NOAEL Studies Active Ingredient

Homosalate NOAEL Studies

INCI: HOMOSALATE

CAS: 118-56-9

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

ECHA 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA LOAEL 590 mg/kg bw/day rabbit - - sub-chronic toxicity: dermal dossier=809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6z; document=67b5926a-9bbe-4828-b3d2-17e8f313465f_809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6d; document_key=67b5926a-9bbe-4828-b3d2-17e8f313465f/809f0480-e0d7-4a09-aa08-99f1ccd93d78; document_subtype=RepeatedDoseToxicityDermal; literature=Name=Unnamed; ReferenceYear=1963; basis=other:; key_result=false; entry_uuid=4bb53fa2-1598-4e63-8203-4e6c3fa25c1f
ECHA LOAEL 1015 mg/kg bw/day rabbit - - sub-chronic toxicity: dermal dossier=809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6z; document=67b5926a-9bbe-4828-b3d2-17e8f313465f_809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6d; document_key=67b5926a-9bbe-4828-b3d2-17e8f313465f/809f0480-e0d7-4a09-aa08-99f1ccd93d78; document_subtype=RepeatedDoseToxicityDermal; literature=Name=Unnamed; ReferenceYear=1963; basis=other:; key_result=false; entry_uuid=d1e52a62-b6df-4393-b6d6-3a547ef70000
ECHA NOAEL 500 mg/kg bw/day rat oral: feed - carcinogenicity: oral dossier=809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6z; document=7cdf1407-8da8-4905-8e9b-381f973380d3_809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6d; document_key=7cdf1407-8da8-4905-8e9b-381f973380d3/809f0480-e0d7-4a09-aa08-99f1ccd93d78; document_subtype=Carcinogenicity; literature=Name=Unnamed; ReferenceYear=1963; basis=other:; key_result=false; entry_uuid=45a87dc1-1459-4337-8158-946d3fbb9d40
ECHA NOAEL 860 mg/kg bw/day rat oral: feed - carcinogenicity: oral dossier=809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6z; document=7cdf1407-8da8-4905-8e9b-381f973380d3_809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6d; document_key=7cdf1407-8da8-4905-8e9b-381f973380d3/809f0480-e0d7-4a09-aa08-99f1ccd93d78; document_subtype=Carcinogenicity; literature=Name=Unnamed; ReferenceYear=1963; basis=other:; key_result=false; entry_uuid=c8daa7e6-752b-4e52-8977-9b67455318b4
ECHA NOAEL 50 mg/kg bw/day dog oral: capsule - chronic toxicity: oral dossier=809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6z; document=3ffe527d-e73e-4791-b54f-5847532dc0ae_809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6d; document_key=3ffe527d-e73e-4791-b54f-5847532dc0ae/809f0480-e0d7-4a09-aa08-99f1ccd93d78; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=1963; basis=other:; key_result=false; entry_uuid=45b999a4-1b10-4946-8d23-9aba949607c5
ECHA NOAEL 86 mg/kg bw/day dog oral: capsule - chronic toxicity: oral dossier=809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6z; document=3ffe527d-e73e-4791-b54f-5847532dc0ae_809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6d; document_key=3ffe527d-e73e-4791-b54f-5847532dc0ae/809f0480-e0d7-4a09-aa08-99f1ccd93d78; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=1963; basis=other:; key_result=false; entry_uuid=0c5a682e-0b7e-490b-b6f3-de8fbef30eec
ECHA NOAEL 300 mg/kg bw/day rat oral: gavage - developmental toxicity dossier=809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6z; document=a8c95254-3d28-4468-b96a-0ac41713a238_809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6d; document_key=a8c95254-3d28-4468-b96a-0ac41713a238/809f0480-e0d7-4a09-aa08-99f1ccd93d78; document_subtype=DevelopmentalToxicityTeratogenicity; literature=Name=Unnamed; ReferenceYear=2013; ReportDate=2013-04-19; basis=other:; key_result=false; entry_uuid=239c10a0-8248-474a-b979-ce2ca43fc1c6
ECHA NOAEL <=120 mg/kg bw/day rat oral: gavage - developmental toxicity dossier=809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6z; document=a8c95254-3d28-4468-b96a-0ac41713a238_809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6d; document_key=a8c95254-3d28-4468-b96a-0ac41713a238/809f0480-e0d7-4a09-aa08-99f1ccd93d78; document_subtype=DevelopmentalToxicityTeratogenicity; literature=Name=Unnamed; ReferenceYear=2013; ReportDate=2013-04-19; basis=reduction in number of live offspring; key_result=false; upper_value=120; entry_uuid=764db93b-9ec2-4a49-bb51-8fd6f0ab686f
ECHA NOAEL 1000 mg/kg bw/day rat subcutaneous - toxicity to reproduction: other studies dossier=809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6z; document=e5705d48-73aa-432c-a4ca-a4036de5a1cb_809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6d; document_key=e5705d48-73aa-432c-a4ca-a4036de5a1cb/809f0480-e0d7-4a09-aa08-99f1ccd93d78; document_subtype=ToxicityReproductionOther; literature=Name=Unnamed; ReferenceYear=2002; basis=other:; key_result=false; entry_uuid=e8373748-ef24-4e59-a25e-fbe38d15ab44
ECHA NOAEL 1180 mg/kg bw/day rabbit - - sub-chronic toxicity: dermal dossier=809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6z; document=67b5926a-9bbe-4828-b3d2-17e8f313465f_809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6d; document_key=67b5926a-9bbe-4828-b3d2-17e8f313465f/809f0480-e0d7-4a09-aa08-99f1ccd93d78; document_subtype=RepeatedDoseToxicityDermal; literature=Name=Unnamed; ReferenceYear=1963; basis=other:; key_result=false; entry_uuid=c07d8c67-064d-468c-83bd-303e26d9301e
ECHA NOAEL 250 mg/kg bw/day dog oral: capsule - sub-chronic toxicity: oral dossier=809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6z; document=8cccc97d-c2ed-4fb5-930f-b2a71925da09_809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6d; document_key=8cccc97d-c2ed-4fb5-930f-b2a71925da09/809f0480-e0d7-4a09-aa08-99f1ccd93d78; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=1963; basis=other:; key_result=false; entry_uuid=6bb65e8d-58c9-4714-bcdd-d5406543e51d
ECHA NOAEL 430 mg/kg bw/day dog oral: capsule - sub-chronic toxicity: oral dossier=809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6z; document=8cccc97d-c2ed-4fb5-930f-b2a71925da09_809f0480-e0d7-4a09-aa08-99f1ccd93d78.i6d; document_key=8cccc97d-c2ed-4fb5-930f-b2a71925da09/809f0480-e0d7-4a09-aa08-99f1ccd93d78; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=1963; basis=other:; key_result=false; entry_uuid=82467a19-1600-4bb6-b02a-bf6d7e16908e
NTP ICE acute oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE acute oral LD50 >5000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_1514; row=2759; data_type=In Vivo; mixture=Chemical; chemical_name=3,3,5-Trimethylcyclohexyl salicylate; preferred_name=3,3,5-Trimethylcyclohexyl salicylate; dtxsid=DTXSID1026241; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1026241; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID1026241; source_file=acute_oral.xlsx
NTP ICE endocrine 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE endocrine AC50 31.3030061241923 uM - - - ERPathway2016; ER Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=2892; RecordID=ERPathway2016_332; DatasetName=ERPathway2016; DTXSID=DTXSID1026241; Assay=ER Pathway Model, Antagonist; Endpoint=AC50; Response=31.3030061241923; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1026241; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1026241
NTP ICE endocrine ACC 15.3394006763907 uM - - - ERPathway2016; ER Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=2893; RecordID=ERPathway2016_332; DatasetName=ERPathway2016; DTXSID=DTXSID1026241; Assay=ER Pathway Model, Antagonist; Endpoint=ACC; Response=15.3394006763907; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1026241; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1026241
NTP ICE endocrine Model Score 0 unitless - - - ARPathway2016; AR Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=2888; RecordID=ARPathway2016_647; DatasetName=ARPathway2016; DTXSID=DTXSID1026241; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1026241; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1026241
NTP ICE endocrine Model Score 0.0217 unitless - - - ERPathway2016; ER Pathway Model, Agonist sheet=Integrated_approaches; excel_row=2894; RecordID=ERPathway2016_332; DatasetName=ERPathway2016; DTXSID=DTXSID1026241; Assay=ER Pathway Model, Agonist; Endpoint=Model Score; Response=0.0217; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1026241; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1026241
NTP ICE skin sensitization 2 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=4082; Record_ID=skin_sensitization_invivo_993; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=8.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1026241; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=RIFM 1977; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1026241; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1026241
NTP ICE skin sensitization Relative reliability score 4 unitless Human Dermal - In Vivo; HPPT2020WIP; Human Maximization Test sheet=Data_invivo; excel_row=4086; Record_ID=skin_sensitization_invivo_993; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=8.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID1026241; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=4; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=RIFM 1977; https://www.rifm.org/rifm-science-database.php#gsc.tab=0|Belsito et al. 2007; 18022746; 10.1016/j.fct.2007.09.066; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1026241; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1026241
SCCS Opinion 18 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =0.5 % - oral - NOAEL study p.48
SCCS Opinion NOAEL =2 % human oral 2 week dermal absorption p.38
SCCS Opinion NOAEL =9 - - - - NOAEL study p.48
SCCS Opinion NOAEL =10 mg/kg bw/day - oral Developmental repeated dose toxicity p.47
SCCS Opinion NOAEL =10 mg/kg bw/d rat oral - dermal absorption p.48
SCCS Opinion NOAEL =20 mg/kg bw/d rat oral - dermal absorption p.48
SCCS Opinion NOAEL =43 mg/kg/day rat oral - NOAEL study p.41
SCCS Opinion NOAEL =50 % - oral Developmental repeated dose toxicity p.47
SCCS Opinion NOAEL =50 % human oral developmental repeated dose toxicity Ref.: SCCS/1622/20 3, p.10
SCCS Opinion NOAEL =75 mg/kg rat oral - NOAEL study p.41
SCCS Opinion NOAEL =75 mg/kg bw/d human - - NOAEL study p.47
SCCS Opinion NOAEL =100 mg/kg bw rat oral 14 days repeated dose toxicity p.20
SCCS Opinion NOAEL =100 mg/kg bw rat - 14 days NOAEL study p.27
SCCS Opinion NOAEL =120 mg/kg bw/d rat oral - NOAEL study (Ref. 50), p.20
SCCS Opinion NOAEL =300 mg/kg bw/day - - - NOAEL study p.30
SCCS Opinion NOAEL =300 mg/kg/day - - - reproductive toxicity p.31
SCCS Opinion NOAEL =300 mg/kg bw/day rat oral Developmental repeated dose toxicity p.9
SCCS Opinion NOAEL >2000 mg/kg bw rat oral 14-day repeated dose toxicity p.39
ToxValDB EPA TSCA 8e 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB EPA TSCA 8e LEL =750 mg/kg bw/day Rat oral subchronic (developmental) reproduction developmental GUIDELINE=OECD 422; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c96d15e4b02565fc7d3269; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://chemview.epa.gov; SUBSOURCE_URL=https://chemview.epa.gov/chemview/proxy?filename=FYI-1608-1744_08.23.2016_Combined.pdf; TOXICOLOGICAL_EFFECT=F1: decreased pup weight; STUDY_GROUP=EPA TSCA 8e_dup_-_15956815_15956823:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_715f2bd4e0a9bec272a78dd613c3afe2
ToxValDB EPA TSCA 8e LOAEL =300 mg/kg bw/day Rat oral subchronic (developmental) reproduction developmental GUIDELINE=OECD 422; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c96d15e4b02565fc7d3269; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://chemview.epa.gov; SUBSOURCE_URL=https://chemview.epa.gov/chemview/proxy?filename=FYI-1608-1744_08.23.2016_Combined.pdf; TOXICOLOGICAL_EFFECT=P0: increased liver weights, changes in glucose concentrations and phosphorus concentrations; STUDY_GROUP=EPA TSCA 8e_dup_-_15956817_15956819_15956822:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_5dd821d45a2336ec0544af7103d22d7e
ToxValDB EPA TSCA 8e NOAEL =120 mg/kg bw/day Rat oral subchronic (developmental) reproduction developmental GUIDELINE=OPPTS 870.3650 (OECD 422) - Combined Repeated Dose Toxicity with the Reproduction/Development Toxicity Screening Test; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c96d15e4b02565fc7d3269; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://chemview.epa.gov; SUBSOURCE_URL=https://chemview.epa.gov/chemview/proxy?filename=FYI-1608-1744_08.23.2016_Combined.pdf; TOXICOLOGICAL_EFFECT=P0: no reproductive toxicity; STUDY_GROUP=EPA TSCA 8e_dup_-_15956815_15956823:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c281e205087413b63c003d6d26267748
ToxValDB GESTIS DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB GESTIS DNEL DNEL systemic =16.09 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:15632565:-:--; 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_d58c633cbfe8a38f3cf908f1e93d18be
Regulatory source 25 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 0.5 % - oral - - p.48
Regulatory source - 9 - - - - - p.48
Regulatory source - 10 mg/kg bw/day - oral - - p.10
Regulatory source - 43 mg/kg/day rat oral - - p.41
Regulatory source - 75 mg/kg rat oral - - p.41
Regulatory source - 75 mg/kg bw/d human - - - p.47
Regulatory source - 100 mg/kg bw rat - 14 days - p.27
Regulatory source - 120 mg/kg bw/d rat oral - - p.20
Regulatory source - 300 mg/kg bw/day - - - - p.30
Regulatory source dermal absorption 2 % human oral 2 week dermal absorption p.38
Regulatory source dermal absorption =10 mg/kg bw/d rat oral - dermal absorption p.48
Regulatory source dermal absorption 20 mg/kg bw/d rat oral - dermal absorption p.48
Regulatory source developmental toxicity 300 mg/kg bw/day - oral Developmental developmental toxicity p.31
Regulatory source genotoxicity 100 mg/kg bw rat oral 14-day genotoxicity p.21
Regulatory source repeated dose toxicity 10 mg/kg bw/day - oral Developmental repeated dose toxicity p.47
Regulatory source repeated dose toxicity 50 % - oral Developmental repeated dose toxicity p.47
Regulatory source repeated dose toxicity 50 % human oral developmental repeated dose toxicity p.10
Regulatory source repeated dose toxicity 100 mg/kg bw rat oral 14 days repeated dose toxicity p.20
Regulatory source repeated dose toxicity 100 mg/kg bw rat oral 90-day repeated dose toxicity p.39
Regulatory source repeated dose toxicity 100 mg/kg bw/d rat oral subacute repeated dose toxicity p.39
Regulatory source repeated dose toxicity 300 mg/kg bw/day - oral - repeated dose toxicity p.50
Regulatory source repeated dose toxicity 300 mg/kg bw/day rat oral Developmental repeated dose toxicity p.9
Regulatory source repeated dose toxicity 300 mg/kg bw/day human - developmental repeated dose toxicity p.9
Regulatory source repeated dose toxicity >2000 mg/kg bw rat oral 14-day repeated dose toxicity p.39
Regulatory source reproductive toxicity 300 mg/kg/day - - - reproductive toxicity p.31
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier V06SV4M95S UNII - - - chemical -