NOAEL Studies Cosmetic Ingredient

NEOTAME NOAEL Studies

CAS: 165450-17-9

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 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB NOAEL 956 mg/kg bw/day rat oral 14 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 500 mg/kg bw/day rabbit oral 14 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1000 mg/kg bw/day rat oral 48 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 300 mg/kg bw/day mouse oral 15 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 8000 mg/kg bw/day mouse oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2500 mg/kg bw/day rat oral NA Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 200 mg/kg bw/day dog oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2000 mg/kg bw/day rat oral 15 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 800 mg/kg bw/day dog oral 364 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 100 mg/kg bw/day rat oral 435 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 4000 mg/kg bw/day mouse oral 728 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 50 mg/kg bw/day rat oral 728 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA NOAEL =200 mg/kg bw/day Dog oral: feed 364 days chronic/long term toxicity EFSA AFC - 2007 - OutputID 315 - clinical chemistry - systemic - Neotame as a sweetener and flavour enhancer - doi:10.2903/j.efsa.2007.581
EFSA ADI <=2 mg/kg bw/day Consumers - - ADI EFSA AFC - 2007 - OutputID 315 - Consumers - Neotame as a sweetener and flavour enhancer - doi:10.2903/j.efsa.2007.581
EFSA NOAEL =200 mg/kg bw/day Dog oral chronic; 52 weeks chronic LONG_REF=EFSA AFC (2007). Neotame as a sweetener and flavour enhancer. doi:10.2903/j.efsa.2007.581.; TITLE=Neotame as a sweetener and flavour enhancer; AUTHOR=EFSA AFC; DOI=doi:10.2903/j.efsa.2007.581; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2007; ORIGINAL_YEAR=2007; TOXICOLOGICAL_EFFECT=clinical chemistry; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry; STUDY_GROUP=EFSA:15614254: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_2fa1b40d00e0e35c807ed03e99b3e3fd
WHO/JECFA 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
WHO/JECFA ADI =0.3 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v52je08; title=NEOTAME (JECFA 52, 2004); path=mirror/documents/jecfa/jecmono/v52je08.htm; row_hash=f49bc574353ba0a4; raw_unit=mg/kg bw; context=In the United States, an ADI of 0–0.3 mg/kg bw was established in 2002; neotame has general approval for use in foods and beverages and is authorized at levels consistent with GMP as a non-nutritive sweetener in all foods, except meat and poultry (Food and Drug Administration, 2002).
WHO/JECFA ADI =2 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v52je08; title=NEOTAME (JECFA 52, 2004); path=mirror/documents/jecfa/jecmono/v52je08.htm; row_hash=d7876f6ad6b84d06; raw_unit=mg/kg bw; context=imum level of neotame in food, by the budget method Distribution of use in the food supply % of solid foods or beverage supply containing neotame Theoretical maximum level (mg/kg) ADI = 0–2 mg/kg bw a Typical use levels a (mg/kg) 50% solid foods 50 80 70 50% beverages 50 20 17 a Highest level excluding chewing gum (for which the typical use level is 250 mg/kg) and tabletop sweeteners, for which use levels are not applicable The theoretical maximum levels
WHO/JECFA ADI <=14000 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v52je08; title=NEOTAME (JECFA 52, 2004); path=mirror/documents/jecfa/jecmono/v52je08.htm; row_hash=410e40268de6e6db; raw_unit=g/kg bw; unit_normalization=converted from grams; context=However, use of neotame in these two categories will not lead to intakes greater than the ADI since conservative calculations based on the lowest sweetness potency of neotame (7000 times that of sugar) suggest that substitution of neotame for dietary sugar at up to 14 g/kg bw (i.e.
WHO/JECFA NOEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v52je08; title=NEOTAME (JECFA 52, 2004); path=mirror/documents/jecfa/jecmono/v52je08.htm; row_hash=3dd8cd551003a900; raw_unit=mg/kg bw per day; context=The NOEL was 1000 mg/kg bw per day on the basis of changes in relative liver weight (Thomford & Carter, 1995).
WHO/JECFA NOEL =300 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v52je08; title=NEOTAME (JECFA 52, 2004); path=mirror/documents/jecfa/jecmono/v52je08.htm; row_hash=fb690176f8d4c880; raw_unit=mg/kg bw per day; context=The NOEL was 300 mg/kg bw per day on the basis of changes in clinical chemistry parameters (Mitchell & Brown, 1995).
WHO/JECFA NOEL =200 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v52je08; title=NEOTAME (JECFA 52, 2004); path=mirror/documents/jecfa/jecmono/v52je08.htm; row_hash=3aebf868a4b49443; raw_unit=mg/kg bw per day; context=The NOEL was 200 mg/kg bw per day on the basis of changes in alkaline phosphatase activity (Thomford & Saunders, 1995).
WHO/JECFA NOEL =4000 mg/kg bw/day - - - Carcinogenicity document_id=jecfa_jecmono_v52je08; title=NEOTAME (JECFA 52, 2004); path=mirror/documents/jecfa/jecmono/v52je08.htm; row_hash=6cc416048665853b; raw_unit=mg/kg bw per day; context=The NOEL was 4000 mg/kg bw per day, on the basis of the absence of target organ toxicity or carcinogenicity at the highest dose tested (Thomford & Carter, 1997a).
WHO/JECFA ADI <=2 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650b0266e4b0d99f5a885b73; 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/5107; YEAR=2003; ORIGINAL_YEAR=2003; STUDY_GROUP=WHO JECFA ADI:15715663:-:--; 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_a328bc50306d6d6780fcd0e00b708175
openFDA substances 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier VJ597D52EX UNII - - - chemical -