NOAEL Studies Humectant

Betaine NOAEL Studies

INCI: BETAINE

CAS: 107-43-7

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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CIR Safety Assessment 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment NOAEL =5 % rat oral 28-day repeated dose toxicity 0; 1; 2, p.9
CIR Safety Assessment NOAEL =20 mg/kg/d rat oral - developmental toxicity 300; 3,4,27; 6, p.7
CIR Safety Assessment NOAEL =40 mg/kg/d rat oral - developmental toxicity 150; 300; 3,4,27, p.7
CIR Safety Assessment NOAEL =50 mg/kg bw/d rat oral - repeated dose toxicity 4; 0, 50, 150; 300, p.9
CIR Safety Assessment NOAEL =100 mg/kg bw/d rat oral - repeated dose toxicity 150; 300; 4, p.9
CIR Safety Assessment NOAEL =150 mg/kg rat oral 104-week repeated dose toxicity 10; 40; 20, p.7
CIR Safety Assessment NOAEL =250 mg/kg/d rat oral 91-day repeated dose toxicity 0; 83; 15, p.7
CIR Safety Assessment NOAEL =300 mg/kg/d rat oral 104-week repeated dose toxicity 50; 250; 150, p.7
CIR Safety Assessment NOAEL >5771 mg/kg bw/d rat oral 28-day repeated dose toxicity 5; 95; 0, p.9
ECHA 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA NOAEL >5771 mg/kg bw/day rat oral: feed - short-term repeated dose toxicity: oral dossier=ae792057-82c6-4e62-a46b-83be601dda8d.i6z; document=60dd4b3a-de1d-4479-8a61-7a7ba77c8017_ae792057-82c6-4e62-a46b-83be601dda8d.i6d; document_key=60dd4b3a-de1d-4479-8a61-7a7ba77c8017/ae792057-82c6-4e62-a46b-83be601dda8d; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=2001; ReportDate=2001-07-03; basis=other:; key_result=false; entry_uuid=d5b70b84-6b1c-4351-beec-11b73bff8b55
ECHA NOAEL >812 mg/kg bw/day rat oral: feed - sub-chronic toxicity: oral dossier=ae792057-82c6-4e62-a46b-83be601dda8d.i6z; document=fa7ea593-45da-48b9-b238-d17b45fc466d_ae792057-82c6-4e62-a46b-83be601dda8d.i6d; document_key=fa7ea593-45da-48b9-b238-d17b45fc466d/ae792057-82c6-4e62-a46b-83be601dda8d; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=2001; ReportDate=2001-02-07; basis=other:; key_result=false; upper_value=4413; entry_uuid=7360fb72-1039-43e9-a6c3-b4bc0139d9d5
NTP ICE acute oral 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE acute oral LD50 >11204 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_1321; row=13474; data_type=In Vivo; mixture=Chemical; chemical_name=Betaine; preferred_name=Betaine; dtxsid=DTXSID8022666; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8022666; source_file=acute_oral.xlsx
NTP ICE acute oral LD50 >11179 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_1319; row=13475; data_type=In Vivo; mixture=Chemical; chemical_name=Betaine; preferred_name=Betaine; dtxsid=DTXSID8022666; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8022666; source_file=acute_oral.xlsx
NTP ICE acute oral LD50 >11148 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_1316; row=13476; data_type=In Vivo; mixture=Chemical; chemical_name=Betaine; preferred_name=Betaine; dtxsid=DTXSID8022666; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8022666; source_file=acute_oral.xlsx
EFSA 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA BMDL (05) =131 mg/kg bw/day Rat oral chronic; 52 weeks chronic LONG_REF=EFSA NDA (2017). Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97. doi:10.2903/j.efsa.2017.5057.; TITLE=Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97; AUTHOR=EFSA NDA; DOI=doi:10.2903/j.efsa.2017.5057; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=hematological; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=EFSA:15613649: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_31dab85963f14ddfa5756e8b4c869860
EFSA LEL =10000 mg/kg bw/day Pig oral subchronic; 6 weeks subchronic LONG_REF=EFSA FEEDAP (2013). Scientific Opinion on the safety and efficacy of betaine anhydrous as a feed additive for all animal species based on a dossier submitted by Trouw Nutritional International B.V. doi:10.2903/j.efsa.2013.3211.; TITLE=Scientific Opinion on the safety and efficacy of betaine anhydrous as a feed additive for all animal species based on a dossier submitted by Trouw Nutritional International B.V.; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2013.3211; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2013; ORIGINAL_YEAR=2013; TOXICOLOGICAL_EFFECT=clinical chemistry; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry; STUDY_GROUP=EFSA_dup_-_15613644_15613645_15613646: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_bcf9329aacac0bfdc03b0897cf2a93f9
EFSA LEL =4000 mg/day Human oral chronic; 6 months clinical LONG_REF=EFSA NDA (2017). Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97. doi:10.2903/j.efsa.2017.5057.; TITLE=Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97; AUTHOR=EFSA NDA; DOI=doi:10.2903/j.efsa.2017.5057; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15613647:-:--; 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_9da255f0fa2a42528f48f2c795746fab
ToxValDB HESS 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB HESS NOEL <1 % Rat oral - subchronic STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/60da0df3e4b0a676289de990; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.nite.go.jp/en/chem/qsar/hess_update-e.html; TOXICOLOGICAL_EFFECT=Food Consumption: decrease|Urinalysis: Urine volume increase,pH decrease|Hematology: Plt increase, Fib increase|Blood Chemistry: Alp increase, Ca decrease, , LDH increase, gamma-GTP increase, Bil increase, TG increase|Relative Organ Weight: Ovary increase, Liver increase, , Spleen increase, Thymus increase, Adrenal decrease|Histopathology: Liver-Hepatocellular vacuolization; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|food and/or water consumption|hematology|nonneoplastic histopathology|organ weight|urinalysis; STUDY_GROUP=HESS:15638402:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_d499ac0d3920adbe4aae7aa6fd43c5a9
Regulatory source 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source developmental toxicity 20 mg/kg/d rat oral - developmental toxicity p.7
Regulatory source developmental toxicity 40 mg/kg/d rat oral - developmental toxicity p.7
Regulatory source repeated dose toxicity 5 % rat oral 28-day repeated dose toxicity p.9
Regulatory source repeated dose toxicity 50 mg/kg bw/d rat oral - repeated dose toxicity p.9
Regulatory source repeated dose toxicity 100 mg/kg bw/d rat oral - repeated dose toxicity p.9
Regulatory source repeated dose toxicity 150 mg/kg rat oral 104-week repeated dose toxicity p.7
Regulatory source repeated dose toxicity 250 mg/kg/d rat oral 91-day repeated dose toxicity p.7
Regulatory source repeated dose toxicity 300 mg/kg/d rat oral 104-week repeated dose toxicity p.7
Regulatory source repeated dose toxicity >5771 mg/kg bw/d rat oral 28-day repeated dose toxicity p.9
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 3SCV180C9W UNII - - - chemical -