| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-0.60.6 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=e589b6c22e2de563; raw_unit=mg/kg body weight; context=At its twenty-sixth meeting, the Committee established a temporary ADI of 0-0.6 mg/kg body weight (bw) for sodium aluminium phosphate (Annex 1, reference 59). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-55 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=b0fe12504c6eaf71; raw_unit=mg/kg body weight; context=he group of benzyl derivatives, including benzoic acid and benzyl benzoate, would not present any safety concerns when used at the estimated current levels and confirmed the group ADI of 0-5 mg/kg body weight (bw) as benzoic acid equivalents (Annex 1, reference 122). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-1010 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=25efe5ad4ad6afdd; raw_unit=mg/kg bw; context=889) was evaluated at the eleventh meeting of the Committee and assigned an ADI of 0-10 mg/kg bw (Annex 1, reference 14). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
=50 |
mg/kg bw/day |
- |
oral |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=aaf4cf5d7481d8d2; raw_unit=mg/kg; context=Assuming that solid food (3 kg) and beverages (6 litres) are each allocated half of the upper limit of the ADI, a maximum concentration for Benzoe Tonkinensis of 50 mg/kg in food and 25 mg/kg in beverages can be calculated. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-0.750.75 |
mg/kg bw/day |
Rat |
oral |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=b680f384cf422dd1; raw_unit=mg/kg body weight; context=At its thirteenth meeting, the Committee reviewed these data and established a temporary ADI of 0-0.75 mg/kg body weight (bw) based on a no-observed-effect level (NOEL)1 of 150 mg/kg bw per day in a long-term feeding study in rats. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-0.1250.125 |
mg/kg bw/day |
Mouse |
oral |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=f38f029feffb3cb0; raw_unit=mg/kg bw; context=At its eighteenth meeting, the Committee considered an additional long-term feeding study in mice that had become available and revised the temporary ADI to 0-0.125 mg/kg bw based on a NOEL of 25 mg/kg bw per day (this NOEL assumed 500 mg/kg in the diet to be equivalent to 25 mg/kg bw per day). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-44 |
mg/kg bw/day |
Rat; Mouse |
- |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=539c59207c6f610a; raw_unit=mg/kg bw.; context=The results of this study in rats and a reconsideration of the severity of the renal effects observed in the long-term study in mice led the Committee to establish an ADI of 0-4 mg/kg bw. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-11 |
mg/kg bw/day |
Rat |
oral |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=360556bcdf13005c; raw_unit=mg/kg body weight; context=At its thirteenth meeting, the Committee reviewed the available data and established a temporary ADI of 0-1 mg/kg body weight (bw) based on a no-observed-effect level (NOEL)1 of 500 mg/kg bw per day in a long-term feeding study in rats. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-0.50.5 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=62ba07ed2d65dbff; raw_unit=mg/ kg bw; context=Using the results of that study, the Committee 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_v65je01 |
ADI |
range:0-2.52.5 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=39652b2c5cdab945; raw_unit=mg/kg bw.; context=At the twenty-sixth meeting, the Committee considered new studies on long- term and reproductive toxicity and established an ADI of 0-2.5 mg/kg bw. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-0.80.8 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=8c66697c7f6b105d; raw_unit=mg/kg body weight; context=Polydimethyl siloxane M The Committee withdrew the temporary ADI of 0-0.8 mg/kg body weight and re-established the ADI of 0-1.5 mg/kg body weight, originally established at the eighteenth meeting. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-0.80.8 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=8c66697c7f6b105d; raw_unit=mg/kg body weight; context=Polydimethyl siloxane M The Committee withdrew the temporary ADI of 0-0.8 mg/kg body weight and re-established the ADI of 0-1.5 mg/kg body weight, originally established at the eighteenth meeting. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-0.60.6 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=e589b6c22e2de563; raw_unit=mg/kg body weight; context=At its twenty-sixth meeting, the Committee established a temporary ADI of 0-0.6 mg/kg body weight (bw) for sodium aluminium phosphate (Annex 1, reference 59). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-55 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=b0fe12504c6eaf71; raw_unit=mg/kg body weight; context=he group of benzyl derivatives, including benzoic acid and benzyl benzoate, would not present any safety concerns when used at the estimated current levels and confirmed the group ADI of 0-5 mg/kg body weight (bw) as benzoic acid equivalents (Annex 1, reference 122). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-1010 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=25efe5ad4ad6afdd; raw_unit=mg/kg bw; context=889) was evaluated at the eleventh meeting of the Committee and assigned an ADI of 0-10 mg/kg bw (Annex 1, reference 14). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
=50 |
mg/kg bw/day |
- |
oral |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=aaf4cf5d7481d8d2; raw_unit=mg/kg; context=Assuming that solid food (3 kg) and beverages (6 litres) are each allocated half of the upper limit of the ADI, a maximum concentration for Benzoe Tonkinensis of 50 mg/kg in food and 25 mg/kg in beverages can be calculated. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-0.750.75 |
mg/kg bw/day |
Rat |
oral |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=b680f384cf422dd1; raw_unit=mg/kg body weight; context=At its thirteenth meeting, the Committee reviewed these data and established a temporary ADI of 0-0.75 mg/kg body weight (bw) based on a no-observed-effect level (NOEL)1 of 150 mg/kg bw per day in a long-term feeding study in rats. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-0.1250.125 |
mg/kg bw/day |
Mouse |
oral |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=f38f029feffb3cb0; raw_unit=mg/kg bw; context=At its eighteenth meeting, the Committee considered an additional long-term feeding study in mice that had become available and revised the temporary ADI to 0-0.125 mg/kg bw based on a NOEL of 25 mg/kg bw per day (this NOEL assumed 500 mg/kg in the diet to be equivalent to 25 mg/kg bw per day). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-44 |
mg/kg bw/day |
Rat; Mouse |
- |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=539c59207c6f610a; raw_unit=mg/kg bw.; context=The results of this study in rats and a reconsideration of the severity of the renal effects observed in the long-term study in mice led the Committee to establish an ADI of 0-4 mg/kg bw. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-11 |
mg/kg bw/day |
Rat |
oral |
long-term |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=360556bcdf13005c; raw_unit=mg/kg body weight; context=At its thirteenth meeting, the Committee reviewed the available data and established a temporary ADI of 0-1 mg/kg body weight (bw) based on a no-observed-effect level (NOEL)1 of 500 mg/kg bw per day in a long-term feeding study in rats. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-0.50.5 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=62ba07ed2d65dbff; raw_unit=mg/ kg bw; context=Using the results of that study, the Committee 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_v65je01 |
ADI |
range:0-2.52.5 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=39652b2c5cdab945; raw_unit=mg/kg bw.; context=At the twenty-sixth meeting, the Committee considered new studies on long- term and reproductive toxicity and established an ADI of 0-2.5 mg/kg bw. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
ADI |
range:0-0.80.8 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=8c66697c7f6b105d; raw_unit=mg/kg body weight; context=Polydimethyl siloxane M The Committee withdrew the temporary ADI of 0-0.8 mg/kg body weight and re-established the ADI of 0-1.5 mg/kg body weight, originally established at the eighteenth meeting. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
~31 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=9926972eba03a85d; raw_unit=mg/kg bw per day; context=The lowest-observed- adverse-effect level (LOAEL) from this study would be equivalent to a total of approximately 31 mg/kg bw per day, expressed as aluminium. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
~35 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=7c4e4b2392fbb24b; raw_unit=mg/kg bw per day; context=The LOAEL from this study would be equivalent to a total aluminium dose of approximately 35 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
=100 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=b12070cf8a338856; raw_unit=mg/kg bw per day; context=Overall, the authors concluded that the study indicated a LOAEL of 100 mg/kg bw per day and a NOAEL of 30 mg/kg bw per day (Semple, 2010; |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
range:50-7575 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=223fb429a29d81e0; raw_unit=mg/kg bw per day; context=At its current meeting, the Committee noted that the new data did not substantially change the LOAEL range of 50-75 mg/kg bw per day, but one of the studies also provided a NOAEL of 30 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
=20 |
mg/kg bw/day |
Hamster |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=392bcd517f838f17; raw_unit=mg/kg bw per day; context=A LOAEL of 20 mg/kg bw per day for cyanide was identified based on altered cerebellar development (Malomo et al., 2004). (b) Hamsters The Committee (Annex 1, reference 102) previously reviewed a study in which pregnant Golden hamsters were exposed to sodium cyanide on days 6-9 of gestation |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
=2.4 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=9c37579674a7cb39; raw_unit=mg/kg bw per day; context=A LOAEL of 2.4 mg/kg bw per day based on increased thyroid weight was determined for this study (Manzano et al., 2007). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
=1.35 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=226ff06d94a06abd; raw_unit=mg/kg bw per day; context=me-dependent increase in sphinganine or sphinganine 1-phosphate in rats consuming the 1.1 mg/kg diet, the Committee concluded that the NOAEL was 0.11 mg/kg bw per day and that the LOAEL was 1.35 mg/kg bw per day (for total fumonisins). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
=1.35 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=226ff06d94a06abd; raw_unit=mg/kg bw per day; context=me-dependent increase in sphinganine or sphinganine 1-phosphate in rats consuming the 1.1 mg/kg diet, the Committee concluded that the NOAEL was 0.11 mg/kg bw per day and that the LOAEL was 1.35 mg/kg bw per day (for total fumonisins). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
~31 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=9926972eba03a85d; raw_unit=mg/kg bw per day; context=The lowest-observed- adverse-effect level (LOAEL) from this study would be equivalent to a total of approximately 31 mg/kg bw per day, expressed as aluminium. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
~35 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=7c4e4b2392fbb24b; raw_unit=mg/kg bw per day; context=The LOAEL from this study would be equivalent to a total aluminium dose of approximately 35 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
=100 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=b12070cf8a338856; raw_unit=mg/kg bw per day; context=Overall, the authors concluded that the study indicated a LOAEL of 100 mg/kg bw per day and a NOAEL of 30 mg/kg bw per day (Semple, 2010; |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
range:50-7575 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=223fb429a29d81e0; raw_unit=mg/kg bw per day; context=At its current meeting, the Committee noted that the new data did not substantially change the LOAEL range of 50-75 mg/kg bw per day, but one of the studies also provided a NOAEL of 30 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
=20 |
mg/kg bw/day |
Hamster |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=392bcd517f838f17; raw_unit=mg/kg bw per day; context=A LOAEL of 20 mg/kg bw per day for cyanide was identified based on altered cerebellar development (Malomo et al., 2004). (b) Hamsters The Committee (Annex 1, reference 102) previously reviewed a study in which pregnant Golden hamsters were exposed to sodium cyanide on days 6-9 of gestation |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
=2.4 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=9c37579674a7cb39; raw_unit=mg/kg bw per day; context=A LOAEL of 2.4 mg/kg bw per day based on increased thyroid weight was determined for this study (Manzano et al., 2007). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
LOAEL |
=1.35 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=226ff06d94a06abd; raw_unit=mg/kg bw per day; context=me-dependent increase in sphinganine or sphinganine 1-phosphate in rats consuming the 1.1 mg/kg diet, the Committee concluded that the NOAEL was 0.11 mg/kg bw per day and that the LOAEL was 1.35 mg/kg bw per day (for total fumonisins). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
~300 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=bd22bd36077e00c0; raw_unit=mg/kg bw per day; context=hat there were no differences between the control and test groups and that the dietary concentration of Iriodin® Ti 100K of 20 000 mg/kg was the no- observed-adverse-effect level (NOAEL) (equivalent to about 300 mg/kg bw per day, expressed as aluminium) (Jochmann, 1972; |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=600 |
mg/L |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=2def14dd3c9159ca; raw_unit=mg/l; context=etardation of sexual development in the F1 females, attributed to inhibition of growth, and decreased body weight gain and liver and spleen weights in the F1 and F2 offspring, the NOAEL was 600 mg/l aluminium sulfate in the drinking- water, corresponding to 41.0 mg/kg bw per day (Fujii, 2009; |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=6.47 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=b5949277170cc618; raw_unit=mg/kg bw per day; context=Expressed as aluminium, the reported NOAEL from this study equates to 6.47 mg/kg bw per day from the test substance plus at least 1.6 mg/kg bw per day from the diet-i.e. a total of about 8 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=500 |
mg/L |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=46b185677eeb8235; raw_unit=mg/l; context=on of sexual development in the F1 females, attributed to inhibition of growth, and decreased body weight gain and liver, spleen and thymus weights in the F1 and F2 offspring, the NOAEL was 500 mg/l aluminium ammonium sulfate in the drinking- water, corresponding to 33.5 mg/kg bw per day (Fujii, 2010; |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=3.81 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=913e2e929b069ef0; raw_unit=mg/kg bw per day; context=Expressed as aluminium, the reported NOAEL from this study equates to 3.81 mg/kg bw per day from the test substance plus at least 1.6 mg/kg bw per day Aluminium-containing food additives (addendum) 23 from the diet-that is, a total of about 6 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=200 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=6be9591c1ac4bd92; raw_unit=mg/kg bw per day; context=The author considered that 1000 mg/kg bw per day was the NOAEL for systemic effects and 200 mg/kg bw per day was the NOAEL for local irritation (Beekhuijzen, 2007). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=30 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=deaabfe21d043e0b; raw_unit=mg/kg bw per day; context=Overall, the authors concluded that the study indicated a LOAEL of 100 mg/kg bw per day and a NOAEL of 30 mg/kg bw per day (Semple, 2010; |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=500 |
mg/kg bw/day |
Rat |
oral |
90-day |
Subchronic toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=27e939e3ec66e67f; raw_unit=mg/kg bw per day; context=Comparing the conservative dietary exposure estimate for Benzoe Tonkinensis of 0.2 mg/kg bw per day with the NOAEL of 500 mg/kg bw per day identified in a 90-day oral toxicity study in rats, the margin of exposure is at least 2500. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=2500 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=90a9d8a8450bdf4d; raw_unit=mg/kg bw per day; context=Overall, it can be concluded that the NOAEL was 2500 mg/kg bw per day (i.e. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=246 |
mg/kg bw/day |
- |
- |
13-week |
Subchronic toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=0ff43bb245ee3789; raw_unit=mg/kg bw per day; context=Therefore, the NOAEL was identified as 246 mg/kg bw per day as TOS, the highest dose tested in the 13-week study. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=50 |
mg/kg bw/day |
- |
- |
- |
Developmental toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=c611713045f4189e; raw_unit=mg/kg bw per day; context=The NOAEL for this study is considered to be 50 mg/kg bw per day, based on the available summarized information reported in SCCNFP (2004). (b) Developmental toxicity No information on the developmental toxicity of Quinoline Yellow was available. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=3750 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=712fc0fa18afa4ac; raw_unit=mg/kg bw per day; context=males at the highest tested dose compared with control animals, it was less than 10%, a value not considered to be biologically significant; the no-observed- adverse-effect level (NOAEL) for this study is therefore considered to be 25 000 mg/kg diet (equivalent to 3750 mg/kg bw per day). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=2250 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=d5614ea2581c08de; raw_unit=mg/kg bw per day; context=However, based on deaths and a body weight decrement relative to the controls at 50 000 mg/kg diet, the NOAEL for the study is 15 000 mg/kg diet (equivalent to 2250 mg/kg bw per day) (USFDA, 1986). (b) Rat Sunset Yellow FCF (FD&C Yellow No. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=1250 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=0b0ba72d1c3dea85; raw_unit=mg/kg bw per day; context=As the body weight decrement among males at the highest dose was less than 10%, a value not considered to be biologically significant, the NOAEL for this study is considered to be 25 000 mg/kg diet (equivalent to 1250 mg/kg bw per day). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=1500 |
mg/kg bw/day |
- |
oral |
chronic |
Chronic toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=0376572d806e6510; raw_unit=mg/kg bw per day; context=Hence, the NOAEL for the chronic phase of the study is 30 000 mg/kg diet (equivalent to 1500 mg/kg bw per day) (USFDA, 1986). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=375 |
mg/kg bw/day |
- |
oral |
- |
Reproductive toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=9f5da0aa9580e98c; raw_unit=mg/kg bw per day; context=Hence, the NOAEL for reproductive toxicity is 7500 mg/kg diet (equivalent to 375 mg/kg bw per day) (USFDA, 1986). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=6000 |
mg/kg bw/day |
- |
oral |
- |
Developmental toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=4405d7cfb1691081; raw_unit=mg/kg; context=Hence, in the absence of any effects on the reproductive parameters and inconsistent neurological outcomes, it can be concluded that the NOAEL for this study is 6000 mg/kg in the diet (approximately 1000 mg/kg bw per day), the highest dose tested (Tanaka, 1996). (b) Developmental toxicity No information on the developmental toxicity of Sunset Yellow FCF was available. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=4.5 |
mg/kg bw/day |
Rat |
- |
13-week |
Reproductive toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=de1f19ebcd59a617; raw_unit=mg/kg bw; context=The Committee of Experts on Flavouring Substances of the Council of Europe (CoE, 2005) established a temporary maximum daily intake of 0.023 mg/ kg bw based on a NOAEL of 4.5 mg/kg bw from a 13-week study showing adverse reproductive effects on male rats, applying a safety factor of 200. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=2.7 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=a26fd9d6716f88e4; raw_unit=mg/kg bw per day; context=A NOAEL of 2.7 mg/kg bw per day was determined based on a statistically significant decrease in relative cauda epididymis weight at the next higher dose level (NTP, 1993; |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.7 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=6ff0fa3a66a1bb5f; raw_unit=mg/kg bw per day; context=Based on reported behavioural changes and decreased thyroid hormones, the LOAEL and NOAEL 240 Cyanogenic glycosides (addendum) values identified for this study are 1.2 and 0.7 mg/kg bw per day, as cyanide, respectively (Jackson, 1988). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.2 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=15bf57925953355f; raw_unit=mg/kg bw per day; context=le daily intake (PMTDI) for fumonisins B1 (FB1), B2 (FB2) and B3 (FB3), alone or in combination, of 2 ug/kg body weight (bw) on the basis of the no- observed-adverse-effect level (NOAEL) of 0.2 mg/kg bw per day for kidney toxicity and application of an uncertainty factor of 100. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.005 |
mg/kg bw |
Rat |
- |
- |
Acute toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=e11f5a628c3ab783; raw_unit=ug/kg bw.; unit_normalization=converted from micrograms; context=Thus, the single-dose NOAEL for apoptosis in male Wistar rat liver would be below 5 ug/kg bw. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=45 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=f4cd1603e3e9f526; raw_unit=mg/kg bw per day; context=As only one dose was tested, a NOAEL could not be determined by the Committee, but would be below 45 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=2.2 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=91b2adfc47cad8b8; raw_unit=mg/kg bw per day; context=The NOAEL was 2.2 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
>=1 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=f13bf9a5eeb2d922; raw_unit=mg/kg bw per day; context=In a previous study using a similar experimental design, the NOAEL for liver toxicity was greater than 1 mg/kg bw per day (Annex 1, reference 153, Table 5). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=4.2 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=a5fbaa03d7f24578; raw_unit=mg/kg bw per day; context=The Committee concluded that, based on reduced body weight gain at and above 11.4 mg/kg bw per day, the NOAEL was 4.2 mg/kg bw per day, whereas for induction of GSTP+ foci, it was 11.4 mg/kg bw per day, and for lipid peroxidation, it was 21 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=15 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=934cb72de292e8cf; raw_unit=mg/kg bw per day; context=A NOAEL could Fumonisins (addendum) 347 not be determined by the Committee, as all treatment groups showed either liver pathology or reduced weight gains, but would be lower than 15 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.11 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=a8ae0ed8293f3da3; raw_unit=mg/kg bw per day; context=er and kidney and the lack of any apparent time-dependent increase in sphinganine or sphinganine 1-phosphate in rats consuming the 1.1 mg/kg diet, the Committee concluded that the NOAEL was 0.11 mg/kg bw per day and that the LOAEL was 1.35 mg/kg bw per day (for total fumonisins). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.03 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=6359a7700c7e4b56; raw_unit=mg/kg bw per day; context=hology scores and the close correlation between fumonisin exposure, the pathology scores and the levels of total sphingoid bases and sphingoid base 1-phosphates in rat kidney, the NOAEL in this study could be 0.03 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.02 |
mg/kg bw/day |
Rabbit |
oral |
24 weeks |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=8d45c093febf19e8; raw_unit=mg/kg bw per day; context=The Committee determined that the NOAEL was the dose of the control group, 0.02 mg/kg bw per day. (iii) Rabbits Crossbred male rabbits (22-24 weeks old, 1.36 ± 0.01 kg, 10 animals per group) were fed diets prepared with maize that had been inoculated with F. verticillioides MRC 826 at silking in the field. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.04 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=c92617afbeccdb5b; raw_unit=mg/ kg bw per day; context=The authors Fumonisins (addendum) 363 concluded that the data indicated a NOAEL of 1 mg/kg diet, equivalent to 0.04 mg/ kg bw per day (Zomborszky-Kovács et al., 2002a,b). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.4 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=c01018654903ff7d; raw_unit=mg/kg bw per day; context=The NOAEL was 10 mg FB1 and FB2 per kilogram diet, equivalent to 0.4 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.01 |
mg/kg bw/day |
- |
oral |
28 days |
Neurotoxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=4beabb7c2ed8c10b; raw_unit=mg/kg bw per day; context=The Committee determined that the NOAEL (intravenous) after 28 days for clinically defined neurological signs was 0.01 mg/kg bw per day. (vi) Other species Mule ducks (7 days old) were gavaged for 77 days with F. verticillioides (NRRL 34281) culture extract that was partially purified and contained FB1 at doses of 0, 2, 8, 32 and 128 mg/kg feed. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=8 |
mg/kg diet |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=7a7a6ce3f47cfe3f; raw_unit=mg/kg diet; context=The NOAEL was 8 mg/kg diet. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
>=20 |
mg/kg diet |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=d6be8b1934342874; raw_unit=mg/kg diet; context=The NOAEL was greater than 20 mg/kg diet. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
>=20 |
mg/kg bw/day |
Mouse |
intraperitoneal |
2 days |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=7e5b290b3ff6e32e; raw_unit=mg/kg bw per day; context=The NOAEL for HFB1-induced NTDs and liver toxicity in mice is greater than 20 mg/kg bw per day when dosed for 2 days intraperitoneally. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=2.2 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=91b2adfc47cad8b8; raw_unit=mg/kg bw per day; context=The NOAEL was 2.2 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
>=1 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=f13bf9a5eeb2d922; raw_unit=mg/kg bw per day; context=In a previous study using a similar experimental design, the NOAEL for liver toxicity was greater than 1 mg/kg bw per day (Annex 1, reference 153, Table 5). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=4.2 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=a5fbaa03d7f24578; raw_unit=mg/kg bw per day; context=The Committee concluded that, based on reduced body weight gain at and above 11.4 mg/kg bw per day, the NOAEL was 4.2 mg/kg bw per day, whereas for induction of GSTP+ foci, it was 11.4 mg/kg bw per day, and for lipid peroxidation, it was 21 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=15 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=934cb72de292e8cf; raw_unit=mg/kg bw per day; context=A NOAEL could Fumonisins (addendum) 347 not be determined by the Committee, as all treatment groups showed either liver pathology or reduced weight gains, but would be lower than 15 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.11 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=a8ae0ed8293f3da3; raw_unit=mg/kg bw per day; context=er and kidney and the lack of any apparent time-dependent increase in sphinganine or sphinganine 1-phosphate in rats consuming the 1.1 mg/kg diet, the Committee concluded that the NOAEL was 0.11 mg/kg bw per day and that the LOAEL was 1.35 mg/kg bw per day (for total fumonisins). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.03 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=6359a7700c7e4b56; raw_unit=mg/kg bw per day; context=hology scores and the close correlation between fumonisin exposure, the pathology scores and the levels of total sphingoid bases and sphingoid base 1-phosphates in rat kidney, the NOAEL in this study could be 0.03 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.02 |
mg/kg bw/day |
Rabbit |
oral |
24 weeks |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=8d45c093febf19e8; raw_unit=mg/kg bw per day; context=The Committee determined that the NOAEL was the dose of the control group, 0.02 mg/kg bw per day. (iii) Rabbits Crossbred male rabbits (22-24 weeks old, 1.36 ± 0.01 kg, 10 animals per group) were fed diets prepared with maize that had been inoculated with F. verticillioides MRC 826 at silking in the field. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.04 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=c92617afbeccdb5b; raw_unit=mg/ kg bw per day; context=The authors Fumonisins (addendum) 363 concluded that the data indicated a NOAEL of 1 mg/kg diet, equivalent to 0.04 mg/ kg bw per day (Zomborszky-Kovács et al., 2002a,b). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.4 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=c01018654903ff7d; raw_unit=mg/kg bw per day; context=The NOAEL was 10 mg FB1 and FB2 per kilogram diet, equivalent to 0.4 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.01 |
mg/kg bw/day |
- |
oral |
28 days |
Neurotoxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=4beabb7c2ed8c10b; raw_unit=mg/kg bw per day; context=The Committee determined that the NOAEL (intravenous) after 28 days for clinically defined neurological signs was 0.01 mg/kg bw per day. (vi) Other species Mule ducks (7 days old) were gavaged for 77 days with F. verticillioides (NRRL 34281) culture extract that was partially purified and contained FB1 at doses of 0, 2, 8, 32 and 128 mg/kg feed. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=8 |
mg/kg diet |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=7a7a6ce3f47cfe3f; raw_unit=mg/kg diet; context=The NOAEL was 8 mg/kg diet. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
>=20 |
mg/kg diet |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=d6be8b1934342874; raw_unit=mg/kg diet; context=The NOAEL was greater than 20 mg/kg diet. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
>=20 |
mg/kg bw/day |
Mouse |
intraperitoneal |
2 days |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=7e5b290b3ff6e32e; raw_unit=mg/kg bw per day; context=The NOAEL for HFB1-induced NTDs and liver toxicity in mice is greater than 20 mg/kg bw per day when dosed for 2 days intraperitoneally. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
~300 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=bd22bd36077e00c0; raw_unit=mg/kg bw per day; context=hat there were no differences between the control and test groups and that the dietary concentration of Iriodin® Ti 100K of 20 000 mg/kg was the no- observed-adverse-effect level (NOAEL) (equivalent to about 300 mg/kg bw per day, expressed as aluminium) (Jochmann, 1972; |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=600 |
mg/L |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=2def14dd3c9159ca; raw_unit=mg/l; context=etardation of sexual development in the F1 females, attributed to inhibition of growth, and decreased body weight gain and liver and spleen weights in the F1 and F2 offspring, the NOAEL was 600 mg/l aluminium sulfate in the drinking- water, corresponding to 41.0 mg/kg bw per day (Fujii, 2009; |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=6.47 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=b5949277170cc618; raw_unit=mg/kg bw per day; context=Expressed as aluminium, the reported NOAEL from this study equates to 6.47 mg/kg bw per day from the test substance plus at least 1.6 mg/kg bw per day from the diet-i.e. a total of about 8 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=500 |
mg/L |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=46b185677eeb8235; raw_unit=mg/l; context=on of sexual development in the F1 females, attributed to inhibition of growth, and decreased body weight gain and liver, spleen and thymus weights in the F1 and F2 offspring, the NOAEL was 500 mg/l aluminium ammonium sulfate in the drinking- water, corresponding to 33.5 mg/kg bw per day (Fujii, 2010; |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=3.81 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=913e2e929b069ef0; raw_unit=mg/kg bw per day; context=Expressed as aluminium, the reported NOAEL from this study equates to 3.81 mg/kg bw per day from the test substance plus at least 1.6 mg/kg bw per day Aluminium-containing food additives (addendum) 23 from the diet-that is, a total of about 6 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=200 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=6be9591c1ac4bd92; raw_unit=mg/kg bw per day; context=The author considered that 1000 mg/kg bw per day was the NOAEL for systemic effects and 200 mg/kg bw per day was the NOAEL for local irritation (Beekhuijzen, 2007). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=30 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=deaabfe21d043e0b; raw_unit=mg/kg bw per day; context=Overall, the authors concluded that the study indicated a LOAEL of 100 mg/kg bw per day and a NOAEL of 30 mg/kg bw per day (Semple, 2010; |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=500 |
mg/kg bw/day |
Rat |
oral |
90-day |
Subchronic toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=27e939e3ec66e67f; raw_unit=mg/kg bw per day; context=Comparing the conservative dietary exposure estimate for Benzoe Tonkinensis of 0.2 mg/kg bw per day with the NOAEL of 500 mg/kg bw per day identified in a 90-day oral toxicity study in rats, the margin of exposure is at least 2500. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=2500 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=90a9d8a8450bdf4d; raw_unit=mg/kg bw per day; context=Overall, it can be concluded that the NOAEL was 2500 mg/kg bw per day (i.e. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=246 |
mg/kg bw/day |
- |
- |
13-week |
Subchronic toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=0ff43bb245ee3789; raw_unit=mg/kg bw per day; context=Therefore, the NOAEL was identified as 246 mg/kg bw per day as TOS, the highest dose tested in the 13-week study. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=50 |
mg/kg bw/day |
- |
- |
- |
Developmental toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=c611713045f4189e; raw_unit=mg/kg bw per day; context=The NOAEL for this study is considered to be 50 mg/kg bw per day, based on the available summarized information reported in SCCNFP (2004). (b) Developmental toxicity No information on the developmental toxicity of Quinoline Yellow was available. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=3750 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=712fc0fa18afa4ac; raw_unit=mg/kg bw per day; context=males at the highest tested dose compared with control animals, it was less than 10%, a value not considered to be biologically significant; the no-observed- adverse-effect level (NOAEL) for this study is therefore considered to be 25 000 mg/kg diet (equivalent to 3750 mg/kg bw per day). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=2250 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=d5614ea2581c08de; raw_unit=mg/kg bw per day; context=However, based on deaths and a body weight decrement relative to the controls at 50 000 mg/kg diet, the NOAEL for the study is 15 000 mg/kg diet (equivalent to 2250 mg/kg bw per day) (USFDA, 1986). (b) Rat Sunset Yellow FCF (FD&C Yellow No. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=1250 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=0b0ba72d1c3dea85; raw_unit=mg/kg bw per day; context=As the body weight decrement among males at the highest dose was less than 10%, a value not considered to be biologically significant, the NOAEL for this study is considered to be 25 000 mg/kg diet (equivalent to 1250 mg/kg bw per day). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=1500 |
mg/kg bw/day |
- |
oral |
chronic |
Chronic toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=0376572d806e6510; raw_unit=mg/kg bw per day; context=Hence, the NOAEL for the chronic phase of the study is 30 000 mg/kg diet (equivalent to 1500 mg/kg bw per day) (USFDA, 1986). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=375 |
mg/kg bw/day |
- |
oral |
- |
Reproductive toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=9f5da0aa9580e98c; raw_unit=mg/kg bw per day; context=Hence, the NOAEL for reproductive toxicity is 7500 mg/kg diet (equivalent to 375 mg/kg bw per day) (USFDA, 1986). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=6000 |
mg/kg bw/day |
- |
oral |
- |
Developmental toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=4405d7cfb1691081; raw_unit=mg/kg; context=Hence, in the absence of any effects on the reproductive parameters and inconsistent neurological outcomes, it can be concluded that the NOAEL for this study is 6000 mg/kg in the diet (approximately 1000 mg/kg bw per day), the highest dose tested (Tanaka, 1996). (b) Developmental toxicity No information on the developmental toxicity of Sunset Yellow FCF was available. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=4.5 |
mg/kg bw/day |
Rat |
- |
13-week |
Reproductive toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=de1f19ebcd59a617; raw_unit=mg/kg bw; context=The Committee of Experts on Flavouring Substances of the Council of Europe (CoE, 2005) established a temporary maximum daily intake of 0.023 mg/ kg bw based on a NOAEL of 4.5 mg/kg bw from a 13-week study showing adverse reproductive effects on male rats, applying a safety factor of 200. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=2.7 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=a26fd9d6716f88e4; raw_unit=mg/kg bw per day; context=A NOAEL of 2.7 mg/kg bw per day was determined based on a statistically significant decrease in relative cauda epididymis weight at the next higher dose level (NTP, 1993; |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.7 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=6ff0fa3a66a1bb5f; raw_unit=mg/kg bw per day; context=Based on reported behavioural changes and decreased thyroid hormones, the LOAEL and NOAEL 240 Cyanogenic glycosides (addendum) values identified for this study are 1.2 and 0.7 mg/kg bw per day, as cyanide, respectively (Jackson, 1988). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.2 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=15bf57925953355f; raw_unit=mg/kg bw per day; context=le daily intake (PMTDI) for fumonisins B1 (FB1), B2 (FB2) and B3 (FB3), alone or in combination, of 2 ug/kg body weight (bw) on the basis of the no- observed-adverse-effect level (NOAEL) of 0.2 mg/kg bw per day for kidney toxicity and application of an uncertainty factor of 100. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.005 |
mg/kg bw |
Rat |
- |
- |
Acute toxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=e11f5a628c3ab783; raw_unit=ug/kg bw.; unit_normalization=converted from micrograms; context=Thus, the single-dose NOAEL for apoptosis in male Wistar rat liver would be below 5 ug/kg bw. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=45 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=f4cd1603e3e9f526; raw_unit=mg/kg bw per day; context=As only one dose was tested, a NOAEL could not be determined by the Committee, but would be below 45 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=2.2 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=91b2adfc47cad8b8; raw_unit=mg/kg bw per day; context=The NOAEL was 2.2 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
>=1 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=f13bf9a5eeb2d922; raw_unit=mg/kg bw per day; context=In a previous study using a similar experimental design, the NOAEL for liver toxicity was greater than 1 mg/kg bw per day (Annex 1, reference 153, Table 5). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=4.2 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=a5fbaa03d7f24578; raw_unit=mg/kg bw per day; context=The Committee concluded that, based on reduced body weight gain at and above 11.4 mg/kg bw per day, the NOAEL was 4.2 mg/kg bw per day, whereas for induction of GSTP+ foci, it was 11.4 mg/kg bw per day, and for lipid peroxidation, it was 21 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=15 |
mg/kg bw/day |
- |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=934cb72de292e8cf; raw_unit=mg/kg bw per day; context=A NOAEL could Fumonisins (addendum) 347 not be determined by the Committee, as all treatment groups showed either liver pathology or reduced weight gains, but would be lower than 15 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.11 |
mg/kg bw/day |
Rat |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=a8ae0ed8293f3da3; raw_unit=mg/kg bw per day; context=er and kidney and the lack of any apparent time-dependent increase in sphinganine or sphinganine 1-phosphate in rats consuming the 1.1 mg/kg diet, the Committee concluded that the NOAEL was 0.11 mg/kg bw per day and that the LOAEL was 1.35 mg/kg bw per day (for total fumonisins). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.03 |
mg/kg bw/day |
Rat |
- |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=6359a7700c7e4b56; raw_unit=mg/kg bw per day; context=hology scores and the close correlation between fumonisin exposure, the pathology scores and the levels of total sphingoid bases and sphingoid base 1-phosphates in rat kidney, the NOAEL in this study could be 0.03 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.02 |
mg/kg bw/day |
Rabbit |
oral |
24 weeks |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=8d45c093febf19e8; raw_unit=mg/kg bw per day; context=The Committee determined that the NOAEL was the dose of the control group, 0.02 mg/kg bw per day. (iii) Rabbits Crossbred male rabbits (22-24 weeks old, 1.36 ± 0.01 kg, 10 animals per group) were fed diets prepared with maize that had been inoculated with F. verticillioides MRC 826 at silking in the field. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.04 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=c92617afbeccdb5b; raw_unit=mg/ kg bw per day; context=The authors Fumonisins (addendum) 363 concluded that the data indicated a NOAEL of 1 mg/kg diet, equivalent to 0.04 mg/ kg bw per day (Zomborszky-Kovács et al., 2002a,b). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.4 |
mg/kg bw/day |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=c01018654903ff7d; raw_unit=mg/kg bw per day; context=The NOAEL was 10 mg FB1 and FB2 per kilogram diet, equivalent to 0.4 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=0.01 |
mg/kg bw/day |
- |
oral |
28 days |
Neurotoxicity |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=4beabb7c2ed8c10b; raw_unit=mg/kg bw per day; context=The Committee determined that the NOAEL (intravenous) after 28 days for clinically defined neurological signs was 0.01 mg/kg bw per day. (vi) Other species Mule ducks (7 days old) were gavaged for 77 days with F. verticillioides (NRRL 34281) culture extract that was partially purified and contained FB1 at doses of 0, 2, 8, 32 and 128 mg/kg feed. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
=8 |
mg/kg diet |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=7a7a6ce3f47cfe3f; raw_unit=mg/kg diet; context=The NOAEL was 8 mg/kg diet. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
>=20 |
mg/kg diet |
- |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=d6be8b1934342874; raw_unit=mg/kg diet; context=The NOAEL was greater than 20 mg/kg diet. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOAEL |
>=20 |
mg/kg bw/day |
Mouse |
intraperitoneal |
2 days |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=7e5b290b3ff6e32e; raw_unit=mg/kg bw per day; context=The NOAEL for HFB1-induced NTDs and liver toxicity in mice is greater than 20 mg/kg bw per day when dosed for 2 days intraperitoneally. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOEL |
=25 |
mg/kg bw/day |
Mouse |
oral |
long-term |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=2d95ceaa5bdf00c7; raw_unit=mg/kg bw per day; context=s eighteenth meeting, the Committee considered an additional long-term feeding study in mice that had become available and revised the temporary ADI to 0-0.125 mg/kg bw based on a NOEL of 25 mg/kg bw per day (this NOEL assumed 500 mg/kg in the diet to be equivalent to 25 mg/kg bw per day). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOEL |
=500 |
mg/kg bw/day |
Rat |
- |
long-term |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=9452780729fdaaf2; raw_unit=mg/kg bw per day; context=The Committee noted that the long-term study in rats showed no adverse effects in the kidneys and had a NOEL of 500 mg/kg bw per day based on reduced body weight gain at higher doses. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOEL |
=375 |
mg/kg bw/day |
Mouse |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=d9139e62007515ed; raw_unit=mg/kg bw per day; context=The ADI was derived by applying a 100-fold safety factor to the higher NOEL from the mouse dietary study, which was equivalent to 375 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOEL |
range:1000-15001500 |
mg/kg bw/day |
Mouse |
oral |
long-term |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=ca9d2e2245da6c6b; raw_unit=mg/kg bw per day; 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 a range of 1000-1500 mg/kg bw per day) in the long-term study in mice. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOEL |
=25 |
mg/kg bw/day |
Mouse |
oral |
long-term |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=2d95ceaa5bdf00c7; raw_unit=mg/kg bw per day; context=s eighteenth meeting, the Committee considered an additional long-term feeding study in mice that had become available and revised the temporary ADI to 0-0.125 mg/kg bw based on a NOEL of 25 mg/kg bw per day (this NOEL assumed 500 mg/kg in the diet to be equivalent to 25 mg/kg bw per day). |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOEL |
=500 |
mg/kg bw/day |
Rat |
- |
long-term |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=9452780729fdaaf2; raw_unit=mg/kg bw per day; context=The Committee noted that the long-term study in rats showed no adverse effects in the kidneys and had a NOEL of 500 mg/kg bw per day based on reduced body weight gain at higher doses. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOEL |
=375 |
mg/kg bw/day |
Mouse |
oral |
- |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=d9139e62007515ed; raw_unit=mg/kg bw per day; context=The ADI was derived by applying a 100-fold safety factor to the higher NOEL from the mouse dietary study, which was equivalent to 375 mg/kg bw per day. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
NOEL |
range:1000-15001500 |
mg/kg bw/day |
Mouse |
oral |
long-term |
Toxicology study |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=ca9d2e2245da6c6b; raw_unit=mg/kg bw per day; 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 a range of 1000-1500 mg/kg bw per day) in the long-term study in mice. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
TDI |
=0.012 |
mg/kg bw/day |
Pig |
oral |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=af26a9adb0225f0a; raw_unit=mg/kg bw; context=For acute exposure, it referred to the then current edition of the WHO Guidelines for Drinking-water Quality, which derived a TDI of 0.012 mg/kg bw, applying an uncertainty factor of 100 to a lowest-observed-adverse-effect level (LOAEL) of 1.2 mg/kg bw in a study in pigs showing functional thyroid changes. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
TDI |
=0.045 |
mg/kg bw/day |
Rat |
oral |
subchronic |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=65dd64f31e9c3cfb; raw_unit=mg/kg bw per day; context=Based on a reported NOAEL for cyanide of 4.5 mg/kg bw per day from the subchronic study described above in which rats were exposed to sodium cyanide through drinking-water, a TDI for cyanide of 0.045 mg/kg bw per day was derived. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
TDI |
=0.002 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=5fe2f1c29b551951; raw_unit=ug/kg body weight; unit_normalization=converted from micrograms; context=The Committee established a group provisional maximum tolerable daily intake (PMTDI) for fumonisins B1 (FB1), B2 (FB2) and B3 (FB3), alone or in combination, of 2 ug/kg body weight (bw) on the basis of the no- observed-adverse-effect level (NOAEL) of 0.2 mg/kg bw per day for kidney toxicity and application of an uncertainty factor of 100. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
TDI |
=0.012 |
mg/kg bw/day |
Pig |
oral |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=af26a9adb0225f0a; raw_unit=mg/kg bw; context=For acute exposure, it referred to the then current edition of the WHO Guidelines for Drinking-water Quality, which derived a TDI of 0.012 mg/kg bw, applying an uncertainty factor of 100 to a lowest-observed-adverse-effect level (LOAEL) of 1.2 mg/kg bw in a study in pigs showing functional thyroid changes. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
TDI |
=0.045 |
mg/kg bw/day |
Rat |
oral |
subchronic |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=65dd64f31e9c3cfb; raw_unit=mg/kg bw per day; context=Based on a reported NOAEL for cyanide of 4.5 mg/kg bw per day from the subchronic study described above in which rats were exposed to sodium cyanide through drinking-water, a TDI for cyanide of 0.045 mg/kg bw per day was derived. |
| INCHEM_WHO_jecfa_jecmono_v65je01 |
TDI |
=0.002 |
mg/kg bw/day |
- |
- |
- |
Health guidance value |
document_id=jecfa_jecmono_v65je01; title=WHO Additives Series 65: Safety Evaluation of Certain Food Additives and Contaminants; path=mirror/documents/jecfa/jecmono/v65je01.pdf; row_hash=5fe2f1c29b551951; raw_unit=ug/kg body weight; unit_normalization=converted from micrograms; context=The Committee established a group provisional maximum tolerable daily intake (PMTDI) for fumonisins B1 (FB1), B2 (FB2) and B3 (FB3), alone or in combination, of 2 ug/kg body weight (bw) on the basis of the no- observed-adverse-effect level (NOAEL) of 0.2 mg/kg bw per day for kidney toxicity and application of an uncertainty factor of 100. |