CI 42090 (Brilliant Blue FCF) NOAEL Studies

COSMOS_DB 8 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
COSMOS_DB	NOAEL	1000	mg/kg bw/day	rat	oral	NA	Multigeneration Reproductive	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	2000	mg/kg bw/day	rat	oral	10 day	Reproductive-developmental	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	250	mg/kg bw/day	mouse	oral	730 day	Carcinogenicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	1500	mg/kg bw/day	rat	oral	525 day	Chronic	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	200	mg/kg bw/day	rabbit	oral	29 day	Developmental	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	2500	mg/kg bw/day	rat	oral	730 day	Chronic	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	1319	mg/kg bw/day	rat	oral	777 day	Carcinogenicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	8966	mg/kg bw/day	rat	oral	728 day	Carcinogenicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study

EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=631	mg/kg bw/day	Rat	oral: feed	900 days	chronic/long term toxicity	EFSA ANS - 2010 - OutputID 461 - mortality - systemic - Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive - doi:10.2903/j.efsa.2010.1853
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=631	mg/kg bw/day	Rat	oral: feed	900 days	chronic/long term toxicity	EFSA ANS - 2010 - OutputID 461 - mortality - systemic - Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive - doi:10.2903/j.efsa.2010.1853

EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx	ADI	=6	mg/kg bw/day	Consumers	-	-	ADI	EFSA ANS - 2010 - OutputID 461 - Consumers - Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive - doi:10.2903/j.efsa.2010.1853
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx	ADI	=6	mg/kg bw/day	Consumers	-	-	ADI	EFSA ANS - 2010 - OutputID 461 - Consumers - Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive - doi:10.2903/j.efsa.2010.1853

IARC Monographs 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
IARC Monographs	IARC carcinogenicity classification	3	IARC group	-	-	1987	IARC Monographs	{"additional_info":"volume_publication_year=1987","evaluation_year":1987,"source_table":"iarc_classifications","volume":"16, Sup 7"}

INCHEM_WHO_jecfa_jecmono_v75je01 99 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-12.512.5	mg/kg bw/day	Rat	oral	2-year	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=e6bfb35815b2fb2c; raw_unit=mg/kg bw; context=In its previous evaluation at the thirteenth meeting (Annex 1, reference 19), the Committee established an ADI of 0-12.5 mg/kg bw based on a 2-year toxicity study in which 24 male and female weanling Osborne-Mendel rats, evenly divided by sex, were fed a diet containing 0, 0.5%, 1.0%, 2.0% or 5.0% Brilliant Blue FCF (purity not reported) (Hansen et al., 1966).
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-66	mg/kg bw/day	-	-	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=832766d583fa2254; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-6 mg/kg bw based on this NOAEL by applying an uncertainty factor of 100 for interspecies and intraspecies differences.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-55	mg/kg bw/day	Human; Rat	oral	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=8474b27f8824ebab; raw_unit=mg/kg bw; context=The group ADI (0-5 mg/kg bw) was derived using a four-generation study in rats with a NOAEL for β-carotene of 50 mg/kg bw per day with application of a safety factor of 10 because of the natural occurrence of carotenoids in the human diet and the low toxicity observed in animal studies.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-2525	mg/kg bw/day	Rat	-	long-term	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=e3a584b7df0c1972; raw_unit=mg/kg bw; context=The Committee concluded that Fast Green FCF was noncarcinogenic in rats and established an ADI of 0-25 mg/kg bw, based on a long-term study of toxicity in rats.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	=12	mg/kg bw/day	-	oral	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=806cfd557b803d6a; raw_unit=mg/kg bw per day; context=The Committee noted that the conservative dietary exposure estimate for Fast Green FCF of 12 mg/kg bw per day (95th percentile for adolescents) was below the upper bound of the ADI.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-3030	mg/kg bw/day	-	-	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=93538314f07d0add; raw_unit=mg/kg bw; context=The Committee concluded that metatartaric acid (when used in winemaking) should be included in the group ADI of 0-30 mg/kg bw for L(+)- tartaric acid and its sodium, potassium and potassium-sodium salts, expressed as L(+)-tartaric acid.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	=100	mg/L	-	oral	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=51d3e4cab082ce30; raw_unit=mg/L; context=The Committee noted that the dietary exposure estimate for metatartaric acid for adult consumers of wine was 4% of the upper bound of the ADI, and concluded that dietary exposure to metatartaric acid in wine at the maximum use level of 100 mg/L does not present a health concern.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-12.512.5	mg/kg bw/day	Rat	oral	2-year	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=e6bfb35815b2fb2c; raw_unit=mg/kg bw; context=In its previous evaluation at the thirteenth meeting (Annex 1, reference 19), the Committee established an ADI of 0-12.5 mg/kg bw based on a 2-year toxicity study in which 24 male and female weanling Osborne-Mendel rats, evenly divided by sex, were fed a diet containing 0, 0.5%, 1.0%, 2.0% or 5.0% Brilliant Blue FCF (purity not reported) (Hansen et al., 1966).
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-66	mg/kg bw/day	-	-	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=832766d583fa2254; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-6 mg/kg bw based on this NOAEL by applying an uncertainty factor of 100 for interspecies and intraspecies differences.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-55	mg/kg bw/day	Human; Rat	oral	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=8474b27f8824ebab; raw_unit=mg/kg bw; context=The group ADI (0-5 mg/kg bw) was derived using a four-generation study in rats with a NOAEL for β-carotene of 50 mg/kg bw per day with application of a safety factor of 10 because of the natural occurrence of carotenoids in the human diet and the low toxicity observed in animal studies.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-2525	mg/kg bw/day	Rat	-	long-term	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=e3a584b7df0c1972; raw_unit=mg/kg bw; context=The Committee concluded that Fast Green FCF was noncarcinogenic in rats and established an ADI of 0-25 mg/kg bw, based on a long-term study of toxicity in rats.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	=12	mg/kg bw/day	-	oral	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=806cfd557b803d6a; raw_unit=mg/kg bw per day; context=The Committee noted that the conservative dietary exposure estimate for Fast Green FCF of 12 mg/kg bw per day (95th percentile for adolescents) was below the upper bound of the ADI.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-3030	mg/kg bw/day	-	-	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=93538314f07d0add; raw_unit=mg/kg bw; context=The Committee concluded that metatartaric acid (when used in winemaking) should be included in the group ADI of 0-30 mg/kg bw for L(+)- tartaric acid and its sodium, potassium and potassium-sodium salts, expressed as L(+)-tartaric acid.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	=100	mg/L	-	oral	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=51d3e4cab082ce30; raw_unit=mg/L; context=The Committee noted that the dietary exposure estimate for metatartaric acid for adult consumers of wine was 4% of the upper bound of the ADI, and concluded that dietary exposure to metatartaric acid in wine at the maximum use level of 100 mg/L does not present a health concern.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-12.512.5	mg/kg bw/day	Rat	oral	2-year	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=e6bfb35815b2fb2c; raw_unit=mg/kg bw; context=In its previous evaluation at the thirteenth meeting (Annex 1, reference 19), the Committee established an ADI of 0-12.5 mg/kg bw based on a 2-year toxicity study in which 24 male and female weanling Osborne-Mendel rats, evenly divided by sex, were fed a diet containing 0, 0.5%, 1.0%, 2.0% or 5.0% Brilliant Blue FCF (purity not reported) (Hansen et al., 1966).
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-66	mg/kg bw/day	-	-	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=832766d583fa2254; raw_unit=mg/kg bw; context=The Committee established an ADI of 0-6 mg/kg bw based on this NOAEL by applying an uncertainty factor of 100 for interspecies and intraspecies differences.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-55	mg/kg bw/day	Human; Rat	oral	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=8474b27f8824ebab; raw_unit=mg/kg bw; context=The group ADI (0-5 mg/kg bw) was derived using a four-generation study in rats with a NOAEL for β-carotene of 50 mg/kg bw per day with application of a safety factor of 10 because of the natural occurrence of carotenoids in the human diet and the low toxicity observed in animal studies.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-2525	mg/kg bw/day	Rat	-	long-term	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=e3a584b7df0c1972; raw_unit=mg/kg bw; context=The Committee concluded that Fast Green FCF was noncarcinogenic in rats and established an ADI of 0-25 mg/kg bw, based on a long-term study of toxicity in rats.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	=12	mg/kg bw/day	-	oral	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=806cfd557b803d6a; raw_unit=mg/kg bw per day; context=The Committee noted that the conservative dietary exposure estimate for Fast Green FCF of 12 mg/kg bw per day (95th percentile for adolescents) was below the upper bound of the ADI.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	range:0-3030	mg/kg bw/day	-	-	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=93538314f07d0add; raw_unit=mg/kg bw; context=The Committee concluded that metatartaric acid (when used in winemaking) should be included in the group ADI of 0-30 mg/kg bw for L(+)- tartaric acid and its sodium, potassium and potassium-sodium salts, expressed as L(+)-tartaric acid.
INCHEM_WHO_jecfa_jecmono_v75je01	ADI	=100	mg/L	-	oral	-	Health guidance value	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=51d3e4cab082ce30; raw_unit=mg/L; context=The Committee noted that the dietary exposure estimate for metatartaric acid for adult consumers of wine was 4% of the upper bound of the ADI, and concluded that dietary exposure to metatartaric acid in wine at the maximum use level of 100 mg/L does not present a health concern.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2500	mg/kg bw/day	Rat	oral	chronic	Chronic toxicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=477f1c70eb15385e; raw_unit=mg/kg bw per day; context=The ADI was based on a no- observed-adverse-effect level (NOAEL) of 5% (equivalent to 2500 mg/kg bw per day) derived from a chronic dietary toxicity study in rats (Hansen et al., 1966), with no explanation for the 200-fold uncertainty factor.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=200	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=d74a97bcf7f22dae; raw_unit=mg/kg bw per day; context=The NOAEL was 0.15% (equivalent to 200 mg/kg bw per day) based on the slight reduction in weight gain and changes in organ weights of doubtful significance and some liver effects at the highest dose (Rowland et al., 1975).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=7354	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=76300ca6d2a52612; raw_unit=mg/kg bw per day; context=The NOAEL was 5%, the highest dose tested (equal to 7354 mg/kg bw per day for males and 8966 mg/kg bw per day for females) (IRDC, 1981a;
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=1073	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=ca272784ff55ce4a; raw_unit=mg/ kg bw per day; context=The NOAEL was the highest dose tested in males (equivalent to 1073 mg/ kg bw per day) and the middle dose in females (equivalent to 631 mg/kg bw per day) based on decreased mean body weight and survival at the highest dose level.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=631	mg/kg bw/day	Rat	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=7a63896cfb16ea5c; raw_unit=mg/kg bw per day; context=The NOAEL was 1% (equal to 631 mg/kg bw per day), based on 15% decreased mean terminal body weight and decreased survival of female rats at the highest dose level (IRDC, 1981b;
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=696	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=57714096378ec426; raw_unit=mg/kg bw per day; context=The study authors considered the NOAEL to be 1.25% (696 mg/kg bw per day) in males based on growth suppression observed at the 2.5% dose level, and 5% (2879 mg/kg bw per day) in females, the highest dose tested (Kuroiwa et al., 2006).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2750	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=41fa373eb5f9567e; raw_unit=mg/kg bw per day; context=The Committee considered the NOAEL to be 5% in the diet (2750 mg/kg bw per day for males and 2879 mg/kg bw per day for females), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3180	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=5aaf6e173728fdb2; raw_unit=mg/kg bw per day; context=The NOAEL for maternal toxicity was 3180 mg/kg bw per day (1000 mg/ kg bw per day, expressed as total carotenes), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=50	mg/kg bw/day	Human; Rat	oral	-	Reproductive toxicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=adf19f4565229c12; raw_unit=mg/kg bw per day; context=The group ADI (0-5 mg/kg bw) was derived using a four-generation study in rats with a NOAEL for β-carotene of 50 mg/kg bw per day with application of a safety factor of 10 because of the natural occurrence of carotenoids in the human diet and the low toxicity observed in animal studies.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	range:636-11131113	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=bd57b17115c50a31; raw_unit=mg/kg bw per day; context=Correction of the dose used to derive the NOAEL for D. salina d-limonene extract of 3180 mg/kg bw per day for the percentage of the algal component (20-35%) gives an adjusted NOAEL of 636-1113 mg/kg bw per day for the algal lipid component of the test substance.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3392	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=08e5cf5ecb350b73; raw_unit=mg/kg bw per day; context=The present Committee concluded that the NOAEL was 1.5% (equal to 3392 mg/kg bw per day) based on the lower body weights observed at 5% (equal to 11 805 mg/kg bw per day) in females (Hogan & Knezevich, 1981).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3184	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=bb3c7a15a37d51b9; raw_unit=mg/kg bw per day; context=Therefore, the NOAEL was identified as 5.0% in the diet (equal to 3184 mg/kg bw per day for males and 4021 mg/kg bw per day for females), the highest dietary concentration tested (Knezevich & Hogan, 1981).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=1000	mg/kg bw/day	-	-	-	Reproductive toxicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=0f2be0d54e3b1efb; raw_unit=mg/kg bw per day; context=The NOAEL for reproductive toxicity was 1000 mg/kg bw per day, the highest dose tested (Smith, 1973).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3000	mg/kg bw/day	Rat; Mouse	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=5e53a75c95c64472; raw_unit=mg/kg bw per day; context=The NOAEL was 2% Fast Green FCF in the diet (equivalent to 3000 mg/kg bw per day) in mice and 5.0% (equivalent to 2500 mg/kg bw per day) in rats (Hansen et al., 1966).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3044	mg/kg bw/day	Rat	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=ae6e24356e963618; raw_unit=mg/kg bw per day; context=Based on the results of these two studies, a NOAEL of 3044 mg/kg bw per day, the highest dose tested in male rats, was identified (equal to 2590 mg/kg bw per day after correcting for purity).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=647	mg/kg bw/day	Rat	-	-	Developmental toxicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=81a429105bcdb8b0; raw_unit=mg/kg bw per day; context=Based on the combined fertility and developmental toxicity study in rats (Collins et al., 1987), an overall NOAEL of 10 647 mg/kg bw per day (the highest dose tested) was identified for reproductive, developmental and parental effects.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=330	mg/kg bw/day	Dog	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=1680d7a9b63a8497; raw_unit=mg/kg bw per day; context=The NOAEL was 330 mg/kg bw per day of Jagua (Genipin-Glycine) Blue on a “blue polymer” basis, the highest dose tested (Allingham et al., 2014). (b) Dogs Mancari (2016) administered Jagua (Genipin-Glycine) Blue (batch no.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=338	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=d55965229f074a91; raw_unit=mg/kg per day; context=131 Jagua (Genipin-Glycine) Blue The NOAEL was the highest dose tested, 338 mg/kg per day on a “blue polymer” basis (Mancari, 2016).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2173	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=a1465cab87ea2b37; raw_unit=mg/kg bw per day; context=The NOAEL was 5% in the diet (2173 mg/kg bw per day in males and 2533 mg/kg bw per day in females), the highest dose tested (Imazawa et al., 2000).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2680	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=c008f017b64bca6f; raw_unit=mg/kg bw per day; context=As a result, the Committee concluded that the no-observed-adverse- effect level (NOAEL) for L(+)-tartaric acid in the study was 2680 mg/kg bw per day, the highest tested dose.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=600	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=a95381cfe4abc403; raw_unit=mg/kg bw per day; context=In the absence of any toxicologically relevant findings, the no-observed- adverse-effect level (NOAEL) was a dietary concentration of 5%, equal to 8200 and 10 600 mg/kg bw per day for males and females, respectively, or 6600 and 8600 mg/kg bw per day when corrected for purity (Sano et al., 1996).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2000	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=e1c3a6b1b5a2076b; raw_unit=mg/kg bw per day; context=In the absence of any observed toxicity, the NOAEL was 2000 mg/kg bw per day, equal to 1620 mg/kg bw per day when corrected for purity (Oka et al., 1962-1964).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=691	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=ebe512a67b3e765e; raw_unit=mg/kg bw per day; context=In the absence of any toxicologically significant findings, the NOAEL for tamarind seed polysaccharide was 120 000 mg/kg feed (equal to 10 597 and 10 691 mg/kg bw per day for males and females, respectively, or 9113 and 9194 mg/kg bw per day, when corrected for purity), the highest concentration tested (Heimbach et al., 2013;
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=8575	mg/kg bw/day	Rat	-	-	Carcinogenicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=1b7fb58c55112bb5; raw_unit=mg/kg bw per day; context=Based on the absence of carcinogenicity and dose-related systemic toxicity, the NOAEL was 5%, equal to 6658 and 8575 mg/kg bw per day for males and females, respectively, or 5380 and 6929 mg/kg bw per day when corrected for purity (Sano et al., 1996). (b) Rats Groups of Sprague Dawley rats (20/sex per group;
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=5150	mg/kg bw/day	-	-	-	Carcinogenicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=9152377be86bb332; raw_unit=mg/kg bw per day; context=Based on the absence of carcinogenicity and lack of dose-related systemic toxicity, the NOAEL was the highest concentration tested, equal to 5150 mg/kg bw per day for males and 6070 mg/kg bw per day for females, or 4161 and 4904 mg/kg bw per day, respectively, when corrected for purity (Iida et al., 1978).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=800	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=71b1eb0058b86cae; raw_unit=mg/ kg bw per day; context=Based on the lack of treatment-related results, the NOAEL was 800 mg/ kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2500	mg/kg bw/day	Rat	oral	chronic	Chronic toxicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=477f1c70eb15385e; raw_unit=mg/kg bw per day; context=The ADI was based on a no- observed-adverse-effect level (NOAEL) of 5% (equivalent to 2500 mg/kg bw per day) derived from a chronic dietary toxicity study in rats (Hansen et al., 1966), with no explanation for the 200-fold uncertainty factor.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=200	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=d74a97bcf7f22dae; raw_unit=mg/kg bw per day; context=The NOAEL was 0.15% (equivalent to 200 mg/kg bw per day) based on the slight reduction in weight gain and changes in organ weights of doubtful significance and some liver effects at the highest dose (Rowland et al., 1975).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=7354	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=76300ca6d2a52612; raw_unit=mg/kg bw per day; context=The NOAEL was 5%, the highest dose tested (equal to 7354 mg/kg bw per day for males and 8966 mg/kg bw per day for females) (IRDC, 1981a;
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=1073	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=ca272784ff55ce4a; raw_unit=mg/ kg bw per day; context=The NOAEL was the highest dose tested in males (equivalent to 1073 mg/ kg bw per day) and the middle dose in females (equivalent to 631 mg/kg bw per day) based on decreased mean body weight and survival at the highest dose level.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=631	mg/kg bw/day	Rat	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=7a63896cfb16ea5c; raw_unit=mg/kg bw per day; context=The NOAEL was 1% (equal to 631 mg/kg bw per day), based on 15% decreased mean terminal body weight and decreased survival of female rats at the highest dose level (IRDC, 1981b;
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=696	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=57714096378ec426; raw_unit=mg/kg bw per day; context=The study authors considered the NOAEL to be 1.25% (696 mg/kg bw per day) in males based on growth suppression observed at the 2.5% dose level, and 5% (2879 mg/kg bw per day) in females, the highest dose tested (Kuroiwa et al., 2006).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2750	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=41fa373eb5f9567e; raw_unit=mg/kg bw per day; context=The Committee considered the NOAEL to be 5% in the diet (2750 mg/kg bw per day for males and 2879 mg/kg bw per day for females), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3180	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=5aaf6e173728fdb2; raw_unit=mg/kg bw per day; context=The NOAEL for maternal toxicity was 3180 mg/kg bw per day (1000 mg/ kg bw per day, expressed as total carotenes), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=50	mg/kg bw/day	Human; Rat	oral	-	Reproductive toxicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=adf19f4565229c12; raw_unit=mg/kg bw per day; context=The group ADI (0-5 mg/kg bw) was derived using a four-generation study in rats with a NOAEL for β-carotene of 50 mg/kg bw per day with application of a safety factor of 10 because of the natural occurrence of carotenoids in the human diet and the low toxicity observed in animal studies.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	range:636-11131113	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=bd57b17115c50a31; raw_unit=mg/kg bw per day; context=Correction of the dose used to derive the NOAEL for D. salina d-limonene extract of 3180 mg/kg bw per day for the percentage of the algal component (20-35%) gives an adjusted NOAEL of 636-1113 mg/kg bw per day for the algal lipid component of the test substance.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3392	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=08e5cf5ecb350b73; raw_unit=mg/kg bw per day; context=The present Committee concluded that the NOAEL was 1.5% (equal to 3392 mg/kg bw per day) based on the lower body weights observed at 5% (equal to 11 805 mg/kg bw per day) in females (Hogan & Knezevich, 1981).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3184	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=bb3c7a15a37d51b9; raw_unit=mg/kg bw per day; context=Therefore, the NOAEL was identified as 5.0% in the diet (equal to 3184 mg/kg bw per day for males and 4021 mg/kg bw per day for females), the highest dietary concentration tested (Knezevich & Hogan, 1981).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=1000	mg/kg bw/day	-	-	-	Reproductive toxicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=0f2be0d54e3b1efb; raw_unit=mg/kg bw per day; context=The NOAEL for reproductive toxicity was 1000 mg/kg bw per day, the highest dose tested (Smith, 1973).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3000	mg/kg bw/day	Rat; Mouse	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=5e53a75c95c64472; raw_unit=mg/kg bw per day; context=The NOAEL was 2% Fast Green FCF in the diet (equivalent to 3000 mg/kg bw per day) in mice and 5.0% (equivalent to 2500 mg/kg bw per day) in rats (Hansen et al., 1966).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3044	mg/kg bw/day	Rat	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=ae6e24356e963618; raw_unit=mg/kg bw per day; context=Based on the results of these two studies, a NOAEL of 3044 mg/kg bw per day, the highest dose tested in male rats, was identified (equal to 2590 mg/kg bw per day after correcting for purity).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=647	mg/kg bw/day	Rat	-	-	Developmental toxicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=81a429105bcdb8b0; raw_unit=mg/kg bw per day; context=Based on the combined fertility and developmental toxicity study in rats (Collins et al., 1987), an overall NOAEL of 10 647 mg/kg bw per day (the highest dose tested) was identified for reproductive, developmental and parental effects.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=330	mg/kg bw/day	Dog	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=1680d7a9b63a8497; raw_unit=mg/kg bw per day; context=The NOAEL was 330 mg/kg bw per day of Jagua (Genipin-Glycine) Blue on a “blue polymer” basis, the highest dose tested (Allingham et al., 2014). (b) Dogs Mancari (2016) administered Jagua (Genipin-Glycine) Blue (batch no.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=338	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=d55965229f074a91; raw_unit=mg/kg per day; context=131 Jagua (Genipin-Glycine) Blue The NOAEL was the highest dose tested, 338 mg/kg per day on a “blue polymer” basis (Mancari, 2016).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2173	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=a1465cab87ea2b37; raw_unit=mg/kg bw per day; context=The NOAEL was 5% in the diet (2173 mg/kg bw per day in males and 2533 mg/kg bw per day in females), the highest dose tested (Imazawa et al., 2000).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2680	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=c008f017b64bca6f; raw_unit=mg/kg bw per day; context=As a result, the Committee concluded that the no-observed-adverse- effect level (NOAEL) for L(+)-tartaric acid in the study was 2680 mg/kg bw per day, the highest tested dose.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=600	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=a95381cfe4abc403; raw_unit=mg/kg bw per day; context=In the absence of any toxicologically relevant findings, the no-observed- adverse-effect level (NOAEL) was a dietary concentration of 5%, equal to 8200 and 10 600 mg/kg bw per day for males and females, respectively, or 6600 and 8600 mg/kg bw per day when corrected for purity (Sano et al., 1996).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2000	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=e1c3a6b1b5a2076b; raw_unit=mg/kg bw per day; context=In the absence of any observed toxicity, the NOAEL was 2000 mg/kg bw per day, equal to 1620 mg/kg bw per day when corrected for purity (Oka et al., 1962-1964).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=691	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=ebe512a67b3e765e; raw_unit=mg/kg bw per day; context=In the absence of any toxicologically significant findings, the NOAEL for tamarind seed polysaccharide was 120 000 mg/kg feed (equal to 10 597 and 10 691 mg/kg bw per day for males and females, respectively, or 9113 and 9194 mg/kg bw per day, when corrected for purity), the highest concentration tested (Heimbach et al., 2013;
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=8575	mg/kg bw/day	Rat	-	-	Carcinogenicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=1b7fb58c55112bb5; raw_unit=mg/kg bw per day; context=Based on the absence of carcinogenicity and dose-related systemic toxicity, the NOAEL was 5%, equal to 6658 and 8575 mg/kg bw per day for males and females, respectively, or 5380 and 6929 mg/kg bw per day when corrected for purity (Sano et al., 1996). (b) Rats Groups of Sprague Dawley rats (20/sex per group;
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=5150	mg/kg bw/day	-	-	-	Carcinogenicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=9152377be86bb332; raw_unit=mg/kg bw per day; context=Based on the absence of carcinogenicity and lack of dose-related systemic toxicity, the NOAEL was the highest concentration tested, equal to 5150 mg/kg bw per day for males and 6070 mg/kg bw per day for females, or 4161 and 4904 mg/kg bw per day, respectively, when corrected for purity (Iida et al., 1978).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=800	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=71b1eb0058b86cae; raw_unit=mg/ kg bw per day; context=Based on the lack of treatment-related results, the NOAEL was 800 mg/ kg bw per day, the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2500	mg/kg bw/day	Rat	oral	chronic	Chronic toxicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=477f1c70eb15385e; raw_unit=mg/kg bw per day; context=The ADI was based on a no- observed-adverse-effect level (NOAEL) of 5% (equivalent to 2500 mg/kg bw per day) derived from a chronic dietary toxicity study in rats (Hansen et al., 1966), with no explanation for the 200-fold uncertainty factor.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=200	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=d74a97bcf7f22dae; raw_unit=mg/kg bw per day; context=The NOAEL was 0.15% (equivalent to 200 mg/kg bw per day) based on the slight reduction in weight gain and changes in organ weights of doubtful significance and some liver effects at the highest dose (Rowland et al., 1975).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=7354	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=76300ca6d2a52612; raw_unit=mg/kg bw per day; context=The NOAEL was 5%, the highest dose tested (equal to 7354 mg/kg bw per day for males and 8966 mg/kg bw per day for females) (IRDC, 1981a;
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=1073	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=ca272784ff55ce4a; raw_unit=mg/ kg bw per day; context=The NOAEL was the highest dose tested in males (equivalent to 1073 mg/ kg bw per day) and the middle dose in females (equivalent to 631 mg/kg bw per day) based on decreased mean body weight and survival at the highest dose level.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=631	mg/kg bw/day	Rat	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=7a63896cfb16ea5c; raw_unit=mg/kg bw per day; context=The NOAEL was 1% (equal to 631 mg/kg bw per day), based on 15% decreased mean terminal body weight and decreased survival of female rats at the highest dose level (IRDC, 1981b;
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=696	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=57714096378ec426; raw_unit=mg/kg bw per day; context=The study authors considered the NOAEL to be 1.25% (696 mg/kg bw per day) in males based on growth suppression observed at the 2.5% dose level, and 5% (2879 mg/kg bw per day) in females, the highest dose tested (Kuroiwa et al., 2006).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2750	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=41fa373eb5f9567e; raw_unit=mg/kg bw per day; context=The Committee considered the NOAEL to be 5% in the diet (2750 mg/kg bw per day for males and 2879 mg/kg bw per day for females), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3180	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=5aaf6e173728fdb2; raw_unit=mg/kg bw per day; context=The NOAEL for maternal toxicity was 3180 mg/kg bw per day (1000 mg/ kg bw per day, expressed as total carotenes), the highest dose tested.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=50	mg/kg bw/day	Human; Rat	oral	-	Reproductive toxicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=adf19f4565229c12; raw_unit=mg/kg bw per day; context=The group ADI (0-5 mg/kg bw) was derived using a four-generation study in rats with a NOAEL for β-carotene of 50 mg/kg bw per day with application of a safety factor of 10 because of the natural occurrence of carotenoids in the human diet and the low toxicity observed in animal studies.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	range:636-11131113	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=bd57b17115c50a31; raw_unit=mg/kg bw per day; context=Correction of the dose used to derive the NOAEL for D. salina d-limonene extract of 3180 mg/kg bw per day for the percentage of the algal component (20-35%) gives an adjusted NOAEL of 636-1113 mg/kg bw per day for the algal lipid component of the test substance.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3392	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=08e5cf5ecb350b73; raw_unit=mg/kg bw per day; context=The present Committee concluded that the NOAEL was 1.5% (equal to 3392 mg/kg bw per day) based on the lower body weights observed at 5% (equal to 11 805 mg/kg bw per day) in females (Hogan & Knezevich, 1981).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3184	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=bb3c7a15a37d51b9; raw_unit=mg/kg bw per day; context=Therefore, the NOAEL was identified as 5.0% in the diet (equal to 3184 mg/kg bw per day for males and 4021 mg/kg bw per day for females), the highest dietary concentration tested (Knezevich & Hogan, 1981).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=1000	mg/kg bw/day	-	-	-	Reproductive toxicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=0f2be0d54e3b1efb; raw_unit=mg/kg bw per day; context=The NOAEL for reproductive toxicity was 1000 mg/kg bw per day, the highest dose tested (Smith, 1973).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3000	mg/kg bw/day	Rat; Mouse	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=5e53a75c95c64472; raw_unit=mg/kg bw per day; context=The NOAEL was 2% Fast Green FCF in the diet (equivalent to 3000 mg/kg bw per day) in mice and 5.0% (equivalent to 2500 mg/kg bw per day) in rats (Hansen et al., 1966).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=3044	mg/kg bw/day	Rat	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=ae6e24356e963618; raw_unit=mg/kg bw per day; context=Based on the results of these two studies, a NOAEL of 3044 mg/kg bw per day, the highest dose tested in male rats, was identified (equal to 2590 mg/kg bw per day after correcting for purity).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=647	mg/kg bw/day	Rat	-	-	Developmental toxicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=81a429105bcdb8b0; raw_unit=mg/kg bw per day; context=Based on the combined fertility and developmental toxicity study in rats (Collins et al., 1987), an overall NOAEL of 10 647 mg/kg bw per day (the highest dose tested) was identified for reproductive, developmental and parental effects.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=330	mg/kg bw/day	Dog	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=1680d7a9b63a8497; raw_unit=mg/kg bw per day; context=The NOAEL was 330 mg/kg bw per day of Jagua (Genipin-Glycine) Blue on a “blue polymer” basis, the highest dose tested (Allingham et al., 2014). (b) Dogs Mancari (2016) administered Jagua (Genipin-Glycine) Blue (batch no.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=338	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=d55965229f074a91; raw_unit=mg/kg per day; context=131 Jagua (Genipin-Glycine) Blue The NOAEL was the highest dose tested, 338 mg/kg per day on a “blue polymer” basis (Mancari, 2016).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2173	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=a1465cab87ea2b37; raw_unit=mg/kg bw per day; context=The NOAEL was 5% in the diet (2173 mg/kg bw per day in males and 2533 mg/kg bw per day in females), the highest dose tested (Imazawa et al., 2000).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2680	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=c008f017b64bca6f; raw_unit=mg/kg bw per day; context=As a result, the Committee concluded that the no-observed-adverse- effect level (NOAEL) for L(+)-tartaric acid in the study was 2680 mg/kg bw per day, the highest tested dose.
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=600	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=a95381cfe4abc403; raw_unit=mg/kg bw per day; context=In the absence of any toxicologically relevant findings, the no-observed- adverse-effect level (NOAEL) was a dietary concentration of 5%, equal to 8200 and 10 600 mg/kg bw per day for males and females, respectively, or 6600 and 8600 mg/kg bw per day when corrected for purity (Sano et al., 1996).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=2000	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=e1c3a6b1b5a2076b; raw_unit=mg/kg bw per day; context=In the absence of any observed toxicity, the NOAEL was 2000 mg/kg bw per day, equal to 1620 mg/kg bw per day when corrected for purity (Oka et al., 1962-1964).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=691	mg/kg bw/day	-	oral	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=ebe512a67b3e765e; raw_unit=mg/kg bw per day; context=In the absence of any toxicologically significant findings, the NOAEL for tamarind seed polysaccharide was 120 000 mg/kg feed (equal to 10 597 and 10 691 mg/kg bw per day for males and females, respectively, or 9113 and 9194 mg/kg bw per day, when corrected for purity), the highest concentration tested (Heimbach et al., 2013;
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=8575	mg/kg bw/day	Rat	-	-	Carcinogenicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=1b7fb58c55112bb5; raw_unit=mg/kg bw per day; context=Based on the absence of carcinogenicity and dose-related systemic toxicity, the NOAEL was 5%, equal to 6658 and 8575 mg/kg bw per day for males and females, respectively, or 5380 and 6929 mg/kg bw per day when corrected for purity (Sano et al., 1996). (b) Rats Groups of Sprague Dawley rats (20/sex per group;
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=5150	mg/kg bw/day	-	-	-	Carcinogenicity	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=9152377be86bb332; raw_unit=mg/kg bw per day; context=Based on the absence of carcinogenicity and lack of dose-related systemic toxicity, the NOAEL was the highest concentration tested, equal to 5150 mg/kg bw per day for males and 6070 mg/kg bw per day for females, or 4161 and 4904 mg/kg bw per day, respectively, when corrected for purity (Iida et al., 1978).
INCHEM_WHO_jecfa_jecmono_v75je01	NOAEL	=800	mg/kg bw/day	-	-	-	Toxicology study	document_id=jecfa_jecmono_v75je01; title=WHO FOOD ADDITIVES SERIES: 75 Prepared by the eighty-fourth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v75je01.pdf; row_hash=71b1eb0058b86cae; raw_unit=mg/ kg bw per day; context=Based on the lack of treatment-related results, the NOAEL was 800 mg/ kg bw per day, the highest dose tested.

NTP_ICE_acute_oral 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_acute_oral	LD50	>2000	mg/kg bw	Rat	oral	acute	Rat Acute Oral Toxicity	record_id=acute_oral_6193; row=3746; data_type=In Vivo; mixture=Chemical; chemical_name=FD&C Blue No. 1; preferred_name=FD&C Blue No. 1; dtxsid=DTXSID2020189; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020189; source_file=acute_oral.xlsx

NTP_ICE_cancer 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_cancer	IARC group	3	unitless	-	-	-	WOE; IARC Carcinogenicity	sheet=Data; excel_row=2268; Record_ID=cancer_1485; Data_Type=WOE; Formulation_Name=FD&C Blue No. 1; Mixture=Chemical; DTXSID=DTXSID2020189; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/34; http://publications.iarc.fr/139; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020189

NTP_ICE_endocrine 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_endocrine	AC50	12.7924374761623	uM	-	-	-	ARPathway2016; AR Pathway Model, Agonist	sheet=Integrated_approaches; excel_row=9296; RecordID=ARPathway2016_167; DatasetName=ARPathway2016; DTXSID=DTXSID2020189; Assay=AR Pathway Model, Agonist; Endpoint=AC50; Response=12.7924374761623; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020189
NTP_ICE_endocrine	ACC	15.17033901	uM	-	-	-	ARPathway2016; AR Pathway Model, Agonist	sheet=Integrated_approaches; excel_row=9297; RecordID=ARPathway2016_167; DatasetName=ARPathway2016; DTXSID=DTXSID2020189; Assay=AR Pathway Model, Agonist; Endpoint=ACC; Response=15.17033901; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020189
NTP_ICE_endocrine	Model Score	0.107	unitless	-	-	-	ARPathway2016; AR Pathway Model, Antagonist	sheet=Integrated_approaches; excel_row=9298; RecordID=ARPathway2016_167; DatasetName=ARPathway2016; DTXSID=DTXSID2020189; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0.107; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020189
NTP_ICE_endocrine	Model Score	0	unitless	-	-	-	ARPathway2016; AR Pathway Model, Agonist	sheet=Integrated_approaches; excel_row=9299; RecordID=ARPathway2016_167; DatasetName=ARPathway2016; DTXSID=DTXSID2020189; Assay=AR Pathway Model, Agonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020189

SCCNFP_vision_codex 28 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
SCCNFP_vision_codex	NOAEL	=5	%	rat	oral	104 weeks	carcinogenicity	{"citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","effect":"y design in the main corresponds to OECD-Guideline 451. The study was terminated after 104 weeks. Two control groups, which received the basal diet, were included to account for random biological variation. The test item was 90 % pure. The remaining 10 % consisted of subsidiary colourings, volatile chlorides and sulphates, and uncombined intermediates. Results on carcinogenicity are provided in section 3.7. Results No consistent, significant compound-related adverse effects of biological relevance were noted. The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive eva","page":8,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=631	mg/kg bw/day	rat	oral	chronic	carcinogenicity	{"citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","effect":", and uncombined intermediates. Results on carcinogenicity are provided in section 3.7. Results No consistent, significant compound-related adverse effects of biological relevance were noted. The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive evaluation, especially the lowest NOAEL of 631 mg/kg/bw in the rat two year study. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Human volunteers Group size : 207 Test substance : Brilliant Blue Batch number : / Purity : / Dose : 5% aqueous solution GLP : / Moderate irritation o","page":8,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=631	mg/kg	rat	oral	chronic	irritation	{"citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","effect":"dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive evaluation, especially the lowest NOAEL of 631 mg/kg/bw in the rat two year study. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Human volunteers Group size : 207 Test substance : Brilliant Blue Batch number : / Purity : / Dose : 5% aqueous solution GLP : / Moderate irritation occurred in 40 of 207 volunteers following 48-hour covered application of test substance. 14 volunteers had similar responses in identical tests with an insoluble Brilliant Blue complex (the aluminium lake). Only a summary and not the","page":8,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_003"}
SCCNFP_vision_codex	NOAEL	=300	mg/kg bw/d	rat	-	developmental	reproductive toxicity	{"citation":"Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested)","dose":"00 mg/kg bw/d) and adults from other generations were not subject to detailed examinations for tissue abnormalities.","effect":"00 mg/kg bw/d) and adults from other generations were not subject to detailed examinations for tissue abnormalities. The investigators considered that the incidence of abnormalities was similar to that previously detected in untreated rats, however no data were provided in support of this statement. Conclusion The highest dose tested in this study was 1000 mg/kg bw/day. No effects on reproductive parameters were observed. A reduction of the bodyweights of F1 and F2 neonates was observed in the highest dose group (NOAEL: 300 mg/kg bw/d). Due to the lack of information regarding details of the study design and outcome the validity of the study is limited. Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested). Also, no developmental toxicity was observed in rats and rabbits exposed in utero to","page":12,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_004"}
SCCNFP_vision_codex	NOAEL	=0.414	mg/kg	rat	-	-	NOAEL study	{"citation":"Ref.: 26 Human studies No data","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No obse...","effect":"occurred in 18 saline-injected control animals Ref.: 26 Human studies No data. 2.10. Special investigations See also point 2.7- Kinetic studies 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No observed adverse effect level (mg/kg) NOAEL = 630 (rat, 2 yrs, lifetime study) Margin of Safety NOAEL / SED = 1522","page":22,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_006"}
SCCNFP_vision_codex	NOAEL	=9000	mg/kg bw/day	rat	oral	chronic	NOAEL study	{"dose":"The EEC Scientific Committee for Food has 1983 recommended an ADI of 10 mg/kg bw.","effect":"O/WHO Expert Committee on Food Additives in 1970. The EEC Scientific Committee for Food has 1983 recommended an ADI of 10 mg/kg bw. Only limited information on the acute toxicity of Acid Blue 9 is available which indicates that the acute oral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw). Valid studies regarding the toxic effects after chronic application have been performed in rats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin","page":23,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_009"}
SCCNFP_vision_codex	NOAEL	=630	mg/kg bw/day	rat	oral	chronic	irritation	{"dose":"ral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw).","effect":"ral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw). Valid studies regarding the toxic effects after chronic application have been performed in rats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin in mice and rabbits. Reports on findings in humans, which were exposed to 5 % aqueous solutions indicate that this concentration might be moderately irritating. 1% aqueous solution of Acid Blue 9, assessed for eye irritation potential with","page":23,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_010"}
SCCNFP_vision_codex	NOAEL	=5	%	rat	oral	104 weeks	carcinogenicity	{"citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","effect":"y design in the main corresponds to OECD-Guideline 451. The study was terminated after 104 weeks. Two control groups, which received the basal diet, were included to account for random biological variation. The test item was 90 % pure. The remaining 10 % consisted of subsidiary colourings, volatile chlorides and sulphates, and uncombined intermediates. Results on carcinogenicity are provided in section 3.7. Results No consistent, significant compound-related adverse effects of biological relevance were noted. The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive eva","page":8,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=631	mg/kg bw/day	rat	oral	chronic	carcinogenicity	{"citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","effect":", and uncombined intermediates. Results on carcinogenicity are provided in section 3.7. Results No consistent, significant compound-related adverse effects of biological relevance were noted. The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive evaluation, especially the lowest NOAEL of 631 mg/kg/bw in the rat two year study. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Human volunteers Group size : 207 Test substance : Brilliant Blue Batch number : / Purity : / Dose : 5% aqueous solution GLP : / Moderate irritation o","page":8,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=631	mg/kg	rat	oral	chronic	irritation	{"citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","effect":"dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive evaluation, especially the lowest NOAEL of 631 mg/kg/bw in the rat two year study. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Human volunteers Group size : 207 Test substance : Brilliant Blue Batch number : / Purity : / Dose : 5% aqueous solution GLP : / Moderate irritation occurred in 40 of 207 volunteers following 48-hour covered application of test substance. 14 volunteers had similar responses in identical tests with an insoluble Brilliant Blue complex (the aluminium lake). Only a summary and not the","page":8,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_003"}
SCCNFP_vision_codex	NOAEL	=300	mg/kg bw/d	rat	-	developmental	reproductive toxicity	{"citation":"Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested)","dose":"00 mg/kg bw/d) and adults from other generations were not subject to detailed examinations for tissue abnormalities.","effect":"00 mg/kg bw/d) and adults from other generations were not subject to detailed examinations for tissue abnormalities. The investigators considered that the incidence of abnormalities was similar to that previously detected in untreated rats, however no data were provided in support of this statement. Conclusion The highest dose tested in this study was 1000 mg/kg bw/day. No effects on reproductive parameters were observed. A reduction of the bodyweights of F1 and F2 neonates was observed in the highest dose group (NOAEL: 300 mg/kg bw/d). Due to the lack of information regarding details of the study design and outcome the validity of the study is limited. Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested). Also, no developmental toxicity was observed in rats and rabbits exposed in utero to","page":12,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_004"}
SCCNFP_vision_codex	NOAEL	=0.414	mg/kg	rat	-	-	NOAEL study	{"citation":"Ref.: 26 Human studies No data","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No obse...","effect":"occurred in 18 saline-injected control animals Ref.: 26 Human studies No data. 2.10. Special investigations See also point 2.7- Kinetic studies 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No observed adverse effect level (mg/kg) NOAEL = 630 (rat, 2 yrs, lifetime study) Margin of Safety NOAEL / SED = 1522","page":22,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_006"}
SCCNFP_vision_codex	NOAEL	=9000	mg/kg bw/day	rat	oral	chronic	NOAEL study	{"dose":"The EEC Scientific Committee for Food has 1983 recommended an ADI of 10 mg/kg bw.","effect":"O/WHO Expert Committee on Food Additives in 1970. The EEC Scientific Committee for Food has 1983 recommended an ADI of 10 mg/kg bw. Only limited information on the acute toxicity of Acid Blue 9 is available which indicates that the acute oral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw). Valid studies regarding the toxic effects after chronic application have been performed in rats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin","page":23,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_009"}
SCCNFP_vision_codex	NOAEL	=630	mg/kg bw/day	rat	oral	chronic	irritation	{"dose":"ral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw).","effect":"ral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw). Valid studies regarding the toxic effects after chronic application have been performed in rats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin in mice and rabbits. Reports on findings in humans, which were exposed to 5 % aqueous solutions indicate that this concentration might be moderately irritating. 1% aqueous solution of Acid Blue 9, assessed for eye irritation potential with","page":23,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_010"}
SCCNFP_vision_codex	NOAEL	=5	%	rat	oral	104 weeks	carcinogenicity	{"citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","effect":"y design in the main corresponds to OECD-Guideline 451. The study was terminated after 104 weeks. Two control groups, which received the basal diet, were included to account for random biological variation. The test item was 90 % pure. The remaining 10 % consisted of subsidiary colourings, volatile chlorides and sulphates, and uncombined intermediates. Results on carcinogenicity are provided in section 3.7. Results No consistent, significant compound-related adverse effects of biological relevance were noted. The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive eva","page":8,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=631	mg/kg bw/day	rat	oral	chronic	carcinogenicity	{"citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","effect":", and uncombined intermediates. Results on carcinogenicity are provided in section 3.7. Results No consistent, significant compound-related adverse effects of biological relevance were noted. The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive evaluation, especially the lowest NOAEL of 631 mg/kg/bw in the rat two year study. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Human volunteers Group size : 207 Test substance : Brilliant Blue Batch number : / Purity : / Dose : 5% aqueous solution GLP : / Moderate irritation o","page":8,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=631	mg/kg	rat	oral	chronic	irritation	{"citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","effect":"dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive evaluation, especially the lowest NOAEL of 631 mg/kg/bw in the rat two year study. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Human volunteers Group size : 207 Test substance : Brilliant Blue Batch number : / Purity : / Dose : 5% aqueous solution GLP : / Moderate irritation occurred in 40 of 207 volunteers following 48-hour covered application of test substance. 14 volunteers had similar responses in identical tests with an insoluble Brilliant Blue complex (the aluminium lake). Only a summary and not the","page":8,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_003"}
SCCNFP_vision_codex	NOAEL	=300	mg/kg bw/d	rat	-	developmental	reproductive toxicity	{"citation":"Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested)","dose":"00 mg/kg bw/d) and adults from other generations were not subject to detailed examinations for tissue abnormalities.","effect":"00 mg/kg bw/d) and adults from other generations were not subject to detailed examinations for tissue abnormalities. The investigators considered that the incidence of abnormalities was similar to that previously detected in untreated rats, however no data were provided in support of this statement. Conclusion The highest dose tested in this study was 1000 mg/kg bw/day. No effects on reproductive parameters were observed. A reduction of the bodyweights of F1 and F2 neonates was observed in the highest dose group (NOAEL: 300 mg/kg bw/d). Due to the lack of information regarding details of the study design and outcome the validity of the study is limited. Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested). Also, no developmental toxicity was observed in rats and rabbits exposed in utero to","page":12,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_004"}
SCCNFP_vision_codex	NOAEL	=0.414	mg/kg	rat	-	-	NOAEL study	{"citation":"Ref.: 26 Human studies No data","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No obse...","effect":"occurred in 18 saline-injected control animals Ref.: 26 Human studies No data. 2.10. Special investigations See also point 2.7- Kinetic studies 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No observed adverse effect level (mg/kg) NOAEL = 630 (rat, 2 yrs, lifetime study) Margin of Safety NOAEL / SED = 1522","page":22,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_006"}
SCCNFP_vision_codex	NOAEL	=9000	mg/kg bw/day	rat	oral	chronic	NOAEL study	{"dose":"The EEC Scientific Committee for Food has 1983 recommended an ADI of 10 mg/kg bw.","effect":"O/WHO Expert Committee on Food Additives in 1970. The EEC Scientific Committee for Food has 1983 recommended an ADI of 10 mg/kg bw. Only limited information on the acute toxicity of Acid Blue 9 is available which indicates that the acute oral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw). Valid studies regarding the toxic effects after chronic application have been performed in rats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin","page":23,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_009"}
SCCNFP_vision_codex	NOAEL	=630	mg/kg bw/day	rat	oral	chronic	irritation	{"dose":"ral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw).","effect":"ral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw). Valid studies regarding the toxic effects after chronic application have been performed in rats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin in mice and rabbits. Reports on findings in humans, which were exposed to 5 % aqueous solutions indicate that this concentration might be moderately irritating. 1% aqueous solution of Acid Blue 9, assessed for eye irritation potential with","page":23,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_010"}
SCCNFP_vision_codex	NOAEL	=5	%	rat	oral	104 weeks	carcinogenicity	{"citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","effect":"y design in the main corresponds to OECD-Guideline 451. The study was terminated after 104 weeks. Two control groups, which received the basal diet, were included to account for random biological variation. The test item was 90 % pure. The remaining 10 % consisted of subsidiary colourings, volatile chlorides and sulphates, and uncombined intermediates. Results on carcinogenicity are provided in section 3.7. Results No consistent, significant compound-related adverse effects of biological relevance were noted. The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive eva","page":8,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=631	mg/kg bw/day	rat	oral	chronic	carcinogenicity	{"citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","effect":", and uncombined intermediates. Results on carcinogenicity are provided in section 3.7. Results No consistent, significant compound-related adverse effects of biological relevance were noted. The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive evaluation, especially the lowest NOAEL of 631 mg/kg/bw in the rat two year study. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Human volunteers Group size : 207 Test substance : Brilliant Blue Batch number : / Purity : / Dose : 5% aqueous solution GLP : / Moderate irritation o","page":8,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=631	mg/kg	rat	oral	chronic	irritation	{"citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","effect":"dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive evaluation, especially the lowest NOAEL of 631 mg/kg/bw in the rat two year study. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Human volunteers Group size : 207 Test substance : Brilliant Blue Batch number : / Purity : / Dose : 5% aqueous solution GLP : / Moderate irritation occurred in 40 of 207 volunteers following 48-hour covered application of test substance. 14 volunteers had similar responses in identical tests with an insoluble Brilliant Blue complex (the aluminium lake). Only a summary and not the","page":8,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_003"}
SCCNFP_vision_codex	NOAEL	=300	mg/kg bw/d	rat	-	developmental	reproductive toxicity	{"citation":"Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested)","dose":"00 mg/kg bw/d) and adults from other generations were not subject to detailed examinations for tissue abnormalities.","effect":"00 mg/kg bw/d) and adults from other generations were not subject to detailed examinations for tissue abnormalities. The investigators considered that the incidence of abnormalities was similar to that previously detected in untreated rats, however no data were provided in support of this statement. Conclusion The highest dose tested in this study was 1000 mg/kg bw/day. No effects on reproductive parameters were observed. A reduction of the bodyweights of F1 and F2 neonates was observed in the highest dose group (NOAEL: 300 mg/kg bw/d). Due to the lack of information regarding details of the study design and outcome the validity of the study is limited. Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested). Also, no developmental toxicity was observed in rats and rabbits exposed in utero to","page":12,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_004"}
SCCNFP_vision_codex	NOAEL	=0.414	mg/kg	rat	-	-	NOAEL study	{"citation":"Ref.: 26 Human studies No data","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No obse...","effect":"occurred in 18 saline-injected control animals Ref.: 26 Human studies No data. 2.10. Special investigations See also point 2.7- Kinetic studies 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No observed adverse effect level (mg/kg) NOAEL = 630 (rat, 2 yrs, lifetime study) Margin of Safety NOAEL / SED = 1522","page":22,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_006"}
SCCNFP_vision_codex	NOAEL	=9000	mg/kg bw/day	rat	oral	chronic	NOAEL study	{"dose":"The EEC Scientific Committee for Food has 1983 recommended an ADI of 10 mg/kg bw.","effect":"O/WHO Expert Committee on Food Additives in 1970. The EEC Scientific Committee for Food has 1983 recommended an ADI of 10 mg/kg bw. Only limited information on the acute toxicity of Acid Blue 9 is available which indicates that the acute oral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw). Valid studies regarding the toxic effects after chronic application have been performed in rats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin","page":23,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_009"}
SCCNFP_vision_codex	NOAEL	=630	mg/kg bw/day	rat	oral	chronic	irritation	{"dose":"ral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw).","effect":"ral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw). Valid studies regarding the toxic effects after chronic application have been performed in rats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin in mice and rabbits. Reports on findings in humans, which were exposed to 5 % aqueous solutions indicate that this concentration might be moderately irritating. 1% aqueous solution of Acid Blue 9, assessed for eye irritation potential with","page":23,"pdf":"out261_en.pdf","row_type":"noael_study","study_id":"out261_en_noael_010"}

ToxValDB_ECOTOX 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_ECOTOX	LOEL	=5	%	Rat	oral	short-term; 14 days	short-term	LONG_REF=J. Nutr.107(5): 822-828 Ershoff,B.H. Effects of Diet on Growth and Survival of Rats Fed Toxic Levels of Tartrazine (FD & C Yellow No. 5) and Sunset Yellow FCF (FD & C Yellow No. 6) 1977; TITLE=Effects of Diet on Growth and Survival of Rats Fed Toxic Levels of Tartrazine (FD & C Yellow No. 5) and Sunset Yellow FCF (FD & C Yellow No. 6); AUTHOR=Ershoff,B.H.; DOI=10.1093/jn/107.5.822; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76051; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1977; ORIGINAL_YEAR=1977; TOXICOLOGICAL_EFFECT=Growth: Weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX_dup_EPA ORD_15597656_15604791:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=282aebc42ae569b040c21d43fc281c7f
ToxValDB_ECOTOX	NOEL	=2000	mg/kg bw/day	Mouse	oral	acute; 1 days	acute	LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15604109:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=b0adf85947980ea7b2ee00c35aee7677
ToxValDB_ECOTOX	NOEL	=2	% diet	Mouse	oral	chronic; 104 weeks	chronic	LONG_REF=- | Food Chem. Toxicol.28(4): 221-234 Borzelleca,J.F., K. Depukat, and J.B. Hallagan Lifetime Toxicity/Carcinogenicity Studies of FD-and-C Blue No. 1 (Brilliant Blue FCF) in Rats and Mice 1990; TITLE=Lifetime Toxicity/Carcinogenicity Studies of FD-and-C Blue No. 1 (Brilliant Blue FCF) in Rats and Mice; AUTHOR=Borzelleca,J.F., K. Depukat, and J.B. Hallagan; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76018; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=Growth: Weight|Mortality: Survival; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|mortality/survival; STUDY_GROUP=ECOTOX:15612969:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=1d8e74877645089bc8ea71afaf576352
ToxValDB_ECOTOX	NOEL	=1	% diet	Rat	oral	chronic; 111 weeks	chronic	LONG_REF=- | Food Chem. Toxicol.28(4): 221-234 Borzelleca,J.F., K. Depukat, and J.B. Hallagan Lifetime Toxicity/Carcinogenicity Studies of FD-and-C Blue No. 1 (Brilliant Blue FCF) in Rats and Mice 1990; TITLE=Lifetime Toxicity/Carcinogenicity Studies of FD-and-C Blue No. 1 (Brilliant Blue FCF) in Rats and Mice; AUTHOR=Borzelleca,J.F., K. Depukat, and J.B. Hallagan; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=76018; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=Growth: Weight|Mortality: Survival; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|mortality/survival; STUDY_GROUP=ECOTOX:15613281:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=9e7b93c06747ded1226a46d64e1c9a8a

ToxValDB_EFSA 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_EFSA	NOAEL	=631	mg/kg bw/day	Rat	oral	chronic; 30 months	chronic	LONG_REF=EFSA ANS (2010). Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive. doi:10.2903/j.efsa.2010.1853.; TITLE=Scientific Opinion on the re-evaluation of Brilliant Blue FCF (E 133) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2010.1853; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2010; ORIGINAL_YEAR=2010; TOXICOLOGICAL_EFFECT=mortality; TOXICOLOGICAL_EFFECT_CATEGORY=mortality/survival; STUDY_GROUP=EFSA:15614352:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_cc0d2c6140a03b48cb2c4142f4c8a1e5

ToxValDB_GESTIS_DNEL 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_GESTIS_DNEL	DNEL systemic	=106	mg/m3	Human	inhalation	-	Toxicity Value	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15630315:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_55a469a436f44f60c66701fcecee52d1

ToxValDB_WHO_JECFA_ADI 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_WHO_JECFA_ADI	ADI	<=6	mg/kg	Human	oral	-	Toxicity Value	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afb37e4b0d99f5a87a7b8; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/; SUBSOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/3309; YEAR=2017; ORIGINAL_YEAR=2017; STUDY_GROUP=WHO JECFA ADI:15715355:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a8027fe771dc7b7efb9a119986b773b3

UnifiedCodex:SCCNFP:beta.noael_studies 11 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
UnifiedCodex:SCCNFP:beta.noael_studies	-	=0.414	mg/kg	rat	-	-	-	SOURCE_SUBDIR=out261_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9 COLIPA n° C40; OPINION_NUMBER=SCCNFP/0787/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT== 0.414; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No obse...; EFFECT=occurred in 18 saline-injected control animals Ref.: 26 Human studies No data. 2.10. Special investigations See also point 2.7- Kinetic studies 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No observed adverse effect level (mg/kg) NOAEL = 630 (rat, 2 yrs, lifetime study) Margin of Safety NOAEL / SED = 1522; CITATION=Ref.: 26 Human studies No data; CITATION_NUMBERS=[26]; REFERENCE=Ref.: 26 Human studies No data; DETAILS_JSON={"cas_number":"3844-45-9","citation":"Ref.: 26 Human studies No data","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No obse...","duration":"","effect":"occurred in 18 saline-injected control animals Ref.: 26 Human studies No data. 2.10. Special investigations See also point 2.7- Kinetic studies 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No observed adverse effect level (mg/kg) NOAEL = 630 (rat, 2 yrs, lifetime study) Margin of Safety NOAEL / SED = 1522","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.414","page":22,"route":"","species":"rat","study_id":"out261_en_noael_006"}
UnifiedCodex:SCCNFP:beta.noael_studies	-	=0.414	mg/kg	rat	-	-	-	SOURCE_SUBDIR=out261_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9 COLIPA n° C40; OPINION_NUMBER=SCCNFP/0787/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT== 0.414; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No obse...; EFFECT=nimals Ref.: 26 Human studies No data. 2.10. Special investigations See also point 2.7- Kinetic studies 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No observed adverse effect level (mg/kg) NOAEL = 630 (rat, 2 yrs, lifetime study) Margin of Safety NOAEL / SED = 1522; CITATION=Ref.: 26 Human studies No data; CITATION_NUMBERS=[26]; REFERENCE=Ref.: 26 Human studies No data; DETAILS_JSON={"cas_number":"3844-45-9","citation":"Ref.: 26 Human studies No data","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No obse...","duration":"","effect":"nimals Ref.: 26 Human studies No data. 2.10. Special investigations See also point 2.7- Kinetic studies 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No observed adverse effect level (mg/kg) NOAEL = 630 (rat, 2 yrs, lifetime study) Margin of Safety NOAEL / SED = 1522","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.414","page":22,"route":"","species":"rat","study_id":"out261_en_noael_007"}
UnifiedCodex:SCCNFP:beta.noael_studies	-	=0.414	mg/kg	rat	-	-	-	SOURCE_SUBDIR=out261_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9 COLIPA n° C40; OPINION_NUMBER=SCCNFP/0787/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT== 0.414; DOSE=Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No obse...; EFFECT=ions See also point 2.7- Kinetic studies 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No observed adverse effect level (mg/kg) NOAEL = 630 (rat, 2 yrs, lifetime study) Margin of Safety NOAEL / SED = 1522; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3844-45-9","citation":"","dose":"Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No obse...","duration":"","effect":"ions See also point 2.7- Kinetic studies 2.11. Safety evaluation CALCULATION OF THE MARGIN OF SAFETY (Acid Blue 9) (semi-permanent) Maximum absorption through the skin A (µg/cm²) = 35.5 (µg/cm²) Typical body weight of human kg = 60 kg Exposed area (scalp) SAS (cm²) = 700 cm² Systemic exposure A x SAS x 0.001 = 24.8 mg Systemic exposure dose (SED) A x SAS x 0.001 / 60 kg = 0.414 mg/kg No observed adverse effect level (mg/kg) NOAEL = 630 (rat, 2 yrs, lifetime study) Margin of Safety NOAEL / SED = 1522","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"= 0.414","page":22,"route":"","species":"rat","study_id":"out261_en_noael_008"}
UnifiedCodex:SCCNFP:beta.noael_studies	-	9000	mg/kg bw/day	rat	oral	chronic	-	SOURCE_SUBDIR=out261_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9 COLIPA n° C40; OPINION_NUMBER=SCCNFP/0787/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=9000; DOSE=The EEC Scientific Committee for Food has 1983 recommended an ADI of 10 mg/kg bw.; EFFECT=O/WHO Expert Committee on Food Additives in 1970. The EEC Scientific Committee for Food has 1983 recommended an ADI of 10 mg/kg bw. Only limited information on the acute toxicity of Acid Blue 9 is available which indicates that the acute oral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw). Valid studies regarding the toxic effects after chronic application have been performed in rats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3844-45-9","citation":"","dose":"The EEC Scientific Committee for Food has 1983 recommended an ADI of 10 mg/kg bw.","duration":"chronic","effect":"O/WHO Expert Committee on Food Additives in 1970. The EEC Scientific Committee for Food has 1983 recommended an ADI of 10 mg/kg bw. Only limited information on the acute toxicity of Acid Blue 9 is available which indicates that the acute oral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw). Valid studies regarding the toxic effects after chronic application have been performed in rats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"9000","page":23,"route":"oral","species":"rat","study_id":"out261_en_noael_009"}
UnifiedCodex:SCCNFP:beta.noael_studies	carcinogenicity	5	%	rat	oral	104 weeks	carcinogenicity	SOURCE_SUBDIR=out261_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9 COLIPA n° C40; OPINION_NUMBER=SCCNFP/0787/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=5.0; DOSE=The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).; EFFECT=y design in the main corresponds to OECD-Guideline 451. The study was terminated after 104 weeks. Two control groups, which received the basal diet, were included to account for random biological variation. The test item was 90 % pure. The remaining 10 % consisted of subsidiary colourings, volatile chlorides and sulphates, and uncombined intermediates. Results on carcinogenicity are provided in section 3.7. Results No consistent, significant compound-related adverse effects of biological relevance were noted. The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive eva; CITATION=Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies; CITATION_NUMBERS=[2]; REFERENCE=Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies; DETAILS_JSON={"cas_number":"3844-45-9","citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","duration":"104 weeks","effect":"y design in the main corresponds to OECD-Guideline 451. The study was terminated after 104 weeks. Two control groups, which received the basal diet, were included to account for random biological variation. The test item was 90 % pure. The remaining 10 % consisted of subsidiary colourings, volatile chlorides and sulphates, and uncombined intermediates. Results on carcinogenicity are provided in section 3.7. Results No consistent, significant compound-related adverse effects of biological relevance were noted. The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive eva","endpoint":"carcinogenicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"5.0","page":8,"route":"oral","species":"rat","study_id":"out261_en_noael_001"}
UnifiedCodex:SCCNFP:beta.noael_studies	carcinogenicity	631	mg/kg bw/day	rat	oral	chronic	carcinogenicity	SOURCE_SUBDIR=out261_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9 COLIPA n° C40; OPINION_NUMBER=SCCNFP/0787/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=631; DOSE=The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).; EFFECT=, and uncombined intermediates. Results on carcinogenicity are provided in section 3.7. Results No consistent, significant compound-related adverse effects of biological relevance were noted. The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive evaluation, especially the lowest NOAEL of 631 mg/kg/bw in the rat two year study. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Human volunteers Group size : 207 Test substance : Brilliant Blue Batch number : / Purity : / Dose : 5% aqueous solution GLP : / Moderate irritation o; CITATION=Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies; CITATION_NUMBERS=[2]; REFERENCE=Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies; DETAILS_JSON={"cas_number":"3844-45-9","citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","duration":"chronic","effect":", and uncombined intermediates. Results on carcinogenicity are provided in section 3.7. Results No consistent, significant compound-related adverse effects of biological relevance were noted. The NOAEL established in this study is a dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive evaluation, especially the lowest NOAEL of 631 mg/kg/bw in the rat two year study. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Human volunteers Group size : 207 Test substance : Brilliant Blue Batch number : / Purity : / Dose : 5% aqueous solution GLP : / Moderate irritation o","endpoint":"carcinogenicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"631","page":8,"route":"oral","species":"rat","study_id":"out261_en_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies	irritation	631	mg/kg	rat	oral	chronic	irritation	SOURCE_SUBDIR=out261_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9 COLIPA n° C40; OPINION_NUMBER=SCCNFP/0787/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=631; DOSE=dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).; EFFECT=dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive evaluation, especially the lowest NOAEL of 631 mg/kg/bw in the rat two year study. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Human volunteers Group size : 207 Test substance : Brilliant Blue Batch number : / Purity : / Dose : 5% aqueous solution GLP : / Moderate irritation occurred in 40 of 207 volunteers following 48-hour covered application of test substance. 14 volunteers had similar responses in identical tests with an insoluble Brilliant Blue complex (the aluminium lake). Only a summary and not the; CITATION=Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies; CITATION_NUMBERS=[2]; REFERENCE=Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies; DETAILS_JSON={"cas_number":"3844-45-9","citation":"Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies","dose":"dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice).","duration":"chronic","effect":"dietary concentration of 5.0 % (corresponding to 7354 mg/kg bw/day for male and 8966 mg/kg bw/day for female mice). Ref.: 2 Conclusion Both long-term toxicity studies in mice and rats are valid studies. Rats were considerably more sensitive towards Acid Blue 9 toxicity than mice. The NOAEL for chronic oral toxicity of Acid Blue 9 is 631 mg/kg bw/day. This value is used for the final risk assessment and calculation of the margin of safety. All results can be used for a conclusive evaluation, especially the lowest NOAEL of 631 mg/kg/bw in the rat two year study. 2.4. Irritation & corrosivity 2.4.1. Irritation (skin) Guideline : / Species/strain : Human volunteers Group size : 207 Test substance : Brilliant Blue Batch number : / Purity : / Dose : 5% aqueous solution GLP : / Moderate irritation occurred in 40 of 207 volunteers following 48-hour covered application of test substance. 14 volunteers had similar responses in identical tests with an insoluble Brilliant Blue complex (the aluminium lake). Only a summary and not the","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"631","page":8,"route":"oral","species":"rat","study_id":"out261_en_noael_003"}
UnifiedCodex:SCCNFP:beta.noael_studies	irritation	630	mg/kg bw/day	rat	oral	chronic	irritation	SOURCE_SUBDIR=out261_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9 COLIPA n° C40; OPINION_NUMBER=SCCNFP/0787/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=630; DOSE=ral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw).; EFFECT=ral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw). Valid studies regarding the toxic effects after chronic application have been performed in rats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin in mice and rabbits. Reports on findings in humans, which were exposed to 5 % aqueous solutions indicate that this concentration might be moderately irritating. 1% aqueous solution of Acid Blue 9, assessed for eye irritation potential with; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3844-45-9","citation":"","dose":"ral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw).","duration":"chronic","effect":"ral toxicity is low (LD50 (oral, rat) > 2000 mg/kg bw). Valid studies regarding the toxic effects after chronic application have been performed in rats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin in mice and rabbits. Reports on findings in humans, which were exposed to 5 % aqueous solutions indicate that this concentration might be moderately irritating. 1% aqueous solution of Acid Blue 9, assessed for eye irritation potential with","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"630","page":23,"route":"oral","species":"rat","study_id":"out261_en_noael_010"}
UnifiedCodex:SCCNFP:beta.noael_studies	irritation	630	mg/kg bw/day	rat	oral	-	irritation	SOURCE_SUBDIR=out261_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9 COLIPA n° C40; OPINION_NUMBER=SCCNFP/0787/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=630; DOSE=Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females).; EFFECT=ats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin in mice and rabbits. Reports on findings in humans, which were exposed to 5 % aqueous solutions indicate that this concentration might be moderately irritating. 1% aqueous solution of Acid Blue 9, assessed for eye irritation potential with HET-CAM and Neutral-Red Uptake in vitro assays, was considered non-irritant in both assays. These assays have limitations for use with coloured subs; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3844-45-9","citation":"","dose":"Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females).","duration":"","effect":"ats an mice. Mice were less sensitive than rats, no adverse effects were observed in mice even in the highest concentration tested (NOAEL mice: about 9000 mg/kg bw/day (5 % Acid Blue 9 in diet) for females). In rats a decrease in terminal body weight and decreased survival was observed in females of the highest dose group, whereas no adverse effects were seen in males (NOAEL rats: about 630 mg/kg bw/day (1 % Acid Blue 9 in diet) for female rats; about 1000 mg/kg bw/day (2 % Acid Blue 9 in diet) for male rats). The NOAEL of 630 mg/kg bw/day is used for the calculation of the MOS. Acid Blue 9 in aqueous solutions up to 1 % was not irritating to skin in mice and rabbits. Reports on findings in humans, which were exposed to 5 % aqueous solutions indicate that this concentration might be moderately irritating. 1% aqueous solution of Acid Blue 9, assessed for eye irritation potential with HET-CAM and Neutral-Red Uptake in vitro assays, was considered non-irritant in both assays. These assays have limitations for use with coloured subs","endpoint":"irritation","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"630","page":23,"route":"oral","species":"rat","study_id":"out261_en_noael_011"}
UnifiedCodex:SCCNFP:beta.noael_studies	reproductive toxicity	300	mg/kg bw/d	rat	-	developmental	reproductive toxicity	SOURCE_SUBDIR=out261_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9 COLIPA n° C40; OPINION_NUMBER=SCCNFP/0787/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=300; DOSE=00 mg/kg bw/d) and adults from other generations were not subject to detailed examinations for tissue abnormalities.; EFFECT=00 mg/kg bw/d) and adults from other generations were not subject to detailed examinations for tissue abnormalities. The investigators considered that the incidence of abnormalities was similar to that previously detected in untreated rats, however no data were provided in support of this statement. Conclusion The highest dose tested in this study was 1000 mg/kg bw/day. No effects on reproductive parameters were observed. A reduction of the bodyweights of F1 and F2 neonates was observed in the highest dose group (NOAEL: 300 mg/kg bw/d). Due to the lack of information regarding details of the study design and outcome the validity of the study is limited. Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested). Also, no developmental toxicity was observed in rats and rabbits exposed in utero to; CITATION=Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested); CITATION_NUMBERS=[1,9,1000]; REFERENCE=Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested); DETAILS_JSON={"cas_number":"3844-45-9","citation":"Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested)","dose":"00 mg/kg bw/d) and adults from other generations were not subject to detailed examinations for tissue abnormalities.","duration":"developmental","effect":"00 mg/kg bw/d) and adults from other generations were not subject to detailed examinations for tissue abnormalities. The investigators considered that the incidence of abnormalities was similar to that previously detected in untreated rats, however no data were provided in support of this statement. Conclusion The highest dose tested in this study was 1000 mg/kg bw/day. No effects on reproductive parameters were observed. A reduction of the bodyweights of F1 and F2 neonates was observed in the highest dose group (NOAEL: 300 mg/kg bw/d). Due to the lack of information regarding details of the study design and outcome the validity of the study is limited. Ref.: 1 General Conclusion Acid Blue 9 elicits no reproductive toxicity up to 1000 mg/kg bw/day (highest concentration tested). Also, no developmental toxicity was observed in rats and rabbits exposed in utero to","endpoint":"reproductive toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":12,"route":"","species":"rat","study_id":"out261_en_noael_004"}
UnifiedCodex:SCCNFP:beta.noael_studies	reproductive toxicity	300	mg/kg bw/d	pig	-	developmental	reproductive toxicity	SOURCE_SUBDIR=out261_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING ACID BLUE 9 COLIPA n° C40; OPINION_NUMBER=SCCNFP/0787/04; COMMITTEE=SCCNFP; REPORT_DATE=adopted by the SCCNFP on 23 April 2004; VALUE_TEXT=300; DOSE=SCCNFP/0787/04 Evaluation and opinion on Acid Blue 9 _____________________________________________________________________________________________ 13 doses up to 1000 mg/kg bw/d and 200 mg/kg bw/d, respectively.; EFFECT=SCCNFP/0787/04 Evaluation and opinion on Acid Blue 9 _____________________________________________________________________________________________ 13 doses up to 1000 mg/kg bw/d and 200 mg/kg bw/d, respectively. A further study describes slight developmental toxic effects in the highest dose group (1000 mg/kg bw/d: reduced bodyweights of neonates of F1 and F2; NOAEL 300 mg/kg bw/d) Detailed figures are not available. But, no concerns arise from these findings in regard to reproductive toxicity for the application of Acid Blue 9 as hair dye. 2.7. Toxicokinetics (including Percutaneous Absorption) Percutaneous absorption in vitro Guideline : Draft OECD Guideline (1996) Tissue : 400 – 900 µm thickness skin from porcine ears Method : Flow through diffusion cells made of glass. Test substance : FD&C Blue 1 (CI 42090) (experiment I) and formulation with SC Hair Colour Gel; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"3844-45-9","citation":"","dose":"SCCNFP/0787/04 Evaluation and opinion on Acid Blue 9 _____________________________________________________________________________________________ 13 doses up to 1000 mg/kg bw/d and 200 mg/kg bw/d, respectively.","duration":"developmental","effect":"SCCNFP/0787/04 Evaluation and opinion on Acid Blue 9 _____________________________________________________________________________________________ 13 doses up to 1000 mg/kg bw/d and 200 mg/kg bw/d, respectively. A further study describes slight developmental toxic effects in the highest dose group (1000 mg/kg bw/d: reduced bodyweights of neonates of F1 and F2; NOAEL 300 mg/kg bw/d) Detailed figures are not available. But, no concerns arise from these findings in regard to reproductive toxicity for the application of Acid Blue 9 as hair dye. 2.7. Toxicokinetics (including Percutaneous Absorption) Percutaneous absorption in vitro Guideline : Draft OECD Guideline (1996) Tissue : 400 – 900 µm thickness skin from porcine ears Method : Flow through diffusion cells made of glass. Test substance : FD&C Blue 1 (CI 42090) (experiment I) and formulation with SC Hair Colour Gel","endpoint":"reproductive toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":13,"route":"","species":"pig","study_id":"out261_en_noael_005"}

openFDA substances 8 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
openFDA substances	FDA UNII substance identifier	PPQ093M8HR	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C37H34N2O9S3.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PPQ093M8HR"}
openFDA substances	FDA UNII substance identifier	H3R47K3TBD	UNII	-	-	-	mixture	{"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"H3R47K3TBD"}
openFDA substances	FDA UNII substance identifier	PPQ093M8HR	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C37H34N2O9S3.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PPQ093M8HR"}
openFDA substances	FDA UNII substance identifier	PPQ093M8HR	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C37H34N2O9S3.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PPQ093M8HR"}
openFDA substances	FDA UNII substance identifier	PPQ093M8HR	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"C37H34N2O9S3.2Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PPQ093M8HR"}
openFDA substances	FDA UNII substance identifier	H3R47K3TBD	UNII	-	-	-	mixture	{"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"H3R47K3TBD"}
openFDA substances	FDA UNII substance identifier	H3R47K3TBD	UNII	-	-	-	mixture	{"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"H3R47K3TBD"}
openFDA substances	FDA UNII substance identifier	H3R47K3TBD	UNII	-	-	-	mixture	{"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"H3R47K3TBD"}