NOAEL Studies Humectant

Butylene Glycol NOAEL Studies

INCI: BUTYLENE GLYCOL

CAS: 107-88-0

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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CIR_vision_codex 16 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR_vision_codex NOAEL =500 mg/kg rat oral - oral toxicity {"citation":"3; 1; 8","dose":"The relative weights of the kidneys was increased in all 3 species fed the highest concentration of glycol and in mice fed the 1.8 percent diet.","effect":"diet died of renal damage. The relative weights of the kidneys was increased in all 3 species fed the highest concentration of glycol and in mice fed the 1.8 percent diet. Microscopic changes were hydropic degeneration of the proximal renal tubules in all 3 spe- cies fed the highest dosage and in pigs receiving 500 mg/kg per day. Hydropic de- generation of the hepatocytes was observed in those pigs above a dose of 500 mg/kg. Hepatic cell enlargement was found in those mice fed the 1.8 and 5.4 per- cent diets. The “no effect” level for Ethoxydiglycol in rats was 0.5 percent of the","page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"pr193_noael_001"}
CIR_vision_codex NOAEL =0.5 - rat oral (dietary) 90 days NOAEL study {"page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"beta_noael_1"}
CIR_vision_codex NOAEL =0.6 - mouse oral (dietary) 90 days NOAEL study {"page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"beta_noael_2"}
CIR_vision_codex NOAEL =167 - pig oral 90 days NOAEL study {"page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"beta_noael_3"}
CIR_vision_codex NOAEL =500 mg/kg rat oral - oral toxicity {"citation":"3; 1; 8","dose":"The relative weights of the kidneys was increased in all 3 species fed the highest concentration of glycol and in mice fed the 1.8 percent diet.","effect":"diet died of renal damage. The relative weights of the kidneys was increased in all 3 species fed the highest concentration of glycol and in mice fed the 1.8 percent diet. Microscopic changes were hydropic degeneration of the proximal renal tubules in all 3 spe- cies fed the highest dosage and in pigs receiving 500 mg/kg per day. Hydropic de- generation of the hepatocytes was observed in those pigs above a dose of 500 mg/kg. Hepatic cell enlargement was found in those mice fed the 1.8 and 5.4 per- cent diets. The “no effect” level for Ethoxydiglycol in rats was 0.5 percent of the","page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"pr193_noael_001"}
CIR_vision_codex NOAEL =0.5 - rat oral (dietary) 90 days NOAEL study {"page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"beta_noael_1"}
CIR_vision_codex NOAEL =0.6 - mouse oral (dietary) 90 days NOAEL study {"page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"beta_noael_2"}
CIR_vision_codex NOAEL =167 - pig oral 90 days NOAEL study {"page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"beta_noael_3"}
CIR_vision_codex NOAEL =500 mg/kg rat oral - oral toxicity {"citation":"3; 1; 8","dose":"The relative weights of the kidneys was increased in all 3 species fed the highest concentration of glycol and in mice fed the 1.8 percent diet.","effect":"diet died of renal damage. The relative weights of the kidneys was increased in all 3 species fed the highest concentration of glycol and in mice fed the 1.8 percent diet. Microscopic changes were hydropic degeneration of the proximal renal tubules in all 3 spe- cies fed the highest dosage and in pigs receiving 500 mg/kg per day. Hydropic de- generation of the hepatocytes was observed in those pigs above a dose of 500 mg/kg. Hepatic cell enlargement was found in those mice fed the 1.8 and 5.4 per- cent diets. The “no effect” level for Ethoxydiglycol in rats was 0.5 percent of the","page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"pr193_noael_001"}
CIR_vision_codex NOAEL =0.5 - rat oral (dietary) 90 days NOAEL study {"page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"beta_noael_1"}
CIR_vision_codex NOAEL =0.6 - mouse oral (dietary) 90 days NOAEL study {"page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"beta_noael_2"}
CIR_vision_codex NOAEL =167 - pig oral 90 days NOAEL study {"page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"beta_noael_3"}
CIR_vision_codex NOAEL =500 mg/kg rat oral - oral toxicity {"citation":"3; 1; 8","dose":"The relative weights of the kidneys was increased in all 3 species fed the highest concentration of glycol and in mice fed the 1.8 percent diet.","effect":"diet died of renal damage. The relative weights of the kidneys was increased in all 3 species fed the highest concentration of glycol and in mice fed the 1.8 percent diet. Microscopic changes were hydropic degeneration of the proximal renal tubules in all 3 spe- cies fed the highest dosage and in pigs receiving 500 mg/kg per day. Hydropic de- generation of the hepatocytes was observed in those pigs above a dose of 500 mg/kg. Hepatic cell enlargement was found in those mice fed the 1.8 and 5.4 per- cent diets. The “no effect” level for Ethoxydiglycol in rats was 0.5 percent of the","page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"pr193_noael_001"}
CIR_vision_codex NOAEL =0.5 - rat oral (dietary) 90 days NOAEL study {"page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"beta_noael_1"}
CIR_vision_codex NOAEL =0.6 - mouse oral (dietary) 90 days NOAEL study {"page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"beta_noael_2"}
CIR_vision_codex NOAEL =167 - pig oral 90 days NOAEL study {"page":12,"pdf":"pr193.pdf","row_type":"noael_study","study_id":"beta_noael_3"}
COSMOS_DB 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 750 mg/kg bw/day dog oral 730 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 5000 mg/kg bw/day rat oral 730 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 7060 mg/kg bw/day rat oral 10 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 10000 mg/kg bw/day rat oral 450 day Multigeneration Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 6000 mg/kg bw/day dog oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI <=4 mg/kg bw/day Consumers - - ADI EFSA CONTAM - 2011 - OutputID 586 - Consumers - Scientific Opinion on the evaluation of the substances currently on the list in the Annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils - Part I of III - doi:10.2903/j.efsa.2011.2482
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI <=4 mg/kg bw/day Consumers - - ADI EFSA CONTAM - 2011 - OutputID 586 - Consumers - Scientific Opinion on the evaluation of the substances currently on the list in the Annex to Commission Directive 96/3/EC as acceptable previous cargoes for edible fats and oils - Part I of III - doi:10.2903/j.efsa.2011.2482
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=660; RecordID=ARPathway2016_500; DatasetName=ARPathway2016; DTXSID=DTXSID8026773; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026773
ToxValDB_WHO_JECFA_ADI 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_WHO_JECFA_ADI ADI <=4 mg/kg Human oral - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650af042e4b0d99f5a86d48e; 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/2551; YEAR=1979; ORIGINAL_YEAR=1979; STUDY_GROUP=WHO JECFA ADI:15715240:-:--; 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_9fd7181c5dabbfe3511d9e97dd9b1f8d
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 3XUS85K0RA UNII - - - chemical {"approval_status":null,"molecular_formula":"C4H10O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3XUS85K0RA"}
openFDA substances FDA UNII substance identifier 3XUS85K0RA UNII - - - chemical {"approval_status":null,"molecular_formula":"C4H10O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3XUS85K0RA"}
openFDA substances FDA UNII substance identifier 3XUS85K0RA UNII - - - chemical {"approval_status":null,"molecular_formula":"C4H10O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3XUS85K0RA"}
openFDA substances FDA UNII substance identifier 3XUS85K0RA UNII - - - chemical {"approval_status":null,"molecular_formula":"C4H10O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3XUS85K0RA"}