NOAEL Studies Cosmetic Ingredient

Heliotropine NOAEL Studies

INCI: HELIOTROPINE

CAS: 120-57-0

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 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 250 mg/kg bw/day rat oral 704 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 1000 mg/kg bw/day rat oral 105 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 100 mg/kg bw/day rat oral 196 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =250 mg/kg bw/day Rat - 730 days chronic/long term toxicity 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
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =250 mg/kg bw/day Rat - 730 days chronic/long term toxicity 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_skin_sensitization 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_skin_sensitization Incidence of positive responses 0 % Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=4228; Record_ID=skin_sensitization_invivo_1025; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=6.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7025924; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Greif 1967; Not available; Not available|Opdyke 1974; Not available; 10.1016/0015-6264(74)90178-3; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7025924; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID7025924
NTP_ICE_skin_sensitization Induction dose per skin area 3724 ug/cm2 Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=4226; Record_ID=skin_sensitization_invivo_1025; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=6.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7025924; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=3724; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Greif 1967; Not available; Not available|Opdyke 1974; Not available; 10.1016/0015-6264(74)90178-3; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7025924; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID7025924
NTP_ICE_skin_sensitization Relative reliability score 2 unitless Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=4232; Record_ID=skin_sensitization_invivo_1025; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=6.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID7025924; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=2; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Greif 1967; Not available; Not available|Opdyke 1974; Not available; 10.1016/0015-6264(74)90178-3; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7025924; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID7025924
ToxValDB_ECHA_IUCLID 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECHA_IUCLID NOAEL =300 mg/kg bw/day Rat oral - reproduction developmental GUIDELINE=OECD Guideline 414 (Prenatal Developmental Toxicity Study); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabc6e4b0a7c65d1bbb6a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5265/7/9/3?documentUUID=413e93cc-43bf-44c8-b8da-5f3865df3a9f; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: clinical signs|maternal: pre and post implantation loss; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|reproduction; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15824097_15824098:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_1945ea54f4805ee290ef81558b5a39b3
ToxValDB_ECHA_IUCLID NOAEL =390 mg/kg bw/day Rat oral chronic; 2 years chronic QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eacf9e4b0a7c65d1c1db0; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5265/7/6/2?documentUUID=413e93cc-43bf-44c8-b8da-5f3865df3a9f; YEAR=1990; ORIGINAL_YEAR=1990; STUDY_GROUP=ECHA IUCLID:15850494: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_92df172cc226ee573dfd74f29c94167f
ToxValDB_ECHA_IUCLID NOAEL =250 mg/kg bw/day Rat oral - developmental QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa71e4b0a7c65d1b5d98; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/5265/7/9/2?documentUUID=413e93cc-43bf-44c8-b8da-5f3865df3a9f; YEAR=1990; ORIGINAL_YEAR=1990; STUDY_GROUP=ECHA IUCLID:15861029:M/F:F1-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_0bc76e41332abb865269e2edfc58c255
ToxValDB_EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL =250 mg/kg bw/day Rat oral chronic; 2 years 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:15614506:-:--; 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_5a86a2875fe28e67dea94ced5cd8f800
ToxValDB_GESTIS_DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_GESTIS_DNEL DNEL systemic =5.29 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:15634202:-:--; 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_8539682fe0afed9d5e252766a4661d71
ToxValDB_WHO_JECFA_ADI 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_WHO_JECFA_ADI ADI <=2.5 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afe8de4b0d99f5a880590; 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/970; YEAR=2001; ORIGINAL_YEAR=2001; STUDY_GROUP=WHO JECFA ADI:15715564:-:--; 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_e782c8a2e2fcb614a883caf8cd163b75
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier KE109YAK00 UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KE109YAK00"}
openFDA substances FDA UNII substance identifier KE109YAK00 UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KE109YAK00"}
openFDA substances FDA UNII substance identifier KE109YAK00 UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KE109YAK00"}
openFDA substances FDA UNII substance identifier KE109YAK00 UNII - - - chemical {"approval_status":null,"molecular_formula":"C8H6O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"KE109YAK00"}