NOAEL Studies
Humectant
Glycerin NOAEL Studies
INCI: GLYCERIN
CAS: 56-81-5
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR_vision_codex 52 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR_vision_codex | NOAEL | =15 | g/kg | rat | oral | 42 days | repeated dose toxicity | {"citation":"(1; 3; 42","dose":"When glycerin (1 mL/kg/d in 3 doses) was orally admi- nistered for 42 days, increased serum glyceride concentrations were observed in both sexes; however, the increase was greater in men.21 Toxicological Studies In a survey of 4 laboratories of the use of vehicles for in vivo experiments, the highest no-observed-adverse-effect levels (NOAELs) of various r...","effect":"kg in water) in human male patients led to an increase in plasma glycerides. In human female patients, the oral administration of glycerin (1 mL/kg in water) resulted in no change in plasma glyceride concentra- tions. When glycerin (1 mL/kg/d in 3 doses) was orally admi- nistered for 42 days, increased serum glyceride concentrations were observed in both sexes; however, the increase was greater in men.21 Toxicological Studies In a survey of 4 laboratories of the use of vehicles for in vivo experiments, the highest no-observed-adverse-effect levels (NOAELs) of various routes of administration were assem- bled.22 The oral NOAELs for glycerin were 15 g/kg for rats and 500 mg/kg for guinea pigs for 1 month and 500 mg/kg for 90 days for mice (Table 4). The highest subcutaneous NOAELs were 10 mg/kg in rats and mice. Acute Toxicity Nonhuman. Reported oral median lethal dose (LD50) values of glycerin ranged from 2,530 to 58,400 mg/kg in rats; there were no deaths at 24,000 mg/kg in one study (Table 5).3,18,23-27 Reported oral LD50 values of glycerin were 4,090 to 38,000 mg/kg in mice, 27,...","page":6,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_001"} |
| CIR_vision_codex | NOAEL | =53.4 | % | rat | oral | 4 weeks | repeated dose toxicity | {"citation":"6; 30; 20","dose":"Repeated Dose Toxicity Oral—Nonhuman.","effect":"d after treatment. Hypotonic fluids relieve thirst and headache caused by the dehydrating action of glycerin. Repeated Dose Toxicity Oral—Nonhuman. Repeated dose toxicity studies are summar- ized in Table 6. Undiluted glycerin caused a dose-dependent increase in the number of animals showing hyperemia, pete- chial hemorrhage, and erosions in the gastrointestinal tract.30 In short-term feeding experiments, glycerin at 20% for 4 weeks in feed produced no adverse effects, but at 53.4%, an increase in Table 4. Highest NOAEL Reported in a Survey of 4 Research Organizations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated Subcutaneous Acute 10 mg/kg Well tolerated Intraperitoneal 1 month 250 mg/kg Well tolerated Rabbit Intravenous Not provided 10 mg/kg Well tolerated Abbreviation: NOAEL, no-...","page":6,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_002"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg | rat | oral | 1 month | repeated dose toxicity | {"citation":"22; 1,000; 1","dose":"zations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated...","effect":"zations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated Subcutaneous Acute 10 mg/kg Well tolerated Intraperitoneal 1 month 250 mg/kg Well tolerated Rabbit Intravenous Not provided 10 mg/kg Well tolerated Abbreviation: NOAEL, no-observed-adverse-effect level. Becker et al 11S","page":6,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_003"} |
| CIR_vision_codex | NOAEL | =115 | mg/ kg | rat | oral | 44 days | oral toxicity | {"citation":"4,30; 32; 115","dose":"kidney weights and increased liver enzymes were observed.4,30-32 The NOAEL was between 115 and 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When...","effect":"kidney weights and increased liver enzymes were observed.4,30-32 The NOAEL was between 115 and 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased in males fed synthetic gly- cerin versus those fed naturally sourced glycerin. There were no treatment-related effects in organ weights and gross pathology.26 The no-observed-effect-level (NOEL) in mongrel dogs was 950 mg/kg/d when glycerin was orally administered","page":8,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_004"} |
| CIR_vision_codex | NOAEL | =950 | mg/kg/d | rat | oral | 44 days | oral toxicity | {"citation":"2,300; 44; 33","dose":"nd 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased...","effect":"nd 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased in males fed synthetic gly- cerin versus those fed naturally sourced glycerin. There were no treatment-related effects in organ weights and gross pathology.26 The no-observed-effect-level (NOEL) in mongrel dogs was 950 mg/kg/d when glycerin was orally administered for 3 days (Table 6). At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemorrhages.34 Mongrel dogs experienced weight loss after 36 weeks when glycerin (35%) was incorporated into their feed. The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6...","page":8,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_005"} |
| CIR_vision_codex | NOAEL | =2.2 | g/kg/d | rat | oral | 50-week | inhalation toxicity | {"citation":"50; 80; 30","dose":"The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6).35 Oral—Human.","effect":"ted into their feed. The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6).35 Oral—Human. There were no signs of toxicity or effects on blood or urine production when patients (n ¼ 10 males, 4 females) were orally administered glycerin (approximately 1.3-2.2 g/kg/d; glycerin in orange juice with meals) for 50 days.3 The NOAEL was \u00062.2 g/kg/d. No further information was provided. There were no adverse effects observed in patients (n ¼ 14) administered glycerin (30 mL, neat) 3 times daily with each meal for 50 days.16 Dermal—Nonhuman. There were no treatment effects when glycerin (100%; 0.5-4 mL) was administered to 30% of the body surfaces of rabbits 5 d/wk for 45 weeks (Table 6).26 Inhalation—Nonhuman. The inhalation lowest-observed- adverse-effect-level (LOAEL) was 1,000 mg/L for glycerin administered nose only 6 h/d, 5 d/wk for 2 weeks in Crl: DCD Sprague Dawley rats, based on local e...","page":8,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_006"} |
| CIR_vision_codex | NOAEL | >99.8 | % | rat | inhalation | 5 d | inhalation toxicity | {"citation":"(1; 10, 13; 18, 16","dose":"No dose-related increase in the frequency, but the incidence of mild metaplasia was greatest in the high dose (7 animals with minimal and 6 with mild).","effect":"ed effects for hematology, organ weights, and gross pathology. Histopathology: Minimal-to-mild squamous metaplasia of the epiglottis in males and females (1/10, 13/18, 16/19, and 13/14, respectively). No dose-related increase in the frequency, but the incidence of mild metaplasia was greatest in the high dose (7 animals with minimal and 6 with mild). 36 Sprague Dawley Crl: DCD rat, male/female 15/sex 0, 0.033, 0.167, 0.662 mg/L for 5 h/d, 5 d/wk, for 13 weeks. Purity >99.8%, particle size <2.0 mm. Nose-only study. NOAEL ¼ 0.167 mg/L. Minimal-to-mild squamous metaplasia of the epithelium lining the base of the epiglottis at the high dose. Three per sex necropsied at 10 and 13 weeks to examine lungs with electron microscope. No clinical signs or mortalities. No treatment-related effects for body weights, clinical chemistry, hematology, organ weights, and gross pathology. Histopathology at 13 weeks: Minimal squamous metaplasia of the epiglottis in 2/25, 1/19, 4/20, and 10/21 rats, respectively; 1 male at 662 mg/L showed mild squamous metaplasia. No differences in morphology of the Cl...","page":10,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_007"} |
| CIR_vision_codex | NOAEL | =1 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"10; (9; 0","dose":"When glycerin (13.1, 60.8, 282, and 1,310 mg/kg/d) was administered by gavage to Wistar rats (n ¼ 25-28) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,310 mg/kg/d.","effect":"rus cycles, weight gain, and microscopic observations of the endocrine organs were com- parable to those of the controls in both the F1 and the F2 gen- eration. In the F0 generation, all 10 females became pregnant with similar litter size as controls (9.0 vs 8.1). In the F1 gener- ation, 9 of 10 females became pregnant. When glycerin (13.1, 60.8, 282, and 1,310 mg/kg/d) was administered by gavage to Wistar rats (n ¼ 25-28) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,310 mg/kg/d. The numbers of preg- nancies were 23 of 25, 24 of 25, 22 of 28, and 22 of 25 for 13.1, 60.8, 282, and 1,310 mg/kg/d, respectively, and 21 of 25 for controls. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups, as were the incidences of external, visceral, and skeletal abnormalities. When glycerin (12.8, 59.4, 276, and 1,280 mg/kg/d) was administered by gavage to CD-1 mice (n ¼ 25) on days 6 through 15 of gestation, there were no adverse effects observed...","page":11,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_008"} |
| CIR_vision_codex | NOAEL | =2200 | mg/kg/d | rat | oral | 3 days | developmental toxicity | {"citation":"3; 3,800; 36","dose":"At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemor- rhages.","effect":"nistered for 3 days. At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemor- rhages. Mongrel dogs experienced weight loss after 36 weeks when 35% glycerin was incorporated into their feed. There were no pathological changes in guinea pigs orally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days. There were no signs of toxicity or effects on blood or on urine production when human patients were orally adminis- tered approximately 1,300 to 2,200 g/kg/d glycerin for 50 days. The NOAEL was \u00062,200 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogeni...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_011"} |
| CIR_vision_codex | NOAEL | =1000 | mg/m3 | rat | oral | 40 days | developmental toxicity | {"citation":"6,300; 30; 40","dose":"rally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days.","effect":"rally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days. There were no signs of toxicity or effects on blood or on urine production when human patients were orally adminis- tered approximately 1,300 to 2,200 g/kg/d glycerin for 50 days. The NOAEL was \u00062,200 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight)...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_012"} |
| CIR_vision_codex | NOAEL | =1310 | mg/kg/d | rat | oral | 45 weeks | developmental toxicity | {"citation":"0; 100; 30","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","effect":"0 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister ch...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_013"} |
| CIR_vision_codex | NOAEL | =1280 | mg/kg/d | rat | oral | 45 weeks | developmental toxicity | {"citation":"30; 45; 1,000","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","effect":"lied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister chromatid exchange assay, unscheduled DNA synthesis assay, and chromosome aberrat...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_014"} |
| CIR_vision_codex | NOAEL | =1180 | mg/kg/d | rat | oral | 5 d | developmental toxicity | {"citation":"1,000; 6; 5","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","effect":"OAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister chromatid exchange assay, unscheduled DNA synthesis assay, and chromosome aberration test at concentra- tions up to 1.0 mg/mL. In 2 chromosomal aberration assays...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_015"} |
| CIR_vision_codex | NOAEL | =15 | g/kg | rat | oral | 42 days | repeated dose toxicity | {"citation":"(1; 3; 42","dose":"When glycerin (1 mL/kg/d in 3 doses) was orally admi- nistered for 42 days, increased serum glyceride concentrations were observed in both sexes; however, the increase was greater in men.21 Toxicological Studies In a survey of 4 laboratories of the use of vehicles for in vivo experiments, the highest no-observed-adverse-effect levels (NOAELs) of various r...","effect":"kg in water) in human male patients led to an increase in plasma glycerides. In human female patients, the oral administration of glycerin (1 mL/kg in water) resulted in no change in plasma glyceride concentra- tions. When glycerin (1 mL/kg/d in 3 doses) was orally admi- nistered for 42 days, increased serum glyceride concentrations were observed in both sexes; however, the increase was greater in men.21 Toxicological Studies In a survey of 4 laboratories of the use of vehicles for in vivo experiments, the highest no-observed-adverse-effect levels (NOAELs) of various routes of administration were assem- bled.22 The oral NOAELs for glycerin were 15 g/kg for rats and 500 mg/kg for guinea pigs for 1 month and 500 mg/kg for 90 days for mice (Table 4). The highest subcutaneous NOAELs were 10 mg/kg in rats and mice. Acute Toxicity Nonhuman. Reported oral median lethal dose (LD50) values of glycerin ranged from 2,530 to 58,400 mg/kg in rats; there were no deaths at 24,000 mg/kg in one study (Table 5).3,18,23-27 Reported oral LD50 values of glycerin were 4,090 to 38,000 mg/kg in mice, 27,...","page":6,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_001"} |
| CIR_vision_codex | NOAEL | =53.4 | % | rat | oral | 4 weeks | repeated dose toxicity | {"citation":"6; 30; 20","dose":"Repeated Dose Toxicity Oral—Nonhuman.","effect":"d after treatment. Hypotonic fluids relieve thirst and headache caused by the dehydrating action of glycerin. Repeated Dose Toxicity Oral—Nonhuman. Repeated dose toxicity studies are summar- ized in Table 6. Undiluted glycerin caused a dose-dependent increase in the number of animals showing hyperemia, pete- chial hemorrhage, and erosions in the gastrointestinal tract.30 In short-term feeding experiments, glycerin at 20% for 4 weeks in feed produced no adverse effects, but at 53.4%, an increase in Table 4. Highest NOAEL Reported in a Survey of 4 Research Organizations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated Subcutaneous Acute 10 mg/kg Well tolerated Intraperitoneal 1 month 250 mg/kg Well tolerated Rabbit Intravenous Not provided 10 mg/kg Well tolerated Abbreviation: NOAEL, no-...","page":6,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_002"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg | rat | oral | 1 month | repeated dose toxicity | {"citation":"22; 1,000; 1","dose":"zations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated...","effect":"zations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated Subcutaneous Acute 10 mg/kg Well tolerated Intraperitoneal 1 month 250 mg/kg Well tolerated Rabbit Intravenous Not provided 10 mg/kg Well tolerated Abbreviation: NOAEL, no-observed-adverse-effect level. Becker et al 11S","page":6,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_003"} |
| CIR_vision_codex | NOAEL | =115 | mg/ kg | rat | oral | 44 days | oral toxicity | {"citation":"4,30; 32; 115","dose":"kidney weights and increased liver enzymes were observed.4,30-32 The NOAEL was between 115 and 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When...","effect":"kidney weights and increased liver enzymes were observed.4,30-32 The NOAEL was between 115 and 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased in males fed synthetic gly- cerin versus those fed naturally sourced glycerin. There were no treatment-related effects in organ weights and gross pathology.26 The no-observed-effect-level (NOEL) in mongrel dogs was 950 mg/kg/d when glycerin was orally administered","page":8,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_004"} |
| CIR_vision_codex | NOAEL | =950 | mg/kg/d | rat | oral | 44 days | oral toxicity | {"citation":"2,300; 44; 33","dose":"nd 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased...","effect":"nd 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased in males fed synthetic gly- cerin versus those fed naturally sourced glycerin. There were no treatment-related effects in organ weights and gross pathology.26 The no-observed-effect-level (NOEL) in mongrel dogs was 950 mg/kg/d when glycerin was orally administered for 3 days (Table 6). At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemorrhages.34 Mongrel dogs experienced weight loss after 36 weeks when glycerin (35%) was incorporated into their feed. The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6...","page":8,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_005"} |
| CIR_vision_codex | NOAEL | =2.2 | g/kg/d | rat | oral | 50-week | inhalation toxicity | {"citation":"50; 80; 30","dose":"The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6).35 Oral—Human.","effect":"ted into their feed. The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6).35 Oral—Human. There were no signs of toxicity or effects on blood or urine production when patients (n ¼ 10 males, 4 females) were orally administered glycerin (approximately 1.3-2.2 g/kg/d; glycerin in orange juice with meals) for 50 days.3 The NOAEL was \u00062.2 g/kg/d. No further information was provided. There were no adverse effects observed in patients (n ¼ 14) administered glycerin (30 mL, neat) 3 times daily with each meal for 50 days.16 Dermal—Nonhuman. There were no treatment effects when glycerin (100%; 0.5-4 mL) was administered to 30% of the body surfaces of rabbits 5 d/wk for 45 weeks (Table 6).26 Inhalation—Nonhuman. The inhalation lowest-observed- adverse-effect-level (LOAEL) was 1,000 mg/L for glycerin administered nose only 6 h/d, 5 d/wk for 2 weeks in Crl: DCD Sprague Dawley rats, based on local e...","page":8,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_006"} |
| CIR_vision_codex | NOAEL | >99.8 | % | rat | inhalation | 5 d | inhalation toxicity | {"citation":"(1; 10, 13; 18, 16","dose":"No dose-related increase in the frequency, but the incidence of mild metaplasia was greatest in the high dose (7 animals with minimal and 6 with mild).","effect":"ed effects for hematology, organ weights, and gross pathology. Histopathology: Minimal-to-mild squamous metaplasia of the epiglottis in males and females (1/10, 13/18, 16/19, and 13/14, respectively). No dose-related increase in the frequency, but the incidence of mild metaplasia was greatest in the high dose (7 animals with minimal and 6 with mild). 36 Sprague Dawley Crl: DCD rat, male/female 15/sex 0, 0.033, 0.167, 0.662 mg/L for 5 h/d, 5 d/wk, for 13 weeks. Purity >99.8%, particle size <2.0 mm. Nose-only study. NOAEL ¼ 0.167 mg/L. Minimal-to-mild squamous metaplasia of the epithelium lining the base of the epiglottis at the high dose. Three per sex necropsied at 10 and 13 weeks to examine lungs with electron microscope. No clinical signs or mortalities. No treatment-related effects for body weights, clinical chemistry, hematology, organ weights, and gross pathology. Histopathology at 13 weeks: Minimal squamous metaplasia of the epiglottis in 2/25, 1/19, 4/20, and 10/21 rats, respectively; 1 male at 662 mg/L showed mild squamous metaplasia. No differences in morphology of the Cl...","page":10,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_007"} |
| CIR_vision_codex | NOAEL | =1 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"10; (9; 0","dose":"When glycerin (13.1, 60.8, 282, and 1,310 mg/kg/d) was administered by gavage to Wistar rats (n ¼ 25-28) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,310 mg/kg/d.","effect":"rus cycles, weight gain, and microscopic observations of the endocrine organs were com- parable to those of the controls in both the F1 and the F2 gen- eration. In the F0 generation, all 10 females became pregnant with similar litter size as controls (9.0 vs 8.1). In the F1 gener- ation, 9 of 10 females became pregnant. When glycerin (13.1, 60.8, 282, and 1,310 mg/kg/d) was administered by gavage to Wistar rats (n ¼ 25-28) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,310 mg/kg/d. The numbers of preg- nancies were 23 of 25, 24 of 25, 22 of 28, and 22 of 25 for 13.1, 60.8, 282, and 1,310 mg/kg/d, respectively, and 21 of 25 for controls. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups, as were the incidences of external, visceral, and skeletal abnormalities. When glycerin (12.8, 59.4, 276, and 1,280 mg/kg/d) was administered by gavage to CD-1 mice (n ¼ 25) on days 6 through 15 of gestation, there were no adverse effects observed...","page":11,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_008"} |
| CIR_vision_codex | NOAEL | =2200 | mg/kg/d | rat | oral | 3 days | developmental toxicity | {"citation":"3; 3,800; 36","dose":"At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemor- rhages.","effect":"nistered for 3 days. At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemor- rhages. Mongrel dogs experienced weight loss after 36 weeks when 35% glycerin was incorporated into their feed. There were no pathological changes in guinea pigs orally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days. There were no signs of toxicity or effects on blood or on urine production when human patients were orally adminis- tered approximately 1,300 to 2,200 g/kg/d glycerin for 50 days. The NOAEL was \u00062,200 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogeni...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_011"} |
| CIR_vision_codex | NOAEL | =1000 | mg/m3 | rat | oral | 40 days | developmental toxicity | {"citation":"6,300; 30; 40","dose":"rally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days.","effect":"rally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days. There were no signs of toxicity or effects on blood or on urine production when human patients were orally adminis- tered approximately 1,300 to 2,200 g/kg/d glycerin for 50 days. The NOAEL was \u00062,200 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight)...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_012"} |
| CIR_vision_codex | NOAEL | =1310 | mg/kg/d | rat | oral | 45 weeks | developmental toxicity | {"citation":"0; 100; 30","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","effect":"0 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister ch...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_013"} |
| CIR_vision_codex | NOAEL | =1280 | mg/kg/d | rat | oral | 45 weeks | developmental toxicity | {"citation":"30; 45; 1,000","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","effect":"lied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister chromatid exchange assay, unscheduled DNA synthesis assay, and chromosome aberrat...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_014"} |
| CIR_vision_codex | NOAEL | =1180 | mg/kg/d | rat | oral | 5 d | developmental toxicity | {"citation":"1,000; 6; 5","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","effect":"OAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister chromatid exchange assay, unscheduled DNA synthesis assay, and chromosome aberration test at concentra- tions up to 1.0 mg/mL. In 2 chromosomal aberration assays...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_015"} |
| CIR_vision_codex | NOAEL | =15 | g/kg | rat | oral | 42 days | repeated dose toxicity | {"citation":"(1; 3; 42","dose":"When glycerin (1 mL/kg/d in 3 doses) was orally admi- nistered for 42 days, increased serum glyceride concentrations were observed in both sexes; however, the increase was greater in men.21 Toxicological Studies In a survey of 4 laboratories of the use of vehicles for in vivo experiments, the highest no-observed-adverse-effect levels (NOAELs) of various r...","effect":"kg in water) in human male patients led to an increase in plasma glycerides. In human female patients, the oral administration of glycerin (1 mL/kg in water) resulted in no change in plasma glyceride concentra- tions. When glycerin (1 mL/kg/d in 3 doses) was orally admi- nistered for 42 days, increased serum glyceride concentrations were observed in both sexes; however, the increase was greater in men.21 Toxicological Studies In a survey of 4 laboratories of the use of vehicles for in vivo experiments, the highest no-observed-adverse-effect levels (NOAELs) of various routes of administration were assem- bled.22 The oral NOAELs for glycerin were 15 g/kg for rats and 500 mg/kg for guinea pigs for 1 month and 500 mg/kg for 90 days for mice (Table 4). The highest subcutaneous NOAELs were 10 mg/kg in rats and mice. Acute Toxicity Nonhuman. Reported oral median lethal dose (LD50) values of glycerin ranged from 2,530 to 58,400 mg/kg in rats; there were no deaths at 24,000 mg/kg in one study (Table 5).3,18,23-27 Reported oral LD50 values of glycerin were 4,090 to 38,000 mg/kg in mice, 27,...","page":6,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_001"} |
| CIR_vision_codex | NOAEL | =53.4 | % | rat | oral | 4 weeks | repeated dose toxicity | {"citation":"6; 30; 20","dose":"Repeated Dose Toxicity Oral—Nonhuman.","effect":"d after treatment. Hypotonic fluids relieve thirst and headache caused by the dehydrating action of glycerin. Repeated Dose Toxicity Oral—Nonhuman. Repeated dose toxicity studies are summar- ized in Table 6. Undiluted glycerin caused a dose-dependent increase in the number of animals showing hyperemia, pete- chial hemorrhage, and erosions in the gastrointestinal tract.30 In short-term feeding experiments, glycerin at 20% for 4 weeks in feed produced no adverse effects, but at 53.4%, an increase in Table 4. Highest NOAEL Reported in a Survey of 4 Research Organizations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated Subcutaneous Acute 10 mg/kg Well tolerated Intraperitoneal 1 month 250 mg/kg Well tolerated Rabbit Intravenous Not provided 10 mg/kg Well tolerated Abbreviation: NOAEL, no-...","page":6,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_002"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg | rat | oral | 1 month | repeated dose toxicity | {"citation":"22; 1,000; 1","dose":"zations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated...","effect":"zations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated Subcutaneous Acute 10 mg/kg Well tolerated Intraperitoneal 1 month 250 mg/kg Well tolerated Rabbit Intravenous Not provided 10 mg/kg Well tolerated Abbreviation: NOAEL, no-observed-adverse-effect level. Becker et al 11S","page":6,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_003"} |
| CIR_vision_codex | NOAEL | =115 | mg/ kg | rat | oral | 44 days | oral toxicity | {"citation":"4,30; 32; 115","dose":"kidney weights and increased liver enzymes were observed.4,30-32 The NOAEL was between 115 and 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When...","effect":"kidney weights and increased liver enzymes were observed.4,30-32 The NOAEL was between 115 and 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased in males fed synthetic gly- cerin versus those fed naturally sourced glycerin. There were no treatment-related effects in organ weights and gross pathology.26 The no-observed-effect-level (NOEL) in mongrel dogs was 950 mg/kg/d when glycerin was orally administered","page":8,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_004"} |
| CIR_vision_codex | NOAEL | =950 | mg/kg/d | rat | oral | 44 days | oral toxicity | {"citation":"2,300; 44; 33","dose":"nd 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased...","effect":"nd 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased in males fed synthetic gly- cerin versus those fed naturally sourced glycerin. There were no treatment-related effects in organ weights and gross pathology.26 The no-observed-effect-level (NOEL) in mongrel dogs was 950 mg/kg/d when glycerin was orally administered for 3 days (Table 6). At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemorrhages.34 Mongrel dogs experienced weight loss after 36 weeks when glycerin (35%) was incorporated into their feed. The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6...","page":8,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_005"} |
| CIR_vision_codex | NOAEL | =2.2 | g/kg/d | rat | oral | 50-week | inhalation toxicity | {"citation":"50; 80; 30","dose":"The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6).35 Oral—Human.","effect":"ted into their feed. The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6).35 Oral—Human. There were no signs of toxicity or effects on blood or urine production when patients (n ¼ 10 males, 4 females) were orally administered glycerin (approximately 1.3-2.2 g/kg/d; glycerin in orange juice with meals) for 50 days.3 The NOAEL was \u00062.2 g/kg/d. No further information was provided. There were no adverse effects observed in patients (n ¼ 14) administered glycerin (30 mL, neat) 3 times daily with each meal for 50 days.16 Dermal—Nonhuman. There were no treatment effects when glycerin (100%; 0.5-4 mL) was administered to 30% of the body surfaces of rabbits 5 d/wk for 45 weeks (Table 6).26 Inhalation—Nonhuman. The inhalation lowest-observed- adverse-effect-level (LOAEL) was 1,000 mg/L for glycerin administered nose only 6 h/d, 5 d/wk for 2 weeks in Crl: DCD Sprague Dawley rats, based on local e...","page":8,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_006"} |
| CIR_vision_codex | NOAEL | >99.8 | % | rat | inhalation | 5 d | inhalation toxicity | {"citation":"(1; 10, 13; 18, 16","dose":"No dose-related increase in the frequency, but the incidence of mild metaplasia was greatest in the high dose (7 animals with minimal and 6 with mild).","effect":"ed effects for hematology, organ weights, and gross pathology. Histopathology: Minimal-to-mild squamous metaplasia of the epiglottis in males and females (1/10, 13/18, 16/19, and 13/14, respectively). No dose-related increase in the frequency, but the incidence of mild metaplasia was greatest in the high dose (7 animals with minimal and 6 with mild). 36 Sprague Dawley Crl: DCD rat, male/female 15/sex 0, 0.033, 0.167, 0.662 mg/L for 5 h/d, 5 d/wk, for 13 weeks. Purity >99.8%, particle size <2.0 mm. Nose-only study. NOAEL ¼ 0.167 mg/L. Minimal-to-mild squamous metaplasia of the epithelium lining the base of the epiglottis at the high dose. Three per sex necropsied at 10 and 13 weeks to examine lungs with electron microscope. No clinical signs or mortalities. No treatment-related effects for body weights, clinical chemistry, hematology, organ weights, and gross pathology. Histopathology at 13 weeks: Minimal squamous metaplasia of the epiglottis in 2/25, 1/19, 4/20, and 10/21 rats, respectively; 1 male at 662 mg/L showed mild squamous metaplasia. No differences in morphology of the Cl...","page":10,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_007"} |
| CIR_vision_codex | NOAEL | =1 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"10; (9; 0","dose":"When glycerin (13.1, 60.8, 282, and 1,310 mg/kg/d) was administered by gavage to Wistar rats (n ¼ 25-28) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,310 mg/kg/d.","effect":"rus cycles, weight gain, and microscopic observations of the endocrine organs were com- parable to those of the controls in both the F1 and the F2 gen- eration. In the F0 generation, all 10 females became pregnant with similar litter size as controls (9.0 vs 8.1). In the F1 gener- ation, 9 of 10 females became pregnant. When glycerin (13.1, 60.8, 282, and 1,310 mg/kg/d) was administered by gavage to Wistar rats (n ¼ 25-28) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,310 mg/kg/d. The numbers of preg- nancies were 23 of 25, 24 of 25, 22 of 28, and 22 of 25 for 13.1, 60.8, 282, and 1,310 mg/kg/d, respectively, and 21 of 25 for controls. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups, as were the incidences of external, visceral, and skeletal abnormalities. When glycerin (12.8, 59.4, 276, and 1,280 mg/kg/d) was administered by gavage to CD-1 mice (n ¼ 25) on days 6 through 15 of gestation, there were no adverse effects observed...","page":11,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_008"} |
| CIR_vision_codex | NOAEL | =2200 | mg/kg/d | rat | oral | 3 days | developmental toxicity | {"citation":"3; 3,800; 36","dose":"At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemor- rhages.","effect":"nistered for 3 days. At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemor- rhages. Mongrel dogs experienced weight loss after 36 weeks when 35% glycerin was incorporated into their feed. There were no pathological changes in guinea pigs orally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days. There were no signs of toxicity or effects on blood or on urine production when human patients were orally adminis- tered approximately 1,300 to 2,200 g/kg/d glycerin for 50 days. The NOAEL was \u00062,200 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogeni...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_011"} |
| CIR_vision_codex | NOAEL | =1000 | mg/m3 | rat | oral | 40 days | developmental toxicity | {"citation":"6,300; 30; 40","dose":"rally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days.","effect":"rally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days. There were no signs of toxicity or effects on blood or on urine production when human patients were orally adminis- tered approximately 1,300 to 2,200 g/kg/d glycerin for 50 days. The NOAEL was \u00062,200 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight)...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_012"} |
| CIR_vision_codex | NOAEL | =1310 | mg/kg/d | rat | oral | 45 weeks | developmental toxicity | {"citation":"0; 100; 30","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","effect":"0 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister ch...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_013"} |
| CIR_vision_codex | NOAEL | =1280 | mg/kg/d | rat | oral | 45 weeks | developmental toxicity | {"citation":"30; 45; 1,000","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","effect":"lied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister chromatid exchange assay, unscheduled DNA synthesis assay, and chromosome aberrat...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_014"} |
| CIR_vision_codex | NOAEL | =1180 | mg/kg/d | rat | oral | 5 d | developmental toxicity | {"citation":"1,000; 6; 5","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","effect":"OAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister chromatid exchange assay, unscheduled DNA synthesis assay, and chromosome aberration test at concentra- tions up to 1.0 mg/mL. In 2 chromosomal aberration assays...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_015"} |
| CIR_vision_codex | NOAEL | =15 | g/kg | rat | oral | 42 days | repeated dose toxicity | {"citation":"(1; 3; 42","dose":"When glycerin (1 mL/kg/d in 3 doses) was orally admi- nistered for 42 days, increased serum glyceride concentrations were observed in both sexes; however, the increase was greater in men.21 Toxicological Studies In a survey of 4 laboratories of the use of vehicles for in vivo experiments, the highest no-observed-adverse-effect levels (NOAELs) of various r...","effect":"kg in water) in human male patients led to an increase in plasma glycerides. In human female patients, the oral administration of glycerin (1 mL/kg in water) resulted in no change in plasma glyceride concentra- tions. When glycerin (1 mL/kg/d in 3 doses) was orally admi- nistered for 42 days, increased serum glyceride concentrations were observed in both sexes; however, the increase was greater in men.21 Toxicological Studies In a survey of 4 laboratories of the use of vehicles for in vivo experiments, the highest no-observed-adverse-effect levels (NOAELs) of various routes of administration were assem- bled.22 The oral NOAELs for glycerin were 15 g/kg for rats and 500 mg/kg for guinea pigs for 1 month and 500 mg/kg for 90 days for mice (Table 4). The highest subcutaneous NOAELs were 10 mg/kg in rats and mice. Acute Toxicity Nonhuman. Reported oral median lethal dose (LD50) values of glycerin ranged from 2,530 to 58,400 mg/kg in rats; there were no deaths at 24,000 mg/kg in one study (Table 5).3,18,23-27 Reported oral LD50 values of glycerin were 4,090 to 38,000 mg/kg in mice, 27,...","page":6,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_001"} |
| CIR_vision_codex | NOAEL | =53.4 | % | rat | oral | 4 weeks | repeated dose toxicity | {"citation":"6; 30; 20","dose":"Repeated Dose Toxicity Oral—Nonhuman.","effect":"d after treatment. Hypotonic fluids relieve thirst and headache caused by the dehydrating action of glycerin. Repeated Dose Toxicity Oral—Nonhuman. Repeated dose toxicity studies are summar- ized in Table 6. Undiluted glycerin caused a dose-dependent increase in the number of animals showing hyperemia, pete- chial hemorrhage, and erosions in the gastrointestinal tract.30 In short-term feeding experiments, glycerin at 20% for 4 weeks in feed produced no adverse effects, but at 53.4%, an increase in Table 4. Highest NOAEL Reported in a Survey of 4 Research Organizations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated Subcutaneous Acute 10 mg/kg Well tolerated Intraperitoneal 1 month 250 mg/kg Well tolerated Rabbit Intravenous Not provided 10 mg/kg Well tolerated Abbreviation: NOAEL, no-...","page":6,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_002"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg | rat | oral | 1 month | repeated dose toxicity | {"citation":"22; 1,000; 1","dose":"zations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated...","effect":"zations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated Subcutaneous Acute 10 mg/kg Well tolerated Intraperitoneal 1 month 250 mg/kg Well tolerated Rabbit Intravenous Not provided 10 mg/kg Well tolerated Abbreviation: NOAEL, no-observed-adverse-effect level. Becker et al 11S","page":6,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_003"} |
| CIR_vision_codex | NOAEL | =115 | mg/ kg | rat | oral | 44 days | oral toxicity | {"citation":"4,30; 32; 115","dose":"kidney weights and increased liver enzymes were observed.4,30-32 The NOAEL was between 115 and 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When...","effect":"kidney weights and increased liver enzymes were observed.4,30-32 The NOAEL was between 115 and 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased in males fed synthetic gly- cerin versus those fed naturally sourced glycerin. There were no treatment-related effects in organ weights and gross pathology.26 The no-observed-effect-level (NOEL) in mongrel dogs was 950 mg/kg/d when glycerin was orally administered","page":8,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_004"} |
| CIR_vision_codex | NOAEL | =950 | mg/kg/d | rat | oral | 44 days | oral toxicity | {"citation":"2,300; 44; 33","dose":"nd 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased...","effect":"nd 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased in males fed synthetic gly- cerin versus those fed naturally sourced glycerin. There were no treatment-related effects in organ weights and gross pathology.26 The no-observed-effect-level (NOEL) in mongrel dogs was 950 mg/kg/d when glycerin was orally administered for 3 days (Table 6). At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemorrhages.34 Mongrel dogs experienced weight loss after 36 weeks when glycerin (35%) was incorporated into their feed. The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6...","page":8,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_005"} |
| CIR_vision_codex | NOAEL | =2.2 | g/kg/d | rat | oral | 50-week | inhalation toxicity | {"citation":"50; 80; 30","dose":"The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6).35 Oral—Human.","effect":"ted into their feed. The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6).35 Oral—Human. There were no signs of toxicity or effects on blood or urine production when patients (n ¼ 10 males, 4 females) were orally administered glycerin (approximately 1.3-2.2 g/kg/d; glycerin in orange juice with meals) for 50 days.3 The NOAEL was \u00062.2 g/kg/d. No further information was provided. There were no adverse effects observed in patients (n ¼ 14) administered glycerin (30 mL, neat) 3 times daily with each meal for 50 days.16 Dermal—Nonhuman. There were no treatment effects when glycerin (100%; 0.5-4 mL) was administered to 30% of the body surfaces of rabbits 5 d/wk for 45 weeks (Table 6).26 Inhalation—Nonhuman. The inhalation lowest-observed- adverse-effect-level (LOAEL) was 1,000 mg/L for glycerin administered nose only 6 h/d, 5 d/wk for 2 weeks in Crl: DCD Sprague Dawley rats, based on local e...","page":8,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_006"} |
| CIR_vision_codex | NOAEL | >99.8 | % | rat | inhalation | 5 d | inhalation toxicity | {"citation":"(1; 10, 13; 18, 16","dose":"No dose-related increase in the frequency, but the incidence of mild metaplasia was greatest in the high dose (7 animals with minimal and 6 with mild).","effect":"ed effects for hematology, organ weights, and gross pathology. Histopathology: Minimal-to-mild squamous metaplasia of the epiglottis in males and females (1/10, 13/18, 16/19, and 13/14, respectively). No dose-related increase in the frequency, but the incidence of mild metaplasia was greatest in the high dose (7 animals with minimal and 6 with mild). 36 Sprague Dawley Crl: DCD rat, male/female 15/sex 0, 0.033, 0.167, 0.662 mg/L for 5 h/d, 5 d/wk, for 13 weeks. Purity >99.8%, particle size <2.0 mm. Nose-only study. NOAEL ¼ 0.167 mg/L. Minimal-to-mild squamous metaplasia of the epithelium lining the base of the epiglottis at the high dose. Three per sex necropsied at 10 and 13 weeks to examine lungs with electron microscope. No clinical signs or mortalities. No treatment-related effects for body weights, clinical chemistry, hematology, organ weights, and gross pathology. Histopathology at 13 weeks: Minimal squamous metaplasia of the epiglottis in 2/25, 1/19, 4/20, and 10/21 rats, respectively; 1 male at 662 mg/L showed mild squamous metaplasia. No differences in morphology of the Cl...","page":10,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_007"} |
| CIR_vision_codex | NOAEL | =1 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"10; (9; 0","dose":"When glycerin (13.1, 60.8, 282, and 1,310 mg/kg/d) was administered by gavage to Wistar rats (n ¼ 25-28) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,310 mg/kg/d.","effect":"rus cycles, weight gain, and microscopic observations of the endocrine organs were com- parable to those of the controls in both the F1 and the F2 gen- eration. In the F0 generation, all 10 females became pregnant with similar litter size as controls (9.0 vs 8.1). In the F1 gener- ation, 9 of 10 females became pregnant. When glycerin (13.1, 60.8, 282, and 1,310 mg/kg/d) was administered by gavage to Wistar rats (n ¼ 25-28) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,310 mg/kg/d. The numbers of preg- nancies were 23 of 25, 24 of 25, 22 of 28, and 22 of 25 for 13.1, 60.8, 282, and 1,310 mg/kg/d, respectively, and 21 of 25 for controls. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups, as were the incidences of external, visceral, and skeletal abnormalities. When glycerin (12.8, 59.4, 276, and 1,280 mg/kg/d) was administered by gavage to CD-1 mice (n ¼ 25) on days 6 through 15 of gestation, there were no adverse effects observed...","page":11,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_008"} |
| CIR_vision_codex | NOAEL | =2200 | mg/kg/d | rat | oral | 3 days | developmental toxicity | {"citation":"3; 3,800; 36","dose":"At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemor- rhages.","effect":"nistered for 3 days. At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemor- rhages. Mongrel dogs experienced weight loss after 36 weeks when 35% glycerin was incorporated into their feed. There were no pathological changes in guinea pigs orally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days. There were no signs of toxicity or effects on blood or on urine production when human patients were orally adminis- tered approximately 1,300 to 2,200 g/kg/d glycerin for 50 days. The NOAEL was \u00062,200 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogeni...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_011"} |
| CIR_vision_codex | NOAEL | =1000 | mg/m3 | rat | oral | 40 days | developmental toxicity | {"citation":"6,300; 30; 40","dose":"rally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days.","effect":"rally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days. There were no signs of toxicity or effects on blood or on urine production when human patients were orally adminis- tered approximately 1,300 to 2,200 g/kg/d glycerin for 50 days. The NOAEL was \u00062,200 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight)...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_012"} |
| CIR_vision_codex | NOAEL | =1310 | mg/kg/d | rat | oral | 45 weeks | developmental toxicity | {"citation":"0; 100; 30","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","effect":"0 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister ch...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_013"} |
| CIR_vision_codex | NOAEL | =1280 | mg/kg/d | rat | oral | 45 weeks | developmental toxicity | {"citation":"30; 45; 1,000","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","effect":"lied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister chromatid exchange assay, unscheduled DNA synthesis assay, and chromosome aberrat...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_014"} |
| CIR_vision_codex | NOAEL | =1180 | mg/kg/d | rat | oral | 5 d | developmental toxicity | {"citation":"1,000; 6; 5","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","effect":"OAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister chromatid exchange assay, unscheduled DNA synthesis assay, and chromosome aberration test at concentra- tions up to 1.0 mg/mL. In 2 chromosomal aberration assays...","page":15,"pdf":"PRS679.pdf","row_type":"noael_study","study_id":"PRS679_noael_015"} |
COSMOS_DB 14 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | NOAEL | 1000 | mg/kg bw/day | dog | oral | 120 day | Subchronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1180 | mg/kg bw/day | rabbit | oral | 13 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1250 | mg/kg bw/day | dog | oral | 728 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1280 | mg/kg bw/day | mouse | oral | 10 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 1310 | mg/kg bw/day | rat | oral | 10 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 2000 | mg/kg bw/day | rat | oral | 44 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 4000 | mg/kg bw/day | guinea pig | oral | 30 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 5000 | mg/kg bw/day | rabbit | oral | 14 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 6000 | mg/kg bw/day | rabbit | oral | NA | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 9000 | mg/kg bw/day | dog | oral | 350 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 10000 | mg/kg bw/day | rat | oral | 730 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 12500 | mg/kg bw/day | mouse | oral | 56 day | Special Toxicology Study | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 15000 | mg/kg bw/day | rat | oral | NA | Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 20000 | mg/kg bw/day | rat | oral | 14 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
INCHEM_WHO_jecfa_jecmono_v48je16 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| INCHEM_WHO_jecfa_jecmono_v48je16 | ADI | =20 | mg/kg bw/day | - | - | - | Health guidance value | document_id=jecfa_jecmono_v48je16; title=ALIPHATIC ACYCLIC DIOLS, TRIOLS, AND RELATED SUBSTANCES (JECFA Food Additives Series 48); path=mirror/documents/jecfa/jecmono/v48je16.htm; row_hash=5a89a7544a8055e3; raw_unit=mg/kg bw; context=925) was considered at the seventh meeting, when an ADI of 020 mg/kg bw was established (Annex 1, reference 7 ); it was further considered at the seventeenth meeting, when the ADI was increased to 025 mg/kg bw (Annex 1, reference 32 ). |
| INCHEM_WHO_jecfa_jecmono_v48je16 | ADI | =20 | mg/kg bw/day | - | - | - | Health guidance value | document_id=jecfa_jecmono_v48je16; title=ALIPHATIC ACYCLIC DIOLS, TRIOLS, AND RELATED SUBSTANCES (JECFA Food Additives Series 48); path=mirror/documents/jecfa/jecmono/v48je16.htm; row_hash=5a89a7544a8055e3; raw_unit=mg/kg bw; context=925) was considered at the seventh meeting, when an ADI of 020 mg/kg bw was established (Annex 1, reference 7 ); it was further considered at the seventeenth meeting, when the ADI was increased to 025 mg/kg bw (Annex 1, reference 32 ). |
| INCHEM_WHO_jecfa_jecmono_v48je16 | ADI | =25 | mg/kg bw/day | - | - | - | Health guidance value | document_id=jecfa_jecmono_v48je16; title=ALIPHATIC ACYCLIC DIOLS, TRIOLS, AND RELATED SUBSTANCES (JECFA Food Additives Series 48); path=mirror/documents/jecfa/jecmono/v48je16.htm; row_hash=98fcf558c1278b91; raw_unit=mg/kg bw; context=925) was considered at the seventh meeting, when an ADI of 020 mg/kg bw was established (Annex 1, reference 7 ); it was further considered at the seventeenth meeting, when the ADI was increased to 025 mg/kg bw (Annex 1, reference 32 ). |
| INCHEM_WHO_jecfa_jecmono_v48je16 | ADI | =25 | mg/kg bw/day | - | - | - | Health guidance value | document_id=jecfa_jecmono_v48je16; title=ALIPHATIC ACYCLIC DIOLS, TRIOLS, AND RELATED SUBSTANCES (JECFA Food Additives Series 48); path=mirror/documents/jecfa/jecmono/v48je16.htm; row_hash=98fcf558c1278b91; raw_unit=mg/kg bw; context=925) was considered at the seventh meeting, when an ADI of 020 mg/kg bw was established (Annex 1, reference 7 ); it was further considered at the seventeenth meeting, when the ADI was increased to 025 mg/kg bw (Annex 1, reference 32 ). |
| INCHEM_WHO_jecfa_jecmono_v48je16 | NOEL | =1300 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v48je16; title=ALIPHATIC ACYCLIC DIOLS, TRIOLS, AND RELATED SUBSTANCES (JECFA Food Additives Series 48); path=mirror/documents/jecfa/jecmono/v48je16.htm; row_hash=71cb182bb575bc97; raw_unit=mg/kg bw per day; context=The NOEL was 1300 mg/kg bw per day (Gaunt et al., 1972). |
| INCHEM_WHO_jecfa_jecmono_v48je16 | NOEL | =1300 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v48je16; title=ALIPHATIC ACYCLIC DIOLS, TRIOLS, AND RELATED SUBSTANCES (JECFA Food Additives Series 48); path=mirror/documents/jecfa/jecmono/v48je16.htm; row_hash=71cb182bb575bc97; raw_unit=mg/kg bw per day; context=The NOEL was 1300 mg/kg bw per day (Gaunt et al., 1972). |
| INCHEM_WHO_jecfa_jecmono_v48je16 | NOEL | =5000 | mg/kg bw/day | - | oral | - | Toxicology study | document_id=jecfa_jecmono_v48je16; title=ALIPHATIC ACYCLIC DIOLS, TRIOLS, AND RELATED SUBSTANCES (JECFA Food Additives Series 48); path=mirror/documents/jecfa/jecmono/v48je16.htm; row_hash=6bd162aed83dd918; raw_unit=mg/kg bw per day; context=The NOEL was 5% glycerol in the diet, equivalent to 5000 mg/kg bw per day (Guerrant et al., 1947). |
| INCHEM_WHO_jecfa_jecmono_v48je16 | NOEL | =5000 | mg/kg bw/day | - | oral | - | Toxicology study | document_id=jecfa_jecmono_v48je16; title=ALIPHATIC ACYCLIC DIOLS, TRIOLS, AND RELATED SUBSTANCES (JECFA Food Additives Series 48); path=mirror/documents/jecfa/jecmono/v48je16.htm; row_hash=6bd162aed83dd918; raw_unit=mg/kg bw per day; context=The NOEL was 5% glycerol in the diet, equivalent to 5000 mg/kg bw per day (Guerrant et al., 1947). |
NTP_ICE_acute_inhalation 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | LC50 | >0.57 | mg/L | - | Inhalation | Duration=1 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=5017; Record_ID=acute_inhalation_3002; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=0.57; Response_Unit=mg/L; Reference=ChemIDplus; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
NTP_ICE_acute_oral 9 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | =5570 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_7712; row=15335; data_type=In Vivo; mixture=Chemical; chemical_name=Glycerol; preferred_name=Glycerol; dtxsid=DTXSID9020663; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID9020663; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =12600 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_7714; row=15333; data_type=In Vivo; mixture=Chemical; chemical_name=Glycerol; preferred_name=Glycerol; dtxsid=DTXSID9020663; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID9020663; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =15890 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | JRC AcutoxBase (undated); record_id=acute_oral_7716; row=15332; data_type=In Vivo; mixture=Chemical; chemical_name=Glycerol; preferred_name=Glycerol; dtxsid=DTXSID9020663; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID9020663; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | >18315 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | record_id=acute_oral_7718; row=15331; data_type=In Vivo; mixture=Chemical; chemical_name=Glycerol; preferred_name=Glycerol; dtxsid=DTXSID9020663; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID9020663; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | <21980 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | record_id=acute_oral_7719; row=15330; data_type=In Vivo; mixture=Chemical; chemical_name=Glycerol; preferred_name=Glycerol; dtxsid=DTXSID9020663; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID9020663; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =25000 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | JRC AcutoxBase (undated); record_id=acute_oral_7720; row=15329; data_type=In Vivo; mixture=Chemical; chemical_name=Glycerol; preferred_name=Glycerol; dtxsid=DTXSID9020663; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID9020663; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =27200 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | JRC AcutoxBase (undated); record_id=acute_oral_7721; row=15336; data_type=In Vivo; mixture=Chemical; chemical_name=Glycerol; preferred_name=Glycerol; dtxsid=DTXSID9020663; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID9020663; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =27500 | mg/kg bw | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | JRC AcutoxBase (undated); record_id=acute_oral_7723; row=15328; data_type=In Vivo; mixture=Chemical; chemical_name=Glycerol; preferred_name=Glycerol; dtxsid=DTXSID9020663; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID9020663; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =27650 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | JRC AcutoxBase (undated); record_id=acute_oral_7725; row=15334; data_type=In Vivo; mixture=Chemical; chemical_name=Glycerol; preferred_name=Glycerol; dtxsid=DTXSID9020663; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID9020663; source_file=acute_oral.xlsx |
NTP_ICE_endocrine 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=10008; RecordID=ARPathway2016_1335; DatasetName=ARPathway2016; DTXSID=DTXSID9020663; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
NTP_ICE_eye_irritation 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_eye_irritation | Draize rabbit irritation score | 1.7 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=2738; Record_ID=eye_irritation_140; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=1.7; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Draize rabbit irritation score | 1.7 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=2738; Record_ID=eye_irritation_140; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=1.7; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Draize rabbit irritation score | 1.7 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=2738; Record_ID=eye_irritation_140; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=1.7; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Draize rabbit irritation score | 1.7 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=2738; Record_ID=eye_irritation_140; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=1.7; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | EPA Classification | 4 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=2736; Record_ID=eye_irritation_140; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=4; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | EPA Classification | 4 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=2736; Record_ID=eye_irritation_140; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=4; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | EPA Classification | 4 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=2736; Record_ID=eye_irritation_140; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=4; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | EPA Classification | 4 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=2736; Record_ID=eye_irritation_140; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=4; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Intensity | 0.34 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=2740; Record_ID=eye_irritation_1218; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Vitrigel; Endpoint=Intensity; Response=0.34; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Intensity | 0.34 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=2740; Record_ID=eye_irritation_1218; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Vitrigel; Endpoint=Intensity; Response=0.34; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Intensity | 0.34 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=2740; Record_ID=eye_irritation_1218; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Vitrigel; Endpoint=Intensity; Response=0.34; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Intensity | 0.34 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=2740; Record_ID=eye_irritation_1218; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Vitrigel; Endpoint=Intensity; Response=0.34; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Lag time | 0 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=2737; Record_ID=eye_irritation_1218; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Vitrigel; Endpoint=Lag time; Response=0; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Lag time | 0 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=2737; Record_ID=eye_irritation_1218; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Vitrigel; Endpoint=Lag time; Response=0; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Lag time | 0 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=2737; Record_ID=eye_irritation_1218; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Vitrigel; Endpoint=Lag time; Response=0; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Lag time | 0 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=2737; Record_ID=eye_irritation_1218; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Vitrigel; Endpoint=Lag time; Response=0; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Plateau level | 20.4 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=2742; Record_ID=eye_irritation_1218; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Vitrigel; Endpoint=Plateau level; Response=20.40; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Plateau level | 20.4 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=2742; Record_ID=eye_irritation_1218; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Vitrigel; Endpoint=Plateau level; Response=20.40; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Plateau level | 20.4 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=2742; Record_ID=eye_irritation_1218; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Vitrigel; Endpoint=Plateau level; Response=20.40; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_eye_irritation | Plateau level | 20.4 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=2742; Record_ID=eye_irritation_1218; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Vitrigel; Endpoint=Plateau level; Response=20.40; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
NTP_ICE_skin_irritation 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_irritation | Viability | 67.97 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5784; Record_ID=skin_irritation_invitro_913; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=67.97; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 85.5 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5785; Record_ID=skin_irritation_invitro_914; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=85.5; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 89.73 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5790; Record_ID=skin_irritation_invitro_924; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=89.73; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 94 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5793; Record_ID=skin_irritation_invitro_930; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=94; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 96 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5787; Record_ID=skin_irritation_invitro_918; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=96; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 97.23 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5788; Record_ID=skin_irritation_invitro_920; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=97.23; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 98.06 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5796; Record_ID=skin_irritation_invitro_936; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=98.06; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 98.16 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5794; Record_ID=skin_irritation_invitro_932; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=98.16; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 98.48 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5802; Record_ID=skin_irritation_invitro_948; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=98.48; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 99.04 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5797; Record_ID=skin_irritation_invitro_938; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=99.04; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 99.41 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5799; Record_ID=skin_irritation_invitro_942; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=99.41; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 100.58 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5786; Record_ID=skin_irritation_invitro_916; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=100.58; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 101.24 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5800; Record_ID=skin_irritation_invitro_944; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=101.24; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 101.35 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5791; Record_ID=skin_irritation_invitro_926; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=101.35; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 101.75 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5798; Record_ID=skin_irritation_invitro_940; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=101.75; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 103.3 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5792; Record_ID=skin_irritation_invitro_928; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=103.3; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 103.6 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5795; Record_ID=skin_irritation_invitro_934; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=103.6; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 103.63 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5803; Record_ID=skin_irritation_invitro_950; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=103.63; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 104.17 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5804; Record_ID=skin_irritation_invitro_952; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=104.17; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_irritation | Viability | 104.84 | % | - | Dermal | - | In Vitro; LabCyte EPI-MODEL24 Irritation | sheet=Data_invitro; excel_row=5801; Record_ID=skin_irritation_invitro_946; Data_Type=In Vitro; Formulation_Name=Glycerol; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LabCyte EPI-MODEL24 Irritation; Endpoint=Viability; Response=104.84; Response_Unit=%; Reference=Kojima et al. 2012; 22558976; 10.1177/026119291204000108; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
NTP_ICE_skin_sensitization 52 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | CD86, EC150 | >200 | ug/mL | - | Dermal | - | In Vitro; CE_USENSE2018; U-SENS | sheet=Data_invitro; excel_row=8711; Record_ID=skin_sensitization_invitro_2413; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=U-SENS; Endpoint=CD86, EC150; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=200; Reported_Response_Unit=ug/mL; Response=200; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | CD86, EC150 | >644.658 | ug/mL | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; U-SENS | sheet=Data_invitro; excel_row=8149; Record_ID=skin_sensitization_invitro_2172; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=U-SENS; Endpoint=CD86, EC150; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=7000; Reported_Response_Unit=uM; Conversion_Factor_Value=92.094; Conversion_Factor_Source=EPA Dashboard; Converted_Response_Modifier=>; Converted_Response=644.658; Converted_Response_Unit=ug/mL; Response=644.658; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | CV75 | 833.3 | ug/mL | - | Dermal | - | In Vitro; hCLAT2015; h-CLAT | sheet=Data_invitro; excel_row=2717; Record_ID=skin_sensitization_invitro_642; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=h-CLAT; Endpoint=CV75; Reported_Response=833.3; Reported_Response_Unit=ug/mL; Response=833.3; Response_Unit=ug/mL; Reference=Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | CV75 | >5000 | ug/mL | - | Dermal | - | In Vitro; CE_hCLAT2018; h-CLAT | sheet=Data_invitro; excel_row=2244; Record_ID=skin_sensitization_invitro_551; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=h-CLAT; Endpoint=CV75; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=5000; Reported_Response_Unit=ug/mL; Response=5000; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Cys | -3.8 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=582; Record_ID=skin_sensitization_invitro_169; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=-3.8; Reported_Response_Unit=%; Response=-3.8; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064|Jaworska 2011; 23670904; 10.1002/jat.2869|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Cys | -1.1 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1076; Record_ID=skin_sensitization_invitro_293; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=-1.1000000000000001; Reported_Response_Unit=%; Response=-1.1; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Cys | -0.7 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=588; Record_ID=skin_sensitization_invitro_170; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=-0.7; Reported_Response_Unit=%; Response=-0.7; Response_Unit=%; Reference=Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Cys | 1.2 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=599; Record_ID=skin_sensitization_invitro_173; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=1.2; Reported_Response_Unit=%; Response=1.2; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Cys | 1.8 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1068; Record_ID=skin_sensitization_invitro_290; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=1.8; Reported_Response_Unit=%; Response=1.8; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Cys | 2.5 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=595; Record_ID=skin_sensitization_invitro_172; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=2.5; Reported_Response_Unit=%; Response=2.5; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Lys | -4.8 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1074; Record_ID=skin_sensitization_invitro_293; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=-4.8; Reported_Response_Unit=%; Response=-4.8; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Lys | 0 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=598; Record_ID=skin_sensitization_invitro_173; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0; Reported_Response_Unit=%; Response=0; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Lys | 0.1 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1064; Record_ID=skin_sensitization_invitro_290; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0.1; Reported_Response_Unit=%; Response=0.1; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Lys | 0.8 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=593; Record_ID=skin_sensitization_invitro_172; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0.8; Reported_Response_Unit=%; Response=0.8; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Lys | 1.3 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=587; Record_ID=skin_sensitization_invitro_170; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=1.3; Reported_Response_Unit=%; Response=1.3; Response_Unit=%; Reference=Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Lys | 2.1 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=580; Record_ID=skin_sensitization_invitro_169; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=2.1; Reported_Response_Unit=%; Response=2.1; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064|Jaworska 2011; 23670904; 10.1002/jat.2869|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 0.3 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=589; Record_ID=skin_sensitization_invitro_170; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=0.3; Reported_Response_Unit=%; Response=0.3; Response_Unit=%; Reference=Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 0.6 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=600; Record_ID=skin_sensitization_invitro_173; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=0.6; Reported_Response_Unit=%; Response=0.6; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 0.95 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1070; Record_ID=skin_sensitization_invitro_290; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=0.95; Reported_Response_Unit=%; Response=0.95; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 1.05 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=584; Record_ID=skin_sensitization_invitro_169; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=1.05; Reported_Response_Unit=%; Response=1.05; Response_Unit=%; Reference=Gerberick et al. 2007; 17400584; 10.1093/toxsci/kfm064|Jaworska 2011; 23670904; 10.1002/jat.2869|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 1.65 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=596; Record_ID=skin_sensitization_invitro_172; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=1.65; Reported_Response_Unit=%; Response=1.65; Response_Unit=%; Reference=Joint Research Centre of the European Union 2013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | EC1.5 | 1793.9 | uM | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6046; Record_ID=skin_sensitization_invitro_1436; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=1793.9; Reported_Response_Unit=uM; Response=1793.9; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | EC1.5 | >2000 | uM | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6040; Record_ID=skin_sensitization_invitro_1423; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=EC1.5; Response_Modifier=>; Reported_Response=No induction; Reported_Response_Unit=Unitless; Conversion_Factor=Text to numeric; Conversion_Factor_Value=No induction assumed >2000 uM; Conversion_Factor_Source=Manually calculated; Converted_Response_Modifier=>; Converted_Response=2000; Converted_Response_Unit=uM; Response=2000; Response_Unit=uM; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | IC50 | >2400 | uM | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; LuSens | sheet=Data_invitro; excel_row=7628; Record_ID=skin_sensitization_invitro_1796; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LuSens; Endpoint=IC50; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=2400; Reported_Response_Unit=uM; Response=2400; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.024 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6225; Record_ID=skin_sensitization_invitro_1428; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.024; Reported_Response_Unit=Unitless; Response=1.024; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.032 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6227; Record_ID=skin_sensitization_invitro_1431; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.032; Reported_Response_Unit=Unitless; Response=1.032; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.1 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6229; Record_ID=skin_sensitization_invitro_1441; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.1000000000000001; Reported_Response_Unit=Unitless; Response=1.1; Response_Unit=Ratio; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.12 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6231; Record_ID=skin_sensitization_invitro_1433; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.1200000000000001; Reported_Response_Unit=Unitless; Response=1.12; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.127 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6233; Record_ID=skin_sensitization_invitro_1434; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.127; Reported_Response_Unit=Unitless; Response=1.127; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.13 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6235; Record_ID=skin_sensitization_invitro_1416; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.1299999999999999; Reported_Response_Unit=Unitless; Response=1.13; Response_Unit=Ratio; Reference=Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.134 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6056; Record_ID=skin_sensitization_invitro_1425; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.1339999999999999; Reported_Response_Unit=Unitless; Response=1.134; Response_Unit=Ratio; Reference=Bauch et al. 2012; 22659254; 10.1016/j.yrtph.2012.05.013; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.146 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6057; Record_ID=skin_sensitization_invitro_1420; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.1459999999999999; Reported_Response_Unit=Unitless; Response=1.146; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.156 | ratio | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; LuSens | sheet=Data_invitro; excel_row=7525; Record_ID=skin_sensitization_invitro_1796; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=LuSens; Endpoint=Imax; Reported_Response=1.155674771; Reported_Response_Unit=Unitless; Response=1.156; Response_Unit=Ratio; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.16 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6058; Record_ID=skin_sensitization_invitro_1430; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.1599999999999999; Reported_Response_Unit=Unitless; Response=1.16; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.162 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6059; Record_ID=skin_sensitization_invitro_1423; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.1619999999999999; Reported_Response_Unit=Unitless; Response=1.162; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.17 | ratio | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=6060; Record_ID=skin_sensitization_invitro_1442; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.17; Reported_Response_Unit=Unitless; Response=1.17; Response_Unit=Ratio; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.193 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6061; Record_ID=skin_sensitization_invitro_1435; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.1930000000000001; Reported_Response_Unit=Unitless; Response=1.193; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.2 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6062; Record_ID=skin_sensitization_invitro_1414; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.2; Reported_Response_Unit=Unitless; Response=1.2; Response_Unit=Ratio; Reference=Emter et al. 2010; 20307559; 10.1016/j.taap.2010.03.009|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.208 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6065; Record_ID=skin_sensitization_invitro_1432; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.208; Reported_Response_Unit=Unitless; Response=1.208; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.212 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6066; Record_ID=skin_sensitization_invitro_1422; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.212; Reported_Response_Unit=Unitless; Response=1.212; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.216 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6067; Record_ID=skin_sensitization_invitro_1417; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.216; Reported_Response_Unit=Unitless; Response=1.216; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.217 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6068; Record_ID=skin_sensitization_invitro_1421; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.2170000000000001; Reported_Response_Unit=Unitless; Response=1.217; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.22 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6069; Record_ID=skin_sensitization_invitro_1418; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.22; Reported_Response_Unit=Unitless; Response=1.22; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.238 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6070; Record_ID=skin_sensitization_invitro_1419; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.238; Reported_Response_Unit=Unitless; Response=1.238; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.269 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6071; Record_ID=skin_sensitization_invitro_1429; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.2689999999999999; Reported_Response_Unit=Unitless; Response=1.269; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.3 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6072; Record_ID=skin_sensitization_invitro_1439; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.3; Reported_Response_Unit=Unitless; Response=1.3; Response_Unit=Ratio; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.353 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6073; Record_ID=skin_sensitization_invitro_1427; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.353; Reported_Response_Unit=Unitless; Response=1.353; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.4 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6074; Record_ID=skin_sensitization_invitro_1437; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.4; Reported_Response_Unit=Unitless; Response=1.4; Response_Unit=Ratio; Reference=Natsch et al. 2011; 22023385; 10.1021/tx2003678; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.568 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6075; Record_ID=skin_sensitization_invitro_1426; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.5680000000000001; Reported_Response_Unit=Unitless; Response=1.568; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Imax | 1.634 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6076; Record_ID=skin_sensitization_invitro_1436; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.6339999999999999; Reported_Response_Unit=Unitless; Response=1.634; Response_Unit=Ratio; Reference=Joint Research Centre of the European Union 2014; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Incidence of positive responses | 0 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=8212; Record_ID=skin_sensitization_invivo_1856; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Human Repeat Insult Patch Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Gad et al. 1986; 3715870; 10.1016/0041-008X(86)90419-9|Ryan et al. 2000; 10945748; 10.1034/j.1600-0536.2000.043002095.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
| NTP_ICE_skin_sensitization | Relative reliability score | 5 | unitless | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=8216; Record_ID=skin_sensitization_invivo_1856; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Mixture=Chemical; DTXSID=DTXSID9020663; Assay=Human Repeat Insult Patch Test; Endpoint=Relative reliability score; Response=5; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Gad et al. 1986; 3715870; 10.1016/0041-008X(86)90419-9|Ryan et al. 2000; 10945748; 10.1034/j.1600-0536.2000.043002095.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9020663; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID9020663 |
ToxValDB_ECHA_IUCLID 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | NOAEL | =1180 | mg/kg bw/day | Rabbit | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac3ee4b0a7c65d1be1e4; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/13661/7/9/3?documentUUID=36fabf14-e66d-449e-8e83-0eb6fc266aeb; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID:15823644:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_f3806a861ee71b6d8d10307a42a420fb |
| ToxValDB_ECHA_IUCLID | NOAEL | =1280 | mg/kg bw/day | Mouse | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac0de4b0a7c65d1bd210; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/14285?documentUUID=61f7aee5-57e9-47bb-84b8-5dc8cd600c5d; YEAR=1993; ORIGINAL_YEAR=1993; STUDY_GROUP=ECHA IUCLID:15824658:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_d99f88ed71930726f40e033978f1f367 |
| ToxValDB_ECHA_IUCLID | NOAEL | =1310 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac0de4b0a7c65d1bd21a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/14285?documentUUID=61f7aee5-57e9-47bb-84b8-5dc8cd600c5d; YEAR=1993; ORIGINAL_YEAR=1993; STUDY_GROUP=ECHA IUCLID:15824660:-:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_58661f545af5edebb0eccaa8c2fefe34 |
UnifiedCodex:CIR:beta.noael_studies 15 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 1 | mg/kg/d | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=1; 310; DOSE=When glycerin (13.1, 60.8, 282, and 1,310 mg/kg/d) was administered by gavage to Wistar rats (n ¼ 25-28) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,310 mg/kg/d.; EFFECT=rus cycles, weight gain, and microscopic observations of the endocrine organs were com- parable to those of the controls in both the F1 and the F2 gen- eration. In the F0 generation, all 10 females became pregnant with similar litter size as controls (9.0 vs 8.1). In the F1 gener- ation, 9 of 10 females became pregnant. When glycerin (13.1, 60.8, 282, and 1,310 mg/kg/d) was administered by gavage to Wistar rats (n ¼ 25-28) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,310 mg/kg/d. The numbers of preg- nancies were 23 of 25, 24 of 25, 22 of 28, and 22 of 25 for 13.1, 60.8, 282, and 1,310 mg/kg/d, respectively, and 21 of 25 for controls. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups, as were the incidences of external, visceral, and skeletal abnormalities. When glycerin (12.8, 59.4, 276, and 1,280 mg/kg/d) was administered by gavage to CD-1 mice (n ¼ 25) on days 6 through 15 of gestation, there were no adverse effects observed...; CITATION=10; (9; 0; CITATION_NUMBERS=[10,9]; REFERENCE=10; (9; 0; DETAILS_JSON={"cas_number":"56-81-5","citation":"10; (9; 0","dose":"When glycerin (13.1, 60.8, 282, and 1,310 mg/kg/d) was administered by gavage to Wistar rats (n ¼ 25-28) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,310 mg/kg/d.","duration":"","effect":"rus cycles, weight gain, and microscopic observations of the endocrine organs were com- parable to those of the controls in both the F1 and the F2 gen- eration. In the F0 generation, all 10 females became pregnant with similar litter size as controls (9.0 vs 8.1). In the F1 gener- ation, 9 of 10 females became pregnant. When glycerin (13.1, 60.8, 282, and 1,310 mg/kg/d) was administered by gavage to Wistar rats (n ¼ 25-28) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,310 mg/kg/d. The numbers of preg- nancies were 23 of 25, 24 of 25, 22 of 28, and 22 of 25 for 13.1, 60.8, 282, and 1,310 mg/kg/d, respectively, and 21 of 25 for controls. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups, as were the incidences of external, visceral, and skeletal abnormalities. When glycerin (12.8, 59.4, 276, and 1,280 mg/kg/d) was administered by gavage to CD-1 mice (n ¼ 25) on days 6 through 15 of gestation, there were no adverse effects observed...","endpoint":"developmental toxicity","ingredient":"Glycerin","loael_value":"","noael_unit":"mg/kg/d","noael_value":"1; 310","page":11,"route":"oral","species":"rat","study_id":"PRS679_noael_008"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 1 | mg/kg/d | mouse | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=1; 280; DOSE=of preg- nancies were 23 of 25, 24 of 25, 22 of 28, and 22 of 25 for 13.1, 60.8, 282, and 1,310 mg/kg/d, respectively, and 21 of 25 for controls.; EFFECT=of preg- nancies were 23 of 25, 24 of 25, 22 of 28, and 22 of 25 for 13.1, 60.8, 282, and 1,310 mg/kg/d, respectively, and 21 of 25 for controls. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups, as were the incidences of external, visceral, and skeletal abnormalities. When glycerin (12.8, 59.4, 276, and 1,280 mg/kg/d) was administered by gavage to CD-1 mice (n ¼ 25) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and terato- genicity was 1,280 mg/kg/d. The numbers of pregnancies were 14 of 15, 12 of 15, 10 of 18, 13 of 20, and 13 of 15 for controls, 12.8, 59.4, 276, and 1,280 mg/kg, respectively. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups as were external, visceral, and ske- letal abnormalities. When glycerin (11.8, 54.8, 254.5, and 1,180 mg/kg/d) was administered by gavage to Dutch-belted rabbits (n ¼ 25) on days 6 through 18 of gestation, there were no adverse effects found in the dams.37 T...; CITATION=23; 25, 24; 25, 22; CITATION_NUMBERS=[23,25,24,22]; REFERENCE=23; 25, 24; 25, 22; DETAILS_JSON={"cas_number":"56-81-5","citation":"23; 25, 24; 25, 22","dose":"of preg- nancies were 23 of 25, 24 of 25, 22 of 28, and 22 of 25 for 13.1, 60.8, 282, and 1,310 mg/kg/d, respectively, and 21 of 25 for controls.","duration":"","effect":"of preg- nancies were 23 of 25, 24 of 25, 22 of 28, and 22 of 25 for 13.1, 60.8, 282, and 1,310 mg/kg/d, respectively, and 21 of 25 for controls. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups, as were the incidences of external, visceral, and skeletal abnormalities. When glycerin (12.8, 59.4, 276, and 1,280 mg/kg/d) was administered by gavage to CD-1 mice (n ¼ 25) on days 6 through 15 of gestation, there were no adverse effects observed in the dams.37 The NOAEL for maternal toxicity and terato- genicity was 1,280 mg/kg/d. The numbers of pregnancies were 14 of 15, 12 of 15, 10 of 18, 13 of 20, and 13 of 15 for controls, 12.8, 59.4, 276, and 1,280 mg/kg, respectively. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups as were external, visceral, and ske- letal abnormalities. When glycerin (11.8, 54.8, 254.5, and 1,180 mg/kg/d) was administered by gavage to Dutch-belted rabbits (n ¼ 25) on days 6 through 18 of gestation, there were no adverse effects found in the dams.37 T...","endpoint":"developmental toxicity","ingredient":"Glycerin","loael_value":"","noael_unit":"mg/kg/d","noael_value":"1; 280","page":11,"route":"oral","species":"mouse","study_id":"PRS679_noael_009"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 1 | mg/kg/d | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=1; 180; DOSE=The numbers of pregnancies were 14 of 15, 12 of 15, 10 of 18, 13 of 20, and 13 of 15 for controls, 12.8, 59.4, 276, and 1,280 mg/kg, respectively.; EFFECT=/kg/d. The numbers of pregnancies were 14 of 15, 12 of 15, 10 of 18, 13 of 20, and 13 of 15 for controls, 12.8, 59.4, 276, and 1,280 mg/kg, respectively. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups as were external, visceral, and ske- letal abnormalities. When glycerin (11.8, 54.8, 254.5, and 1,180 mg/kg/d) was administered by gavage to Dutch-belted rabbits (n ¼ 25) on days 6 through 18 of gestation, there were no adverse effects found in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,180 mg/kg/d. The numbers of pregnancies were 22 of 25, 23 of 25, 20 of 25, 22 of 25, and 21 of 25 for controls, 11.8, 54.8, 254.5, and 1,180 mg/kg/d, respectively. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups, as were external, visceral, and skeletal abnormalities. Male Fertility—Nonhuman Glycerin injected into the testes of rats (50-200 mL and 862 mg/ kg body weight) and monkeys (119 mg/kg body weight) sup- pressed spermatogenesis (Table 7).38-40 Male Fertili...; CITATION=14; 15, 12; 15, 10; CITATION_NUMBERS=[14,15,12,10]; REFERENCE=14; 15, 12; 15, 10; DETAILS_JSON={"cas_number":"56-81-5","citation":"14; 15, 12; 15, 10","dose":"The numbers of pregnancies were 14 of 15, 12 of 15, 10 of 18, 13 of 20, and 13 of 15 for controls, 12.8, 59.4, 276, and 1,280 mg/kg, respectively.","duration":"","effect":"/kg/d. The numbers of pregnancies were 14 of 15, 12 of 15, 10 of 18, 13 of 20, and 13 of 15 for controls, 12.8, 59.4, 276, and 1,280 mg/kg, respectively. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups as were external, visceral, and ske- letal abnormalities. When glycerin (11.8, 54.8, 254.5, and 1,180 mg/kg/d) was administered by gavage to Dutch-belted rabbits (n ¼ 25) on days 6 through 18 of gestation, there were no adverse effects found in the dams.37 The NOAEL for maternal toxicity and teratogenicity was 1,180 mg/kg/d. The numbers of pregnancies were 22 of 25, 23 of 25, 20 of 25, 22 of 25, and 21 of 25 for controls, 11.8, 54.8, 254.5, and 1,180 mg/kg/d, respectively. The number of implantations, resorptions, litter sizes, weights, and sex ratio were similar among groups, as were external, visceral, and skeletal abnormalities. Male Fertility—Nonhuman Glycerin injected into the testes of rats (50-200 mL and 862 mg/ kg body weight) and monkeys (119 mg/kg body weight) sup- pressed spermatogenesis (Table 7).38-40 Male Fertili...","endpoint":"developmental toxicity","ingredient":"Glycerin","loael_value":"","noael_unit":"mg/kg/d","noael_value":"1; 180","page":11,"route":"oral","species":"rat","study_id":"PRS679_noael_010"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 2200 | mg/kg/d | rat | oral | 3 days | developmental toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=2,200; DOSE=At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemor- rhages.; LOAEL_VALUE=1,000 mg/m3; EFFECT=nistered for 3 days. At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemor- rhages. Mongrel dogs experienced weight loss after 36 weeks when 35% glycerin was incorporated into their feed. There were no pathological changes in guinea pigs orally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days. There were no signs of toxicity or effects on blood or on urine production when human patients were orally adminis- tered approximately 1,300 to 2,200 g/kg/d glycerin for 50 days. The NOAEL was 2,200 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogeni...; CITATION=3; 3,800; 36; CITATION_NUMBERS=[3,800,36]; REFERENCE=3; 3,800; 36; DETAILS_JSON={"cas_number":"56-81-5","citation":"3; 3,800; 36","dose":"At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemor- rhages.","duration":"3 days","effect":"nistered for 3 days. At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemor- rhages. Mongrel dogs experienced weight loss after 36 weeks when 35% glycerin was incorporated into their feed. There were no pathological changes in guinea pigs orally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days. There were no signs of toxicity or effects on blood or on urine production when human patients were orally adminis- tered approximately 1,300 to 2,200 g/kg/d glycerin for 50 days. The NOAEL was \u00062,200 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogeni...","endpoint":"developmental toxicity","ingredient":"Glycerin","loael_value":"1,000 mg/m3","noael_unit":"mg/kg/d","noael_value":"2,200","page":15,"route":"oral","species":"rat","study_id":"PRS679_noael_011"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 1000 | mg/m3 | rat | oral | 40 days | developmental toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=1,000; DOSE=rally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days.; LOAEL_VALUE=1,000 mg/m3; EFFECT=rally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days. There were no signs of toxicity or effects on blood or on urine production when human patients were orally adminis- tered approximately 1,300 to 2,200 g/kg/d glycerin for 50 days. The NOAEL was 2,200 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight)...; CITATION=6,300; 30; 40; CITATION_NUMBERS=[6,300,30,40]; REFERENCE=6,300; 30; 40; DETAILS_JSON={"cas_number":"56-81-5","citation":"6,300; 30; 40","dose":"rally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days.","duration":"40 days","effect":"rally adminis- tered 6,300 mg/kg/d glycerin for 30 to 40 days. There were no signs of toxicity or effects on blood or on urine production when human patients were orally adminis- tered approximately 1,300 to 2,200 g/kg/d glycerin for 50 days. The NOAEL was \u00062,200 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight)...","endpoint":"developmental toxicity","ingredient":"Glycerin","loael_value":"1,000 mg/m3","noael_unit":"mg/m3","noael_value":"1,000","page":15,"route":"oral","species":"rat","study_id":"PRS679_noael_012"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 1310 | mg/kg/d | rat | oral | 45 weeks | developmental toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=1,310; DOSE=The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.; LOAEL_VALUE=1,000 mg/m3; EFFECT=0 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister ch...; CITATION=0; 100; 30; CITATION_NUMBERS=[100,30]; REFERENCE=0; 100; 30; DETAILS_JSON={"cas_number":"56-81-5","citation":"0; 100; 30","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","duration":"45 weeks","effect":"0 mg/kg/d. There were no treatment effects when 100% glycerin was topically applied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister ch...","endpoint":"developmental toxicity","ingredient":"Glycerin","loael_value":"1,000 mg/m3","noael_unit":"mg/kg/d","noael_value":"1,310","page":15,"route":"oral","species":"rat","study_id":"PRS679_noael_013"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 1280 | mg/kg/d | rat | oral | 45 weeks | developmental toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=1,280; DOSE=The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.; LOAEL_VALUE=1,000 mg/m3; EFFECT=lied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister chromatid exchange assay, unscheduled DNA synthesis assay, and chromosome aberrat...; CITATION=30; 45; 1,000; CITATION_NUMBERS=[30,45,1]; REFERENCE=30; 45; 1,000; DETAILS_JSON={"cas_number":"56-81-5","citation":"30; 45; 1,000","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","duration":"45 weeks","effect":"lied daily to 30% of the body surfaces of rabbits for 45 weeks. The inhalation LOAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister chromatid exchange assay, unscheduled DNA synthesis assay, and chromosome aberrat...","endpoint":"developmental toxicity","ingredient":"Glycerin","loael_value":"1,000 mg/m3","noael_unit":"mg/kg/d","noael_value":"1,280","page":15,"route":"oral","species":"rat","study_id":"PRS679_noael_014"} |
| UnifiedCodex:CIR:beta.noael_studies | developmental toxicity | 1180 | mg/kg/d | rat | oral | 5 d | developmental toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=1,180; DOSE=The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.; EFFECT=OAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister chromatid exchange assay, unscheduled DNA synthesis assay, and chromosome aberration test at concentra- tions up to 1.0 mg/mL. In 2 chromosomal aberration assays...; CITATION=1,000; 6; 5; CITATION_NUMBERS=[1,6,5]; REFERENCE=1,000; 6; 5; DETAILS_JSON={"cas_number":"56-81-5","citation":"1,000; 6; 5","dose":"The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats.","duration":"5 d","effect":"OAEL was 1,000 mg/m3 for glycerin admi- nistered 6 h/d, 5 d/wk for 2 weeks in rats. The inhalation NOAEL was 0.167 mg/L for glycerin administered for 5 h/d, 5 d/wk for 13 weeks in rats. No adverse effects were observed in rats administered 20% glycerin in drinking water throughout gestation and nursing of pups. The F1 generation reproduced normally. The oral NOAEL for maternal toxicity and teratogenicity for rats was 1,310 mg/kg/d. The NOAEL for maternal toxicity and terato- genicity in mice was 1,280 mg/kg/d. The NOAEL for maternal toxicity and teratogenicity in rabbits was 1,180 mg/kg/d. Glycerin injected into the testes of rats (50-200 mL and 862 mg/kg body weight) and monkeys (119 mg/kg body weight) suppressed spermatogenesis. Glycerin was not genotoxic in multiple Ames tests using multiple strains of S typhimurium at concentrations up to 50 mg/plate. It was not genotoxic in a cytogenetic assay, X-linked HGPRT, sister chromatid exchange assay, unscheduled DNA synthesis assay, and chromosome aberration test at concentra- tions up to 1.0 mg/mL. In 2 chromosomal aberration assays...","endpoint":"developmental toxicity","ingredient":"Glycerin","loael_value":"","noael_unit":"mg/kg/d","noael_value":"1,180","page":15,"route":"oral","species":"rat","study_id":"PRS679_noael_015"} |
| UnifiedCodex:CIR:beta.noael_studies | inhalation toxicity | 2.2 | g/kg/d | rat | oral | 50-week | inhalation toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=2.2; DOSE=The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6).35 Oral—Human.; EFFECT=ted into their feed. The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6).35 Oral—Human. There were no signs of toxicity or effects on blood or urine production when patients (n ¼ 10 males, 4 females) were orally administered glycerin (approximately 1.3-2.2 g/kg/d; glycerin in orange juice with meals) for 50 days.3 The NOAEL was 2.2 g/kg/d. No further information was provided. There were no adverse effects observed in patients (n ¼ 14) administered glycerin (30 mL, neat) 3 times daily with each meal for 50 days.16 Dermal—Nonhuman. There were no treatment effects when glycerin (100%; 0.5-4 mL) was administered to 30% of the body surfaces of rabbits 5 d/wk for 45 weeks (Table 6).26 Inhalation—Nonhuman. The inhalation lowest-observed- adverse-effect-level (LOAEL) was 1,000 mg/L for glycerin administered nose only 6 h/d, 5 d/wk for 2 weeks in Crl: DCD Sprague Dawley rats, based on local e...; CITATION=50; 80; 30; CITATION_NUMBERS=[50,80,30]; REFERENCE=50; 80; 30; DETAILS_JSON={"cas_number":"56-81-5","citation":"50; 80; 30","dose":"The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6).35 Oral—Human.","duration":"50-week","effect":"ted into their feed. The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6).35 Oral—Human. There were no signs of toxicity or effects on blood or urine production when patients (n ¼ 10 males, 4 females) were orally administered glycerin (approximately 1.3-2.2 g/kg/d; glycerin in orange juice with meals) for 50 days.3 The NOAEL was \u00062.2 g/kg/d. No further information was provided. There were no adverse effects observed in patients (n ¼ 14) administered glycerin (30 mL, neat) 3 times daily with each meal for 50 days.16 Dermal—Nonhuman. There were no treatment effects when glycerin (100%; 0.5-4 mL) was administered to 30% of the body surfaces of rabbits 5 d/wk for 45 weeks (Table 6).26 Inhalation—Nonhuman. The inhalation lowest-observed- adverse-effect-level (LOAEL) was 1,000 mg/L for glycerin administered nose only 6 h/d, 5 d/wk for 2 weeks in Crl: DCD Sprague Dawley rats, based on local e...","endpoint":"inhalation toxicity","ingredient":"Glycerin","loael_value":"","noael_unit":"g/kg/d","noael_value":"2.2","page":8,"route":"oral","species":"rat","study_id":"PRS679_noael_006"} |
| UnifiedCodex:CIR:beta.noael_studies | inhalation toxicity | >99.8 | % | rat | inhalation | 5 d | inhalation toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=> 99.8; DOSE=No dose-related increase in the frequency, but the incidence of mild metaplasia was greatest in the high dose (7 animals with minimal and 6 with mild).; EFFECT=ed effects for hematology, organ weights, and gross pathology. Histopathology: Minimal-to-mild squamous metaplasia of the epiglottis in males and females (1/10, 13/18, 16/19, and 13/14, respectively). No dose-related increase in the frequency, but the incidence of mild metaplasia was greatest in the high dose (7 animals with minimal and 6 with mild). 36 Sprague Dawley Crl: DCD rat, male/female 15/sex 0, 0.033, 0.167, 0.662 mg/L for 5 h/d, 5 d/wk, for 13 weeks. Purity >99.8%, particle size <2.0 mm. Nose-only study. NOAEL ¼ 0.167 mg/L. Minimal-to-mild squamous metaplasia of the epithelium lining the base of the epiglottis at the high dose. Three per sex necropsied at 10 and 13 weeks to examine lungs with electron microscope. No clinical signs or mortalities. No treatment-related effects for body weights, clinical chemistry, hematology, organ weights, and gross pathology. Histopathology at 13 weeks: Minimal squamous metaplasia of the epiglottis in 2/25, 1/19, 4/20, and 10/21 rats, respectively; 1 male at 662 mg/L showed mild squamous metaplasia. No differences in morphology of the Cl...; CITATION=(1; 10, 13; 18, 16; CITATION_NUMBERS=[1,10,13,18,16]; REFERENCE=(1; 10, 13; 18, 16; DETAILS_JSON={"cas_number":"56-81-5","citation":"(1; 10, 13; 18, 16","dose":"No dose-related increase in the frequency, but the incidence of mild metaplasia was greatest in the high dose (7 animals with minimal and 6 with mild).","duration":"5 d","effect":"ed effects for hematology, organ weights, and gross pathology. Histopathology: Minimal-to-mild squamous metaplasia of the epiglottis in males and females (1/10, 13/18, 16/19, and 13/14, respectively). No dose-related increase in the frequency, but the incidence of mild metaplasia was greatest in the high dose (7 animals with minimal and 6 with mild). 36 Sprague Dawley Crl: DCD rat, male/female 15/sex 0, 0.033, 0.167, 0.662 mg/L for 5 h/d, 5 d/wk, for 13 weeks. Purity >99.8%, particle size <2.0 mm. Nose-only study. NOAEL ¼ 0.167 mg/L. Minimal-to-mild squamous metaplasia of the epithelium lining the base of the epiglottis at the high dose. Three per sex necropsied at 10 and 13 weeks to examine lungs with electron microscope. No clinical signs or mortalities. No treatment-related effects for body weights, clinical chemistry, hematology, organ weights, and gross pathology. Histopathology at 13 weeks: Minimal squamous metaplasia of the epiglottis in 2/25, 1/19, 4/20, and 10/21 rats, respectively; 1 male at 662 mg/L showed mild squamous metaplasia. No differences in morphology of the Cl...","endpoint":"inhalation toxicity","ingredient":"Glycerin","loael_value":"","noael_unit":"%","noael_value":"> 99.8","page":10,"route":"inhalation","species":"rat","study_id":"PRS679_noael_007"} |
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 115 | mg/ kg | rat | oral | 44 days | oral toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=between 115 and 2,300; DOSE=kidney weights and increased liver enzymes were observed.4,30-32 The NOAEL was between 115 and 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When...; EFFECT=kidney weights and increased liver enzymes were observed.4,30-32 The NOAEL was between 115 and 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased in males fed synthetic gly- cerin versus those fed naturally sourced glycerin. There were no treatment-related effects in organ weights and gross pathology.26 The no-observed-effect-level (NOEL) in mongrel dogs was 950 mg/kg/d when glycerin was orally administered; CITATION=4,30; 32; 115; CITATION_NUMBERS=[4,30,32,115]; REFERENCE=4,30; 32; 115; DETAILS_JSON={"cas_number":"56-81-5","citation":"4,30; 32; 115","dose":"kidney weights and increased liver enzymes were observed.4,30-32 The NOAEL was between 115 and 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When...","duration":"44 days","effect":"kidney weights and increased liver enzymes were observed.4,30-32 The NOAEL was between 115 and 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased in males fed synthetic gly- cerin versus those fed naturally sourced glycerin. There were no treatment-related effects in organ weights and gross pathology.26 The no-observed-effect-level (NOEL) in mongrel dogs was 950 mg/kg/d when glycerin was orally administered","endpoint":"oral toxicity","ingredient":"Glycerin","loael_value":"","noael_unit":"mg/ kg","noael_value":"between 115 and 2,300","page":8,"route":"oral","species":"rat","study_id":"PRS679_noael_004"} |
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 950 | mg/kg/d | rat | oral | 44 days | oral toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=950; DOSE=nd 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased...; EFFECT=nd 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased in males fed synthetic gly- cerin versus those fed naturally sourced glycerin. There were no treatment-related effects in organ weights and gross pathology.26 The no-observed-effect-level (NOEL) in mongrel dogs was 950 mg/kg/d when glycerin was orally administered for 3 days (Table 6). At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemorrhages.34 Mongrel dogs experienced weight loss after 36 weeks when glycerin (35%) was incorporated into their feed. The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6...; CITATION=2,300; 44; 33; CITATION_NUMBERS=[2,300,44,33]; REFERENCE=2,300; 44; 33; DETAILS_JSON={"cas_number":"56-81-5","citation":"2,300; 44; 33","dose":"nd 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased...","duration":"44 days","effect":"nd 2,300 mg/ kg when administered in water to rats for 44 days.33 Calcified masses were observed in kidney tubules between the cortex and medulla in 3 of 5 rats administered either natural or synthetic glycerin (3,335 mg/kg/d) in drinking water for 6 months.28 When glycerin was administered in the diet for 2 years, feed consumption was slightly increased in males fed synthetic gly- cerin versus those fed naturally sourced glycerin. There were no treatment-related effects in organ weights and gross pathology.26 The no-observed-effect-level (NOEL) in mongrel dogs was 950 mg/kg/d when glycerin was orally administered for 3 days (Table 6). At 3,800 mg/kg/d, the mucosa of the stomach was severely hyperemic with petechial hemorrhages.34 Mongrel dogs experienced weight loss after 36 weeks when glycerin (35%) was incorporated into their feed. The weight loss con- tinued when the glycerin content was reduced by 50% to 80% for the remainder of a 50-week study.30 There were no pathological changes in guinea pigs (n ¼ 10) orally administered glycerin (6,300 mg/kg/d) for 30 to 40 days (Table 6...","endpoint":"oral toxicity","ingredient":"Glycerin","loael_value":"","noael_unit":"mg/kg/d","noael_value":"950","page":8,"route":"oral","species":"rat","study_id":"PRS679_noael_005"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 15 | g/kg | rat | oral | 42 days | repeated dose toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=15; DOSE=When glycerin (1 mL/kg/d in 3 doses) was orally admi- nistered for 42 days, increased serum glyceride concentrations were observed in both sexes; however, the increase was greater in men.21 Toxicological Studies In a survey of 4 laboratories of the use of vehicles for in vivo experiments, the highest no-observed-adverse-effect levels (NOAELs) of various r...; EFFECT=kg in water) in human male patients led to an increase in plasma glycerides. In human female patients, the oral administration of glycerin (1 mL/kg in water) resulted in no change in plasma glyceride concentra- tions. When glycerin (1 mL/kg/d in 3 doses) was orally admi- nistered for 42 days, increased serum glyceride concentrations were observed in both sexes; however, the increase was greater in men.21 Toxicological Studies In a survey of 4 laboratories of the use of vehicles for in vivo experiments, the highest no-observed-adverse-effect levels (NOAELs) of various routes of administration were assem- bled.22 The oral NOAELs for glycerin were 15 g/kg for rats and 500 mg/kg for guinea pigs for 1 month and 500 mg/kg for 90 days for mice (Table 4). The highest subcutaneous NOAELs were 10 mg/kg in rats and mice. Acute Toxicity Nonhuman. Reported oral median lethal dose (LD50) values of glycerin ranged from 2,530 to 58,400 mg/kg in rats; there were no deaths at 24,000 mg/kg in one study (Table 5).3,18,23-27 Reported oral LD50 values of glycerin were 4,090 to 38,000 mg/kg in mice, 27,...; CITATION=(1; 3; 42; CITATION_NUMBERS=[1,3,42]; REFERENCE=(1; 3; 42; DETAILS_JSON={"cas_number":"56-81-5","citation":"(1; 3; 42","dose":"When glycerin (1 mL/kg/d in 3 doses) was orally admi- nistered for 42 days, increased serum glyceride concentrations were observed in both sexes; however, the increase was greater in men.21 Toxicological Studies In a survey of 4 laboratories of the use of vehicles for in vivo experiments, the highest no-observed-adverse-effect levels (NOAELs) of various r...","duration":"42 days","effect":"kg in water) in human male patients led to an increase in plasma glycerides. In human female patients, the oral administration of glycerin (1 mL/kg in water) resulted in no change in plasma glyceride concentra- tions. When glycerin (1 mL/kg/d in 3 doses) was orally admi- nistered for 42 days, increased serum glyceride concentrations were observed in both sexes; however, the increase was greater in men.21 Toxicological Studies In a survey of 4 laboratories of the use of vehicles for in vivo experiments, the highest no-observed-adverse-effect levels (NOAELs) of various routes of administration were assem- bled.22 The oral NOAELs for glycerin were 15 g/kg for rats and 500 mg/kg for guinea pigs for 1 month and 500 mg/kg for 90 days for mice (Table 4). The highest subcutaneous NOAELs were 10 mg/kg in rats and mice. Acute Toxicity Nonhuman. Reported oral median lethal dose (LD50) values of glycerin ranged from 2,530 to 58,400 mg/kg in rats; there were no deaths at 24,000 mg/kg in one study (Table 5).3,18,23-27 Reported oral LD50 values of glycerin were 4,090 to 38,000 mg/kg in mice, 27,...","endpoint":"repeated dose toxicity","ingredient":"Glycerin","loael_value":"","noael_unit":"g/kg","noael_value":"15","page":6,"route":"oral","species":"rat","study_id":"PRS679_noael_001"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 53.4 | % | rat | oral | 4 weeks | repeated dose toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=53.4; DOSE=Repeated Dose Toxicity Oral—Nonhuman.; EFFECT=d after treatment. Hypotonic fluids relieve thirst and headache caused by the dehydrating action of glycerin. Repeated Dose Toxicity Oral—Nonhuman. Repeated dose toxicity studies are summar- ized in Table 6. Undiluted glycerin caused a dose-dependent increase in the number of animals showing hyperemia, pete- chial hemorrhage, and erosions in the gastrointestinal tract.30 In short-term feeding experiments, glycerin at 20% for 4 weeks in feed produced no adverse effects, but at 53.4%, an increase in Table 4. Highest NOAEL Reported in a Survey of 4 Research Organizations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated Subcutaneous Acute 10 mg/kg Well tolerated Intraperitoneal 1 month 250 mg/kg Well tolerated Rabbit Intravenous Not provided 10 mg/kg Well tolerated Abbreviation: NOAEL, no-...; CITATION=6; 30; 20; CITATION_NUMBERS=[6,30,20]; REFERENCE=6; 30; 20; DETAILS_JSON={"cas_number":"56-81-5","citation":"6; 30; 20","dose":"Repeated Dose Toxicity Oral—Nonhuman.","duration":"4 weeks","effect":"d after treatment. Hypotonic fluids relieve thirst and headache caused by the dehydrating action of glycerin. Repeated Dose Toxicity Oral—Nonhuman. Repeated dose toxicity studies are summar- ized in Table 6. Undiluted glycerin caused a dose-dependent increase in the number of animals showing hyperemia, pete- chial hemorrhage, and erosions in the gastrointestinal tract.30 In short-term feeding experiments, glycerin at 20% for 4 weeks in feed produced no adverse effects, but at 53.4%, an increase in Table 4. Highest NOAEL Reported in a Survey of 4 Research Organizations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated Subcutaneous Acute 10 mg/kg Well tolerated Intraperitoneal 1 month 250 mg/kg Well tolerated Rabbit Intravenous Not provided 10 mg/kg Well tolerated Abbreviation: NOAEL, no-...","endpoint":"repeated dose toxicity","ingredient":"Glycerin","loael_value":"","noael_unit":"%","noael_value":"53.4","page":6,"route":"oral","species":"rat","study_id":"PRS679_noael_002"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 10 | mg/kg | rat | oral | 1 month | repeated dose toxicity | SOURCE_SUBDIR=PRS679; REPORT_TITLE=Safety Assessment of Glycerin as Used in Cosmetics Lillian C. Becker1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2, Thomas J. Slaga2,; OPINION_NUMBER=PRS679; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=10; DOSE=zations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated...; EFFECT=zations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated Subcutaneous Acute 10 mg/kg Well tolerated Intraperitoneal 1 month 250 mg/kg Well tolerated Rabbit Intravenous Not provided 10 mg/kg Well tolerated Abbreviation: NOAEL, no-observed-adverse-effect level. Becker et al 11S; CITATION=22; 1,000; 1; CITATION_NUMBERS=[22,1]; REFERENCE=22; 1,000; 1; DETAILS_JSON={"cas_number":"56-81-5","citation":"22; 1,000; 1","dose":"zations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated...","duration":"1 month","effect":"zations for Glycerin Used as a Vehicle.22 Animal Route Duration Dose Comments Rat Oral Not provided 1,000 mg/kg Well tolerated 1 month 15 g/kg Reduced adrenal weight 1 month 1,000 mg/kg Well tolerated Guinea pig Oral 1 month 500 mg/kg Well tolerated Mouse Oral 90 days 50 mg/kg Depression and reduced respiration Intravenous 1 month 100 mg/kg Well tolerated Subcutaneous Acute 10 mg/kg Well tolerated Intraperitoneal 1 month 250 mg/kg Well tolerated Rabbit Intravenous Not provided 10 mg/kg Well tolerated Abbreviation: NOAEL, no-observed-adverse-effect level. Becker et al 11S","endpoint":"repeated dose toxicity","ingredient":"Glycerin","loael_value":"","noael_unit":"mg/kg","noael_value":"10","page":6,"route":"oral","species":"rat","study_id":"PRS679_noael_003"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | PDC6A3C0OX | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C3H8O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PDC6A3C0OX"} |
| openFDA substances | FDA UNII substance identifier | PDC6A3C0OX | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C3H8O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PDC6A3C0OX"} |
| openFDA substances | FDA UNII substance identifier | PDC6A3C0OX | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C3H8O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PDC6A3C0OX"} |
| openFDA substances | FDA UNII substance identifier | PDC6A3C0OX | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C3H8O3","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PDC6A3C0OX"} |