NOAEL Studies Cosmetic Ingredient

Lactoflavin NOAEL Studies

INCI: LACTOFLAVIN

CAS: 83-88-5

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 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 400 mg/kg bw/day mouse oral 3 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 25 mg/kg bw/day dog oral 153 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 50 mg/kg bw/day rat oral 104 day Multigeneration Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 10 mg/kg bw/day rat oral NA Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 4 mg/kg bw/day rat oral NA Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =160 mg/kg bw/day Rat - 90 days subchronic EFSA FEEDAP - 2016 - OutputID 2752 - no adverse effect observed at single/highest dose - Safety and efficacy of vitamin B2 (riboflavin and riboflavin 5'-phosphate ester monosodium salt) produced by Bacillus subtilis for all animal species based on a dossier submitted by DSM - doi:10.2903/j.efsa.2016.4349
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI (group) <=0.5 mg/kg bw/day Consumers - - ADI (group) EFSA ANS - 2013 - OutputID 2368 - Consumers - Scientific Opinion on the re-evaluation of riboflavin (E 101(i)) and riboflavin-5'-phosphate sodium (E 101(ii)) as food additives. - doi:10.2903/j.efsa.2013.3357
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI (group) <=0.5 mg/kg bw/day Consumers - - ADI (group) EFSA ANS - 2013 - OutputID 2368 - Consumers - Scientific Opinion on the re-evaluation of riboflavin (E 101(i)) and riboflavin-5'-phosphate sodium (E 101(ii)) as food additives. - doi:10.2903/j.efsa.2013.3357
NTP_ICE_acute_oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 >10000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_10774; row=13345; data_type=In Vivo; mixture=Chemical; chemical_name=Riboflavin; preferred_name=Riboflavin; dtxsid=DTXSID8021777; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021777; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID8021777; source_file=acute_oral.xlsx
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=14100; RecordID=ARPathway2016_1635; DatasetName=ARPathway2016; DTXSID=DTXSID8021777; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8021777; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8021777
ToxValDB_EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL =160 mg/kg bw/day Rat oral subchronic; 90 days subchronic LONG_REF=EFSA FEEDAP (2016). Safety and efficacy of vitamin B2 (riboflavin and riboflavin 5'-phosphate ester monosodium salt) produced by Bacillus subtilis for all animal species based on a dossier submitted by DSM. doi:10.2903/j.efsa.2016.4349.; TITLE=Safety and efficacy of vitamin B2 (riboflavin and riboflavin 5'-phosphate ester monosodium salt) produced by Bacillus subtilis for all animal species based on a dossier submitted by DSM; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2016.4349; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15622456: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_a7760f6ec2373cd19943476fc58da48d
ToxValDB_WHO_JECFA_ADI 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_WHO_JECFA_ADI ADI <=0.5 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650b03a2e4b0d99f5a8884e5; 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/4091; YEAR=1981; ORIGINAL_YEAR=1981; STUDY_GROUP=WHO JECFA ADI:15715758:-:--; 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_0044ad27fd21d0d73044197d9289bb88
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier TLM2976OFR UNII - - - chemical {"approval_status":null,"molecular_formula":"C17H20N4O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"TLM2976OFR"}
openFDA substances FDA UNII substance identifier TLM2976OFR UNII - - - chemical {"approval_status":null,"molecular_formula":"C17H20N4O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"TLM2976OFR"}
openFDA substances FDA UNII substance identifier TLM2976OFR UNII - - - chemical {"approval_status":null,"molecular_formula":"C17H20N4O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"TLM2976OFR"}
openFDA substances FDA UNII substance identifier TLM2976OFR UNII - - - chemical {"approval_status":null,"molecular_formula":"C17H20N4O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"TLM2976OFR"}