NOAEL Studies Active Ingredient

Melatonin NOAEL Studies

INCI: MELATONIN

CAS: 73-31-4

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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NTP ICE adme parameters 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE adme parameters Clint 0 uL/min/10^6 cells Human - - Measured; httk, Human Hepatic Intrinsic Clearance sheet=Data; excel_row=505; Record_ID=adme_parameters_610; Data_Type=Measured; DTXSID=DTXSID1022421; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=0.0; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1022421; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1022421
NTP ICE adme parameters Fu 0.498 fraction Human - - Measured; httk, Human Plasma Fraction Unbound sheet=Data; excel_row=504; Record_ID=adme_parameters_610; Data_Type=Measured; DTXSID=DTXSID1022421; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.498; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1022421; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1022421
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=11200; RecordID=ARPathway2016_1520; DatasetName=ARPathway2016; DTXSID=DTXSID1022421; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1022421; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID1022421
SCCS Opinion 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =0.3 % rat oral Sub-chronic repeated dose toxicity p.16
SCCS Opinion NOAEL =0.5 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity p.16
SCCS Opinion NOAEL =0.5 mg/kg bw rat dermal 28 days dermal absorption p.27
SCCS Opinion NOAEL =0.5 mg/kg bw/d human dermal - dermal absorption p.29
SCCS Opinion NOAEL =5 mg/kg bw/day rat - - NOAEL study p.16
SCCS Opinion NOAEL =100 mg/kg bw/day rat intravenous prenatal developmental toxicity p.20
SCCS Opinion NOAEL =200 mg/kg/day rat oral subacute repeated dose toxicity p.15
SCCS Opinion NOAEL =200 mg/kg bw/day - - developmental reproductive toxicity p.29
ToxValDB ECOTOX 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB ECOTOX LOEL =3 mg/kg bw/day Rat injection subchronic; 43 days subchronic LONG_REF=Toxicology195(1): 69-75 Baltaci,A.K., R. Mogulkoc, A. Kul, C.S. Bediz, and A. Ugur Opposite Effects of Zinc and Melatonin on Thyroid Hormones in Rats 2004; TITLE=Opposite Effects of Zinc and Melatonin on Thyroid Hormones in Rats; AUTHOR=Baltaci,A.K., R. Mogulkoc, A. Kul, C.S. Bediz, and A. Ugur; DOI=10.1016/j.tox.2003.09.001; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=85833; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2004; ORIGINAL_YEAR=2004; TOXICOLOGICAL_EFFECT=Accumulation: Residue|Biochemistry: Zinc content|Hormone(s): Thyrotropin|Hormone(s): Thyroxine|Hormone(s): Triiodothyronine; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|other; STUDY_GROUP=ECOTOX:15596825:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=8b837f803621ba94706571df4b2f85c7
ToxValDB ECOTOX NOEL =0.5 mg/kg bw/day Rat oral short-term; 28 days short-term LONG_REF=Asian Pac. J. Trop. Biomed.2(8): 645-650 Umosen,A.J., S.F. Ambali, J.O. Ayo, B. Mohammed, and C. Uchendu Alleviating Effects of Melatonin on Oxidative Changes in the Testes and Pituitary Glands Evoked by Subacute Chlorpyrifos Administration in Wistar Rats 2012; TITLE=Alleviating Effects of Melatonin on Oxidative Changes in the Testes and Pituitary Glands Evoked by Subacute Chlorpyrifos Administration in Wistar Rats; AUTHOR=Umosen,A.J., S.F. Ambali, J.O. Ayo, B. Mohammed, and C. Uchendu; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=160416; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=Biochemistry: Malondialdehyde|Enzyme(s): Superoxide dismutase (SOD) enzyme activity; TOXICOLOGICAL_EFFECT_CATEGORY=enzyme activity|other; STUDY_GROUP=ECOTOX:15598461:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=cf4c51ae274fbf2df3299fc1548d69ee
ToxValDB ECOTOX NOEL =10 mg/kg bw/day Rat oral short-term; 28 days short-term LONG_REF=Indian J. Biochem. Biophys.45(4): 278-281 Suke,S.G., R. Pathak, R.S. Ahmed, A.K. Tripathi, and B.D. Banerjee Melatonin Treatment Prevents Modulation of Cell-Mediated Immune Response Induced by Propoxur in Rats 2008; TITLE=Melatonin Treatment Prevents Modulation of Cell-Mediated Immune Response Induced by Propoxur in Rats; AUTHOR=Suke,S.G., R. Pathak, R.S. Ahmed, A.K. Tripathi, and B.D. Banerjee; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=111928; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=Physiology: Cell Migration Inhibition (Immune Response Activity); TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15604425_15607071:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=2a735dc77c9402d8958d3a86c6746c4e
Regulatory source 15 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 5 mg/kg bw/day rat - - - p.16
Regulatory source - 5 mg/kg bw/day rat oral 14 days - p.28
Regulatory source dermal absorption =0.5 mg/kg bw rat dermal 28 days dermal absorption p.27
Regulatory source dermal absorption 0.5 mg/kg bw/d human dermal - dermal absorption p.29
Regulatory source dermal absorption 0.5 mg/kg bw/d human oral - dermal absorption p.29
Regulatory source developmental toxicity 100 mg/kg bw/day rat intravenous prenatal developmental toxicity p.20
Regulatory source repeated dose toxicity 0.3 % rat oral Sub-chronic repeated dose toxicity p.16
Regulatory source repeated dose toxicity 0.5 mg/kg bw/day rat oral Sub-chronic repeated dose toxicity p.16
Regulatory source repeated dose toxicity 0.5 mg/kg bw/day - - Chronic repeated dose toxicity p.17
Regulatory source repeated dose toxicity 0.5 mg/kg bw/day rat oral 28 days repeated dose toxicity p.28
Regulatory source repeated dose toxicity 5 mg/kg bw/day rat oral 28 days repeated dose toxicity p.28
Regulatory source repeated dose toxicity 200 mg/kg/day rat oral subacute repeated dose toxicity p.15
Regulatory source repeated dose toxicity 200 mg/kg bw/day rat oral 28 days repeated dose toxicity p.28
Regulatory source reproductive toxicity 100 mg/kg bw/day - - developmental reproductive toxicity p.29
Regulatory source reproductive toxicity 200 mg/kg bw/day - - developmental reproductive toxicity p.29
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier JL5DK93RCL UNII - - - chemical -