NOAEL Studies
Humectant
Propanediol NOAEL Studies
INCI: PROPANEDIOL
CAS: 504-63-2
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR_vision_codex 40 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR_vision_codex | NOAEL | =1000 | mg/kg/day | rat | oral | Subchronic | repeated dose toxicity | {"citation":"9; 5; 0, 100, 250, 500","dose":"Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Oral Propanediol Rat, Crl:","effect":"Table 9. Short-Term and Subchronic Toxicity Studies. Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Oral Propanediol Rat, Crl: CD(SD) BR 5/sex/dose 0, 100, 250, 500, 1000 mg/kg (vehicle=deionized water) 14 days Animals were dosed daily by gavage as indicated; necropsy performed at study termination NOEL of 1000 mg/kg/day; no mortality; no clinical signs; body weight, food consumption, organ weights were no different than control group; neither gross necropsy nor microscopic examination revealed any treatment-related findings different from control group 12 Propanediol Rat, Crl: CD(SD) BR 10/sex/group 0, 100, 300, 1000 mg/kg/day (control group received water) 90 days Procedures followed (GLP) were in accordance with EPA Toxic Substances Control Act Health Effects Testing Guidelines (40CFR1989); single doses were administered daily by gastric intubation for 91-92 days; food and water were available ad libitum; blood samples (fasting","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_001"} |
| CIR_vision_codex | NOAEL | =500 | mg/kg/day | rat | oral | 28 days | oral toxicity | {"citation":"2; (5; 5","dose":"2 rats died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp:","effect":"mL/kg Propanediol (by gavage); 2 rats died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp: DAK 8/sex/group 0, 5, 50, 500 mg/kg/ day (control group received distilled water) 28 days Food and water were available ad libitum; dose administered by gavage 1 time per day for 28 consecutive days; blood samples (fasting) were collected just prior to necropsy NOEL of 500 mg/kg/day (females) and NOEL of 50 mg/kg/day (males) for clinical chemistry parameters; NOEL of 50 mg/ kg/day and LOEL of 500 mg/kg/day for histopathological changes; no mortality; unremarkable clinical observations; body weight, food consumption, and organ weights were unaffected; hematology parameters showed statistically significant differences compared to controls as follows: decrease in red blood cells and elevated hemoglobin (in various treatment groups, not dose dependent), lower hematocrit (males with 500 mg/kg dose), other parameters were statisticall...","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_002"} |
| CIR_vision_codex | NOAEL | =50 | mg/kg/day | rat | oral | 28 days | oral toxicity | {"citation":"(5; 5; 12","dose":"ts died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp:","effect":"ts died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp: DAK 8/sex/group 0, 5, 50, 500 mg/kg/ day (control group received distilled water) 28 days Food and water were available ad libitum; dose administered by gavage 1 time per day for 28 consecutive days; blood samples (fasting) were collected just prior to necropsy NOEL of 500 mg/kg/day (females) and NOEL of 50 mg/kg/day (males) for clinical chemistry parameters; NOEL of 50 mg/ kg/day and LOEL of 500 mg/kg/day for histopathological changes; no mortality; unremarkable clinical observations; body weight, food consumption, and organ weights were unaffected; hematology parameters showed statistically significant differences compared to controls as follows: decrease in red blood cells and elevated hemoglobin (in various treatment groups, not dose dependent), lower hematocrit (males with 500 mg/kg dose), other parameters were statistically significantly different from cont...","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_003"} |
| CIR_vision_codex | NOAEL | =200 | mg/kg/day | - | oral | 42 days | repeated dose toxicity | {"citation":"13; 200, 400, 800; 42","dose":"Sprague- Dawley 13/sex/dose 200, 400, 800 mg/kg/day (vehicle=water); controls received water 42 days (males), from 14 days prior to mating until day 3 of lactation (females) Food and water were available ad libitum; procedures followed were in accordance with OECD TG 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity S...","effect":"Sprague- Dawley 13/sex/dose 200, 400, 800 mg/kg/day (vehicle=water); controls received water 42 days (males), from 14 days prior to mating until day 3 of lactation (females) Food and water were available ad libitum; procedures followed were in accordance with OECD TG 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test); dose administered by gavage daily as indicated; hematology and clinical chemistry samples were collected at study termination; necropsy performed NOAEL of 200 mg/kg/day for males and females; dose dependent toxic central nervous system signs observed in both sexes; hyperactivity immediately following administration (200 mg/kg/day); hyperactivity observed after a few 400 mg/kg/day doses; some animals exhibited hypoactivity or were recumbent prior to becoming comatose (800 mg/kg/day) but this resolved 5 h post-dosing and animals recovered to normal; lower body weight gains and food consumption earlier in study (at 400 and 800 mg/ kg/day) that remained through study termination; statistically significant (dose-related...","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_004"} |
| CIR_vision_codex | NOAEL | =400 | mg/kg/day | rat | oral | 92 days | repeated dose toxicity | {"citation":"15; 10; 100, 400","dose":"hip and was consistent with historical controls (food consumption was similarly affected); clinical observations, clinical chemistry, gross pathology, and histopathology were unaffected by treatment 15 Hexanediol Rat, Wistar 10/sex/dose 100, 400, 1000 mg/kg/day (controls were dosed with water vehicle only) 91-92 days Procedures followed were in accordance...","effect":"hip and was consistent with historical controls (food consumption was similarly affected); clinical observations, clinical chemistry, gross pathology, and histopathology were unaffected by treatment 15 Hexanediol Rat, Wistar 10/sex/dose 100, 400, 1000 mg/kg/day (controls were dosed with water vehicle only) 91-92 days Procedures followed were in accordance with GLP and OECD TG 408 (Repeated Dose 90-Day Oral Toxicity in Rodents); animals were dosed daily by gavage as indicated; blood and urine samples were collected NOAEL of 400 mg/kg/day (males) and NOAEL of 1000 mg/kg/ day (females); no mortality; treatment-related decrease with 1000 mg/kg/day (males only) in mean body weight (\u000110.5%) and mean body weight change (\u000118.7%); no treatment- related effects were reported for food/water consumption, ophthalmoscopic exam, hematology, clinical chemistry, histopathology, estrous cycle, sperm parameters, gross pathology; non-adverse treatment-related effects for urinalysis (decreased urine volume and pH and increased specific gravity in males with 1000 mg/kg/day); non-adverse treatment-relat...","page":26,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_005"} |
| CIR_vision_codex | NOAEL | =600 | mg/kg/day | rat | oral | 14 days | repeated dose toxicity | {"citation":"5; 0, 300, 600; 14","dose":"r 5/sex/dose 0, 300, 600, 1000 mg/kg/day 14 days Procedures followed were in accordance with OECD Guidelines for Testing Chemicals; doses administered daily by gavage as indicated There were no treatment-related clinical signs and histopathology; clinical chemistry and hematology parameters were unaffected 20 Methylpropanediol Rat, Wistar 10/sex/dose 0, 3...","effect":"r 5/sex/dose 0, 300, 600, 1000 mg/kg/day 14 days Procedures followed were in accordance with OECD Guidelines for Testing Chemicals; doses administered daily by gavage as indicated There were no treatment-related clinical signs and histopathology; clinical chemistry and hematology parameters were unaffected 20 Methylpropanediol Rat, Wistar 10/sex/dose 0, 300, 600, 1000 mg/kg/day 90 days Procedures followed were in accordance with OECD Guidelines for Testing Chemicals; doses administered daily by gavage as indicated NOEL of 600 mg/kg/day; no treatment-related clinical signs or histopathology were reported; small increase in partial thromboplastin time (females with 1000 mg/kg/day); decrease (10%-14%) in ALT and aspartate aminotransferase AST in males with 1000 mg/kg/day; decrease in inorganic phosphate (males and females with 1000 mg/kg/day) 20 Butyl Ethyl Propanediol Rat, Sprague- Dawley (CD) 5/sex/dose 15, 150, 1000 mg/kg/day (controls were dosed with methylcellulose vehicle only, 1% w/v aqueous) 28 days Procedures followed were in accordance with OECD TG 407 (Repeated Dose 28-Day...","page":26,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_006"} |
| CIR_vision_codex | NOAEL | =15 | mg/kg/day | rat | oral | 28 days | repeated dose toxicity | {"citation":"20; 5; 15, 150","dose":"se AST in males with 1000 mg/kg/day; decrease in inorganic phosphate (males and females with 1000 mg/kg/day) 20 Butyl Ethyl Propanediol Rat, Sprague- Dawley (CD) 5/sex/dose 15, 150, 1000 mg/kg/day (controls were dosed with methylcellulose vehicle only, 1% w/v aqueous) 28 days Procedures followed were in accordance with OECD TG 407 (Repeated Dose 28-Day Or...","effect":"se AST in males with 1000 mg/kg/day; decrease in inorganic phosphate (males and females with 1000 mg/kg/day) 20 Butyl Ethyl Propanediol Rat, Sprague- Dawley (CD) 5/sex/dose 15, 150, 1000 mg/kg/day (controls were dosed with methylcellulose vehicle only, 1% w/v aqueous) 28 days Procedures followed were in accordance with OECD TG 407 (Repeated Dose 28-Day Oral Toxicity in Rodents); animals were dosed daily by gavage as indicated; blood samples collected; necropsy performed NOAEL of 1000 mg/kg/day (males and females); NOEL of 15 mg/kg/day (males and females); no mortalities; no treatment- related effects were correlated with clinical signs, body weight and weight gain, food/water consumption, hematology, clinical chemistry, and organ weights; gross pathology revealed liver and kidney enlargement (males with 1000 mg/kg/day) and pale, mottled kidneys (males with 150 or 1000 mg/kg/day); an adaptive liver effect noted (males with 1000 mg/kg/day); dose-related increase in renal cortical tubular eosinophilic inclusions (males with 150 or 1000 mg/ kg/day) 17 (continued) Scott et al. 95S","page":26,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_007"} |
| CIR_vision_codex | NOAEL | =150 | mg/kg/day | rat | oral | 90 days | repeated dose toxicity | {"citation":"10; 15, 150; 90","dose":") Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Butyl Ethyl Propanediol Rat, Wistar 10/sex/dose 15, 150, 1000 mg/kg/day (controls received hydroxypropyl methylcellulose vehicle only) 90 days Procedures (GLP) followed were in accordance with OECD TG 408 (Repeated Dose 90-Day...","effect":") Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Butyl Ethyl Propanediol Rat, Wistar 10/sex/dose 15, 150, 1000 mg/kg/day (controls received hydroxypropyl methylcellulose vehicle only) 90 days Procedures (GLP) followed were in accordance with OECD TG 408 (Repeated Dose 90-Day Oral Toxicity in Rodents); dose administered daily by gavage as indicated; blood and urine samples collected; necropsy performed NOAEL of 15 mg/kg/day (males) and NOAEL of 150 mg/kg/day (females); treatment-related deaths of 3 males (1000 mg/kg/ day) and 1 male (150 mg/kg/day); the following were unaffected by treatment: body weight and weight gain, food/ water consumption, ophthalmoscopic exam, hematology, and gross pathology; clinical signs (with 1000 mg/kg/day) were reduced activity, abnormal locomotion and respiration up to 1-2 hours post-dosing after which animals returned to normal, piloerection, hunched body posture, and partially closed eyes were observed; compared to controls a statistically significant increase in urea (...","page":27,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_008"} |
| CIR_vision_codex | NOAEL | =23 | mg/kg/day | rat | inhalation | 4-month | inhalation toxicity | {"citation":"20; 150; 15","dose":"ay).20 NOAELs of 150 mg/kg/day (females) and 15 mg/kg/day (males) were reported for Butyl Ethyl Propanediol; there were 4 treatment-related deaths (males at 150 or 1000 mg/kg/day), abnormal locomotion and respiration 1 to 2 hours post-dosing (after which animals returned to nor- mal), hunched body, and urinary (at 150 and 1000 mg/kg/ day) and kidney abnor...","effect":"ay).20 NOAELs of 150 mg/kg/day (females) and 15 mg/kg/day (males) were reported for Butyl Ethyl Propanediol; there were 4 treatment-related deaths (males at 150 or 1000 mg/kg/day), abnormal locomotion and respiration 1 to 2 hours post-dosing (after which animals returned to nor- mal), hunched body, and urinary (at 150 and 1000 mg/kg/ day) and kidney abnormalities (at ≥15 mg/kg/day) reported.17 Inhalation. In rat studies of 4-month durations (2 h/day exposure time) evaluating 1,4-Butanediol, a NOAEC of 500 mg/L (or NOAEL of 23 mg/kg/day) and a lowest- observed-adverse-effect-concentration (LOAEC) of 1500 mg/L (or lowest-observed-adverse-effect-level, LOAEL, of 85 mg/kg/day) were reported; observations in the study reporting the LOAEC of 1500 mg/L included a sleepy condition 20 minutes post-exposure, and histo- pathological exam revealed pulmonary emphysema, mild lung edema, treatment-related inflammatory changes of single alveolar cell and weak hyperplasia of alveolar septum.22 In 14-wk studies of diacetyl (potential metab- olite of 2,3-Butanediol) in mice and rats, significant in-...","page":30,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_009"} |
| CIR_vision_codex | NOAEL | =100 | mg/kg/day | rat | oral | - | developmental toxicity | {"citation":"414; 6; 15","dose":"ere in accordance with OECD TG 414 (Prenatal Developmental Toxicity Study); females were dosed by gavage on days 6 through 15 of gestation Maternal and fetal toxicity NOAEL of 1000 mg/kg/day; no maternal toxic effects from treatment (fertility rate was 91% for all dose rates); no embryotoxic or teratogenic effects on fetuses from treatment 12 1,4-Butanedi...","effect":"ere in accordance with OECD TG 414 (Prenatal Developmental Toxicity Study); females were dosed by gavage on days 6 through 15 of gestation Maternal and fetal toxicity NOAEL of 1000 mg/kg/day; no maternal toxic effects from treatment (fertility rate was 91% for all dose rates); no embryotoxic or teratogenic effects on fetuses from treatment 12 1,4-Butanediol Mouse, Swiss (CD-1) 28-32/ group 0, 100, 300, 600 mg/kg/day Pregnant mice were dosed by gavage during days 6 through 15 of gestation Maternal and developmental NOAEL of 100 mg/kg/day; maternal and developmental LOAEL of 300 mg/kg/ day ; no maternal mortality; maternal central nervous system intoxication was observed (300-600 mg/kg/day) 4 h after daily dosing; reduced food consumption and body weight/weight gain noted (maternal with 300-600 mg/ kg/day); developmental toxicity observed was reduced fetal body weight (300-600 mg/kg/day maternal dose) 91 1,4-Butanediol Rat, Sprague- Dawley 13/sex/ dose 200, 400, 800 mg/kg/day (vehicle=water); controls received water Food and water were available ad libitum; procedures followed were...","page":31,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_010"} |
| CIR_vision_codex | NOAEL | =1000 | mg/kg/day | rat | oral | Subchronic | repeated dose toxicity | {"citation":"9; 5; 0, 100, 250, 500","dose":"Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Oral Propanediol Rat, Crl:","effect":"Table 9. Short-Term and Subchronic Toxicity Studies. Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Oral Propanediol Rat, Crl: CD(SD) BR 5/sex/dose 0, 100, 250, 500, 1000 mg/kg (vehicle=deionized water) 14 days Animals were dosed daily by gavage as indicated; necropsy performed at study termination NOEL of 1000 mg/kg/day; no mortality; no clinical signs; body weight, food consumption, organ weights were no different than control group; neither gross necropsy nor microscopic examination revealed any treatment-related findings different from control group 12 Propanediol Rat, Crl: CD(SD) BR 10/sex/group 0, 100, 300, 1000 mg/kg/day (control group received water) 90 days Procedures followed (GLP) were in accordance with EPA Toxic Substances Control Act Health Effects Testing Guidelines (40CFR1989); single doses were administered daily by gastric intubation for 91-92 days; food and water were available ad libitum; blood samples (fasting","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_001"} |
| CIR_vision_codex | NOAEL | =500 | mg/kg/day | rat | oral | 28 days | oral toxicity | {"citation":"2; (5; 5","dose":"2 rats died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp:","effect":"mL/kg Propanediol (by gavage); 2 rats died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp: DAK 8/sex/group 0, 5, 50, 500 mg/kg/ day (control group received distilled water) 28 days Food and water were available ad libitum; dose administered by gavage 1 time per day for 28 consecutive days; blood samples (fasting) were collected just prior to necropsy NOEL of 500 mg/kg/day (females) and NOEL of 50 mg/kg/day (males) for clinical chemistry parameters; NOEL of 50 mg/ kg/day and LOEL of 500 mg/kg/day for histopathological changes; no mortality; unremarkable clinical observations; body weight, food consumption, and organ weights were unaffected; hematology parameters showed statistically significant differences compared to controls as follows: decrease in red blood cells and elevated hemoglobin (in various treatment groups, not dose dependent), lower hematocrit (males with 500 mg/kg dose), other parameters were statisticall...","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_002"} |
| CIR_vision_codex | NOAEL | =50 | mg/kg/day | rat | oral | 28 days | oral toxicity | {"citation":"(5; 5; 12","dose":"ts died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp:","effect":"ts died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp: DAK 8/sex/group 0, 5, 50, 500 mg/kg/ day (control group received distilled water) 28 days Food and water were available ad libitum; dose administered by gavage 1 time per day for 28 consecutive days; blood samples (fasting) were collected just prior to necropsy NOEL of 500 mg/kg/day (females) and NOEL of 50 mg/kg/day (males) for clinical chemistry parameters; NOEL of 50 mg/ kg/day and LOEL of 500 mg/kg/day for histopathological changes; no mortality; unremarkable clinical observations; body weight, food consumption, and organ weights were unaffected; hematology parameters showed statistically significant differences compared to controls as follows: decrease in red blood cells and elevated hemoglobin (in various treatment groups, not dose dependent), lower hematocrit (males with 500 mg/kg dose), other parameters were statistically significantly different from cont...","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_003"} |
| CIR_vision_codex | NOAEL | =200 | mg/kg/day | - | oral | 42 days | repeated dose toxicity | {"citation":"13; 200, 400, 800; 42","dose":"Sprague- Dawley 13/sex/dose 200, 400, 800 mg/kg/day (vehicle=water); controls received water 42 days (males), from 14 days prior to mating until day 3 of lactation (females) Food and water were available ad libitum; procedures followed were in accordance with OECD TG 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity S...","effect":"Sprague- Dawley 13/sex/dose 200, 400, 800 mg/kg/day (vehicle=water); controls received water 42 days (males), from 14 days prior to mating until day 3 of lactation (females) Food and water were available ad libitum; procedures followed were in accordance with OECD TG 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test); dose administered by gavage daily as indicated; hematology and clinical chemistry samples were collected at study termination; necropsy performed NOAEL of 200 mg/kg/day for males and females; dose dependent toxic central nervous system signs observed in both sexes; hyperactivity immediately following administration (200 mg/kg/day); hyperactivity observed after a few 400 mg/kg/day doses; some animals exhibited hypoactivity or were recumbent prior to becoming comatose (800 mg/kg/day) but this resolved 5 h post-dosing and animals recovered to normal; lower body weight gains and food consumption earlier in study (at 400 and 800 mg/ kg/day) that remained through study termination; statistically significant (dose-related...","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_004"} |
| CIR_vision_codex | NOAEL | =400 | mg/kg/day | rat | oral | 92 days | repeated dose toxicity | {"citation":"15; 10; 100, 400","dose":"hip and was consistent with historical controls (food consumption was similarly affected); clinical observations, clinical chemistry, gross pathology, and histopathology were unaffected by treatment 15 Hexanediol Rat, Wistar 10/sex/dose 100, 400, 1000 mg/kg/day (controls were dosed with water vehicle only) 91-92 days Procedures followed were in accordance...","effect":"hip and was consistent with historical controls (food consumption was similarly affected); clinical observations, clinical chemistry, gross pathology, and histopathology were unaffected by treatment 15 Hexanediol Rat, Wistar 10/sex/dose 100, 400, 1000 mg/kg/day (controls were dosed with water vehicle only) 91-92 days Procedures followed were in accordance with GLP and OECD TG 408 (Repeated Dose 90-Day Oral Toxicity in Rodents); animals were dosed daily by gavage as indicated; blood and urine samples were collected NOAEL of 400 mg/kg/day (males) and NOAEL of 1000 mg/kg/ day (females); no mortality; treatment-related decrease with 1000 mg/kg/day (males only) in mean body weight (\u000110.5%) and mean body weight change (\u000118.7%); no treatment- related effects were reported for food/water consumption, ophthalmoscopic exam, hematology, clinical chemistry, histopathology, estrous cycle, sperm parameters, gross pathology; non-adverse treatment-related effects for urinalysis (decreased urine volume and pH and increased specific gravity in males with 1000 mg/kg/day); non-adverse treatment-relat...","page":26,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_005"} |
| CIR_vision_codex | NOAEL | =600 | mg/kg/day | rat | oral | 14 days | repeated dose toxicity | {"citation":"5; 0, 300, 600; 14","dose":"r 5/sex/dose 0, 300, 600, 1000 mg/kg/day 14 days Procedures followed were in accordance with OECD Guidelines for Testing Chemicals; doses administered daily by gavage as indicated There were no treatment-related clinical signs and histopathology; clinical chemistry and hematology parameters were unaffected 20 Methylpropanediol Rat, Wistar 10/sex/dose 0, 3...","effect":"r 5/sex/dose 0, 300, 600, 1000 mg/kg/day 14 days Procedures followed were in accordance with OECD Guidelines for Testing Chemicals; doses administered daily by gavage as indicated There were no treatment-related clinical signs and histopathology; clinical chemistry and hematology parameters were unaffected 20 Methylpropanediol Rat, Wistar 10/sex/dose 0, 300, 600, 1000 mg/kg/day 90 days Procedures followed were in accordance with OECD Guidelines for Testing Chemicals; doses administered daily by gavage as indicated NOEL of 600 mg/kg/day; no treatment-related clinical signs or histopathology were reported; small increase in partial thromboplastin time (females with 1000 mg/kg/day); decrease (10%-14%) in ALT and aspartate aminotransferase AST in males with 1000 mg/kg/day; decrease in inorganic phosphate (males and females with 1000 mg/kg/day) 20 Butyl Ethyl Propanediol Rat, Sprague- Dawley (CD) 5/sex/dose 15, 150, 1000 mg/kg/day (controls were dosed with methylcellulose vehicle only, 1% w/v aqueous) 28 days Procedures followed were in accordance with OECD TG 407 (Repeated Dose 28-Day...","page":26,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_006"} |
| CIR_vision_codex | NOAEL | =15 | mg/kg/day | rat | oral | 28 days | repeated dose toxicity | {"citation":"20; 5; 15, 150","dose":"se AST in males with 1000 mg/kg/day; decrease in inorganic phosphate (males and females with 1000 mg/kg/day) 20 Butyl Ethyl Propanediol Rat, Sprague- Dawley (CD) 5/sex/dose 15, 150, 1000 mg/kg/day (controls were dosed with methylcellulose vehicle only, 1% w/v aqueous) 28 days Procedures followed were in accordance with OECD TG 407 (Repeated Dose 28-Day Or...","effect":"se AST in males with 1000 mg/kg/day; decrease in inorganic phosphate (males and females with 1000 mg/kg/day) 20 Butyl Ethyl Propanediol Rat, Sprague- Dawley (CD) 5/sex/dose 15, 150, 1000 mg/kg/day (controls were dosed with methylcellulose vehicle only, 1% w/v aqueous) 28 days Procedures followed were in accordance with OECD TG 407 (Repeated Dose 28-Day Oral Toxicity in Rodents); animals were dosed daily by gavage as indicated; blood samples collected; necropsy performed NOAEL of 1000 mg/kg/day (males and females); NOEL of 15 mg/kg/day (males and females); no mortalities; no treatment- related effects were correlated with clinical signs, body weight and weight gain, food/water consumption, hematology, clinical chemistry, and organ weights; gross pathology revealed liver and kidney enlargement (males with 1000 mg/kg/day) and pale, mottled kidneys (males with 150 or 1000 mg/kg/day); an adaptive liver effect noted (males with 1000 mg/kg/day); dose-related increase in renal cortical tubular eosinophilic inclusions (males with 150 or 1000 mg/ kg/day) 17 (continued) Scott et al. 95S","page":26,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_007"} |
| CIR_vision_codex | NOAEL | =150 | mg/kg/day | rat | oral | 90 days | repeated dose toxicity | {"citation":"10; 15, 150; 90","dose":") Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Butyl Ethyl Propanediol Rat, Wistar 10/sex/dose 15, 150, 1000 mg/kg/day (controls received hydroxypropyl methylcellulose vehicle only) 90 days Procedures (GLP) followed were in accordance with OECD TG 408 (Repeated Dose 90-Day...","effect":") Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Butyl Ethyl Propanediol Rat, Wistar 10/sex/dose 15, 150, 1000 mg/kg/day (controls received hydroxypropyl methylcellulose vehicle only) 90 days Procedures (GLP) followed were in accordance with OECD TG 408 (Repeated Dose 90-Day Oral Toxicity in Rodents); dose administered daily by gavage as indicated; blood and urine samples collected; necropsy performed NOAEL of 15 mg/kg/day (males) and NOAEL of 150 mg/kg/day (females); treatment-related deaths of 3 males (1000 mg/kg/ day) and 1 male (150 mg/kg/day); the following were unaffected by treatment: body weight and weight gain, food/ water consumption, ophthalmoscopic exam, hematology, and gross pathology; clinical signs (with 1000 mg/kg/day) were reduced activity, abnormal locomotion and respiration up to 1-2 hours post-dosing after which animals returned to normal, piloerection, hunched body posture, and partially closed eyes were observed; compared to controls a statistically significant increase in urea (...","page":27,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_008"} |
| CIR_vision_codex | NOAEL | =23 | mg/kg/day | rat | inhalation | 4-month | inhalation toxicity | {"citation":"20; 150; 15","dose":"ay).20 NOAELs of 150 mg/kg/day (females) and 15 mg/kg/day (males) were reported for Butyl Ethyl Propanediol; there were 4 treatment-related deaths (males at 150 or 1000 mg/kg/day), abnormal locomotion and respiration 1 to 2 hours post-dosing (after which animals returned to nor- mal), hunched body, and urinary (at 150 and 1000 mg/kg/ day) and kidney abnor...","effect":"ay).20 NOAELs of 150 mg/kg/day (females) and 15 mg/kg/day (males) were reported for Butyl Ethyl Propanediol; there were 4 treatment-related deaths (males at 150 or 1000 mg/kg/day), abnormal locomotion and respiration 1 to 2 hours post-dosing (after which animals returned to nor- mal), hunched body, and urinary (at 150 and 1000 mg/kg/ day) and kidney abnormalities (at ≥15 mg/kg/day) reported.17 Inhalation. In rat studies of 4-month durations (2 h/day exposure time) evaluating 1,4-Butanediol, a NOAEC of 500 mg/L (or NOAEL of 23 mg/kg/day) and a lowest- observed-adverse-effect-concentration (LOAEC) of 1500 mg/L (or lowest-observed-adverse-effect-level, LOAEL, of 85 mg/kg/day) were reported; observations in the study reporting the LOAEC of 1500 mg/L included a sleepy condition 20 minutes post-exposure, and histo- pathological exam revealed pulmonary emphysema, mild lung edema, treatment-related inflammatory changes of single alveolar cell and weak hyperplasia of alveolar septum.22 In 14-wk studies of diacetyl (potential metab- olite of 2,3-Butanediol) in mice and rats, significant in-...","page":30,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_009"} |
| CIR_vision_codex | NOAEL | =100 | mg/kg/day | rat | oral | - | developmental toxicity | {"citation":"414; 6; 15","dose":"ere in accordance with OECD TG 414 (Prenatal Developmental Toxicity Study); females were dosed by gavage on days 6 through 15 of gestation Maternal and fetal toxicity NOAEL of 1000 mg/kg/day; no maternal toxic effects from treatment (fertility rate was 91% for all dose rates); no embryotoxic or teratogenic effects on fetuses from treatment 12 1,4-Butanedi...","effect":"ere in accordance with OECD TG 414 (Prenatal Developmental Toxicity Study); females were dosed by gavage on days 6 through 15 of gestation Maternal and fetal toxicity NOAEL of 1000 mg/kg/day; no maternal toxic effects from treatment (fertility rate was 91% for all dose rates); no embryotoxic or teratogenic effects on fetuses from treatment 12 1,4-Butanediol Mouse, Swiss (CD-1) 28-32/ group 0, 100, 300, 600 mg/kg/day Pregnant mice were dosed by gavage during days 6 through 15 of gestation Maternal and developmental NOAEL of 100 mg/kg/day; maternal and developmental LOAEL of 300 mg/kg/ day ; no maternal mortality; maternal central nervous system intoxication was observed (300-600 mg/kg/day) 4 h after daily dosing; reduced food consumption and body weight/weight gain noted (maternal with 300-600 mg/ kg/day); developmental toxicity observed was reduced fetal body weight (300-600 mg/kg/day maternal dose) 91 1,4-Butanediol Rat, Sprague- Dawley 13/sex/ dose 200, 400, 800 mg/kg/day (vehicle=water); controls received water Food and water were available ad libitum; procedures followed were...","page":31,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_010"} |
| CIR_vision_codex | NOAEL | =1000 | mg/kg/day | rat | oral | Subchronic | repeated dose toxicity | {"citation":"9; 5; 0, 100, 250, 500","dose":"Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Oral Propanediol Rat, Crl:","effect":"Table 9. Short-Term and Subchronic Toxicity Studies. Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Oral Propanediol Rat, Crl: CD(SD) BR 5/sex/dose 0, 100, 250, 500, 1000 mg/kg (vehicle=deionized water) 14 days Animals were dosed daily by gavage as indicated; necropsy performed at study termination NOEL of 1000 mg/kg/day; no mortality; no clinical signs; body weight, food consumption, organ weights were no different than control group; neither gross necropsy nor microscopic examination revealed any treatment-related findings different from control group 12 Propanediol Rat, Crl: CD(SD) BR 10/sex/group 0, 100, 300, 1000 mg/kg/day (control group received water) 90 days Procedures followed (GLP) were in accordance with EPA Toxic Substances Control Act Health Effects Testing Guidelines (40CFR1989); single doses were administered daily by gastric intubation for 91-92 days; food and water were available ad libitum; blood samples (fasting","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_001"} |
| CIR_vision_codex | NOAEL | =500 | mg/kg/day | rat | oral | 28 days | oral toxicity | {"citation":"2; (5; 5","dose":"2 rats died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp:","effect":"mL/kg Propanediol (by gavage); 2 rats died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp: DAK 8/sex/group 0, 5, 50, 500 mg/kg/ day (control group received distilled water) 28 days Food and water were available ad libitum; dose administered by gavage 1 time per day for 28 consecutive days; blood samples (fasting) were collected just prior to necropsy NOEL of 500 mg/kg/day (females) and NOEL of 50 mg/kg/day (males) for clinical chemistry parameters; NOEL of 50 mg/ kg/day and LOEL of 500 mg/kg/day for histopathological changes; no mortality; unremarkable clinical observations; body weight, food consumption, and organ weights were unaffected; hematology parameters showed statistically significant differences compared to controls as follows: decrease in red blood cells and elevated hemoglobin (in various treatment groups, not dose dependent), lower hematocrit (males with 500 mg/kg dose), other parameters were statisticall...","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_002"} |
| CIR_vision_codex | NOAEL | =50 | mg/kg/day | rat | oral | 28 days | oral toxicity | {"citation":"(5; 5; 12","dose":"ts died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp:","effect":"ts died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp: DAK 8/sex/group 0, 5, 50, 500 mg/kg/ day (control group received distilled water) 28 days Food and water were available ad libitum; dose administered by gavage 1 time per day for 28 consecutive days; blood samples (fasting) were collected just prior to necropsy NOEL of 500 mg/kg/day (females) and NOEL of 50 mg/kg/day (males) for clinical chemistry parameters; NOEL of 50 mg/ kg/day and LOEL of 500 mg/kg/day for histopathological changes; no mortality; unremarkable clinical observations; body weight, food consumption, and organ weights were unaffected; hematology parameters showed statistically significant differences compared to controls as follows: decrease in red blood cells and elevated hemoglobin (in various treatment groups, not dose dependent), lower hematocrit (males with 500 mg/kg dose), other parameters were statistically significantly different from cont...","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_003"} |
| CIR_vision_codex | NOAEL | =200 | mg/kg/day | - | oral | 42 days | repeated dose toxicity | {"citation":"13; 200, 400, 800; 42","dose":"Sprague- Dawley 13/sex/dose 200, 400, 800 mg/kg/day (vehicle=water); controls received water 42 days (males), from 14 days prior to mating until day 3 of lactation (females) Food and water were available ad libitum; procedures followed were in accordance with OECD TG 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity S...","effect":"Sprague- Dawley 13/sex/dose 200, 400, 800 mg/kg/day (vehicle=water); controls received water 42 days (males), from 14 days prior to mating until day 3 of lactation (females) Food and water were available ad libitum; procedures followed were in accordance with OECD TG 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test); dose administered by gavage daily as indicated; hematology and clinical chemistry samples were collected at study termination; necropsy performed NOAEL of 200 mg/kg/day for males and females; dose dependent toxic central nervous system signs observed in both sexes; hyperactivity immediately following administration (200 mg/kg/day); hyperactivity observed after a few 400 mg/kg/day doses; some animals exhibited hypoactivity or were recumbent prior to becoming comatose (800 mg/kg/day) but this resolved 5 h post-dosing and animals recovered to normal; lower body weight gains and food consumption earlier in study (at 400 and 800 mg/ kg/day) that remained through study termination; statistically significant (dose-related...","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_004"} |
| CIR_vision_codex | NOAEL | =400 | mg/kg/day | rat | oral | 92 days | repeated dose toxicity | {"citation":"15; 10; 100, 400","dose":"hip and was consistent with historical controls (food consumption was similarly affected); clinical observations, clinical chemistry, gross pathology, and histopathology were unaffected by treatment 15 Hexanediol Rat, Wistar 10/sex/dose 100, 400, 1000 mg/kg/day (controls were dosed with water vehicle only) 91-92 days Procedures followed were in accordance...","effect":"hip and was consistent with historical controls (food consumption was similarly affected); clinical observations, clinical chemistry, gross pathology, and histopathology were unaffected by treatment 15 Hexanediol Rat, Wistar 10/sex/dose 100, 400, 1000 mg/kg/day (controls were dosed with water vehicle only) 91-92 days Procedures followed were in accordance with GLP and OECD TG 408 (Repeated Dose 90-Day Oral Toxicity in Rodents); animals were dosed daily by gavage as indicated; blood and urine samples were collected NOAEL of 400 mg/kg/day (males) and NOAEL of 1000 mg/kg/ day (females); no mortality; treatment-related decrease with 1000 mg/kg/day (males only) in mean body weight (\u000110.5%) and mean body weight change (\u000118.7%); no treatment- related effects were reported for food/water consumption, ophthalmoscopic exam, hematology, clinical chemistry, histopathology, estrous cycle, sperm parameters, gross pathology; non-adverse treatment-related effects for urinalysis (decreased urine volume and pH and increased specific gravity in males with 1000 mg/kg/day); non-adverse treatment-relat...","page":26,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_005"} |
| CIR_vision_codex | NOAEL | =600 | mg/kg/day | rat | oral | 14 days | repeated dose toxicity | {"citation":"5; 0, 300, 600; 14","dose":"r 5/sex/dose 0, 300, 600, 1000 mg/kg/day 14 days Procedures followed were in accordance with OECD Guidelines for Testing Chemicals; doses administered daily by gavage as indicated There were no treatment-related clinical signs and histopathology; clinical chemistry and hematology parameters were unaffected 20 Methylpropanediol Rat, Wistar 10/sex/dose 0, 3...","effect":"r 5/sex/dose 0, 300, 600, 1000 mg/kg/day 14 days Procedures followed were in accordance with OECD Guidelines for Testing Chemicals; doses administered daily by gavage as indicated There were no treatment-related clinical signs and histopathology; clinical chemistry and hematology parameters were unaffected 20 Methylpropanediol Rat, Wistar 10/sex/dose 0, 300, 600, 1000 mg/kg/day 90 days Procedures followed were in accordance with OECD Guidelines for Testing Chemicals; doses administered daily by gavage as indicated NOEL of 600 mg/kg/day; no treatment-related clinical signs or histopathology were reported; small increase in partial thromboplastin time (females with 1000 mg/kg/day); decrease (10%-14%) in ALT and aspartate aminotransferase AST in males with 1000 mg/kg/day; decrease in inorganic phosphate (males and females with 1000 mg/kg/day) 20 Butyl Ethyl Propanediol Rat, Sprague- Dawley (CD) 5/sex/dose 15, 150, 1000 mg/kg/day (controls were dosed with methylcellulose vehicle only, 1% w/v aqueous) 28 days Procedures followed were in accordance with OECD TG 407 (Repeated Dose 28-Day...","page":26,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_006"} |
| CIR_vision_codex | NOAEL | =15 | mg/kg/day | rat | oral | 28 days | repeated dose toxicity | {"citation":"20; 5; 15, 150","dose":"se AST in males with 1000 mg/kg/day; decrease in inorganic phosphate (males and females with 1000 mg/kg/day) 20 Butyl Ethyl Propanediol Rat, Sprague- Dawley (CD) 5/sex/dose 15, 150, 1000 mg/kg/day (controls were dosed with methylcellulose vehicle only, 1% w/v aqueous) 28 days Procedures followed were in accordance with OECD TG 407 (Repeated Dose 28-Day Or...","effect":"se AST in males with 1000 mg/kg/day; decrease in inorganic phosphate (males and females with 1000 mg/kg/day) 20 Butyl Ethyl Propanediol Rat, Sprague- Dawley (CD) 5/sex/dose 15, 150, 1000 mg/kg/day (controls were dosed with methylcellulose vehicle only, 1% w/v aqueous) 28 days Procedures followed were in accordance with OECD TG 407 (Repeated Dose 28-Day Oral Toxicity in Rodents); animals were dosed daily by gavage as indicated; blood samples collected; necropsy performed NOAEL of 1000 mg/kg/day (males and females); NOEL of 15 mg/kg/day (males and females); no mortalities; no treatment- related effects were correlated with clinical signs, body weight and weight gain, food/water consumption, hematology, clinical chemistry, and organ weights; gross pathology revealed liver and kidney enlargement (males with 1000 mg/kg/day) and pale, mottled kidneys (males with 150 or 1000 mg/kg/day); an adaptive liver effect noted (males with 1000 mg/kg/day); dose-related increase in renal cortical tubular eosinophilic inclusions (males with 150 or 1000 mg/ kg/day) 17 (continued) Scott et al. 95S","page":26,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_007"} |
| CIR_vision_codex | NOAEL | =150 | mg/kg/day | rat | oral | 90 days | repeated dose toxicity | {"citation":"10; 15, 150; 90","dose":") Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Butyl Ethyl Propanediol Rat, Wistar 10/sex/dose 15, 150, 1000 mg/kg/day (controls received hydroxypropyl methylcellulose vehicle only) 90 days Procedures (GLP) followed were in accordance with OECD TG 408 (Repeated Dose 90-Day...","effect":") Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Butyl Ethyl Propanediol Rat, Wistar 10/sex/dose 15, 150, 1000 mg/kg/day (controls received hydroxypropyl methylcellulose vehicle only) 90 days Procedures (GLP) followed were in accordance with OECD TG 408 (Repeated Dose 90-Day Oral Toxicity in Rodents); dose administered daily by gavage as indicated; blood and urine samples collected; necropsy performed NOAEL of 15 mg/kg/day (males) and NOAEL of 150 mg/kg/day (females); treatment-related deaths of 3 males (1000 mg/kg/ day) and 1 male (150 mg/kg/day); the following were unaffected by treatment: body weight and weight gain, food/ water consumption, ophthalmoscopic exam, hematology, and gross pathology; clinical signs (with 1000 mg/kg/day) were reduced activity, abnormal locomotion and respiration up to 1-2 hours post-dosing after which animals returned to normal, piloerection, hunched body posture, and partially closed eyes were observed; compared to controls a statistically significant increase in urea (...","page":27,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_008"} |
| CIR_vision_codex | NOAEL | =23 | mg/kg/day | rat | inhalation | 4-month | inhalation toxicity | {"citation":"20; 150; 15","dose":"ay).20 NOAELs of 150 mg/kg/day (females) and 15 mg/kg/day (males) were reported for Butyl Ethyl Propanediol; there were 4 treatment-related deaths (males at 150 or 1000 mg/kg/day), abnormal locomotion and respiration 1 to 2 hours post-dosing (after which animals returned to nor- mal), hunched body, and urinary (at 150 and 1000 mg/kg/ day) and kidney abnor...","effect":"ay).20 NOAELs of 150 mg/kg/day (females) and 15 mg/kg/day (males) were reported for Butyl Ethyl Propanediol; there were 4 treatment-related deaths (males at 150 or 1000 mg/kg/day), abnormal locomotion and respiration 1 to 2 hours post-dosing (after which animals returned to nor- mal), hunched body, and urinary (at 150 and 1000 mg/kg/ day) and kidney abnormalities (at ≥15 mg/kg/day) reported.17 Inhalation. In rat studies of 4-month durations (2 h/day exposure time) evaluating 1,4-Butanediol, a NOAEC of 500 mg/L (or NOAEL of 23 mg/kg/day) and a lowest- observed-adverse-effect-concentration (LOAEC) of 1500 mg/L (or lowest-observed-adverse-effect-level, LOAEL, of 85 mg/kg/day) were reported; observations in the study reporting the LOAEC of 1500 mg/L included a sleepy condition 20 minutes post-exposure, and histo- pathological exam revealed pulmonary emphysema, mild lung edema, treatment-related inflammatory changes of single alveolar cell and weak hyperplasia of alveolar septum.22 In 14-wk studies of diacetyl (potential metab- olite of 2,3-Butanediol) in mice and rats, significant in-...","page":30,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_009"} |
| CIR_vision_codex | NOAEL | =100 | mg/kg/day | rat | oral | - | developmental toxicity | {"citation":"414; 6; 15","dose":"ere in accordance with OECD TG 414 (Prenatal Developmental Toxicity Study); females were dosed by gavage on days 6 through 15 of gestation Maternal and fetal toxicity NOAEL of 1000 mg/kg/day; no maternal toxic effects from treatment (fertility rate was 91% for all dose rates); no embryotoxic or teratogenic effects on fetuses from treatment 12 1,4-Butanedi...","effect":"ere in accordance with OECD TG 414 (Prenatal Developmental Toxicity Study); females were dosed by gavage on days 6 through 15 of gestation Maternal and fetal toxicity NOAEL of 1000 mg/kg/day; no maternal toxic effects from treatment (fertility rate was 91% for all dose rates); no embryotoxic or teratogenic effects on fetuses from treatment 12 1,4-Butanediol Mouse, Swiss (CD-1) 28-32/ group 0, 100, 300, 600 mg/kg/day Pregnant mice were dosed by gavage during days 6 through 15 of gestation Maternal and developmental NOAEL of 100 mg/kg/day; maternal and developmental LOAEL of 300 mg/kg/ day ; no maternal mortality; maternal central nervous system intoxication was observed (300-600 mg/kg/day) 4 h after daily dosing; reduced food consumption and body weight/weight gain noted (maternal with 300-600 mg/ kg/day); developmental toxicity observed was reduced fetal body weight (300-600 mg/kg/day maternal dose) 91 1,4-Butanediol Rat, Sprague- Dawley 13/sex/ dose 200, 400, 800 mg/kg/day (vehicle=water); controls received water Food and water were available ad libitum; procedures followed were...","page":31,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_010"} |
| CIR_vision_codex | NOAEL | =1000 | mg/kg/day | rat | oral | Subchronic | repeated dose toxicity | {"citation":"9; 5; 0, 100, 250, 500","dose":"Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Oral Propanediol Rat, Crl:","effect":"Table 9. Short-Term and Subchronic Toxicity Studies. Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Oral Propanediol Rat, Crl: CD(SD) BR 5/sex/dose 0, 100, 250, 500, 1000 mg/kg (vehicle=deionized water) 14 days Animals were dosed daily by gavage as indicated; necropsy performed at study termination NOEL of 1000 mg/kg/day; no mortality; no clinical signs; body weight, food consumption, organ weights were no different than control group; neither gross necropsy nor microscopic examination revealed any treatment-related findings different from control group 12 Propanediol Rat, Crl: CD(SD) BR 10/sex/group 0, 100, 300, 1000 mg/kg/day (control group received water) 90 days Procedures followed (GLP) were in accordance with EPA Toxic Substances Control Act Health Effects Testing Guidelines (40CFR1989); single doses were administered daily by gastric intubation for 91-92 days; food and water were available ad libitum; blood samples (fasting","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_001"} |
| CIR_vision_codex | NOAEL | =500 | mg/kg/day | rat | oral | 28 days | oral toxicity | {"citation":"2; (5; 5","dose":"2 rats died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp:","effect":"mL/kg Propanediol (by gavage); 2 rats died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp: DAK 8/sex/group 0, 5, 50, 500 mg/kg/ day (control group received distilled water) 28 days Food and water were available ad libitum; dose administered by gavage 1 time per day for 28 consecutive days; blood samples (fasting) were collected just prior to necropsy NOEL of 500 mg/kg/day (females) and NOEL of 50 mg/kg/day (males) for clinical chemistry parameters; NOEL of 50 mg/ kg/day and LOEL of 500 mg/kg/day for histopathological changes; no mortality; unremarkable clinical observations; body weight, food consumption, and organ weights were unaffected; hematology parameters showed statistically significant differences compared to controls as follows: decrease in red blood cells and elevated hemoglobin (in various treatment groups, not dose dependent), lower hematocrit (males with 500 mg/kg dose), other parameters were statisticall...","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_002"} |
| CIR_vision_codex | NOAEL | =50 | mg/kg/day | rat | oral | 28 days | oral toxicity | {"citation":"(5; 5; 12","dose":"ts died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp:","effect":"ts died (5 mL/kg group administered by gavage); reduced growth weights were noted in groups dosed in diet with 5% and 12% Propanediol and in rats dosed with 5 mL/kg Propanediol by gavage 12 1,4-Butanediol Rat, Wistar Imp: DAK 8/sex/group 0, 5, 50, 500 mg/kg/ day (control group received distilled water) 28 days Food and water were available ad libitum; dose administered by gavage 1 time per day for 28 consecutive days; blood samples (fasting) were collected just prior to necropsy NOEL of 500 mg/kg/day (females) and NOEL of 50 mg/kg/day (males) for clinical chemistry parameters; NOEL of 50 mg/ kg/day and LOEL of 500 mg/kg/day for histopathological changes; no mortality; unremarkable clinical observations; body weight, food consumption, and organ weights were unaffected; hematology parameters showed statistically significant differences compared to controls as follows: decrease in red blood cells and elevated hemoglobin (in various treatment groups, not dose dependent), lower hematocrit (males with 500 mg/kg dose), other parameters were statistically significantly different from cont...","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_003"} |
| CIR_vision_codex | NOAEL | =200 | mg/kg/day | - | oral | 42 days | repeated dose toxicity | {"citation":"13; 200, 400, 800; 42","dose":"Sprague- Dawley 13/sex/dose 200, 400, 800 mg/kg/day (vehicle=water); controls received water 42 days (males), from 14 days prior to mating until day 3 of lactation (females) Food and water were available ad libitum; procedures followed were in accordance with OECD TG 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity S...","effect":"Sprague- Dawley 13/sex/dose 200, 400, 800 mg/kg/day (vehicle=water); controls received water 42 days (males), from 14 days prior to mating until day 3 of lactation (females) Food and water were available ad libitum; procedures followed were in accordance with OECD TG 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test); dose administered by gavage daily as indicated; hematology and clinical chemistry samples were collected at study termination; necropsy performed NOAEL of 200 mg/kg/day for males and females; dose dependent toxic central nervous system signs observed in both sexes; hyperactivity immediately following administration (200 mg/kg/day); hyperactivity observed after a few 400 mg/kg/day doses; some animals exhibited hypoactivity or were recumbent prior to becoming comatose (800 mg/kg/day) but this resolved 5 h post-dosing and animals recovered to normal; lower body weight gains and food consumption earlier in study (at 400 and 800 mg/ kg/day) that remained through study termination; statistically significant (dose-related...","page":25,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_004"} |
| CIR_vision_codex | NOAEL | =400 | mg/kg/day | rat | oral | 92 days | repeated dose toxicity | {"citation":"15; 10; 100, 400","dose":"hip and was consistent with historical controls (food consumption was similarly affected); clinical observations, clinical chemistry, gross pathology, and histopathology were unaffected by treatment 15 Hexanediol Rat, Wistar 10/sex/dose 100, 400, 1000 mg/kg/day (controls were dosed with water vehicle only) 91-92 days Procedures followed were in accordance...","effect":"hip and was consistent with historical controls (food consumption was similarly affected); clinical observations, clinical chemistry, gross pathology, and histopathology were unaffected by treatment 15 Hexanediol Rat, Wistar 10/sex/dose 100, 400, 1000 mg/kg/day (controls were dosed with water vehicle only) 91-92 days Procedures followed were in accordance with GLP and OECD TG 408 (Repeated Dose 90-Day Oral Toxicity in Rodents); animals were dosed daily by gavage as indicated; blood and urine samples were collected NOAEL of 400 mg/kg/day (males) and NOAEL of 1000 mg/kg/ day (females); no mortality; treatment-related decrease with 1000 mg/kg/day (males only) in mean body weight (\u000110.5%) and mean body weight change (\u000118.7%); no treatment- related effects were reported for food/water consumption, ophthalmoscopic exam, hematology, clinical chemistry, histopathology, estrous cycle, sperm parameters, gross pathology; non-adverse treatment-related effects for urinalysis (decreased urine volume and pH and increased specific gravity in males with 1000 mg/kg/day); non-adverse treatment-relat...","page":26,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_005"} |
| CIR_vision_codex | NOAEL | =600 | mg/kg/day | rat | oral | 14 days | repeated dose toxicity | {"citation":"5; 0, 300, 600; 14","dose":"r 5/sex/dose 0, 300, 600, 1000 mg/kg/day 14 days Procedures followed were in accordance with OECD Guidelines for Testing Chemicals; doses administered daily by gavage as indicated There were no treatment-related clinical signs and histopathology; clinical chemistry and hematology parameters were unaffected 20 Methylpropanediol Rat, Wistar 10/sex/dose 0, 3...","effect":"r 5/sex/dose 0, 300, 600, 1000 mg/kg/day 14 days Procedures followed were in accordance with OECD Guidelines for Testing Chemicals; doses administered daily by gavage as indicated There were no treatment-related clinical signs and histopathology; clinical chemistry and hematology parameters were unaffected 20 Methylpropanediol Rat, Wistar 10/sex/dose 0, 300, 600, 1000 mg/kg/day 90 days Procedures followed were in accordance with OECD Guidelines for Testing Chemicals; doses administered daily by gavage as indicated NOEL of 600 mg/kg/day; no treatment-related clinical signs or histopathology were reported; small increase in partial thromboplastin time (females with 1000 mg/kg/day); decrease (10%-14%) in ALT and aspartate aminotransferase AST in males with 1000 mg/kg/day; decrease in inorganic phosphate (males and females with 1000 mg/kg/day) 20 Butyl Ethyl Propanediol Rat, Sprague- Dawley (CD) 5/sex/dose 15, 150, 1000 mg/kg/day (controls were dosed with methylcellulose vehicle only, 1% w/v aqueous) 28 days Procedures followed were in accordance with OECD TG 407 (Repeated Dose 28-Day...","page":26,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_006"} |
| CIR_vision_codex | NOAEL | =15 | mg/kg/day | rat | oral | 28 days | repeated dose toxicity | {"citation":"20; 5; 15, 150","dose":"se AST in males with 1000 mg/kg/day; decrease in inorganic phosphate (males and females with 1000 mg/kg/day) 20 Butyl Ethyl Propanediol Rat, Sprague- Dawley (CD) 5/sex/dose 15, 150, 1000 mg/kg/day (controls were dosed with methylcellulose vehicle only, 1% w/v aqueous) 28 days Procedures followed were in accordance with OECD TG 407 (Repeated Dose 28-Day Or...","effect":"se AST in males with 1000 mg/kg/day; decrease in inorganic phosphate (males and females with 1000 mg/kg/day) 20 Butyl Ethyl Propanediol Rat, Sprague- Dawley (CD) 5/sex/dose 15, 150, 1000 mg/kg/day (controls were dosed with methylcellulose vehicle only, 1% w/v aqueous) 28 days Procedures followed were in accordance with OECD TG 407 (Repeated Dose 28-Day Oral Toxicity in Rodents); animals were dosed daily by gavage as indicated; blood samples collected; necropsy performed NOAEL of 1000 mg/kg/day (males and females); NOEL of 15 mg/kg/day (males and females); no mortalities; no treatment- related effects were correlated with clinical signs, body weight and weight gain, food/water consumption, hematology, clinical chemistry, and organ weights; gross pathology revealed liver and kidney enlargement (males with 1000 mg/kg/day) and pale, mottled kidneys (males with 150 or 1000 mg/kg/day); an adaptive liver effect noted (males with 1000 mg/kg/day); dose-related increase in renal cortical tubular eosinophilic inclusions (males with 150 or 1000 mg/ kg/day) 17 (continued) Scott et al. 95S","page":26,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_007"} |
| CIR_vision_codex | NOAEL | =150 | mg/kg/day | rat | oral | 90 days | repeated dose toxicity | {"citation":"10; 15, 150; 90","dose":") Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Butyl Ethyl Propanediol Rat, Wistar 10/sex/dose 15, 150, 1000 mg/kg/day (controls received hydroxypropyl methylcellulose vehicle only) 90 days Procedures (GLP) followed were in accordance with OECD TG 408 (Repeated Dose 90-Day...","effect":") Test Substance(s) Species/ Strain Test Population Concentration/ Dosage (Vehicle) Exposure Duration Procedure Results Reference Butyl Ethyl Propanediol Rat, Wistar 10/sex/dose 15, 150, 1000 mg/kg/day (controls received hydroxypropyl methylcellulose vehicle only) 90 days Procedures (GLP) followed were in accordance with OECD TG 408 (Repeated Dose 90-Day Oral Toxicity in Rodents); dose administered daily by gavage as indicated; blood and urine samples collected; necropsy performed NOAEL of 15 mg/kg/day (males) and NOAEL of 150 mg/kg/day (females); treatment-related deaths of 3 males (1000 mg/kg/ day) and 1 male (150 mg/kg/day); the following were unaffected by treatment: body weight and weight gain, food/ water consumption, ophthalmoscopic exam, hematology, and gross pathology; clinical signs (with 1000 mg/kg/day) were reduced activity, abnormal locomotion and respiration up to 1-2 hours post-dosing after which animals returned to normal, piloerection, hunched body posture, and partially closed eyes were observed; compared to controls a statistically significant increase in urea (...","page":27,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_008"} |
| CIR_vision_codex | NOAEL | =23 | mg/kg/day | rat | inhalation | 4-month | inhalation toxicity | {"citation":"20; 150; 15","dose":"ay).20 NOAELs of 150 mg/kg/day (females) and 15 mg/kg/day (males) were reported for Butyl Ethyl Propanediol; there were 4 treatment-related deaths (males at 150 or 1000 mg/kg/day), abnormal locomotion and respiration 1 to 2 hours post-dosing (after which animals returned to nor- mal), hunched body, and urinary (at 150 and 1000 mg/kg/ day) and kidney abnor...","effect":"ay).20 NOAELs of 150 mg/kg/day (females) and 15 mg/kg/day (males) were reported for Butyl Ethyl Propanediol; there were 4 treatment-related deaths (males at 150 or 1000 mg/kg/day), abnormal locomotion and respiration 1 to 2 hours post-dosing (after which animals returned to nor- mal), hunched body, and urinary (at 150 and 1000 mg/kg/ day) and kidney abnormalities (at ≥15 mg/kg/day) reported.17 Inhalation. In rat studies of 4-month durations (2 h/day exposure time) evaluating 1,4-Butanediol, a NOAEC of 500 mg/L (or NOAEL of 23 mg/kg/day) and a lowest- observed-adverse-effect-concentration (LOAEC) of 1500 mg/L (or lowest-observed-adverse-effect-level, LOAEL, of 85 mg/kg/day) were reported; observations in the study reporting the LOAEC of 1500 mg/L included a sleepy condition 20 minutes post-exposure, and histo- pathological exam revealed pulmonary emphysema, mild lung edema, treatment-related inflammatory changes of single alveolar cell and weak hyperplasia of alveolar septum.22 In 14-wk studies of diacetyl (potential metab- olite of 2,3-Butanediol) in mice and rats, significant in-...","page":30,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_009"} |
| CIR_vision_codex | NOAEL | =100 | mg/kg/day | rat | oral | - | developmental toxicity | {"citation":"414; 6; 15","dose":"ere in accordance with OECD TG 414 (Prenatal Developmental Toxicity Study); females were dosed by gavage on days 6 through 15 of gestation Maternal and fetal toxicity NOAEL of 1000 mg/kg/day; no maternal toxic effects from treatment (fertility rate was 91% for all dose rates); no embryotoxic or teratogenic effects on fetuses from treatment 12 1,4-Butanedi...","effect":"ere in accordance with OECD TG 414 (Prenatal Developmental Toxicity Study); females were dosed by gavage on days 6 through 15 of gestation Maternal and fetal toxicity NOAEL of 1000 mg/kg/day; no maternal toxic effects from treatment (fertility rate was 91% for all dose rates); no embryotoxic or teratogenic effects on fetuses from treatment 12 1,4-Butanediol Mouse, Swiss (CD-1) 28-32/ group 0, 100, 300, 600 mg/kg/day Pregnant mice were dosed by gavage during days 6 through 15 of gestation Maternal and developmental NOAEL of 100 mg/kg/day; maternal and developmental LOAEL of 300 mg/kg/ day ; no maternal mortality; maternal central nervous system intoxication was observed (300-600 mg/kg/day) 4 h after daily dosing; reduced food consumption and body weight/weight gain noted (maternal with 300-600 mg/ kg/day); developmental toxicity observed was reduced fetal body weight (300-600 mg/kg/day maternal dose) 91 1,4-Butanediol Rat, Sprague- Dawley 13/sex/ dose 200, 400, 800 mg/kg/day (vehicle=water); controls received water Food and water were available ad libitum; procedures followed were...","page":31,"pdf":"done.pdf","row_type":"noael_study","study_id":"done_noael_010"} |
NTP_ICE_acute_oral 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | =15000 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_6800; row=14376; data_type=In Vivo; mixture=Chemical; chemical_name=1,3-Propanediol; preferred_name=1,3-Propanediol; dtxsid=DTXSID8041246; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8041246; source_file=acute_oral.xlsx |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =12 | 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:15634328:-:--; 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_3c0b1dca90511a2ab893cccef225b769 |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 5965N8W85T | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C3H8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5965N8W85T"} |
| openFDA substances | FDA UNII substance identifier | 5965N8W85T | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C3H8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5965N8W85T"} |
| openFDA substances | FDA UNII substance identifier | 5965N8W85T | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C3H8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5965N8W85T"} |
| openFDA substances | FDA UNII substance identifier | 5965N8W85T | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C3H8O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5965N8W85T"} |