NOAEL Studies Cosmetic Ingredient

Capramide DEA NOAEL Studies

INCI: CAPRAMIDE DEA

CAS: 136-26-5

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 =0.1 % rat oral 13-week repeated dose toxicity {"citation":"100; 400; 3","dose":"The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","effect":"mice and/or rats, irritation was observed at the site of application. Increases in liver and kidney weights were observed in most studies, while decreases in bw were observed sporadically. The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic e...","page":20,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_003"}
CIR_vision_codex NOAEL =0.1 % rat oral 13-week repeated dose toxicity {"citation":"100; 400; 3","dose":"The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","effect":"mice and/or rats, irritation was observed at the site of application. Increases in liver and kidney weights were observed in most studies, while decreases in bw were observed sporadically. The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic e...","page":20,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_003"}
CIR_vision_codex NOAEL =0.1 % rat oral 13-week repeated dose toxicity {"citation":"100; 400; 3","dose":"The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","effect":"mice and/or rats, irritation was observed at the site of application. Increases in liver and kidney weights were observed in most studies, while decreases in bw were observed sporadically. The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic e...","page":20,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_003"}
CIR_vision_codex NOAEL =0.1 % rat oral 13-week repeated dose toxicity {"citation":"100; 400; 3","dose":"The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","effect":"mice and/or rats, irritation was observed at the site of application. Increases in liver and kidney weights were observed in most studies, while decreases in bw were observed sporadically. The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic e...","page":20,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_003"}
CIR_vision_codex NOAEL =200 mg/kg/d rat oral 4 weeks developmental toxicity {"citation":"4; 350; 380","dose":"DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner.","effect":"DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner. In rats and rabbits, dermal dosing with up to 1500 mg/kg/d and 350 mg/kg/d DEA, respectively, during gestation, did not have any fetotoxic or teratogenic effects. The NOEL for embryonal/fetal toxicity was 380 mg/kg/d for rats and 350 mg/kg/d for rabbits.28 In an oral developmental study in which rats were dosed with up to 1200 mg/kg/d DEA on days 6 to 15 of gestation, maternal mortality was observed at doses of \u000550 mg/kg; the NOEL for embryonal/fetal toxicity was 200 mg/kg/d. In a study in which gravid rats were dosed orally with up to 300 mg/kg/d DEA, the dams of the 300 mg/kg group were killed due to excessive toxicity; the LD50 was calculated to be 218 mg/kg. The LOAEL for both maternal toxicity and teratogenicity was 125 mg/kg/d.28 In a developmental study in which rats were exposed by inhalation to DEA on days 6 to 15 of gestation, the NOAEC for both maternal and developmental toxicity was 0.05 mg/L, and the NOAEC for teratogenicity was >0.2 mg/L.28 Lecithin. In oral studies, \u00021600 mg/kg...","page":14,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_002"}
CIR_vision_codex NOAEL =200 mg/kg/d rat oral 4 weeks developmental toxicity {"citation":"4; 350; 380","dose":"DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner.","effect":"DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner. In rats and rabbits, dermal dosing with up to 1500 mg/kg/d and 350 mg/kg/d DEA, respectively, during gestation, did not have any fetotoxic or teratogenic effects. The NOEL for embryonal/fetal toxicity was 380 mg/kg/d for rats and 350 mg/kg/d for rabbits.28 In an oral developmental study in which rats were dosed with up to 1200 mg/kg/d DEA on days 6 to 15 of gestation, maternal mortality was observed at doses of \u000550 mg/kg; the NOEL for embryonal/fetal toxicity was 200 mg/kg/d. In a study in which gravid rats were dosed orally with up to 300 mg/kg/d DEA, the dams of the 300 mg/kg group were killed due to excessive toxicity; the LD50 was calculated to be 218 mg/kg. The LOAEL for both maternal toxicity and teratogenicity was 125 mg/kg/d.28 In a developmental study in which rats were exposed by inhalation to DEA on days 6 to 15 of gestation, the NOAEC for both maternal and developmental toxicity was 0.05 mg/L, and the NOAEC for teratogenicity was >0.2 mg/L.28 Lecithin. In oral studies, \u00021600 mg/kg...","page":14,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_002"}
CIR_vision_codex NOAEL =200 mg/kg/d rat oral 4 weeks developmental toxicity {"citation":"4; 350; 380","dose":"DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner.","effect":"DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner. In rats and rabbits, dermal dosing with up to 1500 mg/kg/d and 350 mg/kg/d DEA, respectively, during gestation, did not have any fetotoxic or teratogenic effects. The NOEL for embryonal/fetal toxicity was 380 mg/kg/d for rats and 350 mg/kg/d for rabbits.28 In an oral developmental study in which rats were dosed with up to 1200 mg/kg/d DEA on days 6 to 15 of gestation, maternal mortality was observed at doses of \u000550 mg/kg; the NOEL for embryonal/fetal toxicity was 200 mg/kg/d. In a study in which gravid rats were dosed orally with up to 300 mg/kg/d DEA, the dams of the 300 mg/kg group were killed due to excessive toxicity; the LD50 was calculated to be 218 mg/kg. The LOAEL for both maternal toxicity and teratogenicity was 125 mg/kg/d.28 In a developmental study in which rats were exposed by inhalation to DEA on days 6 to 15 of gestation, the NOAEC for both maternal and developmental toxicity was 0.05 mg/L, and the NOAEC for teratogenicity was >0.2 mg/L.28 Lecithin. In oral studies, \u00021600 mg/kg...","page":14,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_002"}
CIR_vision_codex NOAEL =200 mg/kg/d rat oral 4 weeks developmental toxicity {"citation":"4; 350; 380","dose":"DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner.","effect":"DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner. In rats and rabbits, dermal dosing with up to 1500 mg/kg/d and 350 mg/kg/d DEA, respectively, during gestation, did not have any fetotoxic or teratogenic effects. The NOEL for embryonal/fetal toxicity was 380 mg/kg/d for rats and 350 mg/kg/d for rabbits.28 In an oral developmental study in which rats were dosed with up to 1200 mg/kg/d DEA on days 6 to 15 of gestation, maternal mortality was observed at doses of \u000550 mg/kg; the NOEL for embryonal/fetal toxicity was 200 mg/kg/d. In a study in which gravid rats were dosed orally with up to 300 mg/kg/d DEA, the dams of the 300 mg/kg group were killed due to excessive toxicity; the LD50 was calculated to be 218 mg/kg. The LOAEL for both maternal toxicity and teratogenicity was 125 mg/kg/d.28 In a developmental study in which rats were exposed by inhalation to DEA on days 6 to 15 of gestation, the NOAEC for both maternal and developmental toxicity was 0.05 mg/L, and the NOAEC for teratogenicity was >0.2 mg/L.28 Lecithin. In oral studies, \u00021600 mg/kg...","page":14,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_002"}
CIR_vision_codex NOAEL =380 mg/kg/d rat oral 4 weeks developmental toxicity {"citation":"20; 320; 6","dose":"20 to 320 mg/kg DEA from day 6 of gestation through PND 21 showed no effects on skeletal formation, but dose-dependent effects on some growth and developmental parameters were observed.","effect":"20 to 320 mg/kg DEA from day 6 of gestation through PND 21 showed no effects on skeletal formation, but dose-dependent effects on some growth and developmental parameters were observed. In a study in which parental mice were treated dermally with 20 to 320 mg/kg DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner. In rats and rabbits, dermal dosing with up to 1500 mg/kg/d and 350 mg/kg/d DEA, respectively, during gestation, did not have any fetotoxic or teratogenic effects. The NOEL for embryonal/fetal toxicity was 380 mg/kg/d for rats and 350 mg/kg/d for rabbits.28 In an oral developmental study in which rats were dosed with up to 1200 mg/kg/d DEA on days 6 to 15 of gestation, maternal mortality was observed at doses of \u000550 mg/kg; the NOEL for embryonal/fetal toxicity was 200 mg/kg/d. In a study in which gravid rats were dosed orally with up to 300 mg/kg/d DEA, the dams of the 300 mg/kg group were killed due to excessive toxicity; the LD50 was calculated to be 218 mg/kg. The LOAEL for both maternal toxicity and teratogenicity was 125 mg/kg/d.2...","page":14,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_001"}
CIR_vision_codex NOAEL =380 mg/kg/d rat oral 4 weeks developmental toxicity {"citation":"20; 320; 6","dose":"20 to 320 mg/kg DEA from day 6 of gestation through PND 21 showed no effects on skeletal formation, but dose-dependent effects on some growth and developmental parameters were observed.","effect":"20 to 320 mg/kg DEA from day 6 of gestation through PND 21 showed no effects on skeletal formation, but dose-dependent effects on some growth and developmental parameters were observed. In a study in which parental mice were treated dermally with 20 to 320 mg/kg DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner. In rats and rabbits, dermal dosing with up to 1500 mg/kg/d and 350 mg/kg/d DEA, respectively, during gestation, did not have any fetotoxic or teratogenic effects. The NOEL for embryonal/fetal toxicity was 380 mg/kg/d for rats and 350 mg/kg/d for rabbits.28 In an oral developmental study in which rats were dosed with up to 1200 mg/kg/d DEA on days 6 to 15 of gestation, maternal mortality was observed at doses of \u000550 mg/kg; the NOEL for embryonal/fetal toxicity was 200 mg/kg/d. In a study in which gravid rats were dosed orally with up to 300 mg/kg/d DEA, the dams of the 300 mg/kg group were killed due to excessive toxicity; the LD50 was calculated to be 218 mg/kg. The LOAEL for both maternal toxicity and teratogenicity was 125 mg/kg/d.2...","page":14,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_001"}
CIR_vision_codex NOAEL =380 mg/kg/d rat oral 4 weeks developmental toxicity {"citation":"20; 320; 6","dose":"20 to 320 mg/kg DEA from day 6 of gestation through PND 21 showed no effects on skeletal formation, but dose-dependent effects on some growth and developmental parameters were observed.","effect":"20 to 320 mg/kg DEA from day 6 of gestation through PND 21 showed no effects on skeletal formation, but dose-dependent effects on some growth and developmental parameters were observed. In a study in which parental mice were treated dermally with 20 to 320 mg/kg DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner. In rats and rabbits, dermal dosing with up to 1500 mg/kg/d and 350 mg/kg/d DEA, respectively, during gestation, did not have any fetotoxic or teratogenic effects. The NOEL for embryonal/fetal toxicity was 380 mg/kg/d for rats and 350 mg/kg/d for rabbits.28 In an oral developmental study in which rats were dosed with up to 1200 mg/kg/d DEA on days 6 to 15 of gestation, maternal mortality was observed at doses of \u000550 mg/kg; the NOEL for embryonal/fetal toxicity was 200 mg/kg/d. In a study in which gravid rats were dosed orally with up to 300 mg/kg/d DEA, the dams of the 300 mg/kg group were killed due to excessive toxicity; the LD50 was calculated to be 218 mg/kg. The LOAEL for both maternal toxicity and teratogenicity was 125 mg/kg/d.2...","page":14,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_001"}
CIR_vision_codex NOAEL =380 mg/kg/d rat oral 4 weeks developmental toxicity {"citation":"20; 320; 6","dose":"20 to 320 mg/kg DEA from day 6 of gestation through PND 21 showed no effects on skeletal formation, but dose-dependent effects on some growth and developmental parameters were observed.","effect":"20 to 320 mg/kg DEA from day 6 of gestation through PND 21 showed no effects on skeletal formation, but dose-dependent effects on some growth and developmental parameters were observed. In a study in which parental mice were treated dermally with 20 to 320 mg/kg DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner. In rats and rabbits, dermal dosing with up to 1500 mg/kg/d and 350 mg/kg/d DEA, respectively, during gestation, did not have any fetotoxic or teratogenic effects. The NOEL for embryonal/fetal toxicity was 380 mg/kg/d for rats and 350 mg/kg/d for rabbits.28 In an oral developmental study in which rats were dosed with up to 1200 mg/kg/d DEA on days 6 to 15 of gestation, maternal mortality was observed at doses of \u000550 mg/kg; the NOEL for embryonal/fetal toxicity was 200 mg/kg/d. In a study in which gravid rats were dosed orally with up to 300 mg/kg/d DEA, the dams of the 300 mg/kg group were killed due to excessive toxicity; the LD50 was calculated to be 218 mg/kg. The LOAEL for both maternal toxicity and teratogenicity was 125 mg/kg/d.2...","page":14,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_001"}
CIR_vision_codex NOAEL =1000 mg/kg/d rat oral 13-week repeated dose toxicity {"citation":"100; 400; 3","dose":"n was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","effect":"n was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic effects noted. For DEA, the NOEL for embryonal/fetal toxicity with dermal application was 380 mg/kg/d for rats and 350 mg/ kg/d for rabbits. In one oral study, the NOEL for embryonal/ fetal toxicity was 200 mg/kg/d in rats, and in an...","page":20,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_005"}
CIR_vision_codex NOAEL =1000 mg/kg/d rat oral 13-week repeated dose toxicity {"citation":"100; 400; 3","dose":"n was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","effect":"n was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic effects noted. For DEA, the NOEL for embryonal/fetal toxicity with dermal application was 380 mg/kg/d for rats and 350 mg/ kg/d for rabbits. In one oral study, the NOEL for embryonal/ fetal toxicity was 200 mg/kg/d in rats, and in an...","page":20,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_005"}
CIR_vision_codex NOAEL =1000 mg/kg/d rat oral 13-week repeated dose toxicity {"citation":"100; 400; 3","dose":"n was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","effect":"n was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic effects noted. For DEA, the NOEL for embryonal/fetal toxicity with dermal application was 380 mg/kg/d for rats and 350 mg/ kg/d for rabbits. In one oral study, the NOEL for embryonal/ fetal toxicity was 200 mg/kg/d in rats, and in an...","page":20,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_005"}
CIR_vision_codex NOAEL =1000 mg/kg/d rat oral 13-week repeated dose toxicity {"citation":"100; 400; 3","dose":"n was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","effect":"n was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic effects noted. For DEA, the NOEL for embryonal/fetal toxicity with dermal application was 380 mg/kg/d for rats and 350 mg/ kg/d for rabbits. In one oral study, the NOEL for embryonal/ fetal toxicity was 200 mg/kg/d in rats, and in an...","page":20,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_005"}
CIR_vision_codex NOAEL =5000 ppm rat oral 13-week repeated dose toxicity {"citation":"100; 400; 3","dose":"The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","effect":"hts were observed in most studies, while decreases in bw were observed sporadically. The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic effects noted. For DEA, the NOEL for embryonal/fetal toxicity with dermal application was 380 mg/kg/d for...","page":20,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_004"}
CIR_vision_codex NOAEL =5000 ppm rat oral 13-week repeated dose toxicity {"citation":"100; 400; 3","dose":"The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","effect":"hts were observed in most studies, while decreases in bw were observed sporadically. The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic effects noted. For DEA, the NOEL for embryonal/fetal toxicity with dermal application was 380 mg/kg/d for...","page":20,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_004"}
CIR_vision_codex NOAEL =5000 ppm rat oral 13-week repeated dose toxicity {"citation":"100; 400; 3","dose":"The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","effect":"hts were observed in most studies, while decreases in bw were observed sporadically. The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic effects noted. For DEA, the NOEL for embryonal/fetal toxicity with dermal application was 380 mg/kg/d for...","page":20,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_004"}
CIR_vision_codex NOAEL =5000 ppm rat oral 13-week repeated dose toxicity {"citation":"100; 400; 3","dose":"The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","effect":"hts were observed in most studies, while decreases in bw were observed sporadically. The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic effects noted. For DEA, the NOEL for embryonal/fetal toxicity with dermal application was 380 mg/kg/d for...","page":20,"pdf":"PRS593.pdf","row_type":"noael_study","study_id":"PRS593_noael_004"}
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 200 mg/kg/d rat oral 4 weeks developmental toxicity SOURCE_SUBDIR=PRS593; REPORT_TITLE=Safety Assessment of Diethanolamides as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel C. Liebler3, James G. Marks Jr3, Ronald C. Shank3,; OPINION_NUMBER=PRS593; COMMITTEE=CIR Expert Panel; REPORT_DATE=1996; VALUE_TEXT=200; DOSE=DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner.; LOAEL_VALUE=125 mg/kg/d; EFFECT=DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner. In rats and rabbits, dermal dosing with up to 1500 mg/kg/d and 350 mg/kg/d DEA, respectively, during gestation, did not have any fetotoxic or teratogenic effects. The NOEL for embryonal/fetal toxicity was 380 mg/kg/d for rats and 350 mg/kg/d for rabbits.28 In an oral developmental study in which rats were dosed with up to 1200 mg/kg/d DEA on days 6 to 15 of gestation, maternal mortality was observed at doses of 50 mg/kg; the NOEL for embryonal/fetal toxicity was 200 mg/kg/d. In a study in which gravid rats were dosed orally with up to 300 mg/kg/d DEA, the dams of the 300 mg/kg group were killed due to excessive toxicity; the LD50 was calculated to be 218 mg/kg. The LOAEL for both maternal toxicity and teratogenicity was 125 mg/kg/d.28 In a developmental study in which rats were exposed by inhalation to DEA on days 6 to 15 of gestation, the NOAEC for both maternal and developmental toxicity was 0.05 mg/L, and the NOAEC for teratogenicity was >0.2 mg/L.28 Lecithin. In oral studies, 1600 mg/kg...; CITATION=4; 350; 380; CITATION_NUMBERS=[4,350,380]; REFERENCE=4; 350; 380; DETAILS_JSON={"cas_number":"136-26-5","citation":"4; 350; 380","dose":"DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner.","duration":"4 weeks","effect":"DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner. In rats and rabbits, dermal dosing with up to 1500 mg/kg/d and 350 mg/kg/d DEA, respectively, during gestation, did not have any fetotoxic or teratogenic effects. The NOEL for embryonal/fetal toxicity was 380 mg/kg/d for rats and 350 mg/kg/d for rabbits.28 In an oral developmental study in which rats were dosed with up to 1200 mg/kg/d DEA on days 6 to 15 of gestation, maternal mortality was observed at doses of \u000550 mg/kg; the NOEL for embryonal/fetal toxicity was 200 mg/kg/d. In a study in which gravid rats were dosed orally with up to 300 mg/kg/d DEA, the dams of the 300 mg/kg group were killed due to excessive toxicity; the LD50 was calculated to be 218 mg/kg. The LOAEL for both maternal toxicity and teratogenicity was 125 mg/kg/d.28 In a developmental study in which rats were exposed by inhalation to DEA on days 6 to 15 of gestation, the NOAEC for both maternal and developmental toxicity was 0.05 mg/L, and the NOAEC for teratogenicity was >0.2 mg/L.28 Lecithin. In oral studies, \u00021600 mg/kg...","endpoint":"developmental toxicity","ingredient":"Diethanolamides","loael_value":"125 mg/kg/d","noael_unit":"mg/kg/d","noael_value":"200","page":14,"route":"oral","species":"rat","study_id":"PRS593_noael_002"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 380 mg/kg/d rat oral 4 weeks developmental toxicity SOURCE_SUBDIR=PRS593; REPORT_TITLE=Safety Assessment of Diethanolamides as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel C. Liebler3, James G. Marks Jr3, Ronald C. Shank3,; OPINION_NUMBER=PRS593; COMMITTEE=CIR Expert Panel; REPORT_DATE=1996; VALUE_TEXT=380; DOSE=20 to 320 mg/kg DEA from day 6 of gestation through PND 21 showed no effects on skeletal formation, but dose-dependent effects on some growth and developmental parameters were observed.; LOAEL_VALUE=125 mg/kg/d; EFFECT=20 to 320 mg/kg DEA from day 6 of gestation through PND 21 showed no effects on skeletal formation, but dose-dependent effects on some growth and developmental parameters were observed. In a study in which parental mice were treated dermally with 20 to 320 mg/kg DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner. In rats and rabbits, dermal dosing with up to 1500 mg/kg/d and 350 mg/kg/d DEA, respectively, during gestation, did not have any fetotoxic or teratogenic effects. The NOEL for embryonal/fetal toxicity was 380 mg/kg/d for rats and 350 mg/kg/d for rabbits.28 In an oral developmental study in which rats were dosed with up to 1200 mg/kg/d DEA on days 6 to 15 of gestation, maternal mortality was observed at doses of 50 mg/kg; the NOEL for embryonal/fetal toxicity was 200 mg/kg/d. In a study in which gravid rats were dosed orally with up to 300 mg/kg/d DEA, the dams of the 300 mg/kg group were killed due to excessive toxicity; the LD50 was calculated to be 218 mg/kg. The LOAEL for both maternal toxicity and teratogenicity was 125 mg/kg/d.2...; CITATION=20; 320; 6; CITATION_NUMBERS=[20,320,6]; REFERENCE=20; 320; 6; DETAILS_JSON={"cas_number":"136-26-5","citation":"20; 320; 6","dose":"20 to 320 mg/kg DEA from day 6 of gestation through PND 21 showed no effects on skeletal formation, but dose-dependent effects on some growth and developmental parameters were observed.","duration":"4 weeks","effect":"20 to 320 mg/kg DEA from day 6 of gestation through PND 21 showed no effects on skeletal formation, but dose-dependent effects on some growth and developmental parameters were observed. In a study in which parental mice were treated dermally with 20 to 320 mg/kg DEA for 4 weeks prior to mating, sperm motility was decreased in a dose-dependent manner. In rats and rabbits, dermal dosing with up to 1500 mg/kg/d and 350 mg/kg/d DEA, respectively, during gestation, did not have any fetotoxic or teratogenic effects. The NOEL for embryonal/fetal toxicity was 380 mg/kg/d for rats and 350 mg/kg/d for rabbits.28 In an oral developmental study in which rats were dosed with up to 1200 mg/kg/d DEA on days 6 to 15 of gestation, maternal mortality was observed at doses of \u000550 mg/kg; the NOEL for embryonal/fetal toxicity was 200 mg/kg/d. In a study in which gravid rats were dosed orally with up to 300 mg/kg/d DEA, the dams of the 300 mg/kg group were killed due to excessive toxicity; the LD50 was calculated to be 218 mg/kg. The LOAEL for both maternal toxicity and teratogenicity was 125 mg/kg/d.2...","endpoint":"developmental toxicity","ingredient":"Diethanolamides","loael_value":"125 mg/kg/d","noael_unit":"mg/kg/d","noael_value":"380","page":14,"route":"oral","species":"rat","study_id":"PRS593_noael_001"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 0.1 % rat oral 13-week repeated dose toxicity SOURCE_SUBDIR=PRS593; REPORT_TITLE=Safety Assessment of Diethanolamides as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel C. Liebler3, James G. Marks Jr3, Ronald C. Shank3,; OPINION_NUMBER=PRS593; COMMITTEE=CIR Expert Panel; REPORT_DATE=1996; VALUE_TEXT=0.1; DOSE=The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.; EFFECT=mice and/or rats, irritation was observed at the site of application. Increases in liver and kidney weights were observed in most studies, while decreases in bw were observed sporadically. The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic e...; CITATION=100; 400; 3; CITATION_NUMBERS=[100,400,3]; REFERENCE=100; 400; 3; DETAILS_JSON={"cas_number":"136-26-5","citation":"100; 400; 3","dose":"The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","duration":"13-week","effect":"mice and/or rats, irritation was observed at the site of application. Increases in liver and kidney weights were observed in most studies, while decreases in bw were observed sporadically. The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic e...","endpoint":"repeated dose toxicity","ingredient":"Diethanolamides","loael_value":"","noael_unit":"%","noael_value":"0.1","page":20,"route":"oral","species":"rat","study_id":"PRS593_noael_003"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 1000 mg/kg/d rat oral 13-week repeated dose toxicity SOURCE_SUBDIR=PRS593; REPORT_TITLE=Safety Assessment of Diethanolamides as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel C. Liebler3, James G. Marks Jr3, Ronald C. Shank3,; OPINION_NUMBER=PRS593; COMMITTEE=CIR Expert Panel; REPORT_DATE=1996; VALUE_TEXT=1000; DOSE=n was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.; EFFECT=n was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic effects noted. For DEA, the NOEL for embryonal/fetal toxicity with dermal application was 380 mg/kg/d for rats and 350 mg/ kg/d for rabbits. In one oral study, the NOEL for embryonal/ fetal toxicity was 200 mg/kg/d in rats, and in an...; CITATION=100; 400; 3; CITATION_NUMBERS=[100,400,3]; REFERENCE=100; 400; 3; DETAILS_JSON={"cas_number":"136-26-5","citation":"100; 400; 3","dose":"n was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","duration":"13-week","effect":"n was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic effects noted. For DEA, the NOEL for embryonal/fetal toxicity with dermal application was 380 mg/kg/d for rats and 350 mg/ kg/d for rabbits. In one oral study, the NOEL for embryonal/ fetal toxicity was 200 mg/kg/d in rats, and in an...","endpoint":"repeated dose toxicity","ingredient":"Diethanolamides","loael_value":"","noael_unit":"mg/kg/d","noael_value":"1000","page":20,"route":"oral","species":"rat","study_id":"PRS593_noael_005"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 5000 ppm rat oral 13-week repeated dose toxicity SOURCE_SUBDIR=PRS593; REPORT_TITLE=Safety Assessment of Diethanolamides as Used in Cosmetics Monice M. Fiume1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel C. Liebler3, James G. Marks Jr3, Ronald C. Shank3,; OPINION_NUMBER=PRS593; COMMITTEE=CIR Expert Panel; REPORT_DATE=1996; VALUE_TEXT=5000; DOSE=The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.; EFFECT=hts were observed in most studies, while decreases in bw were observed sporadically. The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic effects noted. For DEA, the NOEL for embryonal/fetal toxicity with dermal application was 380 mg/kg/d for...; CITATION=100; 400; 3; CITATION_NUMBERS=[100,400,3]; REFERENCE=100; 400; 3; DETAILS_JSON={"cas_number":"136-26-5","citation":"100; 400; 3","dose":"The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls.","duration":"13-week","effect":"hts were observed in most studies, while decreases in bw were observed sporadically. The incidence of renal tubule regenera- tion was greater in female rats dosed with 100 to 400 mg/kg cocamide DEA when compared to controls. A formulation containing 3% linoleamide DEA was not a cumulative sys- temic toxicant in a 13-week dermal study; dermal irritation was observed. With repeat oral dosing of lauramide DEA, the NOEL was 0.1% in feed in a study with SPF rats and 250 mg/kg/d in a feeding study using Wistar rats. The NOEL for Beagle dogs fed lauramide DEA for 12 weeks was 5000 ppm. In a developmental toxicity study in Sprague-Dawley rats, the NOAEL for maternal toxicity and developmental toxicity was 1000 mg/kg/d that was the highest dose tested. No other data on the reproductive and developmental toxicity of the diethanolamides were found. Available reproductive and developmental toxicity data on DEA and some of the fatty acids from previous CIR reports show no significant toxic effects noted. For DEA, the NOEL for embryonal/fetal toxicity with dermal application was 380 mg/kg/d for...","endpoint":"repeated dose toxicity","ingredient":"Diethanolamides","loael_value":"","noael_unit":"ppm","noael_value":"5000","page":20,"route":"oral","species":"rat","study_id":"PRS593_noael_004"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier SHH19DQ1DH UNII - - - chemical {"approval_status":null,"molecular_formula":"C14H29NO3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SHH19DQ1DH"}
openFDA substances FDA UNII substance identifier SHH19DQ1DH UNII - - - chemical {"approval_status":null,"molecular_formula":"C14H29NO3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SHH19DQ1DH"}
openFDA substances FDA UNII substance identifier SHH19DQ1DH UNII - - - chemical {"approval_status":null,"molecular_formula":"C14H29NO3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SHH19DQ1DH"}
openFDA substances FDA UNII substance identifier SHH19DQ1DH UNII - - - chemical {"approval_status":null,"molecular_formula":"C14H29NO3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SHH19DQ1DH"}