NOAEL Studies Cosmetic Ingredient

2,3-Dihydro-2,2,6-trimethylbenzaldehyde (Safranal) NOAEL Studies

INCI: 2,3-DIHYDRO-2,2,6-TRIMETHYLBENZALDEHYDE

CAS: 116-26-7

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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EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOEL =10 mg/kg bw/day Rat - 90 days subchronic EFSA CEF - 2012 - OutputID 2130 - Scientific Opinion on Flavouring Group Evaluation 73, Revision 1 (FGE.73Rev1): Consideration of alicyclic primary alcohols, aldehydes, acids and related esters evaluated by JECFA (59th meeting) structurally related to primary saturated or unsaturated alicyclic alcohol, aldehyde, and esters evaluated by EFSA in FGE.12Rev2 (2011)EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) - doi:10.2903/j.efsa.2012.2638
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOEL =10 mg/kg bw/day Rat - 90 days subchronic EFSA CEF - 2012 - OutputID 2130 - Scientific Opinion on Flavouring Group Evaluation 73, Revision 1 (FGE.73Rev1): Consideration of alicyclic primary alcohols, aldehydes, acids and related esters evaluated by JECFA (59th meeting) structurally related to primary saturated or unsaturated alicyclic alcohol, aldehyde, and esters evaluated by EFSA in FGE.12Rev2 (2011)EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) - doi:10.2903/j.efsa.2012.2638
NTP_ICE_skin_sensitization 15 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_skin_sensitization CD86, EC150 12.4 ug/mL - Dermal - In Vitro; Urbisch_SkinSensitization2020; U-SENS sheet=Data_invitro; excel_row=8238; Record_ID=skin_sensitization_invitro_2261; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=82.54559979; Reported_Response_Unit=uM; Conversion_Factor_Value=150.221; Conversion_Factor_Source=EPA Dashboard; Converted_Response=12.4; Converted_Response_Unit=ug/mL; Response=12.4; 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/DTXSID7049398
NTP_ICE_skin_sensitization Concentration, 5% incidence of positive responses 0.27 % Human Dermal - In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test sheet=Data_invivo; excel_row=4019; Record_ID=skin_sensitization_invivo_981; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.5; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=Human Repeat Insult Patch Test; Endpoint=Concentration, 5% incidence of positive responses; Response=0.27; Response_Unit=%; Species=Human; Route=Dermal; Reference=RIFM 1996; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Anonymous 2000; Not available; 10.1016/S0278-6915(00)80061-7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7049398
NTP_ICE_skin_sensitization Concentration, one positive response 0.1 % Human Dermal - In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test sheet=Data_invivo; excel_row=4015; Record_ID=skin_sensitization_invivo_981; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.5; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=Human Repeat Insult Patch Test; Endpoint=Concentration, one positive response; Response=0.1; Response_Unit=%; Species=Human; Route=Dermal; Reference=RIFM 1996; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Anonymous 2000; Not available; 10.1016/S0278-6915(00)80061-7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7049398
NTP_ICE_skin_sensitization Depletion Cys 91.8 % - Dermal - In Vitro; Urbisch_SkinSensitization2020; DPRA sheet=Data_invitro; excel_row=86; Record_ID=skin_sensitization_invitro_9; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=91.8; Reported_Response_Unit=%; Response=91.8; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7049398
NTP_ICE_skin_sensitization Depletion Lys 0 % - Dermal - In Vitro; Urbisch_SkinSensitization2020; DPRA sheet=Data_invitro; excel_row=140; Record_ID=skin_sensitization_invitro_9; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0; Reported_Response_Unit=%; Response=0; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7049398
NTP_ICE_skin_sensitization EC1.5 5.39 uM - Dermal - In Vitro; Urbisch_SkinSensitization2020; KeratinoSens sheet=Data_invitro; excel_row=4780; Record_ID=skin_sensitization_invitro_1104; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=5.389564401; Reported_Response_Unit=uM; Response=5.39; 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/DTXSID7049398
NTP_ICE_skin_sensitization EC3 7.5 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=12969; Record_ID=skin_sensitization_invivo_2887; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=LLNA; Endpoint=EC3; Response=7.5; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7049398
NTP_ICE_skin_sensitization IC50 337.3 uM - Dermal - In Vitro; Urbisch_SkinSensitization2020; KeratinoSens sheet=Data_invitro; excel_row=4782; Record_ID=skin_sensitization_invitro_1104; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=337.2667038; Reported_Response_Unit=uM; Response=337.3; 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/DTXSID7049398
NTP_ICE_skin_sensitization Imax 339.1 ratio - Dermal - In Vitro; Urbisch_SkinSensitization2020; KeratinoSens sheet=Data_invitro; excel_row=4784; Record_ID=skin_sensitization_invitro_1104; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=339.0978295; Reported_Response_Unit=Unitless; Response=339.1; 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/DTXSID7049398
NTP_ICE_skin_sensitization Incidence of positive responses 0 % Human Dermal - In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test sheet=Data_invivo; excel_row=4003; Record_ID=skin_sensitization_invivo_979; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.05; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=Human Repeat Insult Patch Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=RIFM 1998; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Anonymous 2000; Not available; 10.1016/S0278-6915(00)80061-7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7049398
NTP_ICE_skin_sensitization Incidence of positive responses 9.434 % Human Dermal - In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test sheet=Data_invivo; excel_row=4011; Record_ID=skin_sensitization_invivo_981; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.5; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=Human Repeat Insult Patch Test; Endpoint=Incidence of positive responses; Response=9.434; Response_Unit=%; Species=Human; Route=Dermal; Reference=RIFM 1996; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Anonymous 2000; Not available; 10.1016/S0278-6915(00)80061-7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7049398
NTP_ICE_skin_sensitization Induction dose per skin area 300 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test sheet=Data_invivo; excel_row=4009; Record_ID=skin_sensitization_invivo_981; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.5; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area; Response=300; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=RIFM 1996; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Anonymous 2000; Not available; 10.1016/S0278-6915(00)80061-7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7049398
NTP_ICE_skin_sensitization Induction dose per skin area, 5% incidence of positive responses 160 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test sheet=Data_invivo; excel_row=4021; Record_ID=skin_sensitization_invivo_981; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.5; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area, 5% incidence of positive responses; Response=160; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=RIFM 1996; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Anonymous 2000; Not available; 10.1016/S0278-6915(00)80061-7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7049398
NTP_ICE_skin_sensitization Induction dose per skin area, one positive response 60 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test sheet=Data_invivo; excel_row=4017; Record_ID=skin_sensitization_invivo_981; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.5; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area, one positive response; Response=60; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=RIFM 1996; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Anonymous 2000; Not available; 10.1016/S0278-6915(00)80061-7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7049398
NTP_ICE_skin_sensitization Relative reliability score 4 unitless Human Dermal - In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test sheet=Data_invivo; excel_row=4007; Record_ID=skin_sensitization_invivo_979; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=0.05; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7049398; Assay=Human Repeat Insult Patch Test; Endpoint=Relative reliability score; Response=4; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=RIFM 1998; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Anonymous 2000; Not available; 10.1016/S0278-6915(00)80061-7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7049398
ToxValDB_ECHA_IUCLID 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =125 mg/kg bw/day Rat oral short-term; 29 days short-term QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaceee4b0a7c65d1c19b0; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17302/7/6/2?documentUUID=2ffbbccf-ee41-4900-b5e0-d296b56808e9; YEAR=2015; ORIGINAL_YEAR=2015; TOXICOLOGICAL_EFFECT=gross pathology|histopathology: non-neoplastic|organ weights and organ / body weight ratios|urinalysis; TOXICOLOGICAL_EFFECT_CATEGORY=gross pathology|nonneoplastic histopathology|organ weight|urinalysis; STUDY_GROUP=ECHA IUCLID:15830793: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_05ee8a8be8cab8c6ba7b71d8e909a02c
ToxValDB_ECHA_IUCLID NOEL =50 mg/kg bw/day Rat oral - reproduction developmental QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa64e4b0a7c65d1b5a5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17302/7/9/2?documentUUID=2ffbbccf-ee41-4900-b5e0-d296b56808e9; YEAR=2015; ORIGINAL_YEAR=2015; TOXICOLOGICAL_EFFECT=F1: body weight and weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECHA IUCLID_dup_Toxicity Reproduction_15858463_15858719:M/F:F1-; 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_29bc28e360684d31a1cb14bc7d8faf3a
ToxValDB_EFSA 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA LEL =120 mg/kg bw/day Rat oral subchronic; 90 days subchronic LONG_REF=EFSA CEF (2012). Scientific Opinion on Flavouring Group Evaluation 73, Revision 1 (FGE.73Rev1): Consideration of alicyclic primary alcohols, aldehydes, acids and related esters evaluated by JECFA (59th meeting) structurally related to primary saturated or unsaturated alicyclic alcohol, aldehyde, and esters evaluated by EFSA in FGE.12Rev2 (2011)EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). doi:10.2903/j.efsa.2012.2638.; TITLE=Scientific Opinion on Flavouring Group Evaluation 73, Revision 1 (FGE.73Rev1): Consideration of alicyclic primary alcohols, aldehydes, acids and related esters evaluated by JECFA (59th meeting) structurally related to primary saturated or unsaturated alicyclic alcohol, aldehyde, and esters evaluated by EFSA in FGE.12Rev2 (2011)EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); AUTHOR=EFSA CEF; DOI=doi:10.2903/j.efsa.2012.2638; 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=no effects; STUDY_GROUP=EFSA_dup_-_15622018_15622021_15622024: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_8fbe537975008bacb64252f9a99cd8ca
ToxValDB_EFSA NOEL =10 mg/kg bw/day Rat oral subchronic; 90 days subchronic LONG_REF=EFSA CEF (2012). Scientific Opinion on Flavouring Group Evaluation 73, Revision 1 (FGE.73Rev1): Consideration of alicyclic primary alcohols, aldehydes, acids and related esters evaluated by JECFA (59th meeting) structurally related to primary saturated or unsaturated alicyclic alcohol, aldehyde, and esters evaluated by EFSA in FGE.12Rev2 (2011)EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF). doi:10.2903/j.efsa.2012.2638.; TITLE=Scientific Opinion on Flavouring Group Evaluation 73, Revision 1 (FGE.73Rev1): Consideration of alicyclic primary alcohols, aldehydes, acids and related esters evaluated by JECFA (59th meeting) structurally related to primary saturated or unsaturated alicyclic alcohol, aldehyde, and esters evaluated by EFSA in FGE.12Rev2 (2011)EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); AUTHOR=EFSA CEF; DOI=doi:10.2903/j.efsa.2012.2638; 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; STUDY_GROUP=EFSA_dup_-_15622020_15622023_15622026:-:--; 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_ded9b8561d110aa46a3a61e481322330
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =3.08 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:15631249:-:--; 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_d31a0747d6088e1f35ef8dc45053115b
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 4393FR07EA UNII - - - chemical {"approval_status":null,"molecular_formula":"C10H14O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"4393FR07EA"}
openFDA substances FDA UNII substance identifier 4393FR07EA UNII - - - chemical {"approval_status":null,"molecular_formula":"C10H14O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"4393FR07EA"}
openFDA substances FDA UNII substance identifier 4393FR07EA UNII - - - chemical {"approval_status":null,"molecular_formula":"C10H14O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"4393FR07EA"}
openFDA substances FDA UNII substance identifier 4393FR07EA UNII - - - chemical {"approval_status":null,"molecular_formula":"C10H14O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"4393FR07EA"}