NOAEL Studies Cosmetic Ingredient

Aspartame NOAEL Studies

INCI: ASPARTAME

CAS: 22839-47-0

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 28 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB LOAEL 125 mg/kg bw/day rat oral 60 day Short Term Toxicity PAFA; FMF
COSMOS DB NOAEL 5 mg/kg bw/day rat oral 60 day Short Term Toxicity PAFA; FMF
COSMOS DB NOAEL 71 mg/kg bw/day rat oral 98 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 120 mg/kg bw/day rat oral 24 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 125 mg/kg bw/day rat oral 60 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 133 mg/kg bw/day mouse oral 30 day Neurotoxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 200 mg/kg bw/day rat oral 10 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 500 mg/kg bw/day guinea pig oral 69 day Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1000 mg/kg bw/day mouse oral 1 day Neurotoxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1188 mg/kg bw/day rat oral 30 day Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1350 mg/kg bw/day rabbit oral 13 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1767 mg/kg bw/day rat oral 224 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1900 mg/kg bw/day rabbit oral 13 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1950 mg/kg bw/day rabbit oral 15 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2000 mg/kg bw/day rabbit oral 13 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2400 mg/kg bw/day rabbit oral 13 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 3000 mg/kg bw/day monkey oral 364 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 3040 mg/kg bw/day rat oral 9 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 3125 mg/kg bw/day rat oral 28 day Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 3225 mg/kg bw/day rat oral 28 day Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 3325 mg/kg bw/day rat oral 28 day Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 3566 mg/kg bw/day rat oral NA Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 4000 mg/kg bw/day dog oral 742 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 5000 mg/kg bw/day rat oral 1113 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 6850 mg/kg bw/day rat oral 28 day Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 8000 mg/kg bw/day hamster oral 322 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 8226 mg/kg bw/day rat oral 21 day Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 11000 mg/kg bw/day rat oral NA Neurotoxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA ADI =40 mg/kg bw/day Consumers - - ADI EFSA AFC - 2006 - OutputID 301 - Consumers - Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) on a request from the Commission related to a new long-term carcinogenicity study on aspartame - doi:10.2903/j.efsa.2006.356
EFSA ADI =40 mg/kg bw/day Consumers - - ADI EFSA AFC - 2006 - OutputID 301 - Consumers - Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in contact with Food (AFC) on a request from the Commission related to a new long-term carcinogenicity study on aspartame - doi:10.2903/j.efsa.2006.356
IARC Monographs 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
IARC Monographs IARC carcinogenicity classification 2B IARC group - - 2023 IARC Monographs {"additional_info":"volume_publication_year=2024","evaluation_year":2023,"source_table":"iarc_classifications","volume":"134"}
IARC Monographs IARC carcinogenicity classification 2B IARC group - - 2023 IARC Monographs {"additional_info":"volume_publication_year=2024","evaluation_year":2023,"source_table":"iarc_classifications","volume":"134"}
IARC Monographs IARC carcinogenicity classification 2B IARC group - - 2023 IARC Monographs {"additional_info":"volume_publication_year=2024","evaluation_year":2023,"source_table":"iarc_classifications","volume":"134"}
WHO/JECFA 110 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
WHO/JECFA ADI =7.5 mg/kg bw/day - - - Health guidance value document_id=iarc_iarcmono_v134iarc; title=ASPARTAME, METHYLEUGENOL, AND ISOEUGENOL VOLUME 134 IARC MONOGRAPHS ON THE IDENTIFICATION OF CARCINOGENIC HAZARDS TO HUMANS This publication represents the view; path=mirror/documents/iarc/iarcmono/v134iarc.pdf; row_hash=20de32f146b22a96; raw_unit=mg/kg bw per day; context=An ADI of 7.5 mg/kg bw per day was also established for the diketopiperazine of aspar­ tame (JECFA, 1981).
WHO/JECFA ADI =7.5 mg/kg bw/day - - - Health guidance value document_id=iarc_iarcmono_v134iarc; title=ASPARTAME, METHYLEUGENOL, AND ISOEUGENOL VOLUME 134 IARC MONOGRAPHS ON THE IDENTIFICATION OF CARCINOGENIC HAZARDS TO HUMANS This publication represents the view; path=mirror/documents/iarc/iarcmono/v134iarc.pdf; row_hash=20de32f146b22a96; raw_unit=mg/kg bw per day; context=An ADI of 7.5 mg/kg bw per day was also established for the diketopiperazine of aspar­ tame (JECFA, 1981).
WHO/JECFA ADI =40 mg/kg bw/day Bird - - Health guidance value document_id=iarc_iarcmono_v134iarc; title=ASPARTAME, METHYLEUGENOL, AND ISOEUGENOL VOLUME 134 IARC MONOGRAPHS ON THE IDENTIFICATION OF CARCINOGENIC HAZARDS TO HUMANS This publication represents the view; path=mirror/documents/iarc/iarcmono/v134iarc.pdf; row_hash=ce4751aec6ca9807; raw_unit=mg/kg per day; context=hen carbon dioxide, the Working Group noted that there was no evidence that the overall amount of formaldehyde formed as a result of aspartame consumption (up to the levels of the ADI of 40 mg/kg per day) would significantly alter normal endogenous form­ aldehyde concentrations.
WHO/JECFA ADI =40 mg/kg bw/day Bird - - Health guidance value document_id=iarc_iarcmono_v134iarc; title=ASPARTAME, METHYLEUGENOL, AND ISOEUGENOL VOLUME 134 IARC MONOGRAPHS ON THE IDENTIFICATION OF CARCINOGENIC HAZARDS TO HUMANS This publication represents the view; path=mirror/documents/iarc/iarcmono/v134iarc.pdf; row_hash=ce4751aec6ca9807; raw_unit=mg/kg per day; context=hen carbon dioxide, the Working Group noted that there was no evidence that the overall amount of formaldehyde formed as a result of aspartame consumption (up to the levels of the ADI of 40 mg/kg per day) would significantly alter normal endogenous form­ aldehyde concentrations.
WHO/JECFA ADI =50 mg/kg bw/day - - - Health guidance value document_id=iarc_iarcmono_v134iarc; title=ASPARTAME, METHYLEUGENOL, AND ISOEUGENOL VOLUME 134 IARC MONOGRAPHS ON THE IDENTIFICATION OF CARCINOGENIC HAZARDS TO HUMANS This publication represents the view; path=mirror/documents/iarc/iarcmono/v134iarc.pdf; row_hash=04f78ecf32ab1c50; raw_unit=mg/kg bw; context=The US FDA has set the ADI for aspartame at 50 mg/kg bw (Office of the Federal Register, 1984).
WHO/JECFA ADI =50 mg/kg bw/day - - - Health guidance value document_id=iarc_iarcmono_v134iarc; title=ASPARTAME, METHYLEUGENOL, AND ISOEUGENOL VOLUME 134 IARC MONOGRAPHS ON THE IDENTIFICATION OF CARCINOGENIC HAZARDS TO HUMANS This publication represents the view; path=mirror/documents/iarc/iarcmono/v134iarc.pdf; row_hash=04f78ecf32ab1c50; raw_unit=mg/kg bw; context=The US FDA has set the ADI for aspartame at 50 mg/kg bw (Office of the Federal Register, 1984).
WHO/JECFA ADI =250 mg/kg bw/day Rat - 8 weeks Health guidance value document_id=iarc_iarcmono_v134iarc; title=ASPARTAME, METHYLEUGENOL, AND ISOEUGENOL VOLUME 134 IARC MONOGRAPHS ON THE IDENTIFICATION OF CARCINOGENIC HAZARDS TO HUMANS This publication represents the view; path=mirror/documents/iarc/iarcmono/v134iarc.pdf; row_hash=af2569b4e30ac49f; raw_unit=mg/kg bw per day; context=In two groups of male Wistar albino rats (age 8 weeks) who were exposed to aspartame at daily doses equivalent to five times the ADI (250 mg/kg bw per day) or 10 times the ADI (1000 mg/kg bw per day) for 8 weeks, a decrease was observed in both CAT activity and TAC in blood plasma, when compared with the control group (Alkafafy et al., 2015).
WHO/JECFA ADI =250 mg/kg bw/day Rat - 8 weeks Health guidance value document_id=iarc_iarcmono_v134iarc; title=ASPARTAME, METHYLEUGENOL, AND ISOEUGENOL VOLUME 134 IARC MONOGRAPHS ON THE IDENTIFICATION OF CARCINOGENIC HAZARDS TO HUMANS This publication represents the view; path=mirror/documents/iarc/iarcmono/v134iarc.pdf; row_hash=af2569b4e30ac49f; raw_unit=mg/kg bw per day; context=In two groups of male Wistar albino rats (age 8 weeks) who were exposed to aspartame at daily doses equivalent to five times the ADI (250 mg/kg bw per day) or 10 times the ADI (1000 mg/kg bw per day) for 8 weeks, a decrease was observed in both CAT activity and TAC in blood plasma, when compared with the control group (Alkafafy et al., 2015).
WHO/JECFA ADI range:0-0.50.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=e3ec4fde8b62b278; raw_unit=mg/kg bw; context=899) was evaluated by the Committee at its Eleventh meeting, and an ADI of 0-0.5 mg/kg bw was established.
WHO/JECFA ADI range:0-0.50.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=e3ec4fde8b62b278; raw_unit=mg/kg bw; context=899) was evaluated by the Committee at its Eleventh meeting, and an ADI of 0-0.5 mg/kg bw was established.
WHO/JECFA ADI range:0-2.52.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=4dcb0c149d071cd8; raw_unit=mg/kg bw; context=896) was evaluated at the Eleventh meeting of the Committee and an ADI of 0-2.5 mg/kg bw was established.
WHO/JECFA ADI range:0-2.52.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=4dcb0c149d071cd8; raw_unit=mg/kg bw; context=896) was evaluated at the Eleventh meeting of the Committee and an ADI of 0-2.5 mg/kg bw was established.
WHO/JECFA ADI range:0-33 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=609cc44a8a68c489; raw_unit=mg/kg bw.; context=At its Forty-fourth meeting (20), the Committee established an ADI of 0-3 mg/kg bw.
WHO/JECFA ADI range:0-33 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=609cc44a8a68c489; raw_unit=mg/kg bw.; context=At its Forty-fourth meeting (20), the Committee established an ADI of 0-3 mg/kg bw.
WHO/JECFA ADI range:0-55 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=00af364b6347017e; raw_unit=mg/kg bw.; context=1050, 2023 Joint FAO/WHO Expert Committee on Food Additives Ninety-sixth report ADI of 0-5 mg/kg bw.
WHO/JECFA ADI range:0-55 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=00af364b6347017e; raw_unit=mg/kg bw.; context=1050, 2023 Joint FAO/WHO Expert Committee on Food Additives Ninety-sixth report ADI of 0-5 mg/kg bw.
WHO/JECFA ADI range:0-7.57.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=e4fb4093d45f6cd9; raw_unit=mg/ kg bw; context=For diketopiperazine (DKP), the major degradation product of aspartame, the Committee allocated an ADI of 0-7.5 mg/ kg bw (1).
WHO/JECFA ADI range:0-7.57.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=e4fb4093d45f6cd9; raw_unit=mg/ kg bw; context=For diketopiperazine (DKP), the major degradation product of aspartame, the Committee allocated an ADI of 0-7.5 mg/ kg bw (1).
WHO/JECFA ADI range:0-1010 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=15023b1ee8bc2e5e; raw_unit=mg/kg bw; context=889) was evaluated by the Committee at its Eleventh meeting and an ADI of 0-10 mg/kg bw was established.
WHO/JECFA ADI range:0-1010 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=15023b1ee8bc2e5e; raw_unit=mg/kg bw; context=889) was evaluated by the Committee at its Eleventh meeting and an ADI of 0-10 mg/kg bw was established.
WHO/JECFA ADI range:0-4040 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=903c3d38ceddef3f; raw_unit=mg/kg bw; context=At its Twenty-fifth meeting, the Committee confirmed the ADI of 0-40 mg/kg bw for aspartame (2).
WHO/JECFA ADI range:0-4040 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=903c3d38ceddef3f; raw_unit=mg/kg bw; context=At its Twenty-fifth meeting, the Committee confirmed the ADI of 0-40 mg/kg bw for aspartame (2).
WHO/JECFA NOAEL =50 mg/kg bw/day Rat oral 2-year Chronic toxicity document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=4874e92e9b463171; raw_unit=mg/kg bw per day; context=2279), the NOAEL in a 2-year dietary study in rats (27) of 50 mg/kg bw per day for the structurally related substance methyl salicylate (No.
WHO/JECFA NOAEL =50 mg/kg bw/day Rat oral 2-year Chronic toxicity document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=4874e92e9b463171; raw_unit=mg/kg bw per day; context=2279), the NOAEL in a 2-year dietary study in rats (27) of 50 mg/kg bw per day for the structurally related substance methyl salicylate (No.
WHO/JECFA NOAEL =119 mg/kg bw/day Human; Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=62ef09761cce7a86; raw_unit=mg/kg bw per day; context=2278) the NOAEL in a 90-day dietary study in rats (26) of 119 mg/kg bw per day for the structurally related substance gallic acid provides an adequate MOE of 714 relative to the SPET estimate of 10 000 ug/day (167 ug/kg bw per day for a 60-kg person).3 For 3-hydroxybenzoic acid (No.
WHO/JECFA NOAEL =119 mg/kg bw/day Human; Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=62ef09761cce7a86; raw_unit=mg/kg bw per day; context=2278) the NOAEL in a 90-day dietary study in rats (26) of 119 mg/kg bw per day for the structurally related substance gallic acid provides an adequate MOE of 714 relative to the SPET estimate of 10 000 ug/day (167 ug/kg bw per day for a 60-kg person).3 For 3-hydroxybenzoic acid (No.
WHO/JECFA NOAEL =220 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=f0adbbba8b0599c1; raw_unit=mg/kg bw per day; context=2281), the NOAEL of 220 mg/kg bw per day for the structurally related substance isoamyl isovalerate (No.
WHO/JECFA NOAEL =220 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=f0adbbba8b0599c1; raw_unit=mg/kg bw per day; context=2281), the NOAEL of 220 mg/kg bw per day for the structurally related substance isoamyl isovalerate (No.
WHO/JECFA NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=ceeeb03d940c580b; raw_unit=mg/kg bw per day; context=The NOAEL of 1000 mg/kg bw per day for the structurally related substance vanillin (No.
WHO/JECFA NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=ceeeb03d940c580b; raw_unit=mg/kg bw per day; context=The NOAEL of 1000 mg/kg bw per day for the structurally related substance vanillin (No.
WHO/JECFA NOAEL =4000 mg/kg bw/day Rat oral 104-week Toxicology study document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=18877f49d597d214; raw_unit=mg/kg bw per day; context=This ADI was calculated based on the no- observed-adverse-effect level (NOAEL) of 4000 mg/kg bw per day, the highest dose tested in a long-term (104-week) study in rats exposed to aspartame in the diet (3) and application of a 100-fold uncertainty factor.
WHO/JECFA NOAEL =4000 mg/kg bw/day Rat oral 104-week Toxicology study document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=18877f49d597d214; raw_unit=mg/kg bw per day; context=This ADI was calculated based on the no- observed-adverse-effect level (NOAEL) of 4000 mg/kg bw per day, the highest dose tested in a long-term (104-week) study in rats exposed to aspartame in the diet (3) and application of a 100-fold uncertainty factor.
WHO/JECFA NOAEL =5700 mg/kg bw/day Mouse - - Developmental toxicity document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=a7e9c98ede71cc2f; raw_unit=mg/kg bw per day; context=In a developmental toxicity study in mice (54) not previously reviewed by the Committee, the NOAEL was 5700 mg/kg bw per day, the highest dose level tested.
WHO/JECFA NOAEL =5700 mg/kg bw/day Mouse - - Developmental toxicity document_id=jecfa_jecmono_v1050je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-sixth report of the Joint FAO/WHO Expert Committee on Food Additives; path=mirror/documents/jecfa/jecmono/v1050je01.pdf; row_hash=a7e9c98ede71cc2f; raw_unit=mg/kg bw per day; context=In a developmental toxicity study in mice (54) not previously reviewed by the Committee, the NOAEL was 5700 mg/kg bw per day, the highest dose level tested.
WHO/JECFA ADI =40 mg/kg bw/day Rat - - Health guidance value document_id=jecfa_jecmono_v15je03; title=488. Aspartame (WHO Food Additives Series 15); path=mirror/documents/jecfa/jecmono/v15je03.htm; row_hash=4af704c598bf00d4; raw_unit=mg/kg bw; context=Estimated level causing no toxicological effect in the rat 4 g/kg bw Estimate of acceptable daily intake for man 40 mg/kg bw Diketo piperazine:
WHO/JECFA ADI =7.5 mg/kg bw/day Rat - - Health guidance value document_id=jecfa_jecmono_v15je03; title=488. Aspartame (WHO Food Additives Series 15); path=mirror/documents/jecfa/jecmono/v15je03.htm; row_hash=6c9c678e49477729; raw_unit=mg/kg bw; context=Estimated level causing no toxicological effect in the rat 750 mg/kg bw Estimate of acceptable daily intake for man 7.5 mg/kg bw REFERENCES Andress, J., Martinez, T. & Youkilis, G.
WHO/JECFA ADI range:0-4040 mg/kg bw/day Human - - Health guidance value document_id=jecfa_jecmono_v16je03; title=497. Aspartame (WHO Food Additives Series 16); path=mirror/documents/jecfa/jecmono/v16je03.htm; row_hash=372f7002fda49540; raw_unit=mg/kg bw; context=In 1980 JECFA evaluated additional toxicity animal studies and several human studies and an ADI of 0-40 mg/kg bw for aspertame and an ADI of 0-7.5 mg/kg bw for its breakdown, diketopiperazine, were established (see Annex, Refs.
WHO/JECFA ADI range:0-0.50.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=4098bd4ecdc9b29b; raw_unit=mg/kg bw; context=899) was evaluated by the Committee at its Eleventh meeting, and an ADI of 0-0.5 mg/kg bw was established.
WHO/JECFA ADI range:0-0.50.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=4098bd4ecdc9b29b; raw_unit=mg/kg bw; context=899) was evaluated by the Committee at its Eleventh meeting, and an ADI of 0-0.5 mg/kg bw was established.
WHO/JECFA ADI range:0-2.52.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=a4341a71ad78fb21; raw_unit=mg/kg bw; context=896) was evaluated at the Eleventh meeting of the Committee and an ADI of 0-2.5 mg/kg bw was established.
WHO/JECFA ADI range:0-2.52.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=a4341a71ad78fb21; raw_unit=mg/kg bw; context=896) was evaluated at the Eleventh meeting of the Committee and an ADI of 0-2.5 mg/kg bw was established.
WHO/JECFA ADI range:0-33 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=aeac58320af17db3; raw_unit=mg/kg bw.; context=At its Forty-fourth meeting (58), the Committee established an ADI of 0-3 mg/kg bw.
WHO/JECFA ADI range:0-33 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=aeac58320af17db3; raw_unit=mg/kg bw.; context=At its Forty-fourth meeting (58), the Committee established an ADI of 0-3 mg/kg bw.
WHO/JECFA ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=369ec90de2b9a47d; raw_unit=mg/kg bw.; context=At its Thirty-ninth meeting (57), the Committee extended the temporary ADI of 0-5 mg/kg bw.
WHO/JECFA ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=369ec90de2b9a47d; raw_unit=mg/kg bw.; context=At its Thirty-ninth meeting (57), the Committee extended the temporary ADI of 0-5 mg/kg bw.
WHO/JECFA ADI range:0-7.57.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=1e33cec40b509f45; raw_unit=mg/ kg bw; context=For diketopiperazine (DKP), the major degradation product of aspartame, the Committee allocated an ADI of 0-7.5 mg/ kg bw (1).
WHO/JECFA ADI range:0-7.57.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=1e33cec40b509f45; raw_unit=mg/ kg bw; context=For diketopiperazine (DKP), the major degradation product of aspartame, the Committee allocated an ADI of 0-7.5 mg/ kg bw (1).
WHO/JECFA ADI range:0-1010 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=061a082f037aaf3e; raw_unit=mg/kg bw; context=889) was evaluated by the Committee at its Eleventh meeting and an ADI of 0-10 mg/kg bw was established.
WHO/JECFA ADI range:0-1010 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=061a082f037aaf3e; raw_unit=mg/kg bw; context=889) was evaluated by the Committee at its Eleventh meeting and an ADI of 0-10 mg/kg bw was established.
WHO/JECFA ADI range:0-4040 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=cecb3e8cf859de39; raw_unit=mg/kg bw; context=At its Twenty-fifth meeting, the Committee confirmed the ADI of 0-40 mg/kg bw for aspartame (2).
WHO/JECFA ADI range:0-4040 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=cecb3e8cf859de39; raw_unit=mg/kg bw; context=At its Twenty-fifth meeting, the Committee confirmed the ADI of 0-40 mg/kg bw for aspartame (2).
WHO/JECFA LOAEL =30 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=e222efb2815a83c5; raw_unit=mg/kg bw per day; context=The LOAEL for developmental toxicity was identified as 30 mg/kg bw per day, based on the lower body weights of offspring on PND 0 or 4 (101).
WHO/JECFA LOAEL =30 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=e222efb2815a83c5; raw_unit=mg/kg bw per day; context=The LOAEL for developmental toxicity was identified as 30 mg/kg bw per day, based on the lower body weights of offspring on PND 0 or 4 (101).
WHO/JECFA LOAEL =343 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=9e56b0f0aeeae90d; raw_unit=mg/kg bw per day; context=This was observed at a lower exposure than the F0 LOAEL (15 000 mg/kg feed, equal to 343 mg/kg bw per day) (93).
WHO/JECFA LOAEL =343 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=9e56b0f0aeeae90d; raw_unit=mg/kg bw per day; context=This was observed at a lower exposure than the F0 LOAEL (15 000 mg/kg feed, equal to 343 mg/kg bw per day) (93).
WHO/JECFA NOAEL =25 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=5561c34a43ea0807; raw_unit=mg/ kg bw per day; context=Based on clinical signs (abortion or death), the NOAEL for maternal toxicity was 25 mg/ kg bw per day.
WHO/JECFA NOAEL =25 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=5561c34a43ea0807; raw_unit=mg/ kg bw per day; context=Based on clinical signs (abortion or death), the NOAEL for maternal toxicity was 25 mg/ kg bw per day.
WHO/JECFA NOAEL =30 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=f33fd604357db4ac; raw_unit=mg/kg bw per day; context=87, 2023 Safety evaluation of certain food additives Ninety-sixth JECFA The NOAEL for parental toxicity was identified as 30 mg/kg bw per day by the Committee, based on the decreased weight of the thymus observed at 100 and 300 mg/kg bw per day (101).
WHO/JECFA NOAEL =30 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=f33fd604357db4ac; raw_unit=mg/kg bw per day; context=87, 2023 Safety evaluation of certain food additives Ninety-sixth JECFA The NOAEL for parental toxicity was identified as 30 mg/kg bw per day by the Committee, based on the decreased weight of the thymus observed at 100 and 300 mg/kg bw per day (101).
WHO/JECFA NOAEL =50 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=4f34c033ddff65f2; raw_unit=mg/kg bw per day; context=10 000 ug/day Yes; the NOAEL of 50 mg/kg bw per day for structurally related methyl salicylate (No.
WHO/JECFA NOAEL =50 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=4f34c033ddff65f2; raw_unit=mg/kg bw per day; context=10 000 ug/day Yes; the NOAEL of 50 mg/kg bw per day for structurally related methyl salicylate (No.
WHO/JECFA NOAEL =61 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=cda15f343722fc24; raw_unit=mg/kg bw per day; context=The NOAEL for 2-ethylhexanoic acid in rats was therefore considered to be 61 mg/kg bw per day, based on histopathological abnormalities observed in the liver of both sexes (31). (iv) Isoamyl isovalerate (No.
WHO/JECFA NOAEL =61 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=cda15f343722fc24; raw_unit=mg/kg bw per day; context=The NOAEL for 2-ethylhexanoic acid in rats was therefore considered to be 61 mg/kg bw per day, based on histopathological abnormalities observed in the liver of both sexes (31). (iv) Isoamyl isovalerate (No.
WHO/JECFA NOAEL =72 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=51f7340483424e07; raw_unit=mg/kg bw per day; context=Based on lower mean fetal body weights in the 3000 mg/kg group, a dosage level of 1000 mg/kg, equal to 72 mg/kg bw per day, was the NOAEL for embryo/fetal development (185).
WHO/JECFA NOAEL =72 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=51f7340483424e07; raw_unit=mg/kg bw per day; context=Based on lower mean fetal body weights in the 3000 mg/kg group, a dosage level of 1000 mg/kg, equal to 72 mg/kg bw per day, was the NOAEL for embryo/fetal development (185).
WHO/JECFA NOAEL =80 mg/kg bw/day - - - Reproductive toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=20f0e18c5ef2d260; raw_unit=mg/kg bw per day; context=The Committee identified a NOAEL for maternal reproductive toxicity of 80 mg/kg bw per day, based on a statistically significant decrease in the survival rate of delivery females at 200 mg/ kg bw per day (188). (f) Special studies (i) 3,4-Dihydroxybenzoic acid (No.
WHO/JECFA NOAEL =80 mg/kg bw/day - - - Reproductive toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=20f0e18c5ef2d260; raw_unit=mg/kg bw per day; context=The Committee identified a NOAEL for maternal reproductive toxicity of 80 mg/kg bw per day, based on a statistically significant decrease in the survival rate of delivery females at 200 mg/ kg bw per day (188). (f) Special studies (i) 3,4-Dihydroxybenzoic acid (No.
WHO/JECFA NOAEL =100 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=c5f307ae796083b7; raw_unit=mg/kg bw per day; context=In the absence of any evidence of teratogenicity, but retarded ossification in fetuses caused by exposure at 250 mg/ kg bw per day, the NOAEL for developmental toxicity is 100 mg/kg bw per day.
WHO/JECFA NOAEL =100 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=c5f307ae796083b7; raw_unit=mg/kg bw per day; context=In the absence of any evidence of teratogenicity, but retarded ossification in fetuses caused by exposure at 250 mg/ kg bw per day, the NOAEL for developmental toxicity is 100 mg/kg bw per day.
WHO/JECFA NOAEL =109.3 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=811a0cb2e39f46cf; raw_unit=mg/kg bw per day; context=The Committee identified a NOAEL of 109.3 mg/kg bw per day, based on the lowered testosterone levels at week 3 in the high-dose group.
WHO/JECFA NOAEL =109.3 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=811a0cb2e39f46cf; raw_unit=mg/kg bw per day; context=The Committee identified a NOAEL of 109.3 mg/kg bw per day, based on the lowered testosterone levels at week 3 in the high-dose group.
WHO/JECFA NOAEL =119 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=478f41457d7cb0aa; raw_unit=mg/kg bw per day; context=SPET 10 000 ug/day Yes; the NOAEL of 119 mg/kg bw per day for structurally related gallic acid in a 90-day study in rats (64) is 714 times the estimated dietary exposure of No.
WHO/JECFA NOAEL =119 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=478f41457d7cb0aa; raw_unit=mg/kg bw per day; context=SPET 10 000 ug/day Yes; the NOAEL of 119 mg/kg bw per day for structurally related gallic acid in a 90-day study in rats (64) is 714 times the estimated dietary exposure of No.
WHO/JECFA NOAEL =158 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=a5ecd9e60da4228b; raw_unit=mg/kg bw per day; context=245 Hydroxy- and alkoxy-substituted benzyl derivatives (addendum) The Committee identified a NOAEL for parental toxicity of 2500 mg/ kg feed, equal to 158 mg/kg bw per day, the highest dose tested.
WHO/JECFA NOAEL =158 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=a5ecd9e60da4228b; raw_unit=mg/kg bw per day; context=245 Hydroxy- and alkoxy-substituted benzyl derivatives (addendum) The Committee identified a NOAEL for parental toxicity of 2500 mg/ kg feed, equal to 158 mg/kg bw per day, the highest dose tested.
WHO/JECFA NOAEL =160 mg/kg bw/day Rat - - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=31e2ddd4583a570b; raw_unit=mg/kg bw per day; context=The developmental toxicity NOAEL for male offspring rats was 160 mg/kg bw per day, based on the changes in the function of the testis in steroidogenesis and spermatogenesis at the two highest doses (182).
WHO/JECFA NOAEL =160 mg/kg bw/day Rat - - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=31e2ddd4583a570b; raw_unit=mg/kg bw per day; context=The developmental toxicity NOAEL for male offspring rats was 160 mg/kg bw per day, based on the changes in the function of the testis in steroidogenesis and spermatogenesis at the two highest doses (182).
WHO/JECFA NOAEL =177 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=2dc0a8facfa74637; raw_unit=mg/ kg bw per day; context=87, 2023 Safety evaluation of certain food additives Ninety-sixth JECFA Committee concluded that the NOAEL was 3000 mg/kg feed, equal to 177 mg/ kg bw per day. (x) 4-Hydroxy-3-methoxybenzoic acid (No.
WHO/JECFA NOAEL =177 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=2dc0a8facfa74637; raw_unit=mg/ kg bw per day; context=87, 2023 Safety evaluation of certain food additives Ninety-sixth JECFA Committee concluded that the NOAEL was 3000 mg/kg feed, equal to 177 mg/ kg bw per day. (x) 4-Hydroxy-3-methoxybenzoic acid (No.
WHO/JECFA NOAEL =180 mg/kg bw/day Mouse - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=e187eee7cf6bfbb4; raw_unit=mg/kg bw per day; context=The NOAEL for 2-ethylhexanoic acid in mice was therefore 180 mg/kg bw per day based on a reduced rate of body weight gain (31).
WHO/JECFA NOAEL =180 mg/kg bw/day Mouse - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=e187eee7cf6bfbb4; raw_unit=mg/kg bw per day; context=The NOAEL for 2-ethylhexanoic acid in mice was therefore 180 mg/kg bw per day based on a reduced rate of body weight gain (31).
WHO/JECFA NOAEL =214 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=65e09082094eb4c7; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL for maternal toxicity was 3000 mg/kg feed, equal to 214 mg/kg bw per day, based on adverse mean body weight loss, lower mean body weights and feed consumption at 4000 mg/kg.
WHO/JECFA NOAEL =214 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=65e09082094eb4c7; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL for maternal toxicity was 3000 mg/kg feed, equal to 214 mg/kg bw per day, based on adverse mean body weight loss, lower mean body weights and feed consumption at 4000 mg/kg.
WHO/JECFA NOAEL =220 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=ce802556b8824281; raw_unit=mg/kg bw per day; context=3000 ug/day Yes; the NOAEL of 220 mg/kg bw per day for structurally related isoamyl isovalerate (No.
WHO/JECFA NOAEL =220 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=ce802556b8824281; raw_unit=mg/kg bw per day; context=3000 ug/day Yes; the NOAEL of 220 mg/kg bw per day for structurally related isoamyl isovalerate (No.
WHO/JECFA NOAEL =250 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=0bd14d33bf8aabc3; raw_unit=mg/kg bw per day; context=Based on clinical signs and increase in liver weight at a dose of 500 mg/kg bw per day, the NOAEL for maternal toxicity is 250 mg/kg bw per day (51).
WHO/JECFA NOAEL =250 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=0bd14d33bf8aabc3; raw_unit=mg/kg bw per day; context=Based on clinical signs and increase in liver weight at a dose of 500 mg/kg bw per day, the NOAEL for maternal toxicity is 250 mg/kg bw per day (51).
WHO/JECFA NOAEL =300 mg/kg bw/day Mouse - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=79fdcb090ffe168d; raw_unit=mg/kg bw per day; context=The NOAEL for this study was therefore 0.6% (equivalent to 300 mg/kg bw per day) based on the absence of any observed adverse effects at the highest tested concentration (30). (iii) 2-Ethylhexanoic acid Mice.
WHO/JECFA NOAEL =300 mg/kg bw/day Mouse - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=79fdcb090ffe168d; raw_unit=mg/kg bw per day; context=The NOAEL for this study was therefore 0.6% (equivalent to 300 mg/kg bw per day) based on the absence of any observed adverse effects at the highest tested concentration (30). (iii) 2-Ethylhexanoic acid Mice.
WHO/JECFA NOAEL =400 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=1cd0ee13922f188d; raw_unit=mg/kg bw per day; context=The Committee identified a parental NOAEL of 400 mg/kg bw per day, the highest dose tested (94).
WHO/JECFA NOAEL =400 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=1cd0ee13922f188d; raw_unit=mg/kg bw per day; context=The Committee identified a parental NOAEL of 400 mg/kg bw per day, the highest dose tested (94).
WHO/JECFA NOAEL =600 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=fee186e9cb7523af; raw_unit=mg/kg bw per day; context=The Committee therefore identified a NOAEL of 600 mg/kg bw per day, the highest dose tested (98). (vii) Vanillin isobutyrate (No.
WHO/JECFA NOAEL =600 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=fee186e9cb7523af; raw_unit=mg/kg bw per day; context=The Committee therefore identified a NOAEL of 600 mg/kg bw per day, the highest dose tested (98). (vii) Vanillin isobutyrate (No.
WHO/JECFA NOAEL =900 mg/kg bw/day Mouse - 2-year Carcinogenicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=845754f4e4b73f59; raw_unit=mg/kg bw per day; context=In a 2-year study in mice, no increases in tumour incidences were observed with a NOAEL of 900 mg/kg bw per day butyl-p-hydroxybenzoate, the highest dose tested (176).
WHO/JECFA NOAEL =900 mg/kg bw/day Mouse - 2-year Carcinogenicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=845754f4e4b73f59; raw_unit=mg/kg bw per day; context=In a 2-year study in mice, no increases in tumour incidences were observed with a NOAEL of 900 mg/kg bw per day butyl-p-hydroxybenzoate, the highest dose tested (176).
WHO/JECFA NOAEL =986 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=dfe0c31db19c8ca7; raw_unit=mg/ kg bw per day; context=The Committee identified a NOAEL for parental toxicity of 986 mg/ kg bw per day, the highest dose tested (99).
WHO/JECFA NOAEL =986 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=dfe0c31db19c8ca7; raw_unit=mg/ kg bw per day; context=The Committee identified a NOAEL for parental toxicity of 986 mg/ kg bw per day, the highest dose tested (99).
WHO/JECFA NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=92e6d772209dd9c6; raw_unit=mg/kg bw per day; context=7500 ug/day Yes; the NOAEL of 1000 mg/kg bw per day for structurally related vanillin (No.
WHO/JECFA NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=92e6d772209dd9c6; raw_unit=mg/kg bw per day; context=7500 ug/day Yes; the NOAEL of 1000 mg/kg bw per day for structurally related vanillin (No.
WHO/JECFA NOAEL =2195 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=c3b4cb7d89184406; raw_unit=mg/ kg bw per day; context=The NOAEL for this study is therefore 2195 mg/ kg bw per day, based on the absence of any treatment-related effects at the highest tested dietary concentration. (ii) 2-Ethylbutyric acid (No.
WHO/JECFA NOAEL =2195 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=c3b4cb7d89184406; raw_unit=mg/ kg bw per day; context=The NOAEL for this study is therefore 2195 mg/ kg bw per day, based on the absence of any treatment-related effects at the highest tested dietary concentration. (ii) 2-Ethylbutyric acid (No.
WHO/JECFA NOAEL =4000 mg/kg bw/day Rat oral 104-week Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=fd0963cca60dea62; raw_unit=mg/kg bw per day; context=This ADI was calculated based on the no- observed-adverse-effect level (NOAEL) of 4000 mg/kg bw per day, the highest 5 Aspartame (addendum) dose tested in a long-term (104-week) study in rats exposed to aspartame in the diet (3) and application of a 100-fold uncertainty factor.
WHO/JECFA NOAEL =4000 mg/kg bw/day Rat oral 104-week Toxicology study document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=fd0963cca60dea62; raw_unit=mg/kg bw per day; context=This ADI was calculated based on the no- observed-adverse-effect level (NOAEL) of 4000 mg/kg bw per day, the highest 5 Aspartame (addendum) dose tested in a long-term (104-week) study in rats exposed to aspartame in the diet (3) and application of a 100-fold uncertainty factor.
WHO/JECFA NOAEL =5000 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=bb2afe6089e0554c; raw_unit=mg/kg; context=Based on pup body weights, which decreased in the high-dose group (persistent effects at PND 28), the Committee identified a developmental NOAEL of 5000 mg/kg, equal to 360.3 mg/kg bw per day (83).
WHO/JECFA NOAEL =5000 mg/kg bw - oral - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=fafd183df635e81f; raw_unit=mg/kg; context=The Committee concluded a reproductive and developmental NOAEL of 5000 mg/kg butyl-p-hydroxybenzoate, equivalent 270 WHO Food Additives Series No.
WHO/JECFA NOAEL =5000 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=bb2afe6089e0554c; raw_unit=mg/kg; context=Based on pup body weights, which decreased in the high-dose group (persistent effects at PND 28), the Committee identified a developmental NOAEL of 5000 mg/kg, equal to 360.3 mg/kg bw per day (83).
WHO/JECFA NOAEL =5000 mg/kg bw - oral - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=fafd183df635e81f; raw_unit=mg/kg; context=The Committee concluded a reproductive and developmental NOAEL of 5000 mg/kg butyl-p-hydroxybenzoate, equivalent 270 WHO Food Additives Series No.
WHO/JECFA NOAEL =5700 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=1490e2c391b62a65; raw_unit=mg/kg bw per day; context=The NOAEL for maternal and developmental toxicity in this study was 5700 mg/kg bw per day, the highest dose level tested (128).
WHO/JECFA NOAEL =5700 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v87je01; title=WHO FOOD ADDITIVES SERIES: 87 Prepared by the ninety-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v87je01.pdf; row_hash=1490e2c391b62a65; raw_unit=mg/kg bw per day; context=The NOAEL for maternal and developmental toxicity in this study was 5700 mg/kg bw per day, the highest dose level tested (128).
WHO/JECFA ADI <=40 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650af9d1e4b0d99f5a878995; 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/62; YEAR=2023; ORIGINAL_YEAR=2023; STUDY_GROUP=WHO JECFA ADI:15715263:-:--; 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_b84658a82360f3d612dbcaa2d96a49e8
NTP ICE acute oral 4 endpoints
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_4264; row=226; data_type=In Vivo; mixture=Chemical; chemical_name=Aspartame; preferred_name=Aspartame; dtxsid=DTXSID0020107; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0020107; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID0020107; source_file=acute_oral.xlsx
NTP ICE acute oral LD50 >10000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_4264; row=226; data_type=In Vivo; mixture=Chemical; chemical_name=Aspartame; preferred_name=Aspartame; dtxsid=DTXSID0020107; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0020107; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID0020107; source_file=acute_oral.xlsx
NTP ICE acute oral LD50 >10000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_4264; row=226; data_type=In Vivo; mixture=Chemical; chemical_name=Aspartame; preferred_name=Aspartame; dtxsid=DTXSID0020107; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0020107; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID0020107; source_file=acute_oral.xlsx
NTP ICE acute oral LD50 >10000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_4264; row=226; data_type=In Vivo; mixture=Chemical; chemical_name=Aspartame; preferred_name=Aspartame; dtxsid=DTXSID0020107; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0020107; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID0020107; 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 53.8124788963568 uM - - - ERPathway2016; ER Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=5028; RecordID=ERPathway2016_436; DatasetName=ERPathway2016; DTXSID=DTXSID0020107; Assay=ER Pathway Model, Antagonist; Endpoint=AC50; Response=53.8124788963568; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0020107; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0020107
NTP ICE endocrine ACC 38.6854899573427 uM - - - ERPathway2016; ER Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=5029; RecordID=ERPathway2016_436; DatasetName=ERPathway2016; DTXSID=DTXSID0020107; Assay=ER Pathway Model, Antagonist; Endpoint=ACC; Response=38.6854899573427; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0020107; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0020107
NTP ICE endocrine Model Score 0 unitless - - - ARPathway2016; AR Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=5024; RecordID=ARPathway2016_1014; DatasetName=ARPathway2016; DTXSID=DTXSID0020107; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0020107; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0020107
NTP ICE endocrine Model Score 0.00559 unitless - - - ERPathway2016; ER Pathway Model, Agonist sheet=Integrated_approaches; excel_row=5030; RecordID=ERPathway2016_436; DatasetName=ERPathway2016; DTXSID=DTXSID0020107; Assay=ER Pathway Model, Agonist; Endpoint=Model Score; Response=0.00559; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0020107; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID0020107
ToxValDB ECOTOX 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB ECOTOX NOEL =2000 mg/kg bw/day Mouse oral acute; 1 days acute LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; 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=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15594906:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=e86543d5b6ddba40d425f2295d899798
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier Z0H242BBR1 UNII - - - chemical {"approval_status":null,"molecular_formula":"C14H18N2O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Z0H242BBR1"}
openFDA substances FDA UNII substance identifier Z0H242BBR1 UNII - - - chemical {"approval_status":null,"molecular_formula":"C14H18N2O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Z0H242BBR1"}
openFDA substances FDA UNII substance identifier Z0H242BBR1 UNII - - - chemical {"approval_status":null,"molecular_formula":"C14H18N2O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Z0H242BBR1"}
openFDA substances FDA UNII substance identifier Z0H242BBR1 UNII - - - chemical {"approval_status":null,"molecular_formula":"C14H18N2O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"Z0H242BBR1"}