d142d-9de8-4a47-81a2-a37a7d1161c6; YEAR=1984; ORIGINAL_YEAR=1984; STUDY_GROUP=ECHA IUCLID:15824115:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_dfed1d96521b7b054908c618547d0a7b
ToxValDB_ECHA_IUCLID NOAEL =1000 ppm Rat oral short-term; 2 weeks short-term QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7ca41e4b0a7c65d220fa8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/13700/7/6/2?documentUUID=132d142d-9de8-4a47-81a2-a37a7d1161c6; YEAR=1984; ORIGINAL_YEAR=1984; STUDY_GROUP=ECHA IUCLID:15841679:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_96d6add4c0a51e6729f1fcb2e0859737
ToxValDB_ECHA_IUCLID NOAEL =1000 mg/kg bw/day Rat oral subchronic; 13 weeks subchronic QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669ead05e4b0a7c65d1c21b5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/13700/7/6/2?documentUUID=132d142d-9de8-4a47-81a2-a37a7d1161c6; YEAR=1984; ORIGINAL_YEAR=1984; STUDY_GROUP=ECHA IUCLID:15850537:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_4e64bf08fc345ece16fb8cc0c419140e
ToxValDB_EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL =500 mg/kg bw/day Rat oral chronic; 14 weeks chronic LONG_REF=EFSA AFC (2008). Flavouring Group Evaluation 52 (FGE.52): Consideration of hydroxy- and alkoxy substituted benzyl derivatives evaluated by JECFA (57th meeting) structurally related to benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters evaluated by EFSA in FGE.20 (2005) (Commission Regulation (EC) No 1565/2000 of 18 July 2000). doi:10.2903/j.efsa.2008.637.; TITLE=Flavouring Group Evaluation 52 (FGE.52): Consideration of hydroxy- and alkoxy substituted benzyl derivatives evaluated by JECFA (57th meeting) structurally related to benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters evaluated by EFSA in FGE.20 (2005) (Commission Regulation (EC) No 1565/2000 of 18 July 2000); AUTHOR=EFSA AFC; DOI=doi:10.2903/j.efsa.2008.637; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=EFSA:15620682:-:--; 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_9da63c2674c5a5547800c4b4fa4f9db1
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =49 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:15631902:-:--; 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_cefdc948eac3689a6205ec93094d1b20
ToxValDB_WHO_JECFA_ADI 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_WHO_JECFA_ADI ADI <=3 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650af4bee4b0d99f5a8729ac; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/; SUBSOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/1465; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=WHO JECFA ADI:15715254:-:--; 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_2bf7ba6878b23c83bb052fc1685c2cdf
openFDA substances 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier YC9ST449YJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H10O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"YC9ST449YJ"}
openFDA substances FDA UNII substance identifier YC9ST449YJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H10O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"YC9ST449YJ"}
openFDA substances FDA UNII substance identifier YC9ST449YJ UNII - - - chemical {"approval_status":null,"molecular_formula":"C9H10O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"YC9ST449YJ"}