NOAEL Studies Cosmetic Ingredient

Vitis Vinifera Leaf Water NOAEL Studies

INCI: VITIS VINIFERA (GRAPE) LEAF WATER

CAS: 85594-37-2

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

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CIR_vision_codex 16 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR_vision_codex NOAEL =300 mg/kg/d rat oral 28 days oral toxicity {"citation":"6; (300; 28","dose":"Component Toxicity information Reference Polyphenol Resveratrol In rats given daily oral administration of resveratrol (300, 1000, and 3000 mg/kg for 28 days), nephrotoxicity, and other signs of toxicity were observed at the high-dose level, dehydration and loss of body wt were observed at the mid-dose level, and the NOAEL was 300 mg/kg/d; in several mamm...","effect":"Table 6. Toxicity Information on Some Components of Vitis vinifera (Grape). Component Toxicity information Reference Polyphenol Resveratrol In rats given daily oral administration of resveratrol (300, 1000, and 3000 mg/kg for 28 days), nephrotoxicity, and other signs of toxicity were observed at the high-dose level, dehydration and loss of body wt were observed at the mid-dose level, and the NOAEL was 300 mg/kg/d; in several mammary cancer cell lines, resveratrol showed mixed estrogen agonist/antagonist activities, whereas in the presence of 17b-estradiol, it was an antiestrogen; progesterone receptor (PR) protein expression was induced with the compound alone, but when combined with estradiol, the expression was suppressed; exhibited estradiol antagonist activity for estrogen receptor (ER)-a with select estrogen response elements and no such activity with ER-b; in vivo, resveratrol was not an agonist at the ER; when resveratrol and 17b-estradiol were administered in combination, a synergistic effect was observed; oral or su","page":10,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_001"}
CIR_vision_codex NOAEL =50 mg/kg bw/d rat oral 47 D inhalation toxicity {"citation":"45; 46; 954","dose":"IARC has concluded that tannins are not classifiable to their carcinogenicity 45 Leucocyanidin Without stating any details, a review source stated this substance has been reported to be toxic to some laboratory animals; symptoms included cardiac failure and hepatic lesions 46 Terpene alcohols Noncyclic Citronellol Percutaneous absorption, 954 mg/cm2/h thr...","effect":"IARC has concluded that tannins are not classifiable to their carcinogenicity 45 Leucocyanidin Without stating any details, a review source stated this substance has been reported to be toxic to some laboratory animals; symptoms included cardiac failure and hepatic lesions 46 Terpene alcohols Noncyclic Citronellol Percutaneous absorption, 954 mg/cm2/h through human cadaver skin; ocular irritant in rabbit eyes (undiluted) 47 D,L-Citronellol Dermal LD50 in rabbits, 2650 mg/kg; oral LD50 in rats, 3450 mg/kg; dietary NOAEL in rats in a 12-week study, 50 mg/kg bw/d; inhalation NOAEC in rats in a 100 day inhalation study, 0.3 mg/m3; not mutagenic in an Ames assay with activation, a rec-assay, or a host-mediated assay; undiluted, dermal irritant in guinea pigs and rabbits in most tests; mostly not an irritant in clinical testing at up to 40%, irritation was reported in a study at 32% in acetone; not a sensitizer in a Buehler (2.5%-25%) or maximization (max) test (10%) in guinea pigs, positive reaction at 50% (but not \u000225% in mice; not a sensitizer in an HRIPT at 25% 47 Geraniol Dermal LD...","page":11,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_002"}
CIR_vision_codex NOAEL >2 g/kg rat oral 14 days oral toxicity {"citation":"14; 3; 12","dose":"The dermal median lethal dose (LD50) of vitis vinifera (grape) seed extract in albino rats was >2 g/kg; this dose was also the no-observed effect level (NOEL) for systemic toxicity in this dermal study.","effect":"s to avoid ingestion. The animals were observed for 14 days. None of the animals died during the study, and there were no test material-related clinical findings, body weight changes, or findings at necropsy. Very slight to slight erythema and desquamation was observed in all animals; these dermal responses subsided in all but 3 ani- mals by day 12. One male rat had edema from days 6 to 9. The dermal median lethal dose (LD50) of vitis vinifera (grape) seed extract in albino rats was >2 g/kg; this dose was also the no-observed effect level (NOEL) for systemic toxicity in this dermal study. Oral Vitis vinifera (grape) seed extract. Five male and five female albino rats were given a single dose of 5 g/kg vitis vinifera (grape) seed extract (trade name ActiVin) by gavage.52 The animals were observed for 14 days. One female died on day 1 of the study. Matting and test material around the mouth, hypoactivity, and ocular discharge were noted for some ani- mals; all animals appeared normal by day 3. The oral LD50 of vitis vinifera (grape) seed extract in albino rats was >5 g/kg. The acute...","page":15,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_003"}
CIR_vision_codex NOAEL =2150 mg/kg bw/d rat oral 90 days repeated dose toxicity {"citation":"2; 5; 7","dose":"l this observation was treatment related; - a small but statistically significant increase in feed consumption by males of the 2.5% grp from day 7 until study termination; similar increases were observed for males of the 1.25% grp, but the occurrence was at irregular intervals; - body wts and body wt gains were similar for treated and control grps; - a de...","effect":"l this observation was treatment related; - a small but statistically significant increase in feed consumption by males of the 2.5% grp from day 7 until study termination; similar increases were observed for males of the 1.25% grp, but the occurrence was at irregular intervals; - body wts and body wt gains were similar for treated and control grps; - a decrease in heart–body wt ratio in females of the 1.25% grp was not considered treatment related; - no gross or microscopic lesions were reported at necropsy; - the NOAEL was *2150 mg/kg bw/d for female rats and 1780 mg/kg bw/d for male rats. 65 Grape seed extract that contained <5.5% catechin monomers Water Sprague-Dawley rats, 20M/20F 90 days 0%, 0.5%, 1.0%, or 2.0%; extract intake was 348, 642, and 1586 mg/kg bw/d for males; 469, 883, and 1928 mg/kg bw/d for females - No mortality and no clinical signs of toxicity; - feed consumption was increased in test grps compared to controls; increases by males of the 2.0% grp reached statistical significance, with no corresponding increase in body wts or body wt gains; - no differences in...","page":16,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_004"}
CIR_vision_codex NOAEL =300 mg/kg/d rat oral 28 days oral toxicity {"citation":"6; (300; 28","dose":"Component Toxicity information Reference Polyphenol Resveratrol In rats given daily oral administration of resveratrol (300, 1000, and 3000 mg/kg for 28 days), nephrotoxicity, and other signs of toxicity were observed at the high-dose level, dehydration and loss of body wt were observed at the mid-dose level, and the NOAEL was 300 mg/kg/d; in several mamm...","effect":"Table 6. Toxicity Information on Some Components of Vitis vinifera (Grape). Component Toxicity information Reference Polyphenol Resveratrol In rats given daily oral administration of resveratrol (300, 1000, and 3000 mg/kg for 28 days), nephrotoxicity, and other signs of toxicity were observed at the high-dose level, dehydration and loss of body wt were observed at the mid-dose level, and the NOAEL was 300 mg/kg/d; in several mammary cancer cell lines, resveratrol showed mixed estrogen agonist/antagonist activities, whereas in the presence of 17b-estradiol, it was an antiestrogen; progesterone receptor (PR) protein expression was induced with the compound alone, but when combined with estradiol, the expression was suppressed; exhibited estradiol antagonist activity for estrogen receptor (ER)-a with select estrogen response elements and no such activity with ER-b; in vivo, resveratrol was not an agonist at the ER; when resveratrol and 17b-estradiol were administered in combination, a synergistic effect was observed; oral or su","page":10,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_001"}
CIR_vision_codex NOAEL =50 mg/kg bw/d rat oral 47 D inhalation toxicity {"citation":"45; 46; 954","dose":"IARC has concluded that tannins are not classifiable to their carcinogenicity 45 Leucocyanidin Without stating any details, a review source stated this substance has been reported to be toxic to some laboratory animals; symptoms included cardiac failure and hepatic lesions 46 Terpene alcohols Noncyclic Citronellol Percutaneous absorption, 954 mg/cm2/h thr...","effect":"IARC has concluded that tannins are not classifiable to their carcinogenicity 45 Leucocyanidin Without stating any details, a review source stated this substance has been reported to be toxic to some laboratory animals; symptoms included cardiac failure and hepatic lesions 46 Terpene alcohols Noncyclic Citronellol Percutaneous absorption, 954 mg/cm2/h through human cadaver skin; ocular irritant in rabbit eyes (undiluted) 47 D,L-Citronellol Dermal LD50 in rabbits, 2650 mg/kg; oral LD50 in rats, 3450 mg/kg; dietary NOAEL in rats in a 12-week study, 50 mg/kg bw/d; inhalation NOAEC in rats in a 100 day inhalation study, 0.3 mg/m3; not mutagenic in an Ames assay with activation, a rec-assay, or a host-mediated assay; undiluted, dermal irritant in guinea pigs and rabbits in most tests; mostly not an irritant in clinical testing at up to 40%, irritation was reported in a study at 32% in acetone; not a sensitizer in a Buehler (2.5%-25%) or maximization (max) test (10%) in guinea pigs, positive reaction at 50% (but not \u000225% in mice; not a sensitizer in an HRIPT at 25% 47 Geraniol Dermal LD...","page":11,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_002"}
CIR_vision_codex NOAEL >2 g/kg rat oral 14 days oral toxicity {"citation":"14; 3; 12","dose":"The dermal median lethal dose (LD50) of vitis vinifera (grape) seed extract in albino rats was >2 g/kg; this dose was also the no-observed effect level (NOEL) for systemic toxicity in this dermal study.","effect":"s to avoid ingestion. The animals were observed for 14 days. None of the animals died during the study, and there were no test material-related clinical findings, body weight changes, or findings at necropsy. Very slight to slight erythema and desquamation was observed in all animals; these dermal responses subsided in all but 3 ani- mals by day 12. One male rat had edema from days 6 to 9. The dermal median lethal dose (LD50) of vitis vinifera (grape) seed extract in albino rats was >2 g/kg; this dose was also the no-observed effect level (NOEL) for systemic toxicity in this dermal study. Oral Vitis vinifera (grape) seed extract. Five male and five female albino rats were given a single dose of 5 g/kg vitis vinifera (grape) seed extract (trade name ActiVin) by gavage.52 The animals were observed for 14 days. One female died on day 1 of the study. Matting and test material around the mouth, hypoactivity, and ocular discharge were noted for some ani- mals; all animals appeared normal by day 3. The oral LD50 of vitis vinifera (grape) seed extract in albino rats was >5 g/kg. The acute...","page":15,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_003"}
CIR_vision_codex NOAEL =2150 mg/kg bw/d rat oral 90 days repeated dose toxicity {"citation":"2; 5; 7","dose":"l this observation was treatment related; - a small but statistically significant increase in feed consumption by males of the 2.5% grp from day 7 until study termination; similar increases were observed for males of the 1.25% grp, but the occurrence was at irregular intervals; - body wts and body wt gains were similar for treated and control grps; - a de...","effect":"l this observation was treatment related; - a small but statistically significant increase in feed consumption by males of the 2.5% grp from day 7 until study termination; similar increases were observed for males of the 1.25% grp, but the occurrence was at irregular intervals; - body wts and body wt gains were similar for treated and control grps; - a decrease in heart–body wt ratio in females of the 1.25% grp was not considered treatment related; - no gross or microscopic lesions were reported at necropsy; - the NOAEL was *2150 mg/kg bw/d for female rats and 1780 mg/kg bw/d for male rats. 65 Grape seed extract that contained <5.5% catechin monomers Water Sprague-Dawley rats, 20M/20F 90 days 0%, 0.5%, 1.0%, or 2.0%; extract intake was 348, 642, and 1586 mg/kg bw/d for males; 469, 883, and 1928 mg/kg bw/d for females - No mortality and no clinical signs of toxicity; - feed consumption was increased in test grps compared to controls; increases by males of the 2.0% grp reached statistical significance, with no corresponding increase in body wts or body wt gains; - no differences in...","page":16,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_004"}
CIR_vision_codex NOAEL =300 mg/kg/d rat oral 28 days oral toxicity {"citation":"6; (300; 28","dose":"Component Toxicity information Reference Polyphenol Resveratrol In rats given daily oral administration of resveratrol (300, 1000, and 3000 mg/kg for 28 days), nephrotoxicity, and other signs of toxicity were observed at the high-dose level, dehydration and loss of body wt were observed at the mid-dose level, and the NOAEL was 300 mg/kg/d; in several mamm...","effect":"Table 6. Toxicity Information on Some Components of Vitis vinifera (Grape). Component Toxicity information Reference Polyphenol Resveratrol In rats given daily oral administration of resveratrol (300, 1000, and 3000 mg/kg for 28 days), nephrotoxicity, and other signs of toxicity were observed at the high-dose level, dehydration and loss of body wt were observed at the mid-dose level, and the NOAEL was 300 mg/kg/d; in several mammary cancer cell lines, resveratrol showed mixed estrogen agonist/antagonist activities, whereas in the presence of 17b-estradiol, it was an antiestrogen; progesterone receptor (PR) protein expression was induced with the compound alone, but when combined with estradiol, the expression was suppressed; exhibited estradiol antagonist activity for estrogen receptor (ER)-a with select estrogen response elements and no such activity with ER-b; in vivo, resveratrol was not an agonist at the ER; when resveratrol and 17b-estradiol were administered in combination, a synergistic effect was observed; oral or su","page":10,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_001"}
CIR_vision_codex NOAEL =50 mg/kg bw/d rat oral 47 D inhalation toxicity {"citation":"45; 46; 954","dose":"IARC has concluded that tannins are not classifiable to their carcinogenicity 45 Leucocyanidin Without stating any details, a review source stated this substance has been reported to be toxic to some laboratory animals; symptoms included cardiac failure and hepatic lesions 46 Terpene alcohols Noncyclic Citronellol Percutaneous absorption, 954 mg/cm2/h thr...","effect":"IARC has concluded that tannins are not classifiable to their carcinogenicity 45 Leucocyanidin Without stating any details, a review source stated this substance has been reported to be toxic to some laboratory animals; symptoms included cardiac failure and hepatic lesions 46 Terpene alcohols Noncyclic Citronellol Percutaneous absorption, 954 mg/cm2/h through human cadaver skin; ocular irritant in rabbit eyes (undiluted) 47 D,L-Citronellol Dermal LD50 in rabbits, 2650 mg/kg; oral LD50 in rats, 3450 mg/kg; dietary NOAEL in rats in a 12-week study, 50 mg/kg bw/d; inhalation NOAEC in rats in a 100 day inhalation study, 0.3 mg/m3; not mutagenic in an Ames assay with activation, a rec-assay, or a host-mediated assay; undiluted, dermal irritant in guinea pigs and rabbits in most tests; mostly not an irritant in clinical testing at up to 40%, irritation was reported in a study at 32% in acetone; not a sensitizer in a Buehler (2.5%-25%) or maximization (max) test (10%) in guinea pigs, positive reaction at 50% (but not \u000225% in mice; not a sensitizer in an HRIPT at 25% 47 Geraniol Dermal LD...","page":11,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_002"}
CIR_vision_codex NOAEL >2 g/kg rat oral 14 days oral toxicity {"citation":"14; 3; 12","dose":"The dermal median lethal dose (LD50) of vitis vinifera (grape) seed extract in albino rats was >2 g/kg; this dose was also the no-observed effect level (NOEL) for systemic toxicity in this dermal study.","effect":"s to avoid ingestion. The animals were observed for 14 days. None of the animals died during the study, and there were no test material-related clinical findings, body weight changes, or findings at necropsy. Very slight to slight erythema and desquamation was observed in all animals; these dermal responses subsided in all but 3 ani- mals by day 12. One male rat had edema from days 6 to 9. The dermal median lethal dose (LD50) of vitis vinifera (grape) seed extract in albino rats was >2 g/kg; this dose was also the no-observed effect level (NOEL) for systemic toxicity in this dermal study. Oral Vitis vinifera (grape) seed extract. Five male and five female albino rats were given a single dose of 5 g/kg vitis vinifera (grape) seed extract (trade name ActiVin) by gavage.52 The animals were observed for 14 days. One female died on day 1 of the study. Matting and test material around the mouth, hypoactivity, and ocular discharge were noted for some ani- mals; all animals appeared normal by day 3. The oral LD50 of vitis vinifera (grape) seed extract in albino rats was >5 g/kg. The acute...","page":15,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_003"}
CIR_vision_codex NOAEL =2150 mg/kg bw/d rat oral 90 days repeated dose toxicity {"citation":"2; 5; 7","dose":"l this observation was treatment related; - a small but statistically significant increase in feed consumption by males of the 2.5% grp from day 7 until study termination; similar increases were observed for males of the 1.25% grp, but the occurrence was at irregular intervals; - body wts and body wt gains were similar for treated and control grps; - a de...","effect":"l this observation was treatment related; - a small but statistically significant increase in feed consumption by males of the 2.5% grp from day 7 until study termination; similar increases were observed for males of the 1.25% grp, but the occurrence was at irregular intervals; - body wts and body wt gains were similar for treated and control grps; - a decrease in heart–body wt ratio in females of the 1.25% grp was not considered treatment related; - no gross or microscopic lesions were reported at necropsy; - the NOAEL was *2150 mg/kg bw/d for female rats and 1780 mg/kg bw/d for male rats. 65 Grape seed extract that contained <5.5% catechin monomers Water Sprague-Dawley rats, 20M/20F 90 days 0%, 0.5%, 1.0%, or 2.0%; extract intake was 348, 642, and 1586 mg/kg bw/d for males; 469, 883, and 1928 mg/kg bw/d for females - No mortality and no clinical signs of toxicity; - feed consumption was increased in test grps compared to controls; increases by males of the 2.0% grp reached statistical significance, with no corresponding increase in body wts or body wt gains; - no differences in...","page":16,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_004"}
CIR_vision_codex NOAEL =300 mg/kg/d rat oral 28 days oral toxicity {"citation":"6; (300; 28","dose":"Component Toxicity information Reference Polyphenol Resveratrol In rats given daily oral administration of resveratrol (300, 1000, and 3000 mg/kg for 28 days), nephrotoxicity, and other signs of toxicity were observed at the high-dose level, dehydration and loss of body wt were observed at the mid-dose level, and the NOAEL was 300 mg/kg/d; in several mamm...","effect":"Table 6. Toxicity Information on Some Components of Vitis vinifera (Grape). Component Toxicity information Reference Polyphenol Resveratrol In rats given daily oral administration of resveratrol (300, 1000, and 3000 mg/kg for 28 days), nephrotoxicity, and other signs of toxicity were observed at the high-dose level, dehydration and loss of body wt were observed at the mid-dose level, and the NOAEL was 300 mg/kg/d; in several mammary cancer cell lines, resveratrol showed mixed estrogen agonist/antagonist activities, whereas in the presence of 17b-estradiol, it was an antiestrogen; progesterone receptor (PR) protein expression was induced with the compound alone, but when combined with estradiol, the expression was suppressed; exhibited estradiol antagonist activity for estrogen receptor (ER)-a with select estrogen response elements and no such activity with ER-b; in vivo, resveratrol was not an agonist at the ER; when resveratrol and 17b-estradiol were administered in combination, a synergistic effect was observed; oral or su","page":10,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_001"}
CIR_vision_codex NOAEL =50 mg/kg bw/d rat oral 47 D inhalation toxicity {"citation":"45; 46; 954","dose":"IARC has concluded that tannins are not classifiable to their carcinogenicity 45 Leucocyanidin Without stating any details, a review source stated this substance has been reported to be toxic to some laboratory animals; symptoms included cardiac failure and hepatic lesions 46 Terpene alcohols Noncyclic Citronellol Percutaneous absorption, 954 mg/cm2/h thr...","effect":"IARC has concluded that tannins are not classifiable to their carcinogenicity 45 Leucocyanidin Without stating any details, a review source stated this substance has been reported to be toxic to some laboratory animals; symptoms included cardiac failure and hepatic lesions 46 Terpene alcohols Noncyclic Citronellol Percutaneous absorption, 954 mg/cm2/h through human cadaver skin; ocular irritant in rabbit eyes (undiluted) 47 D,L-Citronellol Dermal LD50 in rabbits, 2650 mg/kg; oral LD50 in rats, 3450 mg/kg; dietary NOAEL in rats in a 12-week study, 50 mg/kg bw/d; inhalation NOAEC in rats in a 100 day inhalation study, 0.3 mg/m3; not mutagenic in an Ames assay with activation, a rec-assay, or a host-mediated assay; undiluted, dermal irritant in guinea pigs and rabbits in most tests; mostly not an irritant in clinical testing at up to 40%, irritation was reported in a study at 32% in acetone; not a sensitizer in a Buehler (2.5%-25%) or maximization (max) test (10%) in guinea pigs, positive reaction at 50% (but not \u000225% in mice; not a sensitizer in an HRIPT at 25% 47 Geraniol Dermal LD...","page":11,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_002"}
CIR_vision_codex NOAEL >2 g/kg rat oral 14 days oral toxicity {"citation":"14; 3; 12","dose":"The dermal median lethal dose (LD50) of vitis vinifera (grape) seed extract in albino rats was >2 g/kg; this dose was also the no-observed effect level (NOEL) for systemic toxicity in this dermal study.","effect":"s to avoid ingestion. The animals were observed for 14 days. None of the animals died during the study, and there were no test material-related clinical findings, body weight changes, or findings at necropsy. Very slight to slight erythema and desquamation was observed in all animals; these dermal responses subsided in all but 3 ani- mals by day 12. One male rat had edema from days 6 to 9. The dermal median lethal dose (LD50) of vitis vinifera (grape) seed extract in albino rats was >2 g/kg; this dose was also the no-observed effect level (NOEL) for systemic toxicity in this dermal study. Oral Vitis vinifera (grape) seed extract. Five male and five female albino rats were given a single dose of 5 g/kg vitis vinifera (grape) seed extract (trade name ActiVin) by gavage.52 The animals were observed for 14 days. One female died on day 1 of the study. Matting and test material around the mouth, hypoactivity, and ocular discharge were noted for some ani- mals; all animals appeared normal by day 3. The oral LD50 of vitis vinifera (grape) seed extract in albino rats was >5 g/kg. The acute...","page":15,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_003"}
CIR_vision_codex NOAEL =2150 mg/kg bw/d rat oral 90 days repeated dose toxicity {"citation":"2; 5; 7","dose":"l this observation was treatment related; - a small but statistically significant increase in feed consumption by males of the 2.5% grp from day 7 until study termination; similar increases were observed for males of the 1.25% grp, but the occurrence was at irregular intervals; - body wts and body wt gains were similar for treated and control grps; - a de...","effect":"l this observation was treatment related; - a small but statistically significant increase in feed consumption by males of the 2.5% grp from day 7 until study termination; similar increases were observed for males of the 1.25% grp, but the occurrence was at irregular intervals; - body wts and body wt gains were similar for treated and control grps; - a decrease in heart–body wt ratio in females of the 1.25% grp was not considered treatment related; - no gross or microscopic lesions were reported at necropsy; - the NOAEL was *2150 mg/kg bw/d for female rats and 1780 mg/kg bw/d for male rats. 65 Grape seed extract that contained <5.5% catechin monomers Water Sprague-Dawley rats, 20M/20F 90 days 0%, 0.5%, 1.0%, or 2.0%; extract intake was 348, 642, and 1586 mg/kg bw/d for males; 469, 883, and 1928 mg/kg bw/d for females - No mortality and no clinical signs of toxicity; - feed consumption was increased in test grps compared to controls; increases by males of the 2.0% grp reached statistical significance, with no corresponding increase in body wts or body wt gains; - no differences in...","page":16,"pdf":"PRS618.pdf","row_type":"noael_study","study_id":"PRS618_noael_004"}
UnifiedCodex:CIR:beta.noael_studies 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:CIR:beta.noael_studies inhalation toxicity 50 mg/kg bw/d rat oral 47 D inhalation toxicity SOURCE_SUBDIR=PRS618; REPORT_TITLE=Safety Assessment of Vitis vinifera (Grape)- Derived Ingredients as Used in Cosmetics Monice M. Fiume1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2,; OPINION_NUMBER=PRS618; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=50; DOSE=IARC has concluded that tannins are not classifiable to their carcinogenicity 45 Leucocyanidin Without stating any details, a review source stated this substance has been reported to be toxic to some laboratory animals; symptoms included cardiac failure and hepatic lesions 46 Terpene alcohols Noncyclic Citronellol Percutaneous absorption, 954 mg/cm2/h thr...; EFFECT=IARC has concluded that tannins are not classifiable to their carcinogenicity 45 Leucocyanidin Without stating any details, a review source stated this substance has been reported to be toxic to some laboratory animals; symptoms included cardiac failure and hepatic lesions 46 Terpene alcohols Noncyclic Citronellol Percutaneous absorption, 954 mg/cm2/h through human cadaver skin; ocular irritant in rabbit eyes (undiluted) 47 D,L-Citronellol Dermal LD50 in rabbits, 2650 mg/kg; oral LD50 in rats, 3450 mg/kg; dietary NOAEL in rats in a 12-week study, 50 mg/kg bw/d; inhalation NOAEC in rats in a 100 day inhalation study, 0.3 mg/m3; not mutagenic in an Ames assay with activation, a rec-assay, or a host-mediated assay; undiluted, dermal irritant in guinea pigs and rabbits in most tests; mostly not an irritant in clinical testing at up to 40%, irritation was reported in a study at 32% in acetone; not a sensitizer in a Buehler (2.5%-25%) or maximization (max) test (10%) in guinea pigs, positive reaction at 50% (but not 25% in mice; not a sensitizer in an HRIPT at 25% 47 Geraniol Dermal LD...; CITATION=45; 46; 954; CITATION_NUMBERS=[45,46,954]; REFERENCE=45; 46; 954; DETAILS_JSON={"cas_number":"85594-37-2","citation":"45; 46; 954","dose":"IARC has concluded that tannins are not classifiable to their carcinogenicity 45 Leucocyanidin Without stating any details, a review source stated this substance has been reported to be toxic to some laboratory animals; symptoms included cardiac failure and hepatic lesions 46 Terpene alcohols Noncyclic Citronellol Percutaneous absorption, 954 mg/cm2/h thr...","duration":"47 D","effect":"IARC has concluded that tannins are not classifiable to their carcinogenicity 45 Leucocyanidin Without stating any details, a review source stated this substance has been reported to be toxic to some laboratory animals; symptoms included cardiac failure and hepatic lesions 46 Terpene alcohols Noncyclic Citronellol Percutaneous absorption, 954 mg/cm2/h through human cadaver skin; ocular irritant in rabbit eyes (undiluted) 47 D,L-Citronellol Dermal LD50 in rabbits, 2650 mg/kg; oral LD50 in rats, 3450 mg/kg; dietary NOAEL in rats in a 12-week study, 50 mg/kg bw/d; inhalation NOAEC in rats in a 100 day inhalation study, 0.3 mg/m3; not mutagenic in an Ames assay with activation, a rec-assay, or a host-mediated assay; undiluted, dermal irritant in guinea pigs and rabbits in most tests; mostly not an irritant in clinical testing at up to 40%, irritation was reported in a study at 32% in acetone; not a sensitizer in a Buehler (2.5%-25%) or maximization (max) test (10%) in guinea pigs, positive reaction at 50% (but not \u000225% in mice; not a sensitizer in an HRIPT at 25% 47 Geraniol Dermal LD...","endpoint":"inhalation toxicity","ingredient":"Vitis vinifera (Grape)- Derived Ingredients","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"50","page":11,"route":"oral","species":"rat","study_id":"PRS618_noael_002"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity 300 mg/kg/d rat oral 28 days oral toxicity SOURCE_SUBDIR=PRS618; REPORT_TITLE=Safety Assessment of Vitis vinifera (Grape)- Derived Ingredients as Used in Cosmetics Monice M. Fiume1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2,; OPINION_NUMBER=PRS618; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=300; DOSE=Component Toxicity information Reference Polyphenol Resveratrol In rats given daily oral administration of resveratrol (300, 1000, and 3000 mg/kg for 28 days), nephrotoxicity, and other signs of toxicity were observed at the high-dose level, dehydration and loss of body wt were observed at the mid-dose level, and the NOAEL was 300 mg/kg/d; in several mamm...; EFFECT=Table 6. Toxicity Information on Some Components of Vitis vinifera (Grape). Component Toxicity information Reference Polyphenol Resveratrol In rats given daily oral administration of resveratrol (300, 1000, and 3000 mg/kg for 28 days), nephrotoxicity, and other signs of toxicity were observed at the high-dose level, dehydration and loss of body wt were observed at the mid-dose level, and the NOAEL was 300 mg/kg/d; in several mammary cancer cell lines, resveratrol showed mixed estrogen agonist/antagonist activities, whereas in the presence of 17b-estradiol, it was an antiestrogen; progesterone receptor (PR) protein expression was induced with the compound alone, but when combined with estradiol, the expression was suppressed; exhibited estradiol antagonist activity for estrogen receptor (ER)-a with select estrogen response elements and no such activity with ER-b; in vivo, resveratrol was not an agonist at the ER; when resveratrol and 17b-estradiol were administered in combination, a synergistic effect was observed; oral or su; CITATION=6; (300; 28; CITATION_NUMBERS=[6,300,28]; REFERENCE=6; (300; 28; DETAILS_JSON={"cas_number":"85594-37-2","citation":"6; (300; 28","dose":"Component Toxicity information Reference Polyphenol Resveratrol In rats given daily oral administration of resveratrol (300, 1000, and 3000 mg/kg for 28 days), nephrotoxicity, and other signs of toxicity were observed at the high-dose level, dehydration and loss of body wt were observed at the mid-dose level, and the NOAEL was 300 mg/kg/d; in several mamm...","duration":"28 days","effect":"Table 6. Toxicity Information on Some Components of Vitis vinifera (Grape). Component Toxicity information Reference Polyphenol Resveratrol In rats given daily oral administration of resveratrol (300, 1000, and 3000 mg/kg for 28 days), nephrotoxicity, and other signs of toxicity were observed at the high-dose level, dehydration and loss of body wt were observed at the mid-dose level, and the NOAEL was 300 mg/kg/d; in several mammary cancer cell lines, resveratrol showed mixed estrogen agonist/antagonist activities, whereas in the presence of 17b-estradiol, it was an antiestrogen; progesterone receptor (PR) protein expression was induced with the compound alone, but when combined with estradiol, the expression was suppressed; exhibited estradiol antagonist activity for estrogen receptor (ER)-a with select estrogen response elements and no such activity with ER-b; in vivo, resveratrol was not an agonist at the ER; when resveratrol and 17b-estradiol were administered in combination, a synergistic effect was observed; oral or su","endpoint":"oral toxicity","ingredient":"Vitis vinifera (Grape)- Derived Ingredients","loael_value":"","noael_unit":"mg/kg/d","noael_value":"300","page":10,"route":"oral","species":"rat","study_id":"PRS618_noael_001"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity >2 g/kg rat oral 14 days oral toxicity SOURCE_SUBDIR=PRS618; REPORT_TITLE=Safety Assessment of Vitis vinifera (Grape)- Derived Ingredients as Used in Cosmetics Monice M. Fiume1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2,; OPINION_NUMBER=PRS618; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=> 2; DOSE=The dermal median lethal dose (LD50) of vitis vinifera (grape) seed extract in albino rats was >2 g/kg; this dose was also the no-observed effect level (NOEL) for systemic toxicity in this dermal study.; EFFECT=s to avoid ingestion. The animals were observed for 14 days. None of the animals died during the study, and there were no test material-related clinical findings, body weight changes, or findings at necropsy. Very slight to slight erythema and desquamation was observed in all animals; these dermal responses subsided in all but 3 ani- mals by day 12. One male rat had edema from days 6 to 9. The dermal median lethal dose (LD50) of vitis vinifera (grape) seed extract in albino rats was >2 g/kg; this dose was also the no-observed effect level (NOEL) for systemic toxicity in this dermal study. Oral Vitis vinifera (grape) seed extract. Five male and five female albino rats were given a single dose of 5 g/kg vitis vinifera (grape) seed extract (trade name ActiVin) by gavage.52 The animals were observed for 14 days. One female died on day 1 of the study. Matting and test material around the mouth, hypoactivity, and ocular discharge were noted for some ani- mals; all animals appeared normal by day 3. The oral LD50 of vitis vinifera (grape) seed extract in albino rats was >5 g/kg. The acute...; CITATION=14; 3; 12; CITATION_NUMBERS=[14,3,12]; REFERENCE=14; 3; 12; DETAILS_JSON={"cas_number":"85594-37-2","citation":"14; 3; 12","dose":"The dermal median lethal dose (LD50) of vitis vinifera (grape) seed extract in albino rats was >2 g/kg; this dose was also the no-observed effect level (NOEL) for systemic toxicity in this dermal study.","duration":"14 days","effect":"s to avoid ingestion. The animals were observed for 14 days. None of the animals died during the study, and there were no test material-related clinical findings, body weight changes, or findings at necropsy. Very slight to slight erythema and desquamation was observed in all animals; these dermal responses subsided in all but 3 ani- mals by day 12. One male rat had edema from days 6 to 9. The dermal median lethal dose (LD50) of vitis vinifera (grape) seed extract in albino rats was >2 g/kg; this dose was also the no-observed effect level (NOEL) for systemic toxicity in this dermal study. Oral Vitis vinifera (grape) seed extract. Five male and five female albino rats were given a single dose of 5 g/kg vitis vinifera (grape) seed extract (trade name ActiVin) by gavage.52 The animals were observed for 14 days. One female died on day 1 of the study. Matting and test material around the mouth, hypoactivity, and ocular discharge were noted for some ani- mals; all animals appeared normal by day 3. The oral LD50 of vitis vinifera (grape) seed extract in albino rats was >5 g/kg. The acute...","endpoint":"oral toxicity","ingredient":"Vitis vinifera (Grape)- Derived Ingredients","loael_value":"","noael_unit":"g/kg","noael_value":"> 2","page":15,"route":"oral","species":"rat","study_id":"PRS618_noael_003"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 2150 mg/kg bw/d rat oral 90 days repeated dose toxicity SOURCE_SUBDIR=PRS618; REPORT_TITLE=Safety Assessment of Vitis vinifera (Grape)- Derived Ingredients as Used in Cosmetics Monice M. Fiume1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2,; OPINION_NUMBER=PRS618; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=2150; DOSE=l this observation was treatment related; - a small but statistically significant increase in feed consumption by males of the 2.5% grp from day 7 until study termination; similar increases were observed for males of the 1.25% grp, but the occurrence was at irregular intervals; - body wts and body wt gains were similar for treated and control grps; - a de...; EFFECT=l this observation was treatment related; - a small but statistically significant increase in feed consumption by males of the 2.5% grp from day 7 until study termination; similar increases were observed for males of the 1.25% grp, but the occurrence was at irregular intervals; - body wts and body wt gains were similar for treated and control grps; - a decrease in heart–body wt ratio in females of the 1.25% grp was not considered treatment related; - no gross or microscopic lesions were reported at necropsy; - the NOAEL was *2150 mg/kg bw/d for female rats and 1780 mg/kg bw/d for male rats. 65 Grape seed extract that contained <5.5% catechin monomers Water Sprague-Dawley rats, 20M/20F 90 days 0%, 0.5%, 1.0%, or 2.0%; extract intake was 348, 642, and 1586 mg/kg bw/d for males; 469, 883, and 1928 mg/kg bw/d for females - No mortality and no clinical signs of toxicity; - feed consumption was increased in test grps compared to controls; increases by males of the 2.0% grp reached statistical significance, with no corresponding increase in body wts or body wt gains; - no differences in...; CITATION=2; 5; 7; CITATION_NUMBERS=[2,5,7]; REFERENCE=2; 5; 7; DETAILS_JSON={"cas_number":"85594-37-2","citation":"2; 5; 7","dose":"l this observation was treatment related; - a small but statistically significant increase in feed consumption by males of the 2.5% grp from day 7 until study termination; similar increases were observed for males of the 1.25% grp, but the occurrence was at irregular intervals; - body wts and body wt gains were similar for treated and control grps; - a de...","duration":"90 days","effect":"l this observation was treatment related; - a small but statistically significant increase in feed consumption by males of the 2.5% grp from day 7 until study termination; similar increases were observed for males of the 1.25% grp, but the occurrence was at irregular intervals; - body wts and body wt gains were similar for treated and control grps; - a decrease in heart–body wt ratio in females of the 1.25% grp was not considered treatment related; - no gross or microscopic lesions were reported at necropsy; - the NOAEL was *2150 mg/kg bw/d for female rats and 1780 mg/kg bw/d for male rats. 65 Grape seed extract that contained <5.5% catechin monomers Water Sprague-Dawley rats, 20M/20F 90 days 0%, 0.5%, 1.0%, or 2.0%; extract intake was 348, 642, and 1586 mg/kg bw/d for males; 469, 883, and 1928 mg/kg bw/d for females - No mortality and no clinical signs of toxicity; - feed consumption was increased in test grps compared to controls; increases by males of the 2.0% grp reached statistical significance, with no corresponding increase in body wts or body wt gains; - no differences in...","endpoint":"repeated dose toxicity","ingredient":"Vitis vinifera (Grape)- Derived Ingredients","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2150","page":16,"route":"oral","species":"rat","study_id":"PRS618_noael_004"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 2150 mg/kg bw/d rat oral 3-week repeated dose toxicity SOURCE_SUBDIR=PRS618; REPORT_TITLE=Safety Assessment of Vitis vinifera (Grape)- Derived Ingredients as Used in Cosmetics Monice M. Fiume1, Wilma F. Bergfeld2, Donald V. Belsito2, Ronald A. Hill2, Curtis D. Klaassen2, Daniel C. Liebler2, James G. Marks Jr2, Ronald C. Shank2,; OPINION_NUMBER=PRS618; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Suite 1200; VALUE_TEXT=2150; 1780; DOSE=Repeated Dose Toxicity Dietary repeated dose toxicity studies are presented in Table 9.52,63-67 In a 3-week study in which female SKH-1 hairless mice were fed a diet containing 0%, 0.2%, or 0.5% grape seed extract containing 89.3% proanthocyanidins for 3 weeks, no treatment- related signs of toxicity were reported.64 In 90-day dietary repeated dose studie...; EFFECT=Repeated Dose Toxicity Dietary repeated dose toxicity studies are presented in Table 9.52,63-67 In a 3-week study in which female SKH-1 hairless mice were fed a diet containing 0%, 0.2%, or 0.5% grape seed extract containing 89.3% proanthocyanidins for 3 weeks, no treatment- related signs of toxicity were reported.64 In 90-day dietary repeated dose studies in rats, the no-observed adverse effect levels (NOAELs) of grape seed extract and grape skin extract were approximately 2150 and 1780 mg/kg bw/d for male and female rats, respectively.65 No toxic effects were observed in female B6C3F1 mice after 6 months of dietary administration of up to 500 mg/kg bw/d vitis vinifera (grape) seed extract or in male rats fed 100 mg/kg bw/d vitis vinifera (grape) seed extract for 12 months.52 Dietary administration of 7.5% or 15% of a grape color extract to Beagle dogs for 90 days resulted in a statistically significant decrease in body weight gains in the high-dose group; however, feed consumption was comparable, leading the researchers to sugg; CITATION=9; 52,63; 67; CITATION_NUMBERS=[9,52,63,67]; REFERENCE=9; 52,63; 67; DETAILS_JSON={"cas_number":"85594-37-2","citation":"9; 52,63; 67","dose":"Repeated Dose Toxicity Dietary repeated dose toxicity studies are presented in Table 9.52,63-67 In a 3-week study in which female SKH-1 hairless mice were fed a diet containing 0%, 0.2%, or 0.5% grape seed extract containing 89.3% proanthocyanidins for 3 weeks, no treatment- related signs of toxicity were reported.64 In 90-day dietary repeated dose studie...","duration":"3-week","effect":"Repeated Dose Toxicity Dietary repeated dose toxicity studies are presented in Table 9.52,63-67 In a 3-week study in which female SKH-1 hairless mice were fed a diet containing 0%, 0.2%, or 0.5% grape seed extract containing 89.3% proanthocyanidins for 3 weeks, no treatment- related signs of toxicity were reported.64 In 90-day dietary repeated dose studies in rats, the no-observed adverse effect levels (NOAELs) of grape seed extract and grape skin extract were approximately 2150 and 1780 mg/kg bw/d for male and female rats, respectively.65 No toxic effects were observed in female B6C3F1 mice after 6 months of dietary administration of up to 500 mg/kg bw/d vitis vinifera (grape) seed extract or in male rats fed 100 mg/kg bw/d vitis vinifera (grape) seed extract for 12 months.52 Dietary administration of 7.5% or 15% of a grape color extract to Beagle dogs for 90 days resulted in a statistically significant decrease in body weight gains in the high-dose group; however, feed consumption was comparable, leading the researchers to sugg","endpoint":"repeated dose toxicity","ingredient":"Vitis vinifera (Grape)- Derived Ingredients","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"2150; 1780","page":19,"route":"oral","species":"rat","study_id":"PRS618_noael_005"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 3GOV20705G UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"3GOV20705G"}
openFDA substances FDA UNII substance identifier 3GOV20705G UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"3GOV20705G"}
openFDA substances FDA UNII substance identifier 3GOV20705G UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"3GOV20705G"}
openFDA substances FDA UNII substance identifier 3GOV20705G UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"3GOV20705G"}