NOAEL Studies Cosmetic Ingredient

Calcium Stearoyl Lactylate NOAEL Studies

INCI: CALCIUM STEAROYL LACTYLATE

CAS: 5793-94-2

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 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 2500 mg/kg bw/day rat oral NA Multigeneration Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 5000 mg/kg bw/day rat oral 30 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 7500 mg/kg bw/day dog oral NA Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 12500 mg/kg bw/day rat oral 35 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 16000 mg/kg bw/day rat oral 30 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 25000 mg/kg bw/day rat oral 30 day Short Term Toxicity 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 ca.2200 mg/kg bw/day Rat - 365 days chronic/long term toxicity EFSA ANS - 2013 - OutputID 2198 - no adverse effect observed at single/highest dose - Scientific Opinion on the re-evaluation of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) as food additives. - doi:10.2903/j.efsa.2013.3144
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL ca.2200 mg/kg bw/day Rat - 365 days chronic/long term toxicity EFSA ANS - 2013 - OutputID 2198 - no adverse effect observed at single/highest dose - Scientific Opinion on the re-evaluation of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) as food additives. - doi:10.2903/j.efsa.2013.3144
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI =20 mg/kg bw/day Consumers - - ADI EFSA ANS - 2013 - OutputID 2197 - Consumers - Statement on the exposure assessment of sodium stearoyl-2-lactylate and calcium stearoyl-2-lactylate including exposure resulting from extension of the authorisation of sodium stearoyl-2-lactylates. - doi:10.2903/j.efsa.2013.3125
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI =20 mg/kg bw/day Consumers - - ADI EFSA ANS - 2013 - OutputID 2197 - Consumers - Statement on the exposure assessment of sodium stearoyl-2-lactylate and calcium stearoyl-2-lactylate including exposure resulting from extension of the authorisation of sodium stearoyl-2-lactylates. - doi:10.2903/j.efsa.2013.3125
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI =22 mg/kg bw/day Consumers - - ADI EFSA ANS - 2013 - OutputID 2198 - Consumers - Scientific Opinion on the re-evaluation of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) as food additives. - doi:10.2903/j.efsa.2013.3144
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI =22 mg/kg bw/day Consumers - - ADI EFSA ANS - 2013 - OutputID 2198 - Consumers - Scientific Opinion on the re-evaluation of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) as food additives. - doi:10.2903/j.efsa.2013.3144
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI (group) =20 mg/kg bw/day Consumers - - ADI (group) EFSA ANS - 2013 - OutputID 2197 - Consumers - Statement on the exposure assessment of sodium stearoyl-2-lactylate and calcium stearoyl-2-lactylate including exposure resulting from extension of the authorisation of sodium stearoyl-2-lactylates. - doi:10.2903/j.efsa.2013.3125
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI (group) =20 mg/kg bw/day Consumers - - ADI (group) EFSA ANS - 2013 - OutputID 2197 - Consumers - Statement on the exposure assessment of sodium stearoyl-2-lactylate and calcium stearoyl-2-lactylate including exposure resulting from extension of the authorisation of sodium stearoyl-2-lactylates. - doi:10.2903/j.efsa.2013.3125
ToxValDB_EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA NOAEL ~2200 mg/kg bw/day Rat oral chronic; 1 years chronic LONG_REF=EFSA ANS (2013). Scientific Opinion on the re-evaluation of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) as food additives. doi:10.2903/j.efsa.2013.3144.; TITLE=Scientific Opinion on the re-evaluation of sodium stearoyl-2-lactylate (E 481) and calcium stearoyl-2-lactylate (E 482) as food additives.; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2013.3144; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2013; ORIGINAL_YEAR=2013; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15620868: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_3000101f60e25b642fe483f4bc50b4aa
ToxValDB_WHO_JECFA_ADI 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_WHO_JECFA_ADI ADI <=20 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afb5fe4b0d99f5a87ae78; 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/3053; YEAR=1973; ORIGINAL_YEAR=1973; STUDY_GROUP=WHO JECFA ADI:15715428:-:--; 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_4a3748ef734a0213601ad6e035e3e377
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 30MXH4012A UNII - - - chemical {"approval_status":null,"molecular_formula":"2C24H43O6.Ca","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"30MXH4012A"}
openFDA substances FDA UNII substance identifier 30MXH4012A UNII - - - chemical {"approval_status":null,"molecular_formula":"2C24H43O6.Ca","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"30MXH4012A"}
openFDA substances FDA UNII substance identifier 30MXH4012A UNII - - - chemical {"approval_status":null,"molecular_formula":"2C24H43O6.Ca","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"30MXH4012A"}
openFDA substances FDA UNII substance identifier 30MXH4012A UNII - - - chemical {"approval_status":null,"molecular_formula":"2C24H43O6.Ca","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"30MXH4012A"}