NOAEL Studies Cosmetic Ingredient

Ceratonia Siliqua Gum NOAEL Studies

INCI: CERATONIA SILIQUA GUM

CAS: 9000-40-2

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

COSMOS_DB 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 1000 mg/kg bw/day rat oral 28 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 1300 mg/kg bw/day rat oral 10 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 910 mg/kg bw/day rabbit oral 13 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 10000 mg/kg bw/day rat oral 14 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 15000 mg/kg bw/day mouse oral 14 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 2500 mg/kg bw/day rat oral 721 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 7500 mg/kg bw/day mouse oral 721 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 5000 mg/kg bw/day rat oral 28 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =7500 mg/kg bw/day Mouse oral: feed 721 days chronic/long term toxicity EFSA ANS - 2017 - OutputID 2907 - no adverse effect observed at single/highest dose - Re-evaluation of locust bean gum (E 410) as a food additive - doi:10.2903/j.efsa.2017.4646
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =2500 mg/kg bw/day Rat oral: feed 721 days chronic/long term toxicity EFSA ANS - 2017 - OutputID 2907 - no adverse effect observed at single/highest dose - Re-evaluation of locust bean gum (E 410) as a food additive - doi:10.2903/j.efsa.2017.4646
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =20000 mg/kg bw/day Mouse oral: feed 90 days subchronic EFSA ANS - 2017 - OutputID 2907 - no adverse effect observed at single/highest dose - Re-evaluation of locust bean gum (E 410) as a food additive - doi:10.2903/j.efsa.2017.4646
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =9000 mg/kg bw/day Rat oral: feed 90 days subchronic EFSA ANS - 2017 - OutputID 2907 - no adverse effect observed at single/highest dose - Re-evaluation of locust bean gum (E 410) as a food additive - doi:10.2903/j.efsa.2017.4646
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =7500 mg/kg bw/day Mouse oral: feed 721 days chronic/long term toxicity EFSA ANS - 2017 - OutputID 2907 - no adverse effect observed at single/highest dose - Re-evaluation of locust bean gum (E 410) as a food additive - doi:10.2903/j.efsa.2017.4646
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =2500 mg/kg bw/day Rat oral: feed 721 days chronic/long term toxicity EFSA ANS - 2017 - OutputID 2907 - no adverse effect observed at single/highest dose - Re-evaluation of locust bean gum (E 410) as a food additive - doi:10.2903/j.efsa.2017.4646
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =20000 mg/kg bw/day Mouse oral: feed 90 days subchronic EFSA ANS - 2017 - OutputID 2907 - no adverse effect observed at single/highest dose - Re-evaluation of locust bean gum (E 410) as a food additive - doi:10.2903/j.efsa.2017.4646
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =9000 mg/kg bw/day Rat oral: feed 90 days subchronic EFSA ANS - 2017 - OutputID 2907 - no adverse effect observed at single/highest dose - Re-evaluation of locust bean gum (E 410) as a food additive - doi:10.2903/j.efsa.2017.4646
INCHEM_WHO_jecfa_jecmono_v1000je01 90 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-77 mg/kg bw/day Rat - long-term Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=7d268cb03d2ec9fe; raw_unit=mg/kg body weight; context=At its twenty-fourth meeting, the Committee established a temporary ADI of 0-7 mg/kg body weight (bw) based on long-term rat studies.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-22 mg/kg bw/day Human - - Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=1bb58ececd881078; raw_unit=mg/kg bw; context=tee evaluated biochemical data and the results of toxicological and human studies on Tagetes preparations with a high content of unesterified lutein (>80%) and established a group ADI of 0-2 mg/kg bw for lutein from Tagetes erecta and synthetic zeaxanthin.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-11 mg/kg bw/day Rat oral long-term Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=106f4fdce7058119; raw_unit=mg/kg bw; context=At its thirteenth meeting, the Committee established a temporary ADI of 0-1 mg/kg bw, based on a no-observed-effect level (NOEL) of 500 mg/kg bw per day in a long-term feeding study in rats.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-0.50.5 mg/kg bw/day Rat oral long-term Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=c2bc7a971f026b3d; raw_unit=mg/kg bw; context=At its eighteenth meeting, the Committee considered a second long-term feeding study in rats and established a temporary ADI of 0-0.5 mg/kg bw, based on the absence of any adverse effects at the highest tested dose of 50 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-1010 mg/kg bw/day Mouse oral long-term Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=b7c2df6f77fbcf71; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-10 mg/kg bw, based on a NOEL of 10 000 mg/kg in the diet (equivalent to 1500 mg/kg bw per day) in the long-term study in mice.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=8d3b99a6f9c22cf2; raw_unit=mg/kg bw; context=The Committee noted that these studies might have an effect on the ADI, so it withdrew the previously established ADI of 0-10 mg/kg bw and established a temporary ADI of 0-5 mg/kg bw, incorporating an additional 2-fold uncertainty factor, pending submission of the Biodynamics Laboratories studies by the end of 2013.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-33 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=787553ec4160c407; raw_unit=mg/kg bw; context=Using this NOAEL and an uncertainty factor of 100, the Committee established an ADI of 0-3 mg/kg bw (rounded value) for Quinoline Yellow.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-0.30.3 mg/kg bw/day Rat - short-term Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=58f22eb0c3b6b9fd; raw_unit=mg/kg bw; context=The Committee established a temporary ADI of 0-0.3 mg/kg bw for rosemary extract, expressed as carnosic acid plus carnosol, on the basis of a NOAEL of 64 mg/kg bw per day, expressed as carnosic acid plus carnosol, the highest dose tested in a short-term toxicity study in rats, with application of a 200-fold uncertaint
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-44 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=993b438acb5e14ef; raw_unit=mg/kg bw; context=The Committee concluded that the new data were sufficient to allow the additional uncertainty factor of 2 and the temporary designation to be removed and established an ADI for steviol glycosides of 0-4 mg/kg bw, expressed as steviol.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:4.0-4.44.4 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=e61cb3760109e726; raw_unit=mg/kg bw per day; context=The Committee noted that the predicted maximum dietary exposure to steviol glycosides of 4.0-4.4 mg/kg bw per day for young children who were high consumers exceeded the upper bound of the ADI (100-110%), but for other age groups, the ADI was not exceeded.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-7.57.5 mg/kg bw/day Rat - chronic Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=2124b465c38e0022; raw_unit=mg/kg bw; context=The Committee previously evaluated tartrazine at its eighth meeting in 1964 (Annex 1, reference 8), when an ADI of 0-7.5 mg/kg bw was established, based on a NOAEL equivalent to 750 mg/kg bw per day, derived from a chronic toxicity study in rats (as cited in [1], as the JECFA monograph for the eighth meeting is no longer available).
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI <=1000 mg/kg bw/day Rat; Dog - long-term Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=7631bb1e88fb613d; raw_unit=mg/kg bw per day; context=This ADI was based on the absence of toxicity in animal studies, including long-term rat and dog studies in which animals were fed xanthan gum at doses up to 1000 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-77 mg/kg bw/day Rat - long-term Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=7d268cb03d2ec9fe; raw_unit=mg/kg body weight; context=At its twenty-fourth meeting, the Committee established a temporary ADI of 0-7 mg/kg body weight (bw) based on long-term rat studies.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-22 mg/kg bw/day Human - - Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=1bb58ececd881078; raw_unit=mg/kg bw; context=tee evaluated biochemical data and the results of toxicological and human studies on Tagetes preparations with a high content of unesterified lutein (>80%) and established a group ADI of 0-2 mg/kg bw for lutein from Tagetes erecta and synthetic zeaxanthin.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-11 mg/kg bw/day Rat oral long-term Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=106f4fdce7058119; raw_unit=mg/kg bw; context=At its thirteenth meeting, the Committee established a temporary ADI of 0-1 mg/kg bw, based on a no-observed-effect level (NOEL) of 500 mg/kg bw per day in a long-term feeding study in rats.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-0.50.5 mg/kg bw/day Rat oral long-term Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=c2bc7a971f026b3d; raw_unit=mg/kg bw; context=At its eighteenth meeting, the Committee considered a second long-term feeding study in rats and established a temporary ADI of 0-0.5 mg/kg bw, based on the absence of any adverse effects at the highest tested dose of 50 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-1010 mg/kg bw/day Mouse oral long-term Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=b7c2df6f77fbcf71; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-10 mg/kg bw, based on a NOEL of 10 000 mg/kg in the diet (equivalent to 1500 mg/kg bw per day) in the long-term study in mice.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=8d3b99a6f9c22cf2; raw_unit=mg/kg bw; context=The Committee noted that these studies might have an effect on the ADI, so it withdrew the previously established ADI of 0-10 mg/kg bw and established a temporary ADI of 0-5 mg/kg bw, incorporating an additional 2-fold uncertainty factor, pending submission of the Biodynamics Laboratories studies by the end of 2013.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-33 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=787553ec4160c407; raw_unit=mg/kg bw; context=Using this NOAEL and an uncertainty factor of 100, the Committee established an ADI of 0-3 mg/kg bw (rounded value) for Quinoline Yellow.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-0.30.3 mg/kg bw/day Rat - short-term Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=58f22eb0c3b6b9fd; raw_unit=mg/kg bw; context=The Committee established a temporary ADI of 0-0.3 mg/kg bw for rosemary extract, expressed as carnosic acid plus carnosol, on the basis of a NOAEL of 64 mg/kg bw per day, expressed as carnosic acid plus carnosol, the highest dose tested in a short-term toxicity study in rats, with application of a 200-fold uncertaint
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-44 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=993b438acb5e14ef; raw_unit=mg/kg bw; context=The Committee concluded that the new data were sufficient to allow the additional uncertainty factor of 2 and the temporary designation to be removed and established an ADI for steviol glycosides of 0-4 mg/kg bw, expressed as steviol.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:4.0-4.44.4 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=e61cb3760109e726; raw_unit=mg/kg bw per day; context=The Committee noted that the predicted maximum dietary exposure to steviol glycosides of 4.0-4.4 mg/kg bw per day for young children who were high consumers exceeded the upper bound of the ADI (100-110%), but for other age groups, the ADI was not exceeded.
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI range:0-7.57.5 mg/kg bw/day Rat - chronic Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=2124b465c38e0022; raw_unit=mg/kg bw; context=The Committee previously evaluated tartrazine at its eighth meeting in 1964 (Annex 1, reference 8), when an ADI of 0-7.5 mg/kg bw was established, based on a NOAEL equivalent to 750 mg/kg bw per day, derived from a chronic toxicity study in rats (as cited in [1], as the JECFA monograph for the eighth meeting is no longer available).
INCHEM_WHO_jecfa_jecmono_v1000je01 ADI <=1000 mg/kg bw/day Rat; Dog - long-term Health guidance value document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=7631bb1e88fb613d; raw_unit=mg/kg bw per day; context=This ADI was based on the absence of toxicity in animal studies, including long-term rat and dog studies in which animals were fed xanthan gum at doses up to 1000 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v1000je01 LOAEL =3013 mg/kg bw/day Pig oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=4bcfdc2557a6b393; raw_unit=mg/kg bw per day; context=bw per day) at the then proposed level of 0.5% (5000 mg/L) was in the region of the NOAEL of pectin (847 mg/kg bw per day) and close to the lowest-observed- adverse-effect level (LOAEL) (3013 mg/kg bw per day), based on decreased feed intake and body weight gain in a neonatal pig study.
INCHEM_WHO_jecfa_jecmono_v1000je01 LOAEL =3013 mg/kg bw/day Pig oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=4bcfdc2557a6b393; raw_unit=mg/kg bw per day; context=bw per day) at the then proposed level of 0.5% (5000 mg/L) was in the region of the NOAEL of pectin (847 mg/kg bw per day) and close to the lowest-observed- adverse-effect level (LOAEL) (3013 mg/kg bw per day), based on decreased feed intake and body weight gain in a neonatal pig study.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =69 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=4b22cc4d1a62f5de; raw_unit=mg/ kg bw per day; context=1777) are non-genotoxic in bacteria, and the NOAEL of 69 mg/ kg bw per day for No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =490 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=1bdd60227dd2fb07; raw_unit=mg/ kg bw per day; context=2228 is non-genotoxic in bacteria, and the NOAEL of 490 mg/ kg bw per day (the highest dose tested) in a 90-day study in rats [20] is 245 000 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =8 mg/kg bw/day Rat - 28-day Acute toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=5c8aee040d8d3811; raw_unit=mg/ kg bw per day; context=This compound is of low acute toxicity, and from four short-term toxicity studies available, the overall NOAEL of 8 mg/ kg bw per day in a 28-day study in rats [21] is 32 times the SPET estimate and 40 million times the MSDI when No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =300 mg/kg bw/day Rat oral 28-day Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=1270c6b714b66810; raw_unit=mg/kg bw per day; context=The NOAEL of 300 mg/kg bw per day for the structurally related 1-cyclohexylethyl butyrate in a 28-day study in rats [7] is 6 000 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =275 mg/kg bw/day Rat oral 14-week Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=3a579af89365c9db; raw_unit=mg/kg bw per day; context=The NOAEL of 275 mg/kg bw per day for the structurally related cinnamaldehyde in a 14-week study in rats [5] is 92 000 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =25 mg/kg bw/day Rat - - Reproductive toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=7fa6b6ea77c1f70e; raw_unit=mg/kg bw per day; context=The NOAEL of 25 mg/kg bw per day from the rat reproductive toxicity study [15] provides an adequate MOE of 15 million in relation to the MSDI of 0.1 ug/day.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =15 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=a55dab21f94fe60c; raw_unit=mg/kg bw per day; context=2230 is non-genotoxic in bacteria and in mammalian cells in vitro, and the NOAEL of 15 mg/kg bw per day in a 90-day study in rats [9] is 1 500 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =200 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=f5b01b203232dcd0; raw_unit=mg/kg bw per day; context=The NOAEL of 200 mg/kg bw per day for the structurally related 4-hydroxy-2,5- dimethyl-3(2H)-furanone (No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =695 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=b2e19b790be5c9e2; raw_unit=mg/kg bw per day; context=Based on the reduced body weight in both sexes in one study [16] and in females in another study [17] observed at 5.19% Allura Red AC in the diet, the NOAEL was 1.39% (equivalent to 695 mg/kg bw per day, calculated using default dose conversion factors).
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =901 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=b1bb4edb4fe6e432; raw_unit=mg/kg bw per day; context=The present Committee noted that one study [17] was later published in the scientific literature and that the NOAEL of 1.39% in feed was calculated to be equal to 901 mg/kg bw per day, based on measured feed consumption and body weight data [18].
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =7318 mg/kg bw/day Mouse oral - Developmental toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=65f02ef455cdc931; raw_unit=mg/kg bw per day; context=No treatment-related reproductive or developmental toxicity was observed in the two studies in mice; the NOAEL was 5.19% in the diet (equal to 7318 mg/kg bw per day) [15].
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=01aa90b92188267f; raw_unit=mg/kg bw per day; context=The reduced ossification of the hyoid observed in one study was therefore considered to be an incidental finding of no toxicological relevance, and the NOAEL was 1000 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL range:0-77 mg/kg bw Rat oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=856098c14e558fcf; raw_unit=mg/kg bw; context=Evaluation The existing ADI of 0-7 mg/kg bw is based on a NOAEL of 1.39% in the diet derived from three rat studies [16, 17, 38].
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =240 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=4f6080dc23b39c43; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 1% carob bean gum (equal to 240 mg/kg bw per day) [10].
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =847 mg/kg bw/day Pig oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=54fb29f3194726bb; raw_unit=mg/kg bw per day; context=ommittee concluded that estimated exposure to pectin from its use in infant formula (1100 mg/kg bw per day) at the then proposed level of 0.5% (5000 mg/L) was in the region of the NOAEL of pectin (847 mg/kg bw per day) and close to the lowest-observed- adverse-effect level (LOAEL) (3013 mg/kg bw per day), based on decreased feed intake and body weight gain in a neonatal pig study.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL ~7000 mg/kg bw/day Rat - short-term Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=af367543d1c531f9; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL of pAOS from short-term toxicity studies in rats was about 7000 mg/kg bw per day, the highest dose tested, and concluded that pAOS is not genotoxic.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =704 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=36c8674b92d3a989; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 0.2% pectin (equal to 704 mg/kg bw per day for males and females combined).
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =1049 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=226ca11e13703428; raw_unit=mg/kg bw per day; context=The re-evaluation of the dose levels using measured concentrations of pectin in milk replacer rather than target concentrations also indicates a slightly higher NOAEL of 1049 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =7500 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=ac2dc25b119e0169; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL for this study was 7500 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =250 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=6942dd5da6734017; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL for these two related studies was 0.5% in the diet (equivalent to 250 mg/kg bw per day).
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =150 mg/kg bw/day Dog - 2-year Chronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=c032921d0a063588; raw_unit=mg/kg bw per day; context=No treatment-related effects were noted in a 2-year study in dogs [10], and the Committee concluded that the NOAEL for this study was 0.2% (equivalent to 150 mg/kg bw per day), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =64 mg/kg bw/day - - 90-day Subchronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=8ffad4938baac487; raw_unit=mg/kg bw per day; context=The highest NOAEL expressed as carnosic acid plus carnosol in the 90-day studies was 64 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =750 mg/kg bw/day Rat - chronic Chronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=0c99fa832d559850; raw_unit=mg/kg bw per day; context=The Committee previously evaluated tartrazine at its eighth meeting in 1964 (Annex 1, reference 8), when an ADI of 0-7.5 mg/kg bw was established, based on a NOAEL equivalent to 750 mg/kg bw per day, derived from a chronic toxicity study in rats (as cited in [1], as the JECFA monograph for the eighth meeting is no longer available).
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =2173 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=2330cc2d960a7045; raw_unit=mg/kg bw per day; context=Although the authors considered the NOAEL to be the highest dose tested, the Committee concluded that 1.5% in the diet, equal to 2173 mg/kg bw per day, was the NOAEL for this study, on the basis of a body weight reduction concurrent with an increase in feed consumption at the higher dose in males.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =984 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=8e5455b21e987937; raw_unit=mg/kg bw per day; context=The Committee concluded that 2% in the diet, equal to 984 mg/kg bw per day, was the NOAEL for this study.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =2641 mg/kg bw/day - oral - Reproductive toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=bbb3b7f464aba889; raw_unit=mg/kg bw per day; context=The Committee concluded that 5% in the diet, equal to 2641 mg/kg bw per day, the highest dose tested, was the NOAEL for reproductive end-points in this study.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =3301 mg/kg bw/day Rat - 90-day Subchronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=f201e5ffe0704b26; raw_unit=mg/kg bw per day; context=In a 90-day study conducted with a new xanthan gum product in rats, the authors identified a NOAEL of 3301 mg/kg bw per day, the highest dose tested [13].
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =220 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=5814dc38d408fdde; raw_unit=mg/kg bw per day; context=The MOE based on this NOAEL and the conservative estimate of xanthan gum intake of 220 mg/kg bw per day by infants (high energy requirements for fully formula-fed infants) is 3.4.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =1 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=9d0cae76adb4a340; raw_unit=mg/kg bw per day; context=The NOAEL of 1 mg/kg bw per day for the structurally related dehydromenthofurolactone in a 90-day study in rats [5] is 200 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =140 mg/kg bw/day Rat oral 28-day Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=32bb429792434524; raw_unit=mg/kg bw per day; context=2225 is non-genotoxic in bacteria, and the NOAEL of 140 mg/kg bw per day (the highest dose tested) in a 28-day study in rats [12] is 4 200 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =100 mg/kg bw/day Rat oral 28-day Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=692db1afaeef7e88; raw_unit=mg/kg bw per day; context=2226 is non-genotoxic in bacteria and in mammalian cells in vitro and in vivo, and the NOAEL of 100 mg/kg bw per day (the highest dose tested) in a 28-day study in rats [16] is 7 700 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =695 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=b2e19b790be5c9e2; raw_unit=mg/kg bw per day; context=Based on the reduced body weight in both sexes in one study [16] and in females in another study [17] observed at 5.19% Allura Red AC in the diet, the NOAEL was 1.39% (equivalent to 695 mg/kg bw per day, calculated using default dose conversion factors).
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =901 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=b1bb4edb4fe6e432; raw_unit=mg/kg bw per day; context=The present Committee noted that one study [17] was later published in the scientific literature and that the NOAEL of 1.39% in feed was calculated to be equal to 901 mg/kg bw per day, based on measured feed consumption and body weight data [18].
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =7318 mg/kg bw/day Mouse oral - Developmental toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=65f02ef455cdc931; raw_unit=mg/kg bw per day; context=No treatment-related reproductive or developmental toxicity was observed in the two studies in mice; the NOAEL was 5.19% in the diet (equal to 7318 mg/kg bw per day) [15].
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=01aa90b92188267f; raw_unit=mg/kg bw per day; context=The reduced ossification of the hyoid observed in one study was therefore considered to be an incidental finding of no toxicological relevance, and the NOAEL was 1000 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL range:0-77 mg/kg bw Rat oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=856098c14e558fcf; raw_unit=mg/kg bw; context=Evaluation The existing ADI of 0-7 mg/kg bw is based on a NOAEL of 1.39% in the diet derived from three rat studies [16, 17, 38].
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =240 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=4f6080dc23b39c43; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 1% carob bean gum (equal to 240 mg/kg bw per day) [10].
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =847 mg/kg bw/day Pig oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=54fb29f3194726bb; raw_unit=mg/kg bw per day; context=ommittee concluded that estimated exposure to pectin from its use in infant formula (1100 mg/kg bw per day) at the then proposed level of 0.5% (5000 mg/L) was in the region of the NOAEL of pectin (847 mg/kg bw per day) and close to the lowest-observed- adverse-effect level (LOAEL) (3013 mg/kg bw per day), based on decreased feed intake and body weight gain in a neonatal pig study.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL ~7000 mg/kg bw/day Rat - short-term Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=af367543d1c531f9; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL of pAOS from short-term toxicity studies in rats was about 7000 mg/kg bw per day, the highest dose tested, and concluded that pAOS is not genotoxic.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =704 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=36c8674b92d3a989; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 0.2% pectin (equal to 704 mg/kg bw per day for males and females combined).
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =1049 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=226ca11e13703428; raw_unit=mg/kg bw per day; context=The re-evaluation of the dose levels using measured concentrations of pectin in milk replacer rather than target concentrations also indicates a slightly higher NOAEL of 1049 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =7500 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=ac2dc25b119e0169; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL for this study was 7500 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =250 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=6942dd5da6734017; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL for these two related studies was 0.5% in the diet (equivalent to 250 mg/kg bw per day).
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =150 mg/kg bw/day Dog - 2-year Chronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=c032921d0a063588; raw_unit=mg/kg bw per day; context=No treatment-related effects were noted in a 2-year study in dogs [10], and the Committee concluded that the NOAEL for this study was 0.2% (equivalent to 150 mg/kg bw per day), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =64 mg/kg bw/day - - 90-day Subchronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=8ffad4938baac487; raw_unit=mg/kg bw per day; context=The highest NOAEL expressed as carnosic acid plus carnosol in the 90-day studies was 64 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =750 mg/kg bw/day Rat - chronic Chronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=0c99fa832d559850; raw_unit=mg/kg bw per day; context=The Committee previously evaluated tartrazine at its eighth meeting in 1964 (Annex 1, reference 8), when an ADI of 0-7.5 mg/kg bw was established, based on a NOAEL equivalent to 750 mg/kg bw per day, derived from a chronic toxicity study in rats (as cited in [1], as the JECFA monograph for the eighth meeting is no longer available).
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =2173 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=2330cc2d960a7045; raw_unit=mg/kg bw per day; context=Although the authors considered the NOAEL to be the highest dose tested, the Committee concluded that 1.5% in the diet, equal to 2173 mg/kg bw per day, was the NOAEL for this study, on the basis of a body weight reduction concurrent with an increase in feed consumption at the higher dose in males.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =984 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=8e5455b21e987937; raw_unit=mg/kg bw per day; context=The Committee concluded that 2% in the diet, equal to 984 mg/kg bw per day, was the NOAEL for this study.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =2641 mg/kg bw/day - oral - Reproductive toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=bbb3b7f464aba889; raw_unit=mg/kg bw per day; context=The Committee concluded that 5% in the diet, equal to 2641 mg/kg bw per day, the highest dose tested, was the NOAEL for reproductive end-points in this study.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =3301 mg/kg bw/day Rat - 90-day Subchronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=f201e5ffe0704b26; raw_unit=mg/kg bw per day; context=In a 90-day study conducted with a new xanthan gum product in rats, the authors identified a NOAEL of 3301 mg/kg bw per day, the highest dose tested [13].
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =220 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=5814dc38d408fdde; raw_unit=mg/kg bw per day; context=The MOE based on this NOAEL and the conservative estimate of xanthan gum intake of 220 mg/kg bw per day by infants (high energy requirements for fully formula-fed infants) is 3.4.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =1 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=9d0cae76adb4a340; raw_unit=mg/kg bw per day; context=The NOAEL of 1 mg/kg bw per day for the structurally related dehydromenthofurolactone in a 90-day study in rats [5] is 200 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =140 mg/kg bw/day Rat oral 28-day Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=32bb429792434524; raw_unit=mg/kg bw per day; context=2225 is non-genotoxic in bacteria, and the NOAEL of 140 mg/kg bw per day (the highest dose tested) in a 28-day study in rats [12] is 4 200 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =100 mg/kg bw/day Rat oral 28-day Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=692db1afaeef7e88; raw_unit=mg/kg bw per day; context=2226 is non-genotoxic in bacteria and in mammalian cells in vitro and in vivo, and the NOAEL of 100 mg/kg bw per day (the highest dose tested) in a 28-day study in rats [16] is 7 700 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =69 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=4b22cc4d1a62f5de; raw_unit=mg/ kg bw per day; context=1777) are non-genotoxic in bacteria, and the NOAEL of 69 mg/ kg bw per day for No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =490 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=1bdd60227dd2fb07; raw_unit=mg/ kg bw per day; context=2228 is non-genotoxic in bacteria, and the NOAEL of 490 mg/ kg bw per day (the highest dose tested) in a 90-day study in rats [20] is 245 000 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =8 mg/kg bw/day Rat - 28-day Acute toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=5c8aee040d8d3811; raw_unit=mg/ kg bw per day; context=This compound is of low acute toxicity, and from four short-term toxicity studies available, the overall NOAEL of 8 mg/ kg bw per day in a 28-day study in rats [21] is 32 times the SPET estimate and 40 million times the MSDI when No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =300 mg/kg bw/day Rat oral 28-day Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=1270c6b714b66810; raw_unit=mg/kg bw per day; context=The NOAEL of 300 mg/kg bw per day for the structurally related 1-cyclohexylethyl butyrate in a 28-day study in rats [7] is 6 000 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =275 mg/kg bw/day Rat oral 14-week Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=3a579af89365c9db; raw_unit=mg/kg bw per day; context=The NOAEL of 275 mg/kg bw per day for the structurally related cinnamaldehyde in a 14-week study in rats [5] is 92 000 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =25 mg/kg bw/day Rat - - Reproductive toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=7fa6b6ea77c1f70e; raw_unit=mg/kg bw per day; context=The NOAEL of 25 mg/kg bw per day from the rat reproductive toxicity study [15] provides an adequate MOE of 15 million in relation to the MSDI of 0.1 ug/day.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =15 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=a55dab21f94fe60c; raw_unit=mg/kg bw per day; context=2230 is non-genotoxic in bacteria and in mammalian cells in vitro, and the NOAEL of 15 mg/kg bw per day in a 90-day study in rats [9] is 1 500 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOAEL =200 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=f5b01b203232dcd0; raw_unit=mg/kg bw per day; context=The NOAEL of 200 mg/kg bw per day for the structurally related 4-hydroxy-2,5- dimethyl-3(2H)-furanone (No.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOEL =970 mg/kg bw/day Rat oral 2-year Chronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=83ac02b0afb880ce; raw_unit=mg/kg bw per day; context=A temporary ADI of 0-2 mg/kg bw for steviol glycosides, expressed as steviol, was established on the basis of the NOEL of 2.5% stevioside in the diet, equal to 970 mg/kg bw per day, or 383 mg/kg bw per day expressed as steviol, in a 2-year study in rats and the application of an uncertainty factor of 200.
INCHEM_WHO_jecfa_jecmono_v1000je01 NOEL =970 mg/kg bw/day Rat oral 2-year Chronic toxicity document_id=jecfa_jecmono_v1000je01; 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 Eighty-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1000je01.pdf; row_hash=83ac02b0afb880ce; raw_unit=mg/kg bw per day; context=A temporary ADI of 0-2 mg/kg bw for steviol glycosides, expressed as steviol, was established on the basis of the NOEL of 2.5% stevioside in the diet, equal to 970 mg/kg bw per day, or 383 mg/kg bw per day expressed as steviol, in a 2-year study in rats and the application of an uncertainty factor of 200.
INCHEM_WHO_jecfa_jecmono_v73je01 213 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-77 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=007eef0d0205f473; raw_unit=mg/kg bw.; context=At its twenty-fifth meeting, the Committee established a full ADI of 0-7 mg/kg bw.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-0.50.5 mg/kg bw/day Rat oral long-term Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=555440fdd776629f; raw_unit=mg/kg bw; context=At its eighteenth meeting, the Committee considered a second long-term feeding study in rats and established a temporary ADI of 0-0.5 mg/kg bw, based on the absence of any adverse effects at the highest tested dose of 50 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-1010 mg/kg bw/day Mouse oral long-term Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=57e62115827a6500; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-10 mg/kg bw, based on a NOEL of 10 000 mg/kg in the diet (equivalent to 1500 mg/kg bw per day) in the long-term study in mice (Annex 1, reference 66).
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3e4d01a1f1b4080a; raw_unit=mg/kg bw; context=The Committee noted that these studies might have an effect on the ADI, so it withdrew the previously established ADI of 0-10 mg/kg bw and established a temporary ADI of 0-5 mg/kg bw, incorporating an additional 2-fold uncertainty factor, pending submission of the Biodynamics Laboratories studies by the end of 2013 (Annex 1, reference 205).
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-33 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=94b658aa1cdb73d8; raw_unit=mg/kg bw; context=Using this NOAEL and an uncertainty factor of 100, the Committee established an ADI of 0-3 mg/kg bw (rounded value) for Quinoline Yellow.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-0.30.3 mg/kg bw/day Rat - short-term Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=810260b71ab341f0; raw_unit=mg/kg bw; context=The Committee established a temporary ADI of 0-0.3 mg/kg bw for rosemary extract, expressed as carnosic acid plus carnosol, on the basis of a NOAEL of 64 mg/kg bw per day, expressed as carnosic acid plus carnosol, the 175 Rosemary extract highest dose tested in a short-term toxicity study in rats, with application of
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-22 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ad166c6138f7a92c; raw_unit=mg/kg bw; context=183 Steviol glycosides (addendum) At its sixty-eighth meeting (Annex 1, reference 187), the Committee extended the temporary ADI of 0-2 mg/kg bw for steviol glycosides, expressed as steviol, pending submission of the results of ongoing clinical studies.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-44 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b03f390fa0985025; raw_unit=mg/kg bw; context=The Committee concluded that the new data were sufficient to allow the additional uncertainty factor of 2 and the temporary designation to be removed and established an ADI for steviol glycosides of 0-4 mg/kg bw, expressed as steviol.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:4.0-4.44.4 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=376292714aab3c6a; raw_unit=mg/kg bw per day; context=The Committee noted that the predicted maximum dietary exposure to steviol glycosides of 4.0-4.4 mg/kg bw per day for young children who were high consumers exceeded the upper bound of the ADI (100-110%), but for other age groups, the ADI was not exceeded.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI =7.5 mg/kg bw/day Rat oral - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=19c03c92643addb0; raw_unit=mg/kg bw per day; context=AC, amaranth, Brilliant Blue, azorubine and Indigo Carmine) given to female Wistar Han rats (n = 15) by oral gavage before and during gestation, each at a dose of their respective ADI established by the Committee in 1964 (7.5 mg/kg bw per day for tartrazine).
INCHEM_WHO_jecfa_jecmono_v73je01 ADI <=1000 mg/kg bw/day Rat; Dog - long-term Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7a8f2d1308a35ca4; raw_unit=mg/kg bw per day; context=This ADI was based on the absence of toxicity in animal studies, including long-term rat and dog studies in which animals were fed xanthan gum at doses up to 1000 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-77 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=007eef0d0205f473; raw_unit=mg/kg bw.; context=At its twenty-fifth meeting, the Committee established a full ADI of 0-7 mg/kg bw.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-0.50.5 mg/kg bw/day Rat oral long-term Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=555440fdd776629f; raw_unit=mg/kg bw; context=At its eighteenth meeting, the Committee considered a second long-term feeding study in rats and established a temporary ADI of 0-0.5 mg/kg bw, based on the absence of any adverse effects at the highest tested dose of 50 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-1010 mg/kg bw/day Mouse oral long-term Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=57e62115827a6500; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-10 mg/kg bw, based on a NOEL of 10 000 mg/kg in the diet (equivalent to 1500 mg/kg bw per day) in the long-term study in mice (Annex 1, reference 66).
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3e4d01a1f1b4080a; raw_unit=mg/kg bw; context=The Committee noted that these studies might have an effect on the ADI, so it withdrew the previously established ADI of 0-10 mg/kg bw and established a temporary ADI of 0-5 mg/kg bw, incorporating an additional 2-fold uncertainty factor, pending submission of the Biodynamics Laboratories studies by the end of 2013 (Annex 1, reference 205).
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-33 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=94b658aa1cdb73d8; raw_unit=mg/kg bw; context=Using this NOAEL and an uncertainty factor of 100, the Committee established an ADI of 0-3 mg/kg bw (rounded value) for Quinoline Yellow.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-0.30.3 mg/kg bw/day Rat - short-term Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=810260b71ab341f0; raw_unit=mg/kg bw; context=The Committee established a temporary ADI of 0-0.3 mg/kg bw for rosemary extract, expressed as carnosic acid plus carnosol, on the basis of a NOAEL of 64 mg/kg bw per day, expressed as carnosic acid plus carnosol, the 175 Rosemary extract highest dose tested in a short-term toxicity study in rats, with application of
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-22 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ad166c6138f7a92c; raw_unit=mg/kg bw; context=183 Steviol glycosides (addendum) At its sixty-eighth meeting (Annex 1, reference 187), the Committee extended the temporary ADI of 0-2 mg/kg bw for steviol glycosides, expressed as steviol, pending submission of the results of ongoing clinical studies.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-44 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b03f390fa0985025; raw_unit=mg/kg bw; context=The Committee concluded that the new data were sufficient to allow the additional uncertainty factor of 2 and the temporary designation to be removed and established an ADI for steviol glycosides of 0-4 mg/kg bw, expressed as steviol.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:4.0-4.44.4 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=376292714aab3c6a; raw_unit=mg/kg bw per day; context=The Committee noted that the predicted maximum dietary exposure to steviol glycosides of 4.0-4.4 mg/kg bw per day for young children who were high consumers exceeded the upper bound of the ADI (100-110%), but for other age groups, the ADI was not exceeded.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI =7.5 mg/kg bw/day Rat oral - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=19c03c92643addb0; raw_unit=mg/kg bw per day; context=AC, amaranth, Brilliant Blue, azorubine and Indigo Carmine) given to female Wistar Han rats (n = 15) by oral gavage before and during gestation, each at a dose of their respective ADI established by the Committee in 1964 (7.5 mg/kg bw per day for tartrazine).
INCHEM_WHO_jecfa_jecmono_v73je01 ADI <=1000 mg/kg bw/day Rat; Dog - long-term Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7a8f2d1308a35ca4; raw_unit=mg/kg bw per day; context=This ADI was based on the absence of toxicity in animal studies, including long-term rat and dog studies in which animals were fed xanthan gum at doses up to 1000 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-77 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=007eef0d0205f473; raw_unit=mg/kg bw.; context=At its twenty-fifth meeting, the Committee established a full ADI of 0-7 mg/kg bw.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-0.50.5 mg/kg bw/day Rat oral long-term Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=555440fdd776629f; raw_unit=mg/kg bw; context=At its eighteenth meeting, the Committee considered a second long-term feeding study in rats and established a temporary ADI of 0-0.5 mg/kg bw, based on the absence of any adverse effects at the highest tested dose of 50 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-1010 mg/kg bw/day Mouse oral long-term Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=57e62115827a6500; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-10 mg/kg bw, based on a NOEL of 10 000 mg/kg in the diet (equivalent to 1500 mg/kg bw per day) in the long-term study in mice (Annex 1, reference 66).
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3e4d01a1f1b4080a; raw_unit=mg/kg bw; context=The Committee noted that these studies might have an effect on the ADI, so it withdrew the previously established ADI of 0-10 mg/kg bw and established a temporary ADI of 0-5 mg/kg bw, incorporating an additional 2-fold uncertainty factor, pending submission of the Biodynamics Laboratories studies by the end of 2013 (Annex 1, reference 205).
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-33 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=94b658aa1cdb73d8; raw_unit=mg/kg bw; context=Using this NOAEL and an uncertainty factor of 100, the Committee established an ADI of 0-3 mg/kg bw (rounded value) for Quinoline Yellow.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-0.30.3 mg/kg bw/day Rat - short-term Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=810260b71ab341f0; raw_unit=mg/kg bw; context=The Committee established a temporary ADI of 0-0.3 mg/kg bw for rosemary extract, expressed as carnosic acid plus carnosol, on the basis of a NOAEL of 64 mg/kg bw per day, expressed as carnosic acid plus carnosol, the 175 Rosemary extract highest dose tested in a short-term toxicity study in rats, with application of
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-22 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ad166c6138f7a92c; raw_unit=mg/kg bw; context=183 Steviol glycosides (addendum) At its sixty-eighth meeting (Annex 1, reference 187), the Committee extended the temporary ADI of 0-2 mg/kg bw for steviol glycosides, expressed as steviol, pending submission of the results of ongoing clinical studies.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:0-44 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b03f390fa0985025; raw_unit=mg/kg bw; context=The Committee concluded that the new data were sufficient to allow the additional uncertainty factor of 2 and the temporary designation to be removed and established an ADI for steviol glycosides of 0-4 mg/kg bw, expressed as steviol.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI range:4.0-4.44.4 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=376292714aab3c6a; raw_unit=mg/kg bw per day; context=The Committee noted that the predicted maximum dietary exposure to steviol glycosides of 4.0-4.4 mg/kg bw per day for young children who were high consumers exceeded the upper bound of the ADI (100-110%), but for other age groups, the ADI was not exceeded.
INCHEM_WHO_jecfa_jecmono_v73je01 ADI =7.5 mg/kg bw/day Rat oral - Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=19c03c92643addb0; raw_unit=mg/kg bw per day; context=AC, amaranth, Brilliant Blue, azorubine and Indigo Carmine) given to female Wistar Han rats (n = 15) by oral gavage before and during gestation, each at a dose of their respective ADI established by the Committee in 1964 (7.5 mg/kg bw per day for tartrazine).
INCHEM_WHO_jecfa_jecmono_v73je01 ADI <=1000 mg/kg bw/day Rat; Dog - long-term Health guidance value document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7a8f2d1308a35ca4; raw_unit=mg/kg bw per day; context=This ADI was based on the absence of toxicity in animal studies, including long-term rat and dog studies in which animals were fed xanthan gum at doses up to 1000 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 LOAEL =10000 mg/L - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5050b36a28c4b5b3; raw_unit=g/L; unit_normalization=converted from grams; context=The LOAEL was 10 g/L in milk replacer, or 1%, resulting in a dose of 4461 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 LOAEL =600 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=540996922e407844; raw_unit=mg/kg bw per day; context=necrosis in myocardial and hepatic tissues of rats at high dose and some elevated clinical chemistry values indicative of tissue damage, the lowest- observed-adverse-effect level (LOAEL) was 600 mg/kg bw per day of carnosic acid.
INCHEM_WHO_jecfa_jecmono_v73je01 LOAEL =10000 mg/L - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5050b36a28c4b5b3; raw_unit=g/L; unit_normalization=converted from grams; context=The LOAEL was 10 g/L in milk replacer, or 1%, resulting in a dose of 4461 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 LOAEL =600 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=540996922e407844; raw_unit=mg/kg bw per day; context=necrosis in myocardial and hepatic tissues of rats at high dose and some elevated clinical chemistry values indicative of tissue damage, the lowest- observed-adverse-effect level (LOAEL) was 600 mg/kg bw per day of carnosic acid.
INCHEM_WHO_jecfa_jecmono_v73je01 LOAEL =10000 mg/L - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5050b36a28c4b5b3; raw_unit=g/L; unit_normalization=converted from grams; context=The LOAEL was 10 g/L in milk replacer, or 1%, resulting in a dose of 4461 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 LOAEL =600 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=540996922e407844; raw_unit=mg/kg bw per day; context=necrosis in myocardial and hepatic tissues of rats at high dose and some elevated clinical chemistry values indicative of tissue damage, the lowest- observed-adverse-effect level (LOAEL) was 600 mg/kg bw per day of carnosic acid.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1297.5 mg/kg bw/day Dog; Pig oral 21 days Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3dfd49e5e0d8243e; raw_unit=mg/kg bw per day; context=The NOAEL in beagle dogs was 5.19% (equivalent to 1297.5 mg/kg bw per day), the highest dietary concentration tested (Olson, Voelker & Shott, 1970). (c) Pigs SPF Danish Landrace pigs were equilibrated for 21 days whereupon they were distributed according to body weight into nine groups of two males and two females each.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =7318 mg/kg bw/day Mouse oral 109-week Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=1f8bb86b63d22496; raw_unit=mg/kg bw per day; context=Based on this 109-week dietary study in mice, the NOAEL for Allura Red AC was 5.19% (equal to 7318 mg/kg bw per day), the highest dose tested (Reno et al., 1978, later published as Borzelleca, Olson & Reno,1991).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =695 mg/kg bw/day Rat oral 92-week Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=26cccbe7e545b183; raw_unit=mg/kg bw per day; context=Based on the moderate growth depression observed at 5.19% (equivalent to 2595 mg/kg bw per day) in this 92-week dietary study in rats, the NOAEL for Allura Red AC was 1.39% (equivalent to 695 mg/kg bw per day) (Olson & Voelker, 1970).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =901 mg/kg bw/day Rat - 121-week Carcinogenicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=6a67095abae22e23; raw_unit=mg/kg bw per day; context=Allura Red AC (addendum) Based on the body-weight reduction observed in female rats at 5.19% (equal to 3604 mg/kg bw per day) in this 121-week toxicity/carcinogenicity study, the NOAEL was 1.39% (equal to 901 mg/kg bw per day) (Borzelleca, Olson & Reno, 1989).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2520 mg/kg bw/day Mouse oral - Reproductive toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ae950853e8f5e403; raw_unit=mg/kg bw per day; context=Based on this multigenerational reproductive toxicity study in mice, the NOAEL was 1.68% (equivalent to 2520 mg/kg bw per day), the highest dietary concentration tested (Tanaka, 1994).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =8300 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=046f4f64c21955ce; raw_unit=mg/kg bw per day; context=Borzelleca, Olson & Reno (1991) concluded that the NOAEL for Allura Red AC was 5.19% in the diet (approximately equal to 7300 and 8300 mg/kg bw per day for males and females, respectively).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2829 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b39578bbbfc44135; raw_unit=mg/kg bw per day; context=The authors concluded that the NOAEL for Allura Red AC for male rats was 5.19% (equal to 2829 mg/kg bw per day) and for female rats was 1.39% (901 mg/kg bw per day) (Borzelleca, Olson & Reno, 1989).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =200 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=a787790daaf06e61; raw_unit=mg/kg bw per day; context=Based on this developmental toxicity study, the NOAEL for Allura Red AC was 200 mg/kg bw per day, the highest dose tested (Collins, 1974).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1000 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5e4e424faaac8892; raw_unit=mg/ kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA The authors concluded that the NOAEL of Allura Red AC was 1000 mg/ kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =700 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=15972da683c7679b; raw_unit=mg/kg bw per day; context=Based on this developmental toxicity study, the NOAEL of Allura Red AC was 700 mg/kg bw per day, the highest dose tested (Reno, 1974).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL range:0-77 mg/kg bw Rat oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7beed269a3e2d2bc; raw_unit=mg/kg bw; context=Evaluation The existing ADI of 0-7 mg/kg bw is based on a NOAEL of 1.39% in the diet derived from three rat studies (Blackmore, Olson & Voelker, 1969;
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2500 mg/kg bw/day Rat; Mouse - 103-week Carcinogenicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=e238a11ac9d6b3a6; raw_unit=mg/kg bw per day; context=Based on the results of this 103-week toxicity and carcinogenicity study, the NOAEL for locust (carob) bean gum was the highest dose tested in both mice and rats, 7500 and 2500 mg/kg bw per day, respectively (NTP, 1982;
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =240 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b4f8210cba11eb64; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 1% carob bean gum (equal to 240 mg/kg bw per day) (Van Nevel et al., 2005).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =5000 mg/L Pig oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ace25fe780a978ac; raw_unit=mg/L; context=of certain food additives Eighty-second JECFA estimated exposure to pectin from its use in infant formula (1100 mg/kg body weight [bw] per day) at the then proposed level of 0.5% (5000 mg/L) was in the region of the no-observed-adverse-effect level (NOAEL) of pectin (847 mg/kg bw per day) and close to the lowest-observed-adverse-effect level (LOAEL) (3013 mg/kg bw per day), based on decreased feed intake and body weight gain in a neonatal pig study.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =847 mg/kg bw/day Pig oral 21-day Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4d2036eeaf00b7d3; raw_unit=mg/ kg bw per day; context=The NOAEL of pectin in this 21-day dietary study in pigs was 847 mg/ kg bw per day (3.0 g/L) based on the decreased feed intake and body-weight gain observed at 3013 mg/kg bw per day (10.0 g/L).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =3000 mg/L - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=160376d139441d67; raw_unit=g/L; unit_normalization=converted from grams; context=Consistent with the Committee’s previous evaluation, the authors concluded that the NOAEL of pectin derived from this study corresponds to the exposure level at 0.3% (3.0 g/L).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1049 mg/kg bw/day Pig - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5cea270ae00e19f5; raw_unit=mg/kg bw per day; context=The lowest NOAEL calculated using actual intake levels was 1049 mg/kg bw per day for male neonatal pigs.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2000 mg/L Pig - 3-week Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=c3ed6eafa8878af2; raw_unit=g/L; unit_normalization=converted from grams; context=79 Pectin (addendum) The NOAEL for pectin in this 3-week growth study in neonatal pigs was 2 g/L in milk replacer, or 0.2%, resulting in a dose of 704 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL ~7000 mg/kg bw/day Rat - short-term Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7452edf73b316e29; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL of pAOS from short-term toxicity studies in rats was about 7000 mg/kg bw per day, the highest dose tested, and concluded that pAOS is not genotoxic.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =704 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=a37adb0b64b8c511; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 0.2% pectin (equal to 704 mg/kg bw per day for males and females combined).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =7500 mg/kg bw/day Rat; Mouse oral long-term Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=1e7c06e55f93b0cb; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL in mice was 7500 mg/kg bw per day, the highest dose tested (Hogan & Knezevich,1982a). (b) Rats In a long-term rat study, groups of animals (25/sex) were fed diets containing 0%, 0.1% or 0.2% of D&C Yellow No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =250 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4654d01cca5490b5; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL for these two related studies was 0.5% in the diet (equivalent to 250 mg/kg bw per day).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =150 mg/kg bw/day Dog - 2-year Chronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=fbdaac9d04712371; raw_unit=mg/kg bw per day; context=No treatment-related effects were noted in a 2-year study in dogs (Anonymous, 1967b), and the Committee concluded that the NOAEL for this study was 0.2% (equivalent to 150 mg/kg bw per day), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =400 mg/kg bw/day Rat oral 13-week Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=82ba9b8a7ce223c7; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA The NOAEL of deodorized ethanolic extract of rosemary was 5000 mg/ kg diet (equivalent to 400 mg/kg bw per day or 40 mg/kg bw per day carnosol + carnosic acid) in rats, the highest dietary concentration tested (Nestlé Research Center, 2005a). (c) Rosemary extract (deodorized ethanol) In a 13-week study, groups of Sprague Dawley OFA rats (10 animals/sex per group, n =
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =180 mg/kg bw/day Rat oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=2917d847ac1ae37a; raw_unit=mg/kg bw per day; context=The NOAEL of dietary supercritical carbon dioxide extract of rosemary was 2400 mg/kg diet (equal to 180 mg/kg bw per day or 59 mg/kg bw per day carnosol + carnosic acid) in rats, the highest concentration tested (Covance Laboratories Ltd, 2000b).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =195 mg/kg bw/day Rat oral 13-week Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=537e0e53c1542ba7; raw_unit=mg/kg bw per day; context=The NOAEL of a supercritical carbon dioxide extract of rosemary was 2400 mg/kg diet (equal to 195 mg/kg bw per day or 64 mg/kg bw per day carnosol + carnosic acid) in rats, the highest dietary concentration tested (Covance Laboratories Ltd, 2002a). (e) Rosemary extract (hexane plus ethanol) In a 13-week study with a 4-week treatment-free recovery period, groups of Sprague
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =315 mg/kg bw/day - oral 13 weeks Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=09fafa65df775c3d; raw_unit=mg/kg bw per day; context=153 Rosemary extract Following 13 weeks of dietary exposure, the NOAEL of a hexane plus ethanol extract of rosemary was 5000 mg/kg diet (equal to 315 mg/kg bw per day or 47 mg/kg bw per day carnosol + carnosic acid), the highest dietary concentration tested (Nestlé Research Center, 2005b).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =300 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=bb2f3c9f15dfffab; raw_unit=mg/kg bw per day; context=The marginal statistically significant increase in AST and non-dose-dependent decrease in total serum protein and relative liver weight increase observed only in mid-dose males, 300 mg/kg bw per day may be considered a NOAEL; however, in the absence of confirmatory liver histopathology results for these mid-dose animals, the NOAEL for the systemic toxicity of carnosic acid was considered to be 150 mg/kg bw per day, the lowest dose tested (Wang et al., 2012).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =64 mg/kg bw/day - - 90-day Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=fe0d858f9de16710; raw_unit=mg/kg bw per day; context=The highest NOAEL expressed as carnosic acid plus carnosol in the 90-day studies was 64 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2000 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=09813eee6762986f; raw_unit=mg/kg bw per day; context=The no-observed-adverse-effect level for male and female rats was 2000 mg/kg bw per day for ferm-Reb A, the highest dose tested, or at least 660 mg of steviol equivalent/kg bw per day (Rumelhard et al., 2016).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =750 mg/kg bw/day Rat oral chronic Chronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ad7d021f68d57752; raw_unit=mg/kg bw per day; context=eighth meeting in 1964 (Annex 1, reference 8), when an acceptable daily intake (ADI) of 0-7.5 mg/kg body weight (bw) was established, based on a no-observed- adverse-effect level (NOAEL) equivalent to 750 mg/kg bw per day, derived from a chronic toxicity study in rats (as cited in Scientific Committee for Food, 1983, as the JECFA monograph for the eighth meeting is no longer available).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2662 mg/kg bw/day Rat oral 104-week Carcinogenicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=129e899378eb0961; raw_unit=mg/kg bw per day; context=The Committee considered that the changes in body weights and food consumption at 5% tartrazine in the diet were relevant and concluded that the NOAEL for this 104-week carcinogenicity study was 1.5% in the diet (equal to 2173 or 2662 mg/kg bw per day in males and females, respectively). (b) Rats Tartrazine was tested for chronic toxicity in Charles River CD rats in two concurrent studies conducted in the same laboratory.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =984 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=cb28621809db1565; raw_unit=mg/kg bw per day; context=However, the Committee considered the body-weight changes in the 5% group to be significant and determined that the NOAEL should be based on results from the 2% group (equal to 984 mg/kg bw per day for male rats and 1225 mg/kg bw per day for female rats).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =3348 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=909a97237eb6e6fa; raw_unit=mg/kg bw per day; context=The NOAEL was 2641 and 3348 mg/kg bw per day for male and female rats, respectively (Borzelleca & Hallagan, 1988b).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2173 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=678172f306318717; raw_unit=mg/kg bw per day; context=Although the authors considered the NOAEL to be the highest dose tested, the Committee concluded that 1.5% in the diet, equal to 2173 mg/kg bw per day, was the NOAEL for this study, on the basis of a body-weight reduction concurrent with an increase in feed consumption at the higher dose in males.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =375 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7792e014fad7f971; raw_unit=mg/kg bw per day; context=The NOAEL of xanthan gum in neonate piglets was 375 mg/kg bw per day based on the decreased tolerability at 3750 mg/kg bw per day resulting in suboptimal body-weight gain, significant increases in absolute and relative weights of the large intestine (caecum and colon), microscopic findings in the large and small intestine and
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =500 mg/kg bw/day Rat oral - Reproductive toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=6616c34d44d50826; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA Based on the results of this study, the NOAEL for reproductive toxicity of xanthan gum in male and female albino rats was 500 mg/kg bw per day, the highest dose tested (Woodard et al., 1973).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =3301 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=0cbc12b135c4706a; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA a NOAEL of 3301 mg/kg bw per day, the highest dose tested (Hagiwara et al., 2004).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =220 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=aeb9b737eb26aa75; raw_unit=mg/kg bw per day; context=The margin of exposure based on this NOAEL and the conservative estimate of xanthan gum intake of 220 mg/kg bw per day by infants (high energy requirements for fully formula-fed infants) is 3.4.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3bae2407e412fa9e; raw_unit=mg/kg bw per day; context=2223), the no-observed-adverse-affect level (NOAEL)1 of 1 mg/kg bw per day for the structurally related dehydromenthofurolactone (No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =140 mg/kg bw/day Rat oral 28-day Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=518da6b9fd7eda4f; raw_unit=mg/kg bw per day; context=2225 is non-genotoxic in bacte- ria, and the NOAEL of 140 mg/kg bw per day (the highest dose tested) in a 28-day study in rats (Craig, 2011a) is 4 200 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =100 mg/kg bw/day Rat oral 28-day Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=aefbc96bf7780c27; raw_unit=mg/kg bw per day; context=2226 is non-genotoxic in bacteria and in mammalian cells in vitro and in vivo, and the NOAEL of 100 mg/kg bw per day (the highest dose tested) in a 28-day study in rats (Craig, 2011b) is 7 700 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =69 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=409437cbe2a1f656; raw_unit=mg/kg bw per day; context=1777) are non-genotoxic in bacteria, and the NOAEL of 69 mg/kg bw per day for No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =490 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5b953a563aa1dfc7; raw_unit=mg/kg bw per day; context=2228 is non-genotoxic in bacteria, and the NOAEL of 490 mg/kg bw per day (the highest dose tested) in a 90-day study in rats (Koetzner, 2013a) is 245 000 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =8 mg/kg bw/day Rat - 28-day Acute toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=f7765f32e8420ec3; raw_unit=mg/kg bw per day; context=This compound is of low acute toxicity, and from four short-term toxicity studies available, the overall NOAEL of 8 mg/kg bw per day in a 28-day study in rats (Miyata, 1995) is 32 times the SPET estimate and 40 million times the MSDI when No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =40 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=d58d5c83cd42411d; raw_unit=mg/kg bw per day; context=Although the study author proposed that the findings in the liver were an adaptive response to increased metabolic demand at higher concentrations, a NOAEL of 40 mg/kg bw per day was identified for cyclopropanecarboxylic acid (2-isopropyl-5-methyl-cyclohexyl)-amide (No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =23 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=93bfbaac7ae3aada; raw_unit=mg/kg bw per day; context=A NOAEL of 360 mg/kg feed, equal to 23 mg/kg bw per day in males and 28 mg/kg bw per day in females, was identified for (2E,6E/Z,8E)-N-(2- methylpropyl)-2,6,8-decatrienamide (No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =275 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=d314353b7a9ad6c0; raw_unit=mg/kg bw per day; context=2215), the NOAEL of 275 mg/kg bw per day for the structurally related substance cinnamaldehyde (No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =25 mg/kg bw/day Rat - - Reproductive toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=9bfaa27fab31815a; raw_unit=mg/kg bw per day; context=The NOAEL of 25 mg/kg bw per day from the rat reproductive toxicity study (Lewis, 2013) provides an adequate MOE of 15 million in relation to the MSDI of 0.1 ug/day.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =4 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=38712ef3781f456e; raw_unit=mg/kg bw per day; context=656) in this study, the NOAEL was 4 mg/kg bw per day, the highest dose tested (Lin et al., 2011).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =75 mg/kg bw/day - oral 14-day Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=13f289c28ed9218d; raw_unit=mg/kg bw per day; context=Based on reduced body-weight gain and feed consumption at 250 mg/kg bw per day, the NOAEL for systemic toxicity in this 14-day study was considered to be 75 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =15 mg/kg bw/day Rat oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=deed69647af180e2; raw_unit=mg/kg bw per day; context=The NOAEL of 15 mg/kg bw per day in a 90- day toxicity study in rats (Bauter, 2015a) provides an adequate MOE of 1500 in relation to the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =50 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b3bd7c25bf9ef228; raw_unit=mg/kg bw per day; context=The NOAEL was 50 mg/kg bw per day, based on decreased body weight and spleen toxicity observed at 150 mg/kg bw per day (Hirata-Koizumi et al., 2008;
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1832 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=14e3105183c65729; raw_unit=mg/kg bw per day; context=In the absence of any treatment-related adverse effects, the NOAEL was 1832 mg/kg bw per day, the highest dose tested (Moran, 1980). (c) Genotoxicity studies Results of studies of genotoxicity for tetrahydrofuran and furanone derivatives used as flavouring agents are summarized in Table 5 and described below. (i) In vitro 2,5-Dimethyl-3(2H)-furanone
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1297.5 mg/kg bw/day Dog; Pig oral 21 days Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3dfd49e5e0d8243e; raw_unit=mg/kg bw per day; context=The NOAEL in beagle dogs was 5.19% (equivalent to 1297.5 mg/kg bw per day), the highest dietary concentration tested (Olson, Voelker & Shott, 1970). (c) Pigs SPF Danish Landrace pigs were equilibrated for 21 days whereupon they were distributed according to body weight into nine groups of two males and two females each.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =7318 mg/kg bw/day Mouse oral 109-week Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=1f8bb86b63d22496; raw_unit=mg/kg bw per day; context=Based on this 109-week dietary study in mice, the NOAEL for Allura Red AC was 5.19% (equal to 7318 mg/kg bw per day), the highest dose tested (Reno et al., 1978, later published as Borzelleca, Olson & Reno,1991).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =695 mg/kg bw/day Rat oral 92-week Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=26cccbe7e545b183; raw_unit=mg/kg bw per day; context=Based on the moderate growth depression observed at 5.19% (equivalent to 2595 mg/kg bw per day) in this 92-week dietary study in rats, the NOAEL for Allura Red AC was 1.39% (equivalent to 695 mg/kg bw per day) (Olson & Voelker, 1970).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =901 mg/kg bw/day Rat - 121-week Carcinogenicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=6a67095abae22e23; raw_unit=mg/kg bw per day; context=Allura Red AC (addendum) Based on the body-weight reduction observed in female rats at 5.19% (equal to 3604 mg/kg bw per day) in this 121-week toxicity/carcinogenicity study, the NOAEL was 1.39% (equal to 901 mg/kg bw per day) (Borzelleca, Olson & Reno, 1989).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2520 mg/kg bw/day Mouse oral - Reproductive toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ae950853e8f5e403; raw_unit=mg/kg bw per day; context=Based on this multigenerational reproductive toxicity study in mice, the NOAEL was 1.68% (equivalent to 2520 mg/kg bw per day), the highest dietary concentration tested (Tanaka, 1994).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =8300 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=046f4f64c21955ce; raw_unit=mg/kg bw per day; context=Borzelleca, Olson & Reno (1991) concluded that the NOAEL for Allura Red AC was 5.19% in the diet (approximately equal to 7300 and 8300 mg/kg bw per day for males and females, respectively).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2829 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b39578bbbfc44135; raw_unit=mg/kg bw per day; context=The authors concluded that the NOAEL for Allura Red AC for male rats was 5.19% (equal to 2829 mg/kg bw per day) and for female rats was 1.39% (901 mg/kg bw per day) (Borzelleca, Olson & Reno, 1989).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =200 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=a787790daaf06e61; raw_unit=mg/kg bw per day; context=Based on this developmental toxicity study, the NOAEL for Allura Red AC was 200 mg/kg bw per day, the highest dose tested (Collins, 1974).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1000 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5e4e424faaac8892; raw_unit=mg/ kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA The authors concluded that the NOAEL of Allura Red AC was 1000 mg/ kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =700 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=15972da683c7679b; raw_unit=mg/kg bw per day; context=Based on this developmental toxicity study, the NOAEL of Allura Red AC was 700 mg/kg bw per day, the highest dose tested (Reno, 1974).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL range:0-77 mg/kg bw Rat oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7beed269a3e2d2bc; raw_unit=mg/kg bw; context=Evaluation The existing ADI of 0-7 mg/kg bw is based on a NOAEL of 1.39% in the diet derived from three rat studies (Blackmore, Olson & Voelker, 1969;
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2500 mg/kg bw/day Rat; Mouse - 103-week Carcinogenicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=e238a11ac9d6b3a6; raw_unit=mg/kg bw per day; context=Based on the results of this 103-week toxicity and carcinogenicity study, the NOAEL for locust (carob) bean gum was the highest dose tested in both mice and rats, 7500 and 2500 mg/kg bw per day, respectively (NTP, 1982;
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =240 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b4f8210cba11eb64; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 1% carob bean gum (equal to 240 mg/kg bw per day) (Van Nevel et al., 2005).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =5000 mg/L Pig oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ace25fe780a978ac; raw_unit=mg/L; context=of certain food additives Eighty-second JECFA estimated exposure to pectin from its use in infant formula (1100 mg/kg body weight [bw] per day) at the then proposed level of 0.5% (5000 mg/L) was in the region of the no-observed-adverse-effect level (NOAEL) of pectin (847 mg/kg bw per day) and close to the lowest-observed-adverse-effect level (LOAEL) (3013 mg/kg bw per day), based on decreased feed intake and body weight gain in a neonatal pig study.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =847 mg/kg bw/day Pig oral 21-day Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4d2036eeaf00b7d3; raw_unit=mg/ kg bw per day; context=The NOAEL of pectin in this 21-day dietary study in pigs was 847 mg/ kg bw per day (3.0 g/L) based on the decreased feed intake and body-weight gain observed at 3013 mg/kg bw per day (10.0 g/L).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =3000 mg/L - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=160376d139441d67; raw_unit=g/L; unit_normalization=converted from grams; context=Consistent with the Committee’s previous evaluation, the authors concluded that the NOAEL of pectin derived from this study corresponds to the exposure level at 0.3% (3.0 g/L).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1049 mg/kg bw/day Pig - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5cea270ae00e19f5; raw_unit=mg/kg bw per day; context=The lowest NOAEL calculated using actual intake levels was 1049 mg/kg bw per day for male neonatal pigs.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2000 mg/L Pig - 3-week Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=c3ed6eafa8878af2; raw_unit=g/L; unit_normalization=converted from grams; context=79 Pectin (addendum) The NOAEL for pectin in this 3-week growth study in neonatal pigs was 2 g/L in milk replacer, or 0.2%, resulting in a dose of 704 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL ~7000 mg/kg bw/day Rat - short-term Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7452edf73b316e29; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL of pAOS from short-term toxicity studies in rats was about 7000 mg/kg bw per day, the highest dose tested, and concluded that pAOS is not genotoxic.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =704 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=a37adb0b64b8c511; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 0.2% pectin (equal to 704 mg/kg bw per day for males and females combined).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =7500 mg/kg bw/day Rat; Mouse oral long-term Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=1e7c06e55f93b0cb; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL in mice was 7500 mg/kg bw per day, the highest dose tested (Hogan & Knezevich,1982a). (b) Rats In a long-term rat study, groups of animals (25/sex) were fed diets containing 0%, 0.1% or 0.2% of D&C Yellow No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =250 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4654d01cca5490b5; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL for these two related studies was 0.5% in the diet (equivalent to 250 mg/kg bw per day).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =150 mg/kg bw/day Dog - 2-year Chronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=fbdaac9d04712371; raw_unit=mg/kg bw per day; context=No treatment-related effects were noted in a 2-year study in dogs (Anonymous, 1967b), and the Committee concluded that the NOAEL for this study was 0.2% (equivalent to 150 mg/kg bw per day), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =400 mg/kg bw/day Rat oral 13-week Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=82ba9b8a7ce223c7; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA The NOAEL of deodorized ethanolic extract of rosemary was 5000 mg/ kg diet (equivalent to 400 mg/kg bw per day or 40 mg/kg bw per day carnosol + carnosic acid) in rats, the highest dietary concentration tested (Nestlé Research Center, 2005a). (c) Rosemary extract (deodorized ethanol) In a 13-week study, groups of Sprague Dawley OFA rats (10 animals/sex per group, n =
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =180 mg/kg bw/day Rat oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=2917d847ac1ae37a; raw_unit=mg/kg bw per day; context=The NOAEL of dietary supercritical carbon dioxide extract of rosemary was 2400 mg/kg diet (equal to 180 mg/kg bw per day or 59 mg/kg bw per day carnosol + carnosic acid) in rats, the highest concentration tested (Covance Laboratories Ltd, 2000b).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =195 mg/kg bw/day Rat oral 13-week Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=537e0e53c1542ba7; raw_unit=mg/kg bw per day; context=The NOAEL of a supercritical carbon dioxide extract of rosemary was 2400 mg/kg diet (equal to 195 mg/kg bw per day or 64 mg/kg bw per day carnosol + carnosic acid) in rats, the highest dietary concentration tested (Covance Laboratories Ltd, 2002a). (e) Rosemary extract (hexane plus ethanol) In a 13-week study with a 4-week treatment-free recovery period, groups of Sprague
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =315 mg/kg bw/day - oral 13 weeks Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=09fafa65df775c3d; raw_unit=mg/kg bw per day; context=153 Rosemary extract Following 13 weeks of dietary exposure, the NOAEL of a hexane plus ethanol extract of rosemary was 5000 mg/kg diet (equal to 315 mg/kg bw per day or 47 mg/kg bw per day carnosol + carnosic acid), the highest dietary concentration tested (Nestlé Research Center, 2005b).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =300 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=bb2f3c9f15dfffab; raw_unit=mg/kg bw per day; context=The marginal statistically significant increase in AST and non-dose-dependent decrease in total serum protein and relative liver weight increase observed only in mid-dose males, 300 mg/kg bw per day may be considered a NOAEL; however, in the absence of confirmatory liver histopathology results for these mid-dose animals, the NOAEL for the systemic toxicity of carnosic acid was considered to be 150 mg/kg bw per day, the lowest dose tested (Wang et al., 2012).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =64 mg/kg bw/day - - 90-day Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=fe0d858f9de16710; raw_unit=mg/kg bw per day; context=The highest NOAEL expressed as carnosic acid plus carnosol in the 90-day studies was 64 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2000 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=09813eee6762986f; raw_unit=mg/kg bw per day; context=The no-observed-adverse-effect level for male and female rats was 2000 mg/kg bw per day for ferm-Reb A, the highest dose tested, or at least 660 mg of steviol equivalent/kg bw per day (Rumelhard et al., 2016).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =750 mg/kg bw/day Rat oral chronic Chronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ad7d021f68d57752; raw_unit=mg/kg bw per day; context=eighth meeting in 1964 (Annex 1, reference 8), when an acceptable daily intake (ADI) of 0-7.5 mg/kg body weight (bw) was established, based on a no-observed- adverse-effect level (NOAEL) equivalent to 750 mg/kg bw per day, derived from a chronic toxicity study in rats (as cited in Scientific Committee for Food, 1983, as the JECFA monograph for the eighth meeting is no longer available).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2662 mg/kg bw/day Rat oral 104-week Carcinogenicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=129e899378eb0961; raw_unit=mg/kg bw per day; context=The Committee considered that the changes in body weights and food consumption at 5% tartrazine in the diet were relevant and concluded that the NOAEL for this 104-week carcinogenicity study was 1.5% in the diet (equal to 2173 or 2662 mg/kg bw per day in males and females, respectively). (b) Rats Tartrazine was tested for chronic toxicity in Charles River CD rats in two concurrent studies conducted in the same laboratory.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =984 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=cb28621809db1565; raw_unit=mg/kg bw per day; context=However, the Committee considered the body-weight changes in the 5% group to be significant and determined that the NOAEL should be based on results from the 2% group (equal to 984 mg/kg bw per day for male rats and 1225 mg/kg bw per day for female rats).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =3348 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=909a97237eb6e6fa; raw_unit=mg/kg bw per day; context=The NOAEL was 2641 and 3348 mg/kg bw per day for male and female rats, respectively (Borzelleca & Hallagan, 1988b).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2173 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=678172f306318717; raw_unit=mg/kg bw per day; context=Although the authors considered the NOAEL to be the highest dose tested, the Committee concluded that 1.5% in the diet, equal to 2173 mg/kg bw per day, was the NOAEL for this study, on the basis of a body-weight reduction concurrent with an increase in feed consumption at the higher dose in males.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =375 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7792e014fad7f971; raw_unit=mg/kg bw per day; context=The NOAEL of xanthan gum in neonate piglets was 375 mg/kg bw per day based on the decreased tolerability at 3750 mg/kg bw per day resulting in suboptimal body-weight gain, significant increases in absolute and relative weights of the large intestine (caecum and colon), microscopic findings in the large and small intestine and
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =500 mg/kg bw/day Rat oral - Reproductive toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=6616c34d44d50826; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA Based on the results of this study, the NOAEL for reproductive toxicity of xanthan gum in male and female albino rats was 500 mg/kg bw per day, the highest dose tested (Woodard et al., 1973).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =3301 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=0cbc12b135c4706a; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA a NOAEL of 3301 mg/kg bw per day, the highest dose tested (Hagiwara et al., 2004).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =220 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=aeb9b737eb26aa75; raw_unit=mg/kg bw per day; context=The margin of exposure based on this NOAEL and the conservative estimate of xanthan gum intake of 220 mg/kg bw per day by infants (high energy requirements for fully formula-fed infants) is 3.4.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3bae2407e412fa9e; raw_unit=mg/kg bw per day; context=2223), the no-observed-adverse-affect level (NOAEL)1 of 1 mg/kg bw per day for the structurally related dehydromenthofurolactone (No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =140 mg/kg bw/day Rat oral 28-day Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=518da6b9fd7eda4f; raw_unit=mg/kg bw per day; context=2225 is non-genotoxic in bacte- ria, and the NOAEL of 140 mg/kg bw per day (the highest dose tested) in a 28-day study in rats (Craig, 2011a) is 4 200 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =100 mg/kg bw/day Rat oral 28-day Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=aefbc96bf7780c27; raw_unit=mg/kg bw per day; context=2226 is non-genotoxic in bacteria and in mammalian cells in vitro and in vivo, and the NOAEL of 100 mg/kg bw per day (the highest dose tested) in a 28-day study in rats (Craig, 2011b) is 7 700 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =69 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=409437cbe2a1f656; raw_unit=mg/kg bw per day; context=1777) are non-genotoxic in bacteria, and the NOAEL of 69 mg/kg bw per day for No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =490 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5b953a563aa1dfc7; raw_unit=mg/kg bw per day; context=2228 is non-genotoxic in bacteria, and the NOAEL of 490 mg/kg bw per day (the highest dose tested) in a 90-day study in rats (Koetzner, 2013a) is 245 000 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =8 mg/kg bw/day Rat - 28-day Acute toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=f7765f32e8420ec3; raw_unit=mg/kg bw per day; context=This compound is of low acute toxicity, and from four short-term toxicity studies available, the overall NOAEL of 8 mg/kg bw per day in a 28-day study in rats (Miyata, 1995) is 32 times the SPET estimate and 40 million times the MSDI when No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =40 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=d58d5c83cd42411d; raw_unit=mg/kg bw per day; context=Although the study author proposed that the findings in the liver were an adaptive response to increased metabolic demand at higher concentrations, a NOAEL of 40 mg/kg bw per day was identified for cyclopropanecarboxylic acid (2-isopropyl-5-methyl-cyclohexyl)-amide (No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =23 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=93bfbaac7ae3aada; raw_unit=mg/kg bw per day; context=A NOAEL of 360 mg/kg feed, equal to 23 mg/kg bw per day in males and 28 mg/kg bw per day in females, was identified for (2E,6E/Z,8E)-N-(2- methylpropyl)-2,6,8-decatrienamide (No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =275 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=d314353b7a9ad6c0; raw_unit=mg/kg bw per day; context=2215), the NOAEL of 275 mg/kg bw per day for the structurally related substance cinnamaldehyde (No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =25 mg/kg bw/day Rat - - Reproductive toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=9bfaa27fab31815a; raw_unit=mg/kg bw per day; context=The NOAEL of 25 mg/kg bw per day from the rat reproductive toxicity study (Lewis, 2013) provides an adequate MOE of 15 million in relation to the MSDI of 0.1 ug/day.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =4 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=38712ef3781f456e; raw_unit=mg/kg bw per day; context=656) in this study, the NOAEL was 4 mg/kg bw per day, the highest dose tested (Lin et al., 2011).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =75 mg/kg bw/day - oral 14-day Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=13f289c28ed9218d; raw_unit=mg/kg bw per day; context=Based on reduced body-weight gain and feed consumption at 250 mg/kg bw per day, the NOAEL for systemic toxicity in this 14-day study was considered to be 75 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =15 mg/kg bw/day Rat oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=deed69647af180e2; raw_unit=mg/kg bw per day; context=The NOAEL of 15 mg/kg bw per day in a 90- day toxicity study in rats (Bauter, 2015a) provides an adequate MOE of 1500 in relation to the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =50 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b3bd7c25bf9ef228; raw_unit=mg/kg bw per day; context=The NOAEL was 50 mg/kg bw per day, based on decreased body weight and spleen toxicity observed at 150 mg/kg bw per day (Hirata-Koizumi et al., 2008;
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1832 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=14e3105183c65729; raw_unit=mg/kg bw per day; context=In the absence of any treatment-related adverse effects, the NOAEL was 1832 mg/kg bw per day, the highest dose tested (Moran, 1980). (c) Genotoxicity studies Results of studies of genotoxicity for tetrahydrofuran and furanone derivatives used as flavouring agents are summarized in Table 5 and described below. (i) In vitro 2,5-Dimethyl-3(2H)-furanone
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1297.5 mg/kg bw/day Dog; Pig oral 21 days Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3dfd49e5e0d8243e; raw_unit=mg/kg bw per day; context=The NOAEL in beagle dogs was 5.19% (equivalent to 1297.5 mg/kg bw per day), the highest dietary concentration tested (Olson, Voelker & Shott, 1970). (c) Pigs SPF Danish Landrace pigs were equilibrated for 21 days whereupon they were distributed according to body weight into nine groups of two males and two females each.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =7318 mg/kg bw/day Mouse oral 109-week Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=1f8bb86b63d22496; raw_unit=mg/kg bw per day; context=Based on this 109-week dietary study in mice, the NOAEL for Allura Red AC was 5.19% (equal to 7318 mg/kg bw per day), the highest dose tested (Reno et al., 1978, later published as Borzelleca, Olson & Reno,1991).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =695 mg/kg bw/day Rat oral 92-week Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=26cccbe7e545b183; raw_unit=mg/kg bw per day; context=Based on the moderate growth depression observed at 5.19% (equivalent to 2595 mg/kg bw per day) in this 92-week dietary study in rats, the NOAEL for Allura Red AC was 1.39% (equivalent to 695 mg/kg bw per day) (Olson & Voelker, 1970).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =901 mg/kg bw/day Rat - 121-week Carcinogenicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=6a67095abae22e23; raw_unit=mg/kg bw per day; context=Allura Red AC (addendum) Based on the body-weight reduction observed in female rats at 5.19% (equal to 3604 mg/kg bw per day) in this 121-week toxicity/carcinogenicity study, the NOAEL was 1.39% (equal to 901 mg/kg bw per day) (Borzelleca, Olson & Reno, 1989).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2520 mg/kg bw/day Mouse oral - Reproductive toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ae950853e8f5e403; raw_unit=mg/kg bw per day; context=Based on this multigenerational reproductive toxicity study in mice, the NOAEL was 1.68% (equivalent to 2520 mg/kg bw per day), the highest dietary concentration tested (Tanaka, 1994).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =8300 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=046f4f64c21955ce; raw_unit=mg/kg bw per day; context=Borzelleca, Olson & Reno (1991) concluded that the NOAEL for Allura Red AC was 5.19% in the diet (approximately equal to 7300 and 8300 mg/kg bw per day for males and females, respectively).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2829 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b39578bbbfc44135; raw_unit=mg/kg bw per day; context=The authors concluded that the NOAEL for Allura Red AC for male rats was 5.19% (equal to 2829 mg/kg bw per day) and for female rats was 1.39% (901 mg/kg bw per day) (Borzelleca, Olson & Reno, 1989).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =200 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=a787790daaf06e61; raw_unit=mg/kg bw per day; context=Based on this developmental toxicity study, the NOAEL for Allura Red AC was 200 mg/kg bw per day, the highest dose tested (Collins, 1974).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1000 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5e4e424faaac8892; raw_unit=mg/ kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA The authors concluded that the NOAEL of Allura Red AC was 1000 mg/ kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =700 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=15972da683c7679b; raw_unit=mg/kg bw per day; context=Based on this developmental toxicity study, the NOAEL of Allura Red AC was 700 mg/kg bw per day, the highest dose tested (Reno, 1974).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL range:0-77 mg/kg bw Rat oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7beed269a3e2d2bc; raw_unit=mg/kg bw; context=Evaluation The existing ADI of 0-7 mg/kg bw is based on a NOAEL of 1.39% in the diet derived from three rat studies (Blackmore, Olson & Voelker, 1969;
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2500 mg/kg bw/day Rat; Mouse - 103-week Carcinogenicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=e238a11ac9d6b3a6; raw_unit=mg/kg bw per day; context=Based on the results of this 103-week toxicity and carcinogenicity study, the NOAEL for locust (carob) bean gum was the highest dose tested in both mice and rats, 7500 and 2500 mg/kg bw per day, respectively (NTP, 1982;
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =240 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b4f8210cba11eb64; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 1% carob bean gum (equal to 240 mg/kg bw per day) (Van Nevel et al., 2005).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =5000 mg/L Pig oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ace25fe780a978ac; raw_unit=mg/L; context=of certain food additives Eighty-second JECFA estimated exposure to pectin from its use in infant formula (1100 mg/kg body weight [bw] per day) at the then proposed level of 0.5% (5000 mg/L) was in the region of the no-observed-adverse-effect level (NOAEL) of pectin (847 mg/kg bw per day) and close to the lowest-observed-adverse-effect level (LOAEL) (3013 mg/kg bw per day), based on decreased feed intake and body weight gain in a neonatal pig study.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =847 mg/kg bw/day Pig oral 21-day Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4d2036eeaf00b7d3; raw_unit=mg/ kg bw per day; context=The NOAEL of pectin in this 21-day dietary study in pigs was 847 mg/ kg bw per day (3.0 g/L) based on the decreased feed intake and body-weight gain observed at 3013 mg/kg bw per day (10.0 g/L).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =3000 mg/L - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=160376d139441d67; raw_unit=g/L; unit_normalization=converted from grams; context=Consistent with the Committee’s previous evaluation, the authors concluded that the NOAEL of pectin derived from this study corresponds to the exposure level at 0.3% (3.0 g/L).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1049 mg/kg bw/day Pig - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5cea270ae00e19f5; raw_unit=mg/kg bw per day; context=The lowest NOAEL calculated using actual intake levels was 1049 mg/kg bw per day for male neonatal pigs.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2000 mg/L Pig - 3-week Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=c3ed6eafa8878af2; raw_unit=g/L; unit_normalization=converted from grams; context=79 Pectin (addendum) The NOAEL for pectin in this 3-week growth study in neonatal pigs was 2 g/L in milk replacer, or 0.2%, resulting in a dose of 704 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL ~7000 mg/kg bw/day Rat - short-term Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7452edf73b316e29; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL of pAOS from short-term toxicity studies in rats was about 7000 mg/kg bw per day, the highest dose tested, and concluded that pAOS is not genotoxic.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =704 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=a37adb0b64b8c511; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 0.2% pectin (equal to 704 mg/kg bw per day for males and females combined).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =7500 mg/kg bw/day Rat; Mouse oral long-term Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=1e7c06e55f93b0cb; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL in mice was 7500 mg/kg bw per day, the highest dose tested (Hogan & Knezevich,1982a). (b) Rats In a long-term rat study, groups of animals (25/sex) were fed diets containing 0%, 0.1% or 0.2% of D&C Yellow No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =250 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4654d01cca5490b5; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL for these two related studies was 0.5% in the diet (equivalent to 250 mg/kg bw per day).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =150 mg/kg bw/day Dog - 2-year Chronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=fbdaac9d04712371; raw_unit=mg/kg bw per day; context=No treatment-related effects were noted in a 2-year study in dogs (Anonymous, 1967b), and the Committee concluded that the NOAEL for this study was 0.2% (equivalent to 150 mg/kg bw per day), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =400 mg/kg bw/day Rat oral 13-week Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=82ba9b8a7ce223c7; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA The NOAEL of deodorized ethanolic extract of rosemary was 5000 mg/ kg diet (equivalent to 400 mg/kg bw per day or 40 mg/kg bw per day carnosol + carnosic acid) in rats, the highest dietary concentration tested (Nestlé Research Center, 2005a). (c) Rosemary extract (deodorized ethanol) In a 13-week study, groups of Sprague Dawley OFA rats (10 animals/sex per group, n =
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =180 mg/kg bw/day Rat oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=2917d847ac1ae37a; raw_unit=mg/kg bw per day; context=The NOAEL of dietary supercritical carbon dioxide extract of rosemary was 2400 mg/kg diet (equal to 180 mg/kg bw per day or 59 mg/kg bw per day carnosol + carnosic acid) in rats, the highest concentration tested (Covance Laboratories Ltd, 2000b).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =195 mg/kg bw/day Rat oral 13-week Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=537e0e53c1542ba7; raw_unit=mg/kg bw per day; context=The NOAEL of a supercritical carbon dioxide extract of rosemary was 2400 mg/kg diet (equal to 195 mg/kg bw per day or 64 mg/kg bw per day carnosol + carnosic acid) in rats, the highest dietary concentration tested (Covance Laboratories Ltd, 2002a). (e) Rosemary extract (hexane plus ethanol) In a 13-week study with a 4-week treatment-free recovery period, groups of Sprague
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =315 mg/kg bw/day - oral 13 weeks Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=09fafa65df775c3d; raw_unit=mg/kg bw per day; context=153 Rosemary extract Following 13 weeks of dietary exposure, the NOAEL of a hexane plus ethanol extract of rosemary was 5000 mg/kg diet (equal to 315 mg/kg bw per day or 47 mg/kg bw per day carnosol + carnosic acid), the highest dietary concentration tested (Nestlé Research Center, 2005b).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =300 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=bb2f3c9f15dfffab; raw_unit=mg/kg bw per day; context=The marginal statistically significant increase in AST and non-dose-dependent decrease in total serum protein and relative liver weight increase observed only in mid-dose males, 300 mg/kg bw per day may be considered a NOAEL; however, in the absence of confirmatory liver histopathology results for these mid-dose animals, the NOAEL for the systemic toxicity of carnosic acid was considered to be 150 mg/kg bw per day, the lowest dose tested (Wang et al., 2012).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =64 mg/kg bw/day - - 90-day Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=fe0d858f9de16710; raw_unit=mg/kg bw per day; context=The highest NOAEL expressed as carnosic acid plus carnosol in the 90-day studies was 64 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2000 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=09813eee6762986f; raw_unit=mg/kg bw per day; context=The no-observed-adverse-effect level for male and female rats was 2000 mg/kg bw per day for ferm-Reb A, the highest dose tested, or at least 660 mg of steviol equivalent/kg bw per day (Rumelhard et al., 2016).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =750 mg/kg bw/day Rat oral chronic Chronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ad7d021f68d57752; raw_unit=mg/kg bw per day; context=eighth meeting in 1964 (Annex 1, reference 8), when an acceptable daily intake (ADI) of 0-7.5 mg/kg body weight (bw) was established, based on a no-observed- adverse-effect level (NOAEL) equivalent to 750 mg/kg bw per day, derived from a chronic toxicity study in rats (as cited in Scientific Committee for Food, 1983, as the JECFA monograph for the eighth meeting is no longer available).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2662 mg/kg bw/day Rat oral 104-week Carcinogenicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=129e899378eb0961; raw_unit=mg/kg bw per day; context=The Committee considered that the changes in body weights and food consumption at 5% tartrazine in the diet were relevant and concluded that the NOAEL for this 104-week carcinogenicity study was 1.5% in the diet (equal to 2173 or 2662 mg/kg bw per day in males and females, respectively). (b) Rats Tartrazine was tested for chronic toxicity in Charles River CD rats in two concurrent studies conducted in the same laboratory.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =984 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=cb28621809db1565; raw_unit=mg/kg bw per day; context=However, the Committee considered the body-weight changes in the 5% group to be significant and determined that the NOAEL should be based on results from the 2% group (equal to 984 mg/kg bw per day for male rats and 1225 mg/kg bw per day for female rats).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =3348 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=909a97237eb6e6fa; raw_unit=mg/kg bw per day; context=The NOAEL was 2641 and 3348 mg/kg bw per day for male and female rats, respectively (Borzelleca & Hallagan, 1988b).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =2173 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=678172f306318717; raw_unit=mg/kg bw per day; context=Although the authors considered the NOAEL to be the highest dose tested, the Committee concluded that 1.5% in the diet, equal to 2173 mg/kg bw per day, was the NOAEL for this study, on the basis of a body-weight reduction concurrent with an increase in feed consumption at the higher dose in males.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =375 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7792e014fad7f971; raw_unit=mg/kg bw per day; context=The NOAEL of xanthan gum in neonate piglets was 375 mg/kg bw per day based on the decreased tolerability at 3750 mg/kg bw per day resulting in suboptimal body-weight gain, significant increases in absolute and relative weights of the large intestine (caecum and colon), microscopic findings in the large and small intestine and
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =500 mg/kg bw/day Rat oral - Reproductive toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=6616c34d44d50826; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA Based on the results of this study, the NOAEL for reproductive toxicity of xanthan gum in male and female albino rats was 500 mg/kg bw per day, the highest dose tested (Woodard et al., 1973).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =3301 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=0cbc12b135c4706a; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA a NOAEL of 3301 mg/kg bw per day, the highest dose tested (Hagiwara et al., 2004).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =220 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=aeb9b737eb26aa75; raw_unit=mg/kg bw per day; context=The margin of exposure based on this NOAEL and the conservative estimate of xanthan gum intake of 220 mg/kg bw per day by infants (high energy requirements for fully formula-fed infants) is 3.4.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3bae2407e412fa9e; raw_unit=mg/kg bw per day; context=2223), the no-observed-adverse-affect level (NOAEL)1 of 1 mg/kg bw per day for the structurally related dehydromenthofurolactone (No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =140 mg/kg bw/day Rat oral 28-day Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=518da6b9fd7eda4f; raw_unit=mg/kg bw per day; context=2225 is non-genotoxic in bacte- ria, and the NOAEL of 140 mg/kg bw per day (the highest dose tested) in a 28-day study in rats (Craig, 2011a) is 4 200 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =100 mg/kg bw/day Rat oral 28-day Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=aefbc96bf7780c27; raw_unit=mg/kg bw per day; context=2226 is non-genotoxic in bacteria and in mammalian cells in vitro and in vivo, and the NOAEL of 100 mg/kg bw per day (the highest dose tested) in a 28-day study in rats (Craig, 2011b) is 7 700 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =69 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=409437cbe2a1f656; raw_unit=mg/kg bw per day; context=1777) are non-genotoxic in bacteria, and the NOAEL of 69 mg/kg bw per day for No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =490 mg/kg bw/day Rat oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5b953a563aa1dfc7; raw_unit=mg/kg bw per day; context=2228 is non-genotoxic in bacteria, and the NOAEL of 490 mg/kg bw per day (the highest dose tested) in a 90-day study in rats (Koetzner, 2013a) is 245 000 times the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =8 mg/kg bw/day Rat - 28-day Acute toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=f7765f32e8420ec3; raw_unit=mg/kg bw per day; context=This compound is of low acute toxicity, and from four short-term toxicity studies available, the overall NOAEL of 8 mg/kg bw per day in a 28-day study in rats (Miyata, 1995) is 32 times the SPET estimate and 40 million times the MSDI when No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =40 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=d58d5c83cd42411d; raw_unit=mg/kg bw per day; context=Although the study author proposed that the findings in the liver were an adaptive response to increased metabolic demand at higher concentrations, a NOAEL of 40 mg/kg bw per day was identified for cyclopropanecarboxylic acid (2-isopropyl-5-methyl-cyclohexyl)-amide (No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =23 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=93bfbaac7ae3aada; raw_unit=mg/kg bw per day; context=A NOAEL of 360 mg/kg feed, equal to 23 mg/kg bw per day in males and 28 mg/kg bw per day in females, was identified for (2E,6E/Z,8E)-N-(2- methylpropyl)-2,6,8-decatrienamide (No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =275 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=d314353b7a9ad6c0; raw_unit=mg/kg bw per day; context=2215), the NOAEL of 275 mg/kg bw per day for the structurally related substance cinnamaldehyde (No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =25 mg/kg bw/day Rat - - Reproductive toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=9bfaa27fab31815a; raw_unit=mg/kg bw per day; context=The NOAEL of 25 mg/kg bw per day from the rat reproductive toxicity study (Lewis, 2013) provides an adequate MOE of 15 million in relation to the MSDI of 0.1 ug/day.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =4 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=38712ef3781f456e; raw_unit=mg/kg bw per day; context=656) in this study, the NOAEL was 4 mg/kg bw per day, the highest dose tested (Lin et al., 2011).
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =75 mg/kg bw/day - oral 14-day Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=13f289c28ed9218d; raw_unit=mg/kg bw per day; context=Based on reduced body-weight gain and feed consumption at 250 mg/kg bw per day, the NOAEL for systemic toxicity in this 14-day study was considered to be 75 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =15 mg/kg bw/day Rat oral - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=deed69647af180e2; raw_unit=mg/kg bw per day; context=The NOAEL of 15 mg/kg bw per day in a 90- day toxicity study in rats (Bauter, 2015a) provides an adequate MOE of 1500 in relation to the estimated dietary exposure to No.
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =50 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b3bd7c25bf9ef228; raw_unit=mg/kg bw per day; context=The NOAEL was 50 mg/kg bw per day, based on decreased body weight and spleen toxicity observed at 150 mg/kg bw per day (Hirata-Koizumi et al., 2008;
INCHEM_WHO_jecfa_jecmono_v73je01 NOAEL =1832 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=14e3105183c65729; raw_unit=mg/kg bw per day; context=In the absence of any treatment-related adverse effects, the NOAEL was 1832 mg/kg bw per day, the highest dose tested (Moran, 1980). (c) Genotoxicity studies Results of studies of genotoxicity for tetrahydrofuran and furanone derivatives used as flavouring agents are summarized in Table 5 and described below. (i) In vitro 2,5-Dimethyl-3(2H)-furanone
INCHEM_WHO_jecfa_jecmono_v73je01 NOEL =500 mg/kg bw/day Rat oral long-term Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4e4886708b5e3ffe; raw_unit=mg/kg bw per day; context=At its thirteenth meeting, the Committee established a temporary acceptable daily intake (ADI) of 0-1 mg/kg body weight (bw), based on a no- observed-effect level (NOEL) of 500 mg/kg bw per day in a long-term feeding study in rats.
INCHEM_WHO_jecfa_jecmono_v73je01 NOEL =150 mg/kg bw/day - oral 2 years Carcinogenicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=041996915f142105; raw_unit=mg/kg bw per day; context=The NOEL for D&C Yellow No.10 over 2 years was 0.2% in the diet, the highest dose tested (equivalent to 150 mg/kg bw per day). (c) Long-term studies of toxicity and carcinogenicity of unconfirmed test substances There were no long-term studies in which the test substance was unconfirmed.
INCHEM_WHO_jecfa_jecmono_v73je01 NOEL =970 mg/kg bw/day Rat oral 2-year Chronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=c4f2afdd150a201b; raw_unit=mg/kg bw per day; context=temporary acceptable daily intake (ADI) of 0-2 mg/kg body weight (bw) for steviol glycosides, expressed as steviol, was established on the basis of the no-observed-effect levels (NOEL) of 2.5% stevioside in the diet, equal to 970 mg/kg bw per day, or 383 mg/kg bw per day expressed as steviol, in a 2-year study in rats and the application of an uncertainty factor of 200.
INCHEM_WHO_jecfa_jecmono_v73je01 NOEL =2153 mg/kg bw/day Mouse - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=f38f9996ef1ab8e3; raw_unit=mg/kg bw per day; context=The NOEL for stevioside in mice was 2153 mg/kg bw per day (Lee et al., 2012).
INCHEM_WHO_jecfa_jecmono_v73je01 NOEL =500 mg/kg bw/day Rat oral long-term Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4e4886708b5e3ffe; raw_unit=mg/kg bw per day; context=At its thirteenth meeting, the Committee established a temporary acceptable daily intake (ADI) of 0-1 mg/kg body weight (bw), based on a no- observed-effect level (NOEL) of 500 mg/kg bw per day in a long-term feeding study in rats.
INCHEM_WHO_jecfa_jecmono_v73je01 NOEL =150 mg/kg bw/day - oral 2 years Carcinogenicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=041996915f142105; raw_unit=mg/kg bw per day; context=The NOEL for D&C Yellow No.10 over 2 years was 0.2% in the diet, the highest dose tested (equivalent to 150 mg/kg bw per day). (c) Long-term studies of toxicity and carcinogenicity of unconfirmed test substances There were no long-term studies in which the test substance was unconfirmed.
INCHEM_WHO_jecfa_jecmono_v73je01 NOEL =970 mg/kg bw/day Rat oral 2-year Chronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=c4f2afdd150a201b; raw_unit=mg/kg bw per day; context=temporary acceptable daily intake (ADI) of 0-2 mg/kg body weight (bw) for steviol glycosides, expressed as steviol, was established on the basis of the no-observed-effect levels (NOEL) of 2.5% stevioside in the diet, equal to 970 mg/kg bw per day, or 383 mg/kg bw per day expressed as steviol, in a 2-year study in rats and the application of an uncertainty factor of 200.
INCHEM_WHO_jecfa_jecmono_v73je01 NOEL =2153 mg/kg bw/day Mouse - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=f38f9996ef1ab8e3; raw_unit=mg/kg bw per day; context=The NOEL for stevioside in mice was 2153 mg/kg bw per day (Lee et al., 2012).
INCHEM_WHO_jecfa_jecmono_v73je01 NOEL =500 mg/kg bw/day Rat oral long-term Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4e4886708b5e3ffe; raw_unit=mg/kg bw per day; context=At its thirteenth meeting, the Committee established a temporary acceptable daily intake (ADI) of 0-1 mg/kg body weight (bw), based on a no- observed-effect level (NOEL) of 500 mg/kg bw per day in a long-term feeding study in rats.
INCHEM_WHO_jecfa_jecmono_v73je01 NOEL =150 mg/kg bw/day - oral 2 years Carcinogenicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=041996915f142105; raw_unit=mg/kg bw per day; context=The NOEL for D&C Yellow No.10 over 2 years was 0.2% in the diet, the highest dose tested (equivalent to 150 mg/kg bw per day). (c) Long-term studies of toxicity and carcinogenicity of unconfirmed test substances There were no long-term studies in which the test substance was unconfirmed.
INCHEM_WHO_jecfa_jecmono_v73je01 NOEL =970 mg/kg bw/day Rat oral 2-year Chronic toxicity document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=c4f2afdd150a201b; raw_unit=mg/kg bw per day; context=temporary acceptable daily intake (ADI) of 0-2 mg/kg body weight (bw) for steviol glycosides, expressed as steviol, was established on the basis of the no-observed-effect levels (NOEL) of 2.5% stevioside in the diet, equal to 970 mg/kg bw per day, or 383 mg/kg bw per day expressed as steviol, in a 2-year study in rats and the application of an uncertainty factor of 200.
INCHEM_WHO_jecfa_jecmono_v73je01 NOEL =2153 mg/kg bw/day Mouse - - Toxicology study document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=f38f9996ef1ab8e3; raw_unit=mg/kg bw per day; context=The NOEL for stevioside in mice was 2153 mg/kg bw per day (Lee et al., 2012).
NTP_ICE_acute_oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 =13000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_11324; row=8529; data_type=In Vivo; mixture=Chemical; chemical_name=Locust bean gum; preferred_name=Locust bean gum; dtxsid=DTXSID5020780; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5020780; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID5020780; source_file=acute_oral.xlsx
NTP_ICE_cancer 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_cancer Top dose 50000 ppm Rat Dosed feed - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=5533; Record_ID=cancer_4752; Data_Type=In Vivo; Formulation_Name=Locust bean gum; Mixture=Chemical; DTXSID=DTXSID5020780; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=50000; Response_Unit=ppm; Species=Rat; Strain=F344/N; Sex=Female; Route=Dosed feed; Reference=TR-221; URL=https://ntp.niehs.nih.gov/publications/reports/tr/200s/tr221/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5020780; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID5020780
ToxValDB_EFSA 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL =7500 mg/kg bw/day Mouse oral chronic; 103 weeks chronic LONG_REF=EFSA ANS (2017). Re-evaluation of locust bean gum (E 410) as a food additive. doi:10.2903/j.efsa.2017.4646.; TITLE=Re-evaluation of locust bean gum (E 410) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2017.4646; 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:15624960: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_b56c84cc877d034b2b977fd4547ec4be
ToxValDB_EFSA NOAEL =2500 mg/kg bw/day Rat oral chronic; 103 weeks chronic LONG_REF=EFSA ANS (2017). Re-evaluation of locust bean gum (E 410) as a food additive. doi:10.2903/j.efsa.2017.4646.; TITLE=Re-evaluation of locust bean gum (E 410) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2017.4646; 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:15624961: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_c9ab3cea38bc29b45c6933fed38781db
ToxValDB_EFSA NOAEL =20000 mg/kg bw/day Mouse oral subchronic; 90 days subchronic LONG_REF=EFSA ANS (2017). Re-evaluation of locust bean gum (E 410) as a food additive. doi:10.2903/j.efsa.2017.4646.; TITLE=Re-evaluation of locust bean gum (E 410) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2017.4646; 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:15624962: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_1343eb43bd00d7ea57216c42e5d8e879
ToxValDB_EFSA NOAEL =9000 mg/kg bw/day Rat oral subchronic; 90 days subchronic LONG_REF=EFSA ANS (2017). Re-evaluation of locust bean gum (E 410) as a food additive. doi:10.2903/j.efsa.2017.4646.; TITLE=Re-evaluation of locust bean gum (E 410) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2017.4646; 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:15624963: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_637e3969ebf2cbf7f349d727a114e3db
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier V4716MY704 UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"V4716MY704"}
openFDA substances FDA UNII substance identifier V4716MY704 UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"V4716MY704"}
openFDA substances FDA UNII substance identifier V4716MY704 UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"V4716MY704"}
openFDA substances FDA UNII substance identifier V4716MY704 UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"V4716MY704"}