NOAEL Studies Surfactant

Cocamidopropyl Betaine NOAEL Studies

INCI: COCAMIDOPROPYL BETAINE

CAS: 61789-40-0

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

CIR Safety Assessment 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment NOAEL =250 mg/kg rat dermal subchronic repeated dose toxicity 1; 6; 3, p.14
CIR Safety Assessment NOAEL =500 mg/kg rat - - NOAEL study 500, p.13
NTP ICE skin sensitization 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE skin sensitization CD86, EC120 range1.449 ug/mL - Dermal - In Vitro; Urbisch_SkinSensitization2020; mMUSST sheet=Data_invitro; excel_row=7771; Record_ID=skin_sensitization_invitro_1869; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6028072; Assay=mMUSST; Endpoint=CD86, EC120; Response_Modifier=range; Reported_Response=4.23 to 8.47; Reported_Response_Unit=uM; Conversion_Factor_Value=342.5; Conversion_Factor_Source=PubChem; Converted_Response=1.449 to 2.901; Converted_Response_Unit=ug/mL; Response=1.449 - 2.901; 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/DTXSID6028072
NTP ICE skin sensitization Depletion Cys 3.9 % - Dermal - In Vitro; Urbisch_SkinSensitization2020; DPRA sheet=Data_invitro; excel_row=251; Record_ID=skin_sensitization_invitro_70; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6028072; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=3.9; Reported_Response_Unit=%; Response=3.9; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6028072
NTP ICE skin sensitization Depletion Lys 0 % - Dermal - In Vitro; Urbisch_SkinSensitization2020; DPRA sheet=Data_invitro; excel_row=224; Record_ID=skin_sensitization_invitro_70; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6028072; 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/DTXSID6028072
NTP ICE skin sensitization EC1.5 range31.1 uM - Dermal - In Vitro; Urbisch_SkinSensitization2020; LuSens sheet=Data_invitro; excel_row=8024; Record_ID=skin_sensitization_invitro_1814; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6028072; Assay=LuSens; Endpoint=EC1.5; Response_Modifier=range; Reported_Response=31.10 to 62.20; Reported_Response_Unit=uM; Response=31.10 - 62.20; 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/DTXSID6028072
NTP ICE skin sensitization EC3 >35 % Mouse Dermal - In Vivo; Urbisch_SkinSensitization2020; LLNA sheet=Data_invivo; excel_row=12781; Record_ID=skin_sensitization_invivo_2793; Data_Type=In Vivo; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6028072; Assay=LLNA; Endpoint=EC3; Response_Modifier=>; Response=35; 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/DTXSID6028072
NTP ICE skin sensitization Imax <1.16 ratio - Dermal - In Vitro; Urbisch_SkinSensitization2020; LuSens sheet=Data_invitro; excel_row=7548; Record_ID=skin_sensitization_invitro_1814; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6028072; Assay=LuSens; Endpoint=Imax; Response_Modifier=<; Reported_Response_Modifier=<; Reported_Response=1.1599999999999999; Reported_Response_Unit=Unitless; Response=1.16; 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/DTXSID6028072
ECHA 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA NOAEL =95 mg/kg bw/day Rat oral - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1b5e4b0a7c65d22fd88; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15928/7/9/3?documentUUID=316af4ce-fbb8-4f1a-b826-8916103a82a2; YEAR=1967; ORIGINAL_YEAR=1967; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: clinical signs|maternal: food consumption and compound intake|maternal: gross pathology|maternal: mortality|maternal: organ weights and organ / body weight ratios|maternal: pre and post implantation loss|maternal: total litter losses by resorption; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|gross pathology|mortality/survival|organ weight|reproduction; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822442_15825350:F:-maternal; 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_8f0a3b1e462234a85d6f5ffcf175385b
ECHA NOAEL =250 mg/kg bw/day Rat oral subchronic; 90 days subchronic QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cac6e4b0a7c65d2235f0; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15928/7/6/2?documentUUID=316af4ce-fbb8-4f1a-b826-8916103a82a2; YEAR=1967; ORIGINAL_YEAR=1967; TOXICOLOGICAL_EFFECT=body weight and weight gain|organ weights and organ / body weight ratios|urinalysis|clinical biochemistry|clinical signs|food consumption and compound intake|gross pathology|haematology|histopathology: neoplastic|histopathology: non-neoplastic|mortality|ophthalmological examination; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical chemistry|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|nonneoplastic histopathology|organ weight|urinalysis; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15847174_15847253_15848622: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_921c9963d7e8cf3fd8badddab5c85b55
ECHA NOAEL =286 mg/kg bw/day Rat oral - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac7be4b0a7c65d1bf4ca; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23579/7/9/3?documentUUID=5c6d1924-6cb5-40be-ae9f-50b1b7e4e74d; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=fetus: reduction in number of live offspring; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15825230:M/F:-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_14018bc0900684e406f5a2f52ade8708
ECHA NOAEL =500 mg/kg bw/day Rat oral short-term; 28 days short-term QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf22e4b0a7c65d1cc962; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23579/7/6/2?documentUUID=5c6d1924-6cb5-40be-ae9f-50b1b7e4e74d; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=gross pathology; TOXICOLOGICAL_EFFECT_CATEGORY=gross pathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15849724_15849725: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_0533e2ec34fef219a26c5c4a29563bf5
ECHA NOAEL >950 mg/kg bw/day Rat oral - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1b5e4b0a7c65d22fd88; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15928/7/9/3?documentUUID=316af4ce-fbb8-4f1a-b826-8916103a82a2; YEAR=1967; ORIGINAL_YEAR=1967; TOXICOLOGICAL_EFFECT=fetus: reduction in number of live offspring|fetus: fetal/pup body weight changes|fetus: external malformations|fetus: skeletal malformations|fetus: visceral malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15821123_15825351:-:-fetal; 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_bcd8042cac46134a490d4a026869c69b
ECHA NOAEL =1000 mg/kg bw/day Rat oral - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d24ce4b0a7c65d232864; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15928/7/9/3?documentUUID=316af4ce-fbb8-4f1a-b826-8916103a82a2; YEAR=1967; ORIGINAL_YEAR=1967; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: clinical signs|maternal: food consumption and compound intake|maternal: gross pathology|maternal: histopathology: non-neoplastic|maternal: mortality|maternal: organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|gross pathology|mortality/survival|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822442_15825350: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_c9fc9313502fd681f501fcfa578834b0
ToxValDB GESTIS DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB GESTIS DNEL DNEL systemic =8.22 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:15634317:-:--; 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_4976fbc683507de8e0ab875efdc838b2
ToxValDB HPVIS 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB HPVIS LOAEL =300 mg/kg bw/day Rat oral short-term; 7 days short-term LONG_REF=Bailey, D. E. 1988. Dose Range-finding Toxicity Study in Rats. Report number 444-223. Hazleton Laboratories America, Inc., Vienna, VA, U. S.; TITLE=Dose Range-finding Toxicity Study in Rats. Report number 444-223; AUTHOR=Bailey, D. E; QUALITY=1; EXTERNAL_SOURCE_ID=60981; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=HPVIS:15639692:-:--; 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_bf6dae4f8e6733b16d4f725b7270c270
ToxValDB HPVIS LOAEL =1000 mg/kg bw/day Rat oral short-term; 28 days short-term LONG_REF=Potokar, M., W. Sterzel and W. Pittermann. 1991. Dehyton K, 28-Tage-Test mit Wiederholter Oraler Verabreichung an Ratten. Report number TED 910119. Henkel KGaA, Duesseldorf, Germany.; TITLE=Dehyton K, 28-Tage-Test mit Wiederholter Oraler Verabreichung an Ratten. Report number TED 910119; AUTHOR=Potokar, M., W. Sterzel and W. Pittermann; QUALITY=1; EXTERNAL_SOURCE_ID=61792; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT_CATEGORY=-|multiple; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Repeat Dose_15639647_15639799:-:--; 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_8c89b4a30bd653b75df1b7428e232fc2
ToxValDB HPVIS NOAEL =250 mg/kg bw/day Rat oral chronic; 92 days chronic LONG_REF=Zuehlke, U. 1991. 90 Day Oral (Gavage) Subchronic Toxicity Study in the Rat. Report number 954-348-155. Hazleton Laboratories Deutschland GmbH, Muenster, Germany; TITLE=90 Day Oral (Gavage) Subchronic Toxicity Study in the Rat. Report number 954-348-155; AUTHOR=Zuehlke, U; QUALITY=1; EXTERNAL_SOURCE_ID=63098; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=HPVIS:15639977:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_7dcabec514364f25c68e52278b6df645
Regulatory source 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 500 mg/kg rat - - - p.13
Regulatory source repeated dose toxicity 250 mg/kg rat dermal subchronic repeated dose toxicity p.14
Regulatory source repeated dose toxicity 500 mg/kg rat oral 28-day repeated dose toxicity p.28
openFDA substances 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 5OCF3O11KX UNII - - - mixture -
openFDA substances FDA UNII substance identifier concept identifier - - - concept -