NOAEL Studies Cosmetic Ingredient

PEG-15 Cocamine NOAEL Studies

INCI: PEG-15 COCAMINE

CAS: 61791-14-8

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 68 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR_vision_codex NOAEL =1 ppm rat oral 28 days reproductive toxicity {"citation":"1,500; 4,500; 500","dose":"he 1,500 ppm group exhib- ited similar effects, although to a lesser degree than observed in the 4,500 ppm group.","effect":"he 1,500 ppm group exhib- ited similar effects, although to a lesser degree than observed in the 4,500 ppm group. Body weight gain was decreased in both the 1,500 ppm group and the 4,500 ppm group, which was attributed to the reduced palatability of the diets. No clinical effects were noted at any dietary concentration less than 4,500 ppm, and no definite hematological abnormality, differences in organ weights, or abnormalities of the reproductive organs were found at any dietary concentration tested. The reported no-observed-effect level (NOEL) was 500 ppm (about 50 mg/kg/d) and the lowest-observed-effect level (LOEL) was 1,500 ppm in this study. Four groups of 40 Crl:CD(SD)BR rats (20 males and 20 females) were fed diets, ad libitum, containing PEG-2 tallow amine at concentrations of 0%, 0.001%, 0.015%, or 0.5% (wt/wt) for 28 days or until necropsy.4,5,9,13,29 The test substance was added to the diets as 1% solutions in corn oil. All animals were examined at least once every day for overt toxi- city or behavioral changes, individual body weights and group food consumption were r...","page":23,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_001"}
CIR_vision_codex NOAEL =0.015 % dog oral 90 days repeated dose toxicity {"citation":"0; 5; 015","dose":"The no-observed- adverse-effect level (NOAEL) was estimated to be 0.015% (approximately 12 mg/kg/d), based on body weight gain.","effect":"loss observed across all groups was not considered to be treatment related. Body weight gain was slightly decreased in males and females at 0.5% and in males at 0.015% in the diet. Feed con- sumption, hematology, and organ weights were not statistically different from controls. Histiocytosis (ie, aggregations of macro- phages with foamy cytoplasm) in the jejunum and mesenteric lymph node in the 0.5% group was the only treatment-related histopathological finding in this study. The no-observed- adverse-effect level (NOAEL) was estimated to be 0.015% (approximately 12 mg/kg/d), based on body weight gain. Groups of 4 male and female Beagle dogs were fed diets (ad libitum) containing PEG-2 tallow amine at concentrations cor- responding to doses of 0, 13, 40, and 120 mg/kg/d for 90 days.4,5,9 Body weights were recorded at the beginning of the treatment period and weekly thereafter. Hemoglobin concen- trations, packed cell volumes, white cell counts, and differen- tial white cell counts were measured before initiating treatment and immediately before sacrificing the animals at the end of...","page":23,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_002"}
CIR_vision_codex NOAEL =13 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"13; 50; 2","dose":"The NOEL was reported to be 13 mg/kg/d, and the LOEL was 50 mg/kg/d.","effect":". The liver, heart, lung, adrenals, kid- neys, spleen, thyroid, testes, epididymides, brain, and pituitary glands were weighed when the animals were necropsied. Rep- resentative sections were collected for microscopic examina- tion of the brain (cerebrum, cerebellum, and medulla), spinal cord, pituitary, submaxillary gland, thyroid, thymus, heart, lung, aorta, stomach, duodenum, jejunum, ileum, colon, liver, spleen, kidney, urinary bladder, adrenal, ovary and uterus or testes and epididymis, and sciatic nerve. The NOEL was reported to be 13 mg/kg/d, and the LOEL was 50 mg/kg/d. No other findings of this study were presented. Polyethylene glycol 2 C13-C15 alkyl amine. PEG-2 C13-C15 alkyl amine was tested in rats in a 90-day oral repeated-dose toxicity study.10 The PEG-2 C13-C15 alkyl amine is not 32S International Journal of Toxicology 37(Supplement 2)","page":23,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_003"}
CIR_vision_codex NOAEL =15 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"150; 30; 15","dose":"statistically signifi- cant elevations in mean platelet, white blood cell, segmented neutrophil, and lymphocyte counts in the 150 mg/kg/d group.","effect":"statistically signifi- cant elevations in mean platelet, white blood cell, segmented neutrophil, and lymphocyte counts in the 150 mg/kg/d group. The inflammation observed in the lungs was attributed to inad- vertent aspiration following gavage. Desquamation and altera- tion of the mucosa of the nonglandular stomach was observed primarily in rats of the 150 mg/kg/d group, but also in some rats of the 30 mg/kg/d. Two females in the 150 mg/kg/d group had suppurative inflammation of the glandular stomach. The reported NOAEL was 15 mg/kg/d, and the lowest-observed- adverse-effect level (LOAEL) was 30 mg/kg/d in this study. Polyethylene glycol 15 tallow amine. In a 90-day oral toxicity study, PEG-15 tallow amine was administered in the diet ad libitum to 3 groups of 10 male and 10 female Sprague Dawley rats.10 The concentrations of the test substance in the test diets were approximately 500, 1,500, or 4,500 ppm (equivalent to about 33, 99, and 292 mg/kg/d for males, respectively, and 40, 123, and 357 mg/kg/d for females, respectively). The control group received the basal diet. Exposure...","page":24,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_004"}
CIR_vision_codex NOAEL =500 ppm rat oral 28-day oral toxicity {"citation":"500; (33; 40","dose":"There were no treatment-related gross or histopathological findings or statistically significant effects on body weight, body weight gain, food consumption, hematological and clinical chemistry parameters, or organ weights at 500 ppm.","effect":"aled inflammatory changes in the digestive tract, including hypertrophy and vacuolation of his- tiocytes in the lamina propria of the ileum and jejunum, sinus histiocytosis, and accumulation of macrophage aggregates in the cortex and medullary cords of the mesenteric lymph nodes. There were no treatment-related gross or histopathological findings or statistically significant effects on body weight, body weight gain, food consumption, hematological and clinical chemistry parameters, or organ weights at 500 ppm. The NOAEL was 500 ppm (33-40 mg/kg/d) and the LOAEL was 1,500 ppm (99-123 mg/kg/d) in this study. POE-5/POP-12 tallow amine. POE-5/POP-12 tallow amine was tested in rats in a 28-day oral repeated-dose toxicity study.10 This substance is not identified as a cosmetic ingredi- ent in the INCI Dictionary. However, POE-5/POP-12 tallow amine is a likely analog for PEGs cocamine and related ingre- dients in a read-across assessment. Groups of 5 male and 5 female CD rats received 0, 15, 75, or 200 mg/kg/d POE-5/ POP-12 tallow amine by gavage for 28 days. There were no unscheduled de...","page":24,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_005"}
CIR_vision_codex NOAEL =300 ppm rat oral - developmental toxicity {"citation":"300; (23; 16","dose":"The NOAEL was 300 ppm (23-16 mg/kg/d) for parental and developmental effects and 2,000 ppm for repro- ductive effects in this study.","effect":"or 300 ppm. The NOAEL was 300 ppm (23-16 mg/kg/d) for parental and developmental effects and 2,000 ppm for repro- ductive effects in this study. The LOAEL was 2,000 ppm for parental and developmental effects. Polyethylene Glycol 15 Tallow Amine In a developmental toxicity study, groups of 25 female Charles River Crl:CDBr rats received 0 (corn oil only), 15, 100, or 300 mg/kg/d PEG-15 tallow amine by gavage from days 6 through 15 of gestation.10 Developmental parameters measured included numbers of viable fetuses, early and late resorptions, total implantations, total corpora lutea, and the sex and weight of the fetuses. The fetuses were examined for ext","page":26,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_006"}
CIR_vision_codex NOAEL =100 mg/kg/d rat oral 70 days developmental toxicity {"citation":"15; 100; 300","dose":"No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups.","effect":"had vertebral anomalies. These effects were not considered to be treatment related because situs inver- sus was seen also in one of the control fetuses, and the inci- dences of all of the other effects were within the ranges of historical controls. No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups. Several skeletal varia- tions of the sternebrae and ribs were observed in the fetuses of these groups, as well as in the control group, and were not considered to be treatment related. The maternal NOAEL was 100 mg/kg/d and the developmental NOAEL and maternal LOAEL was 300 mg/kg/d in this study. In a 2-generation DART screening study, groups of 40 CD (Sprague-Dawley) rats (20 males and 20 females per group) were fed a diet containing 100, 300, or 1,000 ppm PEG-15 tallow amine, and a similar group of control rats received the basal diet only.10 The parental animals of the first generation (F0) were exposed to the test substance for at least 70 days before mating, and exposure continued until these animals were sacrificed; female F0 rats were sacrificed on PND 21 of...","page":26,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_007"}
CIR_vision_codex NOAEL =1000 ppm - - - developmental toxicity {"citation":"1,000; (65; 66","dose":"The NOAEL for systemic effects and the LOAEL for developmental and reproductive effects was 1,000 ppm (65- 66 mg/kg/d), and the NOAEL for developmental and reproduc- tive effects was 300 ppm (15-17 mg/kg/d) in this study.","effect":"in the F0 females and F1 litters, including litter loss, increased mean number of unaccounted-for implantation sites, decreased mean number of pups born, live litter size, and postnatal sur- vival. These effects were observed only in a small number of litters, were not always statistically significant, and were not observed in the F2 litters. However, the statistically significant increase in the mean number of unaccounted-for implantation sites exceeded the maximum mean of laboratory historical control data. The NOAEL for systemic effects and the LOAEL for developmental and reproductive effects was 1,000 ppm (65- 66 mg/kg/d), and the NOAEL for developmental and reproduc- tive effects was 300 ppm (15-17 mg/kg/d) in this study. Genotoxicity PEG-15 Cocamine was tested for mutagenicity using the paper- disk method. Nutrient agar was seeded with streptomycin- dependent Sd-4-73 Escherichia coli and filter paper disks con- taining PEG-15 cocamine were placed on the surface of the cultures. The frequency of reversion from streptomycin depen- dence to independence was used as the measure...","page":26,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_009"}
CIR_vision_codex NOAEL =23 mg/kg/d rat oral 72 days repeated dose toxicity {"citation":"12; 1; 2","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen:","effect":"Table 12. Analog Group 1: PEG-2 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_010"}
CIR_vision_codex NOAEL =134 mg/kg/d rat oral 72 days repeated dose toxicity {"citation":"12; 1; 2","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen:","effect":"able 12. Analog Group 1: PEG-2 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOE...","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_011"}
CIR_vision_codex NOAEL =50 mg/kg/d rat oral 72 days repeated dose toxicity {"citation":"2, 8, 23, 134; 3, 9, 26, 148; 69","dose":"2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days.","effect":"No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOEL ¼ 12 mg/kg/d (based on body weight gain) or 40 mg/kg/d (based on histiocytosis). Food consumption in all treated groups similar to control. Small decrease in body weight gain in mid-dose males and high-dose males and females; h...","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_012"}
CIR_vision_codex NOAEL =12 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"23; 10; 2","dose":"AEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test:","effect":"AEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOEL ¼ 12 mg/kg/d (based on body weight gain) or 40 mg/kg/d (based on histiocytosis). Food consumption in all treated groups similar to control. Small decrease in body weight gain in mid-dose males and high-dose males and females; histiocytosis in small intestine and mesenteric lymph nodes at high dose No data 9,12,13 Dog 90-day oral study. 13, 40, or 120 mg/kg/d via diet; NOEL ¼ 13 mg/kg/d. Palatability issues at mid and high dose. GI clinical signs at mid and high dose (vomiting); histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-...","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_013"}
CIR_vision_codex NOAEL =30 mg/kg/d rat oral 28-day repeated dose toxicity {"citation":"28; 0; 1","dose":"histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-day percutaneous study.","effect":"histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-day percutaneous study. 0.1% or 0.5% aqueous dispersion (2 or 10 mg/kg/d), 5 d/wk for 4 weeks. Slight to moderate skin irritation at both concentrations; no evidence of systemic toxicity PEG-2 C13-C15 alkyl amine 70955-14-5 13-15 2 No data Rat 90-day oral study. 15, 30, or 150 mg/kg/d via gavage; NOAEL ¼ 15 mg/kg/d. Macro and microscopic changes in nonglandular stomach Dog 90-day oral study. 15, 30, or 100 mg/kg/d via capsule; NOAEL ¼ 30 mg/kg/d. GI clinical signs: increased alanine aminotransferase (ALT) females only; increased pigment accumulation in Kupffer cells and bile canaliculi females only 10 PEG-4 cocamine 61791-14-8 8-16 4 No data No data No data - Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 50S","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_014"}
CIR_vision_codex NOAEL =33 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"14; 3; 10","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data - Analogs PEG-8 stearamine 26635-92-7 16-18 8 Ames test:","effect":"performance at doses that were Table 14. Analog Group 3: PEG-10 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data - Analogs PEG-8 stearamine 26635-92-7 16-18 8 Ames test: (\u0006) No data No data 9,11 PEG-15 tallow amine 61791-26-2 16-18 15 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 33, 99, and 292 mg/kg/d via diet; NOEL ¼ 33 mg/kg/d. GI irritation (hypertrophy and vacuolation of histiocytes in the lamina propria of the small intestine); histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat developmental toxicity test. 15, 100, or 300 mg/kg/d via gavage on GD 6-15; NOAEL ¼ 300 mg/kg/d (highest dose tested); maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen. 100, 300, or 1000 ppm in diet. Reproductive/developmental NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased litter size, and postnatal survival 10 POE-5/POP-12 tallow amine 68213...","page":43,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_015"}
CIR_vision_codex NOAEL =5 mg/kg/d rat oral 4-week developmental toxicity {"citation":"100; 2; 100, 300","dose":"maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen.","effect":"maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen. 100, 300, or 1000 ppm in diet. Reproductive/developmental NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased litter size, and postnatal survival 10 POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study: 15, 75, or 200 mg/kg/d via gavage. NOAEL ¼ 75 mg/kg/d; decreased body weight gain and food consumption at high dose No data 10 PEG-4 cocamine 61791-14-8 8-16 4 No data No data No data - Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 52S International Journal of Toxicology 37(Supplement 2) 52S","page":43,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_016"}
CIR_vision_codex NOAEL =75 mg/kg/d rat oral 4-week repeated dose toxicity {"citation":"15; 4; 14","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-15 cocamine 61491-14-8 8-16 15 No data No data No data – Analogs PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data – POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study.","effect":"Table 15. Analog Group 4: PEG-15 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-15 cocamine 61491-14-8 8-16 15 No data No data No data – Analogs PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data – POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study. 15, 75, or 200 mg/kg/d via gavage. NOAEL ¼ 75 mg/kg/d. Decreased body weight gain and food consumption No data 10 PEG-8 stearamine 26635-92-7 16-18 8 Ames test: (\u0006) No data No data 9,11 PEG-15 tallow amine 61791-26-2 16-18 15 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 33, 99, and 292 mg/kg/d via diet. NOEL ¼ 33 mg/kg/d. GI irritation, histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat developmental toxicity study: 15, 100, or 300 mg/ kg/d via gavage on gestation days 6-15. NOAEL 300 ¼ mg/kg/d Rat 2-generation DART study. NOAEL ¼ 15 mg/kg/ d; NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased lit","page":44,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_017"}
CIR_vision_codex NOAEL =40 mg/kg/d mouse - 28-day NOAEL study {"citation":"9; 28; 10","dose":"10% aqueous dispersion, reduced to 2% aqueous dispersion after 2 treatments (200 mg/kg/d reduced to 40 mg/kg/d), 5 d/wk for 4 weeks.","effect":"S-9 In vivo mouse chromosome aberration test: (\u0006) Rabbit 28-day percutaneous study: 10% aqueous dispersion, reduced to 2% aqueous dispersion after 2 treatments (200 mg/kg/d reduced to 40 mg/kg/d), 5 d/wk for 4 weeks. Severe skin irritation at 10% leading to reduction in concentration to 2%. No evidence of systemic toxicity Rabbit 28-day percutaneous study: 2% aqueous dispersion (40 mg/kg/d), 5 d/wk for 4 weeks. Severe skin irritation. No evidence of systemic toxicity No data 9 Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 53S","page":44,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_018"}
CIR_vision_codex NOAEL =1 ppm rat oral 28 days reproductive toxicity {"citation":"1,500; 4,500; 500","dose":"he 1,500 ppm group exhib- ited similar effects, although to a lesser degree than observed in the 4,500 ppm group.","effect":"he 1,500 ppm group exhib- ited similar effects, although to a lesser degree than observed in the 4,500 ppm group. Body weight gain was decreased in both the 1,500 ppm group and the 4,500 ppm group, which was attributed to the reduced palatability of the diets. No clinical effects were noted at any dietary concentration less than 4,500 ppm, and no definite hematological abnormality, differences in organ weights, or abnormalities of the reproductive organs were found at any dietary concentration tested. The reported no-observed-effect level (NOEL) was 500 ppm (about 50 mg/kg/d) and the lowest-observed-effect level (LOEL) was 1,500 ppm in this study. Four groups of 40 Crl:CD(SD)BR rats (20 males and 20 females) were fed diets, ad libitum, containing PEG-2 tallow amine at concentrations of 0%, 0.001%, 0.015%, or 0.5% (wt/wt) for 28 days or until necropsy.4,5,9,13,29 The test substance was added to the diets as 1% solutions in corn oil. All animals were examined at least once every day for overt toxi- city or behavioral changes, individual body weights and group food consumption were r...","page":23,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_001"}
CIR_vision_codex NOAEL =0.015 % dog oral 90 days repeated dose toxicity {"citation":"0; 5; 015","dose":"The no-observed- adverse-effect level (NOAEL) was estimated to be 0.015% (approximately 12 mg/kg/d), based on body weight gain.","effect":"loss observed across all groups was not considered to be treatment related. Body weight gain was slightly decreased in males and females at 0.5% and in males at 0.015% in the diet. Feed con- sumption, hematology, and organ weights were not statistically different from controls. Histiocytosis (ie, aggregations of macro- phages with foamy cytoplasm) in the jejunum and mesenteric lymph node in the 0.5% group was the only treatment-related histopathological finding in this study. The no-observed- adverse-effect level (NOAEL) was estimated to be 0.015% (approximately 12 mg/kg/d), based on body weight gain. Groups of 4 male and female Beagle dogs were fed diets (ad libitum) containing PEG-2 tallow amine at concentrations cor- responding to doses of 0, 13, 40, and 120 mg/kg/d for 90 days.4,5,9 Body weights were recorded at the beginning of the treatment period and weekly thereafter. Hemoglobin concen- trations, packed cell volumes, white cell counts, and differen- tial white cell counts were measured before initiating treatment and immediately before sacrificing the animals at the end of...","page":23,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_002"}
CIR_vision_codex NOAEL =13 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"13; 50; 2","dose":"The NOEL was reported to be 13 mg/kg/d, and the LOEL was 50 mg/kg/d.","effect":". The liver, heart, lung, adrenals, kid- neys, spleen, thyroid, testes, epididymides, brain, and pituitary glands were weighed when the animals were necropsied. Rep- resentative sections were collected for microscopic examina- tion of the brain (cerebrum, cerebellum, and medulla), spinal cord, pituitary, submaxillary gland, thyroid, thymus, heart, lung, aorta, stomach, duodenum, jejunum, ileum, colon, liver, spleen, kidney, urinary bladder, adrenal, ovary and uterus or testes and epididymis, and sciatic nerve. The NOEL was reported to be 13 mg/kg/d, and the LOEL was 50 mg/kg/d. No other findings of this study were presented. Polyethylene glycol 2 C13-C15 alkyl amine. PEG-2 C13-C15 alkyl amine was tested in rats in a 90-day oral repeated-dose toxicity study.10 The PEG-2 C13-C15 alkyl amine is not 32S International Journal of Toxicology 37(Supplement 2)","page":23,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_003"}
CIR_vision_codex NOAEL =15 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"150; 30; 15","dose":"statistically signifi- cant elevations in mean platelet, white blood cell, segmented neutrophil, and lymphocyte counts in the 150 mg/kg/d group.","effect":"statistically signifi- cant elevations in mean platelet, white blood cell, segmented neutrophil, and lymphocyte counts in the 150 mg/kg/d group. The inflammation observed in the lungs was attributed to inad- vertent aspiration following gavage. Desquamation and altera- tion of the mucosa of the nonglandular stomach was observed primarily in rats of the 150 mg/kg/d group, but also in some rats of the 30 mg/kg/d. Two females in the 150 mg/kg/d group had suppurative inflammation of the glandular stomach. The reported NOAEL was 15 mg/kg/d, and the lowest-observed- adverse-effect level (LOAEL) was 30 mg/kg/d in this study. Polyethylene glycol 15 tallow amine. In a 90-day oral toxicity study, PEG-15 tallow amine was administered in the diet ad libitum to 3 groups of 10 male and 10 female Sprague Dawley rats.10 The concentrations of the test substance in the test diets were approximately 500, 1,500, or 4,500 ppm (equivalent to about 33, 99, and 292 mg/kg/d for males, respectively, and 40, 123, and 357 mg/kg/d for females, respectively). The control group received the basal diet. Exposure...","page":24,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_004"}
CIR_vision_codex NOAEL =500 ppm rat oral 28-day oral toxicity {"citation":"500; (33; 40","dose":"There were no treatment-related gross or histopathological findings or statistically significant effects on body weight, body weight gain, food consumption, hematological and clinical chemistry parameters, or organ weights at 500 ppm.","effect":"aled inflammatory changes in the digestive tract, including hypertrophy and vacuolation of his- tiocytes in the lamina propria of the ileum and jejunum, sinus histiocytosis, and accumulation of macrophage aggregates in the cortex and medullary cords of the mesenteric lymph nodes. There were no treatment-related gross or histopathological findings or statistically significant effects on body weight, body weight gain, food consumption, hematological and clinical chemistry parameters, or organ weights at 500 ppm. The NOAEL was 500 ppm (33-40 mg/kg/d) and the LOAEL was 1,500 ppm (99-123 mg/kg/d) in this study. POE-5/POP-12 tallow amine. POE-5/POP-12 tallow amine was tested in rats in a 28-day oral repeated-dose toxicity study.10 This substance is not identified as a cosmetic ingredi- ent in the INCI Dictionary. However, POE-5/POP-12 tallow amine is a likely analog for PEGs cocamine and related ingre- dients in a read-across assessment. Groups of 5 male and 5 female CD rats received 0, 15, 75, or 200 mg/kg/d POE-5/ POP-12 tallow amine by gavage for 28 days. There were no unscheduled de...","page":24,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_005"}
CIR_vision_codex NOAEL =300 ppm rat oral - developmental toxicity {"citation":"300; (23; 16","dose":"The NOAEL was 300 ppm (23-16 mg/kg/d) for parental and developmental effects and 2,000 ppm for repro- ductive effects in this study.","effect":"or 300 ppm. The NOAEL was 300 ppm (23-16 mg/kg/d) for parental and developmental effects and 2,000 ppm for repro- ductive effects in this study. The LOAEL was 2,000 ppm for parental and developmental effects. Polyethylene Glycol 15 Tallow Amine In a developmental toxicity study, groups of 25 female Charles River Crl:CDBr rats received 0 (corn oil only), 15, 100, or 300 mg/kg/d PEG-15 tallow amine by gavage from days 6 through 15 of gestation.10 Developmental parameters measured included numbers of viable fetuses, early and late resorptions, total implantations, total corpora lutea, and the sex and weight of the fetuses. The fetuses were examined for ext","page":26,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_006"}
CIR_vision_codex NOAEL =100 mg/kg/d rat oral 70 days developmental toxicity {"citation":"15; 100; 300","dose":"No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups.","effect":"had vertebral anomalies. These effects were not considered to be treatment related because situs inver- sus was seen also in one of the control fetuses, and the inci- dences of all of the other effects were within the ranges of historical controls. No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups. Several skeletal varia- tions of the sternebrae and ribs were observed in the fetuses of these groups, as well as in the control group, and were not considered to be treatment related. The maternal NOAEL was 100 mg/kg/d and the developmental NOAEL and maternal LOAEL was 300 mg/kg/d in this study. In a 2-generation DART screening study, groups of 40 CD (Sprague-Dawley) rats (20 males and 20 females per group) were fed a diet containing 100, 300, or 1,000 ppm PEG-15 tallow amine, and a similar group of control rats received the basal diet only.10 The parental animals of the first generation (F0) were exposed to the test substance for at least 70 days before mating, and exposure continued until these animals were sacrificed; female F0 rats were sacrificed on PND 21 of...","page":26,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_007"}
CIR_vision_codex NOAEL =1000 ppm - - - developmental toxicity {"citation":"1,000; (65; 66","dose":"The NOAEL for systemic effects and the LOAEL for developmental and reproductive effects was 1,000 ppm (65- 66 mg/kg/d), and the NOAEL for developmental and reproduc- tive effects was 300 ppm (15-17 mg/kg/d) in this study.","effect":"in the F0 females and F1 litters, including litter loss, increased mean number of unaccounted-for implantation sites, decreased mean number of pups born, live litter size, and postnatal sur- vival. These effects were observed only in a small number of litters, were not always statistically significant, and were not observed in the F2 litters. However, the statistically significant increase in the mean number of unaccounted-for implantation sites exceeded the maximum mean of laboratory historical control data. The NOAEL for systemic effects and the LOAEL for developmental and reproductive effects was 1,000 ppm (65- 66 mg/kg/d), and the NOAEL for developmental and reproduc- tive effects was 300 ppm (15-17 mg/kg/d) in this study. Genotoxicity PEG-15 Cocamine was tested for mutagenicity using the paper- disk method. Nutrient agar was seeded with streptomycin- dependent Sd-4-73 Escherichia coli and filter paper disks con- taining PEG-15 cocamine were placed on the surface of the cultures. The frequency of reversion from streptomycin depen- dence to independence was used as the measure...","page":26,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_009"}
CIR_vision_codex NOAEL =23 mg/kg/d rat oral 72 days repeated dose toxicity {"citation":"12; 1; 2","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen:","effect":"Table 12. Analog Group 1: PEG-2 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_010"}
CIR_vision_codex NOAEL =134 mg/kg/d rat oral 72 days repeated dose toxicity {"citation":"12; 1; 2","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen:","effect":"able 12. Analog Group 1: PEG-2 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOE...","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_011"}
CIR_vision_codex NOAEL =50 mg/kg/d rat oral 72 days repeated dose toxicity {"citation":"2, 8, 23, 134; 3, 9, 26, 148; 69","dose":"2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days.","effect":"No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOEL ¼ 12 mg/kg/d (based on body weight gain) or 40 mg/kg/d (based on histiocytosis). Food consumption in all treated groups similar to control. Small decrease in body weight gain in mid-dose males and high-dose males and females; h...","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_012"}
CIR_vision_codex NOAEL =12 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"23; 10; 2","dose":"AEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test:","effect":"AEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOEL ¼ 12 mg/kg/d (based on body weight gain) or 40 mg/kg/d (based on histiocytosis). Food consumption in all treated groups similar to control. Small decrease in body weight gain in mid-dose males and high-dose males and females; histiocytosis in small intestine and mesenteric lymph nodes at high dose No data 9,12,13 Dog 90-day oral study. 13, 40, or 120 mg/kg/d via diet; NOEL ¼ 13 mg/kg/d. Palatability issues at mid and high dose. GI clinical signs at mid and high dose (vomiting); histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-...","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_013"}
CIR_vision_codex NOAEL =30 mg/kg/d rat oral 28-day repeated dose toxicity {"citation":"28; 0; 1","dose":"histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-day percutaneous study.","effect":"histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-day percutaneous study. 0.1% or 0.5% aqueous dispersion (2 or 10 mg/kg/d), 5 d/wk for 4 weeks. Slight to moderate skin irritation at both concentrations; no evidence of systemic toxicity PEG-2 C13-C15 alkyl amine 70955-14-5 13-15 2 No data Rat 90-day oral study. 15, 30, or 150 mg/kg/d via gavage; NOAEL ¼ 15 mg/kg/d. Macro and microscopic changes in nonglandular stomach Dog 90-day oral study. 15, 30, or 100 mg/kg/d via capsule; NOAEL ¼ 30 mg/kg/d. GI clinical signs: increased alanine aminotransferase (ALT) females only; increased pigment accumulation in Kupffer cells and bile canaliculi females only 10 PEG-4 cocamine 61791-14-8 8-16 4 No data No data No data - Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 50S","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_014"}
CIR_vision_codex NOAEL =33 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"14; 3; 10","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data - Analogs PEG-8 stearamine 26635-92-7 16-18 8 Ames test:","effect":"performance at doses that were Table 14. Analog Group 3: PEG-10 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data - Analogs PEG-8 stearamine 26635-92-7 16-18 8 Ames test: (\u0006) No data No data 9,11 PEG-15 tallow amine 61791-26-2 16-18 15 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 33, 99, and 292 mg/kg/d via diet; NOEL ¼ 33 mg/kg/d. GI irritation (hypertrophy and vacuolation of histiocytes in the lamina propria of the small intestine); histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat developmental toxicity test. 15, 100, or 300 mg/kg/d via gavage on GD 6-15; NOAEL ¼ 300 mg/kg/d (highest dose tested); maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen. 100, 300, or 1000 ppm in diet. Reproductive/developmental NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased litter size, and postnatal survival 10 POE-5/POP-12 tallow amine 68213...","page":43,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_015"}
CIR_vision_codex NOAEL =5 mg/kg/d rat oral 4-week developmental toxicity {"citation":"100; 2; 100, 300","dose":"maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen.","effect":"maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen. 100, 300, or 1000 ppm in diet. Reproductive/developmental NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased litter size, and postnatal survival 10 POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study: 15, 75, or 200 mg/kg/d via gavage. NOAEL ¼ 75 mg/kg/d; decreased body weight gain and food consumption at high dose No data 10 PEG-4 cocamine 61791-14-8 8-16 4 No data No data No data - Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 52S International Journal of Toxicology 37(Supplement 2) 52S","page":43,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_016"}
CIR_vision_codex NOAEL =75 mg/kg/d rat oral 4-week repeated dose toxicity {"citation":"15; 4; 14","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-15 cocamine 61491-14-8 8-16 15 No data No data No data – Analogs PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data – POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study.","effect":"Table 15. Analog Group 4: PEG-15 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-15 cocamine 61491-14-8 8-16 15 No data No data No data – Analogs PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data – POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study. 15, 75, or 200 mg/kg/d via gavage. NOAEL ¼ 75 mg/kg/d. Decreased body weight gain and food consumption No data 10 PEG-8 stearamine 26635-92-7 16-18 8 Ames test: (\u0006) No data No data 9,11 PEG-15 tallow amine 61791-26-2 16-18 15 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 33, 99, and 292 mg/kg/d via diet. NOEL ¼ 33 mg/kg/d. GI irritation, histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat developmental toxicity study: 15, 100, or 300 mg/ kg/d via gavage on gestation days 6-15. NOAEL 300 ¼ mg/kg/d Rat 2-generation DART study. NOAEL ¼ 15 mg/kg/ d; NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased lit","page":44,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_017"}
CIR_vision_codex NOAEL =40 mg/kg/d mouse - 28-day NOAEL study {"citation":"9; 28; 10","dose":"10% aqueous dispersion, reduced to 2% aqueous dispersion after 2 treatments (200 mg/kg/d reduced to 40 mg/kg/d), 5 d/wk for 4 weeks.","effect":"S-9 In vivo mouse chromosome aberration test: (\u0006) Rabbit 28-day percutaneous study: 10% aqueous dispersion, reduced to 2% aqueous dispersion after 2 treatments (200 mg/kg/d reduced to 40 mg/kg/d), 5 d/wk for 4 weeks. Severe skin irritation at 10% leading to reduction in concentration to 2%. No evidence of systemic toxicity Rabbit 28-day percutaneous study: 2% aqueous dispersion (40 mg/kg/d), 5 d/wk for 4 weeks. Severe skin irritation. No evidence of systemic toxicity No data 9 Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 53S","page":44,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_018"}
CIR_vision_codex NOAEL =1 ppm rat oral 28 days reproductive toxicity {"citation":"1,500; 4,500; 500","dose":"he 1,500 ppm group exhib- ited similar effects, although to a lesser degree than observed in the 4,500 ppm group.","effect":"he 1,500 ppm group exhib- ited similar effects, although to a lesser degree than observed in the 4,500 ppm group. Body weight gain was decreased in both the 1,500 ppm group and the 4,500 ppm group, which was attributed to the reduced palatability of the diets. No clinical effects were noted at any dietary concentration less than 4,500 ppm, and no definite hematological abnormality, differences in organ weights, or abnormalities of the reproductive organs were found at any dietary concentration tested. The reported no-observed-effect level (NOEL) was 500 ppm (about 50 mg/kg/d) and the lowest-observed-effect level (LOEL) was 1,500 ppm in this study. Four groups of 40 Crl:CD(SD)BR rats (20 males and 20 females) were fed diets, ad libitum, containing PEG-2 tallow amine at concentrations of 0%, 0.001%, 0.015%, or 0.5% (wt/wt) for 28 days or until necropsy.4,5,9,13,29 The test substance was added to the diets as 1% solutions in corn oil. All animals were examined at least once every day for overt toxi- city or behavioral changes, individual body weights and group food consumption were r...","page":23,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_001"}
CIR_vision_codex NOAEL =0.015 % dog oral 90 days repeated dose toxicity {"citation":"0; 5; 015","dose":"The no-observed- adverse-effect level (NOAEL) was estimated to be 0.015% (approximately 12 mg/kg/d), based on body weight gain.","effect":"loss observed across all groups was not considered to be treatment related. Body weight gain was slightly decreased in males and females at 0.5% and in males at 0.015% in the diet. Feed con- sumption, hematology, and organ weights were not statistically different from controls. Histiocytosis (ie, aggregations of macro- phages with foamy cytoplasm) in the jejunum and mesenteric lymph node in the 0.5% group was the only treatment-related histopathological finding in this study. The no-observed- adverse-effect level (NOAEL) was estimated to be 0.015% (approximately 12 mg/kg/d), based on body weight gain. Groups of 4 male and female Beagle dogs were fed diets (ad libitum) containing PEG-2 tallow amine at concentrations cor- responding to doses of 0, 13, 40, and 120 mg/kg/d for 90 days.4,5,9 Body weights were recorded at the beginning of the treatment period and weekly thereafter. Hemoglobin concen- trations, packed cell volumes, white cell counts, and differen- tial white cell counts were measured before initiating treatment and immediately before sacrificing the animals at the end of...","page":23,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_002"}
CIR_vision_codex NOAEL =13 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"13; 50; 2","dose":"The NOEL was reported to be 13 mg/kg/d, and the LOEL was 50 mg/kg/d.","effect":". The liver, heart, lung, adrenals, kid- neys, spleen, thyroid, testes, epididymides, brain, and pituitary glands were weighed when the animals were necropsied. Rep- resentative sections were collected for microscopic examina- tion of the brain (cerebrum, cerebellum, and medulla), spinal cord, pituitary, submaxillary gland, thyroid, thymus, heart, lung, aorta, stomach, duodenum, jejunum, ileum, colon, liver, spleen, kidney, urinary bladder, adrenal, ovary and uterus or testes and epididymis, and sciatic nerve. The NOEL was reported to be 13 mg/kg/d, and the LOEL was 50 mg/kg/d. No other findings of this study were presented. Polyethylene glycol 2 C13-C15 alkyl amine. PEG-2 C13-C15 alkyl amine was tested in rats in a 90-day oral repeated-dose toxicity study.10 The PEG-2 C13-C15 alkyl amine is not 32S International Journal of Toxicology 37(Supplement 2)","page":23,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_003"}
CIR_vision_codex NOAEL =15 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"150; 30; 15","dose":"statistically signifi- cant elevations in mean platelet, white blood cell, segmented neutrophil, and lymphocyte counts in the 150 mg/kg/d group.","effect":"statistically signifi- cant elevations in mean platelet, white blood cell, segmented neutrophil, and lymphocyte counts in the 150 mg/kg/d group. The inflammation observed in the lungs was attributed to inad- vertent aspiration following gavage. Desquamation and altera- tion of the mucosa of the nonglandular stomach was observed primarily in rats of the 150 mg/kg/d group, but also in some rats of the 30 mg/kg/d. Two females in the 150 mg/kg/d group had suppurative inflammation of the glandular stomach. The reported NOAEL was 15 mg/kg/d, and the lowest-observed- adverse-effect level (LOAEL) was 30 mg/kg/d in this study. Polyethylene glycol 15 tallow amine. In a 90-day oral toxicity study, PEG-15 tallow amine was administered in the diet ad libitum to 3 groups of 10 male and 10 female Sprague Dawley rats.10 The concentrations of the test substance in the test diets were approximately 500, 1,500, or 4,500 ppm (equivalent to about 33, 99, and 292 mg/kg/d for males, respectively, and 40, 123, and 357 mg/kg/d for females, respectively). The control group received the basal diet. Exposure...","page":24,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_004"}
CIR_vision_codex NOAEL =500 ppm rat oral 28-day oral toxicity {"citation":"500; (33; 40","dose":"There were no treatment-related gross or histopathological findings or statistically significant effects on body weight, body weight gain, food consumption, hematological and clinical chemistry parameters, or organ weights at 500 ppm.","effect":"aled inflammatory changes in the digestive tract, including hypertrophy and vacuolation of his- tiocytes in the lamina propria of the ileum and jejunum, sinus histiocytosis, and accumulation of macrophage aggregates in the cortex and medullary cords of the mesenteric lymph nodes. There were no treatment-related gross or histopathological findings or statistically significant effects on body weight, body weight gain, food consumption, hematological and clinical chemistry parameters, or organ weights at 500 ppm. The NOAEL was 500 ppm (33-40 mg/kg/d) and the LOAEL was 1,500 ppm (99-123 mg/kg/d) in this study. POE-5/POP-12 tallow amine. POE-5/POP-12 tallow amine was tested in rats in a 28-day oral repeated-dose toxicity study.10 This substance is not identified as a cosmetic ingredi- ent in the INCI Dictionary. However, POE-5/POP-12 tallow amine is a likely analog for PEGs cocamine and related ingre- dients in a read-across assessment. Groups of 5 male and 5 female CD rats received 0, 15, 75, or 200 mg/kg/d POE-5/ POP-12 tallow amine by gavage for 28 days. There were no unscheduled de...","page":24,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_005"}
CIR_vision_codex NOAEL =300 ppm rat oral - developmental toxicity {"citation":"300; (23; 16","dose":"The NOAEL was 300 ppm (23-16 mg/kg/d) for parental and developmental effects and 2,000 ppm for repro- ductive effects in this study.","effect":"or 300 ppm. The NOAEL was 300 ppm (23-16 mg/kg/d) for parental and developmental effects and 2,000 ppm for repro- ductive effects in this study. The LOAEL was 2,000 ppm for parental and developmental effects. Polyethylene Glycol 15 Tallow Amine In a developmental toxicity study, groups of 25 female Charles River Crl:CDBr rats received 0 (corn oil only), 15, 100, or 300 mg/kg/d PEG-15 tallow amine by gavage from days 6 through 15 of gestation.10 Developmental parameters measured included numbers of viable fetuses, early and late resorptions, total implantations, total corpora lutea, and the sex and weight of the fetuses. The fetuses were examined for ext","page":26,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_006"}
CIR_vision_codex NOAEL =100 mg/kg/d rat oral 70 days developmental toxicity {"citation":"15; 100; 300","dose":"No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups.","effect":"had vertebral anomalies. These effects were not considered to be treatment related because situs inver- sus was seen also in one of the control fetuses, and the inci- dences of all of the other effects were within the ranges of historical controls. No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups. Several skeletal varia- tions of the sternebrae and ribs were observed in the fetuses of these groups, as well as in the control group, and were not considered to be treatment related. The maternal NOAEL was 100 mg/kg/d and the developmental NOAEL and maternal LOAEL was 300 mg/kg/d in this study. In a 2-generation DART screening study, groups of 40 CD (Sprague-Dawley) rats (20 males and 20 females per group) were fed a diet containing 100, 300, or 1,000 ppm PEG-15 tallow amine, and a similar group of control rats received the basal diet only.10 The parental animals of the first generation (F0) were exposed to the test substance for at least 70 days before mating, and exposure continued until these animals were sacrificed; female F0 rats were sacrificed on PND 21 of...","page":26,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_007"}
CIR_vision_codex NOAEL =1000 ppm - - - developmental toxicity {"citation":"1,000; (65; 66","dose":"The NOAEL for systemic effects and the LOAEL for developmental and reproductive effects was 1,000 ppm (65- 66 mg/kg/d), and the NOAEL for developmental and reproduc- tive effects was 300 ppm (15-17 mg/kg/d) in this study.","effect":"in the F0 females and F1 litters, including litter loss, increased mean number of unaccounted-for implantation sites, decreased mean number of pups born, live litter size, and postnatal sur- vival. These effects were observed only in a small number of litters, were not always statistically significant, and were not observed in the F2 litters. However, the statistically significant increase in the mean number of unaccounted-for implantation sites exceeded the maximum mean of laboratory historical control data. The NOAEL for systemic effects and the LOAEL for developmental and reproductive effects was 1,000 ppm (65- 66 mg/kg/d), and the NOAEL for developmental and reproduc- tive effects was 300 ppm (15-17 mg/kg/d) in this study. Genotoxicity PEG-15 Cocamine was tested for mutagenicity using the paper- disk method. Nutrient agar was seeded with streptomycin- dependent Sd-4-73 Escherichia coli and filter paper disks con- taining PEG-15 cocamine were placed on the surface of the cultures. The frequency of reversion from streptomycin depen- dence to independence was used as the measure...","page":26,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_009"}
CIR_vision_codex NOAEL =23 mg/kg/d rat oral 72 days repeated dose toxicity {"citation":"12; 1; 2","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen:","effect":"Table 12. Analog Group 1: PEG-2 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_010"}
CIR_vision_codex NOAEL =134 mg/kg/d rat oral 72 days repeated dose toxicity {"citation":"12; 1; 2","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen:","effect":"able 12. Analog Group 1: PEG-2 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOE...","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_011"}
CIR_vision_codex NOAEL =50 mg/kg/d rat oral 72 days repeated dose toxicity {"citation":"2, 8, 23, 134; 3, 9, 26, 148; 69","dose":"2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days.","effect":"No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOEL ¼ 12 mg/kg/d (based on body weight gain) or 40 mg/kg/d (based on histiocytosis). Food consumption in all treated groups similar to control. Small decrease in body weight gain in mid-dose males and high-dose males and females; h...","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_012"}
CIR_vision_codex NOAEL =12 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"23; 10; 2","dose":"AEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test:","effect":"AEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOEL ¼ 12 mg/kg/d (based on body weight gain) or 40 mg/kg/d (based on histiocytosis). Food consumption in all treated groups similar to control. Small decrease in body weight gain in mid-dose males and high-dose males and females; histiocytosis in small intestine and mesenteric lymph nodes at high dose No data 9,12,13 Dog 90-day oral study. 13, 40, or 120 mg/kg/d via diet; NOEL ¼ 13 mg/kg/d. Palatability issues at mid and high dose. GI clinical signs at mid and high dose (vomiting); histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-...","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_013"}
CIR_vision_codex NOAEL =30 mg/kg/d rat oral 28-day repeated dose toxicity {"citation":"28; 0; 1","dose":"histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-day percutaneous study.","effect":"histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-day percutaneous study. 0.1% or 0.5% aqueous dispersion (2 or 10 mg/kg/d), 5 d/wk for 4 weeks. Slight to moderate skin irritation at both concentrations; no evidence of systemic toxicity PEG-2 C13-C15 alkyl amine 70955-14-5 13-15 2 No data Rat 90-day oral study. 15, 30, or 150 mg/kg/d via gavage; NOAEL ¼ 15 mg/kg/d. Macro and microscopic changes in nonglandular stomach Dog 90-day oral study. 15, 30, or 100 mg/kg/d via capsule; NOAEL ¼ 30 mg/kg/d. GI clinical signs: increased alanine aminotransferase (ALT) females only; increased pigment accumulation in Kupffer cells and bile canaliculi females only 10 PEG-4 cocamine 61791-14-8 8-16 4 No data No data No data - Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 50S","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_014"}
CIR_vision_codex NOAEL =33 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"14; 3; 10","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data - Analogs PEG-8 stearamine 26635-92-7 16-18 8 Ames test:","effect":"performance at doses that were Table 14. Analog Group 3: PEG-10 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data - Analogs PEG-8 stearamine 26635-92-7 16-18 8 Ames test: (\u0006) No data No data 9,11 PEG-15 tallow amine 61791-26-2 16-18 15 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 33, 99, and 292 mg/kg/d via diet; NOEL ¼ 33 mg/kg/d. GI irritation (hypertrophy and vacuolation of histiocytes in the lamina propria of the small intestine); histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat developmental toxicity test. 15, 100, or 300 mg/kg/d via gavage on GD 6-15; NOAEL ¼ 300 mg/kg/d (highest dose tested); maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen. 100, 300, or 1000 ppm in diet. Reproductive/developmental NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased litter size, and postnatal survival 10 POE-5/POP-12 tallow amine 68213...","page":43,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_015"}
CIR_vision_codex NOAEL =5 mg/kg/d rat oral 4-week developmental toxicity {"citation":"100; 2; 100, 300","dose":"maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen.","effect":"maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen. 100, 300, or 1000 ppm in diet. Reproductive/developmental NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased litter size, and postnatal survival 10 POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study: 15, 75, or 200 mg/kg/d via gavage. NOAEL ¼ 75 mg/kg/d; decreased body weight gain and food consumption at high dose No data 10 PEG-4 cocamine 61791-14-8 8-16 4 No data No data No data - Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 52S International Journal of Toxicology 37(Supplement 2) 52S","page":43,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_016"}
CIR_vision_codex NOAEL =75 mg/kg/d rat oral 4-week repeated dose toxicity {"citation":"15; 4; 14","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-15 cocamine 61491-14-8 8-16 15 No data No data No data – Analogs PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data – POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study.","effect":"Table 15. Analog Group 4: PEG-15 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-15 cocamine 61491-14-8 8-16 15 No data No data No data – Analogs PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data – POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study. 15, 75, or 200 mg/kg/d via gavage. NOAEL ¼ 75 mg/kg/d. Decreased body weight gain and food consumption No data 10 PEG-8 stearamine 26635-92-7 16-18 8 Ames test: (\u0006) No data No data 9,11 PEG-15 tallow amine 61791-26-2 16-18 15 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 33, 99, and 292 mg/kg/d via diet. NOEL ¼ 33 mg/kg/d. GI irritation, histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat developmental toxicity study: 15, 100, or 300 mg/ kg/d via gavage on gestation days 6-15. NOAEL 300 ¼ mg/kg/d Rat 2-generation DART study. NOAEL ¼ 15 mg/kg/ d; NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased lit","page":44,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_017"}
CIR_vision_codex NOAEL =40 mg/kg/d mouse - 28-day NOAEL study {"citation":"9; 28; 10","dose":"10% aqueous dispersion, reduced to 2% aqueous dispersion after 2 treatments (200 mg/kg/d reduced to 40 mg/kg/d), 5 d/wk for 4 weeks.","effect":"S-9 In vivo mouse chromosome aberration test: (\u0006) Rabbit 28-day percutaneous study: 10% aqueous dispersion, reduced to 2% aqueous dispersion after 2 treatments (200 mg/kg/d reduced to 40 mg/kg/d), 5 d/wk for 4 weeks. Severe skin irritation at 10% leading to reduction in concentration to 2%. No evidence of systemic toxicity Rabbit 28-day percutaneous study: 2% aqueous dispersion (40 mg/kg/d), 5 d/wk for 4 weeks. Severe skin irritation. No evidence of systemic toxicity No data 9 Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 53S","page":44,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_018"}
CIR_vision_codex NOAEL =1 ppm rat oral 28 days reproductive toxicity {"citation":"1,500; 4,500; 500","dose":"he 1,500 ppm group exhib- ited similar effects, although to a lesser degree than observed in the 4,500 ppm group.","effect":"he 1,500 ppm group exhib- ited similar effects, although to a lesser degree than observed in the 4,500 ppm group. Body weight gain was decreased in both the 1,500 ppm group and the 4,500 ppm group, which was attributed to the reduced palatability of the diets. No clinical effects were noted at any dietary concentration less than 4,500 ppm, and no definite hematological abnormality, differences in organ weights, or abnormalities of the reproductive organs were found at any dietary concentration tested. The reported no-observed-effect level (NOEL) was 500 ppm (about 50 mg/kg/d) and the lowest-observed-effect level (LOEL) was 1,500 ppm in this study. Four groups of 40 Crl:CD(SD)BR rats (20 males and 20 females) were fed diets, ad libitum, containing PEG-2 tallow amine at concentrations of 0%, 0.001%, 0.015%, or 0.5% (wt/wt) for 28 days or until necropsy.4,5,9,13,29 The test substance was added to the diets as 1% solutions in corn oil. All animals were examined at least once every day for overt toxi- city or behavioral changes, individual body weights and group food consumption were r...","page":23,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_001"}
CIR_vision_codex NOAEL =0.015 % dog oral 90 days repeated dose toxicity {"citation":"0; 5; 015","dose":"The no-observed- adverse-effect level (NOAEL) was estimated to be 0.015% (approximately 12 mg/kg/d), based on body weight gain.","effect":"loss observed across all groups was not considered to be treatment related. Body weight gain was slightly decreased in males and females at 0.5% and in males at 0.015% in the diet. Feed con- sumption, hematology, and organ weights were not statistically different from controls. Histiocytosis (ie, aggregations of macro- phages with foamy cytoplasm) in the jejunum and mesenteric lymph node in the 0.5% group was the only treatment-related histopathological finding in this study. The no-observed- adverse-effect level (NOAEL) was estimated to be 0.015% (approximately 12 mg/kg/d), based on body weight gain. Groups of 4 male and female Beagle dogs were fed diets (ad libitum) containing PEG-2 tallow amine at concentrations cor- responding to doses of 0, 13, 40, and 120 mg/kg/d for 90 days.4,5,9 Body weights were recorded at the beginning of the treatment period and weekly thereafter. Hemoglobin concen- trations, packed cell volumes, white cell counts, and differen- tial white cell counts were measured before initiating treatment and immediately before sacrificing the animals at the end of...","page":23,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_002"}
CIR_vision_codex NOAEL =13 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"13; 50; 2","dose":"The NOEL was reported to be 13 mg/kg/d, and the LOEL was 50 mg/kg/d.","effect":". The liver, heart, lung, adrenals, kid- neys, spleen, thyroid, testes, epididymides, brain, and pituitary glands were weighed when the animals were necropsied. Rep- resentative sections were collected for microscopic examina- tion of the brain (cerebrum, cerebellum, and medulla), spinal cord, pituitary, submaxillary gland, thyroid, thymus, heart, lung, aorta, stomach, duodenum, jejunum, ileum, colon, liver, spleen, kidney, urinary bladder, adrenal, ovary and uterus or testes and epididymis, and sciatic nerve. The NOEL was reported to be 13 mg/kg/d, and the LOEL was 50 mg/kg/d. No other findings of this study were presented. Polyethylene glycol 2 C13-C15 alkyl amine. PEG-2 C13-C15 alkyl amine was tested in rats in a 90-day oral repeated-dose toxicity study.10 The PEG-2 C13-C15 alkyl amine is not 32S International Journal of Toxicology 37(Supplement 2)","page":23,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_003"}
CIR_vision_codex NOAEL =15 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"150; 30; 15","dose":"statistically signifi- cant elevations in mean platelet, white blood cell, segmented neutrophil, and lymphocyte counts in the 150 mg/kg/d group.","effect":"statistically signifi- cant elevations in mean platelet, white blood cell, segmented neutrophil, and lymphocyte counts in the 150 mg/kg/d group. The inflammation observed in the lungs was attributed to inad- vertent aspiration following gavage. Desquamation and altera- tion of the mucosa of the nonglandular stomach was observed primarily in rats of the 150 mg/kg/d group, but also in some rats of the 30 mg/kg/d. Two females in the 150 mg/kg/d group had suppurative inflammation of the glandular stomach. The reported NOAEL was 15 mg/kg/d, and the lowest-observed- adverse-effect level (LOAEL) was 30 mg/kg/d in this study. Polyethylene glycol 15 tallow amine. In a 90-day oral toxicity study, PEG-15 tallow amine was administered in the diet ad libitum to 3 groups of 10 male and 10 female Sprague Dawley rats.10 The concentrations of the test substance in the test diets were approximately 500, 1,500, or 4,500 ppm (equivalent to about 33, 99, and 292 mg/kg/d for males, respectively, and 40, 123, and 357 mg/kg/d for females, respectively). The control group received the basal diet. Exposure...","page":24,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_004"}
CIR_vision_codex NOAEL =500 ppm rat oral 28-day oral toxicity {"citation":"500; (33; 40","dose":"There were no treatment-related gross or histopathological findings or statistically significant effects on body weight, body weight gain, food consumption, hematological and clinical chemistry parameters, or organ weights at 500 ppm.","effect":"aled inflammatory changes in the digestive tract, including hypertrophy and vacuolation of his- tiocytes in the lamina propria of the ileum and jejunum, sinus histiocytosis, and accumulation of macrophage aggregates in the cortex and medullary cords of the mesenteric lymph nodes. There were no treatment-related gross or histopathological findings or statistically significant effects on body weight, body weight gain, food consumption, hematological and clinical chemistry parameters, or organ weights at 500 ppm. The NOAEL was 500 ppm (33-40 mg/kg/d) and the LOAEL was 1,500 ppm (99-123 mg/kg/d) in this study. POE-5/POP-12 tallow amine. POE-5/POP-12 tallow amine was tested in rats in a 28-day oral repeated-dose toxicity study.10 This substance is not identified as a cosmetic ingredi- ent in the INCI Dictionary. However, POE-5/POP-12 tallow amine is a likely analog for PEGs cocamine and related ingre- dients in a read-across assessment. Groups of 5 male and 5 female CD rats received 0, 15, 75, or 200 mg/kg/d POE-5/ POP-12 tallow amine by gavage for 28 days. There were no unscheduled de...","page":24,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_005"}
CIR_vision_codex NOAEL =300 ppm rat oral - developmental toxicity {"citation":"300; (23; 16","dose":"The NOAEL was 300 ppm (23-16 mg/kg/d) for parental and developmental effects and 2,000 ppm for repro- ductive effects in this study.","effect":"or 300 ppm. The NOAEL was 300 ppm (23-16 mg/kg/d) for parental and developmental effects and 2,000 ppm for repro- ductive effects in this study. The LOAEL was 2,000 ppm for parental and developmental effects. Polyethylene Glycol 15 Tallow Amine In a developmental toxicity study, groups of 25 female Charles River Crl:CDBr rats received 0 (corn oil only), 15, 100, or 300 mg/kg/d PEG-15 tallow amine by gavage from days 6 through 15 of gestation.10 Developmental parameters measured included numbers of viable fetuses, early and late resorptions, total implantations, total corpora lutea, and the sex and weight of the fetuses. The fetuses were examined for ext","page":26,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_006"}
CIR_vision_codex NOAEL =100 mg/kg/d rat oral 70 days developmental toxicity {"citation":"15; 100; 300","dose":"No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups.","effect":"had vertebral anomalies. These effects were not considered to be treatment related because situs inver- sus was seen also in one of the control fetuses, and the inci- dences of all of the other effects were within the ranges of historical controls. No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups. Several skeletal varia- tions of the sternebrae and ribs were observed in the fetuses of these groups, as well as in the control group, and were not considered to be treatment related. The maternal NOAEL was 100 mg/kg/d and the developmental NOAEL and maternal LOAEL was 300 mg/kg/d in this study. In a 2-generation DART screening study, groups of 40 CD (Sprague-Dawley) rats (20 males and 20 females per group) were fed a diet containing 100, 300, or 1,000 ppm PEG-15 tallow amine, and a similar group of control rats received the basal diet only.10 The parental animals of the first generation (F0) were exposed to the test substance for at least 70 days before mating, and exposure continued until these animals were sacrificed; female F0 rats were sacrificed on PND 21 of...","page":26,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_007"}
CIR_vision_codex NOAEL =1000 ppm - - - developmental toxicity {"citation":"1,000; (65; 66","dose":"The NOAEL for systemic effects and the LOAEL for developmental and reproductive effects was 1,000 ppm (65- 66 mg/kg/d), and the NOAEL for developmental and reproduc- tive effects was 300 ppm (15-17 mg/kg/d) in this study.","effect":"in the F0 females and F1 litters, including litter loss, increased mean number of unaccounted-for implantation sites, decreased mean number of pups born, live litter size, and postnatal sur- vival. These effects were observed only in a small number of litters, were not always statistically significant, and were not observed in the F2 litters. However, the statistically significant increase in the mean number of unaccounted-for implantation sites exceeded the maximum mean of laboratory historical control data. The NOAEL for systemic effects and the LOAEL for developmental and reproductive effects was 1,000 ppm (65- 66 mg/kg/d), and the NOAEL for developmental and reproduc- tive effects was 300 ppm (15-17 mg/kg/d) in this study. Genotoxicity PEG-15 Cocamine was tested for mutagenicity using the paper- disk method. Nutrient agar was seeded with streptomycin- dependent Sd-4-73 Escherichia coli and filter paper disks con- taining PEG-15 cocamine were placed on the surface of the cultures. The frequency of reversion from streptomycin depen- dence to independence was used as the measure...","page":26,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_009"}
CIR_vision_codex NOAEL =23 mg/kg/d rat oral 72 days repeated dose toxicity {"citation":"12; 1; 2","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen:","effect":"Table 12. Analog Group 1: PEG-2 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_010"}
CIR_vision_codex NOAEL =134 mg/kg/d rat oral 72 days repeated dose toxicity {"citation":"12; 1; 2","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen:","effect":"able 12. Analog Group 1: PEG-2 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOE...","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_011"}
CIR_vision_codex NOAEL =50 mg/kg/d rat oral 72 days repeated dose toxicity {"citation":"2, 8, 23, 134; 3, 9, 26, 148; 69","dose":"2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days.","effect":"No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOEL ¼ 12 mg/kg/d (based on body weight gain) or 40 mg/kg/d (based on histiocytosis). Food consumption in all treated groups similar to control. Small decrease in body weight gain in mid-dose males and high-dose males and females; h...","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_012"}
CIR_vision_codex NOAEL =12 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"23; 10; 2","dose":"AEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test:","effect":"AEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOEL ¼ 12 mg/kg/d (based on body weight gain) or 40 mg/kg/d (based on histiocytosis). Food consumption in all treated groups similar to control. Small decrease in body weight gain in mid-dose males and high-dose males and females; histiocytosis in small intestine and mesenteric lymph nodes at high dose No data 9,12,13 Dog 90-day oral study. 13, 40, or 120 mg/kg/d via diet; NOEL ¼ 13 mg/kg/d. Palatability issues at mid and high dose. GI clinical signs at mid and high dose (vomiting); histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-...","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_013"}
CIR_vision_codex NOAEL =30 mg/kg/d rat oral 28-day repeated dose toxicity {"citation":"28; 0; 1","dose":"histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-day percutaneous study.","effect":"histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-day percutaneous study. 0.1% or 0.5% aqueous dispersion (2 or 10 mg/kg/d), 5 d/wk for 4 weeks. Slight to moderate skin irritation at both concentrations; no evidence of systemic toxicity PEG-2 C13-C15 alkyl amine 70955-14-5 13-15 2 No data Rat 90-day oral study. 15, 30, or 150 mg/kg/d via gavage; NOAEL ¼ 15 mg/kg/d. Macro and microscopic changes in nonglandular stomach Dog 90-day oral study. 15, 30, or 100 mg/kg/d via capsule; NOAEL ¼ 30 mg/kg/d. GI clinical signs: increased alanine aminotransferase (ALT) females only; increased pigment accumulation in Kupffer cells and bile canaliculi females only 10 PEG-4 cocamine 61791-14-8 8-16 4 No data No data No data - Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 50S","page":41,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_014"}
CIR_vision_codex NOAEL =33 mg/kg/d rat oral 90-day repeated dose toxicity {"citation":"14; 3; 10","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data - Analogs PEG-8 stearamine 26635-92-7 16-18 8 Ames test:","effect":"performance at doses that were Table 14. Analog Group 3: PEG-10 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data - Analogs PEG-8 stearamine 26635-92-7 16-18 8 Ames test: (\u0006) No data No data 9,11 PEG-15 tallow amine 61791-26-2 16-18 15 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 33, 99, and 292 mg/kg/d via diet; NOEL ¼ 33 mg/kg/d. GI irritation (hypertrophy and vacuolation of histiocytes in the lamina propria of the small intestine); histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat developmental toxicity test. 15, 100, or 300 mg/kg/d via gavage on GD 6-15; NOAEL ¼ 300 mg/kg/d (highest dose tested); maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen. 100, 300, or 1000 ppm in diet. Reproductive/developmental NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased litter size, and postnatal survival 10 POE-5/POP-12 tallow amine 68213...","page":43,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_015"}
CIR_vision_codex NOAEL =5 mg/kg/d rat oral 4-week developmental toxicity {"citation":"100; 2; 100, 300","dose":"maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen.","effect":"maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen. 100, 300, or 1000 ppm in diet. Reproductive/developmental NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased litter size, and postnatal survival 10 POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study: 15, 75, or 200 mg/kg/d via gavage. NOAEL ¼ 75 mg/kg/d; decreased body weight gain and food consumption at high dose No data 10 PEG-4 cocamine 61791-14-8 8-16 4 No data No data No data - Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 52S International Journal of Toxicology 37(Supplement 2) 52S","page":43,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_016"}
CIR_vision_codex NOAEL =75 mg/kg/d rat oral 4-week repeated dose toxicity {"citation":"15; 4; 14","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-15 cocamine 61491-14-8 8-16 15 No data No data No data – Analogs PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data – POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study.","effect":"Table 15. Analog Group 4: PEG-15 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-15 cocamine 61491-14-8 8-16 15 No data No data No data – Analogs PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data – POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study. 15, 75, or 200 mg/kg/d via gavage. NOAEL ¼ 75 mg/kg/d. Decreased body weight gain and food consumption No data 10 PEG-8 stearamine 26635-92-7 16-18 8 Ames test: (\u0006) No data No data 9,11 PEG-15 tallow amine 61791-26-2 16-18 15 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 33, 99, and 292 mg/kg/d via diet. NOEL ¼ 33 mg/kg/d. GI irritation, histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat developmental toxicity study: 15, 100, or 300 mg/ kg/d via gavage on gestation days 6-15. NOAEL 300 ¼ mg/kg/d Rat 2-generation DART study. NOAEL ¼ 15 mg/kg/ d; NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased lit","page":44,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_017"}
CIR_vision_codex NOAEL =40 mg/kg/d mouse - 28-day NOAEL study {"citation":"9; 28; 10","dose":"10% aqueous dispersion, reduced to 2% aqueous dispersion after 2 treatments (200 mg/kg/d reduced to 40 mg/kg/d), 5 d/wk for 4 weeks.","effect":"S-9 In vivo mouse chromosome aberration test: (\u0006) Rabbit 28-day percutaneous study: 10% aqueous dispersion, reduced to 2% aqueous dispersion after 2 treatments (200 mg/kg/d reduced to 40 mg/kg/d), 5 d/wk for 4 weeks. Severe skin irritation at 10% leading to reduction in concentration to 2%. No evidence of systemic toxicity Rabbit 28-day percutaneous study: 2% aqueous dispersion (40 mg/kg/d), 5 d/wk for 4 weeks. Severe skin irritation. No evidence of systemic toxicity No data 9 Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 53S","page":44,"pdf":"PRS638.pdf","row_type":"noael_study","study_id":"PRS638_noael_018"}
UnifiedCodex:CIR:beta.noael_studies 18 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:CIR:beta.noael_studies - 40 mg/kg/d mouse - 28-day - SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=40; DOSE=10% aqueous dispersion, reduced to 2% aqueous dispersion after 2 treatments (200 mg/kg/d reduced to 40 mg/kg/d), 5 d/wk for 4 weeks.; EFFECT=S-9 In vivo mouse chromosome aberration test: () Rabbit 28-day percutaneous study: 10% aqueous dispersion, reduced to 2% aqueous dispersion after 2 treatments (200 mg/kg/d reduced to 40 mg/kg/d), 5 d/wk for 4 weeks. Severe skin irritation at 10% leading to reduction in concentration to 2%. No evidence of systemic toxicity Rabbit 28-day percutaneous study: 2% aqueous dispersion (40 mg/kg/d), 5 d/wk for 4 weeks. Severe skin irritation. No evidence of systemic toxicity No data 9 Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 53S; CITATION=9; 28; 10; CITATION_NUMBERS=[9,28,10]; REFERENCE=9; 28; 10; DETAILS_JSON={"cas_number":"61791-14-8","citation":"9; 28; 10","dose":"10% aqueous dispersion, reduced to 2% aqueous dispersion after 2 treatments (200 mg/kg/d reduced to 40 mg/kg/d), 5 d/wk for 4 weeks.","duration":"28-day","effect":"S-9 In vivo mouse chromosome aberration test: (\u0006) Rabbit 28-day percutaneous study: 10% aqueous dispersion, reduced to 2% aqueous dispersion after 2 treatments (200 mg/kg/d reduced to 40 mg/kg/d), 5 d/wk for 4 weeks. Severe skin irritation at 10% leading to reduction in concentration to 2%. No evidence of systemic toxicity Rabbit 28-day percutaneous study: 2% aqueous dispersion (40 mg/kg/d), 5 d/wk for 4 weeks. Severe skin irritation. No evidence of systemic toxicity No data 9 Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 53S","endpoint":"","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"","noael_unit":"mg/kg/d","noael_value":"40","page":44,"route":"","species":"mouse","study_id":"PRS638_noael_018"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 300 ppm rat oral - developmental toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=300; DOSE=The NOAEL was 300 ppm (23-16 mg/kg/d) for parental and developmental effects and 2,000 ppm for repro- ductive effects in this study.; LOAEL_VALUE=2,000 ppm; EFFECT=or 300 ppm. The NOAEL was 300 ppm (23-16 mg/kg/d) for parental and developmental effects and 2,000 ppm for repro- ductive effects in this study. The LOAEL was 2,000 ppm for parental and developmental effects. Polyethylene Glycol 15 Tallow Amine In a developmental toxicity study, groups of 25 female Charles River Crl:CDBr rats received 0 (corn oil only), 15, 100, or 300 mg/kg/d PEG-15 tallow amine by gavage from days 6 through 15 of gestation.10 Developmental parameters measured included numbers of viable fetuses, early and late resorptions, total implantations, total corpora lutea, and the sex and weight of the fetuses. The fetuses were examined for ext; CITATION=300; (23; 16; CITATION_NUMBERS=[300,23,16]; REFERENCE=300; (23; 16; DETAILS_JSON={"cas_number":"61791-14-8","citation":"300; (23; 16","dose":"The NOAEL was 300 ppm (23-16 mg/kg/d) for parental and developmental effects and 2,000 ppm for repro- ductive effects in this study.","duration":"","effect":"or 300 ppm. The NOAEL was 300 ppm (23-16 mg/kg/d) for parental and developmental effects and 2,000 ppm for repro- ductive effects in this study. The LOAEL was 2,000 ppm for parental and developmental effects. Polyethylene Glycol 15 Tallow Amine In a developmental toxicity study, groups of 25 female Charles River Crl:CDBr rats received 0 (corn oil only), 15, 100, or 300 mg/kg/d PEG-15 tallow amine by gavage from days 6 through 15 of gestation.10 Developmental parameters measured included numbers of viable fetuses, early and late resorptions, total implantations, total corpora lutea, and the sex and weight of the fetuses. The fetuses were examined for ext","endpoint":"developmental toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"2,000 ppm","noael_unit":"ppm","noael_value":"300","page":26,"route":"oral","species":"rat","study_id":"PRS638_noael_006"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 100 mg/kg/d rat oral 70 days developmental toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=100; DOSE=No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups.; LOAEL_VALUE=300 mg/kg/d; EFFECT=had vertebral anomalies. These effects were not considered to be treatment related because situs inver- sus was seen also in one of the control fetuses, and the inci- dences of all of the other effects were within the ranges of historical controls. No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups. Several skeletal varia- tions of the sternebrae and ribs were observed in the fetuses of these groups, as well as in the control group, and were not considered to be treatment related. The maternal NOAEL was 100 mg/kg/d and the developmental NOAEL and maternal LOAEL was 300 mg/kg/d in this study. In a 2-generation DART screening study, groups of 40 CD (Sprague-Dawley) rats (20 males and 20 females per group) were fed a diet containing 100, 300, or 1,000 ppm PEG-15 tallow amine, and a similar group of control rats received the basal diet only.10 The parental animals of the first generation (F0) were exposed to the test substance for at least 70 days before mating, and exposure continued until these animals were sacrificed; female F0 rats were sacrificed on PND 21 of...; CITATION=15; 100; 300; CITATION_NUMBERS=[15,100,300]; REFERENCE=15; 100; 300; DETAILS_JSON={"cas_number":"61791-14-8","citation":"15; 100; 300","dose":"No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups.","duration":"70 days","effect":"had vertebral anomalies. These effects were not considered to be treatment related because situs inver- sus was seen also in one of the control fetuses, and the inci- dences of all of the other effects were within the ranges of historical controls. No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups. Several skeletal varia- tions of the sternebrae and ribs were observed in the fetuses of these groups, as well as in the control group, and were not considered to be treatment related. The maternal NOAEL was 100 mg/kg/d and the developmental NOAEL and maternal LOAEL was 300 mg/kg/d in this study. In a 2-generation DART screening study, groups of 40 CD (Sprague-Dawley) rats (20 males and 20 females per group) were fed a diet containing 100, 300, or 1,000 ppm PEG-15 tallow amine, and a similar group of control rats received the basal diet only.10 The parental animals of the first generation (F0) were exposed to the test substance for at least 70 days before mating, and exposure continued until these animals were sacrificed; female F0 rats were sacrificed on PND 21 of...","endpoint":"developmental toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"300 mg/kg/d","noael_unit":"mg/kg/d","noael_value":"100","page":26,"route":"oral","species":"rat","study_id":"PRS638_noael_007"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 1 ppm rat oral 70 days developmental toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=1; 000; DOSE=No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups.; LOAEL_VALUE=300 mg/kg/d; EFFECT=not considered to be treatment related because situs inver- sus was seen also in one of the control fetuses, and the inci- dences of all of the other effects were within the ranges of historical controls. No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups. Several skeletal varia- tions of the sternebrae and ribs were observed in the fetuses of these groups, as well as in the control group, and were not considered to be treatment related. The maternal NOAEL was 100 mg/kg/d and the developmental NOAEL and maternal LOAEL was 300 mg/kg/d in this study. In a 2-generation DART screening study, groups of 40 CD (Sprague-Dawley) rats (20 males and 20 females per group) were fed a diet containing 100, 300, or 1,000 ppm PEG-15 tallow amine, and a similar group of control rats received the basal diet only.10 The parental animals of the first generation (F0) were exposed to the test substance for at least 70 days before mating, and exposure continued until these animals were sacrificed; female F0 rats were sacrificed on PND 21 of the F1 generation. Weanling F1 animals were...; CITATION=15; 100; 300; CITATION_NUMBERS=[15,100,300]; REFERENCE=15; 100; 300; DETAILS_JSON={"cas_number":"61791-14-8","citation":"15; 100; 300","dose":"No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups.","duration":"70 days","effect":"not considered to be treatment related because situs inver- sus was seen also in one of the control fetuses, and the inci- dences of all of the other effects were within the ranges of historical controls. No malformations were observed in the 15 mg/kg/d and 100 mg/kg/d groups. Several skeletal varia- tions of the sternebrae and ribs were observed in the fetuses of these groups, as well as in the control group, and were not considered to be treatment related. The maternal NOAEL was 100 mg/kg/d and the developmental NOAEL and maternal LOAEL was 300 mg/kg/d in this study. In a 2-generation DART screening study, groups of 40 CD (Sprague-Dawley) rats (20 males and 20 females per group) were fed a diet containing 100, 300, or 1,000 ppm PEG-15 tallow amine, and a similar group of control rats received the basal diet only.10 The parental animals of the first generation (F0) were exposed to the test substance for at least 70 days before mating, and exposure continued until these animals were sacrificed; female F0 rats were sacrificed on PND 21 of the F1 generation. Weanling F1 animals were...","endpoint":"developmental toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"300 mg/kg/d","noael_unit":"ppm","noael_value":"1; 000","page":26,"route":"oral","species":"rat","study_id":"PRS638_noael_008"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 1000 ppm - - - developmental toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=1,000; DOSE=The NOAEL for systemic effects and the LOAEL for developmental and reproductive effects was 1,000 ppm (65- 66 mg/kg/d), and the NOAEL for developmental and reproduc- tive effects was 300 ppm (15-17 mg/kg/d) in this study.; LOAEL_VALUE=1,000 ppm; EFFECT=in the F0 females and F1 litters, including litter loss, increased mean number of unaccounted-for implantation sites, decreased mean number of pups born, live litter size, and postnatal sur- vival. These effects were observed only in a small number of litters, were not always statistically significant, and were not observed in the F2 litters. However, the statistically significant increase in the mean number of unaccounted-for implantation sites exceeded the maximum mean of laboratory historical control data. The NOAEL for systemic effects and the LOAEL for developmental and reproductive effects was 1,000 ppm (65- 66 mg/kg/d), and the NOAEL for developmental and reproduc- tive effects was 300 ppm (15-17 mg/kg/d) in this study. Genotoxicity PEG-15 Cocamine was tested for mutagenicity using the paper- disk method. Nutrient agar was seeded with streptomycin- dependent Sd-4-73 Escherichia coli and filter paper disks con- taining PEG-15 cocamine were placed on the surface of the cultures. The frequency of reversion from streptomycin depen- dence to independence was used as the measure...; CITATION=1,000; (65; 66; CITATION_NUMBERS=[1,65,66]; REFERENCE=1,000; (65; 66; DETAILS_JSON={"cas_number":"61791-14-8","citation":"1,000; (65; 66","dose":"The NOAEL for systemic effects and the LOAEL for developmental and reproductive effects was 1,000 ppm (65- 66 mg/kg/d), and the NOAEL for developmental and reproduc- tive effects was 300 ppm (15-17 mg/kg/d) in this study.","duration":"","effect":"in the F0 females and F1 litters, including litter loss, increased mean number of unaccounted-for implantation sites, decreased mean number of pups born, live litter size, and postnatal sur- vival. These effects were observed only in a small number of litters, were not always statistically significant, and were not observed in the F2 litters. However, the statistically significant increase in the mean number of unaccounted-for implantation sites exceeded the maximum mean of laboratory historical control data. The NOAEL for systemic effects and the LOAEL for developmental and reproductive effects was 1,000 ppm (65- 66 mg/kg/d), and the NOAEL for developmental and reproduc- tive effects was 300 ppm (15-17 mg/kg/d) in this study. Genotoxicity PEG-15 Cocamine was tested for mutagenicity using the paper- disk method. Nutrient agar was seeded with streptomycin- dependent Sd-4-73 Escherichia coli and filter paper disks con- taining PEG-15 cocamine were placed on the surface of the cultures. The frequency of reversion from streptomycin depen- dence to independence was used as the measure...","endpoint":"developmental toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"1,000 ppm","noael_unit":"ppm","noael_value":"1,000","page":26,"route":"","species":"","study_id":"PRS638_noael_009"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 5 mg/kg/d rat oral 4-week developmental toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=5; DOSE=maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen.; LOAEL_VALUE=53 mg/kg/d; EFFECT=maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen. 100, 300, or 1000 ppm in diet. Reproductive/developmental NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased litter size, and postnatal survival 10 POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study: 15, 75, or 200 mg/kg/d via gavage. NOAEL ¼ 75 mg/kg/d; decreased body weight gain and food consumption at high dose No data 10 PEG-4 cocamine 61791-14-8 8-16 4 No data No data No data - Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 52S International Journal of Toxicology 37(Supplement 2) 52S; CITATION=100; 2; 100, 300; CITATION_NUMBERS=[100,2,300]; REFERENCE=100; 2; 100, 300; DETAILS_JSON={"cas_number":"61791-14-8","citation":"100; 2; 100, 300","dose":"maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen.","duration":"4-week","effect":"maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen. 100, 300, or 1000 ppm in diet. Reproductive/developmental NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased litter size, and postnatal survival 10 POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study: 15, 75, or 200 mg/kg/d via gavage. NOAEL ¼ 75 mg/kg/d; decreased body weight gain and food consumption at high dose No data 10 PEG-4 cocamine 61791-14-8 8-16 4 No data No data No data - Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 52S International Journal of Toxicology 37(Supplement 2) 52S","endpoint":"developmental toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"53 mg/kg/d","noael_unit":"mg/kg/d","noael_value":"5","page":43,"route":"oral","species":"rat","study_id":"PRS638_noael_016"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity 500 ppm rat oral 28-day oral toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=500; DOSE=There were no treatment-related gross or histopathological findings or statistically significant effects on body weight, body weight gain, food consumption, hematological and clinical chemistry parameters, or organ weights at 500 ppm.; LOAEL_VALUE=1,500 ppm; EFFECT=aled inflammatory changes in the digestive tract, including hypertrophy and vacuolation of his- tiocytes in the lamina propria of the ileum and jejunum, sinus histiocytosis, and accumulation of macrophage aggregates in the cortex and medullary cords of the mesenteric lymph nodes. There were no treatment-related gross or histopathological findings or statistically significant effects on body weight, body weight gain, food consumption, hematological and clinical chemistry parameters, or organ weights at 500 ppm. The NOAEL was 500 ppm (33-40 mg/kg/d) and the LOAEL was 1,500 ppm (99-123 mg/kg/d) in this study. POE-5/POP-12 tallow amine. POE-5/POP-12 tallow amine was tested in rats in a 28-day oral repeated-dose toxicity study.10 This substance is not identified as a cosmetic ingredi- ent in the INCI Dictionary. However, POE-5/POP-12 tallow amine is a likely analog for PEGs cocamine and related ingre- dients in a read-across assessment. Groups of 5 male and 5 female CD rats received 0, 15, 75, or 200 mg/kg/d POE-5/ POP-12 tallow amine by gavage for 28 days. There were no unscheduled de...; CITATION=500; (33; 40; CITATION_NUMBERS=[500,33,40]; REFERENCE=500; (33; 40; DETAILS_JSON={"cas_number":"61791-14-8","citation":"500; (33; 40","dose":"There were no treatment-related gross or histopathological findings or statistically significant effects on body weight, body weight gain, food consumption, hematological and clinical chemistry parameters, or organ weights at 500 ppm.","duration":"28-day","effect":"aled inflammatory changes in the digestive tract, including hypertrophy and vacuolation of his- tiocytes in the lamina propria of the ileum and jejunum, sinus histiocytosis, and accumulation of macrophage aggregates in the cortex and medullary cords of the mesenteric lymph nodes. There were no treatment-related gross or histopathological findings or statistically significant effects on body weight, body weight gain, food consumption, hematological and clinical chemistry parameters, or organ weights at 500 ppm. The NOAEL was 500 ppm (33-40 mg/kg/d) and the LOAEL was 1,500 ppm (99-123 mg/kg/d) in this study. POE-5/POP-12 tallow amine. POE-5/POP-12 tallow amine was tested in rats in a 28-day oral repeated-dose toxicity study.10 This substance is not identified as a cosmetic ingredi- ent in the INCI Dictionary. However, POE-5/POP-12 tallow amine is a likely analog for PEGs cocamine and related ingre- dients in a read-across assessment. Groups of 5 male and 5 female CD rats received 0, 15, 75, or 200 mg/kg/d POE-5/ POP-12 tallow amine by gavage for 28 days. There were no unscheduled de...","endpoint":"oral toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"1,500 ppm","noael_unit":"ppm","noael_value":"500","page":24,"route":"oral","species":"rat","study_id":"PRS638_noael_005"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 0.015 % dog oral 90 days repeated dose toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=0.015; DOSE=The no-observed- adverse-effect level (NOAEL) was estimated to be 0.015% (approximately 12 mg/kg/d), based on body weight gain.; EFFECT=loss observed across all groups was not considered to be treatment related. Body weight gain was slightly decreased in males and females at 0.5% and in males at 0.015% in the diet. Feed con- sumption, hematology, and organ weights were not statistically different from controls. Histiocytosis (ie, aggregations of macro- phages with foamy cytoplasm) in the jejunum and mesenteric lymph node in the 0.5% group was the only treatment-related histopathological finding in this study. The no-observed- adverse-effect level (NOAEL) was estimated to be 0.015% (approximately 12 mg/kg/d), based on body weight gain. Groups of 4 male and female Beagle dogs were fed diets (ad libitum) containing PEG-2 tallow amine at concentrations cor- responding to doses of 0, 13, 40, and 120 mg/kg/d for 90 days.4,5,9 Body weights were recorded at the beginning of the treatment period and weekly thereafter. Hemoglobin concen- trations, packed cell volumes, white cell counts, and differen- tial white cell counts were measured before initiating treatment and immediately before sacrificing the animals at the end of...; CITATION=0; 5; 015; CITATION_NUMBERS=[5,15]; REFERENCE=0; 5; 015; DETAILS_JSON={"cas_number":"61791-14-8","citation":"0; 5; 015","dose":"The no-observed- adverse-effect level (NOAEL) was estimated to be 0.015% (approximately 12 mg/kg/d), based on body weight gain.","duration":"90 days","effect":"loss observed across all groups was not considered to be treatment related. Body weight gain was slightly decreased in males and females at 0.5% and in males at 0.015% in the diet. Feed con- sumption, hematology, and organ weights were not statistically different from controls. Histiocytosis (ie, aggregations of macro- phages with foamy cytoplasm) in the jejunum and mesenteric lymph node in the 0.5% group was the only treatment-related histopathological finding in this study. The no-observed- adverse-effect level (NOAEL) was estimated to be 0.015% (approximately 12 mg/kg/d), based on body weight gain. Groups of 4 male and female Beagle dogs were fed diets (ad libitum) containing PEG-2 tallow amine at concentrations cor- responding to doses of 0, 13, 40, and 120 mg/kg/d for 90 days.4,5,9 Body weights were recorded at the beginning of the treatment period and weekly thereafter. Hemoglobin concen- trations, packed cell volumes, white cell counts, and differen- tial white cell counts were measured before initiating treatment and immediately before sacrificing the animals at the end of...","endpoint":"repeated dose toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"","noael_unit":"%","noael_value":"0.015","page":23,"route":"oral","species":"dog","study_id":"PRS638_noael_002"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 13 mg/kg/d rat oral 90-day repeated dose toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=13; DOSE=The NOEL was reported to be 13 mg/kg/d, and the LOEL was 50 mg/kg/d.; EFFECT=. The liver, heart, lung, adrenals, kid- neys, spleen, thyroid, testes, epididymides, brain, and pituitary glands were weighed when the animals were necropsied. Rep- resentative sections were collected for microscopic examina- tion of the brain (cerebrum, cerebellum, and medulla), spinal cord, pituitary, submaxillary gland, thyroid, thymus, heart, lung, aorta, stomach, duodenum, jejunum, ileum, colon, liver, spleen, kidney, urinary bladder, adrenal, ovary and uterus or testes and epididymis, and sciatic nerve. The NOEL was reported to be 13 mg/kg/d, and the LOEL was 50 mg/kg/d. No other findings of this study were presented. Polyethylene glycol 2 C13-C15 alkyl amine. PEG-2 C13-C15 alkyl amine was tested in rats in a 90-day oral repeated-dose toxicity study.10 The PEG-2 C13-C15 alkyl amine is not 32S International Journal of Toxicology 37(Supplement 2); CITATION=13; 50; 2; CITATION_NUMBERS=[13,50,2]; REFERENCE=13; 50; 2; DETAILS_JSON={"cas_number":"61791-14-8","citation":"13; 50; 2","dose":"The NOEL was reported to be 13 mg/kg/d, and the LOEL was 50 mg/kg/d.","duration":"90-day","effect":". The liver, heart, lung, adrenals, kid- neys, spleen, thyroid, testes, epididymides, brain, and pituitary glands were weighed when the animals were necropsied. Rep- resentative sections were collected for microscopic examina- tion of the brain (cerebrum, cerebellum, and medulla), spinal cord, pituitary, submaxillary gland, thyroid, thymus, heart, lung, aorta, stomach, duodenum, jejunum, ileum, colon, liver, spleen, kidney, urinary bladder, adrenal, ovary and uterus or testes and epididymis, and sciatic nerve. The NOEL was reported to be 13 mg/kg/d, and the LOEL was 50 mg/kg/d. No other findings of this study were presented. Polyethylene glycol 2 C13-C15 alkyl amine. PEG-2 C13-C15 alkyl amine was tested in rats in a 90-day oral repeated-dose toxicity study.10 The PEG-2 C13-C15 alkyl amine is not 32S International Journal of Toxicology 37(Supplement 2)","endpoint":"repeated dose toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"","noael_unit":"mg/kg/d","noael_value":"13","page":23,"route":"oral","species":"rat","study_id":"PRS638_noael_003"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 15 mg/kg/d rat oral 90-day repeated dose toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=15; DOSE=statistically signifi- cant elevations in mean platelet, white blood cell, segmented neutrophil, and lymphocyte counts in the 150 mg/kg/d group.; LOAEL_VALUE=30 mg/kg/d; EFFECT=statistically signifi- cant elevations in mean platelet, white blood cell, segmented neutrophil, and lymphocyte counts in the 150 mg/kg/d group. The inflammation observed in the lungs was attributed to inad- vertent aspiration following gavage. Desquamation and altera- tion of the mucosa of the nonglandular stomach was observed primarily in rats of the 150 mg/kg/d group, but also in some rats of the 30 mg/kg/d. Two females in the 150 mg/kg/d group had suppurative inflammation of the glandular stomach. The reported NOAEL was 15 mg/kg/d, and the lowest-observed- adverse-effect level (LOAEL) was 30 mg/kg/d in this study. Polyethylene glycol 15 tallow amine. In a 90-day oral toxicity study, PEG-15 tallow amine was administered in the diet ad libitum to 3 groups of 10 male and 10 female Sprague Dawley rats.10 The concentrations of the test substance in the test diets were approximately 500, 1,500, or 4,500 ppm (equivalent to about 33, 99, and 292 mg/kg/d for males, respectively, and 40, 123, and 357 mg/kg/d for females, respectively). The control group received the basal diet. Exposure...; CITATION=150; 30; 15; CITATION_NUMBERS=[150,30,15]; REFERENCE=150; 30; 15; DETAILS_JSON={"cas_number":"61791-14-8","citation":"150; 30; 15","dose":"statistically signifi- cant elevations in mean platelet, white blood cell, segmented neutrophil, and lymphocyte counts in the 150 mg/kg/d group.","duration":"90-day","effect":"statistically signifi- cant elevations in mean platelet, white blood cell, segmented neutrophil, and lymphocyte counts in the 150 mg/kg/d group. The inflammation observed in the lungs was attributed to inad- vertent aspiration following gavage. Desquamation and altera- tion of the mucosa of the nonglandular stomach was observed primarily in rats of the 150 mg/kg/d group, but also in some rats of the 30 mg/kg/d. Two females in the 150 mg/kg/d group had suppurative inflammation of the glandular stomach. The reported NOAEL was 15 mg/kg/d, and the lowest-observed- adverse-effect level (LOAEL) was 30 mg/kg/d in this study. Polyethylene glycol 15 tallow amine. In a 90-day oral toxicity study, PEG-15 tallow amine was administered in the diet ad libitum to 3 groups of 10 male and 10 female Sprague Dawley rats.10 The concentrations of the test substance in the test diets were approximately 500, 1,500, or 4,500 ppm (equivalent to about 33, 99, and 292 mg/kg/d for males, respectively, and 40, 123, and 357 mg/kg/d for females, respectively). The control group received the basal diet. Exposure...","endpoint":"repeated dose toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"30 mg/kg/d","noael_unit":"mg/kg/d","noael_value":"15","page":24,"route":"oral","species":"rat","study_id":"PRS638_noael_004"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 23 mg/kg/d rat oral 72 days repeated dose toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=23; DOSE=R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen:; EFFECT=Table 12. Analog Group 1: PEG-2 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: () In vivo mouse micronucleus test: () Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-; CITATION=12; 1; 2; CITATION_NUMBERS=[12,1,2]; REFERENCE=12; 1; 2; DETAILS_JSON={"cas_number":"61791-14-8","citation":"12; 1; 2","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen:","duration":"72 days","effect":"Table 12. Analog Group 1: PEG-2 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-","endpoint":"repeated dose toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"","noael_unit":"mg/kg/d","noael_value":"23","page":41,"route":"oral","species":"rat","study_id":"PRS638_noael_010"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 134 mg/kg/d rat oral 72 days repeated dose toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=134; DOSE=R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen:; EFFECT=able 12. Analog Group 1: PEG-2 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: () In vivo mouse micronucleus test: () Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOE...; CITATION=12; 1; 2; CITATION_NUMBERS=[12,1,2]; REFERENCE=12; 1; 2; DETAILS_JSON={"cas_number":"61791-14-8","citation":"12; 1; 2","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen:","duration":"72 days","effect":"able 12. Analog Group 1: PEG-2 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-2 cocamine 61791-31-9 8-16 2 No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOE...","endpoint":"repeated dose toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"","noael_unit":"mg/kg/d","noael_value":"134","page":41,"route":"oral","species":"rat","study_id":"PRS638_noael_011"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 50 mg/kg/d rat oral 72 days repeated dose toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=50; DOSE=2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days.; EFFECT=No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: () In vivo mouse micronucleus test: () Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOEL ¼ 12 mg/kg/d (based on body weight gain) or 40 mg/kg/d (based on histiocytosis). Food consumption in all treated groups similar to control. Small decrease in body weight gain in mid-dose males and high-dose males and females; h...; CITATION=2, 8, 23, 134; 3, 9, 26, 148; 69; CITATION_NUMBERS=[2,8,23,134,3,9,26,148,69]; REFERENCE=2, 8, 23, 134; 3, 9, 26, 148; 69; DETAILS_JSON={"cas_number":"61791-14-8","citation":"2, 8, 23, 134; 3, 9, 26, 148; 69","dose":"2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days.","duration":"72 days","effect":"No data No data (other than DART screening data) Rat DART screen: 2, 8, 23, 134 mg/kg/d (males) or 3, 9, 26, 148 mg/kg/d (females) via diet for 69-72 days. Developmental NOAEL ¼ 23 mg/kg/d. Decreased postnatal survival, live litter size, # of pups born, and implantation sites. Reproductive NOAEL ¼ 134 mg/kg/d (highest dose tested). Parental NOAEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOEL ¼ 12 mg/kg/d (based on body weight gain) or 40 mg/kg/d (based on histiocytosis). Food consumption in all treated groups similar to control. Small decrease in body weight gain in mid-dose males and high-dose males and females; h...","endpoint":"repeated dose toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"","noael_unit":"mg/kg/d","noael_value":"50","page":41,"route":"oral","species":"rat","study_id":"PRS638_noael_012"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 12 mg/kg/d rat oral 90-day repeated dose toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=12; DOSE=AEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test:; EFFECT=AEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: () In vivo mouse micronucleus test: () Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOEL ¼ 12 mg/kg/d (based on body weight gain) or 40 mg/kg/d (based on histiocytosis). Food consumption in all treated groups similar to control. Small decrease in body weight gain in mid-dose males and high-dose males and females; histiocytosis in small intestine and mesenteric lymph nodes at high dose No data 9,12,13 Dog 90-day oral study. 13, 40, or 120 mg/kg/d via diet; NOEL ¼ 13 mg/kg/d. Palatability issues at mid and high dose. GI clinical signs at mid and high dose (vomiting); histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-...; CITATION=23; 10; 2; CITATION_NUMBERS=[23,10,2]; REFERENCE=23; 10; 2; DETAILS_JSON={"cas_number":"61791-14-8","citation":"23; 10; 2","dose":"AEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test:","duration":"90-day","effect":"AEL ¼ 23 mg/kg/d 10 Analogs PEG-2 tallow amine 61791-44-4 14-18 2 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 15, 50, or 150 mg/kg/d via diet; NOEL ¼ 50 mg/kg/d. Palatability of diet decreased at high dose. Gross macroscopic observations: yellow coloration and thickening of mucosa in small intestine and regional mesenteric lymph nodes at high dose; histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat 90-day oral study. 0.8, 12, or 400 mg/kg/d via diet; NOEL ¼ 12 mg/kg/d (based on body weight gain) or 40 mg/kg/d (based on histiocytosis). Food consumption in all treated groups similar to control. Small decrease in body weight gain in mid-dose males and high-dose males and females; histiocytosis in small intestine and mesenteric lymph nodes at high dose No data 9,12,13 Dog 90-day oral study. 13, 40, or 120 mg/kg/d via diet; NOEL ¼ 13 mg/kg/d. Palatability issues at mid and high dose. GI clinical signs at mid and high dose (vomiting); histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-...","endpoint":"repeated dose toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"","noael_unit":"mg/kg/d","noael_value":"12","page":41,"route":"oral","species":"rat","study_id":"PRS638_noael_013"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 30 mg/kg/d rat oral 28-day repeated dose toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=30; DOSE=histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-day percutaneous study.; EFFECT=histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-day percutaneous study. 0.1% or 0.5% aqueous dispersion (2 or 10 mg/kg/d), 5 d/wk for 4 weeks. Slight to moderate skin irritation at both concentrations; no evidence of systemic toxicity PEG-2 C13-C15 alkyl amine 70955-14-5 13-15 2 No data Rat 90-day oral study. 15, 30, or 150 mg/kg/d via gavage; NOAEL ¼ 15 mg/kg/d. Macro and microscopic changes in nonglandular stomach Dog 90-day oral study. 15, 30, or 100 mg/kg/d via capsule; NOAEL ¼ 30 mg/kg/d. GI clinical signs: increased alanine aminotransferase (ALT) females only; increased pigment accumulation in Kupffer cells and bile canaliculi females only 10 PEG-4 cocamine 61791-14-8 8-16 4 No data No data No data - Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 50S; CITATION=28; 0; 1; CITATION_NUMBERS=[28,1]; REFERENCE=28; 0; 1; DETAILS_JSON={"cas_number":"61791-14-8","citation":"28; 0; 1","dose":"histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-day percutaneous study.","duration":"28-day","effect":"histiocytosis in small intestine and regional lymph nodes at mid and high dose Rabbit 28-day percutaneous study. 0.1% or 0.5% aqueous dispersion (2 or 10 mg/kg/d), 5 d/wk for 4 weeks. Slight to moderate skin irritation at both concentrations; no evidence of systemic toxicity PEG-2 C13-C15 alkyl amine 70955-14-5 13-15 2 No data Rat 90-day oral study. 15, 30, or 150 mg/kg/d via gavage; NOAEL ¼ 15 mg/kg/d. Macro and microscopic changes in nonglandular stomach Dog 90-day oral study. 15, 30, or 100 mg/kg/d via capsule; NOAEL ¼ 30 mg/kg/d. GI clinical signs: increased alanine aminotransferase (ALT) females only; increased pigment accumulation in Kupffer cells and bile canaliculi females only 10 PEG-4 cocamine 61791-14-8 8-16 4 No data No data No data - Abbreviations: GI, gastrointestinal; NOEL, no-observed-effect level; PEG, polyethylene glycol. 50S","endpoint":"repeated dose toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"","noael_unit":"mg/kg/d","noael_value":"30","page":41,"route":"oral","species":"rat","study_id":"PRS638_noael_014"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 33 mg/kg/d rat oral 90-day repeated dose toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=33; DOSE=R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data - Analogs PEG-8 stearamine 26635-92-7 16-18 8 Ames test:; LOAEL_VALUE=53 mg/kg/d; EFFECT=performance at doses that were Table 14. Analog Group 3: PEG-10 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data - Analogs PEG-8 stearamine 26635-92-7 16-18 8 Ames test: () No data No data 9,11 PEG-15 tallow amine 61791-26-2 16-18 15 Ames test: () In vivo mouse micronucleus test: () Rat 90-day oral study. 33, 99, and 292 mg/kg/d via diet; NOEL ¼ 33 mg/kg/d. GI irritation (hypertrophy and vacuolation of histiocytes in the lamina propria of the small intestine); histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat developmental toxicity test. 15, 100, or 300 mg/kg/d via gavage on GD 6-15; NOAEL ¼ 300 mg/kg/d (highest dose tested); maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen. 100, 300, or 1000 ppm in diet. Reproductive/developmental NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased litter size, and postnatal survival 10 POE-5/POP-12 tallow amine 68213...; CITATION=14; 3; 10; CITATION_NUMBERS=[14,3,10]; REFERENCE=14; 3; 10; DETAILS_JSON={"cas_number":"61791-14-8","citation":"14; 3; 10","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data - Analogs PEG-8 stearamine 26635-92-7 16-18 8 Ames test:","duration":"90-day","effect":"performance at doses that were Table 14. Analog Group 3: PEG-10 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data - Analogs PEG-8 stearamine 26635-92-7 16-18 8 Ames test: (\u0006) No data No data 9,11 PEG-15 tallow amine 61791-26-2 16-18 15 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 33, 99, and 292 mg/kg/d via diet; NOEL ¼ 33 mg/kg/d. GI irritation (hypertrophy and vacuolation of histiocytes in the lamina propria of the small intestine); histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat developmental toxicity test. 15, 100, or 300 mg/kg/d via gavage on GD 6-15; NOAEL ¼ 300 mg/kg/d (highest dose tested); maternal NOAEL ¼ 100 mg/kg/d Rat 2-generation DART screen. 100, 300, or 1000 ppm in diet. Reproductive/developmental NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased litter size, and postnatal survival 10 POE-5/POP-12 tallow amine 68213...","endpoint":"repeated dose toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"53 mg/kg/d","noael_unit":"mg/kg/d","noael_value":"33","page":43,"route":"oral","species":"rat","study_id":"PRS638_noael_015"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 75 mg/kg/d rat oral 4-week repeated dose toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=75; DOSE=R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-15 cocamine 61491-14-8 8-16 15 No data No data No data – Analogs PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data – POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study.; LOAEL_VALUE=53 mg/kg/d; EFFECT=Table 15. Analog Group 4: PEG-15 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-15 cocamine 61491-14-8 8-16 15 No data No data No data – Analogs PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data – POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study. 15, 75, or 200 mg/kg/d via gavage. NOAEL ¼ 75 mg/kg/d. Decreased body weight gain and food consumption No data 10 PEG-8 stearamine 26635-92-7 16-18 8 Ames test: () No data No data 9,11 PEG-15 tallow amine 61791-26-2 16-18 15 Ames test: () In vivo mouse micronucleus test: () Rat 90-day oral study. 33, 99, and 292 mg/kg/d via diet. NOEL ¼ 33 mg/kg/d. GI irritation, histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat developmental toxicity study: 15, 100, or 300 mg/ kg/d via gavage on gestation days 6-15. NOAEL 300 ¼ mg/kg/d Rat 2-generation DART study. NOAEL ¼ 15 mg/kg/ d; NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased lit; CITATION=15; 4; 14; CITATION_NUMBERS=[15,4,14]; REFERENCE=15; 4; 14; DETAILS_JSON={"cas_number":"61791-14-8","citation":"15; 4; 14","dose":"R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-15 cocamine 61491-14-8 8-16 15 No data No data No data – Analogs PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data – POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study.","duration":"4-week","effect":"Table 15. Analog Group 4: PEG-15 Cocamine as a Structure of Interest (SOI). Chemical CAS No. R x þ y Genotoxicity Repeated-dose toxicity Developmental and reproductive toxicity (DART) Reference SOI PEG-15 cocamine 61491-14-8 8-16 15 No data No data No data – Analogs PEG-10 cocamine 61791-14-8 8-16 10 No data No data No data – POE-5/POP-12 tallow amine 68213-26-3 16-18 17 No data Rat 4-week oral study. 15, 75, or 200 mg/kg/d via gavage. NOAEL ¼ 75 mg/kg/d. Decreased body weight gain and food consumption No data 10 PEG-8 stearamine 26635-92-7 16-18 8 Ames test: (\u0006) No data No data 9,11 PEG-15 tallow amine 61791-26-2 16-18 15 Ames test: (\u0006) In vivo mouse micronucleus test: (\u0006) Rat 90-day oral study. 33, 99, and 292 mg/kg/d via diet. NOEL ¼ 33 mg/kg/d. GI irritation, histiocytosis in small intestine and mesenteric lymph nodes at mid and high dose Rat developmental toxicity study: 15, 100, or 300 mg/ kg/d via gavage on gestation days 6-15. NOAEL 300 ¼ mg/kg/d Rat 2-generation DART study. NOAEL ¼ 15 mg/kg/ d; NOAEL ¼ 15 mg/kg/d; LOAEL ¼ 53 mg/kg/d. Litter loss, decreased lit","endpoint":"repeated dose toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"53 mg/kg/d","noael_unit":"mg/kg/d","noael_value":"75","page":44,"route":"oral","species":"rat","study_id":"PRS638_noael_017"}
UnifiedCodex:CIR:beta.noael_studies reproductive toxicity 1 ppm rat oral 28 days reproductive toxicity SOURCE_SUBDIR=PRS638; REPORT_TITLE=Safety Assessment of PEGs Cocamine and Related Ingredients as Used in Cosmetics Ivan Boyer1, Christina L. Burnett2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3,; OPINION_NUMBER=PRS638; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=1; 500; DOSE=he 1,500 ppm group exhib- ited similar effects, although to a lesser degree than observed in the 4,500 ppm group.; EFFECT=he 1,500 ppm group exhib- ited similar effects, although to a lesser degree than observed in the 4,500 ppm group. Body weight gain was decreased in both the 1,500 ppm group and the 4,500 ppm group, which was attributed to the reduced palatability of the diets. No clinical effects were noted at any dietary concentration less than 4,500 ppm, and no definite hematological abnormality, differences in organ weights, or abnormalities of the reproductive organs were found at any dietary concentration tested. The reported no-observed-effect level (NOEL) was 500 ppm (about 50 mg/kg/d) and the lowest-observed-effect level (LOEL) was 1,500 ppm in this study. Four groups of 40 Crl:CD(SD)BR rats (20 males and 20 females) were fed diets, ad libitum, containing PEG-2 tallow amine at concentrations of 0%, 0.001%, 0.015%, or 0.5% (wt/wt) for 28 days or until necropsy.4,5,9,13,29 The test substance was added to the diets as 1% solutions in corn oil. All animals were examined at least once every day for overt toxi- city or behavioral changes, individual body weights and group food consumption were r...; CITATION=1,500; 4,500; 500; CITATION_NUMBERS=[1,500,4]; REFERENCE=1,500; 4,500; 500; DETAILS_JSON={"cas_number":"61791-14-8","citation":"1,500; 4,500; 500","dose":"he 1,500 ppm group exhib- ited similar effects, although to a lesser degree than observed in the 4,500 ppm group.","duration":"28 days","effect":"he 1,500 ppm group exhib- ited similar effects, although to a lesser degree than observed in the 4,500 ppm group. Body weight gain was decreased in both the 1,500 ppm group and the 4,500 ppm group, which was attributed to the reduced palatability of the diets. No clinical effects were noted at any dietary concentration less than 4,500 ppm, and no definite hematological abnormality, differences in organ weights, or abnormalities of the reproductive organs were found at any dietary concentration tested. The reported no-observed-effect level (NOEL) was 500 ppm (about 50 mg/kg/d) and the lowest-observed-effect level (LOEL) was 1,500 ppm in this study. Four groups of 40 Crl:CD(SD)BR rats (20 males and 20 females) were fed diets, ad libitum, containing PEG-2 tallow amine at concentrations of 0%, 0.001%, 0.015%, or 0.5% (wt/wt) for 28 days or until necropsy.4,5,9,13,29 The test substance was added to the diets as 1% solutions in corn oil. All animals were examined at least once every day for overt toxi- city or behavioral changes, individual body weights and group food consumption were r...","endpoint":"reproductive toxicity","ingredient":"PEGs Cocamine and Related Ingredients","loael_value":"","noael_unit":"ppm","noael_value":"1; 500","page":23,"route":"oral","species":"rat","study_id":"PRS638_noael_001"}
openFDA substances 26 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
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openFDA substances FDA UNII substance identifier 28053HD34J UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"28053HD34J"}
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openFDA substances FDA UNII substance identifier PMT39AFQ4Z UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"PMT39AFQ4Z"}
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openFDA substances FDA UNII substance identifier ZA36V5XS8F UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"ZA36V5XS8F"}
openFDA substances FDA UNII substance identifier ZA36V5XS8F UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"ZA36V5XS8F"}
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openFDA substances FDA UNII substance identifier 2F9J4Q575K UNII - - - mixture {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"2F9J4Q575K"}
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