NOAEL Studies
Cosmetic Ingredient
CI 75130 (Beta-Carotene) NOAEL Studies
INCI: CI 75130
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.
EFSA 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA | 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 | 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 |
| 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 |
WHO/JECFA 40 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| WHO/JECFA | 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. |
| WHO/JECFA | 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. |
| WHO/JECFA | 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. |
| WHO/JECFA | 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. |
| WHO/JECFA | 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]. |
| WHO/JECFA | 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 |
| WHO/JECFA | 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). |
| WHO/JECFA | 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. |
| WHO/JECFA | 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]. |
| WHO/JECFA | 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. |
| WHO/JECFA | 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 |
| WHO/JECFA | 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. |
| WHO/JECFA | 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]. |
| WHO/JECFA | 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]. |
| WHO/JECFA | 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]. |
| WHO/JECFA | 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). |
| WHO/JECFA | 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. |
| WHO/JECFA | 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]. |
| WHO/JECFA | 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. |
| WHO/JECFA | 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]. |
| WHO/JECFA | 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. |
| WHO/JECFA | 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. |
| WHO/JECFA | 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 |
| WHO/JECFA | 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). |
| WHO/JECFA | 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). |
| WHO/JECFA | 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). |
| WHO/JECFA | 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. |
| WHO/JECFA | 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). |
| WHO/JECFA | 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 |
| WHO/JECFA | 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). |
| WHO/JECFA | 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). |
| WHO/JECFA | 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). |
| WHO/JECFA | 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. |
| WHO/JECFA | 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 |
| WHO/JECFA | 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). |
| WHO/JECFA | 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). |
| WHO/JECFA | 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). |
| WHO/JECFA | 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). |
| WHO/JECFA | 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). |
| WHO/JECFA | 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). |
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 |
openFDA substances 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 01YAE03M7J | UNII | - | - | - | chemical | - |