NOAEL Studies
Cosmetic Ingredient
Monoethanolamine (MEA) NOAEL Studies
INCI: ETHANOLAMINE
CAS: 141-43-5
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR_vision_codex 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR_vision_codex | NOAEL | =75 | mg/kg/d | rat | - | - | developmental toxicity | {"citation":"6; 15; 1","dose":"ks of rats on days 6 to 15 of gestation, with a dose volume of 1 mL/kg.","effect":"ks of rats on days 6 to 15 of gestation, with a dose volume of 1 mL/kg. Significant skin irritation, consisting of erythema fol- lowed by necrosis, scabs, and scar formation, occurred with 225 mg/kg ethanolamine but not at the other dose levels. No effects on kidney or liver weights were reported. Despite maternal effects in the 225 mg/kg dose group, no effects on reproductive parameters were observed at any dose, and there were no treatment-related increases in the visceral or skeletal malformations. In rats, the no-observed effect level (NOEL) was 75 mg/kg/d for maternal toxicity and 225 mg/kg/d for embryonal/fetal toxicity. In rabbits, 0, 10, 25, and 75 mg/kg bw/d ethanolamine was applied to the back (2 mL/kg) on days 6 to 18 of gestation. Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group. No effects on kidney or liver weights were reported. As with the rats, no effects on reproductive paramete...","page":8,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_001"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg bw/d | rat | oral | - | developmental toxicity | {"citation":"2; 6; 18","dose":"Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group.","effect":"2 mL/kg) on days 6 to 18 of gestation. Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group. No effects on kidney or liver weights were reported. As with the rats, no effects on reproductive parameters were observed at any dose, and there were no treatment-related increases in the visceral or skeletal malformations. In rab- bits, the NOEL was 10 mg/kg bw/d for maternal toxicity. No effect on embryonal/fetal toxicity was observed at the highest dose level of 75 mg/kg bw/d. Oral Ethanolamine. The teratogenic potential of ethanolamine was evaluated in a Chernoff-Kavlock postnatal mouse screening assay.28 Gravid CD-1 mice were dosed orally with 850 mg/ kg/d ethanolamine on days 6 to 15 of gestation, resulting in 16% mortality of maternal mice and reduced numbers of viable litters. Litter size, percentage survival of pups, birth weight, and pup weight gains were not affected. A preliminary study was perfo...","page":8,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_002"} |
| CIR_vision_codex | NOAEL | =120 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"0; 6; 15","dose":"0 mg/kg bw/d aq ethanolamine on days 6 to 15 of gesta- tion.","effect":"0 mg/kg bw/d aq ethanolamine on days 6 to 15 of gesta- tion. On day 20 of gestation, 25 dams/group were killed and necropsied, while the remaining 15 were allowed to litter and then killed on day 21 of lactation. Despite evidence of mater- nal toxicity in the 450 mg/kg group, as indicated by statisti- cally significant decreases in maternal body weights and feed consumption, no effects on reproductive parameters, inci- dences of visceral or skeletal malformations, or postnatal growth were observed at any dose. The NOEL for maternal toxicity was 120 mg/kg/d. No effect on developmental toxi- city was observed at the highest dose level of 450 mg/kg/d. Groups of 10 gravid Long-Evans rats were dosed by gavage with 50, 300, or 500 mg/kg aq ethanolamine on days 6 to 15 of gestation, and a negative control group of 34 gravid rats was dosed with water only.30 The animals were killed and exam- ined on day 20 of gestation. Significant maternal toxicity was not noted. Embryolethality was significantly increased in the 500-mg/kg group, and male pups were affected more than female pups. Male pu...","page":9,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_003"} |
| CIR_vision_codex | NOAEL | =300 | mg/kg bw/d | rat | oral | - | developmental toxicity | {"citation":"300; 32; 1","dose":"There were no test-related signs of developmental toxicity observed in F1 and F2 pups of this dose group.","effect":"ostimplantation loss, and smaller litters in female F0 and F1 parents. Sperm head count in the cauda epididymidis and absolute and relative liver weights were also statistically significantly decreased in male F0 parents. Body weight gains of both the F0 and F1 parental animals were statistically significantly decreased during gestation when compared to controls, as was feed consump- tion during lactation. There were no test-related signs of developmental toxicity observed in F1 and F2 pups of this dose group. The NOAEL was 300 mg/kg bw/d for systemic toxicity and for reproductive effects. No effect on developmental toxicity was observed at the highest dose level of 1000 mg/kg/d. Genotoxicity In Vitro Ethanolamine was negative in most Ames tests at concentra- tions \u00032000 mg/plate31,32; however, ‘‘weak mutagenic effects’’ were reported in 1 study.33 Ethanolamine, 25 to 500 mg/mL, was negative in a cell transformation assay using hamster embryo cells.34 Ethanolamine was clearly cytotoxic at 500 mg/mL. Ethanolamine did not produce chromosomal aber- rations in rat liver cells,31 but a...","page":9,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_004"} |
| CIR_vision_codex | NOAEL | =1000 | mg/kg bw/d | rat | oral | - | reproductive toxicity | {"citation":"2; 100; 300","dose":"There was an increase in malformed pups in all dose groups.","effect":"compared to female pups. There was an increase in malformed pups in all dose groups. In a dietary 2-generation study in rats with 100- to 1000-mg/kg bw/d ethanolamine HCl, the NOAEL was 300 mg/kg bw/d for systemic toxicity and for reproductive effects, and the NOAEL was 1000 mg/kg bw/d for develop- mental toxicity. The effect of ethanolamine HCl on hepatic choline was investigated in the F0 and F1 parental rats, and it was concluded that ethanolamine HCl did not affect the hepatic choline metabolism in the rat. Ethanolamine was mostly negative in Ames tests (\u00032000 mg/plate). Ethanolamine (\u0003500 mg/mL) was negative in a cell transformation assay. Ethanolamine did not produce chromo- somal aberrations in rat liver cells but did produce a ‘‘weak positive’’ response in human lymphocytes. Carcinogenicity data were not found in the published literature. Semiocclusive application of 30% to 100% ethano","page":12,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_005"} |
| CIR_vision_codex | NOAEL | =75 | mg/kg/d | rat | - | - | developmental toxicity | {"citation":"6; 15; 1","dose":"ks of rats on days 6 to 15 of gestation, with a dose volume of 1 mL/kg.","effect":"ks of rats on days 6 to 15 of gestation, with a dose volume of 1 mL/kg. Significant skin irritation, consisting of erythema fol- lowed by necrosis, scabs, and scar formation, occurred with 225 mg/kg ethanolamine but not at the other dose levels. No effects on kidney or liver weights were reported. Despite maternal effects in the 225 mg/kg dose group, no effects on reproductive parameters were observed at any dose, and there were no treatment-related increases in the visceral or skeletal malformations. In rats, the no-observed effect level (NOEL) was 75 mg/kg/d for maternal toxicity and 225 mg/kg/d for embryonal/fetal toxicity. In rabbits, 0, 10, 25, and 75 mg/kg bw/d ethanolamine was applied to the back (2 mL/kg) on days 6 to 18 of gestation. Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group. No effects on kidney or liver weights were reported. As with the rats, no effects on reproductive paramete...","page":8,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_001"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg bw/d | rat | oral | - | developmental toxicity | {"citation":"2; 6; 18","dose":"Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group.","effect":"2 mL/kg) on days 6 to 18 of gestation. Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group. No effects on kidney or liver weights were reported. As with the rats, no effects on reproductive parameters were observed at any dose, and there were no treatment-related increases in the visceral or skeletal malformations. In rab- bits, the NOEL was 10 mg/kg bw/d for maternal toxicity. No effect on embryonal/fetal toxicity was observed at the highest dose level of 75 mg/kg bw/d. Oral Ethanolamine. The teratogenic potential of ethanolamine was evaluated in a Chernoff-Kavlock postnatal mouse screening assay.28 Gravid CD-1 mice were dosed orally with 850 mg/ kg/d ethanolamine on days 6 to 15 of gestation, resulting in 16% mortality of maternal mice and reduced numbers of viable litters. Litter size, percentage survival of pups, birth weight, and pup weight gains were not affected. A preliminary study was perfo...","page":8,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_002"} |
| CIR_vision_codex | NOAEL | =120 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"0; 6; 15","dose":"0 mg/kg bw/d aq ethanolamine on days 6 to 15 of gesta- tion.","effect":"0 mg/kg bw/d aq ethanolamine on days 6 to 15 of gesta- tion. On day 20 of gestation, 25 dams/group were killed and necropsied, while the remaining 15 were allowed to litter and then killed on day 21 of lactation. Despite evidence of mater- nal toxicity in the 450 mg/kg group, as indicated by statisti- cally significant decreases in maternal body weights and feed consumption, no effects on reproductive parameters, inci- dences of visceral or skeletal malformations, or postnatal growth were observed at any dose. The NOEL for maternal toxicity was 120 mg/kg/d. No effect on developmental toxi- city was observed at the highest dose level of 450 mg/kg/d. Groups of 10 gravid Long-Evans rats were dosed by gavage with 50, 300, or 500 mg/kg aq ethanolamine on days 6 to 15 of gestation, and a negative control group of 34 gravid rats was dosed with water only.30 The animals were killed and exam- ined on day 20 of gestation. Significant maternal toxicity was not noted. Embryolethality was significantly increased in the 500-mg/kg group, and male pups were affected more than female pups. Male pu...","page":9,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_003"} |
| CIR_vision_codex | NOAEL | =300 | mg/kg bw/d | rat | oral | - | developmental toxicity | {"citation":"300; 32; 1","dose":"There were no test-related signs of developmental toxicity observed in F1 and F2 pups of this dose group.","effect":"ostimplantation loss, and smaller litters in female F0 and F1 parents. Sperm head count in the cauda epididymidis and absolute and relative liver weights were also statistically significantly decreased in male F0 parents. Body weight gains of both the F0 and F1 parental animals were statistically significantly decreased during gestation when compared to controls, as was feed consump- tion during lactation. There were no test-related signs of developmental toxicity observed in F1 and F2 pups of this dose group. The NOAEL was 300 mg/kg bw/d for systemic toxicity and for reproductive effects. No effect on developmental toxicity was observed at the highest dose level of 1000 mg/kg/d. Genotoxicity In Vitro Ethanolamine was negative in most Ames tests at concentra- tions \u00032000 mg/plate31,32; however, ‘‘weak mutagenic effects’’ were reported in 1 study.33 Ethanolamine, 25 to 500 mg/mL, was negative in a cell transformation assay using hamster embryo cells.34 Ethanolamine was clearly cytotoxic at 500 mg/mL. Ethanolamine did not produce chromosomal aber- rations in rat liver cells,31 but a...","page":9,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_004"} |
| CIR_vision_codex | NOAEL | =1000 | mg/kg bw/d | rat | oral | - | reproductive toxicity | {"citation":"2; 100; 300","dose":"There was an increase in malformed pups in all dose groups.","effect":"compared to female pups. There was an increase in malformed pups in all dose groups. In a dietary 2-generation study in rats with 100- to 1000-mg/kg bw/d ethanolamine HCl, the NOAEL was 300 mg/kg bw/d for systemic toxicity and for reproductive effects, and the NOAEL was 1000 mg/kg bw/d for develop- mental toxicity. The effect of ethanolamine HCl on hepatic choline was investigated in the F0 and F1 parental rats, and it was concluded that ethanolamine HCl did not affect the hepatic choline metabolism in the rat. Ethanolamine was mostly negative in Ames tests (\u00032000 mg/plate). Ethanolamine (\u0003500 mg/mL) was negative in a cell transformation assay. Ethanolamine did not produce chromo- somal aberrations in rat liver cells but did produce a ‘‘weak positive’’ response in human lymphocytes. Carcinogenicity data were not found in the published literature. Semiocclusive application of 30% to 100% ethano","page":12,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_005"} |
| CIR_vision_codex | NOAEL | =75 | mg/kg/d | rat | - | - | developmental toxicity | {"citation":"6; 15; 1","dose":"ks of rats on days 6 to 15 of gestation, with a dose volume of 1 mL/kg.","effect":"ks of rats on days 6 to 15 of gestation, with a dose volume of 1 mL/kg. Significant skin irritation, consisting of erythema fol- lowed by necrosis, scabs, and scar formation, occurred with 225 mg/kg ethanolamine but not at the other dose levels. No effects on kidney or liver weights were reported. Despite maternal effects in the 225 mg/kg dose group, no effects on reproductive parameters were observed at any dose, and there were no treatment-related increases in the visceral or skeletal malformations. In rats, the no-observed effect level (NOEL) was 75 mg/kg/d for maternal toxicity and 225 mg/kg/d for embryonal/fetal toxicity. In rabbits, 0, 10, 25, and 75 mg/kg bw/d ethanolamine was applied to the back (2 mL/kg) on days 6 to 18 of gestation. Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group. No effects on kidney or liver weights were reported. As with the rats, no effects on reproductive paramete...","page":8,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_001"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg bw/d | rat | oral | - | developmental toxicity | {"citation":"2; 6; 18","dose":"Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group.","effect":"2 mL/kg) on days 6 to 18 of gestation. Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group. No effects on kidney or liver weights were reported. As with the rats, no effects on reproductive parameters were observed at any dose, and there were no treatment-related increases in the visceral or skeletal malformations. In rab- bits, the NOEL was 10 mg/kg bw/d for maternal toxicity. No effect on embryonal/fetal toxicity was observed at the highest dose level of 75 mg/kg bw/d. Oral Ethanolamine. The teratogenic potential of ethanolamine was evaluated in a Chernoff-Kavlock postnatal mouse screening assay.28 Gravid CD-1 mice were dosed orally with 850 mg/ kg/d ethanolamine on days 6 to 15 of gestation, resulting in 16% mortality of maternal mice and reduced numbers of viable litters. Litter size, percentage survival of pups, birth weight, and pup weight gains were not affected. A preliminary study was perfo...","page":8,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_002"} |
| CIR_vision_codex | NOAEL | =120 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"0; 6; 15","dose":"0 mg/kg bw/d aq ethanolamine on days 6 to 15 of gesta- tion.","effect":"0 mg/kg bw/d aq ethanolamine on days 6 to 15 of gesta- tion. On day 20 of gestation, 25 dams/group were killed and necropsied, while the remaining 15 were allowed to litter and then killed on day 21 of lactation. Despite evidence of mater- nal toxicity in the 450 mg/kg group, as indicated by statisti- cally significant decreases in maternal body weights and feed consumption, no effects on reproductive parameters, inci- dences of visceral or skeletal malformations, or postnatal growth were observed at any dose. The NOEL for maternal toxicity was 120 mg/kg/d. No effect on developmental toxi- city was observed at the highest dose level of 450 mg/kg/d. Groups of 10 gravid Long-Evans rats were dosed by gavage with 50, 300, or 500 mg/kg aq ethanolamine on days 6 to 15 of gestation, and a negative control group of 34 gravid rats was dosed with water only.30 The animals were killed and exam- ined on day 20 of gestation. Significant maternal toxicity was not noted. Embryolethality was significantly increased in the 500-mg/kg group, and male pups were affected more than female pups. Male pu...","page":9,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_003"} |
| CIR_vision_codex | NOAEL | =300 | mg/kg bw/d | rat | oral | - | developmental toxicity | {"citation":"300; 32; 1","dose":"There were no test-related signs of developmental toxicity observed in F1 and F2 pups of this dose group.","effect":"ostimplantation loss, and smaller litters in female F0 and F1 parents. Sperm head count in the cauda epididymidis and absolute and relative liver weights were also statistically significantly decreased in male F0 parents. Body weight gains of both the F0 and F1 parental animals were statistically significantly decreased during gestation when compared to controls, as was feed consump- tion during lactation. There were no test-related signs of developmental toxicity observed in F1 and F2 pups of this dose group. The NOAEL was 300 mg/kg bw/d for systemic toxicity and for reproductive effects. No effect on developmental toxicity was observed at the highest dose level of 1000 mg/kg/d. Genotoxicity In Vitro Ethanolamine was negative in most Ames tests at concentra- tions \u00032000 mg/plate31,32; however, ‘‘weak mutagenic effects’’ were reported in 1 study.33 Ethanolamine, 25 to 500 mg/mL, was negative in a cell transformation assay using hamster embryo cells.34 Ethanolamine was clearly cytotoxic at 500 mg/mL. Ethanolamine did not produce chromosomal aber- rations in rat liver cells,31 but a...","page":9,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_004"} |
| CIR_vision_codex | NOAEL | =1000 | mg/kg bw/d | rat | oral | - | reproductive toxicity | {"citation":"2; 100; 300","dose":"There was an increase in malformed pups in all dose groups.","effect":"compared to female pups. There was an increase in malformed pups in all dose groups. In a dietary 2-generation study in rats with 100- to 1000-mg/kg bw/d ethanolamine HCl, the NOAEL was 300 mg/kg bw/d for systemic toxicity and for reproductive effects, and the NOAEL was 1000 mg/kg bw/d for develop- mental toxicity. The effect of ethanolamine HCl on hepatic choline was investigated in the F0 and F1 parental rats, and it was concluded that ethanolamine HCl did not affect the hepatic choline metabolism in the rat. Ethanolamine was mostly negative in Ames tests (\u00032000 mg/plate). Ethanolamine (\u0003500 mg/mL) was negative in a cell transformation assay. Ethanolamine did not produce chromo- somal aberrations in rat liver cells but did produce a ‘‘weak positive’’ response in human lymphocytes. Carcinogenicity data were not found in the published literature. Semiocclusive application of 30% to 100% ethano","page":12,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_005"} |
| CIR_vision_codex | NOAEL | =75 | mg/kg/d | rat | - | - | developmental toxicity | {"citation":"6; 15; 1","dose":"ks of rats on days 6 to 15 of gestation, with a dose volume of 1 mL/kg.","effect":"ks of rats on days 6 to 15 of gestation, with a dose volume of 1 mL/kg. Significant skin irritation, consisting of erythema fol- lowed by necrosis, scabs, and scar formation, occurred with 225 mg/kg ethanolamine but not at the other dose levels. No effects on kidney or liver weights were reported. Despite maternal effects in the 225 mg/kg dose group, no effects on reproductive parameters were observed at any dose, and there were no treatment-related increases in the visceral or skeletal malformations. In rats, the no-observed effect level (NOEL) was 75 mg/kg/d for maternal toxicity and 225 mg/kg/d for embryonal/fetal toxicity. In rabbits, 0, 10, 25, and 75 mg/kg bw/d ethanolamine was applied to the back (2 mL/kg) on days 6 to 18 of gestation. Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group. No effects on kidney or liver weights were reported. As with the rats, no effects on reproductive paramete...","page":8,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_001"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg bw/d | rat | oral | - | developmental toxicity | {"citation":"2; 6; 18","dose":"Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group.","effect":"2 mL/kg) on days 6 to 18 of gestation. Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group. No effects on kidney or liver weights were reported. As with the rats, no effects on reproductive parameters were observed at any dose, and there were no treatment-related increases in the visceral or skeletal malformations. In rab- bits, the NOEL was 10 mg/kg bw/d for maternal toxicity. No effect on embryonal/fetal toxicity was observed at the highest dose level of 75 mg/kg bw/d. Oral Ethanolamine. The teratogenic potential of ethanolamine was evaluated in a Chernoff-Kavlock postnatal mouse screening assay.28 Gravid CD-1 mice were dosed orally with 850 mg/ kg/d ethanolamine on days 6 to 15 of gestation, resulting in 16% mortality of maternal mice and reduced numbers of viable litters. Litter size, percentage survival of pups, birth weight, and pup weight gains were not affected. A preliminary study was perfo...","page":8,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_002"} |
| CIR_vision_codex | NOAEL | =120 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"0; 6; 15","dose":"0 mg/kg bw/d aq ethanolamine on days 6 to 15 of gesta- tion.","effect":"0 mg/kg bw/d aq ethanolamine on days 6 to 15 of gesta- tion. On day 20 of gestation, 25 dams/group were killed and necropsied, while the remaining 15 were allowed to litter and then killed on day 21 of lactation. Despite evidence of mater- nal toxicity in the 450 mg/kg group, as indicated by statisti- cally significant decreases in maternal body weights and feed consumption, no effects on reproductive parameters, inci- dences of visceral or skeletal malformations, or postnatal growth were observed at any dose. The NOEL for maternal toxicity was 120 mg/kg/d. No effect on developmental toxi- city was observed at the highest dose level of 450 mg/kg/d. Groups of 10 gravid Long-Evans rats were dosed by gavage with 50, 300, or 500 mg/kg aq ethanolamine on days 6 to 15 of gestation, and a negative control group of 34 gravid rats was dosed with water only.30 The animals were killed and exam- ined on day 20 of gestation. Significant maternal toxicity was not noted. Embryolethality was significantly increased in the 500-mg/kg group, and male pups were affected more than female pups. Male pu...","page":9,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_003"} |
| CIR_vision_codex | NOAEL | =300 | mg/kg bw/d | rat | oral | - | developmental toxicity | {"citation":"300; 32; 1","dose":"There were no test-related signs of developmental toxicity observed in F1 and F2 pups of this dose group.","effect":"ostimplantation loss, and smaller litters in female F0 and F1 parents. Sperm head count in the cauda epididymidis and absolute and relative liver weights were also statistically significantly decreased in male F0 parents. Body weight gains of both the F0 and F1 parental animals were statistically significantly decreased during gestation when compared to controls, as was feed consump- tion during lactation. There were no test-related signs of developmental toxicity observed in F1 and F2 pups of this dose group. The NOAEL was 300 mg/kg bw/d for systemic toxicity and for reproductive effects. No effect on developmental toxicity was observed at the highest dose level of 1000 mg/kg/d. Genotoxicity In Vitro Ethanolamine was negative in most Ames tests at concentra- tions \u00032000 mg/plate31,32; however, ‘‘weak mutagenic effects’’ were reported in 1 study.33 Ethanolamine, 25 to 500 mg/mL, was negative in a cell transformation assay using hamster embryo cells.34 Ethanolamine was clearly cytotoxic at 500 mg/mL. Ethanolamine did not produce chromosomal aber- rations in rat liver cells,31 but a...","page":9,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_004"} |
| CIR_vision_codex | NOAEL | =1000 | mg/kg bw/d | rat | oral | - | reproductive toxicity | {"citation":"2; 100; 300","dose":"There was an increase in malformed pups in all dose groups.","effect":"compared to female pups. There was an increase in malformed pups in all dose groups. In a dietary 2-generation study in rats with 100- to 1000-mg/kg bw/d ethanolamine HCl, the NOAEL was 300 mg/kg bw/d for systemic toxicity and for reproductive effects, and the NOAEL was 1000 mg/kg bw/d for develop- mental toxicity. The effect of ethanolamine HCl on hepatic choline was investigated in the F0 and F1 parental rats, and it was concluded that ethanolamine HCl did not affect the hepatic choline metabolism in the rat. Ethanolamine was mostly negative in Ames tests (\u00032000 mg/plate). Ethanolamine (\u0003500 mg/mL) was negative in a cell transformation assay. Ethanolamine did not produce chromo- somal aberrations in rat liver cells but did produce a ‘‘weak positive’’ response in human lymphocytes. Carcinogenicity data were not found in the published literature. Semiocclusive application of 30% to 100% ethano","page":12,"pdf":"PRS604.pdf","row_type":"noael_study","study_id":"PRS604_noael_005"} |
COSMOS_DB 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 450 | mg/kg bw/day | rat | oral | 6-15 Gestation day | Developmental | REACH; Fundam Appl Toxicol.; 40(1):158-62 |
| COSMOS_DB | NOAEL | 850 | mg/kg bw/day | mouse | oral | 10 day | Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 50 | mg/kg bw/day | rat | oral | 10 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 500 | mg/kg bw/day | rat | oral | 32 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 40 | mg/kg bw/day | rat | oral | 10 day | Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 120 | mg/kg bw/day | rat | oral | 6-15 Gestation day | Developmental | REACH; Fundam Appl Toxicol.; 40(1):158-62 |
NTP_ICE_acute_inhalation 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | LC50 | >1.3 | mg/L | - | Inhalation | Duration=6 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=3365; Record_ID=acute_inhalation_3536; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=1.3; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15808/7/3/3/?documentUUID=d4a813ed-c5d7-4bcf-ad7c-5a557003c259; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
NTP_ICE_acute_oral 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | =2050 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_3243; row=10102; data_type=In Vivo; mixture=Chemical; chemical_name=Ethanolamine; preferred_name=Ethanolamine; dtxsid=DTXSID6022000; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID6022000; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1720 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM ChemIDplus TEST (undated); record_id=acute_oral_3242; row=10103; data_type=In Vivo; mixture=Chemical; chemical_name=Ethanolamine; preferred_name=Ethanolamine; dtxsid=DTXSID6022000; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID6022000; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =10200 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_3246; row=10104; data_type=In Vivo; mixture=Chemical; chemical_name=Ethanolamine; preferred_name=Ethanolamine; dtxsid=DTXSID6022000; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID6022000; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =3320 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_3245; row=10105; data_type=In Vivo; mixture=Chemical; chemical_name=Ethanolamine; preferred_name=Ethanolamine; dtxsid=DTXSID6022000; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID6022000; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =2740 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_3244; row=10106; data_type=In Vivo; mixture=Chemical; chemical_name=Ethanolamine; preferred_name=Ethanolamine; dtxsid=DTXSID6022000; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID6022000; 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=8950; RecordID=ARPathway2016_837; DatasetName=ARPathway2016; DTXSID=DTXSID6022000; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
NTP_ICE_eye_irritation 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_eye_irritation | Draize rabbit irritation score | 23.3 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=1794; Record_ID=eye_irritation_192; Data_Type=In Vivo; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=23.3; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_eye_irritation | EPA Classification | 3 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=1795; Record_ID=eye_irritation_192; Data_Type=In Vivo; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=3; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_eye_irritation | GHS Classification | 1 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=1793; Record_ID=eye_irritation_192; Data_Type=In Vivo; Concentration=10.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=GHS Classification; Response=1; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_eye_irritation | Intensity | 0.36 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=1797; Record_ID=eye_irritation_1312; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=Vitrigel; Endpoint=Intensity; Response=0.36; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_eye_irritation | Lag time | 0 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=1796; Record_ID=eye_irritation_1312; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=Vitrigel; Endpoint=Lag time; Response=0; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_eye_irritation | Plateau level | 65.4 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=1798; Record_ID=eye_irritation_1312; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=Vitrigel; Endpoint=Plateau level; Response=65.40; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
NTP_ICE_skin_irritation 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_irritation | Breakthrough Time | 23.88 | min | - | Dermal | - | In Vitro; Corrositex | sheet=Data_invitro; excel_row=4157; Record_ID=skin_irritation_invitro_82; Data_Type=In Vitro; Concentration=99; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=Corrositex; Endpoint=Breakthrough Time; Response=23.88; Response_Unit=min; Reference=ICCVAM 1999; Not available; ntp.niehs.nih.gov/iccvam/docs/dermal_docs/corprrep.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_skin_irritation | Breakthrough Time | 22.09 | min | - | Dermal | - | In Vitro; Corrositex | sheet=Data_invitro; excel_row=4159; Record_ID=skin_irritation_invitro_84; Data_Type=In Vitro; Concentration=80; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=Corrositex; Endpoint=Breakthrough Time; Response=22.09; Response_Unit=min; Reference=ICCVAM 1999; Not available; ntp.niehs.nih.gov/iccvam/docs/dermal_docs/corprrep.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_skin_irritation | GHS classification | 1 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=1170; Record_ID=skin_irritation_invivo_133; Data_Type=In Vivo; Concentration=>99; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=GHS classification; Response=1B; Response_Unit=Unitless; Species=Rabbit; Reference=ICCVAM 2002; Not available; https://ntp.niehs.nih.gov/iccvam/docs/dermal_docs/cwgfinal02/cwgfinal.pdf; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_skin_irritation | Viability (240 minutes) | 10.8 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=4161; Record_ID=skin_irritation_invitro_1967; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=EpiSkin Corrosion; Endpoint=Viability (240 minutes); Response=10.8; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_skin_irritation | Viability (240 minutes) | 20.8 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=4167; Record_ID=skin_irritation_invitro_1963; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=EpiSkin Corrosion; Endpoint=Viability (240 minutes); Response=20.8; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_skin_irritation | Viability (240 minutes) | 20.2 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=4168; Record_ID=skin_irritation_invitro_1965; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=EpiSkin Corrosion; Endpoint=Viability (240 minutes); Response=20.2; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_skin_irritation | Viability (3 minutes) | 66.2 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=4160; Record_ID=skin_irritation_invitro_1963; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=EpiSkin Corrosion; Endpoint=Viability (3 minutes); Response=66.2; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_skin_irritation | Viability (3 minutes) | 105.7 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=4165; Record_ID=skin_irritation_invitro_1965; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=EpiSkin Corrosion; Endpoint=Viability (3 minutes); Response=105.7; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_skin_irritation | Viability (3 minutes) | 78.7 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=4166; Record_ID=skin_irritation_invitro_1967; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=EpiSkin Corrosion; Endpoint=Viability (3 minutes); Response=78.7; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_skin_irritation | Viability (60 minutes) | 67.4 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=4169; Record_ID=skin_irritation_invitro_1967; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=EpiSkin Corrosion; Endpoint=Viability (60 minutes); Response=67.40; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_skin_irritation | Viability (60 minutes) | 40.3 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=4170; Record_ID=skin_irritation_invitro_1963; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=EpiSkin Corrosion; Endpoint=Viability (60 minutes); Response=40.30; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
| NTP_ICE_skin_irritation | Viability (60 minutes) | 52.3 | % | - | Dermal | - | In Vitro; EpiSkin Corrosion | sheet=Data_invitro; excel_row=4171; Record_ID=skin_irritation_invitro_1965; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID6022000; Assay=EpiSkin Corrosion; Endpoint=Viability (60 minutes); Response=52.3; Response_Unit=%; Reference=Alepee et al. 2014; 24211528; 10.1016/j.tiv.2013.10.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6022000; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6022000 |
ToxValDB_DOE_Protective_Action_Criteria 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_DOE_Protective_Action_Criteria | LEL | =74950.1 | mg/m3 | Human | inhalation | - | acute | LONG_REF=U.S. Department of Energy (DOE) Protective Action Criteria (PAC). 2023. PAC Chemical Database. Updated 11 October 2023. Available: https://edms3.energy.gov/pac/ (Accessed November 16, 2023); TITLE=U.S. Department of Energy (DOE) Protective Action Criteria (PAC) Chemical Database; AUTHOR=U.S. Department of Energy; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65428efee4b045b9ff7cc432; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://edms3.energy.gov/pac/TeelDocs; YEAR=2012; ORIGINAL_YEAR=2012; STUDY_GROUP=DOE Protective Action Criteria:15515236:-:--; 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_71de229499ef14dcf14e90b3fa0b67d0 |
ToxValDB_ECHA_IUCLID 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | NOAEL | =450 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac00e4b0a7c65d1bcdc4; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14411/7/9/3?documentUUID=7d2b74ff-0044-4bed-8bd6-bb99dd8eb7cf; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=fetus: reduction in number of live offspring|fetus: fetal/pup body weight changes|fetus: changes in litter size and weights|fetus: changes in postnatal survival|fetus: external malformations|fetus: skeletal malformations|fetus: visceral malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development|reproduction; STUDY_GROUP=ECHA IUCLID:15820579:M/F:-fetal; 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_dae3118f904c58cfb0875cee41c87f4f |
| ToxValDB_ECHA_IUCLID | NOAEL | =225 | mg/kg bw/day | Rat | dermal | - | developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1c1e4b0a7c65d22ff99; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14411/7/9/3?documentUUID=7d2b74ff-0044-4bed-8bd6-bb99dd8eb7cf; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=fetus: reduction in number of live offspring|fetus: changes in sex ratio|fetus: fetal/pup body weight changes|fetus: changes in litter size and weights|fetus: changes in postnatal survival|fetus: external malformations|fetus: skeletal malformations|fetus: visceral malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15820638:M/F:-fetal; 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_2d25e7ae35352069c812b9dc8ea26a86 |
| ToxValDB_ECHA_IUCLID | NOAEL | =75 | mg/kg bw/day | Rabbit | dermal | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1c1e4b0a7c65d22ffa1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14411/7/9/3?documentUUID=7d2b74ff-0044-4bed-8bd6-bb99dd8eb7cf; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=fetus: reduction in number of live offspring|fetus: changes in sex ratio|fetus: fetal/pup body weight changes|fetus: changes in litter size and weights|fetus: changes in postnatal survival|fetus: external malformations|fetus: skeletal malformations|fetus: visceral malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15821465:M/F:-fetal; 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_78fa7c66aebce9767d6a9bce96fa657d |
| ToxValDB_ECHA_IUCLID | NOAEL | >=97.5 | mg/kg bw/day | Dog | oral | chronic; 2 years | chronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadc7e4b0a7c65d1c5dfe; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14411/7/6/2?documentUUID=7d2b74ff-0044-4bed-8bd6-bb99dd8eb7cf; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical biochemistry|clinical signs|food consumption and compound intake|gross pathology|haematology|histopathology: non-neoplastic|mortality|organ weights and organ / body weight ratios|urinalysis; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|nonneoplastic histopathology|organ weight|urinalysis; STUDY_GROUP=ECHA IUCLID:15830755: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_7f24a8703bfdcc00aaaa79e0cbd0639a |
| ToxValDB_ECHA_IUCLID | NOAEL | =300 | mg/kg bw/day | Rat | oral | subchronic; 75 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadc7e4b0a7c65d1c5e06; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14411/7/6/2?documentUUID=7d2b74ff-0044-4bed-8bd6-bb99dd8eb7cf; YEAR=2002; ORIGINAL_YEAR=2002; STUDY_GROUP=ECHA IUCLID:15834863: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_90f2603d4ad6cce57c327fb9b541a507 |
| ToxValDB_ECHA_IUCLID | NOAEL | =320 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadc7e4b0a7c65d1c5e0a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14411/7/6/2?documentUUID=7d2b74ff-0044-4bed-8bd6-bb99dd8eb7cf; YEAR=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical biochemistry|clinical signs|food consumption and compound intake|gross pathology|haematology|histopathology: non-neoplastic|mortality|organ weights and organ / body weight ratios|urinalysis; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|nonneoplastic histopathology|organ weight|urinalysis; STUDY_GROUP=ECHA IUCLID:15845100: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_74862f8930e2085a627b9b0f25723598 |
ToxValDB_EU_SCOEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_EU_SCOEL | LOAEL | =12.4917 | mg/m3 | Rat | inhalation | - | short-term | LONG_REF=Weeks, M.H., Downing, T.O., Musselman, N.P., Carson, T.R. and Groff, W.A. (1960). The effect of continuous exposure of animals to ethanolamine vapour. Am. Ind. Hyg. Ass. J. 21 , 374-381.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c985c4e4b02565fc7d3995; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu; SUBSOURCE_URL=https://echa.europa.eu/documents/10162/35144386/022_2-aminoethanol_oel_en.pdf; YEAR=1996; ORIGINAL_YEAR=1996; TOXICOLOGICAL_EFFECT=behavioural effects; STUDY_GROUP=EU SCOEL:15952262:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_48e87f90357fc49fd4197a13ef8f1c5c |
ToxValDB_GESTIS_DNEL 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL local | =0.51 | 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_-_15629739_15629740:-:--; 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_6daf665d29fcffee2d634ce3bd164d16 |
| ToxValDB_GESTIS_DNEL | DNEL systemic | =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_-_15629739_15629740:-:--; 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_fd372813bc00389b5ef814b5d8b6c107 |
ToxValDB_TX_TCEQ 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_TX_TCEQ | LOAEL | =5 | ppm | Rat | - | subchronic; 40 days | subchronic | LONG_REF=Weeks, M. H., Downing, T. O., Musselman, N. P., Carson, T. R., & Groff, W. A. (1960). The effects of continuous exposure of animals to ethanolamine vapor. Am Ind Hyg Assoc J, 21, 374-381. doi: 10.1080/00028896009344089; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c993f9e4b02565fc7d5adf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.tceq.texas.gov; SUBSOURCE_URL=https://www.tceq.texas.gov/downloads/toxicology/dsd/final/monoethanolamine.pdf; YEAR=2015; ORIGINAL_YEAR=2015; TOXICOLOGICAL_EFFECT=Neurobehavioral effects/CNS depression; STUDY_GROUP=TX TCEQ:15954557:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_9daa7909e947c53b6955bce0c1158e06 |
| ToxValDB_TX_TCEQ | NOAEL | =29.98 | mg/m3 | Dog | inhalation | subchronic; 60 days | subchronic | LONG_REF=Weeks, M. H., Downing, T. O., Musselman, N. P., Carson, T. R., & Groff, W. A. (1960). The effects of continuous exposure of animals to ethanolamine vapor. Am Ind Hyg Assoc J, 21, 374-381. doi: 10.1080/00028896009344089; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c993f9e4b02565fc7d5adf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.tceq.texas.gov; SUBSOURCE_URL=https://www.tceq.texas.gov/downloads/toxicology/dsd/final/monoethanolamine.pdf; YEAR=2015; ORIGINAL_YEAR=2015; TOXICOLOGICAL_EFFECT=Nasal irritation symptoms; STUDY_GROUP=TX TCEQ_dup_-_15954558_15954559:M:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2b7fdfe2708783bf507676ac29f2400e |
UnifiedCodex:CIR:beta.noael_studies 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 75 | mg/kg/d | rat | - | - | developmental toxicity | SOURCE_SUBDIR=PRS604; REPORT_TITLE=Safety Assessment of Ethanolamine and Ethanolamine Salts as Used in Cosmetics Monice M. Fiume1, Bart A. Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS604; COMMITTEE=CIR Expert Panel; REPORT_DATE=1 In 1983; VALUE_TEXT=75; DOSE=ks of rats on days 6 to 15 of gestation, with a dose volume of 1 mL/kg.; EFFECT=ks of rats on days 6 to 15 of gestation, with a dose volume of 1 mL/kg. Significant skin irritation, consisting of erythema fol- lowed by necrosis, scabs, and scar formation, occurred with 225 mg/kg ethanolamine but not at the other dose levels. No effects on kidney or liver weights were reported. Despite maternal effects in the 225 mg/kg dose group, no effects on reproductive parameters were observed at any dose, and there were no treatment-related increases in the visceral or skeletal malformations. In rats, the no-observed effect level (NOEL) was 75 mg/kg/d for maternal toxicity and 225 mg/kg/d for embryonal/fetal toxicity. In rabbits, 0, 10, 25, and 75 mg/kg bw/d ethanolamine was applied to the back (2 mL/kg) on days 6 to 18 of gestation. Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group. No effects on kidney or liver weights were reported. As with the rats, no effects on reproductive paramete...; CITATION=6; 15; 1; CITATION_NUMBERS=[6,15,1]; REFERENCE=6; 15; 1; DETAILS_JSON={"cas_number":"141-43-5","citation":"6; 15; 1","dose":"ks of rats on days 6 to 15 of gestation, with a dose volume of 1 mL/kg.","duration":"","effect":"ks of rats on days 6 to 15 of gestation, with a dose volume of 1 mL/kg. Significant skin irritation, consisting of erythema fol- lowed by necrosis, scabs, and scar formation, occurred with 225 mg/kg ethanolamine but not at the other dose levels. No effects on kidney or liver weights were reported. Despite maternal effects in the 225 mg/kg dose group, no effects on reproductive parameters were observed at any dose, and there were no treatment-related increases in the visceral or skeletal malformations. In rats, the no-observed effect level (NOEL) was 75 mg/kg/d for maternal toxicity and 225 mg/kg/d for embryonal/fetal toxicity. In rabbits, 0, 10, 25, and 75 mg/kg bw/d ethanolamine was applied to the back (2 mL/kg) on days 6 to 18 of gestation. Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group. No effects on kidney or liver weights were reported. As with the rats, no effects on reproductive paramete...","endpoint":"developmental toxicity","ingredient":"Ethanolamine and Ethanolamine Salts","loael_value":"","noael_unit":"mg/kg/d","noael_value":"75","page":8,"route":"","species":"rat","study_id":"PRS604_noael_001"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 10 | mg/kg bw/d | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS604; REPORT_TITLE=Safety Assessment of Ethanolamine and Ethanolamine Salts as Used in Cosmetics Monice M. Fiume1, Bart A. Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS604; COMMITTEE=CIR Expert Panel; REPORT_DATE=1 In 1983; VALUE_TEXT=10; DOSE=Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group.; EFFECT=2 mL/kg) on days 6 to 18 of gestation. Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group. No effects on kidney or liver weights were reported. As with the rats, no effects on reproductive parameters were observed at any dose, and there were no treatment-related increases in the visceral or skeletal malformations. In rab- bits, the NOEL was 10 mg/kg bw/d for maternal toxicity. No effect on embryonal/fetal toxicity was observed at the highest dose level of 75 mg/kg bw/d. Oral Ethanolamine. The teratogenic potential of ethanolamine was evaluated in a Chernoff-Kavlock postnatal mouse screening assay.28 Gravid CD-1 mice were dosed orally with 850 mg/ kg/d ethanolamine on days 6 to 15 of gestation, resulting in 16% mortality of maternal mice and reduced numbers of viable litters. Litter size, percentage survival of pups, birth weight, and pup weight gains were not affected. A preliminary study was perfo...; CITATION=2; 6; 18; CITATION_NUMBERS=[2,6,18]; REFERENCE=2; 6; 18; DETAILS_JSON={"cas_number":"141-43-5","citation":"2; 6; 18","dose":"Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group.","duration":"","effect":"2 mL/kg) on days 6 to 18 of gestation. Severe skin irritation at the application site, consisting of necrosis, exfoliation, and crusting, was observed in the 75 mg/kg group, and crusting, transient erythema, and edema were observed in a few rabbits of the 25-mg/kg dose group. No effects on kidney or liver weights were reported. As with the rats, no effects on reproductive parameters were observed at any dose, and there were no treatment-related increases in the visceral or skeletal malformations. In rab- bits, the NOEL was 10 mg/kg bw/d for maternal toxicity. No effect on embryonal/fetal toxicity was observed at the highest dose level of 75 mg/kg bw/d. Oral Ethanolamine. The teratogenic potential of ethanolamine was evaluated in a Chernoff-Kavlock postnatal mouse screening assay.28 Gravid CD-1 mice were dosed orally with 850 mg/ kg/d ethanolamine on days 6 to 15 of gestation, resulting in 16% mortality of maternal mice and reduced numbers of viable litters. Litter size, percentage survival of pups, birth weight, and pup weight gains were not affected. A preliminary study was perfo...","endpoint":"developmental toxicity","ingredient":"Ethanolamine and Ethanolamine Salts","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":8,"route":"oral","species":"rat","study_id":"PRS604_noael_002"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 120 | mg/kg/d | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS604; REPORT_TITLE=Safety Assessment of Ethanolamine and Ethanolamine Salts as Used in Cosmetics Monice M. Fiume1, Bart A. Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS604; COMMITTEE=CIR Expert Panel; REPORT_DATE=1 In 1983; VALUE_TEXT=120; DOSE=0 mg/kg bw/d aq ethanolamine on days 6 to 15 of gesta- tion.; EFFECT=0 mg/kg bw/d aq ethanolamine on days 6 to 15 of gesta- tion. On day 20 of gestation, 25 dams/group were killed and necropsied, while the remaining 15 were allowed to litter and then killed on day 21 of lactation. Despite evidence of mater- nal toxicity in the 450 mg/kg group, as indicated by statisti- cally significant decreases in maternal body weights and feed consumption, no effects on reproductive parameters, inci- dences of visceral or skeletal malformations, or postnatal growth were observed at any dose. The NOEL for maternal toxicity was 120 mg/kg/d. No effect on developmental toxi- city was observed at the highest dose level of 450 mg/kg/d. Groups of 10 gravid Long-Evans rats were dosed by gavage with 50, 300, or 500 mg/kg aq ethanolamine on days 6 to 15 of gestation, and a negative control group of 34 gravid rats was dosed with water only.30 The animals were killed and exam- ined on day 20 of gestation. Significant maternal toxicity was not noted. Embryolethality was significantly increased in the 500-mg/kg group, and male pups were affected more than female pups. Male pu...; CITATION=0; 6; 15; CITATION_NUMBERS=[6,15]; REFERENCE=0; 6; 15; DETAILS_JSON={"cas_number":"141-43-5","citation":"0; 6; 15","dose":"0 mg/kg bw/d aq ethanolamine on days 6 to 15 of gesta- tion.","duration":"","effect":"0 mg/kg bw/d aq ethanolamine on days 6 to 15 of gesta- tion. On day 20 of gestation, 25 dams/group were killed and necropsied, while the remaining 15 were allowed to litter and then killed on day 21 of lactation. Despite evidence of mater- nal toxicity in the 450 mg/kg group, as indicated by statisti- cally significant decreases in maternal body weights and feed consumption, no effects on reproductive parameters, inci- dences of visceral or skeletal malformations, or postnatal growth were observed at any dose. The NOEL for maternal toxicity was 120 mg/kg/d. No effect on developmental toxi- city was observed at the highest dose level of 450 mg/kg/d. Groups of 10 gravid Long-Evans rats were dosed by gavage with 50, 300, or 500 mg/kg aq ethanolamine on days 6 to 15 of gestation, and a negative control group of 34 gravid rats was dosed with water only.30 The animals were killed and exam- ined on day 20 of gestation. Significant maternal toxicity was not noted. Embryolethality was significantly increased in the 500-mg/kg group, and male pups were affected more than female pups. Male pu...","endpoint":"developmental toxicity","ingredient":"Ethanolamine and Ethanolamine Salts","loael_value":"","noael_unit":"mg/kg/d","noael_value":"120","page":9,"route":"oral","species":"rat","study_id":"PRS604_noael_003"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 300 | mg/kg bw/d | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS604; REPORT_TITLE=Safety Assessment of Ethanolamine and Ethanolamine Salts as Used in Cosmetics Monice M. Fiume1, Bart A. Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS604; COMMITTEE=CIR Expert Panel; REPORT_DATE=1 In 1983; VALUE_TEXT=300; DOSE=There were no test-related signs of developmental toxicity observed in F1 and F2 pups of this dose group.; EFFECT=ostimplantation loss, and smaller litters in female F0 and F1 parents. Sperm head count in the cauda epididymidis and absolute and relative liver weights were also statistically significantly decreased in male F0 parents. Body weight gains of both the F0 and F1 parental animals were statistically significantly decreased during gestation when compared to controls, as was feed consump- tion during lactation. There were no test-related signs of developmental toxicity observed in F1 and F2 pups of this dose group. The NOAEL was 300 mg/kg bw/d for systemic toxicity and for reproductive effects. No effect on developmental toxicity was observed at the highest dose level of 1000 mg/kg/d. Genotoxicity In Vitro Ethanolamine was negative in most Ames tests at concentra- tions 2000 mg/plate31,32; however, ‘‘weak mutagenic effects’’ were reported in 1 study.33 Ethanolamine, 25 to 500 mg/mL, was negative in a cell transformation assay using hamster embryo cells.34 Ethanolamine was clearly cytotoxic at 500 mg/mL. Ethanolamine did not produce chromosomal aber- rations in rat liver cells,31 but a...; CITATION=300; 32; 1; CITATION_NUMBERS=[300,32,1]; REFERENCE=300; 32; 1; DETAILS_JSON={"cas_number":"141-43-5","citation":"300; 32; 1","dose":"There were no test-related signs of developmental toxicity observed in F1 and F2 pups of this dose group.","duration":"","effect":"ostimplantation loss, and smaller litters in female F0 and F1 parents. Sperm head count in the cauda epididymidis and absolute and relative liver weights were also statistically significantly decreased in male F0 parents. Body weight gains of both the F0 and F1 parental animals were statistically significantly decreased during gestation when compared to controls, as was feed consump- tion during lactation. There were no test-related signs of developmental toxicity observed in F1 and F2 pups of this dose group. The NOAEL was 300 mg/kg bw/d for systemic toxicity and for reproductive effects. No effect on developmental toxicity was observed at the highest dose level of 1000 mg/kg/d. Genotoxicity In Vitro Ethanolamine was negative in most Ames tests at concentra- tions \u00032000 mg/plate31,32; however, ‘‘weak mutagenic effects’’ were reported in 1 study.33 Ethanolamine, 25 to 500 mg/mL, was negative in a cell transformation assay using hamster embryo cells.34 Ethanolamine was clearly cytotoxic at 500 mg/mL. Ethanolamine did not produce chromosomal aber- rations in rat liver cells,31 but a...","endpoint":"developmental toxicity","ingredient":"Ethanolamine and Ethanolamine Salts","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"300","page":9,"route":"oral","species":"rat","study_id":"PRS604_noael_004"} |
| UnifiedCodex:CIR:beta.noael_studies | reproductive toxicity | 1000 | mg/kg bw/d | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=PRS604; REPORT_TITLE=Safety Assessment of Ethanolamine and Ethanolamine Salts as Used in Cosmetics Monice M. Fiume1, Bart A. Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS604; COMMITTEE=CIR Expert Panel; REPORT_DATE=1 In 1983; VALUE_TEXT=1000; DOSE=There was an increase in malformed pups in all dose groups.; EFFECT=compared to female pups. There was an increase in malformed pups in all dose groups. In a dietary 2-generation study in rats with 100- to 1000-mg/kg bw/d ethanolamine HCl, the NOAEL was 300 mg/kg bw/d for systemic toxicity and for reproductive effects, and the NOAEL was 1000 mg/kg bw/d for develop- mental toxicity. The effect of ethanolamine HCl on hepatic choline was investigated in the F0 and F1 parental rats, and it was concluded that ethanolamine HCl did not affect the hepatic choline metabolism in the rat. Ethanolamine was mostly negative in Ames tests (2000 mg/plate). Ethanolamine (500 mg/mL) was negative in a cell transformation assay. Ethanolamine did not produce chromo- somal aberrations in rat liver cells but did produce a ‘‘weak positive’’ response in human lymphocytes. Carcinogenicity data were not found in the published literature. Semiocclusive application of 30% to 100% ethano; CITATION=2; 100; 300; CITATION_NUMBERS=[2,100,300]; REFERENCE=2; 100; 300; DETAILS_JSON={"cas_number":"141-43-5","citation":"2; 100; 300","dose":"There was an increase in malformed pups in all dose groups.","duration":"","effect":"compared to female pups. There was an increase in malformed pups in all dose groups. In a dietary 2-generation study in rats with 100- to 1000-mg/kg bw/d ethanolamine HCl, the NOAEL was 300 mg/kg bw/d for systemic toxicity and for reproductive effects, and the NOAEL was 1000 mg/kg bw/d for develop- mental toxicity. The effect of ethanolamine HCl on hepatic choline was investigated in the F0 and F1 parental rats, and it was concluded that ethanolamine HCl did not affect the hepatic choline metabolism in the rat. Ethanolamine was mostly negative in Ames tests (\u00032000 mg/plate). Ethanolamine (\u0003500 mg/mL) was negative in a cell transformation assay. Ethanolamine did not produce chromo- somal aberrations in rat liver cells but did produce a ‘‘weak positive’’ response in human lymphocytes. Carcinogenicity data were not found in the published literature. Semiocclusive application of 30% to 100% ethano","endpoint":"reproductive toxicity","ingredient":"Ethanolamine and Ethanolamine Salts","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":12,"route":"oral","species":"rat","study_id":"PRS604_noael_005"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 5KV86114PT | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C2H7NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5KV86114PT"} |
| openFDA substances | FDA UNII substance identifier | 5KV86114PT | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C2H7NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5KV86114PT"} |
| openFDA substances | FDA UNII substance identifier | 5KV86114PT | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C2H7NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5KV86114PT"} |
| openFDA substances | FDA UNII substance identifier | 5KV86114PT | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C2H7NO","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"5KV86114PT"} |