NOAEL Studies Cosmetic Ingredient

Beta-Carotene NOAEL Studies

INCI: BETA-CAROTENE

CAS: 7235-40-7

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

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EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =6.5 g/kg bw/day Rat - 90 days subchronic EFSA NDA - 2021 - OutputID 4059 - urinalysis - systemic - Safety of Wolffia globosa powder as a Novel food pursuant to Regulation (EU) 2015/2283 - doi:10.2903/j.efsa.2021.6938
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =6.5 g/kg bw/day Rat - 90 days subchronic EFSA NDA - 2021 - OutputID 4059 - urinalysis - systemic - Safety of Wolffia globosa powder as a Novel food pursuant to Regulation (EU) 2015/2283 - doi:10.2903/j.efsa.2021.6938
INCHEM_WHO_jecfa_jecmono_v1020je01 42 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI range:0-0.20.2 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=90be7706a3e5005b; raw_unit=mg/kg bw; context=An “unconditional” ADI of 0-0.2 mg/kg bw for 2-phenylphenol was first established by JECFA at its eighth meeting in 1964.
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI range:0-44 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=3a9aeb04d05dc10d; raw_unit=mg/kg bw; context=The Committee indicated that the ADI of 0-4 mg/kg bw established at the sixty-ninth meeting of JECFA for steviol glycosides (expressed as steviol) (Annex 1, reference 190) applies to steviol glycosides produced by the four methods indicated in the annexes of the specifications monograph produced at the current
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI range:0-2.52.5 mg/kg bw/day Rat dermal two-generation Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=473292ab8cd47238; raw_unit=mg/kg bw; context=At that meeting, the Committee established an ADI for anthocyanins in grape skin extract of 0-2.5 mg/kg bw, based on a NOAEL of 225 mg/kg bw per day expressed as anthocyanins from a two-generation reproductive toxicity study in rats [1].
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI range:0-11 mg/kg bw/day Pig - - Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=9a8cf87872429673; raw_unit=mg/kg bw; context=Therefore, the Committee established a new ADI of 0-1 mg/kg bw on the basis of the no-effect level of 100 mg/kg bw per day in the pig study.
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=a5ce708f8b9c4a49; raw_unit=mg/kg bw; context=A group ADI of 0-5 mg/kg bw for β-carotene, β-apo-8′-carotenal and β-apo-8′-carotenoic acid methyl and ethyl esters was first established at the tenth JECFA meeting (Annex 1, reference 13).
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI range:0-0.30.3 mg/kg bw/day Rat oral 13-week Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=cc1fe78e23bca4ec; raw_unit=mg/kg bw; context=1020, 2019 Joint FAO/WHO Expert Committee on Food Additives Eighty-seventh report The present Committee established an ADI of 0-0.3 mg/kg bw for β-apo- 8′-carotenal on the basis of a NOAEL of 30 mg/kg bw per day in a 13-week study in rats and application of an uncertainty factor of 100.
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI =0.28 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=b7344b819e590cb0; raw_unit=mg/kg bw per day; context=Estimated dietary exposure to β-apo-8′-carotenal of 0.28 mg/kg bw per day was at the upper end of the ADI established by the Committee (i.e.
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI range:0-0.20.2 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=90be7706a3e5005b; raw_unit=mg/kg bw; context=An “unconditional” ADI of 0-0.2 mg/kg bw for 2-phenylphenol was first established by JECFA at its eighth meeting in 1964.
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI range:0-44 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=3a9aeb04d05dc10d; raw_unit=mg/kg bw; context=The Committee indicated that the ADI of 0-4 mg/kg bw established at the sixty-ninth meeting of JECFA for steviol glycosides (expressed as steviol) (Annex 1, reference 190) applies to steviol glycosides produced by the four methods indicated in the annexes of the specifications monograph produced at the current
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI range:0-2.52.5 mg/kg bw/day Rat dermal two-generation Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=473292ab8cd47238; raw_unit=mg/kg bw; context=At that meeting, the Committee established an ADI for anthocyanins in grape skin extract of 0-2.5 mg/kg bw, based on a NOAEL of 225 mg/kg bw per day expressed as anthocyanins from a two-generation reproductive toxicity study in rats [1].
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI range:0-11 mg/kg bw/day Pig - - Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=9a8cf87872429673; raw_unit=mg/kg bw; context=Therefore, the Committee established a new ADI of 0-1 mg/kg bw on the basis of the no-effect level of 100 mg/kg bw per day in the pig study.
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=a5ce708f8b9c4a49; raw_unit=mg/kg bw; context=A group ADI of 0-5 mg/kg bw for β-carotene, β-apo-8′-carotenal and β-apo-8′-carotenoic acid methyl and ethyl esters was first established at the tenth JECFA meeting (Annex 1, reference 13).
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI range:0-0.30.3 mg/kg bw/day Rat oral 13-week Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=cc1fe78e23bca4ec; raw_unit=mg/kg bw; context=1020, 2019 Joint FAO/WHO Expert Committee on Food Additives Eighty-seventh report The present Committee established an ADI of 0-0.3 mg/kg bw for β-apo- 8′-carotenal on the basis of a NOAEL of 30 mg/kg bw per day in a 13-week study in rats and application of an uncertainty factor of 100.
INCHEM_WHO_jecfa_jecmono_v1020je01 ADI =0.28 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=b7344b819e590cb0; raw_unit=mg/kg bw per day; context=Estimated dietary exposure to β-apo-8′-carotenal of 0.28 mg/kg bw per day was at the upper end of the ADI established by the Committee (i.e.
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =225 mg/kg bw/day Rat dermal two-generation Reproductive toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=f947db6d2033c963; raw_unit=mg/kg bw per day; context=At that meeting, the Committee established an ADI for anthocyanins in grape skin extract of 0-2.5 mg/kg bw, based on a NOAEL of 225 mg/kg bw per day expressed as anthocyanins from a two-generation reproductive toxicity study in rats [1].
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =14 mg/kg bw/day - dermal - Dermal toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=240631497af52ed8; raw_unit=mg/kg bw per day; context=A NOAEL of 14 mg/kg bw per day expressed as anthocyanin (10 000 mg/kg feed expressed as grape skin extract, equal to 700 mg/kg bw per day) was identified [21].
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =249 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=b0fafc7b3d5946e9; raw_unit=mg/kg bw per day; context=oncluded that the NOAEL was the highest dose tested, the Committee was of the opinion that the effects observed at 50 000 mg/kg feed were toxicologically relevant and identified a NOAEL of 15 000 mg/kg feed (equal to 249 mg/kg bw per day).
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =500 mg/kg bw/day Rat - chronic Chronic toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=b760c61382b90153; raw_unit=mg/kg bw per day; context=JECFA first evaluated Brilliant Black PN at its eighteenth meeting (Annex 1, reference 35) and established a temporary ADI of 0-2.5 mg/kg bw, based on a NOAEL of 500 mg/kg bw per day obtained from a chronic rat study.
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =100 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=6921140064a5fa88; raw_unit=mg/kg bw per day; context=The NOAEL in this study was 100 mg/kg bw per day [12].
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =50 mg/kg bw/day Human; Rat oral - Reproductive toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=a8774ea260ed2721; raw_unit=mg/kg bw per day; context=The group ADI was derived using a four- generation study in rats with a NOAEL for β-carotene of 50 mg/kg bw per day and application of an uncertainty factor of 10 because of the natural occurrence of provitamin A carotenoids in the human diet and the low toxicity observed in animal studies. β-Carotenes from natural sources were reviewed at the thirty-first, thirty- fifth a
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =30 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=91fe67c2d71c8a26; raw_unit=mg/kg bw per day; context=The Committee identified a NOAEL of 30 mg/kg bw per day, on the basis of increased liver weight, serum ALT and AST activities and incidence of inflammatory cell foci in the liver of high-dose female rats and evidence of tubular injury in the kidney of high-dose males and females.
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =495 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=8ff3c0fd16732a86; raw_unit=mg/kg bw per day; context=The NOAEL for maternal toxicity and for embryo and fetal toxicity was 495 mg/kg bw per day, the highest dose tested [53].
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =3520 mg/kg bw/day - oral - Reproductive toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=26772bebd7c14cf5; raw_unit=mg/kg bw per day; context=The NOAEL for parental, reproductive and offspring toxicity was 50 000 mg/kg feed (equal to 3520 mg/kg bw per day), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =205 mg/L - - - Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=1d4a16f64c41b8b7; raw_unit=mg/L; context=The NOAEL for gellan gum was 205 mg/L (equal to 100 mg/kg bw per day), the highest dose tested [18].
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =13 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=6b21f8e6bcf7cab9; raw_unit=mg/kg bw per day; context=Based on this NOAEL and the high estimate of dietary exposure of infants to gellan gum of 13 mg/kg bw per day (based on the requested maximum concentration of gellan gum of 50 mg/L and the high level of consumption of infant formula of 260 mL/kg bw per day), an MOE of 7.7 was calculated.
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=4befb8c6c51132fc; raw_unit=mg/kg bw per day; context=The NOAEL was 1000 mg/kg bw per day, the highest dose tested [6, 7].
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =64 mg/kg bw/day Rat - short-term Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=921a094640645180; raw_unit=mg/kg bw per day; context=This ADI was based on a NOAEL of 64 mg/kg bw per day, the highest dose tested in a short-term toxicity study in rats.
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =316 mg/kg bw/day - oral - Reproductive toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=72f2673b36687648; raw_unit=mg/kg bw per day; context=A NOAEL of 5000 mg/kg feed (equal to 316 mg/kg bw per day), the highest dose tested, was identified for reproductive and parental toxicity.
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =225 mg/kg bw/day Rat dermal two-generation Reproductive toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=f947db6d2033c963; raw_unit=mg/kg bw per day; context=At that meeting, the Committee established an ADI for anthocyanins in grape skin extract of 0-2.5 mg/kg bw, based on a NOAEL of 225 mg/kg bw per day expressed as anthocyanins from a two-generation reproductive toxicity study in rats [1].
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =14 mg/kg bw/day - dermal - Dermal toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=240631497af52ed8; raw_unit=mg/kg bw per day; context=A NOAEL of 14 mg/kg bw per day expressed as anthocyanin (10 000 mg/kg feed expressed as grape skin extract, equal to 700 mg/kg bw per day) was identified [21].
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =249 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=b0fafc7b3d5946e9; raw_unit=mg/kg bw per day; context=oncluded that the NOAEL was the highest dose tested, the Committee was of the opinion that the effects observed at 50 000 mg/kg feed were toxicologically relevant and identified a NOAEL of 15 000 mg/kg feed (equal to 249 mg/kg bw per day).
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =500 mg/kg bw/day Rat - chronic Chronic toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=b760c61382b90153; raw_unit=mg/kg bw per day; context=JECFA first evaluated Brilliant Black PN at its eighteenth meeting (Annex 1, reference 35) and established a temporary ADI of 0-2.5 mg/kg bw, based on a NOAEL of 500 mg/kg bw per day obtained from a chronic rat study.
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =100 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=6921140064a5fa88; raw_unit=mg/kg bw per day; context=The NOAEL in this study was 100 mg/kg bw per day [12].
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =50 mg/kg bw/day Human; Rat oral - Reproductive toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=a8774ea260ed2721; raw_unit=mg/kg bw per day; context=The group ADI was derived using a four- generation study in rats with a NOAEL for β-carotene of 50 mg/kg bw per day and application of an uncertainty factor of 10 because of the natural occurrence of provitamin A carotenoids in the human diet and the low toxicity observed in animal studies. β-Carotenes from natural sources were reviewed at the thirty-first, thirty- fifth a
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =30 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=91fe67c2d71c8a26; raw_unit=mg/kg bw per day; context=The Committee identified a NOAEL of 30 mg/kg bw per day, on the basis of increased liver weight, serum ALT and AST activities and incidence of inflammatory cell foci in the liver of high-dose female rats and evidence of tubular injury in the kidney of high-dose males and females.
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =495 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=8ff3c0fd16732a86; raw_unit=mg/kg bw per day; context=The NOAEL for maternal toxicity and for embryo and fetal toxicity was 495 mg/kg bw per day, the highest dose tested [53].
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =3520 mg/kg bw/day - oral - Reproductive toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=26772bebd7c14cf5; raw_unit=mg/kg bw per day; context=The NOAEL for parental, reproductive and offspring toxicity was 50 000 mg/kg feed (equal to 3520 mg/kg bw per day), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =205 mg/L - - - Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=1d4a16f64c41b8b7; raw_unit=mg/L; context=The NOAEL for gellan gum was 205 mg/L (equal to 100 mg/kg bw per day), the highest dose tested [18].
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =13 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=6b21f8e6bcf7cab9; raw_unit=mg/kg bw per day; context=Based on this NOAEL and the high estimate of dietary exposure of infants to gellan gum of 13 mg/kg bw per day (based on the requested maximum concentration of gellan gum of 50 mg/L and the high level of consumption of infant formula of 260 mL/kg bw per day), an MOE of 7.7 was calculated.
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=4befb8c6c51132fc; raw_unit=mg/kg bw per day; context=The NOAEL was 1000 mg/kg bw per day, the highest dose tested [6, 7].
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =64 mg/kg bw/day Rat - short-term Toxicology study document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=921a094640645180; raw_unit=mg/kg bw per day; context=This ADI was based on a NOAEL of 64 mg/kg bw per day, the highest dose tested in a short-term toxicity study in rats.
INCHEM_WHO_jecfa_jecmono_v1020je01 NOAEL =316 mg/kg bw/day - oral - Reproductive toxicity document_id=jecfa_jecmono_v1020je01; 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-seventh report of the Joint FAO/WHO Expert Committee on Food Additiv; path=mirror/documents/jecfa/jecmono/v1020je01.pdf; row_hash=72f2673b36687648; raw_unit=mg/kg bw per day; context=A NOAEL of 5000 mg/kg feed (equal to 316 mg/kg bw per day), the highest dose tested, was identified for reproductive and parental toxicity.
INCHEM_WHO_jecfa_jecmono_v78je01 62 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_jecfa_jecmono_v78je01 ADI range:0-2.52.5 mg/kg bw/day - dermal - Health guidance value document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=c98ba2f3e59ee2fe; raw_unit=mg/kg bw; context=The 1982 JECFA ADI of 0-2.5 mg/kg bw anthocyanins from grape skin extract was based on this study, with the intake of 225 mg/kg bw per day divided by an uncertainty factor of 100 and rounded up to 2.5 mg/kg bw per day. (b) Developmental toxicity The anthocyanin glycosides (an extract from curran
INCHEM_WHO_jecfa_jecmono_v78je01 ADI range:0-11 mg/kg bw/day Pig - - Health guidance value document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=ef8fc659c38bb539; raw_unit=mg/kg bw; context=Therefore, the Committee established a new ADI of 0-1 mg/kg bw on the basis of the no-effect level of 100 mg/kg bw per day in the pig study.
INCHEM_WHO_jecfa_jecmono_v78je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=3046a613adbac129; raw_unit=mg/kg bw; context=At the thirty-first meeting, the Committee concluded that the group ADI of 0-5 mg/kg bw established for the sum of the synthetic carotenoids β-carotene, β-apo-8′-carotenal and β-apo-8′-carotenoic acid methyl and ethyl esters by the eighteenth Committee was not applicable to natural carotenes as they did not comply with the specifications for β-c
INCHEM_WHO_jecfa_jecmono_v78je01 ADI range:0-0.30.3 mg/kg bw/day Rat - 13-week Health guidance value document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=80dfadfc82bc5d95; raw_unit=mg/kg bw; context=The present Committee established an ADI of 0-0.3 mg/kg bw for β-apo- 8′-carotenal on the basis of a NOAEL of 30 mg/kg bw per day in a 13-week study in rats and application of an uncertainty factor of 100.
INCHEM_WHO_jecfa_jecmono_v78je01 ADI =0.28 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=0d3c7b66edc533bd; raw_unit=mg/kg bw per day; context=78, 2020 Estimated dietary exposure to β-apo-8′-carotenal of 0.28 mg/kg bw per day was at the upper end of the ADI established by the Committee (i.e.
INCHEM_WHO_jecfa_jecmono_v78je01 ADI range:0-2.52.5 mg/kg bw/day - dermal - Health guidance value document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=c98ba2f3e59ee2fe; raw_unit=mg/kg bw; context=The 1982 JECFA ADI of 0-2.5 mg/kg bw anthocyanins from grape skin extract was based on this study, with the intake of 225 mg/kg bw per day divided by an uncertainty factor of 100 and rounded up to 2.5 mg/kg bw per day. (b) Developmental toxicity The anthocyanin glycosides (an extract from curran
INCHEM_WHO_jecfa_jecmono_v78je01 ADI range:0-11 mg/kg bw/day Pig - - Health guidance value document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=ef8fc659c38bb539; raw_unit=mg/kg bw; context=Therefore, the Committee established a new ADI of 0-1 mg/kg bw on the basis of the no-effect level of 100 mg/kg bw per day in the pig study.
INCHEM_WHO_jecfa_jecmono_v78je01 ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=3046a613adbac129; raw_unit=mg/kg bw; context=At the thirty-first meeting, the Committee concluded that the group ADI of 0-5 mg/kg bw established for the sum of the synthetic carotenoids β-carotene, β-apo-8′-carotenal and β-apo-8′-carotenoic acid methyl and ethyl esters by the eighteenth Committee was not applicable to natural carotenes as they did not comply with the specifications for β-c
INCHEM_WHO_jecfa_jecmono_v78je01 ADI range:0-0.30.3 mg/kg bw/day Rat - 13-week Health guidance value document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=80dfadfc82bc5d95; raw_unit=mg/kg bw; context=The present Committee established an ADI of 0-0.3 mg/kg bw for β-apo- 8′-carotenal on the basis of a NOAEL of 30 mg/kg bw per day in a 13-week study in rats and application of an uncertainty factor of 100.
INCHEM_WHO_jecfa_jecmono_v78je01 ADI =0.28 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=0d3c7b66edc533bd; raw_unit=mg/kg bw per day; context=78, 2020 Estimated dietary exposure to β-apo-8′-carotenal of 0.28 mg/kg bw per day was at the upper end of the ADI established by the Committee (i.e.
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =10000 mg/kg diet Rat oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=dab3ce66f0ceb353; raw_unit=g/kg feed; unit_normalization=converted from grams; context=Owing to the effects observed in the parotid gland and in the kidneys of female rats, the NOAEL was 10 g/kg feed (equal to anthocyanin doses of 12 and 14 mg/kg bw per day for males and females, respectively) (Inoue et al., 2013).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =50000 mg/kg diet - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=bfd31849c5e1e374; raw_unit=g/kg feed; unit_normalization=converted from grams; context=The authors concluded that the NOAEL for this study was the top dose tested, 50 g/kg feed (Nabae et al., 2008).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =15000 mg/kg diet - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=9fcb75369ebe9f2d; raw_unit=g/ kg feed; unit_normalization=converted from grams; context=cal and clinical chemistry parameters, decreased relative liver and thymus weights and increased pituitary weights in males and increased salivary gland weights in both sexes, the NOAEL was 15 g/ kg feed (equal to 942 mg/kg bw per day for males and 1031 mg/kg bw per day for females, expressed as the purple corn colour material; equivalent to 249 mg/ kg bw per day for males and 272 mg/kg bw per day for females, expressed as C3G).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =1409.8 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=d3b95a5346a48346; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 1409.8 mg/kg bw per day expressed as grape seed extract, the highest dose tested (Yamakoshi et al., 2002).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =14 mg/kg bw/day - dermal - Dermal toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=fb0629bca10e88b4; raw_unit=mg/kg bw per day; context=A NOAEL of 14 mg/kg bw per day expressed as anthocyanins (10 000 mg/kg feed expressed as grape skin extract, equal to 700 mg/kg bw per day) was identified (Inoue et al., 2013).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =249 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=43bf2675327e90b7; raw_unit=mg/kg bw per day; context=oncluded that the NOAEL was the highest dose tested, the Committee was of the opinion that the effects observed at 50 000 mg/kg feed were toxicologically relevant and identified a NOAEL of 15 000 mg/kg feed (equal to 249 mg/kg bw per day).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =225 mg/kg bw/day - dermal - Dermal toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=0a166308812fcde2; raw_unit=mg/kg bw per day; context=The NOAEL identified by the previous Committee for this grape skin extract preparation was 75 000 mg/kg feed (equivalent to 7500 mg/kg bw per day and estimated to be 225 mg/kg bw per day expressed as anthocyanins) (Cox & Babish, 1978a).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =100 mg/kg bw/day Pig - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=3bd6a1d3c5f2138c; raw_unit=mg/kg bw per day; context=They concluded that the NOAEL in pigs was 100 mg/kg bw per day (Gaunt et al., 1969).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL ~185.714285714286 mg/kg bw/day Rat - 365 days Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=d0cf827465c409cc; raw_unit=mg/kg bw per day; unit_normalization=converted from weekly dose; context=The authors concluded that the NOAEL in this study was approximately 1300 mg/kg bw per day, the highest dose tested (Drake et al., 1977). (b) Rats A group of 10 rats received 0.5 mL of a 1% solution (= 5 mg) of Brilliant Black PN twice weekly for 365 days and was observed for 653 days.
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =360 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=6c5393e8f9500ce6; raw_unit=mg/kg bw per day; context=In this study, the NOAEL was 10 000 mg/kg feed (equal to 360 mg/kg bw per day), the highest dose tested (Gaunt et al., 1972).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=39445422893254da; raw_unit=mg/kg bw per day; context=The NOAEL was 1000 mg/kg bw per day, the highest dose tested (ECHA, 2010a).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =3127 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=d92cd8deb1eb16d7; raw_unit=mg/kg bw per day; context=The NOAEL was 50 000 mg/kg feed (equal to 3127 mg/kg bw per day), the highest dietary concentration tested (Nabae et al., 2005).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =1013 mg/kg bw/day Rat - 6 weeks Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=b2e2efb2101d63be; raw_unit=mg/kg bw per day; context=The NOAEL in this study was 1013 mg/kg bw per day, the highest dose tested (Buser & Arceo, 1995). (b) β-Apo-8′-carotenal (i) Rats Groups of five male and five female Sprague Dawley rats (6 weeks of age) were administered β-apo-8′-carotenal (Apocarotenal 10% WS/N; β-apo-8′-carotenal at 116 g/kg, β-carotene at
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =10 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=726af187d0afae36; raw_unit=mg/kg bw per day; context=The study authors identified a NOAEL of 10 mg/kg bw per day on the basis of hepatic effects at 30 mg/kg bw per day (Edwards et al., 2007).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =30 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=19631be147c6dbdb; raw_unit=mg/kg bw per day; context=Accordingly, the NOAEL was considered to be 30 mg/kg bw per day, on the basis of an increased incidence of hepatic inflammatory cell foci in females at 100 mg/kg bw per day (Perry & Shearer, 2008).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =250 mg/kg bw/day Rat; Dog - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=f26f39add8dbe0b8; raw_unit=mg/kg bw per day; context=The Committee disagreed with the study authors’ conclusion and identified the NOAEL as the target dose of 250 mg/kg bw per day (equal to a mean achieved intake of 194 mg/ kg bw per day), based on consistently decreased body weight and body weight gain in male and female rats compared with placebo controls at 500 and 1000 mg/kg bw per day. (iii) Dogs In a GLP-compliant study, groups o
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =400 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=0be378ee5a794078; raw_unit=mg/kg bw per day; context=The NOAEL for embryo and fetal toxicity and for maternal toxicity was 400 mg/kg bw per day, the highest dose tested (Kistler, 1982).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =500 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=b74caefef504d2b0; raw_unit=mg/kg bw per day; context=The Committee considered the NOAEL for maternal toxicity and for embryo and fetal toxicity to be the target dose of 500 mg/kg bw per day (equal to a mean achieved dose of 495 mg/kg bw per day), the highest dose tested (Loget et al., 2006).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =495 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=f11070dfe96b7084; raw_unit=mg/kg bw per day; context=The NOAEL for maternal toxicity and for embryo and fetal toxicity was 495 mg/kg bw per day, the highest dose tested (Loget et al., 2006).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =205 mg/L - - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=917b64f085874070; raw_unit=mg/L; context=The NOAEL of gellan gum in this study was 205 mg/L (equal to 100 mg/ kg bw per day), the highest dose tested (Lanphear, 2016).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =3520 mg/kg bw/day - oral - Reproductive toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=4928080fcd0843df; raw_unit=mg/kg bw per day; context=The NOAEL for parental, reproductive and offspring toxicity was 50 000 mg/kg feed (equal to 3520 mg/kg bw per day), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =13 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=7d6c4d693284a404; raw_unit=mg/kg bw per day; context=Based on this NOAEL and the high estimate of dietary exposure of infants to gellan gum of 13 mg/kg bw per day (based on the requested maximum concentration of gellan gum of 50 mg/L and the high level of consumption of infant formula of 260 mL/kg bw per day), a margin of exposure (MOE) of 7.7 was calculated.
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =12500 mg/kg diet - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=25f18e8d2ac71706; raw_unit=g/kg feed; unit_normalization=converted from grams; context=The NOAEL was 12.5 g/kg feed (equal to 697 mg/kg bw per day for males and 715 mg/kg bw per day for females) (Tada et al., 2008).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL ~700 mg/kg bw/day - oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=06972ddb3a3b7a61; raw_unit=mg/kg bw per day; context=neral sources added for nutritional purposes to food supplements, EFSA (2008) noted that reported estimates of dietary exposure to L-aspartic acid are about 3 times lower than the NOAEL of approximately 700 mg/kg bw per day identified in the 90-day study performed by Tada et al. (2008) in which tubular dilatation was observed in kidneys of males and effects on salivary glands were observed in both sexes at higher doses.
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =64 mg/kg bw/day Rat - short-term Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=ff64c112099b65cf; raw_unit=mg/kg bw per day; context=This ADI was based on a no- observed-adverse-effect level (NOAEL) of 64 mg/kg bw per day, the highest dose tested in a short-term toxicity study in rats.
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =316 mg/kg bw/day - oral - Reproductive toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=6f8aec800a56ebfb; raw_unit=mg/kg bw per day; context=A NOAEL of 5000 mg/kg feed (equal to 316 mg/kg bw per day), the highest dose tested, was identified for reproductive and parental toxicity.
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =10000 mg/kg diet Rat oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=dab3ce66f0ceb353; raw_unit=g/kg feed; unit_normalization=converted from grams; context=Owing to the effects observed in the parotid gland and in the kidneys of female rats, the NOAEL was 10 g/kg feed (equal to anthocyanin doses of 12 and 14 mg/kg bw per day for males and females, respectively) (Inoue et al., 2013).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =50000 mg/kg diet - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=bfd31849c5e1e374; raw_unit=g/kg feed; unit_normalization=converted from grams; context=The authors concluded that the NOAEL for this study was the top dose tested, 50 g/kg feed (Nabae et al., 2008).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =15000 mg/kg diet - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=9fcb75369ebe9f2d; raw_unit=g/ kg feed; unit_normalization=converted from grams; context=cal and clinical chemistry parameters, decreased relative liver and thymus weights and increased pituitary weights in males and increased salivary gland weights in both sexes, the NOAEL was 15 g/ kg feed (equal to 942 mg/kg bw per day for males and 1031 mg/kg bw per day for females, expressed as the purple corn colour material; equivalent to 249 mg/ kg bw per day for males and 272 mg/kg bw per day for females, expressed as C3G).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =1409.8 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=d3b95a5346a48346; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 1409.8 mg/kg bw per day expressed as grape seed extract, the highest dose tested (Yamakoshi et al., 2002).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =14 mg/kg bw/day - dermal - Dermal toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=fb0629bca10e88b4; raw_unit=mg/kg bw per day; context=A NOAEL of 14 mg/kg bw per day expressed as anthocyanins (10 000 mg/kg feed expressed as grape skin extract, equal to 700 mg/kg bw per day) was identified (Inoue et al., 2013).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =249 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=43bf2675327e90b7; raw_unit=mg/kg bw per day; context=oncluded that the NOAEL was the highest dose tested, the Committee was of the opinion that the effects observed at 50 000 mg/kg feed were toxicologically relevant and identified a NOAEL of 15 000 mg/kg feed (equal to 249 mg/kg bw per day).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =225 mg/kg bw/day - dermal - Dermal toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=0a166308812fcde2; raw_unit=mg/kg bw per day; context=The NOAEL identified by the previous Committee for this grape skin extract preparation was 75 000 mg/kg feed (equivalent to 7500 mg/kg bw per day and estimated to be 225 mg/kg bw per day expressed as anthocyanins) (Cox & Babish, 1978a).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =100 mg/kg bw/day Pig - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=3bd6a1d3c5f2138c; raw_unit=mg/kg bw per day; context=They concluded that the NOAEL in pigs was 100 mg/kg bw per day (Gaunt et al., 1969).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL ~185.714285714286 mg/kg bw/day Rat - 365 days Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=d0cf827465c409cc; raw_unit=mg/kg bw per day; unit_normalization=converted from weekly dose; context=The authors concluded that the NOAEL in this study was approximately 1300 mg/kg bw per day, the highest dose tested (Drake et al., 1977). (b) Rats A group of 10 rats received 0.5 mL of a 1% solution (= 5 mg) of Brilliant Black PN twice weekly for 365 days and was observed for 653 days.
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =360 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=6c5393e8f9500ce6; raw_unit=mg/kg bw per day; context=In this study, the NOAEL was 10 000 mg/kg feed (equal to 360 mg/kg bw per day), the highest dose tested (Gaunt et al., 1972).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=39445422893254da; raw_unit=mg/kg bw per day; context=The NOAEL was 1000 mg/kg bw per day, the highest dose tested (ECHA, 2010a).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =3127 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=d92cd8deb1eb16d7; raw_unit=mg/kg bw per day; context=The NOAEL was 50 000 mg/kg feed (equal to 3127 mg/kg bw per day), the highest dietary concentration tested (Nabae et al., 2005).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =1013 mg/kg bw/day Rat - 6 weeks Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=b2e2efb2101d63be; raw_unit=mg/kg bw per day; context=The NOAEL in this study was 1013 mg/kg bw per day, the highest dose tested (Buser & Arceo, 1995). (b) β-Apo-8′-carotenal (i) Rats Groups of five male and five female Sprague Dawley rats (6 weeks of age) were administered β-apo-8′-carotenal (Apocarotenal 10% WS/N; β-apo-8′-carotenal at 116 g/kg, β-carotene at
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =10 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=726af187d0afae36; raw_unit=mg/kg bw per day; context=The study authors identified a NOAEL of 10 mg/kg bw per day on the basis of hepatic effects at 30 mg/kg bw per day (Edwards et al., 2007).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =30 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=19631be147c6dbdb; raw_unit=mg/kg bw per day; context=Accordingly, the NOAEL was considered to be 30 mg/kg bw per day, on the basis of an increased incidence of hepatic inflammatory cell foci in females at 100 mg/kg bw per day (Perry & Shearer, 2008).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =250 mg/kg bw/day Rat; Dog - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=f26f39add8dbe0b8; raw_unit=mg/kg bw per day; context=The Committee disagreed with the study authors’ conclusion and identified the NOAEL as the target dose of 250 mg/kg bw per day (equal to a mean achieved intake of 194 mg/ kg bw per day), based on consistently decreased body weight and body weight gain in male and female rats compared with placebo controls at 500 and 1000 mg/kg bw per day. (iii) Dogs In a GLP-compliant study, groups o
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =400 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=0be378ee5a794078; raw_unit=mg/kg bw per day; context=The NOAEL for embryo and fetal toxicity and for maternal toxicity was 400 mg/kg bw per day, the highest dose tested (Kistler, 1982).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =500 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=b74caefef504d2b0; raw_unit=mg/kg bw per day; context=The Committee considered the NOAEL for maternal toxicity and for embryo and fetal toxicity to be the target dose of 500 mg/kg bw per day (equal to a mean achieved dose of 495 mg/kg bw per day), the highest dose tested (Loget et al., 2006).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =495 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=f11070dfe96b7084; raw_unit=mg/kg bw per day; context=The NOAEL for maternal toxicity and for embryo and fetal toxicity was 495 mg/kg bw per day, the highest dose tested (Loget et al., 2006).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =205 mg/L - - - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=917b64f085874070; raw_unit=mg/L; context=The NOAEL of gellan gum in this study was 205 mg/L (equal to 100 mg/ kg bw per day), the highest dose tested (Lanphear, 2016).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =3520 mg/kg bw/day - oral - Reproductive toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=4928080fcd0843df; raw_unit=mg/kg bw per day; context=The NOAEL for parental, reproductive and offspring toxicity was 50 000 mg/kg feed (equal to 3520 mg/kg bw per day), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =13 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=7d6c4d693284a404; raw_unit=mg/kg bw per day; context=Based on this NOAEL and the high estimate of dietary exposure of infants to gellan gum of 13 mg/kg bw per day (based on the requested maximum concentration of gellan gum of 50 mg/L and the high level of consumption of infant formula of 260 mL/kg bw per day), a margin of exposure (MOE) of 7.7 was calculated.
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =12500 mg/kg diet - oral - Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=25f18e8d2ac71706; raw_unit=g/kg feed; unit_normalization=converted from grams; context=The NOAEL was 12.5 g/kg feed (equal to 697 mg/kg bw per day for males and 715 mg/kg bw per day for females) (Tada et al., 2008).
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL ~700 mg/kg bw/day - oral 90-day Subchronic toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=06972ddb3a3b7a61; raw_unit=mg/kg bw per day; context=neral sources added for nutritional purposes to food supplements, EFSA (2008) noted that reported estimates of dietary exposure to L-aspartic acid are about 3 times lower than the NOAEL of approximately 700 mg/kg bw per day identified in the 90-day study performed by Tada et al. (2008) in which tubular dilatation was observed in kidneys of males and effects on salivary glands were observed in both sexes at higher doses.
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =64 mg/kg bw/day Rat - short-term Toxicology study document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=ff64c112099b65cf; raw_unit=mg/kg bw per day; context=This ADI was based on a no- observed-adverse-effect level (NOAEL) of 64 mg/kg bw per day, the highest dose tested in a short-term toxicity study in rats.
INCHEM_WHO_jecfa_jecmono_v78je01 NOAEL =316 mg/kg bw/day - oral - Reproductive toxicity document_id=jecfa_jecmono_v78je01; title=WHO FOOD ADDITIVES SERIES: 78 Prepared by the eighty-seventh meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certai; path=mirror/documents/jecfa/jecmono/v78je01.pdf; row_hash=6f8aec800a56ebfb; raw_unit=mg/kg bw per day; context=A NOAEL of 5000 mg/kg feed (equal to 316 mg/kg bw per day), the highest dose tested, was identified for reproductive and parental toxicity.
NTP_ICE_acute_oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 >2000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_9723; row=5424; data_type=In Vivo; mixture=Chemical; chemical_name=beta-Carotene; preferred_name=beta-Carotene; dtxsid=DTXSID3020253; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3020253; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID3020253; source_file=acute_oral.xlsx
ToxValDB_EFSA 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA LEL >=20 mg/day Human oral - epidemiologic LONG_REF=EFSA ANS (2012). Scientific Opinion on the re-evaluation of mixed carotenes (E 160a (i)) and beta-carotene (E 160a (ii)) as a food additive. doi:10.2903/j.efsa.2012.2593.; TITLE=Scientific Opinion on the re-evaluation of mixed carotenes (E 160a (i)) and beta-carotene (E 160a (ii)) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2012.2593; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=histopathology: neoplastic; STUDY_GROUP=EFSA:15614146:-:--; 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_118beb39ada050d80cdba159a77f0339
ToxValDB_EFSA LEL <=15 mg/day Human oral chronic; 5 years clinical LONG_REF=EFSA ANS (2012). Statement on the safety of Beta-carotene use in heavy smokers. doi:10.2903/j.efsa.2012.2953.; TITLE=Statement on the safety of Beta-carotene use in heavy smokers.; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2012.2953; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2012; ORIGINAL_YEAR=2012; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15614147:-:--; 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_353574d09434f6d87792f3b2a1d43ca9
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 01YAE03M7J UNII - - - chemical {"approval_status":null,"molecular_formula":"C40H56","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"01YAE03M7J"}
openFDA substances FDA UNII substance identifier 01YAE03M7J UNII - - - chemical {"approval_status":null,"molecular_formula":"C40H56","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"01YAE03M7J"}
openFDA substances FDA UNII substance identifier 01YAE03M7J UNII - - - chemical {"approval_status":null,"molecular_formula":"C40H56","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"01YAE03M7J"}
openFDA substances FDA UNII substance identifier 01YAE03M7J UNII - - - chemical {"approval_status":null,"molecular_formula":"C40H56","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"01YAE03M7J"}