NOAEL Studies Antioxidant

Lycopene Cosmetic NOAEL Studies

INCI: LYCOPENE

CAS: 502-65-8

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 =50 mg/kg bw/day Rat - 365 days chronic/long term toxicity EFSA AFC - 2008 - OutputID 319 - clinical chemistry - systemic - Use of lycopene as a food colour - doi:10.2903/j.efsa.2008.674
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =50 mg/kg bw/day Rat - 365 days chronic/long term toxicity EFSA AFC - 2008 - OutputID 319 - clinical chemistry - systemic - Use of lycopene as a food colour - doi:10.2903/j.efsa.2008.674
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI =0.5 mg/kg bw/day Consumers - - ADI EFSA AFC - 2008 - OutputID 319 - Consumers - Use of lycopene as a food colour - doi:10.2903/j.efsa.2008.674
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI =0.5 mg/kg bw/day Consumers - - ADI EFSA AFC - 2008 - OutputID 319 - Consumers - Use of lycopene as a food colour - doi:10.2903/j.efsa.2008.674
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI (group) =0.5 mg/kg bw/day Consumers - - ADI (group) EFSA NDA - 2008 - OutputID 20 - Consumers - Safety of Synthetic Lycopene - Scientific Opinion of the Panel on Scientific Panel on Dietetic Products, Nutrition and Allergies - doi:10.2903/j.efsa.2008.676
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI (group) =0.5 mg/kg bw/day Consumers - - ADI (group) EFSA NDA - 2008 - OutputID 20 - Consumers - Safety of Synthetic Lycopene - Scientific Opinion of the Panel on Scientific Panel on Dietetic Products, Nutrition and Allergies - doi:10.2903/j.efsa.2008.676
INCHEM_WHO_jecfa_jecmono_v58je01 48 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_jecfa_jecmono_v58je01 ADI range:0-0.0650.065 mg/kg bw/day Rat oral long-term Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=69aaf801ae877d1f; raw_unit=mg/kg bw; context=The NOEL in the original long-term study in rats was identified as 0.5% in the diet, equivalent to 250 mg/kg bw, and the ADI for these annatto extracts was set at 0-0.065 mg/kg bw expressed as bixin.
INCHEM_WHO_jecfa_jecmono_v58je01 ADI range:0-1212 mg/kg bw/day Rat - 90-day Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=f8f59c46874a18ce; raw_unit=mg/kg bw; context=The Committee established an ADI for bixin of 0-12 mg/kg bw on the basis of the NOEL of 1311 mg/kg bw per day from a 90-day study in male rats fed an extract containing 92% bixin, corrected for pigment content and applying a safety factor of 100.
INCHEM_WHO_jecfa_jecmono_v58je01 ADI range:0-0.60.6 mg/kg bw/day Rat - 90-day Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=09ced9dd77d75bc9; raw_unit=mg/kg bw; context=The Committee established a group ADI for norbixin and its sodium and potassium salts of 0-0.6 mg/kg bw (expressed as norbixin) on the basis of the NOEL of 69 mg/kg bw per day from a 90-day study in male rats fed an extract containing 91.6% norbixin, corrected for pigment content and applying a safety factor of 100.
INCHEM_WHO_jecfa_jecmono_v58je01 ADI range:0-0.50.5 mg/kg bw/day Human; Rat - 104-week Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=baf5784171a564fa; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-0.5 mg/kg bw for synthetic lycopene based on the highest dose of 50 mg/kg bw per day tested in the 104-week study in LYCOPENE (SYNTHETIC) 61 rats (at which no adverse effects relevant to humans were induced), and a safety factor of 100.
INCHEM_WHO_jecfa_jecmono_v58je01 ADI =10 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=0309178d97f1eded; raw_unit=mg/kg bw per day; context=Intakes were below the EU temporary group ADI for the parabens of 10 mg/kg bw per day (European Commission, 2001).
INCHEM_WHO_jecfa_jecmono_v58je01 ADI range:0-0.30.3 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=4b360aad9e552193; raw_unit=mg/kg bw; context=and calculations for consumers with a high intake and children, confirm the results of the assessment made by the Committee at its fifty-seventh meeting and show that the current ADI of 0-0.3 mg/kg bw is unlikely to be exceeded.
INCHEM_WHO_jecfa_jecmono_v58je01 ADI range:0-0.0650.065 mg/kg bw/day Rat oral long-term Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=69aaf801ae877d1f; raw_unit=mg/kg bw; context=The NOEL in the original long-term study in rats was identified as 0.5% in the diet, equivalent to 250 mg/kg bw, and the ADI for these annatto extracts was set at 0-0.065 mg/kg bw expressed as bixin.
INCHEM_WHO_jecfa_jecmono_v58je01 ADI range:0-1212 mg/kg bw/day Rat - 90-day Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=f8f59c46874a18ce; raw_unit=mg/kg bw; context=The Committee established an ADI for bixin of 0-12 mg/kg bw on the basis of the NOEL of 1311 mg/kg bw per day from a 90-day study in male rats fed an extract containing 92% bixin, corrected for pigment content and applying a safety factor of 100.
INCHEM_WHO_jecfa_jecmono_v58je01 ADI range:0-0.60.6 mg/kg bw/day Rat - 90-day Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=09ced9dd77d75bc9; raw_unit=mg/kg bw; context=The Committee established a group ADI for norbixin and its sodium and potassium salts of 0-0.6 mg/kg bw (expressed as norbixin) on the basis of the NOEL of 69 mg/kg bw per day from a 90-day study in male rats fed an extract containing 91.6% norbixin, corrected for pigment content and applying a safety factor of 100.
INCHEM_WHO_jecfa_jecmono_v58je01 ADI range:0-0.50.5 mg/kg bw/day Human; Rat - 104-week Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=baf5784171a564fa; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-0.5 mg/kg bw for synthetic lycopene based on the highest dose of 50 mg/kg bw per day tested in the 104-week study in LYCOPENE (SYNTHETIC) 61 rats (at which no adverse effects relevant to humans were induced), and a safety factor of 100.
INCHEM_WHO_jecfa_jecmono_v58je01 ADI =10 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=0309178d97f1eded; raw_unit=mg/kg bw per day; context=Intakes were below the EU temporary group ADI for the parabens of 10 mg/kg bw per day (European Commission, 2001).
INCHEM_WHO_jecfa_jecmono_v58je01 ADI range:0-0.30.3 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=4b360aad9e552193; raw_unit=mg/kg bw; context=and calculations for consumers with a high intake and children, confirm the results of the assessment made by the Committee at its fifty-seventh meeting and show that the current ADI of 0-0.3 mg/kg bw is unlikely to be exceeded.
INCHEM_WHO_jecfa_jecmono_v58je01 LOAEL =266 mg/kg bw/day Mouse oral - Developmental toxicity document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=eda30e4d1dbf0706; raw_unit=mg/kg bw per day; context=oxicity with aluminium salts administered orally, published since the previous evaluation performed by the Committee Species Route Compound Dose Duration (days of gestation) NOAEL/LOAEL Reference Mouse (Swiss, 20 per group) Gavage Al(OH)3 66.5, 133, 266 mg/kg bw per day a,b Days 6-15 No evidence of maternal toxicity, embryo/fetal toxicity or teratogenicity reported Domingo et al. (1989) Mouse (Swiss Webster) Diet Aluminium lactate 25 and 1000 mg Al/ kg diet, equivalent to 4 and 100 mg Al/kg bw per day Day 0 to weaning LOAEL:
INCHEM_WHO_jecfa_jecmono_v58je01 LOAEL =6 mg/kg bw/day Rat oral - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=1208d6049aa46309; raw_unit=mg/kg bw per day; context=Clayton et al. (1992), cited in WHO (1997) ALUMINIUM FROM ALL SOURCES, INCLUDING FOOD ADDITIVES 139 Table 1. (contd) Species Route Compound Dose Duration (days of gestation) NOAEL/LOAEL Reference Rat (Sprague-Dawley) Gavage Al(NO3)3 13, 26 or 52 mg Al/kg bw per day (+ equivalent of 6 mg/kg bw per day from diet) Days 14-21 LOAEL:
INCHEM_WHO_jecfa_jecmono_v58je01 LOAEL =768 mg/kg bw/day Rat oral - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=b56ec222f5df768c; raw_unit=mg/kg bw per day; context=) Gómez et al. (1991), cited in WHO (1997) 140 ALUMINIUM FROM ALL SOURCES, INCLUDING FOOD ADDITIVES Table 1. (contd) Species Route Compound Dose Duration (days of gestation) NOAEL/LOAEL Reference Rat (Wistar, 18-19 per group) Gavage Al(OH)3 192, 384, 768 mg/kg bw per day a,b Days 6-15 NOEL:
INCHEM_WHO_jecfa_jecmono_v58je01 LOAEL =75 mg/kg bw/day Mouse oral - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=c580cdbe186edbbe; raw_unit=mg/kg per day; context=Golub & Germann (2001) Mouse (Swiss Webster) Diet Aluminium lactate 25 (control), 500 or 1000 mg Al/kg diet, equivalent to 4, 75 or150 mg/kg bw per day Conception through weaning LOAEL 75 mg/kg per day (foot splay, forelimb and hind limb grip strengths, thermal sensitivity) Donald et al. (1989)* Mouse (Swiss Webster) Diet Aluminium lactate 25 (control) or 1000 mg Al/kg 100 mg/kg bw per day Conception through lactation LOAEL:
INCHEM_WHO_jecfa_jecmono_v58je01 LOAEL =1000 mg/kg diet Mouse oral 21 day Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=683acda89e738592; raw_unit=mg/kg diet; context=mperature sensitivity in 21 day old mice) Donald et al. (1989) 144 ALUMINIUM FROM ALL SOURCES, INCLUDING FOOD ADDITIVES Table 2. (contd) Species Route Compound Dose Duration NOAEL/LOAEL Reference Mouse (Swiss Webster) Diet Aluminium lactate with and without citrate 7 (control),100, 500, 750 or 1000 mg/kg diet <1, 10, 50, 75 or 100 mg/kg bw per day 4 or 8 weeks from beginning of puberty (45 days) NOAEL:
INCHEM_WHO_jecfa_jecmono_v58je01 LOAEL =266 mg/kg bw/day Mouse oral - Developmental toxicity document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=eda30e4d1dbf0706; raw_unit=mg/kg bw per day; context=oxicity with aluminium salts administered orally, published since the previous evaluation performed by the Committee Species Route Compound Dose Duration (days of gestation) NOAEL/LOAEL Reference Mouse (Swiss, 20 per group) Gavage Al(OH)3 66.5, 133, 266 mg/kg bw per day a,b Days 6-15 No evidence of maternal toxicity, embryo/fetal toxicity or teratogenicity reported Domingo et al. (1989) Mouse (Swiss Webster) Diet Aluminium lactate 25 and 1000 mg Al/ kg diet, equivalent to 4 and 100 mg Al/kg bw per day Day 0 to weaning LOAEL:
INCHEM_WHO_jecfa_jecmono_v58je01 LOAEL =6 mg/kg bw/day Rat oral - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=1208d6049aa46309; raw_unit=mg/kg bw per day; context=Clayton et al. (1992), cited in WHO (1997) ALUMINIUM FROM ALL SOURCES, INCLUDING FOOD ADDITIVES 139 Table 1. (contd) Species Route Compound Dose Duration (days of gestation) NOAEL/LOAEL Reference Rat (Sprague-Dawley) Gavage Al(NO3)3 13, 26 or 52 mg Al/kg bw per day (+ equivalent of 6 mg/kg bw per day from diet) Days 14-21 LOAEL:
INCHEM_WHO_jecfa_jecmono_v58je01 LOAEL =768 mg/kg bw/day Rat oral - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=b56ec222f5df768c; raw_unit=mg/kg bw per day; context=) Gómez et al. (1991), cited in WHO (1997) 140 ALUMINIUM FROM ALL SOURCES, INCLUDING FOOD ADDITIVES Table 1. (contd) Species Route Compound Dose Duration (days of gestation) NOAEL/LOAEL Reference Rat (Wistar, 18-19 per group) Gavage Al(OH)3 192, 384, 768 mg/kg bw per day a,b Days 6-15 NOEL:
INCHEM_WHO_jecfa_jecmono_v58je01 LOAEL =75 mg/kg bw/day Mouse oral - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=c580cdbe186edbbe; raw_unit=mg/kg per day; context=Golub & Germann (2001) Mouse (Swiss Webster) Diet Aluminium lactate 25 (control), 500 or 1000 mg Al/kg diet, equivalent to 4, 75 or150 mg/kg bw per day Conception through weaning LOAEL 75 mg/kg per day (foot splay, forelimb and hind limb grip strengths, thermal sensitivity) Donald et al. (1989)* Mouse (Swiss Webster) Diet Aluminium lactate 25 (control) or 1000 mg Al/kg 100 mg/kg bw per day Conception through lactation LOAEL:
INCHEM_WHO_jecfa_jecmono_v58je01 LOAEL =1000 mg/kg diet Mouse oral 21 day Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=683acda89e738592; raw_unit=mg/kg diet; context=mperature sensitivity in 21 day old mice) Donald et al. (1989) 144 ALUMINIUM FROM ALL SOURCES, INCLUDING FOOD ADDITIVES Table 2. (contd) Species Route Compound Dose Duration NOAEL/LOAEL Reference Mouse (Swiss Webster) Diet Aluminium lactate with and without citrate 7 (control),100, 500, 750 or 1000 mg/kg diet <1, 10, 50, 75 or 100 mg/kg bw per day 4 or 8 weeks from beginning of puberty (45 days) NOAEL:
INCHEM_WHO_jecfa_jecmono_v58je01 LOEL =1.1 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=98ba90cbe2eba043; raw_unit=mg/kg bw per day; context=The Committee concluded that 1.1 mg/kg bw per day, the lowest dose, was a lowest-observed-effect level (LOEL) and that this was close to a no-observed-effect level (NOEL).
INCHEM_WHO_jecfa_jecmono_v58je01 LOEL =1.1 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=98ba90cbe2eba043; raw_unit=mg/kg bw per day; context=The Committee concluded that 1.1 mg/kg bw per day, the lowest dose, was a lowest-observed-effect level (LOEL) and that this was close to a no-observed-effect level (NOEL).
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =250 mg/kg bw Rat oral long-term Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=de8f95100f1236f2; raw_unit=mg/kg bw; context=The NOEL in the original long-term study in rats was identified as 0.5% in the diet, equivalent to 250 mg/kg bw, and the ADI for these annatto extracts was set at 0-0.065 mg/kg bw expressed as bixin.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =1311 mg/kg bw/day Rat - 90-day Subchronic toxicity document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=b66b04a256f8d38f; raw_unit=mg/kg bw per day; context=The Committee established an ADI for bixin of 0-12 mg/kg bw on the basis of the NOEL of 1311 mg/kg bw per day from a 90-day study in male rats fed an extract containing 92% bixin, corrected for pigment content and applying a safety factor of 100.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =69 mg/kg bw/day Rat - 90-day Subchronic toxicity document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=7b9d121f4c5a6530; raw_unit=mg/kg bw per day; context=The Committee established a group ADI for norbixin and its sodium and potassium salts of 0-0.6 mg/kg bw (expressed as norbixin) on the basis of the NOEL of 69 mg/kg bw per day from a 90-day study in male rats fed an extract containing 91.6% norbixin, corrected for pigment content and applying a safety factor of 100.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =500 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=09a781c20f479bed; raw_unit=mg/kg bw per day; context=The NOEL for maternal and developmental toxicity was 500 mg/kg bw per day, the highest dose tested (Edwards et al., 2004b).
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =1 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=74222fee81242cb2; raw_unit=mg/kg bw per day; context=The NOEL was 20 mg/kg feed, equivalent to 1 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =5 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=abbca33bda2449ec; raw_unit=mg/kg bw per day; context=The NOEL was 200 mg/kg feed, equivalent to 5 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =4500 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=1b1c75676c703331; raw_unit=mg/kg bw per day; context=The highest dose tested, 4500 mg/kg bw per day, equivalent to 270 mg of lycopene/kg bw per day, was reported to be the NOEL for NTOE (Matulka et al., 2004).
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL ~300 mg/kg bw/day Rat; Rabbit - - Developmental toxicity document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=d0491f74d0be7dc7; raw_unit=mg/kg bw per day; context=The NOEL for maternal and developmental toxicity was approximately 300 mg/kg bw per day for rats and approximately 200 mg/kg bw per day for rabbits, corresponding to the highest doses tested in the studies.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL ~600 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=01d3cd5190b25a8a; raw_unit=mg/kg bw per day; context=The NOEL for lycopene was approximately 600 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =702 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=b70706ce01f5bc97; raw_unit=mg/kg; context=The NOEL in this study was a dietary concentration of 702 mg/kg, equal to 27 mg Al/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=f498f4ecc754128d; raw_unit=mg/ kg bw per day; context=This conclusion was reached on the grounds that the group ADI was originally set on a NOEL of 1000 mg/ kg bw per day for a different toxicological end-point- growth depression-taken from the range of studies then available for the methyl, ethyl and propyl parabens.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =250 mg/kg bw Rat oral long-term Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=de8f95100f1236f2; raw_unit=mg/kg bw; context=The NOEL in the original long-term study in rats was identified as 0.5% in the diet, equivalent to 250 mg/kg bw, and the ADI for these annatto extracts was set at 0-0.065 mg/kg bw expressed as bixin.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =1311 mg/kg bw/day Rat - 90-day Subchronic toxicity document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=b66b04a256f8d38f; raw_unit=mg/kg bw per day; context=The Committee established an ADI for bixin of 0-12 mg/kg bw on the basis of the NOEL of 1311 mg/kg bw per day from a 90-day study in male rats fed an extract containing 92% bixin, corrected for pigment content and applying a safety factor of 100.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =69 mg/kg bw/day Rat - 90-day Subchronic toxicity document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=7b9d121f4c5a6530; raw_unit=mg/kg bw per day; context=The Committee established a group ADI for norbixin and its sodium and potassium salts of 0-0.6 mg/kg bw (expressed as norbixin) on the basis of the NOEL of 69 mg/kg bw per day from a 90-day study in male rats fed an extract containing 91.6% norbixin, corrected for pigment content and applying a safety factor of 100.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =500 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=09a781c20f479bed; raw_unit=mg/kg bw per day; context=The NOEL for maternal and developmental toxicity was 500 mg/kg bw per day, the highest dose tested (Edwards et al., 2004b).
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =1 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=74222fee81242cb2; raw_unit=mg/kg bw per day; context=The NOEL was 20 mg/kg feed, equivalent to 1 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =5 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=abbca33bda2449ec; raw_unit=mg/kg bw per day; context=The NOEL was 200 mg/kg feed, equivalent to 5 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =4500 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=1b1c75676c703331; raw_unit=mg/kg bw per day; context=The highest dose tested, 4500 mg/kg bw per day, equivalent to 270 mg of lycopene/kg bw per day, was reported to be the NOEL for NTOE (Matulka et al., 2004).
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL ~300 mg/kg bw/day Rat; Rabbit - - Developmental toxicity document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=d0491f74d0be7dc7; raw_unit=mg/kg bw per day; context=The NOEL for maternal and developmental toxicity was approximately 300 mg/kg bw per day for rats and approximately 200 mg/kg bw per day for rabbits, corresponding to the highest doses tested in the studies.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL ~600 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=01d3cd5190b25a8a; raw_unit=mg/kg bw per day; context=The NOEL for lycopene was approximately 600 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =702 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=b70706ce01f5bc97; raw_unit=mg/kg; context=The NOEL in this study was a dietary concentration of 702 mg/kg, equal to 27 mg Al/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v58je01 NOEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=f498f4ecc754128d; raw_unit=mg/ kg bw per day; context=This conclusion was reached on the grounds that the group ADI was originally set on a NOEL of 1000 mg/ kg bw per day for a different toxicological end-point- growth depression-taken from the range of studies then available for the methyl, ethyl and propyl parabens.
INCHEM_WHO_jecfa_jecmono_v58je01 TDI =0.002 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=9adce9959079a755; raw_unit=ug/kg bw; unit_normalization=converted from micrograms; context=The Committee established a provisional maximum tolerable daily intake (PMTDI) of 2 ug/kg bw for 3-chloro-1,2-propanediol on the basis of this LOEL, using a safety factor of 500.
INCHEM_WHO_jecfa_jecmono_v58je01 TDI =0.002 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v58je01; title=Who Food Additives Series 58 Safety Evaluation Of Certain Food Additives And Contaminants; path=mirror/documents/jecfa/jecmono/v58je01.pdf; row_hash=9adce9959079a755; raw_unit=ug/kg bw; unit_normalization=converted from micrograms; context=The Committee established a provisional maximum tolerable daily intake (PMTDI) of 2 ug/kg bw for 3-chloro-1,2-propanediol on the basis of this LOEL, using a safety factor of 500.
INCHEM_WHO_jecfa_jecmono_v62je01 70 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
INCHEM_WHO_jecfa_jecmono_v62je01 ADI range:0-1111 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=833e52f2b9d61bf7; raw_unit=mg/kg bw; context=A safety factor of 100 was assumed to derive the ADI of 0-11 mg/kg bw for cyclamates.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI range:0-77 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=12ec3ebe10c88a66; raw_unit=mg/kg bw; context=In 2000, the SCF published a revised opinion on cyclamic acid and its salts, establishing an ADI of 0-7 mg/kg bw (Scientific Committee on Food, 2000).
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =120 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=0b40bf858e673d4d; raw_unit=mg/kg bw per day; context== 11 167) Use level scenarios Baseline (0 mg/kg) 250 mg/kg 350 mg/kg 500 mg/kg 750 mg/kg 1000 mg/kg Mean mg/day 139 151 157 166 182 197 mg/kg bw per day 3 3 3 3 3 3 Intake as % of ADI 25 25 25 25 30 30 Median mg/day 103 110 114 118 119 120 mg/kg bw per day 2 2 2 2 2 2 Intake as % of ADI 15 15 15 15 20 20 90th percentile mg/day 305 330 347 372 410 450 mg/kg bw per day 6 6 6 7 7 8 Intake as % of ADI 55 55 55 60 65 75 b.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =450 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=01ce2aaa1fba62b1; raw_unit=mg/kg bw per day; context=mg/day 139 151 157 166 182 197 mg/kg bw per day 3 3 3 3 3 3 Intake as % of ADI 25 25 25 25 30 30 Median mg/day 103 110 114 118 119 120 mg/kg bw per day 2 2 2 2 2 2 Intake as % of ADI 15 15 15 15 20 20 90th percentile mg/day 305 330 347 372 410 450 mg/kg bw per day 6 6 6 7 7 8 Intake as % of ADI 55 55 55 60 65 75 b.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =99 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=75d13b80e4d03110; raw_unit=mg/kg bw per day; context=n = 862) Use level scenarios Baseline (0 mg/kg) 250 mg/kg 350 mg/kg 500 mg/kg 750 mg/kg 1000 mg/kg Mean mg/day 116 120 122 124 128 133 mg/kg bw per day 6 7 7 7 7 7 Intake as % of ADI 60 60 60 60 65 65 Median mg/day 87 93 94 96 98 99 mg/kg bw per day 5 5 5 5 5 5 46 CYCLAMIC ACID AND ITS SALTS:
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =293 mg/kg bw/day Human oral 6 years Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=fca03be708f3ae73; raw_unit=mg/kg bw per day; context=2-6 years (contd) Use level scenarios Baseline (0 mg/kg) 250 mg/kg 350 mg/kg 500 mg/kg 750 mg/kg 1000 mg/kg Intake as % of ADI 45 45 45 45 45 45 90th percentile mg/day 249 252 258 265 272 293 mg/kg bw per day 13 14 14 14 15 16 Intake as % of ADI 120 120 120 130 140 150 a Consumers only: includes only those people who have consumed a food with GSFA permissions, based on 1995 National Nutrition Survey food consumption data.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =221 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=195e6b17396a31e4; raw_unit=mg/kg bw per day; context== 12 105) Use level scenarios Baseline (0 mg/kg) 250 mg/kg 350 mg/kg 500 mg/kg 750 mg/kg 1000 mg/kg Mean mg/day 139 181 204 238 295 351 mg/kg bw per day 3 3 4 4 5 6 Intake as % of ADI 25 30 35 40 45 55 Median mg/day 103 136 152 174 200 221 mg/kg bw per day 2 2 2 3 3 4 Intake as % of ADI 15 20 20 25 30 35 90th percentile mg/day 305 388 439 525 675 832 mg/kg bw per day 6 7 8 10 12 15 Intake as % of ADI 55 65 75 90 110 140 CYCLAMIC ACID AND ITS SALTS:
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =832 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=979342fac196b3a0; raw_unit=mg/kg bw per day; context=mg/day 139 181 204 238 295 351 mg/kg bw per day 3 3 4 4 5 6 Intake as % of ADI 25 30 35 40 45 55 Median mg/day 103 136 152 174 200 221 mg/kg bw per day 2 2 2 3 3 4 Intake as % of ADI 15 20 20 25 30 35 90th percentile mg/day 305 388 439 525 675 832 mg/kg bw per day 6 7 8 10 12 15 Intake as % of ADI 55 65 75 90 110 140 CYCLAMIC ACID AND ITS SALTS:
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =204 mg/kg bw/day Human oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=8d4e39ac0a673566; raw_unit=mg/kg bw per day; context== 937) Use level scenarios Baseline (0 mg/kg) 250 mg/kg 350 mg/kg 500 mg/kg 750 mg/kg 1000 mg/kg Mean mg/day 116 144 160 182 220 258 mg/kg bw per day 6 8 9 10 12 14 Intake as % of ADI 60 70 80 90 110 130 Median mg/day 87 115 131 151 181 204 mg/kg bw per day 5 6 7 8 10 11 Intake as % of ADI 45 55 65 75 90 100 90th percentile mg/day 249 302 330 380 467 566 mg/kg bw per day 13 15 17 20 24 29 Intake as % of ADI 120 140 150 180 220 270 a Consumers only: includes only those people who have consumed a food with GSFA pe
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =566 mg/kg bw/day Human oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=084ec8d0f9014194; raw_unit=mg/kg bw per day; context=y 116 144 160 182 220 258 mg/kg bw per day 6 8 9 10 12 14 Intake as % of ADI 60 70 80 90 110 130 Median mg/day 87 115 131 151 181 204 mg/kg bw per day 5 6 7 8 10 11 Intake as % of ADI 45 55 65 75 90 100 90th percentile mg/day 249 302 330 380 467 566 mg/kg bw per day 13 15 17 20 24 29 Intake as % of ADI 120 140 150 180 220 270 a Consumers only: includes only those people who have consumed a food with GSFA permissions, based on 1995 National Nutrition Survey food consumption data.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =400 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=8190a9599a16b3f5; raw_unit=mg/kg; context=In this analysis, 90th- percentile consumers in this age group were predicted to have dietary exposures to cyclamates that exceeded the ADI only at maximum use levels for cyclamates of 400 mg/kg and above in beverages covered by Food Category 14.1.4; at 350 mg/ kg, dietary exposures were less than the ADI.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =350 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=85351a2cbf643267; raw_unit=mg/ kg; context=cted to have dietary exposures to cyclamates that exceeded the ADI only at maximum use levels for cyclamates of 400 mg/kg and above in beverages covered by Food Category 14.1.4; at 350 mg/ kg, dietary exposures were less than the ADI.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =250 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=67c35b140ab3c34a; raw_unit=mg/kg; context=(250, 500, 750 and 1000 mg/kg) that the Committee considered at the request of CCFA for cyclamates in beverages covered by Codex GSFA Food Category 14.1.4, only the lowest level of 250 mg/kg was not likely to lead to dietary exposures exceeding the ADI for high consumers, including children.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI range:0-2525 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=5b9963c4499da6e9; raw_unit=mg/ kg bw; context=On the basis of these results, the Committee allocated an ADI for GEWR of 0-25 mg/ kg bw (Blair, 1991, 1992).
INCHEM_WHO_jecfa_jecmono_v62je01 ADI range:0-0.50.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=9a83b01eee38a9fd; raw_unit=mg/kg body weight; context=meeting (Annex 1, reference 184), the Committee evaluated both synthetic lycopene and lycopene derived from Blakeslea trispora and developed specifications and established a group ADI of 0-0.5 mg/kg body weight (bw).
INCHEM_WHO_jecfa_jecmono_v62je01 ADI range:0-3030 mg/kg bw/day Human - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=41915631492489d1; raw_unit=mg/kg bw; context=At its forty-ninth meeting, the Committee established a group ADI of 0-30 mg/kg bw for sucrose esters of fatty acids and sucroglycerides on the basis of potential to induce laxative effects at doses exceeding 30 mg/kg bw per day in humans.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI range:0-300.0821917808219178 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=ff8cc39f7dff4117; raw_unit=mg/kg bw.; unit_normalization=converted from yearly dose; context=1.8 6 USA 1987 3 195 000 tonnes per yeard 0.6 correction factor Population 24.3 × 107 10% of all emulsifiers are SOE 60 1.0 3 a Assumes a 60-kg body weight for each population. b ADI of 0-30 mg/kg bw. c Includes SOE and sucrose esters of fatty acids. d Reported as 71 million pounds per year for all emulsifiers (converted to tonnes assuming 0.45 kg per pound).
INCHEM_WHO_jecfa_jecmono_v62je01 ADI range:0-1111 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=833e52f2b9d61bf7; raw_unit=mg/kg bw; context=A safety factor of 100 was assumed to derive the ADI of 0-11 mg/kg bw for cyclamates.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI range:0-77 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=12ec3ebe10c88a66; raw_unit=mg/kg bw; context=In 2000, the SCF published a revised opinion on cyclamic acid and its salts, establishing an ADI of 0-7 mg/kg bw (Scientific Committee on Food, 2000).
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =120 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=0b40bf858e673d4d; raw_unit=mg/kg bw per day; context== 11 167) Use level scenarios Baseline (0 mg/kg) 250 mg/kg 350 mg/kg 500 mg/kg 750 mg/kg 1000 mg/kg Mean mg/day 139 151 157 166 182 197 mg/kg bw per day 3 3 3 3 3 3 Intake as % of ADI 25 25 25 25 30 30 Median mg/day 103 110 114 118 119 120 mg/kg bw per day 2 2 2 2 2 2 Intake as % of ADI 15 15 15 15 20 20 90th percentile mg/day 305 330 347 372 410 450 mg/kg bw per day 6 6 6 7 7 8 Intake as % of ADI 55 55 55 60 65 75 b.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =450 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=01ce2aaa1fba62b1; raw_unit=mg/kg bw per day; context=mg/day 139 151 157 166 182 197 mg/kg bw per day 3 3 3 3 3 3 Intake as % of ADI 25 25 25 25 30 30 Median mg/day 103 110 114 118 119 120 mg/kg bw per day 2 2 2 2 2 2 Intake as % of ADI 15 15 15 15 20 20 90th percentile mg/day 305 330 347 372 410 450 mg/kg bw per day 6 6 6 7 7 8 Intake as % of ADI 55 55 55 60 65 75 b.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =99 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=75d13b80e4d03110; raw_unit=mg/kg bw per day; context=n = 862) Use level scenarios Baseline (0 mg/kg) 250 mg/kg 350 mg/kg 500 mg/kg 750 mg/kg 1000 mg/kg Mean mg/day 116 120 122 124 128 133 mg/kg bw per day 6 7 7 7 7 7 Intake as % of ADI 60 60 60 60 65 65 Median mg/day 87 93 94 96 98 99 mg/kg bw per day 5 5 5 5 5 5 46 CYCLAMIC ACID AND ITS SALTS:
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =293 mg/kg bw/day Human oral 6 years Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=fca03be708f3ae73; raw_unit=mg/kg bw per day; context=2-6 years (contd) Use level scenarios Baseline (0 mg/kg) 250 mg/kg 350 mg/kg 500 mg/kg 750 mg/kg 1000 mg/kg Intake as % of ADI 45 45 45 45 45 45 90th percentile mg/day 249 252 258 265 272 293 mg/kg bw per day 13 14 14 14 15 16 Intake as % of ADI 120 120 120 130 140 150 a Consumers only: includes only those people who have consumed a food with GSFA permissions, based on 1995 National Nutrition Survey food consumption data.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =221 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=195e6b17396a31e4; raw_unit=mg/kg bw per day; context== 12 105) Use level scenarios Baseline (0 mg/kg) 250 mg/kg 350 mg/kg 500 mg/kg 750 mg/kg 1000 mg/kg Mean mg/day 139 181 204 238 295 351 mg/kg bw per day 3 3 4 4 5 6 Intake as % of ADI 25 30 35 40 45 55 Median mg/day 103 136 152 174 200 221 mg/kg bw per day 2 2 2 3 3 4 Intake as % of ADI 15 20 20 25 30 35 90th percentile mg/day 305 388 439 525 675 832 mg/kg bw per day 6 7 8 10 12 15 Intake as % of ADI 55 65 75 90 110 140 CYCLAMIC ACID AND ITS SALTS:
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =832 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=979342fac196b3a0; raw_unit=mg/kg bw per day; context=mg/day 139 181 204 238 295 351 mg/kg bw per day 3 3 4 4 5 6 Intake as % of ADI 25 30 35 40 45 55 Median mg/day 103 136 152 174 200 221 mg/kg bw per day 2 2 2 3 3 4 Intake as % of ADI 15 20 20 25 30 35 90th percentile mg/day 305 388 439 525 675 832 mg/kg bw per day 6 7 8 10 12 15 Intake as % of ADI 55 65 75 90 110 140 CYCLAMIC ACID AND ITS SALTS:
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =204 mg/kg bw/day Human oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=8d4e39ac0a673566; raw_unit=mg/kg bw per day; context== 937) Use level scenarios Baseline (0 mg/kg) 250 mg/kg 350 mg/kg 500 mg/kg 750 mg/kg 1000 mg/kg Mean mg/day 116 144 160 182 220 258 mg/kg bw per day 6 8 9 10 12 14 Intake as % of ADI 60 70 80 90 110 130 Median mg/day 87 115 131 151 181 204 mg/kg bw per day 5 6 7 8 10 11 Intake as % of ADI 45 55 65 75 90 100 90th percentile mg/day 249 302 330 380 467 566 mg/kg bw per day 13 15 17 20 24 29 Intake as % of ADI 120 140 150 180 220 270 a Consumers only: includes only those people who have consumed a food with GSFA pe
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =566 mg/kg bw/day Human oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=084ec8d0f9014194; raw_unit=mg/kg bw per day; context=y 116 144 160 182 220 258 mg/kg bw per day 6 8 9 10 12 14 Intake as % of ADI 60 70 80 90 110 130 Median mg/day 87 115 131 151 181 204 mg/kg bw per day 5 6 7 8 10 11 Intake as % of ADI 45 55 65 75 90 100 90th percentile mg/day 249 302 330 380 467 566 mg/kg bw per day 13 15 17 20 24 29 Intake as % of ADI 120 140 150 180 220 270 a Consumers only: includes only those people who have consumed a food with GSFA permissions, based on 1995 National Nutrition Survey food consumption data.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =400 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=8190a9599a16b3f5; raw_unit=mg/kg; context=In this analysis, 90th- percentile consumers in this age group were predicted to have dietary exposures to cyclamates that exceeded the ADI only at maximum use levels for cyclamates of 400 mg/kg and above in beverages covered by Food Category 14.1.4; at 350 mg/ kg, dietary exposures were less than the ADI.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =350 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=85351a2cbf643267; raw_unit=mg/ kg; context=cted to have dietary exposures to cyclamates that exceeded the ADI only at maximum use levels for cyclamates of 400 mg/kg and above in beverages covered by Food Category 14.1.4; at 350 mg/ kg, dietary exposures were less than the ADI.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI =250 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=67c35b140ab3c34a; raw_unit=mg/kg; context=(250, 500, 750 and 1000 mg/kg) that the Committee considered at the request of CCFA for cyclamates in beverages covered by Codex GSFA Food Category 14.1.4, only the lowest level of 250 mg/kg was not likely to lead to dietary exposures exceeding the ADI for high consumers, including children.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI range:0-2525 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=5b9963c4499da6e9; raw_unit=mg/ kg bw; context=On the basis of these results, the Committee allocated an ADI for GEWR of 0-25 mg/ kg bw (Blair, 1991, 1992).
INCHEM_WHO_jecfa_jecmono_v62je01 ADI range:0-0.50.5 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=9a83b01eee38a9fd; raw_unit=mg/kg body weight; context=meeting (Annex 1, reference 184), the Committee evaluated both synthetic lycopene and lycopene derived from Blakeslea trispora and developed specifications and established a group ADI of 0-0.5 mg/kg body weight (bw).
INCHEM_WHO_jecfa_jecmono_v62je01 ADI range:0-3030 mg/kg bw/day Human - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=41915631492489d1; raw_unit=mg/kg bw; context=At its forty-ninth meeting, the Committee established a group ADI of 0-30 mg/kg bw for sucrose esters of fatty acids and sucroglycerides on the basis of potential to induce laxative effects at doses exceeding 30 mg/kg bw per day in humans.
INCHEM_WHO_jecfa_jecmono_v62je01 ADI range:0-300.0821917808219178 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=ff8cc39f7dff4117; raw_unit=mg/kg bw.; unit_normalization=converted from yearly dose; context=1.8 6 USA 1987 3 195 000 tonnes per yeard 0.6 correction factor Population 24.3 × 107 10% of all emulsifiers are SOE 60 1.0 3 a Assumes a 60-kg body weight for each population. b ADI of 0-30 mg/kg bw. c Includes SOE and sucrose esters of fatty acids. d Reported as 71 million pounds per year for all emulsifiers (converted to tonnes assuming 0.45 kg per pound).
INCHEM_WHO_jecfa_jecmono_v62je01 LOAEL =586 mg/kg bw/day Rat - Three-month Reproductive toxicity document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=f81b0c5ede64efe7; raw_unit=mg/ kg bw per day; context=Levels relevant for risk assessment Species Study Effect NOAEL LOAEL Rat Three-month studies of toxicitya,b,c Toxicity 1%, equal to 586 mg/ kg bw per dayd - One-year study of toxicitya Toxicity 1.3%, equal to 250 mg/kg bw per day - Two-year studies of toxicity and carcinogenicitya Toxicity 50 mg/kg bw per day - Carcinogenicity 50 mg/kg bw per day - Multigeneration reproductive toxicity studya,b Parental toxici
INCHEM_WHO_jecfa_jecmono_v62je01 LOAEL =586 mg/kg bw/day Rat - Three-month Reproductive toxicity document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=f81b0c5ede64efe7; raw_unit=mg/ kg bw per day; context=Levels relevant for risk assessment Species Study Effect NOAEL LOAEL Rat Three-month studies of toxicitya,b,c Toxicity 1%, equal to 586 mg/ kg bw per dayd - One-year study of toxicitya Toxicity 1.3%, equal to 250 mg/kg bw per day - Two-year studies of toxicity and carcinogenicitya Toxicity 50 mg/kg bw per day - Carcinogenicity 50 mg/kg bw per day - Multigeneration reproductive toxicity studya,b Parental toxici
INCHEM_WHO_jecfa_jecmono_v62je01 NOAEL =3290 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=b1743e3578e5d18d; raw_unit=mg/kg bw per day; context=Overall, it can be concluded that the NOAEL was 25 000 mg/kg feed, equal to 3290 mg/kg bw per day, the highest dose tested (Schuh, 1990).
INCHEM_WHO_jecfa_jecmono_v62je01 NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=65cbfb5265e5daa6; raw_unit=mg/kg bw per day; context=The NOAEL was 1000 mg/kg bw per day, the highest dose tested (Müller, 1989a).
INCHEM_WHO_jecfa_jecmono_v62je01 NOAEL =100 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=4338a8e052e6fa46; raw_unit=mg/kg bw per day; context=ished at the twenty-sixth meeting (Annex 1, reference 59), based on testicular atrophy induced by the metabolite cyclohexylamine in rats, with a no-observed-adverse- effect level (NOAEL) of 100 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v62je01 NOAEL =616 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=4796304df7d59dc5; raw_unit=mg/kg bw per day; context=In the absence of toxicologically relevant findings, the NOAEL was a dietary concentration of 1.0% lycopene, the highest dose tested, equal to 586 and 616 mg/kg bw per day for males and females, respectively (Jonker et al., 2003).
INCHEM_WHO_jecfa_jecmono_v62je01 NOAEL =4500 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=d4255a51568a0cea; raw_unit=mg/kg bw per day; context=The highest dose tested, 4500 mg/kg bw per day, equivalent to 270 mg lycopene/kg bw per day, was reported to be the NOAEL for natural tomato extract (Matulka et al., 2004).
INCHEM_WHO_jecfa_jecmono_v62je01 NOAEL =500 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=2c2473ce14ba90c9; raw_unit=mg/kg bw per day; context=The NOAEL for maternal and developmental toxicity was 500 mg/kg bw per day, the highest dose tested (Edwards et al., 2004b).
INCHEM_WHO_jecfa_jecmono_v62je01 NOAEL =3290 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=b1743e3578e5d18d; raw_unit=mg/kg bw per day; context=Overall, it can be concluded that the NOAEL was 25 000 mg/kg feed, equal to 3290 mg/kg bw per day, the highest dose tested (Schuh, 1990).
INCHEM_WHO_jecfa_jecmono_v62je01 NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=65cbfb5265e5daa6; raw_unit=mg/kg bw per day; context=The NOAEL was 1000 mg/kg bw per day, the highest dose tested (Müller, 1989a).
INCHEM_WHO_jecfa_jecmono_v62je01 NOAEL =100 mg/kg bw/day Rat - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=4338a8e052e6fa46; raw_unit=mg/kg bw per day; context=ished at the twenty-sixth meeting (Annex 1, reference 59), based on testicular atrophy induced by the metabolite cyclohexylamine in rats, with a no-observed-adverse- effect level (NOAEL) of 100 mg/kg bw per day.
INCHEM_WHO_jecfa_jecmono_v62je01 NOAEL =616 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=4796304df7d59dc5; raw_unit=mg/kg bw per day; context=In the absence of toxicologically relevant findings, the NOAEL was a dietary concentration of 1.0% lycopene, the highest dose tested, equal to 586 and 616 mg/kg bw per day for males and females, respectively (Jonker et al., 2003).
INCHEM_WHO_jecfa_jecmono_v62je01 NOAEL =4500 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=d4255a51568a0cea; raw_unit=mg/kg bw per day; context=The highest dose tested, 4500 mg/kg bw per day, equivalent to 270 mg lycopene/kg bw per day, was reported to be the NOAEL for natural tomato extract (Matulka et al., 2004).
INCHEM_WHO_jecfa_jecmono_v62je01 NOAEL =500 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=2c2473ce14ba90c9; raw_unit=mg/kg bw per day; context=The NOAEL for maternal and developmental toxicity was 500 mg/kg bw per day, the highest dose tested (Edwards et al., 2004b).
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =5280 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=493188e34301bf15; raw_unit=mg/kg bw per day; context=Therefore, 50 000 mg/kg diet (equal to a dose of 5280 mg/kg bw per day) was taken to be the NOEL (McIntyre, 1990).
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =2410 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=d0b623d0b70b385d; raw_unit=mg/kg bw per day; context=The NOEL in cats was 2410 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =2500 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=140098d1e15e42e0; raw_unit=mg/kg bw per day; context=The NOEL in this study was 2500 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =630 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=55f057bfd0290053; raw_unit=mg/kg bw per day; context=The NOEL was considered to be the 1.0% dietary concentration (equal to 630 mg/kg bw per day) (Kay, 1960c;
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL ~500 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=6b6a0277af40668b; raw_unit=mg/kg bw per day; context=Based on these data, the NOEL was approximately 500 mg/kg bw per day (Calandra, 1960a).
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =250 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=a750b27736f8fe24; raw_unit=mg/kg bw per day; context=The NOEL in this study was 1.0% in the diet (equivalent to 250 mg/kg bw per day).
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =3410 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=7063636c084e6cc3; raw_unit=mg/kg bw per day; context=Therefore, 50 000 mg/kg feed (equal to 3410 mg/kg bw per day), the highest dose tested, was taken to be the NOEL.
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =2370 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=e32a15dcea36f825; raw_unit=mg/kg bw per day; context=The NOEL was 2370 mg/kg bw per day, the highest dose tested (Yoshida et al., 2004;
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =2120 mg/kg bw/day - - 2-year Carcinogenicity document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=4b7f14df3a15f606; raw_unit=mg/kg bw per day; context=The NOEL from the 2-year carcinogenicity study was 2120 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =5280 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=493188e34301bf15; raw_unit=mg/kg bw per day; context=Therefore, 50 000 mg/kg diet (equal to a dose of 5280 mg/kg bw per day) was taken to be the NOEL (McIntyre, 1990).
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =2410 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=d0b623d0b70b385d; raw_unit=mg/kg bw per day; context=The NOEL in cats was 2410 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =2500 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=140098d1e15e42e0; raw_unit=mg/kg bw per day; context=The NOEL in this study was 2500 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =630 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=55f057bfd0290053; raw_unit=mg/kg bw per day; context=The NOEL was considered to be the 1.0% dietary concentration (equal to 630 mg/kg bw per day) (Kay, 1960c;
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL ~500 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=6b6a0277af40668b; raw_unit=mg/kg bw per day; context=Based on these data, the NOEL was approximately 500 mg/kg bw per day (Calandra, 1960a).
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =250 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=a750b27736f8fe24; raw_unit=mg/kg bw per day; context=The NOEL in this study was 1.0% in the diet (equivalent to 250 mg/kg bw per day).
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =3410 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=7063636c084e6cc3; raw_unit=mg/kg bw per day; context=Therefore, 50 000 mg/kg feed (equal to 3410 mg/kg bw per day), the highest dose tested, was taken to be the NOEL.
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =2370 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=e32a15dcea36f825; raw_unit=mg/kg bw per day; context=The NOEL was 2370 mg/kg bw per day, the highest dose tested (Yoshida et al., 2004;
INCHEM_WHO_jecfa_jecmono_v62je01 NOEL =2120 mg/kg bw/day - - 2-year Carcinogenicity document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=4b7f14df3a15f606; raw_unit=mg/kg bw per day; context=The NOEL from the 2-year carcinogenicity study was 2120 mg/kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v62je01 TDI =0.8 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=61a40e93c0f40cb6; raw_unit=mg/kg body weight; context=Iron was evaluated at the twenty-seventh meeting (Annex 1, reference 62) and assigned a group provisional maximum tolerable daily intake (PMTDI) of 0.8 mg/kg body weight (bw), which applies to iron from all sources except for iron oxides used as colouring agents, supplemental iron taken during pregnancy and lactation, and supplemental iron for specific clinical requirements.
INCHEM_WHO_jecfa_jecmono_v62je01 TDI =70 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=5b4b94eb28af96a7; raw_unit=mg/kg bw; context=A group maximum tolerable daily intake (MTDI) of 70 mg/kg bw, expressed as phosphorus, was established at the twenty-sixth meeting and applies to the sum of phosphates present naturally in food and those present as additives.
INCHEM_WHO_jecfa_jecmono_v62je01 TDI =0.8 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=61a40e93c0f40cb6; raw_unit=mg/kg body weight; context=Iron was evaluated at the twenty-seventh meeting (Annex 1, reference 62) and assigned a group provisional maximum tolerable daily intake (PMTDI) of 0.8 mg/kg body weight (bw), which applies to iron from all sources except for iron oxides used as colouring agents, supplemental iron taken during pregnancy and lactation, and supplemental iron for specific clinical requirements.
INCHEM_WHO_jecfa_jecmono_v62je01 TDI =70 mg/kg bw/day - oral - Health guidance value document_id=jecfa_jecmono_v62je01; title=Safety evaluation of certain food additives; path=mirror/documents/jecfa/jecmono/v62je01.pdf; row_hash=5b4b94eb28af96a7; raw_unit=mg/kg bw; context=A group maximum tolerable daily intake (MTDI) of 70 mg/kg bw, expressed as phosphorus, was established at the twenty-sixth meeting and applies to the sum of phosphates present naturally in food and those present as additives.
ToxValDB_ECOTOX 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_ECOTOX NOEL =1 mg/kg bw/day Rat oral short-term; 30 days short-term LONG_REF=Toxicol. Ind. Health30(2): 160-173 El-Gerbed,M.S.A. Protective Effect of Lycopene on Deltamethrin-Induced Histological and Ultrastructural Changes in Kidney Tissue of Rats 2014; TITLE=Protective Effect of Lycopene on Deltamethrin-Induced Histological and Ultrastructural Changes in Kidney Tissue of Rats; AUTHOR=El-Gerbed,M.S.A.; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=168420; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2014; ORIGINAL_YEAR=2014; TOXICOLOGICAL_EFFECT=Feeding behavior: Food consumption|Growth: Weight gain|Morphology: Weight|Physiology: Food conversion efficiency; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|other; STUDY_GROUP=ECOTOX:15603656:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=e38a6f2293c2fde3290ba5407fd461a9
ToxValDB_EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL =50 mg/kg bw/day Rat oral chronic; 1 years chronic LONG_REF=EFSA NDA (2008). Safety of Synthetic Lycopene - Scientific Opinion of the Panel on Scientific Panel on Dietetic Products, Nutrition and Allergies. doi:10.2903/j.efsa.2008.676.; TITLE=Safety of Synthetic Lycopene - Scientific Opinion of the Panel on Scientific Panel on Dietetic Products, Nutrition and Allergies; AUTHOR=EFSA NDA; DOI=doi:10.2903/j.efsa.2008.676; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2008; ORIGINAL_YEAR=2008; TOXICOLOGICAL_EFFECT=clinical chemistry; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry; STUDY_GROUP=EFSA_dup_-_15613655_15613656_15613657:-:--; 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_c65fb2db2c1702d3d4abdd4c7b7e2a58
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier SB0N2N0WV6 UNII - - - chemical {"approval_status":null,"molecular_formula":"C40H56","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SB0N2N0WV6"}
openFDA substances FDA UNII substance identifier SB0N2N0WV6 UNII - - - chemical {"approval_status":null,"molecular_formula":"C40H56","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SB0N2N0WV6"}
openFDA substances FDA UNII substance identifier SB0N2N0WV6 UNII - - - chemical {"approval_status":null,"molecular_formula":"C40H56","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SB0N2N0WV6"}
openFDA substances FDA UNII substance identifier SB0N2N0WV6 UNII - - - chemical {"approval_status":null,"molecular_formula":"C40H56","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SB0N2N0WV6"}