| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-77 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=007eef0d0205f473; raw_unit=mg/kg bw.; context=At its twenty-fifth meeting, the Committee established a full ADI of 0-7 mg/kg bw. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-0.50.5 |
mg/kg bw/day |
Rat |
oral |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=555440fdd776629f; raw_unit=mg/kg bw; context=At its eighteenth meeting, the Committee considered a second long-term feeding study in rats and established a temporary ADI of 0-0.5 mg/kg bw, based on the absence of any adverse effects at the highest tested dose of 50 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-1010 |
mg/kg bw/day |
Mouse |
oral |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=57e62115827a6500; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-10 mg/kg bw, based on a NOEL of 10 000 mg/kg in the diet (equivalent to 1500 mg/kg bw per day) in the long-term study in mice (Annex 1, reference 66). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-55 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3e4d01a1f1b4080a; raw_unit=mg/kg bw; context=The Committee noted that these studies might have an effect on the ADI, so it withdrew the previously established ADI of 0-10 mg/kg bw and established a temporary ADI of 0-5 mg/kg bw, incorporating an additional 2-fold uncertainty factor, pending submission of the Biodynamics Laboratories studies by the end of 2013 (Annex 1, reference 205). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-33 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=94b658aa1cdb73d8; raw_unit=mg/kg bw; context=Using this NOAEL and an uncertainty factor of 100, the Committee established an ADI of 0-3 mg/kg bw (rounded value) for Quinoline Yellow. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-0.30.3 |
mg/kg bw/day |
Rat |
- |
short-term |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=810260b71ab341f0; raw_unit=mg/kg bw; context=The Committee established a temporary ADI of 0-0.3 mg/kg bw for rosemary extract, expressed as carnosic acid plus carnosol, on the basis of a NOAEL of 64 mg/kg bw per day, expressed as carnosic acid plus carnosol, the 175 Rosemary extract highest dose tested in a short-term toxicity study in rats, with application of |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-22 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ad166c6138f7a92c; raw_unit=mg/kg bw; context=183 Steviol glycosides (addendum) At its sixty-eighth meeting (Annex 1, reference 187), the Committee extended the temporary ADI of 0-2 mg/kg bw for steviol glycosides, expressed as steviol, pending submission of the results of ongoing clinical studies. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-44 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b03f390fa0985025; raw_unit=mg/kg bw; context=The Committee concluded that the new data were sufficient to allow the additional uncertainty factor of 2 and the temporary designation to be removed and established an ADI for steviol glycosides of 0-4 mg/kg bw, expressed as steviol. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:4.0-4.44.4 |
mg/kg bw/day |
- |
oral |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=376292714aab3c6a; raw_unit=mg/kg bw per day; context=The Committee noted that the predicted maximum dietary exposure to steviol glycosides of 4.0-4.4 mg/kg bw per day for young children who were high consumers exceeded the upper bound of the ADI (100-110%), but for other age groups, the ADI was not exceeded. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
=7.5 |
mg/kg bw/day |
Rat |
oral |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=19c03c92643addb0; raw_unit=mg/kg bw per day; context=AC, amaranth, Brilliant Blue, azorubine and Indigo Carmine) given to female Wistar Han rats (n = 15) by oral gavage before and during gestation, each at a dose of their respective ADI established by the Committee in 1964 (7.5 mg/kg bw per day for tartrazine). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
<=1000 |
mg/kg bw/day |
Rat; Dog |
- |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7a8f2d1308a35ca4; raw_unit=mg/kg bw per day; context=This ADI was based on the absence of toxicity in animal studies, including long-term rat and dog studies in which animals were fed xanthan gum at doses up to 1000 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-77 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=007eef0d0205f473; raw_unit=mg/kg bw.; context=At its twenty-fifth meeting, the Committee established a full ADI of 0-7 mg/kg bw. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-0.50.5 |
mg/kg bw/day |
Rat |
oral |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=555440fdd776629f; raw_unit=mg/kg bw; context=At its eighteenth meeting, the Committee considered a second long-term feeding study in rats and established a temporary ADI of 0-0.5 mg/kg bw, based on the absence of any adverse effects at the highest tested dose of 50 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-1010 |
mg/kg bw/day |
Mouse |
oral |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=57e62115827a6500; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-10 mg/kg bw, based on a NOEL of 10 000 mg/kg in the diet (equivalent to 1500 mg/kg bw per day) in the long-term study in mice (Annex 1, reference 66). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-55 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3e4d01a1f1b4080a; raw_unit=mg/kg bw; context=The Committee noted that these studies might have an effect on the ADI, so it withdrew the previously established ADI of 0-10 mg/kg bw and established a temporary ADI of 0-5 mg/kg bw, incorporating an additional 2-fold uncertainty factor, pending submission of the Biodynamics Laboratories studies by the end of 2013 (Annex 1, reference 205). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-33 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=94b658aa1cdb73d8; raw_unit=mg/kg bw; context=Using this NOAEL and an uncertainty factor of 100, the Committee established an ADI of 0-3 mg/kg bw (rounded value) for Quinoline Yellow. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-0.30.3 |
mg/kg bw/day |
Rat |
- |
short-term |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=810260b71ab341f0; raw_unit=mg/kg bw; context=The Committee established a temporary ADI of 0-0.3 mg/kg bw for rosemary extract, expressed as carnosic acid plus carnosol, on the basis of a NOAEL of 64 mg/kg bw per day, expressed as carnosic acid plus carnosol, the 175 Rosemary extract highest dose tested in a short-term toxicity study in rats, with application of |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-22 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ad166c6138f7a92c; raw_unit=mg/kg bw; context=183 Steviol glycosides (addendum) At its sixty-eighth meeting (Annex 1, reference 187), the Committee extended the temporary ADI of 0-2 mg/kg bw for steviol glycosides, expressed as steviol, pending submission of the results of ongoing clinical studies. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-44 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b03f390fa0985025; raw_unit=mg/kg bw; context=The Committee concluded that the new data were sufficient to allow the additional uncertainty factor of 2 and the temporary designation to be removed and established an ADI for steviol glycosides of 0-4 mg/kg bw, expressed as steviol. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:4.0-4.44.4 |
mg/kg bw/day |
- |
oral |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=376292714aab3c6a; raw_unit=mg/kg bw per day; context=The Committee noted that the predicted maximum dietary exposure to steviol glycosides of 4.0-4.4 mg/kg bw per day for young children who were high consumers exceeded the upper bound of the ADI (100-110%), but for other age groups, the ADI was not exceeded. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
=7.5 |
mg/kg bw/day |
Rat |
oral |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=19c03c92643addb0; raw_unit=mg/kg bw per day; context=AC, amaranth, Brilliant Blue, azorubine and Indigo Carmine) given to female Wistar Han rats (n = 15) by oral gavage before and during gestation, each at a dose of their respective ADI established by the Committee in 1964 (7.5 mg/kg bw per day for tartrazine). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
<=1000 |
mg/kg bw/day |
Rat; Dog |
- |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7a8f2d1308a35ca4; raw_unit=mg/kg bw per day; context=This ADI was based on the absence of toxicity in animal studies, including long-term rat and dog studies in which animals were fed xanthan gum at doses up to 1000 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-77 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=007eef0d0205f473; raw_unit=mg/kg bw.; context=At its twenty-fifth meeting, the Committee established a full ADI of 0-7 mg/kg bw. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-0.50.5 |
mg/kg bw/day |
Rat |
oral |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=555440fdd776629f; raw_unit=mg/kg bw; context=At its eighteenth meeting, the Committee considered a second long-term feeding study in rats and established a temporary ADI of 0-0.5 mg/kg bw, based on the absence of any adverse effects at the highest tested dose of 50 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-1010 |
mg/kg bw/day |
Mouse |
oral |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=57e62115827a6500; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-10 mg/kg bw, based on a NOEL of 10 000 mg/kg in the diet (equivalent to 1500 mg/kg bw per day) in the long-term study in mice (Annex 1, reference 66). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-55 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3e4d01a1f1b4080a; raw_unit=mg/kg bw; context=The Committee noted that these studies might have an effect on the ADI, so it withdrew the previously established ADI of 0-10 mg/kg bw and established a temporary ADI of 0-5 mg/kg bw, incorporating an additional 2-fold uncertainty factor, pending submission of the Biodynamics Laboratories studies by the end of 2013 (Annex 1, reference 205). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-33 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=94b658aa1cdb73d8; raw_unit=mg/kg bw; context=Using this NOAEL and an uncertainty factor of 100, the Committee established an ADI of 0-3 mg/kg bw (rounded value) for Quinoline Yellow. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-0.30.3 |
mg/kg bw/day |
Rat |
- |
short-term |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=810260b71ab341f0; raw_unit=mg/kg bw; context=The Committee established a temporary ADI of 0-0.3 mg/kg bw for rosemary extract, expressed as carnosic acid plus carnosol, on the basis of a NOAEL of 64 mg/kg bw per day, expressed as carnosic acid plus carnosol, the 175 Rosemary extract highest dose tested in a short-term toxicity study in rats, with application of |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-22 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ad166c6138f7a92c; raw_unit=mg/kg bw; context=183 Steviol glycosides (addendum) At its sixty-eighth meeting (Annex 1, reference 187), the Committee extended the temporary ADI of 0-2 mg/kg bw for steviol glycosides, expressed as steviol, pending submission of the results of ongoing clinical studies. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:0-44 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b03f390fa0985025; raw_unit=mg/kg bw; context=The Committee concluded that the new data were sufficient to allow the additional uncertainty factor of 2 and the temporary designation to be removed and established an ADI for steviol glycosides of 0-4 mg/kg bw, expressed as steviol. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
range:4.0-4.44.4 |
mg/kg bw/day |
- |
oral |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=376292714aab3c6a; raw_unit=mg/kg bw per day; context=The Committee noted that the predicted maximum dietary exposure to steviol glycosides of 4.0-4.4 mg/kg bw per day for young children who were high consumers exceeded the upper bound of the ADI (100-110%), but for other age groups, the ADI was not exceeded. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
=7.5 |
mg/kg bw/day |
Rat |
oral |
- |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=19c03c92643addb0; raw_unit=mg/kg bw per day; context=AC, amaranth, Brilliant Blue, azorubine and Indigo Carmine) given to female Wistar Han rats (n = 15) by oral gavage before and during gestation, each at a dose of their respective ADI established by the Committee in 1964 (7.5 mg/kg bw per day for tartrazine). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
ADI |
<=1000 |
mg/kg bw/day |
Rat; Dog |
- |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7a8f2d1308a35ca4; raw_unit=mg/kg bw per day; context=This ADI was based on the absence of toxicity in animal studies, including long-term rat and dog studies in which animals were fed xanthan gum at doses up to 1000 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
LOAEL |
=10000 |
mg/L |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5050b36a28c4b5b3; raw_unit=g/L; unit_normalization=converted from grams; context=The LOAEL was 10 g/L in milk replacer, or 1%, resulting in a dose of 4461 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
LOAEL |
=600 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=540996922e407844; raw_unit=mg/kg bw per day; context=necrosis in myocardial and hepatic tissues of rats at high dose and some elevated clinical chemistry values indicative of tissue damage, the lowest- observed-adverse-effect level (LOAEL) was 600 mg/kg bw per day of carnosic acid. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
LOAEL |
=10000 |
mg/L |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5050b36a28c4b5b3; raw_unit=g/L; unit_normalization=converted from grams; context=The LOAEL was 10 g/L in milk replacer, or 1%, resulting in a dose of 4461 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
LOAEL |
=600 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=540996922e407844; raw_unit=mg/kg bw per day; context=necrosis in myocardial and hepatic tissues of rats at high dose and some elevated clinical chemistry values indicative of tissue damage, the lowest- observed-adverse-effect level (LOAEL) was 600 mg/kg bw per day of carnosic acid. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
LOAEL |
=10000 |
mg/L |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5050b36a28c4b5b3; raw_unit=g/L; unit_normalization=converted from grams; context=The LOAEL was 10 g/L in milk replacer, or 1%, resulting in a dose of 4461 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
LOAEL |
=600 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=540996922e407844; raw_unit=mg/kg bw per day; context=necrosis in myocardial and hepatic tissues of rats at high dose and some elevated clinical chemistry values indicative of tissue damage, the lowest- observed-adverse-effect level (LOAEL) was 600 mg/kg bw per day of carnosic acid. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1297.5 |
mg/kg bw/day |
Dog; Pig |
oral |
21 days |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3dfd49e5e0d8243e; raw_unit=mg/kg bw per day; context=The NOAEL in beagle dogs was 5.19% (equivalent to 1297.5 mg/kg bw per day), the highest dietary concentration tested (Olson, Voelker & Shott, 1970). (c) Pigs SPF Danish Landrace pigs were equilibrated for 21 days whereupon they were distributed according to body weight into nine groups of two males and two females each. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=7318 |
mg/kg bw/day |
Mouse |
oral |
109-week |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=1f8bb86b63d22496; raw_unit=mg/kg bw per day; context=Based on this 109-week dietary study in mice, the NOAEL for Allura Red AC was 5.19% (equal to 7318 mg/kg bw per day), the highest dose tested (Reno et al., 1978, later published as Borzelleca, Olson & Reno,1991). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=695 |
mg/kg bw/day |
Rat |
oral |
92-week |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=26cccbe7e545b183; raw_unit=mg/kg bw per day; context=Based on the moderate growth depression observed at 5.19% (equivalent to 2595 mg/kg bw per day) in this 92-week dietary study in rats, the NOAEL for Allura Red AC was 1.39% (equivalent to 695 mg/kg bw per day) (Olson & Voelker, 1970). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=901 |
mg/kg bw/day |
Rat |
- |
121-week |
Carcinogenicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=6a67095abae22e23; raw_unit=mg/kg bw per day; context=Allura Red AC (addendum) Based on the body-weight reduction observed in female rats at 5.19% (equal to 3604 mg/kg bw per day) in this 121-week toxicity/carcinogenicity study, the NOAEL was 1.39% (equal to 901 mg/kg bw per day) (Borzelleca, Olson & Reno, 1989). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2520 |
mg/kg bw/day |
Mouse |
oral |
- |
Reproductive toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ae950853e8f5e403; raw_unit=mg/kg bw per day; context=Based on this multigenerational reproductive toxicity study in mice, the NOAEL was 1.68% (equivalent to 2520 mg/kg bw per day), the highest dietary concentration tested (Tanaka, 1994). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=8300 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=046f4f64c21955ce; raw_unit=mg/kg bw per day; context=Borzelleca, Olson & Reno (1991) concluded that the NOAEL for Allura Red AC was 5.19% in the diet (approximately equal to 7300 and 8300 mg/kg bw per day for males and females, respectively). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2829 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b39578bbbfc44135; raw_unit=mg/kg bw per day; context=The authors concluded that the NOAEL for Allura Red AC for male rats was 5.19% (equal to 2829 mg/kg bw per day) and for female rats was 1.39% (901 mg/kg bw per day) (Borzelleca, Olson & Reno, 1989). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=200 |
mg/kg bw/day |
- |
- |
- |
Developmental toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=a787790daaf06e61; raw_unit=mg/kg bw per day; context=Based on this developmental toxicity study, the NOAEL for Allura Red AC was 200 mg/kg bw per day, the highest dose tested (Collins, 1974). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1000 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5e4e424faaac8892; raw_unit=mg/ kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA The authors concluded that the NOAEL of Allura Red AC was 1000 mg/ kg bw per day, the highest dose tested. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=700 |
mg/kg bw/day |
- |
- |
- |
Developmental toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=15972da683c7679b; raw_unit=mg/kg bw per day; context=Based on this developmental toxicity study, the NOAEL of Allura Red AC was 700 mg/kg bw per day, the highest dose tested (Reno, 1974). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
range:0-77 |
mg/kg bw |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7beed269a3e2d2bc; raw_unit=mg/kg bw; context=Evaluation The existing ADI of 0-7 mg/kg bw is based on a NOAEL of 1.39% in the diet derived from three rat studies (Blackmore, Olson & Voelker, 1969; |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2500 |
mg/kg bw/day |
Rat; Mouse |
- |
103-week |
Carcinogenicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=e238a11ac9d6b3a6; raw_unit=mg/kg bw per day; context=Based on the results of this 103-week toxicity and carcinogenicity study, the NOAEL for locust (carob) bean gum was the highest dose tested in both mice and rats, 7500 and 2500 mg/kg bw per day, respectively (NTP, 1982; |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=240 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b4f8210cba11eb64; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 1% carob bean gum (equal to 240 mg/kg bw per day) (Van Nevel et al., 2005). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=5000 |
mg/L |
Pig |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ace25fe780a978ac; raw_unit=mg/L; context=of certain food additives Eighty-second JECFA estimated exposure to pectin from its use in infant formula (1100 mg/kg body weight [bw] per day) at the then proposed level of 0.5% (5000 mg/L) was in the region of the no-observed-adverse-effect level (NOAEL) of pectin (847 mg/kg bw per day) and close to the lowest-observed-adverse-effect level (LOAEL) (3013 mg/kg bw per day), based on decreased feed intake and body weight gain in a neonatal pig study. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=847 |
mg/kg bw/day |
Pig |
oral |
21-day |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4d2036eeaf00b7d3; raw_unit=mg/ kg bw per day; context=The NOAEL of pectin in this 21-day dietary study in pigs was 847 mg/ kg bw per day (3.0 g/L) based on the decreased feed intake and body-weight gain observed at 3013 mg/kg bw per day (10.0 g/L). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=3000 |
mg/L |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=160376d139441d67; raw_unit=g/L; unit_normalization=converted from grams; context=Consistent with the Committee’s previous evaluation, the authors concluded that the NOAEL of pectin derived from this study corresponds to the exposure level at 0.3% (3.0 g/L). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1049 |
mg/kg bw/day |
Pig |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5cea270ae00e19f5; raw_unit=mg/kg bw per day; context=The lowest NOAEL calculated using actual intake levels was 1049 mg/kg bw per day for male neonatal pigs. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2000 |
mg/L |
Pig |
- |
3-week |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=c3ed6eafa8878af2; raw_unit=g/L; unit_normalization=converted from grams; context=79 Pectin (addendum) The NOAEL for pectin in this 3-week growth study in neonatal pigs was 2 g/L in milk replacer, or 0.2%, resulting in a dose of 704 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
~7000 |
mg/kg bw/day |
Rat |
- |
short-term |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7452edf73b316e29; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL of pAOS from short-term toxicity studies in rats was about 7000 mg/kg bw per day, the highest dose tested, and concluded that pAOS is not genotoxic. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=704 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=a37adb0b64b8c511; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 0.2% pectin (equal to 704 mg/kg bw per day for males and females combined). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=7500 |
mg/kg bw/day |
Rat; Mouse |
oral |
long-term |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=1e7c06e55f93b0cb; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL in mice was 7500 mg/kg bw per day, the highest dose tested (Hogan & Knezevich,1982a). (b) Rats In a long-term rat study, groups of animals (25/sex) were fed diets containing 0%, 0.1% or 0.2% of D&C Yellow No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=250 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4654d01cca5490b5; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL for these two related studies was 0.5% in the diet (equivalent to 250 mg/kg bw per day). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=150 |
mg/kg bw/day |
Dog |
- |
2-year |
Chronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=fbdaac9d04712371; raw_unit=mg/kg bw per day; context=No treatment-related effects were noted in a 2-year study in dogs (Anonymous, 1967b), and the Committee concluded that the NOAEL for this study was 0.2% (equivalent to 150 mg/kg bw per day), the highest dose tested. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=400 |
mg/kg bw/day |
Rat |
oral |
13-week |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=82ba9b8a7ce223c7; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA The NOAEL of deodorized ethanolic extract of rosemary was 5000 mg/ kg diet (equivalent to 400 mg/kg bw per day or 40 mg/kg bw per day carnosol + carnosic acid) in rats, the highest dietary concentration tested (Nestlé Research Center, 2005a). (c) Rosemary extract (deodorized ethanol) In a 13-week study, groups of Sprague Dawley OFA rats (10 animals/sex per group, n = |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=180 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=2917d847ac1ae37a; raw_unit=mg/kg bw per day; context=The NOAEL of dietary supercritical carbon dioxide extract of rosemary was 2400 mg/kg diet (equal to 180 mg/kg bw per day or 59 mg/kg bw per day carnosol + carnosic acid) in rats, the highest concentration tested (Covance Laboratories Ltd, 2000b). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=195 |
mg/kg bw/day |
Rat |
oral |
13-week |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=537e0e53c1542ba7; raw_unit=mg/kg bw per day; context=The NOAEL of a supercritical carbon dioxide extract of rosemary was 2400 mg/kg diet (equal to 195 mg/kg bw per day or 64 mg/kg bw per day carnosol + carnosic acid) in rats, the highest dietary concentration tested (Covance Laboratories Ltd, 2002a). (e) Rosemary extract (hexane plus ethanol) In a 13-week study with a 4-week treatment-free recovery period, groups of Sprague |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=315 |
mg/kg bw/day |
- |
oral |
13 weeks |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=09fafa65df775c3d; raw_unit=mg/kg bw per day; context=153 Rosemary extract Following 13 weeks of dietary exposure, the NOAEL of a hexane plus ethanol extract of rosemary was 5000 mg/kg diet (equal to 315 mg/kg bw per day or 47 mg/kg bw per day carnosol + carnosic acid), the highest dietary concentration tested (Nestlé Research Center, 2005b). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=300 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=bb2f3c9f15dfffab; raw_unit=mg/kg bw per day; context=The marginal statistically significant increase in AST and non-dose-dependent decrease in total serum protein and relative liver weight increase observed only in mid-dose males, 300 mg/kg bw per day may be considered a NOAEL; however, in the absence of confirmatory liver histopathology results for these mid-dose animals, the NOAEL for the systemic toxicity of carnosic acid was considered to be 150 mg/kg bw per day, the lowest dose tested (Wang et al., 2012). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=64 |
mg/kg bw/day |
- |
- |
90-day |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=fe0d858f9de16710; raw_unit=mg/kg bw per day; context=The highest NOAEL expressed as carnosic acid plus carnosol in the 90-day studies was 64 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2000 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=09813eee6762986f; raw_unit=mg/kg bw per day; context=The no-observed-adverse-effect level for male and female rats was 2000 mg/kg bw per day for ferm-Reb A, the highest dose tested, or at least 660 mg of steviol equivalent/kg bw per day (Rumelhard et al., 2016). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=750 |
mg/kg bw/day |
Rat |
oral |
chronic |
Chronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ad7d021f68d57752; raw_unit=mg/kg bw per day; context=eighth meeting in 1964 (Annex 1, reference 8), when an acceptable daily intake (ADI) of 0-7.5 mg/kg body weight (bw) was established, based on a no-observed- adverse-effect level (NOAEL) equivalent to 750 mg/kg bw per day, derived from a chronic toxicity study in rats (as cited in Scientific Committee for Food, 1983, as the JECFA monograph for the eighth meeting is no longer available). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2662 |
mg/kg bw/day |
Rat |
oral |
104-week |
Carcinogenicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=129e899378eb0961; raw_unit=mg/kg bw per day; context=The Committee considered that the changes in body weights and food consumption at 5% tartrazine in the diet were relevant and concluded that the NOAEL for this 104-week carcinogenicity study was 1.5% in the diet (equal to 2173 or 2662 mg/kg bw per day in males and females, respectively). (b) Rats Tartrazine was tested for chronic toxicity in Charles River CD rats in two concurrent studies conducted in the same laboratory. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=984 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=cb28621809db1565; raw_unit=mg/kg bw per day; context=However, the Committee considered the body-weight changes in the 5% group to be significant and determined that the NOAEL should be based on results from the 2% group (equal to 984 mg/kg bw per day for male rats and 1225 mg/kg bw per day for female rats). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=3348 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=909a97237eb6e6fa; raw_unit=mg/kg bw per day; context=The NOAEL was 2641 and 3348 mg/kg bw per day for male and female rats, respectively (Borzelleca & Hallagan, 1988b). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2173 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=678172f306318717; raw_unit=mg/kg bw per day; context=Although the authors considered the NOAEL to be the highest dose tested, the Committee concluded that 1.5% in the diet, equal to 2173 mg/kg bw per day, was the NOAEL for this study, on the basis of a body-weight reduction concurrent with an increase in feed consumption at the higher dose in males. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=375 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7792e014fad7f971; raw_unit=mg/kg bw per day; context=The NOAEL of xanthan gum in neonate piglets was 375 mg/kg bw per day based on the decreased tolerability at 3750 mg/kg bw per day resulting in suboptimal body-weight gain, significant increases in absolute and relative weights of the large intestine (caecum and colon), microscopic findings in the large and small intestine and |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=500 |
mg/kg bw/day |
Rat |
oral |
- |
Reproductive toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=6616c34d44d50826; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA Based on the results of this study, the NOAEL for reproductive toxicity of xanthan gum in male and female albino rats was 500 mg/kg bw per day, the highest dose tested (Woodard et al., 1973). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=3301 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=0cbc12b135c4706a; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA a NOAEL of 3301 mg/kg bw per day, the highest dose tested (Hagiwara et al., 2004). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=220 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=aeb9b737eb26aa75; raw_unit=mg/kg bw per day; context=The margin of exposure based on this NOAEL and the conservative estimate of xanthan gum intake of 220 mg/kg bw per day by infants (high energy requirements for fully formula-fed infants) is 3.4. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3bae2407e412fa9e; raw_unit=mg/kg bw per day; context=2223), the no-observed-adverse-affect level (NOAEL)1 of 1 mg/kg bw per day for the structurally related dehydromenthofurolactone (No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=140 |
mg/kg bw/day |
Rat |
oral |
28-day |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=518da6b9fd7eda4f; raw_unit=mg/kg bw per day; context=2225 is non-genotoxic in bacte- ria, and the NOAEL of 140 mg/kg bw per day (the highest dose tested) in a 28-day study in rats (Craig, 2011a) is 4 200 times the estimated dietary exposure to No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=100 |
mg/kg bw/day |
Rat |
oral |
28-day |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=aefbc96bf7780c27; raw_unit=mg/kg bw per day; context=2226 is non-genotoxic in bacteria and in mammalian cells in vitro and in vivo, and the NOAEL of 100 mg/kg bw per day (the highest dose tested) in a 28-day study in rats (Craig, 2011b) is 7 700 times the estimated dietary exposure to No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=69 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=409437cbe2a1f656; raw_unit=mg/kg bw per day; context=1777) are non-genotoxic in bacteria, and the NOAEL of 69 mg/kg bw per day for No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=490 |
mg/kg bw/day |
Rat |
oral |
90-day |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5b953a563aa1dfc7; raw_unit=mg/kg bw per day; context=2228 is non-genotoxic in bacteria, and the NOAEL of 490 mg/kg bw per day (the highest dose tested) in a 90-day study in rats (Koetzner, 2013a) is 245 000 times the estimated dietary exposure to No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=8 |
mg/kg bw/day |
Rat |
- |
28-day |
Acute toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=f7765f32e8420ec3; raw_unit=mg/kg bw per day; context=This compound is of low acute toxicity, and from four short-term toxicity studies available, the overall NOAEL of 8 mg/kg bw per day in a 28-day study in rats (Miyata, 1995) is 32 times the SPET estimate and 40 million times the MSDI when No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=40 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=d58d5c83cd42411d; raw_unit=mg/kg bw per day; context=Although the study author proposed that the findings in the liver were an adaptive response to increased metabolic demand at higher concentrations, a NOAEL of 40 mg/kg bw per day was identified for cyclopropanecarboxylic acid (2-isopropyl-5-methyl-cyclohexyl)-amide (No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=23 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=93bfbaac7ae3aada; raw_unit=mg/kg bw per day; context=A NOAEL of 360 mg/kg feed, equal to 23 mg/kg bw per day in males and 28 mg/kg bw per day in females, was identified for (2E,6E/Z,8E)-N-(2- methylpropyl)-2,6,8-decatrienamide (No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=275 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=d314353b7a9ad6c0; raw_unit=mg/kg bw per day; context=2215), the NOAEL of 275 mg/kg bw per day for the structurally related substance cinnamaldehyde (No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=25 |
mg/kg bw/day |
Rat |
- |
- |
Reproductive toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=9bfaa27fab31815a; raw_unit=mg/kg bw per day; context=The NOAEL of 25 mg/kg bw per day from the rat reproductive toxicity study (Lewis, 2013) provides an adequate MOE of 15 million in relation to the MSDI of 0.1 ug/day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=4 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=38712ef3781f456e; raw_unit=mg/kg bw per day; context=656) in this study, the NOAEL was 4 mg/kg bw per day, the highest dose tested (Lin et al., 2011). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=75 |
mg/kg bw/day |
- |
oral |
14-day |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=13f289c28ed9218d; raw_unit=mg/kg bw per day; context=Based on reduced body-weight gain and feed consumption at 250 mg/kg bw per day, the NOAEL for systemic toxicity in this 14-day study was considered to be 75 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=15 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=deed69647af180e2; raw_unit=mg/kg bw per day; context=The NOAEL of 15 mg/kg bw per day in a 90- day toxicity study in rats (Bauter, 2015a) provides an adequate MOE of 1500 in relation to the estimated dietary exposure to No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=50 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b3bd7c25bf9ef228; raw_unit=mg/kg bw per day; context=The NOAEL was 50 mg/kg bw per day, based on decreased body weight and spleen toxicity observed at 150 mg/kg bw per day (Hirata-Koizumi et al., 2008; |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1832 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=14e3105183c65729; raw_unit=mg/kg bw per day; context=In the absence of any treatment-related adverse effects, the NOAEL was 1832 mg/kg bw per day, the highest dose tested (Moran, 1980). (c) Genotoxicity studies Results of studies of genotoxicity for tetrahydrofuran and furanone derivatives used as flavouring agents are summarized in Table 5 and described below. (i) In vitro 2,5-Dimethyl-3(2H)-furanone |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1297.5 |
mg/kg bw/day |
Dog; Pig |
oral |
21 days |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3dfd49e5e0d8243e; raw_unit=mg/kg bw per day; context=The NOAEL in beagle dogs was 5.19% (equivalent to 1297.5 mg/kg bw per day), the highest dietary concentration tested (Olson, Voelker & Shott, 1970). (c) Pigs SPF Danish Landrace pigs were equilibrated for 21 days whereupon they were distributed according to body weight into nine groups of two males and two females each. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=7318 |
mg/kg bw/day |
Mouse |
oral |
109-week |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=1f8bb86b63d22496; raw_unit=mg/kg bw per day; context=Based on this 109-week dietary study in mice, the NOAEL for Allura Red AC was 5.19% (equal to 7318 mg/kg bw per day), the highest dose tested (Reno et al., 1978, later published as Borzelleca, Olson & Reno,1991). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=695 |
mg/kg bw/day |
Rat |
oral |
92-week |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=26cccbe7e545b183; raw_unit=mg/kg bw per day; context=Based on the moderate growth depression observed at 5.19% (equivalent to 2595 mg/kg bw per day) in this 92-week dietary study in rats, the NOAEL for Allura Red AC was 1.39% (equivalent to 695 mg/kg bw per day) (Olson & Voelker, 1970). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=901 |
mg/kg bw/day |
Rat |
- |
121-week |
Carcinogenicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=6a67095abae22e23; raw_unit=mg/kg bw per day; context=Allura Red AC (addendum) Based on the body-weight reduction observed in female rats at 5.19% (equal to 3604 mg/kg bw per day) in this 121-week toxicity/carcinogenicity study, the NOAEL was 1.39% (equal to 901 mg/kg bw per day) (Borzelleca, Olson & Reno, 1989). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2520 |
mg/kg bw/day |
Mouse |
oral |
- |
Reproductive toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ae950853e8f5e403; raw_unit=mg/kg bw per day; context=Based on this multigenerational reproductive toxicity study in mice, the NOAEL was 1.68% (equivalent to 2520 mg/kg bw per day), the highest dietary concentration tested (Tanaka, 1994). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=8300 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=046f4f64c21955ce; raw_unit=mg/kg bw per day; context=Borzelleca, Olson & Reno (1991) concluded that the NOAEL for Allura Red AC was 5.19% in the diet (approximately equal to 7300 and 8300 mg/kg bw per day for males and females, respectively). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2829 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b39578bbbfc44135; raw_unit=mg/kg bw per day; context=The authors concluded that the NOAEL for Allura Red AC for male rats was 5.19% (equal to 2829 mg/kg bw per day) and for female rats was 1.39% (901 mg/kg bw per day) (Borzelleca, Olson & Reno, 1989). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=200 |
mg/kg bw/day |
- |
- |
- |
Developmental toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=a787790daaf06e61; raw_unit=mg/kg bw per day; context=Based on this developmental toxicity study, the NOAEL for Allura Red AC was 200 mg/kg bw per day, the highest dose tested (Collins, 1974). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1000 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5e4e424faaac8892; raw_unit=mg/ kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA The authors concluded that the NOAEL of Allura Red AC was 1000 mg/ kg bw per day, the highest dose tested. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=700 |
mg/kg bw/day |
- |
- |
- |
Developmental toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=15972da683c7679b; raw_unit=mg/kg bw per day; context=Based on this developmental toxicity study, the NOAEL of Allura Red AC was 700 mg/kg bw per day, the highest dose tested (Reno, 1974). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
range:0-77 |
mg/kg bw |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7beed269a3e2d2bc; raw_unit=mg/kg bw; context=Evaluation The existing ADI of 0-7 mg/kg bw is based on a NOAEL of 1.39% in the diet derived from three rat studies (Blackmore, Olson & Voelker, 1969; |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2500 |
mg/kg bw/day |
Rat; Mouse |
- |
103-week |
Carcinogenicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=e238a11ac9d6b3a6; raw_unit=mg/kg bw per day; context=Based on the results of this 103-week toxicity and carcinogenicity study, the NOAEL for locust (carob) bean gum was the highest dose tested in both mice and rats, 7500 and 2500 mg/kg bw per day, respectively (NTP, 1982; |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=240 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b4f8210cba11eb64; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 1% carob bean gum (equal to 240 mg/kg bw per day) (Van Nevel et al., 2005). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=5000 |
mg/L |
Pig |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ace25fe780a978ac; raw_unit=mg/L; context=of certain food additives Eighty-second JECFA estimated exposure to pectin from its use in infant formula (1100 mg/kg body weight [bw] per day) at the then proposed level of 0.5% (5000 mg/L) was in the region of the no-observed-adverse-effect level (NOAEL) of pectin (847 mg/kg bw per day) and close to the lowest-observed-adverse-effect level (LOAEL) (3013 mg/kg bw per day), based on decreased feed intake and body weight gain in a neonatal pig study. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=847 |
mg/kg bw/day |
Pig |
oral |
21-day |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4d2036eeaf00b7d3; raw_unit=mg/ kg bw per day; context=The NOAEL of pectin in this 21-day dietary study in pigs was 847 mg/ kg bw per day (3.0 g/L) based on the decreased feed intake and body-weight gain observed at 3013 mg/kg bw per day (10.0 g/L). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=3000 |
mg/L |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=160376d139441d67; raw_unit=g/L; unit_normalization=converted from grams; context=Consistent with the Committee’s previous evaluation, the authors concluded that the NOAEL of pectin derived from this study corresponds to the exposure level at 0.3% (3.0 g/L). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1049 |
mg/kg bw/day |
Pig |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5cea270ae00e19f5; raw_unit=mg/kg bw per day; context=The lowest NOAEL calculated using actual intake levels was 1049 mg/kg bw per day for male neonatal pigs. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2000 |
mg/L |
Pig |
- |
3-week |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=c3ed6eafa8878af2; raw_unit=g/L; unit_normalization=converted from grams; context=79 Pectin (addendum) The NOAEL for pectin in this 3-week growth study in neonatal pigs was 2 g/L in milk replacer, or 0.2%, resulting in a dose of 704 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
~7000 |
mg/kg bw/day |
Rat |
- |
short-term |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7452edf73b316e29; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL of pAOS from short-term toxicity studies in rats was about 7000 mg/kg bw per day, the highest dose tested, and concluded that pAOS is not genotoxic. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=704 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=a37adb0b64b8c511; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 0.2% pectin (equal to 704 mg/kg bw per day for males and females combined). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=7500 |
mg/kg bw/day |
Rat; Mouse |
oral |
long-term |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=1e7c06e55f93b0cb; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL in mice was 7500 mg/kg bw per day, the highest dose tested (Hogan & Knezevich,1982a). (b) Rats In a long-term rat study, groups of animals (25/sex) were fed diets containing 0%, 0.1% or 0.2% of D&C Yellow No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=250 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4654d01cca5490b5; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL for these two related studies was 0.5% in the diet (equivalent to 250 mg/kg bw per day). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=150 |
mg/kg bw/day |
Dog |
- |
2-year |
Chronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=fbdaac9d04712371; raw_unit=mg/kg bw per day; context=No treatment-related effects were noted in a 2-year study in dogs (Anonymous, 1967b), and the Committee concluded that the NOAEL for this study was 0.2% (equivalent to 150 mg/kg bw per day), the highest dose tested. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=400 |
mg/kg bw/day |
Rat |
oral |
13-week |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=82ba9b8a7ce223c7; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA The NOAEL of deodorized ethanolic extract of rosemary was 5000 mg/ kg diet (equivalent to 400 mg/kg bw per day or 40 mg/kg bw per day carnosol + carnosic acid) in rats, the highest dietary concentration tested (Nestlé Research Center, 2005a). (c) Rosemary extract (deodorized ethanol) In a 13-week study, groups of Sprague Dawley OFA rats (10 animals/sex per group, n = |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=180 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=2917d847ac1ae37a; raw_unit=mg/kg bw per day; context=The NOAEL of dietary supercritical carbon dioxide extract of rosemary was 2400 mg/kg diet (equal to 180 mg/kg bw per day or 59 mg/kg bw per day carnosol + carnosic acid) in rats, the highest concentration tested (Covance Laboratories Ltd, 2000b). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=195 |
mg/kg bw/day |
Rat |
oral |
13-week |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=537e0e53c1542ba7; raw_unit=mg/kg bw per day; context=The NOAEL of a supercritical carbon dioxide extract of rosemary was 2400 mg/kg diet (equal to 195 mg/kg bw per day or 64 mg/kg bw per day carnosol + carnosic acid) in rats, the highest dietary concentration tested (Covance Laboratories Ltd, 2002a). (e) Rosemary extract (hexane plus ethanol) In a 13-week study with a 4-week treatment-free recovery period, groups of Sprague |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=315 |
mg/kg bw/day |
- |
oral |
13 weeks |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=09fafa65df775c3d; raw_unit=mg/kg bw per day; context=153 Rosemary extract Following 13 weeks of dietary exposure, the NOAEL of a hexane plus ethanol extract of rosemary was 5000 mg/kg diet (equal to 315 mg/kg bw per day or 47 mg/kg bw per day carnosol + carnosic acid), the highest dietary concentration tested (Nestlé Research Center, 2005b). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=300 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=bb2f3c9f15dfffab; raw_unit=mg/kg bw per day; context=The marginal statistically significant increase in AST and non-dose-dependent decrease in total serum protein and relative liver weight increase observed only in mid-dose males, 300 mg/kg bw per day may be considered a NOAEL; however, in the absence of confirmatory liver histopathology results for these mid-dose animals, the NOAEL for the systemic toxicity of carnosic acid was considered to be 150 mg/kg bw per day, the lowest dose tested (Wang et al., 2012). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=64 |
mg/kg bw/day |
- |
- |
90-day |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=fe0d858f9de16710; raw_unit=mg/kg bw per day; context=The highest NOAEL expressed as carnosic acid plus carnosol in the 90-day studies was 64 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2000 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=09813eee6762986f; raw_unit=mg/kg bw per day; context=The no-observed-adverse-effect level for male and female rats was 2000 mg/kg bw per day for ferm-Reb A, the highest dose tested, or at least 660 mg of steviol equivalent/kg bw per day (Rumelhard et al., 2016). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=750 |
mg/kg bw/day |
Rat |
oral |
chronic |
Chronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ad7d021f68d57752; raw_unit=mg/kg bw per day; context=eighth meeting in 1964 (Annex 1, reference 8), when an acceptable daily intake (ADI) of 0-7.5 mg/kg body weight (bw) was established, based on a no-observed- adverse-effect level (NOAEL) equivalent to 750 mg/kg bw per day, derived from a chronic toxicity study in rats (as cited in Scientific Committee for Food, 1983, as the JECFA monograph for the eighth meeting is no longer available). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2662 |
mg/kg bw/day |
Rat |
oral |
104-week |
Carcinogenicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=129e899378eb0961; raw_unit=mg/kg bw per day; context=The Committee considered that the changes in body weights and food consumption at 5% tartrazine in the diet were relevant and concluded that the NOAEL for this 104-week carcinogenicity study was 1.5% in the diet (equal to 2173 or 2662 mg/kg bw per day in males and females, respectively). (b) Rats Tartrazine was tested for chronic toxicity in Charles River CD rats in two concurrent studies conducted in the same laboratory. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=984 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=cb28621809db1565; raw_unit=mg/kg bw per day; context=However, the Committee considered the body-weight changes in the 5% group to be significant and determined that the NOAEL should be based on results from the 2% group (equal to 984 mg/kg bw per day for male rats and 1225 mg/kg bw per day for female rats). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=3348 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=909a97237eb6e6fa; raw_unit=mg/kg bw per day; context=The NOAEL was 2641 and 3348 mg/kg bw per day for male and female rats, respectively (Borzelleca & Hallagan, 1988b). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2173 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=678172f306318717; raw_unit=mg/kg bw per day; context=Although the authors considered the NOAEL to be the highest dose tested, the Committee concluded that 1.5% in the diet, equal to 2173 mg/kg bw per day, was the NOAEL for this study, on the basis of a body-weight reduction concurrent with an increase in feed consumption at the higher dose in males. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=375 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7792e014fad7f971; raw_unit=mg/kg bw per day; context=The NOAEL of xanthan gum in neonate piglets was 375 mg/kg bw per day based on the decreased tolerability at 3750 mg/kg bw per day resulting in suboptimal body-weight gain, significant increases in absolute and relative weights of the large intestine (caecum and colon), microscopic findings in the large and small intestine and |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=500 |
mg/kg bw/day |
Rat |
oral |
- |
Reproductive toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=6616c34d44d50826; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA Based on the results of this study, the NOAEL for reproductive toxicity of xanthan gum in male and female albino rats was 500 mg/kg bw per day, the highest dose tested (Woodard et al., 1973). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=3301 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=0cbc12b135c4706a; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA a NOAEL of 3301 mg/kg bw per day, the highest dose tested (Hagiwara et al., 2004). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=220 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=aeb9b737eb26aa75; raw_unit=mg/kg bw per day; context=The margin of exposure based on this NOAEL and the conservative estimate of xanthan gum intake of 220 mg/kg bw per day by infants (high energy requirements for fully formula-fed infants) is 3.4. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3bae2407e412fa9e; raw_unit=mg/kg bw per day; context=2223), the no-observed-adverse-affect level (NOAEL)1 of 1 mg/kg bw per day for the structurally related dehydromenthofurolactone (No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=140 |
mg/kg bw/day |
Rat |
oral |
28-day |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=518da6b9fd7eda4f; raw_unit=mg/kg bw per day; context=2225 is non-genotoxic in bacte- ria, and the NOAEL of 140 mg/kg bw per day (the highest dose tested) in a 28-day study in rats (Craig, 2011a) is 4 200 times the estimated dietary exposure to No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=100 |
mg/kg bw/day |
Rat |
oral |
28-day |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=aefbc96bf7780c27; raw_unit=mg/kg bw per day; context=2226 is non-genotoxic in bacteria and in mammalian cells in vitro and in vivo, and the NOAEL of 100 mg/kg bw per day (the highest dose tested) in a 28-day study in rats (Craig, 2011b) is 7 700 times the estimated dietary exposure to No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=69 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=409437cbe2a1f656; raw_unit=mg/kg bw per day; context=1777) are non-genotoxic in bacteria, and the NOAEL of 69 mg/kg bw per day for No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=490 |
mg/kg bw/day |
Rat |
oral |
90-day |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5b953a563aa1dfc7; raw_unit=mg/kg bw per day; context=2228 is non-genotoxic in bacteria, and the NOAEL of 490 mg/kg bw per day (the highest dose tested) in a 90-day study in rats (Koetzner, 2013a) is 245 000 times the estimated dietary exposure to No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=8 |
mg/kg bw/day |
Rat |
- |
28-day |
Acute toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=f7765f32e8420ec3; raw_unit=mg/kg bw per day; context=This compound is of low acute toxicity, and from four short-term toxicity studies available, the overall NOAEL of 8 mg/kg bw per day in a 28-day study in rats (Miyata, 1995) is 32 times the SPET estimate and 40 million times the MSDI when No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=40 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=d58d5c83cd42411d; raw_unit=mg/kg bw per day; context=Although the study author proposed that the findings in the liver were an adaptive response to increased metabolic demand at higher concentrations, a NOAEL of 40 mg/kg bw per day was identified for cyclopropanecarboxylic acid (2-isopropyl-5-methyl-cyclohexyl)-amide (No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=23 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=93bfbaac7ae3aada; raw_unit=mg/kg bw per day; context=A NOAEL of 360 mg/kg feed, equal to 23 mg/kg bw per day in males and 28 mg/kg bw per day in females, was identified for (2E,6E/Z,8E)-N-(2- methylpropyl)-2,6,8-decatrienamide (No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=275 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=d314353b7a9ad6c0; raw_unit=mg/kg bw per day; context=2215), the NOAEL of 275 mg/kg bw per day for the structurally related substance cinnamaldehyde (No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=25 |
mg/kg bw/day |
Rat |
- |
- |
Reproductive toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=9bfaa27fab31815a; raw_unit=mg/kg bw per day; context=The NOAEL of 25 mg/kg bw per day from the rat reproductive toxicity study (Lewis, 2013) provides an adequate MOE of 15 million in relation to the MSDI of 0.1 ug/day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=4 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=38712ef3781f456e; raw_unit=mg/kg bw per day; context=656) in this study, the NOAEL was 4 mg/kg bw per day, the highest dose tested (Lin et al., 2011). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=75 |
mg/kg bw/day |
- |
oral |
14-day |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=13f289c28ed9218d; raw_unit=mg/kg bw per day; context=Based on reduced body-weight gain and feed consumption at 250 mg/kg bw per day, the NOAEL for systemic toxicity in this 14-day study was considered to be 75 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=15 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=deed69647af180e2; raw_unit=mg/kg bw per day; context=The NOAEL of 15 mg/kg bw per day in a 90- day toxicity study in rats (Bauter, 2015a) provides an adequate MOE of 1500 in relation to the estimated dietary exposure to No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=50 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b3bd7c25bf9ef228; raw_unit=mg/kg bw per day; context=The NOAEL was 50 mg/kg bw per day, based on decreased body weight and spleen toxicity observed at 150 mg/kg bw per day (Hirata-Koizumi et al., 2008; |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1832 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=14e3105183c65729; raw_unit=mg/kg bw per day; context=In the absence of any treatment-related adverse effects, the NOAEL was 1832 mg/kg bw per day, the highest dose tested (Moran, 1980). (c) Genotoxicity studies Results of studies of genotoxicity for tetrahydrofuran and furanone derivatives used as flavouring agents are summarized in Table 5 and described below. (i) In vitro 2,5-Dimethyl-3(2H)-furanone |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1297.5 |
mg/kg bw/day |
Dog; Pig |
oral |
21 days |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3dfd49e5e0d8243e; raw_unit=mg/kg bw per day; context=The NOAEL in beagle dogs was 5.19% (equivalent to 1297.5 mg/kg bw per day), the highest dietary concentration tested (Olson, Voelker & Shott, 1970). (c) Pigs SPF Danish Landrace pigs were equilibrated for 21 days whereupon they were distributed according to body weight into nine groups of two males and two females each. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=7318 |
mg/kg bw/day |
Mouse |
oral |
109-week |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=1f8bb86b63d22496; raw_unit=mg/kg bw per day; context=Based on this 109-week dietary study in mice, the NOAEL for Allura Red AC was 5.19% (equal to 7318 mg/kg bw per day), the highest dose tested (Reno et al., 1978, later published as Borzelleca, Olson & Reno,1991). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=695 |
mg/kg bw/day |
Rat |
oral |
92-week |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=26cccbe7e545b183; raw_unit=mg/kg bw per day; context=Based on the moderate growth depression observed at 5.19% (equivalent to 2595 mg/kg bw per day) in this 92-week dietary study in rats, the NOAEL for Allura Red AC was 1.39% (equivalent to 695 mg/kg bw per day) (Olson & Voelker, 1970). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=901 |
mg/kg bw/day |
Rat |
- |
121-week |
Carcinogenicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=6a67095abae22e23; raw_unit=mg/kg bw per day; context=Allura Red AC (addendum) Based on the body-weight reduction observed in female rats at 5.19% (equal to 3604 mg/kg bw per day) in this 121-week toxicity/carcinogenicity study, the NOAEL was 1.39% (equal to 901 mg/kg bw per day) (Borzelleca, Olson & Reno, 1989). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2520 |
mg/kg bw/day |
Mouse |
oral |
- |
Reproductive toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ae950853e8f5e403; raw_unit=mg/kg bw per day; context=Based on this multigenerational reproductive toxicity study in mice, the NOAEL was 1.68% (equivalent to 2520 mg/kg bw per day), the highest dietary concentration tested (Tanaka, 1994). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=8300 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=046f4f64c21955ce; raw_unit=mg/kg bw per day; context=Borzelleca, Olson & Reno (1991) concluded that the NOAEL for Allura Red AC was 5.19% in the diet (approximately equal to 7300 and 8300 mg/kg bw per day for males and females, respectively). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2829 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b39578bbbfc44135; raw_unit=mg/kg bw per day; context=The authors concluded that the NOAEL for Allura Red AC for male rats was 5.19% (equal to 2829 mg/kg bw per day) and for female rats was 1.39% (901 mg/kg bw per day) (Borzelleca, Olson & Reno, 1989). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=200 |
mg/kg bw/day |
- |
- |
- |
Developmental toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=a787790daaf06e61; raw_unit=mg/kg bw per day; context=Based on this developmental toxicity study, the NOAEL for Allura Red AC was 200 mg/kg bw per day, the highest dose tested (Collins, 1974). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1000 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5e4e424faaac8892; raw_unit=mg/ kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA The authors concluded that the NOAEL of Allura Red AC was 1000 mg/ kg bw per day, the highest dose tested. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=700 |
mg/kg bw/day |
- |
- |
- |
Developmental toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=15972da683c7679b; raw_unit=mg/kg bw per day; context=Based on this developmental toxicity study, the NOAEL of Allura Red AC was 700 mg/kg bw per day, the highest dose tested (Reno, 1974). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
range:0-77 |
mg/kg bw |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7beed269a3e2d2bc; raw_unit=mg/kg bw; context=Evaluation The existing ADI of 0-7 mg/kg bw is based on a NOAEL of 1.39% in the diet derived from three rat studies (Blackmore, Olson & Voelker, 1969; |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2500 |
mg/kg bw/day |
Rat; Mouse |
- |
103-week |
Carcinogenicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=e238a11ac9d6b3a6; raw_unit=mg/kg bw per day; context=Based on the results of this 103-week toxicity and carcinogenicity study, the NOAEL for locust (carob) bean gum was the highest dose tested in both mice and rats, 7500 and 2500 mg/kg bw per day, respectively (NTP, 1982; |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=240 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b4f8210cba11eb64; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 1% carob bean gum (equal to 240 mg/kg bw per day) (Van Nevel et al., 2005). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=5000 |
mg/L |
Pig |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ace25fe780a978ac; raw_unit=mg/L; context=of certain food additives Eighty-second JECFA estimated exposure to pectin from its use in infant formula (1100 mg/kg body weight [bw] per day) at the then proposed level of 0.5% (5000 mg/L) was in the region of the no-observed-adverse-effect level (NOAEL) of pectin (847 mg/kg bw per day) and close to the lowest-observed-adverse-effect level (LOAEL) (3013 mg/kg bw per day), based on decreased feed intake and body weight gain in a neonatal pig study. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=847 |
mg/kg bw/day |
Pig |
oral |
21-day |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4d2036eeaf00b7d3; raw_unit=mg/ kg bw per day; context=The NOAEL of pectin in this 21-day dietary study in pigs was 847 mg/ kg bw per day (3.0 g/L) based on the decreased feed intake and body-weight gain observed at 3013 mg/kg bw per day (10.0 g/L). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=3000 |
mg/L |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=160376d139441d67; raw_unit=g/L; unit_normalization=converted from grams; context=Consistent with the Committee’s previous evaluation, the authors concluded that the NOAEL of pectin derived from this study corresponds to the exposure level at 0.3% (3.0 g/L). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1049 |
mg/kg bw/day |
Pig |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5cea270ae00e19f5; raw_unit=mg/kg bw per day; context=The lowest NOAEL calculated using actual intake levels was 1049 mg/kg bw per day for male neonatal pigs. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2000 |
mg/L |
Pig |
- |
3-week |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=c3ed6eafa8878af2; raw_unit=g/L; unit_normalization=converted from grams; context=79 Pectin (addendum) The NOAEL for pectin in this 3-week growth study in neonatal pigs was 2 g/L in milk replacer, or 0.2%, resulting in a dose of 704 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
~7000 |
mg/kg bw/day |
Rat |
- |
short-term |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7452edf73b316e29; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL of pAOS from short-term toxicity studies in rats was about 7000 mg/kg bw per day, the highest dose tested, and concluded that pAOS is not genotoxic. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=704 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=a37adb0b64b8c511; raw_unit=mg/kg bw per day; context=The NOAEL for this study was 0.2% pectin (equal to 704 mg/kg bw per day for males and females combined). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=7500 |
mg/kg bw/day |
Rat; Mouse |
oral |
long-term |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=1e7c06e55f93b0cb; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL in mice was 7500 mg/kg bw per day, the highest dose tested (Hogan & Knezevich,1982a). (b) Rats In a long-term rat study, groups of animals (25/sex) were fed diets containing 0%, 0.1% or 0.2% of D&C Yellow No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=250 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4654d01cca5490b5; raw_unit=mg/kg bw per day; context=The Committee concluded that the NOAEL for these two related studies was 0.5% in the diet (equivalent to 250 mg/kg bw per day). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=150 |
mg/kg bw/day |
Dog |
- |
2-year |
Chronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=fbdaac9d04712371; raw_unit=mg/kg bw per day; context=No treatment-related effects were noted in a 2-year study in dogs (Anonymous, 1967b), and the Committee concluded that the NOAEL for this study was 0.2% (equivalent to 150 mg/kg bw per day), the highest dose tested. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=400 |
mg/kg bw/day |
Rat |
oral |
13-week |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=82ba9b8a7ce223c7; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA The NOAEL of deodorized ethanolic extract of rosemary was 5000 mg/ kg diet (equivalent to 400 mg/kg bw per day or 40 mg/kg bw per day carnosol + carnosic acid) in rats, the highest dietary concentration tested (Nestlé Research Center, 2005a). (c) Rosemary extract (deodorized ethanol) In a 13-week study, groups of Sprague Dawley OFA rats (10 animals/sex per group, n = |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=180 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=2917d847ac1ae37a; raw_unit=mg/kg bw per day; context=The NOAEL of dietary supercritical carbon dioxide extract of rosemary was 2400 mg/kg diet (equal to 180 mg/kg bw per day or 59 mg/kg bw per day carnosol + carnosic acid) in rats, the highest concentration tested (Covance Laboratories Ltd, 2000b). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=195 |
mg/kg bw/day |
Rat |
oral |
13-week |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=537e0e53c1542ba7; raw_unit=mg/kg bw per day; context=The NOAEL of a supercritical carbon dioxide extract of rosemary was 2400 mg/kg diet (equal to 195 mg/kg bw per day or 64 mg/kg bw per day carnosol + carnosic acid) in rats, the highest dietary concentration tested (Covance Laboratories Ltd, 2002a). (e) Rosemary extract (hexane plus ethanol) In a 13-week study with a 4-week treatment-free recovery period, groups of Sprague |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=315 |
mg/kg bw/day |
- |
oral |
13 weeks |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=09fafa65df775c3d; raw_unit=mg/kg bw per day; context=153 Rosemary extract Following 13 weeks of dietary exposure, the NOAEL of a hexane plus ethanol extract of rosemary was 5000 mg/kg diet (equal to 315 mg/kg bw per day or 47 mg/kg bw per day carnosol + carnosic acid), the highest dietary concentration tested (Nestlé Research Center, 2005b). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=300 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=bb2f3c9f15dfffab; raw_unit=mg/kg bw per day; context=The marginal statistically significant increase in AST and non-dose-dependent decrease in total serum protein and relative liver weight increase observed only in mid-dose males, 300 mg/kg bw per day may be considered a NOAEL; however, in the absence of confirmatory liver histopathology results for these mid-dose animals, the NOAEL for the systemic toxicity of carnosic acid was considered to be 150 mg/kg bw per day, the lowest dose tested (Wang et al., 2012). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=64 |
mg/kg bw/day |
- |
- |
90-day |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=fe0d858f9de16710; raw_unit=mg/kg bw per day; context=The highest NOAEL expressed as carnosic acid plus carnosol in the 90-day studies was 64 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2000 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=09813eee6762986f; raw_unit=mg/kg bw per day; context=The no-observed-adverse-effect level for male and female rats was 2000 mg/kg bw per day for ferm-Reb A, the highest dose tested, or at least 660 mg of steviol equivalent/kg bw per day (Rumelhard et al., 2016). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=750 |
mg/kg bw/day |
Rat |
oral |
chronic |
Chronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=ad7d021f68d57752; raw_unit=mg/kg bw per day; context=eighth meeting in 1964 (Annex 1, reference 8), when an acceptable daily intake (ADI) of 0-7.5 mg/kg body weight (bw) was established, based on a no-observed- adverse-effect level (NOAEL) equivalent to 750 mg/kg bw per day, derived from a chronic toxicity study in rats (as cited in Scientific Committee for Food, 1983, as the JECFA monograph for the eighth meeting is no longer available). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2662 |
mg/kg bw/day |
Rat |
oral |
104-week |
Carcinogenicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=129e899378eb0961; raw_unit=mg/kg bw per day; context=The Committee considered that the changes in body weights and food consumption at 5% tartrazine in the diet were relevant and concluded that the NOAEL for this 104-week carcinogenicity study was 1.5% in the diet (equal to 2173 or 2662 mg/kg bw per day in males and females, respectively). (b) Rats Tartrazine was tested for chronic toxicity in Charles River CD rats in two concurrent studies conducted in the same laboratory. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=984 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=cb28621809db1565; raw_unit=mg/kg bw per day; context=However, the Committee considered the body-weight changes in the 5% group to be significant and determined that the NOAEL should be based on results from the 2% group (equal to 984 mg/kg bw per day for male rats and 1225 mg/kg bw per day for female rats). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=3348 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=909a97237eb6e6fa; raw_unit=mg/kg bw per day; context=The NOAEL was 2641 and 3348 mg/kg bw per day for male and female rats, respectively (Borzelleca & Hallagan, 1988b). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=2173 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=678172f306318717; raw_unit=mg/kg bw per day; context=Although the authors considered the NOAEL to be the highest dose tested, the Committee concluded that 1.5% in the diet, equal to 2173 mg/kg bw per day, was the NOAEL for this study, on the basis of a body-weight reduction concurrent with an increase in feed consumption at the higher dose in males. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=375 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=7792e014fad7f971; raw_unit=mg/kg bw per day; context=The NOAEL of xanthan gum in neonate piglets was 375 mg/kg bw per day based on the decreased tolerability at 3750 mg/kg bw per day resulting in suboptimal body-weight gain, significant increases in absolute and relative weights of the large intestine (caecum and colon), microscopic findings in the large and small intestine and |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=500 |
mg/kg bw/day |
Rat |
oral |
- |
Reproductive toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=6616c34d44d50826; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA Based on the results of this study, the NOAEL for reproductive toxicity of xanthan gum in male and female albino rats was 500 mg/kg bw per day, the highest dose tested (Woodard et al., 1973). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=3301 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=0cbc12b135c4706a; raw_unit=mg/kg bw per day; context=73, 2017 Safety evaluation of certain food additives Eighty-second JECFA a NOAEL of 3301 mg/kg bw per day, the highest dose tested (Hagiwara et al., 2004). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=220 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=aeb9b737eb26aa75; raw_unit=mg/kg bw per day; context=The margin of exposure based on this NOAEL and the conservative estimate of xanthan gum intake of 220 mg/kg bw per day by infants (high energy requirements for fully formula-fed infants) is 3.4. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=3bae2407e412fa9e; raw_unit=mg/kg bw per day; context=2223), the no-observed-adverse-affect level (NOAEL)1 of 1 mg/kg bw per day for the structurally related dehydromenthofurolactone (No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=140 |
mg/kg bw/day |
Rat |
oral |
28-day |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=518da6b9fd7eda4f; raw_unit=mg/kg bw per day; context=2225 is non-genotoxic in bacte- ria, and the NOAEL of 140 mg/kg bw per day (the highest dose tested) in a 28-day study in rats (Craig, 2011a) is 4 200 times the estimated dietary exposure to No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=100 |
mg/kg bw/day |
Rat |
oral |
28-day |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=aefbc96bf7780c27; raw_unit=mg/kg bw per day; context=2226 is non-genotoxic in bacteria and in mammalian cells in vitro and in vivo, and the NOAEL of 100 mg/kg bw per day (the highest dose tested) in a 28-day study in rats (Craig, 2011b) is 7 700 times the estimated dietary exposure to No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=69 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=409437cbe2a1f656; raw_unit=mg/kg bw per day; context=1777) are non-genotoxic in bacteria, and the NOAEL of 69 mg/kg bw per day for No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=490 |
mg/kg bw/day |
Rat |
oral |
90-day |
Subchronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=5b953a563aa1dfc7; raw_unit=mg/kg bw per day; context=2228 is non-genotoxic in bacteria, and the NOAEL of 490 mg/kg bw per day (the highest dose tested) in a 90-day study in rats (Koetzner, 2013a) is 245 000 times the estimated dietary exposure to No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=8 |
mg/kg bw/day |
Rat |
- |
28-day |
Acute toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=f7765f32e8420ec3; raw_unit=mg/kg bw per day; context=This compound is of low acute toxicity, and from four short-term toxicity studies available, the overall NOAEL of 8 mg/kg bw per day in a 28-day study in rats (Miyata, 1995) is 32 times the SPET estimate and 40 million times the MSDI when No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=40 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=d58d5c83cd42411d; raw_unit=mg/kg bw per day; context=Although the study author proposed that the findings in the liver were an adaptive response to increased metabolic demand at higher concentrations, a NOAEL of 40 mg/kg bw per day was identified for cyclopropanecarboxylic acid (2-isopropyl-5-methyl-cyclohexyl)-amide (No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=23 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=93bfbaac7ae3aada; raw_unit=mg/kg bw per day; context=A NOAEL of 360 mg/kg feed, equal to 23 mg/kg bw per day in males and 28 mg/kg bw per day in females, was identified for (2E,6E/Z,8E)-N-(2- methylpropyl)-2,6,8-decatrienamide (No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=275 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=d314353b7a9ad6c0; raw_unit=mg/kg bw per day; context=2215), the NOAEL of 275 mg/kg bw per day for the structurally related substance cinnamaldehyde (No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=25 |
mg/kg bw/day |
Rat |
- |
- |
Reproductive toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=9bfaa27fab31815a; raw_unit=mg/kg bw per day; context=The NOAEL of 25 mg/kg bw per day from the rat reproductive toxicity study (Lewis, 2013) provides an adequate MOE of 15 million in relation to the MSDI of 0.1 ug/day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=4 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=38712ef3781f456e; raw_unit=mg/kg bw per day; context=656) in this study, the NOAEL was 4 mg/kg bw per day, the highest dose tested (Lin et al., 2011). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=75 |
mg/kg bw/day |
- |
oral |
14-day |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=13f289c28ed9218d; raw_unit=mg/kg bw per day; context=Based on reduced body-weight gain and feed consumption at 250 mg/kg bw per day, the NOAEL for systemic toxicity in this 14-day study was considered to be 75 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=15 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=deed69647af180e2; raw_unit=mg/kg bw per day; context=The NOAEL of 15 mg/kg bw per day in a 90- day toxicity study in rats (Bauter, 2015a) provides an adequate MOE of 1500 in relation to the estimated dietary exposure to No. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=50 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=b3bd7c25bf9ef228; raw_unit=mg/kg bw per day; context=The NOAEL was 50 mg/kg bw per day, based on decreased body weight and spleen toxicity observed at 150 mg/kg bw per day (Hirata-Koizumi et al., 2008; |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOAEL |
=1832 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=14e3105183c65729; raw_unit=mg/kg bw per day; context=In the absence of any treatment-related adverse effects, the NOAEL was 1832 mg/kg bw per day, the highest dose tested (Moran, 1980). (c) Genotoxicity studies Results of studies of genotoxicity for tetrahydrofuran and furanone derivatives used as flavouring agents are summarized in Table 5 and described below. (i) In vitro 2,5-Dimethyl-3(2H)-furanone |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOEL |
=500 |
mg/kg bw/day |
Rat |
oral |
long-term |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4e4886708b5e3ffe; raw_unit=mg/kg bw per day; context=At its thirteenth meeting, the Committee established a temporary acceptable daily intake (ADI) of 0-1 mg/kg body weight (bw), based on a no- observed-effect level (NOEL) of 500 mg/kg bw per day in a long-term feeding study in rats. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOEL |
=150 |
mg/kg bw/day |
- |
oral |
2 years |
Carcinogenicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=041996915f142105; raw_unit=mg/kg bw per day; context=The NOEL for D&C Yellow No.10 over 2 years was 0.2% in the diet, the highest dose tested (equivalent to 150 mg/kg bw per day). (c) Long-term studies of toxicity and carcinogenicity of unconfirmed test substances There were no long-term studies in which the test substance was unconfirmed. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOEL |
=970 |
mg/kg bw/day |
Rat |
oral |
2-year |
Chronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=c4f2afdd150a201b; raw_unit=mg/kg bw per day; context=temporary acceptable daily intake (ADI) of 0-2 mg/kg body weight (bw) for steviol glycosides, expressed as steviol, was established on the basis of the no-observed-effect levels (NOEL) of 2.5% stevioside in the diet, equal to 970 mg/kg bw per day, or 383 mg/kg bw per day expressed as steviol, in a 2-year study in rats and the application of an uncertainty factor of 200. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOEL |
=2153 |
mg/kg bw/day |
Mouse |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=f38f9996ef1ab8e3; raw_unit=mg/kg bw per day; context=The NOEL for stevioside in mice was 2153 mg/kg bw per day (Lee et al., 2012). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOEL |
=500 |
mg/kg bw/day |
Rat |
oral |
long-term |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4e4886708b5e3ffe; raw_unit=mg/kg bw per day; context=At its thirteenth meeting, the Committee established a temporary acceptable daily intake (ADI) of 0-1 mg/kg body weight (bw), based on a no- observed-effect level (NOEL) of 500 mg/kg bw per day in a long-term feeding study in rats. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOEL |
=150 |
mg/kg bw/day |
- |
oral |
2 years |
Carcinogenicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=041996915f142105; raw_unit=mg/kg bw per day; context=The NOEL for D&C Yellow No.10 over 2 years was 0.2% in the diet, the highest dose tested (equivalent to 150 mg/kg bw per day). (c) Long-term studies of toxicity and carcinogenicity of unconfirmed test substances There were no long-term studies in which the test substance was unconfirmed. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOEL |
=970 |
mg/kg bw/day |
Rat |
oral |
2-year |
Chronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=c4f2afdd150a201b; raw_unit=mg/kg bw per day; context=temporary acceptable daily intake (ADI) of 0-2 mg/kg body weight (bw) for steviol glycosides, expressed as steviol, was established on the basis of the no-observed-effect levels (NOEL) of 2.5% stevioside in the diet, equal to 970 mg/kg bw per day, or 383 mg/kg bw per day expressed as steviol, in a 2-year study in rats and the application of an uncertainty factor of 200. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOEL |
=2153 |
mg/kg bw/day |
Mouse |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=f38f9996ef1ab8e3; raw_unit=mg/kg bw per day; context=The NOEL for stevioside in mice was 2153 mg/kg bw per day (Lee et al., 2012). |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOEL |
=500 |
mg/kg bw/day |
Rat |
oral |
long-term |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=4e4886708b5e3ffe; raw_unit=mg/kg bw per day; context=At its thirteenth meeting, the Committee established a temporary acceptable daily intake (ADI) of 0-1 mg/kg body weight (bw), based on a no- observed-effect level (NOEL) of 500 mg/kg bw per day in a long-term feeding study in rats. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOEL |
=150 |
mg/kg bw/day |
- |
oral |
2 years |
Carcinogenicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=041996915f142105; raw_unit=mg/kg bw per day; context=The NOEL for D&C Yellow No.10 over 2 years was 0.2% in the diet, the highest dose tested (equivalent to 150 mg/kg bw per day). (c) Long-term studies of toxicity and carcinogenicity of unconfirmed test substances There were no long-term studies in which the test substance was unconfirmed. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOEL |
=970 |
mg/kg bw/day |
Rat |
oral |
2-year |
Chronic toxicity |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=c4f2afdd150a201b; raw_unit=mg/kg bw per day; context=temporary acceptable daily intake (ADI) of 0-2 mg/kg body weight (bw) for steviol glycosides, expressed as steviol, was established on the basis of the no-observed-effect levels (NOEL) of 2.5% stevioside in the diet, equal to 970 mg/kg bw per day, or 383 mg/kg bw per day expressed as steviol, in a 2-year study in rats and the application of an uncertainty factor of 200. |
| INCHEM_WHO_jecfa_jecmono_v73je01 |
NOEL |
=2153 |
mg/kg bw/day |
Mouse |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v73je01; title=WHO FOOD ADDITIVES SERIES: 73 Prepared by the eighty-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v73je01.pdf; row_hash=f38f9996ef1ab8e3; raw_unit=mg/kg bw per day; context=The NOEL for stevioside in mice was 2153 mg/kg bw per day (Lee et al., 2012). |