NOAEL Studies Humectant

Betaine NOAEL Studies

INCI: BETAINE

CAS: 107-43-7

Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.

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CIR_vision_codex 36 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR_vision_codex NOAEL =250 mg/kg/d rat oral 91-day repeated dose toxicity {"citation":"0; 83; 15","dose":"The LD50 values were 0.15 g/kg for cetyl betaine and 0.053 g/kg for lauryl betaine in an intraperitoneal study in rats.3-5,25 Repeated Dose Toxicity Repeated dose toxicity data are summarized in Table 5.","effect":"g/kg for lauryl betaine. The intravenous LD50 of betaine in mice has been reported to be 0.83 g/kg body weight (bw). The LD50 values were 0.15 g/kg for cetyl betaine and 0.053 g/kg for lauryl betaine in an intraperitoneal study in rats.3-5,25 Repeated Dose Toxicity Repeated dose toxicity data are summarized in Table 5. No effects were observed at the highest dose tested for betaine in rats. No significant toxic effects were observed in rats that received up to 0.35 g/kg/d cetyl betaine in a 91-day oral study. The no observed effect level (NOEL) for coco-betaine was 250 mg/kg/d and the lowest observed effect level (LOEL) was 500 mg/kg/d in a 90-day oral study in rats when tested up to 500 mg/kg/d. In a study of C12 to C14 alkyldimethyl betaines, systemic no observed adverse effects levels (NOAELs) were 50 and 100 mg/kg bw/d in oral rat studies that tested the mate- rial up to 300 and 1,000 mg/kg/d, respectively. The systemic lowest observed adverse effects levels (LOAELs) for these 2 studies were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic ch...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_001"}
CIR_vision_codex NOAEL =40 mg/kg/d rat oral - developmental toxicity {"citation":"150; 300; 3,4,27","dose":"es were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6.","effect":"es were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6. Dermal reproductive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and inc...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_002"}
CIR_vision_codex NOAEL =20 mg/kg/d rat oral - developmental toxicity {"citation":"300; 3,4,27; 6","dose":"hanges in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6.","effect":"hanges in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6. Dermal reproductive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betain...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_003"}
CIR_vision_codex NOAEL =150 mg/kg rat oral 104-week repeated dose toxicity {"citation":"10; 40; 20","dose":"ive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established.","effect":"ive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betaines study determined the reproductive NOAEL to be 300 mg/kg/d when the test material was tested up to 1,000 mg/kg/d.4,28,29 Carcinogenicity Repeated dose toxicity results are presented in Table 5. Betaine was not carcinogenic when tested up to 5% in a 104-week dietary rat...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_004"}
CIR_vision_codex NOAEL =300 mg/kg/d rat oral 104-week repeated dose toxicity {"citation":"50; 250; 150","dose":"in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated.","effect":"in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betaines study determined the reproductive NOAEL to be 300 mg/kg/d when the test material was tested up to 1,000 mg/kg/d.4,28,29 Carcinogenicity Repeated dose toxicity results are presented in Table 5. Betaine was not carcinogenic when tested up to 5% in a 104-week dietary rat study.3 34S International Journal of Toxicology 37(Supplement 1)","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_005"}
CIR_vision_codex NOAEL >5771 mg/kg bw/d rat oral 28-day repeated dose toxicity {"citation":"5; 95; 0","dose":"Repeated Dose Toxicity in Animals.","effect":"Table 5. Repeated Dose Toxicity in Animals. Ingredient and concentration/dose Method Results/conclusions References Betaine >95% pure; doses ¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided; GLP compliant NOAEL >5,771 mg/kg bw/d; NOEL could not be derived due to high tolerance and reversibility of slight to moderate hepatocellular vacuolation effects in rats 3 Betaine >95% pure; tested up to 5% in animal feed OECD Guideline 408 for repeated dose 90-day oral toxicity in male and female Sprague Dawley rats; 20 rats of each sex per dose; GLP compliant NOAEL and NOEL could not be determined due to high tolerance, slight hematology, and hepatic changes that included increased liver weights, hepatocellular vacuolation, but no microscopic evidence of hepatotoxicity; no significant systemic signs of toxicity were observed in any treatment group d","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_006"}
CIR_vision_codex NOAEL =5 % rat oral 28-day repeated dose toxicity {"citation":"0; 1; 2","dose":"¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided;","effect":"¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided; GLP compliant NOAEL >5,771 mg/kg bw/d; NOEL could not be derived due to high tolerance and reversibility of slight to moderate hepatocellular vacuolation effects in rats 3 Betaine >95% pure; tested up to 5% in animal feed OECD Guideline 408 for repeated dose 90-day oral toxicity in male and female Sprague Dawley rats; 20 rats of each sex per dose; GLP compliant NOAEL and NOEL could not be determined due to high tolerance, slight hematology, and hepatic changes that included increased liver weights, hepatocellular vacuolation, but no microscopic evidence of hepatotoxicity; no significant systemic signs of toxicity were observed in any treatment group during dosing 3 Betaine >99.9% pure; tested up to 5% in animal feed for both chronic and carcinogenicity studies OECD Guideline 453 for combined chronic toxicity/carcinogenicity studies in male and female Fischer 344 rats; 52-week study had 10 rats of each sex per dose; 104-week stud...","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_007"}
CIR_vision_codex NOAEL =50 mg/kg bw/d rat oral - repeated dose toxicity {"citation":"4; 0, 50, 150; 300","dose":"tative effects observed in the forestomach of mid- and high-dose group, possibly due to gavage dosing.","effect":"tative effects observed in the forestomach of mid- and high-dose group, possibly due to gavage dosing. No adverse effects on reproductive organs noted in microscopic or macroscopic examinations 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 50, 150, and 300 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test in male and female Wistar rats; 10 rats of each sex per dose; GLP compliant NOAEL (systemic) ¼ 50 mg/kg bw/d; LOAEL (systemic) ¼ 150 mg/kg bw/d due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder; NOEL (reproduction) ¼ 150 mg/kg bw/ d; LOAEL (reproduction) ¼ 300 mg/kg bw/d due to pup weight, litter size, postimplantation loss, and postnatal loss 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 33, 100, 300, and 1,000 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity sc...","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_008"}
CIR_vision_codex NOAEL =100 mg/kg bw/d rat oral - repeated dose toxicity {"citation":"150; 300; 4","dose":"NOEL (reproduction) ¼ 150 mg/kg bw/ d;","effect":"anges in the kidney and bladder; NOEL (reproduction) ¼ 150 mg/kg bw/ d; LOAEL (reproduction) ¼ 300 mg/kg bw/d due to pup weight, litter size, postimplantation loss, and postnatal loss 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 33, 100, 300, and 1,000 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test in male and female Wistar rats; 3 rats of each sex per dose; not GLP compliant NOAEL (systemic) ¼ 100 mg/kg bw/d; LOAEL (systemic) ¼ 300 mg/kg bw/d due to decreased food consumption, bw gain, and absolute bw; no reproductive results reported due to small group sizes 4 Abbreviations: bw, body weight; GLP, Good Laboratory Practice; LOAEL, lowest observed adverse effects level; LOEL, lowest observed effect level; OECD, Organization for Economic Cooperation and Development; NOAEL, no observed adverse effects level; NOEL, no observed effect level. 36S International Journal of Toxicology 37(Supplement 1)","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_009"}
CIR_vision_codex NOAEL =250 mg/kg/d rat oral 91-day repeated dose toxicity {"citation":"0; 83; 15","dose":"The LD50 values were 0.15 g/kg for cetyl betaine and 0.053 g/kg for lauryl betaine in an intraperitoneal study in rats.3-5,25 Repeated Dose Toxicity Repeated dose toxicity data are summarized in Table 5.","effect":"g/kg for lauryl betaine. The intravenous LD50 of betaine in mice has been reported to be 0.83 g/kg body weight (bw). The LD50 values were 0.15 g/kg for cetyl betaine and 0.053 g/kg for lauryl betaine in an intraperitoneal study in rats.3-5,25 Repeated Dose Toxicity Repeated dose toxicity data are summarized in Table 5. No effects were observed at the highest dose tested for betaine in rats. No significant toxic effects were observed in rats that received up to 0.35 g/kg/d cetyl betaine in a 91-day oral study. The no observed effect level (NOEL) for coco-betaine was 250 mg/kg/d and the lowest observed effect level (LOEL) was 500 mg/kg/d in a 90-day oral study in rats when tested up to 500 mg/kg/d. In a study of C12 to C14 alkyldimethyl betaines, systemic no observed adverse effects levels (NOAELs) were 50 and 100 mg/kg bw/d in oral rat studies that tested the mate- rial up to 300 and 1,000 mg/kg/d, respectively. The systemic lowest observed adverse effects levels (LOAELs) for these 2 studies were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic ch...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_001"}
CIR_vision_codex NOAEL =40 mg/kg/d rat oral - developmental toxicity {"citation":"150; 300; 3,4,27","dose":"es were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6.","effect":"es were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6. Dermal reproductive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and inc...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_002"}
CIR_vision_codex NOAEL =20 mg/kg/d rat oral - developmental toxicity {"citation":"300; 3,4,27; 6","dose":"hanges in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6.","effect":"hanges in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6. Dermal reproductive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betain...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_003"}
CIR_vision_codex NOAEL =150 mg/kg rat oral 104-week repeated dose toxicity {"citation":"10; 40; 20","dose":"ive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established.","effect":"ive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betaines study determined the reproductive NOAEL to be 300 mg/kg/d when the test material was tested up to 1,000 mg/kg/d.4,28,29 Carcinogenicity Repeated dose toxicity results are presented in Table 5. Betaine was not carcinogenic when tested up to 5% in a 104-week dietary rat...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_004"}
CIR_vision_codex NOAEL =300 mg/kg/d rat oral 104-week repeated dose toxicity {"citation":"50; 250; 150","dose":"in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated.","effect":"in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betaines study determined the reproductive NOAEL to be 300 mg/kg/d when the test material was tested up to 1,000 mg/kg/d.4,28,29 Carcinogenicity Repeated dose toxicity results are presented in Table 5. Betaine was not carcinogenic when tested up to 5% in a 104-week dietary rat study.3 34S International Journal of Toxicology 37(Supplement 1)","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_005"}
CIR_vision_codex NOAEL >5771 mg/kg bw/d rat oral 28-day repeated dose toxicity {"citation":"5; 95; 0","dose":"Repeated Dose Toxicity in Animals.","effect":"Table 5. Repeated Dose Toxicity in Animals. Ingredient and concentration/dose Method Results/conclusions References Betaine >95% pure; doses ¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided; GLP compliant NOAEL >5,771 mg/kg bw/d; NOEL could not be derived due to high tolerance and reversibility of slight to moderate hepatocellular vacuolation effects in rats 3 Betaine >95% pure; tested up to 5% in animal feed OECD Guideline 408 for repeated dose 90-day oral toxicity in male and female Sprague Dawley rats; 20 rats of each sex per dose; GLP compliant NOAEL and NOEL could not be determined due to high tolerance, slight hematology, and hepatic changes that included increased liver weights, hepatocellular vacuolation, but no microscopic evidence of hepatotoxicity; no significant systemic signs of toxicity were observed in any treatment group d","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_006"}
CIR_vision_codex NOAEL =5 % rat oral 28-day repeated dose toxicity {"citation":"0; 1; 2","dose":"¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided;","effect":"¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided; GLP compliant NOAEL >5,771 mg/kg bw/d; NOEL could not be derived due to high tolerance and reversibility of slight to moderate hepatocellular vacuolation effects in rats 3 Betaine >95% pure; tested up to 5% in animal feed OECD Guideline 408 for repeated dose 90-day oral toxicity in male and female Sprague Dawley rats; 20 rats of each sex per dose; GLP compliant NOAEL and NOEL could not be determined due to high tolerance, slight hematology, and hepatic changes that included increased liver weights, hepatocellular vacuolation, but no microscopic evidence of hepatotoxicity; no significant systemic signs of toxicity were observed in any treatment group during dosing 3 Betaine >99.9% pure; tested up to 5% in animal feed for both chronic and carcinogenicity studies OECD Guideline 453 for combined chronic toxicity/carcinogenicity studies in male and female Fischer 344 rats; 52-week study had 10 rats of each sex per dose; 104-week stud...","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_007"}
CIR_vision_codex NOAEL =50 mg/kg bw/d rat oral - repeated dose toxicity {"citation":"4; 0, 50, 150; 300","dose":"tative effects observed in the forestomach of mid- and high-dose group, possibly due to gavage dosing.","effect":"tative effects observed in the forestomach of mid- and high-dose group, possibly due to gavage dosing. No adverse effects on reproductive organs noted in microscopic or macroscopic examinations 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 50, 150, and 300 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test in male and female Wistar rats; 10 rats of each sex per dose; GLP compliant NOAEL (systemic) ¼ 50 mg/kg bw/d; LOAEL (systemic) ¼ 150 mg/kg bw/d due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder; NOEL (reproduction) ¼ 150 mg/kg bw/ d; LOAEL (reproduction) ¼ 300 mg/kg bw/d due to pup weight, litter size, postimplantation loss, and postnatal loss 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 33, 100, 300, and 1,000 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity sc...","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_008"}
CIR_vision_codex NOAEL =100 mg/kg bw/d rat oral - repeated dose toxicity {"citation":"150; 300; 4","dose":"NOEL (reproduction) ¼ 150 mg/kg bw/ d;","effect":"anges in the kidney and bladder; NOEL (reproduction) ¼ 150 mg/kg bw/ d; LOAEL (reproduction) ¼ 300 mg/kg bw/d due to pup weight, litter size, postimplantation loss, and postnatal loss 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 33, 100, 300, and 1,000 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test in male and female Wistar rats; 3 rats of each sex per dose; not GLP compliant NOAEL (systemic) ¼ 100 mg/kg bw/d; LOAEL (systemic) ¼ 300 mg/kg bw/d due to decreased food consumption, bw gain, and absolute bw; no reproductive results reported due to small group sizes 4 Abbreviations: bw, body weight; GLP, Good Laboratory Practice; LOAEL, lowest observed adverse effects level; LOEL, lowest observed effect level; OECD, Organization for Economic Cooperation and Development; NOAEL, no observed adverse effects level; NOEL, no observed effect level. 36S International Journal of Toxicology 37(Supplement 1)","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_009"}
CIR_vision_codex NOAEL =250 mg/kg/d rat oral 91-day repeated dose toxicity {"citation":"0; 83; 15","dose":"The LD50 values were 0.15 g/kg for cetyl betaine and 0.053 g/kg for lauryl betaine in an intraperitoneal study in rats.3-5,25 Repeated Dose Toxicity Repeated dose toxicity data are summarized in Table 5.","effect":"g/kg for lauryl betaine. The intravenous LD50 of betaine in mice has been reported to be 0.83 g/kg body weight (bw). The LD50 values were 0.15 g/kg for cetyl betaine and 0.053 g/kg for lauryl betaine in an intraperitoneal study in rats.3-5,25 Repeated Dose Toxicity Repeated dose toxicity data are summarized in Table 5. No effects were observed at the highest dose tested for betaine in rats. No significant toxic effects were observed in rats that received up to 0.35 g/kg/d cetyl betaine in a 91-day oral study. The no observed effect level (NOEL) for coco-betaine was 250 mg/kg/d and the lowest observed effect level (LOEL) was 500 mg/kg/d in a 90-day oral study in rats when tested up to 500 mg/kg/d. In a study of C12 to C14 alkyldimethyl betaines, systemic no observed adverse effects levels (NOAELs) were 50 and 100 mg/kg bw/d in oral rat studies that tested the mate- rial up to 300 and 1,000 mg/kg/d, respectively. The systemic lowest observed adverse effects levels (LOAELs) for these 2 studies were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic ch...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_001"}
CIR_vision_codex NOAEL =40 mg/kg/d rat oral - developmental toxicity {"citation":"150; 300; 3,4,27","dose":"es were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6.","effect":"es were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6. Dermal reproductive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and inc...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_002"}
CIR_vision_codex NOAEL =20 mg/kg/d rat oral - developmental toxicity {"citation":"300; 3,4,27; 6","dose":"hanges in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6.","effect":"hanges in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6. Dermal reproductive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betain...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_003"}
CIR_vision_codex NOAEL =150 mg/kg rat oral 104-week repeated dose toxicity {"citation":"10; 40; 20","dose":"ive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established.","effect":"ive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betaines study determined the reproductive NOAEL to be 300 mg/kg/d when the test material was tested up to 1,000 mg/kg/d.4,28,29 Carcinogenicity Repeated dose toxicity results are presented in Table 5. Betaine was not carcinogenic when tested up to 5% in a 104-week dietary rat...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_004"}
CIR_vision_codex NOAEL =300 mg/kg/d rat oral 104-week repeated dose toxicity {"citation":"50; 250; 150","dose":"in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated.","effect":"in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betaines study determined the reproductive NOAEL to be 300 mg/kg/d when the test material was tested up to 1,000 mg/kg/d.4,28,29 Carcinogenicity Repeated dose toxicity results are presented in Table 5. Betaine was not carcinogenic when tested up to 5% in a 104-week dietary rat study.3 34S International Journal of Toxicology 37(Supplement 1)","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_005"}
CIR_vision_codex NOAEL >5771 mg/kg bw/d rat oral 28-day repeated dose toxicity {"citation":"5; 95; 0","dose":"Repeated Dose Toxicity in Animals.","effect":"Table 5. Repeated Dose Toxicity in Animals. Ingredient and concentration/dose Method Results/conclusions References Betaine >95% pure; doses ¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided; GLP compliant NOAEL >5,771 mg/kg bw/d; NOEL could not be derived due to high tolerance and reversibility of slight to moderate hepatocellular vacuolation effects in rats 3 Betaine >95% pure; tested up to 5% in animal feed OECD Guideline 408 for repeated dose 90-day oral toxicity in male and female Sprague Dawley rats; 20 rats of each sex per dose; GLP compliant NOAEL and NOEL could not be determined due to high tolerance, slight hematology, and hepatic changes that included increased liver weights, hepatocellular vacuolation, but no microscopic evidence of hepatotoxicity; no significant systemic signs of toxicity were observed in any treatment group d","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_006"}
CIR_vision_codex NOAEL =5 % rat oral 28-day repeated dose toxicity {"citation":"0; 1; 2","dose":"¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided;","effect":"¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided; GLP compliant NOAEL >5,771 mg/kg bw/d; NOEL could not be derived due to high tolerance and reversibility of slight to moderate hepatocellular vacuolation effects in rats 3 Betaine >95% pure; tested up to 5% in animal feed OECD Guideline 408 for repeated dose 90-day oral toxicity in male and female Sprague Dawley rats; 20 rats of each sex per dose; GLP compliant NOAEL and NOEL could not be determined due to high tolerance, slight hematology, and hepatic changes that included increased liver weights, hepatocellular vacuolation, but no microscopic evidence of hepatotoxicity; no significant systemic signs of toxicity were observed in any treatment group during dosing 3 Betaine >99.9% pure; tested up to 5% in animal feed for both chronic and carcinogenicity studies OECD Guideline 453 for combined chronic toxicity/carcinogenicity studies in male and female Fischer 344 rats; 52-week study had 10 rats of each sex per dose; 104-week stud...","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_007"}
CIR_vision_codex NOAEL =50 mg/kg bw/d rat oral - repeated dose toxicity {"citation":"4; 0, 50, 150; 300","dose":"tative effects observed in the forestomach of mid- and high-dose group, possibly due to gavage dosing.","effect":"tative effects observed in the forestomach of mid- and high-dose group, possibly due to gavage dosing. No adverse effects on reproductive organs noted in microscopic or macroscopic examinations 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 50, 150, and 300 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test in male and female Wistar rats; 10 rats of each sex per dose; GLP compliant NOAEL (systemic) ¼ 50 mg/kg bw/d; LOAEL (systemic) ¼ 150 mg/kg bw/d due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder; NOEL (reproduction) ¼ 150 mg/kg bw/ d; LOAEL (reproduction) ¼ 300 mg/kg bw/d due to pup weight, litter size, postimplantation loss, and postnatal loss 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 33, 100, 300, and 1,000 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity sc...","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_008"}
CIR_vision_codex NOAEL =100 mg/kg bw/d rat oral - repeated dose toxicity {"citation":"150; 300; 4","dose":"NOEL (reproduction) ¼ 150 mg/kg bw/ d;","effect":"anges in the kidney and bladder; NOEL (reproduction) ¼ 150 mg/kg bw/ d; LOAEL (reproduction) ¼ 300 mg/kg bw/d due to pup weight, litter size, postimplantation loss, and postnatal loss 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 33, 100, 300, and 1,000 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test in male and female Wistar rats; 3 rats of each sex per dose; not GLP compliant NOAEL (systemic) ¼ 100 mg/kg bw/d; LOAEL (systemic) ¼ 300 mg/kg bw/d due to decreased food consumption, bw gain, and absolute bw; no reproductive results reported due to small group sizes 4 Abbreviations: bw, body weight; GLP, Good Laboratory Practice; LOAEL, lowest observed adverse effects level; LOEL, lowest observed effect level; OECD, Organization for Economic Cooperation and Development; NOAEL, no observed adverse effects level; NOEL, no observed effect level. 36S International Journal of Toxicology 37(Supplement 1)","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_009"}
CIR_vision_codex NOAEL =250 mg/kg/d rat oral 91-day repeated dose toxicity {"citation":"0; 83; 15","dose":"The LD50 values were 0.15 g/kg for cetyl betaine and 0.053 g/kg for lauryl betaine in an intraperitoneal study in rats.3-5,25 Repeated Dose Toxicity Repeated dose toxicity data are summarized in Table 5.","effect":"g/kg for lauryl betaine. The intravenous LD50 of betaine in mice has been reported to be 0.83 g/kg body weight (bw). The LD50 values were 0.15 g/kg for cetyl betaine and 0.053 g/kg for lauryl betaine in an intraperitoneal study in rats.3-5,25 Repeated Dose Toxicity Repeated dose toxicity data are summarized in Table 5. No effects were observed at the highest dose tested for betaine in rats. No significant toxic effects were observed in rats that received up to 0.35 g/kg/d cetyl betaine in a 91-day oral study. The no observed effect level (NOEL) for coco-betaine was 250 mg/kg/d and the lowest observed effect level (LOEL) was 500 mg/kg/d in a 90-day oral study in rats when tested up to 500 mg/kg/d. In a study of C12 to C14 alkyldimethyl betaines, systemic no observed adverse effects levels (NOAELs) were 50 and 100 mg/kg bw/d in oral rat studies that tested the mate- rial up to 300 and 1,000 mg/kg/d, respectively. The systemic lowest observed adverse effects levels (LOAELs) for these 2 studies were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic ch...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_001"}
CIR_vision_codex NOAEL =40 mg/kg/d rat oral - developmental toxicity {"citation":"150; 300; 3,4,27","dose":"es were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6.","effect":"es were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6. Dermal reproductive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and inc...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_002"}
CIR_vision_codex NOAEL =20 mg/kg/d rat oral - developmental toxicity {"citation":"300; 3,4,27; 6","dose":"hanges in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6.","effect":"hanges in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6. Dermal reproductive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betain...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_003"}
CIR_vision_codex NOAEL =150 mg/kg rat oral 104-week repeated dose toxicity {"citation":"10; 40; 20","dose":"ive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established.","effect":"ive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betaines study determined the reproductive NOAEL to be 300 mg/kg/d when the test material was tested up to 1,000 mg/kg/d.4,28,29 Carcinogenicity Repeated dose toxicity results are presented in Table 5. Betaine was not carcinogenic when tested up to 5% in a 104-week dietary rat...","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_004"}
CIR_vision_codex NOAEL =300 mg/kg/d rat oral 104-week repeated dose toxicity {"citation":"50; 250; 150","dose":"in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated.","effect":"in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betaines study determined the reproductive NOAEL to be 300 mg/kg/d when the test material was tested up to 1,000 mg/kg/d.4,28,29 Carcinogenicity Repeated dose toxicity results are presented in Table 5. Betaine was not carcinogenic when tested up to 5% in a 104-week dietary rat study.3 34S International Journal of Toxicology 37(Supplement 1)","page":7,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_005"}
CIR_vision_codex NOAEL >5771 mg/kg bw/d rat oral 28-day repeated dose toxicity {"citation":"5; 95; 0","dose":"Repeated Dose Toxicity in Animals.","effect":"Table 5. Repeated Dose Toxicity in Animals. Ingredient and concentration/dose Method Results/conclusions References Betaine >95% pure; doses ¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided; GLP compliant NOAEL >5,771 mg/kg bw/d; NOEL could not be derived due to high tolerance and reversibility of slight to moderate hepatocellular vacuolation effects in rats 3 Betaine >95% pure; tested up to 5% in animal feed OECD Guideline 408 for repeated dose 90-day oral toxicity in male and female Sprague Dawley rats; 20 rats of each sex per dose; GLP compliant NOAEL and NOEL could not be determined due to high tolerance, slight hematology, and hepatic changes that included increased liver weights, hepatocellular vacuolation, but no microscopic evidence of hepatotoxicity; no significant systemic signs of toxicity were observed in any treatment group d","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_006"}
CIR_vision_codex NOAEL =5 % rat oral 28-day repeated dose toxicity {"citation":"0; 1; 2","dose":"¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided;","effect":"¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided; GLP compliant NOAEL >5,771 mg/kg bw/d; NOEL could not be derived due to high tolerance and reversibility of slight to moderate hepatocellular vacuolation effects in rats 3 Betaine >95% pure; tested up to 5% in animal feed OECD Guideline 408 for repeated dose 90-day oral toxicity in male and female Sprague Dawley rats; 20 rats of each sex per dose; GLP compliant NOAEL and NOEL could not be determined due to high tolerance, slight hematology, and hepatic changes that included increased liver weights, hepatocellular vacuolation, but no microscopic evidence of hepatotoxicity; no significant systemic signs of toxicity were observed in any treatment group during dosing 3 Betaine >99.9% pure; tested up to 5% in animal feed for both chronic and carcinogenicity studies OECD Guideline 453 for combined chronic toxicity/carcinogenicity studies in male and female Fischer 344 rats; 52-week study had 10 rats of each sex per dose; 104-week stud...","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_007"}
CIR_vision_codex NOAEL =50 mg/kg bw/d rat oral - repeated dose toxicity {"citation":"4; 0, 50, 150; 300","dose":"tative effects observed in the forestomach of mid- and high-dose group, possibly due to gavage dosing.","effect":"tative effects observed in the forestomach of mid- and high-dose group, possibly due to gavage dosing. No adverse effects on reproductive organs noted in microscopic or macroscopic examinations 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 50, 150, and 300 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test in male and female Wistar rats; 10 rats of each sex per dose; GLP compliant NOAEL (systemic) ¼ 50 mg/kg bw/d; LOAEL (systemic) ¼ 150 mg/kg bw/d due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder; NOEL (reproduction) ¼ 150 mg/kg bw/ d; LOAEL (reproduction) ¼ 300 mg/kg bw/d due to pup weight, litter size, postimplantation loss, and postnatal loss 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 33, 100, 300, and 1,000 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity sc...","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_008"}
CIR_vision_codex NOAEL =100 mg/kg bw/d rat oral - repeated dose toxicity {"citation":"150; 300; 4","dose":"NOEL (reproduction) ¼ 150 mg/kg bw/ d;","effect":"anges in the kidney and bladder; NOEL (reproduction) ¼ 150 mg/kg bw/ d; LOAEL (reproduction) ¼ 300 mg/kg bw/d due to pup weight, litter size, postimplantation loss, and postnatal loss 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 33, 100, 300, and 1,000 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test in male and female Wistar rats; 3 rats of each sex per dose; not GLP compliant NOAEL (systemic) ¼ 100 mg/kg bw/d; LOAEL (systemic) ¼ 300 mg/kg bw/d due to decreased food consumption, bw gain, and absolute bw; no reproductive results reported due to small group sizes 4 Abbreviations: bw, body weight; GLP, Good Laboratory Practice; LOAEL, lowest observed adverse effects level; LOEL, lowest observed effect level; OECD, Organization for Economic Cooperation and Development; NOAEL, no observed adverse effects level; NOEL, no observed effect level. 36S International Journal of Toxicology 37(Supplement 1)","page":9,"pdf":"PRS650.pdf","row_type":"noael_study","study_id":"PRS650_noael_009"}
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip 6 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip NOAEL >5771 mg/kg bw/day rat oral: feed - short-term repeated dose toxicity: oral dossier=ae792057-82c6-4e62-a46b-83be601dda8d.i6z; document=60dd4b3a-de1d-4479-8a61-7a7ba77c8017_ae792057-82c6-4e62-a46b-83be601dda8d.i6d; document_key=60dd4b3a-de1d-4479-8a61-7a7ba77c8017/ae792057-82c6-4e62-a46b-83be601dda8d; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=2001; ReportDate=2001-07-03; basis=other:; key_result=false; entry_uuid=d5b70b84-6b1c-4351-beec-11b73bff8b55
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip NOAEL >812 mg/kg bw/day rat oral: feed - sub-chronic toxicity: oral dossier=ae792057-82c6-4e62-a46b-83be601dda8d.i6z; document=fa7ea593-45da-48b9-b238-d17b45fc466d_ae792057-82c6-4e62-a46b-83be601dda8d.i6d; document_key=fa7ea593-45da-48b9-b238-d17b45fc466d/ae792057-82c6-4e62-a46b-83be601dda8d; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=2001; ReportDate=2001-02-07; basis=other:; key_result=false; upper_value=4413; entry_uuid=7360fb72-1039-43e9-a6c3-b4bc0139d9d5
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip NOAEL >5771 mg/kg bw/day rat oral: feed - short-term repeated dose toxicity: oral dossier=ae792057-82c6-4e62-a46b-83be601dda8d.i6z; document=60dd4b3a-de1d-4479-8a61-7a7ba77c8017_ae792057-82c6-4e62-a46b-83be601dda8d.i6d; document_key=60dd4b3a-de1d-4479-8a61-7a7ba77c8017/ae792057-82c6-4e62-a46b-83be601dda8d; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=2001; ReportDate=2001-07-03; basis=other:; key_result=false; entry_uuid=d5b70b84-6b1c-4351-beec-11b73bff8b55
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip NOAEL >812 mg/kg bw/day rat oral: feed - sub-chronic toxicity: oral dossier=ae792057-82c6-4e62-a46b-83be601dda8d.i6z; document=fa7ea593-45da-48b9-b238-d17b45fc466d_ae792057-82c6-4e62-a46b-83be601dda8d.i6d; document_key=fa7ea593-45da-48b9-b238-d17b45fc466d/ae792057-82c6-4e62-a46b-83be601dda8d; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=2001; ReportDate=2001-02-07; basis=other:; key_result=false; upper_value=4413; entry_uuid=7360fb72-1039-43e9-a6c3-b4bc0139d9d5
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip NOAEL >5771 mg/kg bw/day rat oral: feed - short-term repeated dose toxicity: oral dossier=ae792057-82c6-4e62-a46b-83be601dda8d.i6z; document=60dd4b3a-de1d-4479-8a61-7a7ba77c8017_ae792057-82c6-4e62-a46b-83be601dda8d.i6d; document_key=60dd4b3a-de1d-4479-8a61-7a7ba77c8017/ae792057-82c6-4e62-a46b-83be601dda8d; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=2001; ReportDate=2001-07-03; basis=other:; key_result=false; entry_uuid=d5b70b84-6b1c-4351-beec-11b73bff8b55
ECHA_REACH_reach_study_results_dossiers_23-05-2023.zip NOAEL >812 mg/kg bw/day rat oral: feed - sub-chronic toxicity: oral dossier=ae792057-82c6-4e62-a46b-83be601dda8d.i6z; document=fa7ea593-45da-48b9-b238-d17b45fc466d_ae792057-82c6-4e62-a46b-83be601dda8d.i6d; document_key=fa7ea593-45da-48b9-b238-d17b45fc466d/ae792057-82c6-4e62-a46b-83be601dda8d; document_subtype=RepeatedDoseToxicityOral; literature=Name=Unnamed; ReferenceYear=2001; ReportDate=2001-02-07; basis=other:; key_result=false; upper_value=4413; entry_uuid=7360fb72-1039-43e9-a6c3-b4bc0139d9d5
NTP_ICE_acute_oral 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 >11204 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_1321; row=13474; data_type=In Vivo; mixture=Chemical; chemical_name=Betaine; preferred_name=Betaine; dtxsid=DTXSID8022666; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8022666; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 >11179 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_1319; row=13475; data_type=In Vivo; mixture=Chemical; chemical_name=Betaine; preferred_name=Betaine; dtxsid=DTXSID8022666; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8022666; source_file=acute_oral.xlsx
NTP_ICE_acute_oral LD50 >11148 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_1316; row=13476; data_type=In Vivo; mixture=Chemical; chemical_name=Betaine; preferred_name=Betaine; dtxsid=DTXSID8022666; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8022666; source_file=acute_oral.xlsx
ToxValDB_EFSA 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA BMDL (05) =131 mg/kg bw/day Rat oral chronic; 52 weeks chronic LONG_REF=EFSA NDA (2017). Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97. doi:10.2903/j.efsa.2017.5057.; TITLE=Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97; AUTHOR=EFSA NDA; DOI=doi:10.2903/j.efsa.2017.5057; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=hematological; TOXICOLOGICAL_EFFECT_CATEGORY=hematology; STUDY_GROUP=EFSA:15613649: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_31dab85963f14ddfa5756e8b4c869860
ToxValDB_EFSA LEL =10000 mg/kg bw/day Pig oral subchronic; 6 weeks subchronic LONG_REF=EFSA FEEDAP (2013). Scientific Opinion on the safety and efficacy of betaine anhydrous as a feed additive for all animal species based on a dossier submitted by Trouw Nutritional International B.V. doi:10.2903/j.efsa.2013.3211.; TITLE=Scientific Opinion on the safety and efficacy of betaine anhydrous as a feed additive for all animal species based on a dossier submitted by Trouw Nutritional International B.V.; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2013.3211; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2013; ORIGINAL_YEAR=2013; TOXICOLOGICAL_EFFECT=clinical chemistry; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry; STUDY_GROUP=EFSA_dup_-_15613644_15613645_15613646: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_bcf9329aacac0bfdc03b0897cf2a93f9
ToxValDB_EFSA LEL =4000 mg/day Human oral chronic; 6 months clinical LONG_REF=EFSA NDA (2017). Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97. doi:10.2903/j.efsa.2017.5057.; TITLE=Safety of betaine as a novel food pursuant to Regulation (EC) No 258/97; AUTHOR=EFSA NDA; DOI=doi:10.2903/j.efsa.2017.5057; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15613647:-:--; 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_9da255f0fa2a42528f48f2c795746fab
ToxValDB_HESS 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_HESS NOEL <1 % Rat oral - subchronic STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/60da0df3e4b0a676289de990; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.nite.go.jp/en/chem/qsar/hess_update-e.html; TOXICOLOGICAL_EFFECT=Food Consumption: decrease|Urinalysis: Urine volume increase,pH decrease|Hematology: Plt increase, Fib increase|Blood Chemistry: Alp increase, Ca decrease, , LDH increase, gamma-GTP increase, Bil increase, TG increase|Relative Organ Weight: Ovary increase, Liver increase, , Spleen increase, Thymus increase, Adrenal decrease|Histopathology: Liver-Hepatocellular vacuolization; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|food and/or water consumption|hematology|nonneoplastic histopathology|organ weight|urinalysis; STUDY_GROUP=HESS:15638402:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_d499ac0d3920adbe4aae7aa6fd43c5a9
UnifiedCodex:CIR:beta.noael_studies 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 40 mg/kg/d rat oral - developmental toxicity SOURCE_SUBDIR=PRS650; REPORT_TITLE=Safety Assessment of Alkyl Betaines as Used in Cosmetics Christina L. Burnett1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks, Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS650; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=40; DOSE=es were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6.; LOAEL_VALUE=10 mg/kg/d; EFFECT=es were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6. Dermal reproductive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and inc...; CITATION=150; 300; 3,4,27; CITATION_NUMBERS=[150,300,3,4,27]; REFERENCE=150; 300; 3,4,27; DETAILS_JSON={"cas_number":"107-43-7","citation":"150; 300; 3,4,27","dose":"es were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6.","duration":"","effect":"es were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6. Dermal reproductive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and inc...","endpoint":"developmental toxicity","ingredient":"Alkyl Betaines","loael_value":"10 mg/kg/d","noael_unit":"mg/kg/d","noael_value":"40","page":7,"route":"oral","species":"rat","study_id":"PRS650_noael_002"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 20 mg/kg/d rat oral - developmental toxicity SOURCE_SUBDIR=PRS650; REPORT_TITLE=Safety Assessment of Alkyl Betaines as Used in Cosmetics Christina L. Burnett1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks, Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS650; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=20; DOSE=hanges in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6.; LOAEL_VALUE=10 mg/kg/d; EFFECT=hanges in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6. Dermal reproductive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betain...; CITATION=300; 3,4,27; 6; CITATION_NUMBERS=[300,3,4,27,6]; REFERENCE=300; 3,4,27; 6; DETAILS_JSON={"cas_number":"107-43-7","citation":"300; 3,4,27; 6","dose":"hanges in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6.","duration":"","effect":"hanges in the kidney and bladder) and 300 mg/kg bw/d (due to decreased food consump- tion, bw gain, and absolute bw), respectively.3,4,27 Reproductive and Developmental Toxicity Reproductive and developmental toxicity studies are summar- ized in Table 6. Dermal reproductive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betain...","endpoint":"developmental toxicity","ingredient":"Alkyl Betaines","loael_value":"10 mg/kg/d","noael_unit":"mg/kg/d","noael_value":"20","page":7,"route":"oral","species":"rat","study_id":"PRS650_noael_003"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 250 mg/kg/d rat oral 91-day repeated dose toxicity SOURCE_SUBDIR=PRS650; REPORT_TITLE=Safety Assessment of Alkyl Betaines as Used in Cosmetics Christina L. Burnett1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks, Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS650; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=250; DOSE=The LD50 values were 0.15 g/kg for cetyl betaine and 0.053 g/kg for lauryl betaine in an intraperitoneal study in rats.3-5,25 Repeated Dose Toxicity Repeated dose toxicity data are summarized in Table 5.; EFFECT=g/kg for lauryl betaine. The intravenous LD50 of betaine in mice has been reported to be 0.83 g/kg body weight (bw). The LD50 values were 0.15 g/kg for cetyl betaine and 0.053 g/kg for lauryl betaine in an intraperitoneal study in rats.3-5,25 Repeated Dose Toxicity Repeated dose toxicity data are summarized in Table 5. No effects were observed at the highest dose tested for betaine in rats. No significant toxic effects were observed in rats that received up to 0.35 g/kg/d cetyl betaine in a 91-day oral study. The no observed effect level (NOEL) for coco-betaine was 250 mg/kg/d and the lowest observed effect level (LOEL) was 500 mg/kg/d in a 90-day oral study in rats when tested up to 500 mg/kg/d. In a study of C12 to C14 alkyldimethyl betaines, systemic no observed adverse effects levels (NOAELs) were 50 and 100 mg/kg bw/d in oral rat studies that tested the mate- rial up to 300 and 1,000 mg/kg/d, respectively. The systemic lowest observed adverse effects levels (LOAELs) for these 2 studies were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic ch...; CITATION=0; 83; 15; CITATION_NUMBERS=[83,15]; REFERENCE=0; 83; 15; DETAILS_JSON={"cas_number":"107-43-7","citation":"0; 83; 15","dose":"The LD50 values were 0.15 g/kg for cetyl betaine and 0.053 g/kg for lauryl betaine in an intraperitoneal study in rats.3-5,25 Repeated Dose Toxicity Repeated dose toxicity data are summarized in Table 5.","duration":"91-day","effect":"g/kg for lauryl betaine. The intravenous LD50 of betaine in mice has been reported to be 0.83 g/kg body weight (bw). The LD50 values were 0.15 g/kg for cetyl betaine and 0.053 g/kg for lauryl betaine in an intraperitoneal study in rats.3-5,25 Repeated Dose Toxicity Repeated dose toxicity data are summarized in Table 5. No effects were observed at the highest dose tested for betaine in rats. No significant toxic effects were observed in rats that received up to 0.35 g/kg/d cetyl betaine in a 91-day oral study. The no observed effect level (NOEL) for coco-betaine was 250 mg/kg/d and the lowest observed effect level (LOEL) was 500 mg/kg/d in a 90-day oral study in rats when tested up to 500 mg/kg/d. In a study of C12 to C14 alkyldimethyl betaines, systemic no observed adverse effects levels (NOAELs) were 50 and 100 mg/kg bw/d in oral rat studies that tested the mate- rial up to 300 and 1,000 mg/kg/d, respectively. The systemic lowest observed adverse effects levels (LOAELs) for these 2 studies were 150 (due to increased salivation, increased urea, and nonneoplastic histopathologic ch...","endpoint":"repeated dose toxicity","ingredient":"Alkyl Betaines","loael_value":"","noael_unit":"mg/kg/d","noael_value":"250","page":7,"route":"oral","species":"rat","study_id":"PRS650_noael_001"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 150 mg/kg rat oral 104-week repeated dose toxicity SOURCE_SUBDIR=PRS650; REPORT_TITLE=Safety Assessment of Alkyl Betaines as Used in Cosmetics Christina L. Burnett1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks, Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS650; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=150; DOSE=ive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established.; LOAEL_VALUE=10 mg/kg/d; EFFECT=ive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betaines study determined the reproductive NOAEL to be 300 mg/kg/d when the test material was tested up to 1,000 mg/kg/d.4,28,29 Carcinogenicity Repeated dose toxicity results are presented in Table 5. Betaine was not carcinogenic when tested up to 5% in a 104-week dietary rat...; CITATION=10; 40; 20; CITATION_NUMBERS=[10,40,20]; REFERENCE=10; 40; 20; DETAILS_JSON={"cas_number":"107-43-7","citation":"10; 40; 20","dose":"ive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established.","duration":"104-week","effect":"ive and developmental toxi- city studies of cetyl betaine in rabbits determined the maternal LOAEL to be 10 mg/kg/d due to decreased bw gain and a maternal NOAEL could not be established. The developmental LOAEL was 40 mg/kg/d and the developmental NOAEL was 20 mg/kg/d. In oral reproductive and developmental toxicity studies of cetyl betaine in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betaines study determined the reproductive NOAEL to be 300 mg/kg/d when the test material was tested up to 1,000 mg/kg/d.4,28,29 Carcinogenicity Repeated dose toxicity results are presented in Table 5. Betaine was not carcinogenic when tested up to 5% in a 104-week dietary rat...","endpoint":"repeated dose toxicity","ingredient":"Alkyl Betaines","loael_value":"10 mg/kg/d","noael_unit":"mg/kg","noael_value":"150","page":7,"route":"oral","species":"rat","study_id":"PRS650_noael_004"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 300 mg/kg/d rat oral 104-week repeated dose toxicity SOURCE_SUBDIR=PRS650; REPORT_TITLE=Safety Assessment of Alkyl Betaines as Used in Cosmetics Christina L. Burnett1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks, Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS650; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=300; DOSE=in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated.; LOAEL_VALUE=50 mg/kg d; EFFECT=in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betaines study determined the reproductive NOAEL to be 300 mg/kg/d when the test material was tested up to 1,000 mg/kg/d.4,28,29 Carcinogenicity Repeated dose toxicity results are presented in Table 5. Betaine was not carcinogenic when tested up to 5% in a 104-week dietary rat study.3 34S International Journal of Toxicology 37(Supplement 1); CITATION=50; 250; 150; CITATION_NUMBERS=[50,250,150]; REFERENCE=50; 250; 150; DETAILS_JSON={"cas_number":"107-43-7","citation":"50; 250; 150","dose":"in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated.","duration":"104-week","effect":"in rats, the LOAEL for the dams was 50 mg/kg due to decreased bw gain and a maternal NOAEL could not be calculated. The developmental LOAEL was 250 mg/kg and the developmental NOAEL was 150 mg/kg. In an oral C12 to C14 alkyldimethyl betaines study, the repro- ductive NOEL was 150 mg/kg bw/d and the reproductive LOAEL was 300 mg/kg bw/d due to decreased pup weight and litter size and increased postimplantation loss and postnatal loss. Another oral C12 to C14 alkyldimethyl betaines study determined the reproductive NOAEL to be 300 mg/kg/d when the test material was tested up to 1,000 mg/kg/d.4,28,29 Carcinogenicity Repeated dose toxicity results are presented in Table 5. Betaine was not carcinogenic when tested up to 5% in a 104-week dietary rat study.3 34S International Journal of Toxicology 37(Supplement 1)","endpoint":"repeated dose toxicity","ingredient":"Alkyl Betaines","loael_value":"50 mg/kg d","noael_unit":"mg/kg/d","noael_value":"300","page":7,"route":"oral","species":"rat","study_id":"PRS650_noael_005"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity >5771 mg/kg bw/d rat oral 28-day repeated dose toxicity SOURCE_SUBDIR=PRS650; REPORT_TITLE=Safety Assessment of Alkyl Betaines as Used in Cosmetics Christina L. Burnett1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks, Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS650; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=> 5,771; DOSE=Repeated Dose Toxicity in Animals.; EFFECT=Table 5. Repeated Dose Toxicity in Animals. Ingredient and concentration/dose Method Results/conclusions References Betaine >95% pure; doses ¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided; GLP compliant NOAEL >5,771 mg/kg bw/d; NOEL could not be derived due to high tolerance and reversibility of slight to moderate hepatocellular vacuolation effects in rats 3 Betaine >95% pure; tested up to 5% in animal feed OECD Guideline 408 for repeated dose 90-day oral toxicity in male and female Sprague Dawley rats; 20 rats of each sex per dose; GLP compliant NOAEL and NOEL could not be determined due to high tolerance, slight hematology, and hepatic changes that included increased liver weights, hepatocellular vacuolation, but no microscopic evidence of hepatotoxicity; no significant systemic signs of toxicity were observed in any treatment group d; CITATION=5; 95; 0; CITATION_NUMBERS=[5,95]; REFERENCE=5; 95; 0; DETAILS_JSON={"cas_number":"107-43-7","citation":"5; 95; 0","dose":"Repeated Dose Toxicity in Animals.","duration":"28-day","effect":"Table 5. Repeated Dose Toxicity in Animals. Ingredient and concentration/dose Method Results/conclusions References Betaine >95% pure; doses ¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided; GLP compliant NOAEL >5,771 mg/kg bw/d; NOEL could not be derived due to high tolerance and reversibility of slight to moderate hepatocellular vacuolation effects in rats 3 Betaine >95% pure; tested up to 5% in animal feed OECD Guideline 408 for repeated dose 90-day oral toxicity in male and female Sprague Dawley rats; 20 rats of each sex per dose; GLP compliant NOAEL and NOEL could not be determined due to high tolerance, slight hematology, and hepatic changes that included increased liver weights, hepatocellular vacuolation, but no microscopic evidence of hepatotoxicity; no significant systemic signs of toxicity were observed in any treatment group d","endpoint":"repeated dose toxicity","ingredient":"Alkyl Betaines","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"> 5,771","page":9,"route":"oral","species":"rat","study_id":"PRS650_noael_006"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 5 % rat oral 28-day repeated dose toxicity SOURCE_SUBDIR=PRS650; REPORT_TITLE=Safety Assessment of Alkyl Betaines as Used in Cosmetics Christina L. Burnett1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks, Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS650; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=5; DOSE=¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided;; EFFECT=¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided; GLP compliant NOAEL >5,771 mg/kg bw/d; NOEL could not be derived due to high tolerance and reversibility of slight to moderate hepatocellular vacuolation effects in rats 3 Betaine >95% pure; tested up to 5% in animal feed OECD Guideline 408 for repeated dose 90-day oral toxicity in male and female Sprague Dawley rats; 20 rats of each sex per dose; GLP compliant NOAEL and NOEL could not be determined due to high tolerance, slight hematology, and hepatic changes that included increased liver weights, hepatocellular vacuolation, but no microscopic evidence of hepatotoxicity; no significant systemic signs of toxicity were observed in any treatment group during dosing 3 Betaine >99.9% pure; tested up to 5% in animal feed for both chronic and carcinogenicity studies OECD Guideline 453 for combined chronic toxicity/carcinogenicity studies in male and female Fischer 344 rats; 52-week study had 10 rats of each sex per dose; 104-week stud...; CITATION=0; 1; 2; CITATION_NUMBERS=[1,2]; REFERENCE=0; 1; 2; DETAILS_JSON={"cas_number":"107-43-7","citation":"0; 1; 2","dose":"¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided;","duration":"28-day","effect":"¼ 0%, 1%, 2%, and 5% in animal feed OECD Guideline 407 for repeated dose 28-day oral toxicity in female Sprague Dawley rats; number per dose not provided; GLP compliant NOAEL >5,771 mg/kg bw/d; NOEL could not be derived due to high tolerance and reversibility of slight to moderate hepatocellular vacuolation effects in rats 3 Betaine >95% pure; tested up to 5% in animal feed OECD Guideline 408 for repeated dose 90-day oral toxicity in male and female Sprague Dawley rats; 20 rats of each sex per dose; GLP compliant NOAEL and NOEL could not be determined due to high tolerance, slight hematology, and hepatic changes that included increased liver weights, hepatocellular vacuolation, but no microscopic evidence of hepatotoxicity; no significant systemic signs of toxicity were observed in any treatment group during dosing 3 Betaine >99.9% pure; tested up to 5% in animal feed for both chronic and carcinogenicity studies OECD Guideline 453 for combined chronic toxicity/carcinogenicity studies in male and female Fischer 344 rats; 52-week study had 10 rats of each sex per dose; 104-week stud...","endpoint":"repeated dose toxicity","ingredient":"Alkyl Betaines","loael_value":"","noael_unit":"%","noael_value":"5","page":9,"route":"oral","species":"rat","study_id":"PRS650_noael_007"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 50 mg/kg bw/d rat oral - repeated dose toxicity SOURCE_SUBDIR=PRS650; REPORT_TITLE=Safety Assessment of Alkyl Betaines as Used in Cosmetics Christina L. Burnett1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks, Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS650; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=50; DOSE=tative effects observed in the forestomach of mid- and high-dose group, possibly due to gavage dosing.; LOAEL_VALUE=150 mg/kg bw/d; EFFECT=tative effects observed in the forestomach of mid- and high-dose group, possibly due to gavage dosing. No adverse effects on reproductive organs noted in microscopic or macroscopic examinations 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 50, 150, and 300 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test in male and female Wistar rats; 10 rats of each sex per dose; GLP compliant NOAEL (systemic) ¼ 50 mg/kg bw/d; LOAEL (systemic) ¼ 150 mg/kg bw/d due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder; NOEL (reproduction) ¼ 150 mg/kg bw/ d; LOAEL (reproduction) ¼ 300 mg/kg bw/d due to pup weight, litter size, postimplantation loss, and postnatal loss 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 33, 100, 300, and 1,000 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity sc...; CITATION=4; 0, 50, 150; 300; CITATION_NUMBERS=[4,50,150,300]; REFERENCE=4; 0, 50, 150; 300; DETAILS_JSON={"cas_number":"107-43-7","citation":"4; 0, 50, 150; 300","dose":"tative effects observed in the forestomach of mid- and high-dose group, possibly due to gavage dosing.","duration":"","effect":"tative effects observed in the forestomach of mid- and high-dose group, possibly due to gavage dosing. No adverse effects on reproductive organs noted in microscopic or macroscopic examinations 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 50, 150, and 300 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test in male and female Wistar rats; 10 rats of each sex per dose; GLP compliant NOAEL (systemic) ¼ 50 mg/kg bw/d; LOAEL (systemic) ¼ 150 mg/kg bw/d due to increased salivation, increased urea, and nonneoplastic histopathologic changes in the kidney and bladder; NOEL (reproduction) ¼ 150 mg/kg bw/ d; LOAEL (reproduction) ¼ 300 mg/kg bw/d due to pup weight, litter size, postimplantation loss, and postnatal loss 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 33, 100, 300, and 1,000 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity sc...","endpoint":"repeated dose toxicity","ingredient":"Alkyl Betaines","loael_value":"150 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"50","page":9,"route":"oral","species":"rat","study_id":"PRS650_noael_008"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 100 mg/kg bw/d rat oral - repeated dose toxicity SOURCE_SUBDIR=PRS650; REPORT_TITLE=Safety Assessment of Alkyl Betaines as Used in Cosmetics Christina L. Burnett1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks, Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS650; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=100; DOSE=NOEL (reproduction) ¼ 150 mg/kg bw/ d;; LOAEL_VALUE=300 mg/kg bw/d; EFFECT=anges in the kidney and bladder; NOEL (reproduction) ¼ 150 mg/kg bw/ d; LOAEL (reproduction) ¼ 300 mg/kg bw/d due to pup weight, litter size, postimplantation loss, and postnatal loss 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 33, 100, 300, and 1,000 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test in male and female Wistar rats; 3 rats of each sex per dose; not GLP compliant NOAEL (systemic) ¼ 100 mg/kg bw/d; LOAEL (systemic) ¼ 300 mg/kg bw/d due to decreased food consumption, bw gain, and absolute bw; no reproductive results reported due to small group sizes 4 Abbreviations: bw, body weight; GLP, Good Laboratory Practice; LOAEL, lowest observed adverse effects level; LOEL, lowest observed effect level; OECD, Organization for Economic Cooperation and Development; NOAEL, no observed adverse effects level; NOEL, no observed effect level. 36S International Journal of Toxicology 37(Supplement 1); CITATION=150; 300; 4; CITATION_NUMBERS=[150,300,4]; REFERENCE=150; 300; 4; DETAILS_JSON={"cas_number":"107-43-7","citation":"150; 300; 4","dose":"NOEL (reproduction) ¼ 150 mg/kg bw/ d;","duration":"","effect":"anges in the kidney and bladder; NOEL (reproduction) ¼ 150 mg/kg bw/ d; LOAEL (reproduction) ¼ 300 mg/kg bw/d due to pup weight, litter size, postimplantation loss, and postnatal loss 4 Betaines, C12-C14-alkyldimethyl (a mixture of lauryl betaine and myristyl betaine) in water at 0, 33, 100, 300, and 1,000 mg/kg bw/d OECD Guideline 422 for combined repeated dose oral toxicity study with reproduction/developmental toxicity screening test in male and female Wistar rats; 3 rats of each sex per dose; not GLP compliant NOAEL (systemic) ¼ 100 mg/kg bw/d; LOAEL (systemic) ¼ 300 mg/kg bw/d due to decreased food consumption, bw gain, and absolute bw; no reproductive results reported due to small group sizes 4 Abbreviations: bw, body weight; GLP, Good Laboratory Practice; LOAEL, lowest observed adverse effects level; LOEL, lowest observed effect level; OECD, Organization for Economic Cooperation and Development; NOAEL, no observed adverse effects level; NOEL, no observed effect level. 36S International Journal of Toxicology 37(Supplement 1)","endpoint":"repeated dose toxicity","ingredient":"Alkyl Betaines","loael_value":"300 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"100","page":9,"route":"oral","species":"rat","study_id":"PRS650_noael_009"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 3SCV180C9W UNII - - - chemical {"approval_status":null,"molecular_formula":"C5H11NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3SCV180C9W"}
openFDA substances FDA UNII substance identifier 3SCV180C9W UNII - - - chemical {"approval_status":null,"molecular_formula":"C5H11NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3SCV180C9W"}
openFDA substances FDA UNII substance identifier 3SCV180C9W UNII - - - chemical {"approval_status":null,"molecular_formula":"C5H11NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3SCV180C9W"}
openFDA substances FDA UNII substance identifier 3SCV180C9W UNII - - - chemical {"approval_status":null,"molecular_formula":"C5H11NO2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"3SCV180C9W"}