NOAEL Studies Cosmetic Ingredient

Ingredient compliance data extraction NOAEL Studies

INCI: INGREDIENT COMPLIANCE DATA EXTRACTION

CAS: 532-32-1

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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COSMOS DB 18 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB LOAEL 6290 mg/kg bw/day rat oral 90 day Subchronic REACH
COSMOS DB NOAEL 175 mg/kg bw/day mouse oral 10 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 250 mg/kg bw/day rabbit oral 13 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 300 mg/kg bw/day hamster oral 5 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 510 mg/kg bw/day rat oral 3 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1000 mg/kg bw/day rat oral NA Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1095 mg/kg bw/day rat oral 540 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 1250 mg/kg bw/day rat oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2000 mg/kg bw/day rat oral 28 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2090 mg/kg bw/day rat oral 10 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2500 mg/kg bw/day rat oral 161 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2620 mg/kg bw/day rat oral 90 day Subchronic REACH
COSMOS DB NOAEL 3750 mg/kg bw/day mouse oral 10 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 4000 mg/kg bw/day rat oral 42 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 5000 mg/kg bw/day rat oral 21 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 5960 mg/kg bw/day mouse oral NA Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 8000 mg/kg bw/day rat oral 90 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 10000 mg/kg bw/day mouse oral 35 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA 7 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA NOAEL =500 mg/kg bw/day Rat oral: feed - reproduction toxicity EFSA ANS - 2016 - OutputID 2794 - no adverse effect observed at single/highest dose - Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives - doi:10.2903/j.efsa.2016.4433
EFSA NOAEL =1310 mg/kg bw/day Rat oral: feed - reproduction toxicity EFSA ANS - 2016 - OutputID 2794 - no adverse effect observed at single/highest dose - Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives - doi:10.2903/j.efsa.2016.4433
EFSA ADI (group) =5 mg/kg bw/day Consumers - - ADI (group) EFSA ANS - 2016 - OutputID 2794 - Consumers - Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives - doi:10.2903/j.efsa.2016.4433
EFSA ADI (group) =5 mg/kg bw/day Consumers - - ADI (group) EFSA ANS - 2016 - OutputID 2794 - Consumers - Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives - doi:10.2903/j.efsa.2016.4433
EFSA LEL =36000 mg/kg bw/day Pig oral subchronic; 36 days subchronic LONG_REF=EFSA FEEDAP (2011). Scientific Opinion on Safety and efficacy of Protural (sodium benzoate) as feed additive for weaned piglets. doi:10.2903/j.efsa.2011.2005.; TITLE=Scientific Opinion on Safety and efficacy of Protural (sodium benzoate) as feed additive for weaned piglets; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2011.2005; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2011; ORIGINAL_YEAR=2011; TOXICOLOGICAL_EFFECT=body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=EFSA:15614192:-:--; 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_0757c8cc31c5c60da3cdf410cb58e41e
EFSA NOAEL =500 mg/kg bw/day Rat oral - reproduction developmental LONG_REF=EFSA ANS (2016). Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives. doi:10.2903/j.efsa.2016.4433.; TITLE=Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2016.4433; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15614196: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_66ebe0ac9ea76ad8dc78948c417edc68
EFSA NOAEL =1310 mg/kg bw/day Rat oral - reproduction developmental LONG_REF=EFSA ANS (2016). Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives. doi:10.2903/j.efsa.2016.4433.; TITLE=Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2016.4433; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15614195:-:--; 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_c03ec76301886eb7e4aa784bd4af0f95
WHO/JECFA 38 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
WHO/JECFA ADI range:0-0.50.5 mg/kg bw/day Rat - - Health guidance value document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=031852f42d80ba77; raw_unit=mg/kg bw; context=At its thirteenth meeting, the Committee established an ADI of 0-0.5 mg/kg bw for riboflavin on the basis of the absence of any adverse effects at the only dose tested of 50 mg/kg bw per day in a three-generation study of reproductive toxicity in rats (1).
WHO/JECFA ADI range:0-0.50.5 mg/kg bw/day Rat - - Health guidance value document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=031852f42d80ba77; raw_unit=mg/kg bw; context=At its thirteenth meeting, the Committee established an ADI of 0-0.5 mg/kg bw for riboflavin on the basis of the absence of any adverse effects at the only dose tested of 50 mg/kg bw per day in a three-generation study of reproductive toxicity in rats (1).
WHO/JECFA ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=2c1a79b7ea87a124; raw_unit=mg/kg bw; context=forty-sixth meeting evaluated benzyl acetate, benzyl alcohol, benzaldehyde, benzoic acid and the benzoate salts (calcium, potassium and sodium) together and re-affirmed the group ADI of 0-5 mg/kg bw expressed as benzoic acid equivalents (Annex 1, reference 122).
WHO/JECFA ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=2c1a79b7ea87a124; raw_unit=mg/kg bw; context=forty-sixth meeting evaluated benzyl acetate, benzyl alcohol, benzaldehyde, benzoic acid and the benzoate salts (calcium, potassium and sodium) together and re-affirmed the group ADI of 0-5 mg/kg bw expressed as benzoic acid equivalents (Annex 1, reference 122).
WHO/JECFA ADI range:0-2020 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=569703ce55e94b07; raw_unit=mg/kg bw.; context=The Committee established a group ADI of 0-20 mg/kg bw.
WHO/JECFA ADI range:0-2020 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=569703ce55e94b07; raw_unit=mg/kg bw.; context=The Committee established a group ADI of 0-20 mg/kg bw.
WHO/JECFA NOAEL =3.6 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=6446880d02fadd48; raw_unit=mg/kg bw per day; context=Comparison of this NOAEL with the estimated dietary exposure of 3.6 mg/kg bw per day, based on maximum reported use levels, resulted in an MOE > 800.
WHO/JECFA NOAEL =3.6 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=6446880d02fadd48; raw_unit=mg/kg bw per day; context=Comparison of this NOAEL with the estimated dietary exposure of 3.6 mg/kg bw per day, based on maximum reported use levels, resulted in an MOE > 800.
WHO/JECFA NOAEL =200 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=991dce7794ed32b1; raw_unit=mg/kg bw per day; context=The previous Committee identified a NOAEL of 200 mg/kg bw per day (3).
WHO/JECFA NOAEL =200 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=991dce7794ed32b1; raw_unit=mg/kg bw per day; context=The previous Committee identified a NOAEL of 200 mg/kg bw per day (3).
WHO/JECFA NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=041b8e384ab4e91f; raw_unit=mg/kg bw per day; context=This study showed no treatment-related adverse effects, indicating a NOAEL of 1000 mg/kg bw per day, the highest dose tested.
WHO/JECFA NOAEL =1000 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=041b8e384ab4e91f; raw_unit=mg/kg bw per day; context=This study showed no treatment-related adverse effects, indicating a NOAEL of 1000 mg/kg bw per day, the highest dose tested.
WHO/JECFA NOAEL =3000 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=0d9aff4d8838b758; raw_unit=mg/kg bw per day; context=Comparison of the NOAEL of 3000 mg/kg bw per day with the estimate of dietary exposure of 3.6 mg/kg bw per day, based on maximum reported use levels, resulted in an MOE > 800.
WHO/JECFA NOAEL =3000 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=0d9aff4d8838b758; raw_unit=mg/kg bw per day; context=Comparison of the NOAEL of 3000 mg/kg bw per day with the estimate of dietary exposure of 3.6 mg/kg bw per day, based on maximum reported use levels, resulted in an MOE > 800.
WHO/JECFA NOAEL =3011 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=a4a8da2169a22a0d; raw_unit=mg/kg bw per day; context=When accounting for the purity of the preparation used, the Committee identified a NOAEL of 3011 mg/kg bw per day for males and 3559 mg/kg bw per day for females, the highest doses tested.
WHO/JECFA NOAEL =3011 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v1037je01; title=W H O T e c h n i c a l R e p o r t S e r i e s Evaluation of certain food additives Ninety-second report of the Joint FAO/WHO Expert Committee on Food Additive; path=mirror/documents/jecfa/jecmono/v1037je01.pdf; row_hash=a4a8da2169a22a0d; raw_unit=mg/kg bw per day; context=When accounting for the purity of the preparation used, the Committee identified a NOAEL of 3011 mg/kg bw per day for males and 3559 mg/kg bw per day for females, the highest doses tested.
WHO/JECFA ADI range:0-0.50.5 mg/kg bw/day Rat - - Health guidance value document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=9c6df5d2652c889b; raw_unit=mg/kg bw; context=At its thirteenth meeting, the Committee established an ADI of 0-0.5 mg/kg bw for riboflavin in the absence of any adverse effects at the only dose tested of 50 mg/kg bw per day in a three-generation study of reproductive toxicity in rats (2).
WHO/JECFA ADI range:0-0.50.5 mg/kg bw/day Rat - - Health guidance value document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=9c6df5d2652c889b; raw_unit=mg/kg bw; context=At its thirteenth meeting, the Committee established an ADI of 0-0.5 mg/kg bw for riboflavin in the absence of any adverse effects at the only dose tested of 50 mg/kg bw per day in a three-generation study of reproductive toxicity in rats (2).
WHO/JECFA ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=1a87beeebf2a8fd5; raw_unit=mg/kg bw; context=rty-sixth meeting evaluated benzyl acetate, benzyl alcohol, benzaldehyde, benzoic acid and the benzoate salts (calcium, potassium and sodium) together and included them in a group ADI of 0-5 mg/kg bw when expressed as benzoic acid equivalents (Annex 1, reference 122).
WHO/JECFA ADI range:0-55 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=1a87beeebf2a8fd5; raw_unit=mg/kg bw; context=rty-sixth meeting evaluated benzyl acetate, benzyl alcohol, benzaldehyde, benzoic acid and the benzoate salts (calcium, potassium and sodium) together and included them in a group ADI of 0-5 mg/kg bw when expressed as benzoic acid equivalents (Annex 1, reference 122).
WHO/JECFA ADI range:0-2020 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=7cfd02f8ef23e11f; raw_unit=mg/kg bw.; context=The Committee established a group ADI of 0-20 mg/kg bw.
WHO/JECFA ADI range:0-2020 mg/kg bw/day - - - Health guidance value document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=7cfd02f8ef23e11f; raw_unit=mg/kg bw.; context=The Committee established a group ADI of 0-20 mg/kg bw.
WHO/JECFA NOAEL =3.6 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=1e10766ccf3cf5ba; raw_unit=mg/kg bw per day; context=Comparison of this NOAEL with the estimated dietary exposure of 3.6 mg/kg bw per day, based on maximum reported use levels, resulted in an MOE > 800.
WHO/JECFA NOAEL =3.6 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=1e10766ccf3cf5ba; raw_unit=mg/kg bw per day; context=Comparison of this NOAEL with the estimated dietary exposure of 3.6 mg/kg bw per day, based on maximum reported use levels, resulted in an MOE > 800.
WHO/JECFA NOAEL =190 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=b661c8c97e1e8287; raw_unit=mg/kg per day; context=83, 2022 On this basis, the Committee identified a NOAEL of 190 mg/kg per day (rounded by the Committee from 191 mg/kg bw per day).
WHO/JECFA NOAEL =190 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=b661c8c97e1e8287; raw_unit=mg/kg per day; context=83, 2022 On this basis, the Committee identified a NOAEL of 190 mg/kg per day (rounded by the Committee from 191 mg/kg bw per day).
WHO/JECFA NOAEL =200 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=7c954c139f7eebf9; raw_unit=mg/kg bw per day; context=83, 2022 NOAEL of 200 mg/kg bw per day.
WHO/JECFA NOAEL =200 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=7c954c139f7eebf9; raw_unit=mg/kg bw per day; context=83, 2022 NOAEL of 200 mg/kg bw per day.
WHO/JECFA NOAEL =410 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=be1ef3df60b625ca; raw_unit=mg/kg bw per day; context=According to the authors, the NOAEL in this study was 5000 ppm (equal to 410 mg/kg bw per day) for females, on the basis of increased urinary volume with decreased specific gravity, and 50 000 ppm (equal to 3659 mg/kg bw per day), the highest dose tested, for males (27).
WHO/JECFA NOAEL =410 mg/kg bw/day - - - Toxicology study document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=be1ef3df60b625ca; raw_unit=mg/kg bw per day; context=According to the authors, the NOAEL in this study was 5000 ppm (equal to 410 mg/kg bw per day) for females, on the basis of increased urinary volume with decreased specific gravity, and 50 000 ppm (equal to 3659 mg/kg bw per day), the highest dose tested, for males (27).
WHO/JECFA NOAEL =500 mg/kg bw/day Rat; Bird oral - Developmental toxicity document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=269a627254331ffc; raw_unit=mg/kg bw per day; context=At its seventeenth meeting, the Committee concluded that the NOAEL in rats was 10 000 ppm (1%) in the diet, equivalent to 500 mg/kg bw per day. (b) Developmental toxicity The effects of sodium benzoate on neural tube development were studied in chicken embryos (30).
WHO/JECFA NOAEL =500 mg/kg bw/day Rat; Bird oral - Developmental toxicity document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=269a627254331ffc; raw_unit=mg/kg bw per day; context=At its seventeenth meeting, the Committee concluded that the NOAEL in rats was 10 000 ppm (1%) in the diet, equivalent to 500 mg/kg bw per day. (b) Developmental toxicity The effects of sodium benzoate on neural tube development were studied in chicken embryos (30).
WHO/JECFA NOAEL =1000 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=b627241512eb6b9a; raw_unit=mg/kg bw per day; context=The Committee identified a NOAEL of 1000 mg/kg bw per day, the highest dose tested, for reproductive and developmental toxicity.
WHO/JECFA NOAEL =1000 mg/kg bw/day - - - Developmental toxicity document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=b627241512eb6b9a; raw_unit=mg/kg bw per day; context=The Committee identified a NOAEL of 1000 mg/kg bw per day, the highest dose tested, for reproductive and developmental toxicity.
WHO/JECFA NOAEL =3000 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=1bca293605fb913b; raw_unit=mg/kg bw per day; context=Comparison of the NOAEL of 3000 mg/kg bw per day with the estimate of dietary exposure of 3.6 mg/kg bw per day, based on maximum reported use levels, resulted in an MOE > 800.
WHO/JECFA NOAEL =3000 mg/kg bw/day - oral - Toxicology study document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=1bca293605fb913b; raw_unit=mg/kg bw per day; context=Comparison of the NOAEL of 3000 mg/kg bw per day with the estimate of dietary exposure of 3.6 mg/kg bw per day, based on maximum reported use levels, resulted in an MOE > 800.
WHO/JECFA NOAEL =4325 mg/kg bw/day Rat oral - Acute toxicity document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=99601bf9a06967f0; raw_unit=mg/kg bw per day; context=As no other treatment-related changes were observed, the Committee concluded that the NOAEL for the test substance was 50 000 ppm, equal to 4325 mg/kg bw per day for females and 3659 mg/kg bw per day for Table 1 Acute toxicity of riboflavin from Ashbya gossypii after oral administration to Wistar rats Purity of test substance LD50 (mg/kg bw) Reference 82.3% (feed grade) > 2500 28 100.5% (food grade) > 10 000 29 Source
WHO/JECFA NOAEL =4325 mg/kg bw/day Rat oral - Acute toxicity document_id=jecfa_jecmono_v83je01; title=WHO FOOD ADDITIVES SERIES: 83 Prepared by the ninety-second meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) Safety evaluation of certain; path=mirror/documents/jecfa/jecmono/v83je01.pdf; row_hash=99601bf9a06967f0; raw_unit=mg/kg bw per day; context=As no other treatment-related changes were observed, the Committee concluded that the NOAEL for the test substance was 50 000 ppm, equal to 4325 mg/kg bw per day for females and 3659 mg/kg bw per day for Table 1 Acute toxicity of riboflavin from Ashbya gossypii after oral administration to Wistar rats Purity of test substance LD50 (mg/kg bw) Reference 82.3% (feed grade) > 2500 28 100.5% (food grade) > 10 000 29 Source
NTP ICE acute oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE acute oral LD50 =4070 mg/kg bw Rat oral acute Rat Acute Oral Toxicity NLM ChemIDplus TEST (undated); record_id=acute_oral_7226; row=1990; data_type=In Vivo; mixture=Chemical; chemical_name=Sodium benzoate; preferred_name=Sodium benzoate; dtxsid=DTXSID1020140; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1020140; source_file=acute_oral.xlsx
NTP ICE endocrine 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE endocrine Model Score 0 unitless - - - ARPathway2016; AR Pathway Model, Antagonist sheet=Integrated_approaches; excel_row=14462; RecordID=ARPathway2016_1288; DatasetName=ARPathway2016; DTXSID=DTXSID1020140; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID1020140
ECHA 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA NOAEL =250 mg/kg bw/day Rabbit oral - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabe9e4b0a7c65d1bc62a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14570/7/9/3?documentUUID=dceee63d-323b-4fcf-bc39-df538471570c; YEAR=1980; ORIGINAL_YEAR=1980; STUDY_GROUP=ECHA IUCLID:15823578:F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_53c1ad7d99a27a56b1c2c12486d05c7f
ECHA NOAEL =905 mg/kg bw/day Rat oral short-term; 10 days short-term QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cad6e4b0a7c65d223acb; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24934/7/6/2?documentUUID=11d691ad-8c1b-4c0d-9f47-9c18d29c10a5; YEAR=1976; ORIGINAL_YEAR=1976; STUDY_GROUP=ECHA IUCLID:15837047: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_643251e9308bc9f7514dcbbde7674e89
ECHA NOAEL =1000 mg/kg bw/day Rat oral subchronic; 6 weeks subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadd4e4b0a7c65d1c61ee; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24934/7/6/2?documentUUID=11d691ad-8c1b-4c0d-9f47-9c18d29c10a5; YEAR=1976; ORIGINAL_YEAR=1976; STUDY_GROUP=ECHA IUCLID:15849270:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_74c9360e05a75017da17b525f9a965e4
ECHA NOAEL =2620 mg/kg bw/day Rat oral subchronic; 90 days subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadd4e4b0a7c65d1c61fb; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24934/7/6/2?documentUUID=11d691ad-8c1b-4c0d-9f47-9c18d29c10a5; YEAR=1976; ORIGINAL_YEAR=1976; STUDY_GROUP=ECHA IUCLID:15849271:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_7135db1c60a62d7569c6b6183956943b
ECHA NOAEL =3571 mg/kg bw/day Mouse oral short-term; 10 days short-term QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cad6e4b0a7c65d223ae5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24934/7/6/2?documentUUID=11d691ad-8c1b-4c0d-9f47-9c18d29c10a5; YEAR=1976; ORIGINAL_YEAR=1976; STUDY_GROUP=ECHA IUCLID:15843311: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_c3de81471e492f6279219404c8bc198e
ECHA NOEL =1000 mg/kg bw/day Rat oral chronic; 24 months chronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadd4e4b0a7c65d1c61df; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24934/7/6/2?documentUUID=11d691ad-8c1b-4c0d-9f47-9c18d29c10a5; YEAR=1976; ORIGINAL_YEAR=1976; STUDY_GROUP=ECHA IUCLID:15848063:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_3673f5391674d8bae11bb258c519a0ca
ToxValDB ECOTOX 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB ECOTOX LOEL =2002 mg/kg bw/day Rat oral short-term; 28 days short-term LONG_REF=- | Arch. Int. Pharmacodyn. Ther.144(1/2): 120-125 Fanelli,G.M., and S.L. Halliday Relative Toxicity of Chlortetracycline and Sodium Benzoate After Oral Administration to Rats 1963; TITLE=Relative Toxicity of Chlortetracycline and Sodium Benzoate After Oral Administration to Rats; AUTHOR=Fanelli,G.M., and S.L. Halliday; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=102470; 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=1963; ORIGINAL_YEAR=1963; TOXICOLOGICAL_EFFECT=Growth: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX:15613614:M:--; 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=988fafa8b9bb89644568e6bc9c6558d5
ToxValDB ECOTOX NOEL =1000 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:15602596:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=33ab940990fec707c0de064bca982b22
ToxValDB ECOTOX NOEL =2171 mg/kg bw/day Rat oral short-term; 28 days short-term LONG_REF=- | Arch. Int. Pharmacodyn. Ther.144(1/2): 120-125 Fanelli,G.M., and S.L. Halliday Relative Toxicity of Chlortetracycline and Sodium Benzoate After Oral Administration to Rats 1963; TITLE=Relative Toxicity of Chlortetracycline and Sodium Benzoate After Oral Administration to Rats; AUTHOR=Fanelli,G.M., and S.L. Halliday; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=102470; 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=1963; ORIGINAL_YEAR=1963; TOXICOLOGICAL_EFFECT=Growth: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX:15613615: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=e801728795441e4b8f91012601863d84
ToxValDB GESTIS DNEL 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB GESTIS DNEL DNEL local =0.1 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_dup_-_15634738_15634739:-:--; 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_62727321784a77dea3366df853e1d86f
ToxValDB GESTIS DNEL DNEL systemic =3 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_dup_-_15634738_15634739:-:--; 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_dafc5af4d85f64c09198ebd8ae9b5cc3
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier OJ245FE5EU UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H5O2.Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"OJ245FE5EU"}
openFDA substances FDA UNII substance identifier OJ245FE5EU UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H5O2.Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"OJ245FE5EU"}
openFDA substances FDA UNII substance identifier OJ245FE5EU UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H5O2.Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"OJ245FE5EU"}
openFDA substances FDA UNII substance identifier OJ245FE5EU UNII - - - chemical {"approval_status":null,"molecular_formula":"C7H5O2.Na","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"OJ245FE5EU"}