NOAEL Studies
Cosmetic Ingredient
Triheptanoin NOAEL Studies
INCI: TRIHEPTANOIN
CAS: 620-67-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR_vision_codex 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR_vision_codex | NOAEL | =10 | mg/kg bw/d | rat | oral | 30 d | repeated dose toxicity | {"citation":"36; 37; 0","dose":"In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and...","effect":"prylic/Capric Triglyceride did not produce any signs of toxicity,36 but undiluted test material produced some gastrointestinal effects, decreased thymic weight, caused inflammation in the lungs, and resulted in changes in some clinical pathology parameters.37 These changes were reversible. In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and a NOAEL of 3500 mg/kg/d was reported with MLCT.28 In a human study, no adverse effects were observed in a placebo-controlled double-blind study in which healthy subjects ingested 42 g/d MLCT.28 No adverse effects were observed in a study in which rabbits were given a Tripelargonin/LCT emulsion via a TPN infusion regimen for 7 h/d for 11 d.30,40 Subchronic Toxicity Studies Application of a perfumed skin softener formulation con- taining 4% Capryl...","page":30,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_001"} |
| CIR_vision_codex | NOAEL | =3500 | mg/kg/d | rat | oral | 30 d | repeated dose toxicity | {"citation":"37; 0; 5","dose":"In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and...","effect":"ects, decreased thymic weight, caused inflammation in the lungs, and resulted in changes in some clinical pathology parameters.37 These changes were reversible. In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and a NOAEL of 3500 mg/kg/d was reported with MLCT.28 In a human study, no adverse effects were observed in a placebo-controlled double-blind study in which healthy subjects ingested 42 g/d MLCT.28 No adverse effects were observed in a study in which rabbits were given a Tripelargonin/LCT emulsion via a TPN infusion regimen for 7 h/d for 11 d.30,40 Subchronic Toxicity Studies Application of a perfumed skin softener formulation con- taining 4% Caprylic/Capric Triglyceride to the shaved skin of female rats at a dose of 2 ml/kg 5 d/wk for 13 wk did not produce any toxic effects.5...","page":30,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_002"} |
| CIR_vision_codex | NOAEL | =10 | g/kg | rat | oral | chronic | oral toxicity | {"citation":"3; 6; 38","dose":"he lung of 3/6 animals presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation (attributed by the researchers to aspiration pneumonia) No changes in organ weights or gross or microscopic lesions were observed, and no toxicologically- relevant changes in hematology or urinalysis parameters were noted 38...","effect":"he lung of 3/6 animals presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation (attributed by the researchers to aspiration pneumonia) No changes in organ weights or gross or microscopic lesions were observed, and no toxicologically- relevant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the first days of the study 39 MLCT Wistar rats; 20 males/ group 6 wks none diet containing 7% MLCT or rapeseed oil (control) (equiv to 3.5 g/kg/day) 6-wk dietary study NOAEL = 3.5 g/kg/day no adverse effects were observed feed consumption, total carcass protein, and serum cholesterol values were statistically significantly increased; total body fat was statistically significantly decreased 28 PARENTERAL Tripelargonin/LCT (7/3 wt/wt) emulsion New Zeal...","page":33,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_003"} |
| CIR_vision_codex | NOAEL | =3.5 | g/kg/day | rat | oral | 30 days | oral toxicity | {"citation":"38; 10; 30","dose":"vant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the fi...","effect":"vant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the first days of the study 39 MLCT Wistar rats; 20 males/ group 6 wks none diet containing 7% MLCT or rapeseed oil (control) (equiv to 3.5 g/kg/day) 6-wk dietary study NOAEL = 3.5 g/kg/day no adverse effects were observed feed consumption, total carcass protein, and serum cholesterol values were statistically significantly increased; total body fat was statistically significantly decreased 28 PARENTERAL Tripelargonin/LCT (7/3 wt/wt) emulsion New Zealand rabbits; 8 male 11 days none 46.5% of total daily energy TPN infusions 7 h/day; controls were given isocaloric amounts of a standard food; the animals were killed on day 12 No signs of toxicity; no effect on organ weights or liver lipid concentrations; macroscopic, but not microscopic,...","page":33,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_004"} |
| CIR_vision_codex | NOAEL | =5 | % | rat | oral | SUBCHRONIC | repeated dose toxicity | {"citation":"(7; 3; 42","effect":"d soybean oils (7:3; controls) or MLCT; 42 g oil/ day consumed placebo-controlled double blind study ; hematology and urinalysis were conducted at study initiation and study termination; liver and renal function were measured; body wts and body mass index were measured no adverse effects 28 SUBCHRONIC TOXICITY STUDIES Caprylic/Capric Triglyceride Wistar rats, 20/sex 90 days none 1 and 5% dietary study, in accord with OECD TG 408; changes in organ weights were not measured; microscopic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog food with beef tallow; animals were observed daily; body weight and feed consumption were measured; hematology, serum chemistry, and urine analysis were performed NOAEL = 15% No toxicologically-significant clinical signs of toxicity; no significant differ...","page":34,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_005"} |
| CIR_vision_codex | NOAEL | =15 | % | rat | oral | 91 days | oral toxicity | {"citation":"5; 39; 4","dose":"opic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog...","effect":"opic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog food with beef tallow; animals were observed daily; body weight and feed consumption were measured; hematology, serum chemistry, and urine analysis were performed NOAEL = 15% No toxicologically-significant clinical signs of toxicity; no significant differences in body wts or feed consumption; no mortality; no test article-related changes in hematology parameters; some changes in clinical chemistry parameters may have been related to the test article; decreased urine volume with increased specific gravity was reported in the mid- and high-dose group 41 CHRONIC TOXICITY STUDIES oil consisting of: 64% Triheptanoin 34% diheptanoin 2% monoheptanoin Wistar rats, 10 males 9 mos none control diet with either 30% or 50% substitution of soy...","page":34,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_006"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg bw/d | rat | oral | 30 d | repeated dose toxicity | {"citation":"36; 37; 0","dose":"In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and...","effect":"prylic/Capric Triglyceride did not produce any signs of toxicity,36 but undiluted test material produced some gastrointestinal effects, decreased thymic weight, caused inflammation in the lungs, and resulted in changes in some clinical pathology parameters.37 These changes were reversible. In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and a NOAEL of 3500 mg/kg/d was reported with MLCT.28 In a human study, no adverse effects were observed in a placebo-controlled double-blind study in which healthy subjects ingested 42 g/d MLCT.28 No adverse effects were observed in a study in which rabbits were given a Tripelargonin/LCT emulsion via a TPN infusion regimen for 7 h/d for 11 d.30,40 Subchronic Toxicity Studies Application of a perfumed skin softener formulation con- taining 4% Capryl...","page":30,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_001"} |
| CIR_vision_codex | NOAEL | =3500 | mg/kg/d | rat | oral | 30 d | repeated dose toxicity | {"citation":"37; 0; 5","dose":"In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and...","effect":"ects, decreased thymic weight, caused inflammation in the lungs, and resulted in changes in some clinical pathology parameters.37 These changes were reversible. In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and a NOAEL of 3500 mg/kg/d was reported with MLCT.28 In a human study, no adverse effects were observed in a placebo-controlled double-blind study in which healthy subjects ingested 42 g/d MLCT.28 No adverse effects were observed in a study in which rabbits were given a Tripelargonin/LCT emulsion via a TPN infusion regimen for 7 h/d for 11 d.30,40 Subchronic Toxicity Studies Application of a perfumed skin softener formulation con- taining 4% Caprylic/Capric Triglyceride to the shaved skin of female rats at a dose of 2 ml/kg 5 d/wk for 13 wk did not produce any toxic effects.5...","page":30,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_002"} |
| CIR_vision_codex | NOAEL | =10 | g/kg | rat | oral | chronic | oral toxicity | {"citation":"3; 6; 38","dose":"he lung of 3/6 animals presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation (attributed by the researchers to aspiration pneumonia) No changes in organ weights or gross or microscopic lesions were observed, and no toxicologically- relevant changes in hematology or urinalysis parameters were noted 38...","effect":"he lung of 3/6 animals presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation (attributed by the researchers to aspiration pneumonia) No changes in organ weights or gross or microscopic lesions were observed, and no toxicologically- relevant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the first days of the study 39 MLCT Wistar rats; 20 males/ group 6 wks none diet containing 7% MLCT or rapeseed oil (control) (equiv to 3.5 g/kg/day) 6-wk dietary study NOAEL = 3.5 g/kg/day no adverse effects were observed feed consumption, total carcass protein, and serum cholesterol values were statistically significantly increased; total body fat was statistically significantly decreased 28 PARENTERAL Tripelargonin/LCT (7/3 wt/wt) emulsion New Zeal...","page":33,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_003"} |
| CIR_vision_codex | NOAEL | =3.5 | g/kg/day | rat | oral | 30 days | oral toxicity | {"citation":"38; 10; 30","dose":"vant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the fi...","effect":"vant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the first days of the study 39 MLCT Wistar rats; 20 males/ group 6 wks none diet containing 7% MLCT or rapeseed oil (control) (equiv to 3.5 g/kg/day) 6-wk dietary study NOAEL = 3.5 g/kg/day no adverse effects were observed feed consumption, total carcass protein, and serum cholesterol values were statistically significantly increased; total body fat was statistically significantly decreased 28 PARENTERAL Tripelargonin/LCT (7/3 wt/wt) emulsion New Zealand rabbits; 8 male 11 days none 46.5% of total daily energy TPN infusions 7 h/day; controls were given isocaloric amounts of a standard food; the animals were killed on day 12 No signs of toxicity; no effect on organ weights or liver lipid concentrations; macroscopic, but not microscopic,...","page":33,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_004"} |
| CIR_vision_codex | NOAEL | =5 | % | rat | oral | SUBCHRONIC | repeated dose toxicity | {"citation":"(7; 3; 42","effect":"d soybean oils (7:3; controls) or MLCT; 42 g oil/ day consumed placebo-controlled double blind study ; hematology and urinalysis were conducted at study initiation and study termination; liver and renal function were measured; body wts and body mass index were measured no adverse effects 28 SUBCHRONIC TOXICITY STUDIES Caprylic/Capric Triglyceride Wistar rats, 20/sex 90 days none 1 and 5% dietary study, in accord with OECD TG 408; changes in organ weights were not measured; microscopic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog food with beef tallow; animals were observed daily; body weight and feed consumption were measured; hematology, serum chemistry, and urine analysis were performed NOAEL = 15% No toxicologically-significant clinical signs of toxicity; no significant differ...","page":34,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_005"} |
| CIR_vision_codex | NOAEL | =15 | % | rat | oral | 91 days | oral toxicity | {"citation":"5; 39; 4","dose":"opic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog...","effect":"opic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog food with beef tallow; animals were observed daily; body weight and feed consumption were measured; hematology, serum chemistry, and urine analysis were performed NOAEL = 15% No toxicologically-significant clinical signs of toxicity; no significant differences in body wts or feed consumption; no mortality; no test article-related changes in hematology parameters; some changes in clinical chemistry parameters may have been related to the test article; decreased urine volume with increased specific gravity was reported in the mid- and high-dose group 41 CHRONIC TOXICITY STUDIES oil consisting of: 64% Triheptanoin 34% diheptanoin 2% monoheptanoin Wistar rats, 10 males 9 mos none control diet with either 30% or 50% substitution of soy...","page":34,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_006"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg bw/d | rat | oral | 30 d | repeated dose toxicity | {"citation":"36; 37; 0","dose":"In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and...","effect":"prylic/Capric Triglyceride did not produce any signs of toxicity,36 but undiluted test material produced some gastrointestinal effects, decreased thymic weight, caused inflammation in the lungs, and resulted in changes in some clinical pathology parameters.37 These changes were reversible. In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and a NOAEL of 3500 mg/kg/d was reported with MLCT.28 In a human study, no adverse effects were observed in a placebo-controlled double-blind study in which healthy subjects ingested 42 g/d MLCT.28 No adverse effects were observed in a study in which rabbits were given a Tripelargonin/LCT emulsion via a TPN infusion regimen for 7 h/d for 11 d.30,40 Subchronic Toxicity Studies Application of a perfumed skin softener formulation con- taining 4% Capryl...","page":30,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_001"} |
| CIR_vision_codex | NOAEL | =3500 | mg/kg/d | rat | oral | 30 d | repeated dose toxicity | {"citation":"37; 0; 5","dose":"In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and...","effect":"ects, decreased thymic weight, caused inflammation in the lungs, and resulted in changes in some clinical pathology parameters.37 These changes were reversible. In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and a NOAEL of 3500 mg/kg/d was reported with MLCT.28 In a human study, no adverse effects were observed in a placebo-controlled double-blind study in which healthy subjects ingested 42 g/d MLCT.28 No adverse effects were observed in a study in which rabbits were given a Tripelargonin/LCT emulsion via a TPN infusion regimen for 7 h/d for 11 d.30,40 Subchronic Toxicity Studies Application of a perfumed skin softener formulation con- taining 4% Caprylic/Capric Triglyceride to the shaved skin of female rats at a dose of 2 ml/kg 5 d/wk for 13 wk did not produce any toxic effects.5...","page":30,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_002"} |
| CIR_vision_codex | NOAEL | =10 | g/kg | rat | oral | chronic | oral toxicity | {"citation":"3; 6; 38","dose":"he lung of 3/6 animals presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation (attributed by the researchers to aspiration pneumonia) No changes in organ weights or gross or microscopic lesions were observed, and no toxicologically- relevant changes in hematology or urinalysis parameters were noted 38...","effect":"he lung of 3/6 animals presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation (attributed by the researchers to aspiration pneumonia) No changes in organ weights or gross or microscopic lesions were observed, and no toxicologically- relevant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the first days of the study 39 MLCT Wistar rats; 20 males/ group 6 wks none diet containing 7% MLCT or rapeseed oil (control) (equiv to 3.5 g/kg/day) 6-wk dietary study NOAEL = 3.5 g/kg/day no adverse effects were observed feed consumption, total carcass protein, and serum cholesterol values were statistically significantly increased; total body fat was statistically significantly decreased 28 PARENTERAL Tripelargonin/LCT (7/3 wt/wt) emulsion New Zeal...","page":33,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_003"} |
| CIR_vision_codex | NOAEL | =3.5 | g/kg/day | rat | oral | 30 days | oral toxicity | {"citation":"38; 10; 30","dose":"vant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the fi...","effect":"vant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the first days of the study 39 MLCT Wistar rats; 20 males/ group 6 wks none diet containing 7% MLCT or rapeseed oil (control) (equiv to 3.5 g/kg/day) 6-wk dietary study NOAEL = 3.5 g/kg/day no adverse effects were observed feed consumption, total carcass protein, and serum cholesterol values were statistically significantly increased; total body fat was statistically significantly decreased 28 PARENTERAL Tripelargonin/LCT (7/3 wt/wt) emulsion New Zealand rabbits; 8 male 11 days none 46.5% of total daily energy TPN infusions 7 h/day; controls were given isocaloric amounts of a standard food; the animals were killed on day 12 No signs of toxicity; no effect on organ weights or liver lipid concentrations; macroscopic, but not microscopic,...","page":33,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_004"} |
| CIR_vision_codex | NOAEL | =5 | % | rat | oral | SUBCHRONIC | repeated dose toxicity | {"citation":"(7; 3; 42","effect":"d soybean oils (7:3; controls) or MLCT; 42 g oil/ day consumed placebo-controlled double blind study ; hematology and urinalysis were conducted at study initiation and study termination; liver and renal function were measured; body wts and body mass index were measured no adverse effects 28 SUBCHRONIC TOXICITY STUDIES Caprylic/Capric Triglyceride Wistar rats, 20/sex 90 days none 1 and 5% dietary study, in accord with OECD TG 408; changes in organ weights were not measured; microscopic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog food with beef tallow; animals were observed daily; body weight and feed consumption were measured; hematology, serum chemistry, and urine analysis were performed NOAEL = 15% No toxicologically-significant clinical signs of toxicity; no significant differ...","page":34,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_005"} |
| CIR_vision_codex | NOAEL | =15 | % | rat | oral | 91 days | oral toxicity | {"citation":"5; 39; 4","dose":"opic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog...","effect":"opic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog food with beef tallow; animals were observed daily; body weight and feed consumption were measured; hematology, serum chemistry, and urine analysis were performed NOAEL = 15% No toxicologically-significant clinical signs of toxicity; no significant differences in body wts or feed consumption; no mortality; no test article-related changes in hematology parameters; some changes in clinical chemistry parameters may have been related to the test article; decreased urine volume with increased specific gravity was reported in the mid- and high-dose group 41 CHRONIC TOXICITY STUDIES oil consisting of: 64% Triheptanoin 34% diheptanoin 2% monoheptanoin Wistar rats, 10 males 9 mos none control diet with either 30% or 50% substitution of soy...","page":34,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_006"} |
| CIR_vision_codex | NOAEL | =10 | mg/kg bw/d | rat | oral | 30 d | repeated dose toxicity | {"citation":"36; 37; 0","dose":"In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and...","effect":"prylic/Capric Triglyceride did not produce any signs of toxicity,36 but undiluted test material produced some gastrointestinal effects, decreased thymic weight, caused inflammation in the lungs, and resulted in changes in some clinical pathology parameters.37 These changes were reversible. In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and a NOAEL of 3500 mg/kg/d was reported with MLCT.28 In a human study, no adverse effects were observed in a placebo-controlled double-blind study in which healthy subjects ingested 42 g/d MLCT.28 No adverse effects were observed in a study in which rabbits were given a Tripelargonin/LCT emulsion via a TPN infusion regimen for 7 h/d for 11 d.30,40 Subchronic Toxicity Studies Application of a perfumed skin softener formulation con- taining 4% Capryl...","page":30,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_001"} |
| CIR_vision_codex | NOAEL | =3500 | mg/kg/d | rat | oral | 30 d | repeated dose toxicity | {"citation":"37; 0; 5","dose":"In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and...","effect":"ects, decreased thymic weight, caused inflammation in the lungs, and resulted in changes in some clinical pathology parameters.37 These changes were reversible. In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and a NOAEL of 3500 mg/kg/d was reported with MLCT.28 In a human study, no adverse effects were observed in a placebo-controlled double-blind study in which healthy subjects ingested 42 g/d MLCT.28 No adverse effects were observed in a study in which rabbits were given a Tripelargonin/LCT emulsion via a TPN infusion regimen for 7 h/d for 11 d.30,40 Subchronic Toxicity Studies Application of a perfumed skin softener formulation con- taining 4% Caprylic/Capric Triglyceride to the shaved skin of female rats at a dose of 2 ml/kg 5 d/wk for 13 wk did not produce any toxic effects.5...","page":30,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_002"} |
| CIR_vision_codex | NOAEL | =10 | g/kg | rat | oral | chronic | oral toxicity | {"citation":"3; 6; 38","dose":"he lung of 3/6 animals presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation (attributed by the researchers to aspiration pneumonia) No changes in organ weights or gross or microscopic lesions were observed, and no toxicologically- relevant changes in hematology or urinalysis parameters were noted 38...","effect":"he lung of 3/6 animals presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation (attributed by the researchers to aspiration pneumonia) No changes in organ weights or gross or microscopic lesions were observed, and no toxicologically- relevant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the first days of the study 39 MLCT Wistar rats; 20 males/ group 6 wks none diet containing 7% MLCT or rapeseed oil (control) (equiv to 3.5 g/kg/day) 6-wk dietary study NOAEL = 3.5 g/kg/day no adverse effects were observed feed consumption, total carcass protein, and serum cholesterol values were statistically significantly increased; total body fat was statistically significantly decreased 28 PARENTERAL Tripelargonin/LCT (7/3 wt/wt) emulsion New Zeal...","page":33,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_003"} |
| CIR_vision_codex | NOAEL | =3.5 | g/kg/day | rat | oral | 30 days | oral toxicity | {"citation":"38; 10; 30","dose":"vant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the fi...","effect":"vant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the first days of the study 39 MLCT Wistar rats; 20 males/ group 6 wks none diet containing 7% MLCT or rapeseed oil (control) (equiv to 3.5 g/kg/day) 6-wk dietary study NOAEL = 3.5 g/kg/day no adverse effects were observed feed consumption, total carcass protein, and serum cholesterol values were statistically significantly increased; total body fat was statistically significantly decreased 28 PARENTERAL Tripelargonin/LCT (7/3 wt/wt) emulsion New Zealand rabbits; 8 male 11 days none 46.5% of total daily energy TPN infusions 7 h/day; controls were given isocaloric amounts of a standard food; the animals were killed on day 12 No signs of toxicity; no effect on organ weights or liver lipid concentrations; macroscopic, but not microscopic,...","page":33,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_004"} |
| CIR_vision_codex | NOAEL | =5 | % | rat | oral | SUBCHRONIC | repeated dose toxicity | {"citation":"(7; 3; 42","effect":"d soybean oils (7:3; controls) or MLCT; 42 g oil/ day consumed placebo-controlled double blind study ; hematology and urinalysis were conducted at study initiation and study termination; liver and renal function were measured; body wts and body mass index were measured no adverse effects 28 SUBCHRONIC TOXICITY STUDIES Caprylic/Capric Triglyceride Wistar rats, 20/sex 90 days none 1 and 5% dietary study, in accord with OECD TG 408; changes in organ weights were not measured; microscopic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog food with beef tallow; animals were observed daily; body weight and feed consumption were measured; hematology, serum chemistry, and urine analysis were performed NOAEL = 15% No toxicologically-significant clinical signs of toxicity; no significant differ...","page":34,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_005"} |
| CIR_vision_codex | NOAEL | =15 | % | rat | oral | 91 days | oral toxicity | {"citation":"5; 39; 4","dose":"opic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog...","effect":"opic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog food with beef tallow; animals were observed daily; body weight and feed consumption were measured; hematology, serum chemistry, and urine analysis were performed NOAEL = 15% No toxicologically-significant clinical signs of toxicity; no significant differences in body wts or feed consumption; no mortality; no test article-related changes in hematology parameters; some changes in clinical chemistry parameters may have been related to the test article; decreased urine volume with increased specific gravity was reported in the mid- and high-dose group 41 CHRONIC TOXICITY STUDIES oil consisting of: 64% Triheptanoin 34% diheptanoin 2% monoheptanoin Wistar rats, 10 males 9 mos none control diet with either 30% or 50% substitution of soy...","page":34,"pdf":"PRS742.pdf","row_type":"noael_study","study_id":"PRS742_noael_006"} |
UnifiedCodex:CIR:beta.noael_studies 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 10 | g/kg | rat | oral | chronic | oral toxicity | SOURCE_SUBDIR=PRS742; REPORT_TITLE=Amended Safety Assessment of Triglycerides as Used in Cosmetics Monice M. Fiume*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks Jr***, Ronald C. Shank***, Thomas J. S; OPINION_NUMBER=PRS742; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=10; DOSE=he lung of 3/6 animals presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation (attributed by the researchers to aspiration pneumonia) No changes in organ weights or gross or microscopic lesions were observed, and no toxicologically- relevant changes in hematology or urinalysis parameters were noted 38...; EFFECT=he lung of 3/6 animals presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation (attributed by the researchers to aspiration pneumonia) No changes in organ weights or gross or microscopic lesions were observed, and no toxicologically- relevant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the first days of the study 39 MLCT Wistar rats; 20 males/ group 6 wks none diet containing 7% MLCT or rapeseed oil (control) (equiv to 3.5 g/kg/day) 6-wk dietary study NOAEL = 3.5 g/kg/day no adverse effects were observed feed consumption, total carcass protein, and serum cholesterol values were statistically significantly increased; total body fat was statistically significantly decreased 28 PARENTERAL Tripelargonin/LCT (7/3 wt/wt) emulsion New Zeal...; CITATION=3; 6; 38; CITATION_NUMBERS=[3,6,38]; REFERENCE=3; 6; 38; DETAILS_JSON={"cas_number":"620-67-7","citation":"3; 6; 38","dose":"he lung of 3/6 animals presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation (attributed by the researchers to aspiration pneumonia) No changes in organ weights or gross or microscopic lesions were observed, and no toxicologically- relevant changes in hematology or urinalysis parameters were noted 38...","duration":"chronic","effect":"he lung of 3/6 animals presented abnormal color and/or irregular surface correlated with a chronic bronchiolo-alveolar inflammation (attributed by the researchers to aspiration pneumonia) No changes in organ weights or gross or microscopic lesions were observed, and no toxicologically- relevant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the first days of the study 39 MLCT Wistar rats; 20 males/ group 6 wks none diet containing 7% MLCT or rapeseed oil (control) (equiv to 3.5 g/kg/day) 6-wk dietary study NOAEL = 3.5 g/kg/day no adverse effects were observed feed consumption, total carcass protein, and serum cholesterol values were statistically significantly increased; total body fat was statistically significantly decreased 28 PARENTERAL Tripelargonin/LCT (7/3 wt/wt) emulsion New Zeal...","endpoint":"oral toxicity","ingredient":"Triglycerides","loael_value":"","noael_unit":"g/kg","noael_value":"10","page":33,"route":"oral","species":"rat","study_id":"PRS742_noael_003"} |
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 3.5 | g/kg/day | rat | oral | 30 days | oral toxicity | SOURCE_SUBDIR=PRS742; REPORT_TITLE=Amended Safety Assessment of Triglycerides as Used in Cosmetics Monice M. Fiume*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks Jr***, Ronald C. Shank***, Thomas J. S; OPINION_NUMBER=PRS742; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=3.5; DOSE=vant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the fi...; EFFECT=vant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the first days of the study 39 MLCT Wistar rats; 20 males/ group 6 wks none diet containing 7% MLCT or rapeseed oil (control) (equiv to 3.5 g/kg/day) 6-wk dietary study NOAEL = 3.5 g/kg/day no adverse effects were observed feed consumption, total carcass protein, and serum cholesterol values were statistically significantly increased; total body fat was statistically significantly decreased 28 PARENTERAL Tripelargonin/LCT (7/3 wt/wt) emulsion New Zealand rabbits; 8 male 11 days none 46.5% of total daily energy TPN infusions 7 h/day; controls were given isocaloric amounts of a standard food; the animals were killed on day 12 No signs of toxicity; no effect on organ weights or liver lipid concentrations; macroscopic, but not microscopic,...; CITATION=38; 10; 30; CITATION_NUMBERS=[38,10,30]; REFERENCE=38; 10; 30; DETAILS_JSON={"cas_number":"620-67-7","citation":"38; 10; 30","dose":"vant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the fi...","duration":"30 days","effect":"vant changes in hematology or urinalysis parameters were noted 38 Caprylic/Capric Triglyceride Wistar rats, 10 males/ group 30 days none 10.2 – 20.1 g/kg bw/day animals were dosed once daily by gavage, in accord with OECD TG 407 NOAEL = ∼10 g/kg bw/day reduced food consumption, softened feces, ruffled fur were observed in the high dose group during the first days of the study 39 MLCT Wistar rats; 20 males/ group 6 wks none diet containing 7% MLCT or rapeseed oil (control) (equiv to 3.5 g/kg/day) 6-wk dietary study NOAEL = 3.5 g/kg/day no adverse effects were observed feed consumption, total carcass protein, and serum cholesterol values were statistically significantly increased; total body fat was statistically significantly decreased 28 PARENTERAL Tripelargonin/LCT (7/3 wt/wt) emulsion New Zealand rabbits; 8 male 11 days none 46.5% of total daily energy TPN infusions 7 h/day; controls were given isocaloric amounts of a standard food; the animals were killed on day 12 No signs of toxicity; no effect on organ weights or liver lipid concentrations; macroscopic, but not microscopic,...","endpoint":"oral toxicity","ingredient":"Triglycerides","loael_value":"","noael_unit":"g/kg/day","noael_value":"3.5","page":33,"route":"oral","species":"rat","study_id":"PRS742_noael_004"} |
| UnifiedCodex:CIR:beta.noael_studies | oral toxicity | 15 | % | rat | oral | 91 days | oral toxicity | SOURCE_SUBDIR=PRS742; REPORT_TITLE=Amended Safety Assessment of Triglycerides as Used in Cosmetics Monice M. Fiume*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks Jr***, Ronald C. Shank***, Thomas J. S; OPINION_NUMBER=PRS742; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=15; DOSE=opic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog...; EFFECT=opic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog food with beef tallow; animals were observed daily; body weight and feed consumption were measured; hematology, serum chemistry, and urine analysis were performed NOAEL = 15% No toxicologically-significant clinical signs of toxicity; no significant differences in body wts or feed consumption; no mortality; no test article-related changes in hematology parameters; some changes in clinical chemistry parameters may have been related to the test article; decreased urine volume with increased specific gravity was reported in the mid- and high-dose group 41 CHRONIC TOXICITY STUDIES oil consisting of: 64% Triheptanoin 34% diheptanoin 2% monoheptanoin Wistar rats, 10 males 9 mos none control diet with either 30% or 50% substitution of soy...; CITATION=5; 39; 4; CITATION_NUMBERS=[5,39,4]; REFERENCE=5; 39; 4; DETAILS_JSON={"cas_number":"620-67-7","citation":"5; 39; 4","dose":"opic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog...","duration":"91 days","effect":"opic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog food with beef tallow; animals were observed daily; body weight and feed consumption were measured; hematology, serum chemistry, and urine analysis were performed NOAEL = 15% No toxicologically-significant clinical signs of toxicity; no significant differences in body wts or feed consumption; no mortality; no test article-related changes in hematology parameters; some changes in clinical chemistry parameters may have been related to the test article; decreased urine volume with increased specific gravity was reported in the mid- and high-dose group 41 CHRONIC TOXICITY STUDIES oil consisting of: 64% Triheptanoin 34% diheptanoin 2% monoheptanoin Wistar rats, 10 males 9 mos none control diet with either 30% or 50% substitution of soy...","endpoint":"oral toxicity","ingredient":"Triglycerides","loael_value":"","noael_unit":"%","noael_value":"15","page":34,"route":"oral","species":"rat","study_id":"PRS742_noael_006"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 10 | mg/kg bw/d | rat | oral | 30 d | repeated dose toxicity | SOURCE_SUBDIR=PRS742; REPORT_TITLE=Amended Safety Assessment of Triglycerides as Used in Cosmetics Monice M. Fiume*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks Jr***, Ronald C. Shank***, Thomas J. S; OPINION_NUMBER=PRS742; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=10; DOSE=In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and...; EFFECT=prylic/Capric Triglyceride did not produce any signs of toxicity,36 but undiluted test material produced some gastrointestinal effects, decreased thymic weight, caused inflammation in the lungs, and resulted in changes in some clinical pathology parameters.37 These changes were reversible. In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and a NOAEL of 3500 mg/kg/d was reported with MLCT.28 In a human study, no adverse effects were observed in a placebo-controlled double-blind study in which healthy subjects ingested 42 g/d MLCT.28 No adverse effects were observed in a study in which rabbits were given a Tripelargonin/LCT emulsion via a TPN infusion regimen for 7 h/d for 11 d.30,40 Subchronic Toxicity Studies Application of a perfumed skin softener formulation con- taining 4% Capryl...; CITATION=36; 37; 0; CITATION_NUMBERS=[36,37]; REFERENCE=36; 37; 0; DETAILS_JSON={"cas_number":"620-67-7","citation":"36; 37; 0","dose":"In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and...","duration":"30 d","effect":"prylic/Capric Triglyceride did not produce any signs of toxicity,36 but undiluted test material produced some gastrointestinal effects, decreased thymic weight, caused inflammation in the lungs, and resulted in changes in some clinical pathology parameters.37 These changes were reversible. In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and a NOAEL of 3500 mg/kg/d was reported with MLCT.28 In a human study, no adverse effects were observed in a placebo-controlled double-blind study in which healthy subjects ingested 42 g/d MLCT.28 No adverse effects were observed in a study in which rabbits were given a Tripelargonin/LCT emulsion via a TPN infusion regimen for 7 h/d for 11 d.30,40 Subchronic Toxicity Studies Application of a perfumed skin softener formulation con- taining 4% Capryl...","endpoint":"repeated dose toxicity","ingredient":"Triglycerides","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"10","page":30,"route":"oral","species":"rat","study_id":"PRS742_noael_001"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 3500 | mg/kg/d | rat | oral | 30 d | repeated dose toxicity | SOURCE_SUBDIR=PRS742; REPORT_TITLE=Amended Safety Assessment of Triglycerides as Used in Cosmetics Monice M. Fiume*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks Jr***, Ronald C. Shank***, Thomas J. S; OPINION_NUMBER=PRS742; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=3500; DOSE=In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and...; EFFECT=ects, decreased thymic weight, caused inflammation in the lungs, and resulted in changes in some clinical pathology parameters.37 These changes were reversible. In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and a NOAEL of 3500 mg/kg/d was reported with MLCT.28 In a human study, no adverse effects were observed in a placebo-controlled double-blind study in which healthy subjects ingested 42 g/d MLCT.28 No adverse effects were observed in a study in which rabbits were given a Tripelargonin/LCT emulsion via a TPN infusion regimen for 7 h/d for 11 d.30,40 Subchronic Toxicity Studies Application of a perfumed skin softener formulation con- taining 4% Caprylic/Capric Triglyceride to the shaved skin of female rats at a dose of 2 ml/kg 5 d/wk for 13 wk did not produce any toxic effects.5...; CITATION=37; 0; 5; CITATION_NUMBERS=[37,5]; REFERENCE=37; 0; 5; DETAILS_JSON={"cas_number":"620-67-7","citation":"37; 0; 5","dose":"In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and...","duration":"30 d","effect":"ects, decreased thymic weight, caused inflammation in the lungs, and resulted in changes in some clinical pathology parameters.37 These changes were reversible. In G¨ottingen minipigs, clinical signs of toxicity were observed with 0.5 and 2 ml/kg/d Caprylic/Capric Triglyceride administered by gavage; no changes in organ weights or gross or microscopic lesions were observed.38 In rats, a no-observed-adverse-effect-level (NOAEL) of 10 mg/kg bw/d was reported in a 30 d study with Caprylic/Capric Triglyceride,39 and a NOAEL of 3500 mg/kg/d was reported with MLCT.28 In a human study, no adverse effects were observed in a placebo-controlled double-blind study in which healthy subjects ingested 42 g/d MLCT.28 No adverse effects were observed in a study in which rabbits were given a Tripelargonin/LCT emulsion via a TPN infusion regimen for 7 h/d for 11 d.30,40 Subchronic Toxicity Studies Application of a perfumed skin softener formulation con- taining 4% Caprylic/Capric Triglyceride to the shaved skin of female rats at a dose of 2 ml/kg 5 d/wk for 13 wk did not produce any toxic effects.5...","endpoint":"repeated dose toxicity","ingredient":"Triglycerides","loael_value":"","noael_unit":"mg/kg/d","noael_value":"3500","page":30,"route":"oral","species":"rat","study_id":"PRS742_noael_002"} |
| UnifiedCodex:CIR:beta.noael_studies | repeated dose toxicity | 5 | % | rat | oral | SUBCHRONIC | repeated dose toxicity | SOURCE_SUBDIR=PRS742; REPORT_TITLE=Amended Safety Assessment of Triglycerides as Used in Cosmetics Monice M. Fiume*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks Jr***, Ronald C. Shank***, Thomas J. S; OPINION_NUMBER=PRS742; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=5; EFFECT=d soybean oils (7:3; controls) or MLCT; 42 g oil/ day consumed placebo-controlled double blind study ; hematology and urinalysis were conducted at study initiation and study termination; liver and renal function were measured; body wts and body mass index were measured no adverse effects 28 SUBCHRONIC TOXICITY STUDIES Caprylic/Capric Triglyceride Wistar rats, 20/sex 90 days none 1 and 5% dietary study, in accord with OECD TG 408; changes in organ weights were not measured; microscopic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog food with beef tallow; animals were observed daily; body weight and feed consumption were measured; hematology, serum chemistry, and urine analysis were performed NOAEL = 15% No toxicologically-significant clinical signs of toxicity; no significant differ...; CITATION=(7; 3; 42; CITATION_NUMBERS=[7,3,42]; REFERENCE=(7; 3; 42; DETAILS_JSON={"cas_number":"620-67-7","citation":"(7; 3; 42","dose":"","duration":"SUBCHRONIC","effect":"d soybean oils (7:3; controls) or MLCT; 42 g oil/ day consumed placebo-controlled double blind study ; hematology and urinalysis were conducted at study initiation and study termination; liver and renal function were measured; body wts and body mass index were measured no adverse effects 28 SUBCHRONIC TOXICITY STUDIES Caprylic/Capric Triglyceride Wistar rats, 20/sex 90 days none 1 and 5% dietary study, in accord with OECD TG 408; changes in organ weights were not measured; microscopic examination was not performed NOAEL = 5% no signs of systemic toxicity; all animals survived until study termination; no effects on body weight gain, hematology, clinical chemistry, urinalysis, or gross pathology 39 Caprylic/Capric Triglyceride Beagle dogs, 4/sex 91 days none 0, 5, 10, and 15% 3-h feeding regimen for the course of the study; dry dog food with beef tallow; animals were observed daily; body weight and feed consumption were measured; hematology, serum chemistry, and urine analysis were performed NOAEL = 15% No toxicologically-significant clinical signs of toxicity; no significant differ...","endpoint":"repeated dose toxicity","ingredient":"Triglycerides","loael_value":"","noael_unit":"%","noael_value":"5","page":34,"route":"oral","species":"rat","study_id":"PRS742_noael_005"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 2P6O7CFW5K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C24H44O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"2P6O7CFW5K"} |
| openFDA substances | FDA UNII substance identifier | 2P6O7CFW5K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C24H44O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"2P6O7CFW5K"} |
| openFDA substances | FDA UNII substance identifier | 2P6O7CFW5K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C24H44O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"2P6O7CFW5K"} |
| openFDA substances | FDA UNII substance identifier | 2P6O7CFW5K | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C24H44O6","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"2P6O7CFW5K"} |