NOAEL Studies
Emulsifier
Almond Oil PEG-6 Esters NOAEL Studies
INCI: ALMOND OIL PEG-6 ESTERS
CAS: 124046-50-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR Safety Assessment 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR Safety Assessment | NOAEL | =0.8 | % | rat | oral | 4-week | developmental toxicity | {"citation":"22; 7; 19","dose":"Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence.","effect":"of 22 g/kg, and PEG-7 Glyceryl Cocoate has an oral LD50 of > 19.9 mg/g. In a 4-week study in rats, the NOAEL for a blend of 40% PEG-8 Caprylic/Capric Glycer- ides, 40% apricot kernel oil PEG-6 esters, and 20% ethoxydi- glycol was 5 mL/kg/d. Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence. In a 4-week dietary study in rats, the NOEL of a formulation containing 0.8% PEG-7 Glyceryl Cocoate was 2.5%; at higher concentrations, soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed, and a decrease in spleen weights was reported. No adverse effects were observed in dogs that were dosed orally for 13 weeks with 1.0 g/kg/d PEG-8 Caprylic/Capric Glycerides. PEG-8 Caprylic/Capric Glycerides, up to 3,000 mg/kg in purified water, did not produce embryotoxicity, fetotoxicity, or teratogenicity. The maternal embryo/fetal NOAELs were 2,000 and 3,000 mg/kg/d, respectively. The PEG-6 Ca...","page":28,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_006"} |
| CIR Safety Assessment | NOAEL | =0.8 | % | rat | oral | 4-week | developmental toxicity | {"citation":"22; 7; 19","dose":"Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence.","effect":"of 22 g/kg, and PEG-7 Glyceryl Cocoate has an oral LD50 of > 19.9 mg/g. In a 4-week study in rats, the NOAEL for a blend of 40% PEG-8 Caprylic/Capric Glycer- ides, 40% apricot kernel oil PEG-6 esters, and 20% ethoxydi- glycol was 5 mL/kg/d. Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence. In a 4-week dietary study in rats, the NOEL of a formulation containing 0.8% PEG-7 Glyceryl Cocoate was 2.5%; at higher concentrations, soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed, and a decrease in spleen weights was reported. No adverse effects were observed in dogs that were dosed orally for 13 weeks with 1.0 g/kg/d PEG-8 Caprylic/Capric Glycerides. PEG-8 Caprylic/Capric Glycerides, up to 3,000 mg/kg in purified water, did not produce embryotoxicity, fetotoxicity, or teratogenicity. The maternal embryo/fetal NOAELs were 2,000 and 3,000 mg/kg/d, respectively. The PEG-6 Ca...","page":28,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_006"} |
| CIR Safety Assessment | NOAEL | =0.8 | % | rat | oral | 4-week | developmental toxicity | {"citation":"22; 7; 19","dose":"Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence.","effect":"of 22 g/kg, and PEG-7 Glyceryl Cocoate has an oral LD50 of > 19.9 mg/g. In a 4-week study in rats, the NOAEL for a blend of 40% PEG-8 Caprylic/Capric Glycer- ides, 40% apricot kernel oil PEG-6 esters, and 20% ethoxydi- glycol was 5 mL/kg/d. Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence. In a 4-week dietary study in rats, the NOEL of a formulation containing 0.8% PEG-7 Glyceryl Cocoate was 2.5%; at higher concentrations, soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed, and a decrease in spleen weights was reported. No adverse effects were observed in dogs that were dosed orally for 13 weeks with 1.0 g/kg/d PEG-8 Caprylic/Capric Glycerides. PEG-8 Caprylic/Capric Glycerides, up to 3,000 mg/kg in purified water, did not produce embryotoxicity, fetotoxicity, or teratogenicity. The maternal embryo/fetal NOAELs were 2,000 and 3,000 mg/kg/d, respectively. The PEG-6 Ca...","page":28,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_006"} |
| CIR Safety Assessment | NOAEL | =0.8 | % | rat | oral | 4-week | developmental toxicity | {"citation":"22; 7; 19","dose":"Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence.","effect":"of 22 g/kg, and PEG-7 Glyceryl Cocoate has an oral LD50 of > 19.9 mg/g. In a 4-week study in rats, the NOAEL for a blend of 40% PEG-8 Caprylic/Capric Glycer- ides, 40% apricot kernel oil PEG-6 esters, and 20% ethoxydi- glycol was 5 mL/kg/d. Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence. In a 4-week dietary study in rats, the NOEL of a formulation containing 0.8% PEG-7 Glyceryl Cocoate was 2.5%; at higher concentrations, soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed, and a decrease in spleen weights was reported. No adverse effects were observed in dogs that were dosed orally for 13 weeks with 1.0 g/kg/d PEG-8 Caprylic/Capric Glycerides. PEG-8 Caprylic/Capric Glycerides, up to 3,000 mg/kg in purified water, did not produce embryotoxicity, fetotoxicity, or teratogenicity. The maternal embryo/fetal NOAELs were 2,000 and 3,000 mg/kg/d, respectively. The PEG-6 Ca...","page":28,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_006"} |
| CIR Safety Assessment | NOAEL | =1.1 | g/kg/d | rat | - | - | developmental toxicity | {"citation":"5,700; 0; 25","dose":"s are not genotoxic (up to *5,700 mg/kg/d in a rat dominant lethal assay) or carcinogenic (up to 0.25 mL/ wk in a rat subcutaneous injection study).","effect":"s are not genotoxic (up to *5,700 mg/kg/d in a rat dominant lethal assay) or carcinogenic (up to 0.25 mL/ wk in a rat subcutaneous injection study). PEGs are not reproductive or developmental toxicants at doses up to 6.78 g/kg in mice. Use of antimicrobial creams with a PEG vehicle was associated with renal toxicity when applied to burned skin, but studies of extensively tape stripped skin demonstrated that the levels of PEGs that could penetrate in a worst case analysis are >100 times less than the renal toxicity no observable effect level of 1.1 g/kg/d, providing a margin of safety. 4 Plant-Derived Fatty Acid Oils includes: almond oil; apricot kernel oil; avocado oil; babassu oil; Theobroma cacao (cocoa) seed butter; coconut oil; evening primrose oil; moringa oleifera seed oil; moringa pterygosperma seed oil; olive oil; palm oil; palm kernel oil; safflower oil; Butyrospermum parkii (shea) butter; soybean oil; Carthamus tinctorius (safflower) seed oil; sunflower seed oil; Camellia japonica seed oil Safe for use in cosmetics in the present practices of use and concentration Oils a...","page":9,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_001"} |
| CIR Safety Assessment | NOAEL | =1.1 | g/kg/d | rat | - | - | developmental toxicity | {"citation":"5,700; 0; 25","dose":"s are not genotoxic (up to *5,700 mg/kg/d in a rat dominant lethal assay) or carcinogenic (up to 0.25 mL/ wk in a rat subcutaneous injection study).","effect":"s are not genotoxic (up to *5,700 mg/kg/d in a rat dominant lethal assay) or carcinogenic (up to 0.25 mL/ wk in a rat subcutaneous injection study). PEGs are not reproductive or developmental toxicants at doses up to 6.78 g/kg in mice. Use of antimicrobial creams with a PEG vehicle was associated with renal toxicity when applied to burned skin, but studies of extensively tape stripped skin demonstrated that the levels of PEGs that could penetrate in a worst case analysis are >100 times less than the renal toxicity no observable effect level of 1.1 g/kg/d, providing a margin of safety. 4 Plant-Derived Fatty Acid Oils includes: almond oil; apricot kernel oil; avocado oil; babassu oil; Theobroma cacao (cocoa) seed butter; coconut oil; evening primrose oil; moringa oleifera seed oil; moringa pterygosperma seed oil; olive oil; palm oil; palm kernel oil; safflower oil; Butyrospermum parkii (shea) butter; soybean oil; Carthamus tinctorius (safflower) seed oil; sunflower seed oil; Camellia japonica seed oil Safe for use in cosmetics in the present practices of use and concentration Oils a...","page":9,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_001"} |
| CIR Safety Assessment | NOAEL | =1.1 | g/kg/d | rat | - | - | developmental toxicity | {"citation":"5,700; 0; 25","dose":"s are not genotoxic (up to *5,700 mg/kg/d in a rat dominant lethal assay) or carcinogenic (up to 0.25 mL/ wk in a rat subcutaneous injection study).","effect":"s are not genotoxic (up to *5,700 mg/kg/d in a rat dominant lethal assay) or carcinogenic (up to 0.25 mL/ wk in a rat subcutaneous injection study). PEGs are not reproductive or developmental toxicants at doses up to 6.78 g/kg in mice. Use of antimicrobial creams with a PEG vehicle was associated with renal toxicity when applied to burned skin, but studies of extensively tape stripped skin demonstrated that the levels of PEGs that could penetrate in a worst case analysis are >100 times less than the renal toxicity no observable effect level of 1.1 g/kg/d, providing a margin of safety. 4 Plant-Derived Fatty Acid Oils includes: almond oil; apricot kernel oil; avocado oil; babassu oil; Theobroma cacao (cocoa) seed butter; coconut oil; evening primrose oil; moringa oleifera seed oil; moringa pterygosperma seed oil; olive oil; palm oil; palm kernel oil; safflower oil; Butyrospermum parkii (shea) butter; soybean oil; Carthamus tinctorius (safflower) seed oil; sunflower seed oil; Camellia japonica seed oil Safe for use in cosmetics in the present practices of use and concentration Oils a...","page":9,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_001"} |
| CIR Safety Assessment | NOAEL | =1.1 | g/kg/d | rat | - | - | developmental toxicity | {"citation":"5,700; 0; 25","dose":"s are not genotoxic (up to *5,700 mg/kg/d in a rat dominant lethal assay) or carcinogenic (up to 0.25 mL/ wk in a rat subcutaneous injection study).","effect":"s are not genotoxic (up to *5,700 mg/kg/d in a rat dominant lethal assay) or carcinogenic (up to 0.25 mL/ wk in a rat subcutaneous injection study). PEGs are not reproductive or developmental toxicants at doses up to 6.78 g/kg in mice. Use of antimicrobial creams with a PEG vehicle was associated with renal toxicity when applied to burned skin, but studies of extensively tape stripped skin demonstrated that the levels of PEGs that could penetrate in a worst case analysis are >100 times less than the renal toxicity no observable effect level of 1.1 g/kg/d, providing a margin of safety. 4 Plant-Derived Fatty Acid Oils includes: almond oil; apricot kernel oil; avocado oil; babassu oil; Theobroma cacao (cocoa) seed butter; coconut oil; evening primrose oil; moringa oleifera seed oil; moringa pterygosperma seed oil; olive oil; palm oil; palm kernel oil; safflower oil; Butyrospermum parkii (shea) butter; soybean oil; Carthamus tinctorius (safflower) seed oil; sunflower seed oil; Camellia japonica seed oil Safe for use in cosmetics in the present practices of use and concentration Oils a...","page":9,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_001"} |
| CIR Safety Assessment | NOAEL | =2.5 | % | rat | oral | - | developmental toxicity | {"citation":"2; 5; 0","dose":"Select tissues of animals in the control and high-dose group were examined microscopically.","effect":"All animals survived until study termination. For all groups, select tissues were weighed at necropsy. Select tissues of animals in the control and high-dose group were examined microscopically. Spleen weights were significantly decreased in high-dose ani- mals; although there were no associated microscopic changes, the researchers stated the change could be associated with dos- ing. Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level....","page":22,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_002"} |
| CIR Safety Assessment | NOAEL | =2.5 | % | rat | oral | - | developmental toxicity | {"citation":"2; 5; 0","dose":"Select tissues of animals in the control and high-dose group were examined microscopically.","effect":"All animals survived until study termination. For all groups, select tissues were weighed at necropsy. Select tissues of animals in the control and high-dose group were examined microscopically. Spleen weights were significantly decreased in high-dose ani- mals; although there were no associated microscopic changes, the researchers stated the change could be associated with dos- ing. Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level....","page":22,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_002"} |
| CIR Safety Assessment | NOAEL | =2.5 | % | rat | oral | - | developmental toxicity | {"citation":"2; 5; 0","dose":"Select tissues of animals in the control and high-dose group were examined microscopically.","effect":"All animals survived until study termination. For all groups, select tissues were weighed at necropsy. Select tissues of animals in the control and high-dose group were examined microscopically. Spleen weights were significantly decreased in high-dose ani- mals; although there were no associated microscopic changes, the researchers stated the change could be associated with dos- ing. Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level....","page":22,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_002"} |
| CIR Safety Assessment | NOAEL | =2.5 | % | rat | oral | - | developmental toxicity | {"citation":"2; 5; 0","dose":"Select tissues of animals in the control and high-dose group were examined microscopically.","effect":"All animals survived until study termination. For all groups, select tissues were weighed at necropsy. Select tissues of animals in the control and high-dose group were examined microscopically. Spleen weights were significantly decreased in high-dose ani- mals; although there were no associated microscopic changes, the researchers stated the change could be associated with dos- ing. Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level....","page":22,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_002"} |
| CIR Safety Assessment | NOAEL | =40 | % | rat | oral | 4-week | oral toxicity | {"citation":"11; 3; 7","dose":"The current reported concentration of use in leave-on products is slightly higher, that is, 11.3% PEG-7 Glyceryl Cocoate in tonics, dressings, and other hair grooming aids.","effect":"ve-on products containing PEG Glyceryl Cocoates. The current reported concentration of use in leave-on products is slightly higher, that is, 11.3% PEG-7 Glyceryl Cocoate in tonics, dressings, and other hair grooming aids. PEG-8 Caprylic/Capric Glycerides can be a dermal penetra- tion enhancer. In rats, PEG-6 Caprylic/Capric Glycerides had an oral LD50 of > 5 g/kg, PEG-8 Caprylic/Capric Glycerides had an oral LD50 of 22 g/kg, and PEG-7 Glyceryl Cocoate has an oral LD50 of > 19.9 mg/g. In a 4-week study in rats, the NOAEL for a blend of 40% PEG-8 Caprylic/Capric Glycer- ides, 40% apricot kernel oil PEG-6 esters, and 20% ethoxydi- glycol was 5 mL/kg/d. Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence. In a 4-week dietary study in rats, the NOEL of a formulation containing 0.8% PEG-7 Glyceryl Cocoate was 2.5%; at higher concentrations, soft feces, a distended cecum, and enlarged mesenteric lymph nod...","page":28,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_005"} |
| CIR Safety Assessment | NOAEL | =40 | % | rat | oral | 4-week | oral toxicity | {"citation":"11; 3; 7","dose":"The current reported concentration of use in leave-on products is slightly higher, that is, 11.3% PEG-7 Glyceryl Cocoate in tonics, dressings, and other hair grooming aids.","effect":"ve-on products containing PEG Glyceryl Cocoates. The current reported concentration of use in leave-on products is slightly higher, that is, 11.3% PEG-7 Glyceryl Cocoate in tonics, dressings, and other hair grooming aids. PEG-8 Caprylic/Capric Glycerides can be a dermal penetra- tion enhancer. In rats, PEG-6 Caprylic/Capric Glycerides had an oral LD50 of > 5 g/kg, PEG-8 Caprylic/Capric Glycerides had an oral LD50 of 22 g/kg, and PEG-7 Glyceryl Cocoate has an oral LD50 of > 19.9 mg/g. In a 4-week study in rats, the NOAEL for a blend of 40% PEG-8 Caprylic/Capric Glycer- ides, 40% apricot kernel oil PEG-6 esters, and 20% ethoxydi- glycol was 5 mL/kg/d. Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence. In a 4-week dietary study in rats, the NOEL of a formulation containing 0.8% PEG-7 Glyceryl Cocoate was 2.5%; at higher concentrations, soft feces, a distended cecum, and enlarged mesenteric lymph nod...","page":28,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_005"} |
| CIR Safety Assessment | NOAEL | =40 | % | rat | oral | 4-week | oral toxicity | {"citation":"11; 3; 7","dose":"The current reported concentration of use in leave-on products is slightly higher, that is, 11.3% PEG-7 Glyceryl Cocoate in tonics, dressings, and other hair grooming aids.","effect":"ve-on products containing PEG Glyceryl Cocoates. The current reported concentration of use in leave-on products is slightly higher, that is, 11.3% PEG-7 Glyceryl Cocoate in tonics, dressings, and other hair grooming aids. PEG-8 Caprylic/Capric Glycerides can be a dermal penetra- tion enhancer. In rats, PEG-6 Caprylic/Capric Glycerides had an oral LD50 of > 5 g/kg, PEG-8 Caprylic/Capric Glycerides had an oral LD50 of 22 g/kg, and PEG-7 Glyceryl Cocoate has an oral LD50 of > 19.9 mg/g. In a 4-week study in rats, the NOAEL for a blend of 40% PEG-8 Caprylic/Capric Glycer- ides, 40% apricot kernel oil PEG-6 esters, and 20% ethoxydi- glycol was 5 mL/kg/d. Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence. In a 4-week dietary study in rats, the NOEL of a formulation containing 0.8% PEG-7 Glyceryl Cocoate was 2.5%; at higher concentrations, soft feces, a distended cecum, and enlarged mesenteric lymph nod...","page":28,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_005"} |
| CIR Safety Assessment | NOAEL | =40 | % | rat | oral | 4-week | oral toxicity | {"citation":"11; 3; 7","dose":"The current reported concentration of use in leave-on products is slightly higher, that is, 11.3% PEG-7 Glyceryl Cocoate in tonics, dressings, and other hair grooming aids.","effect":"ve-on products containing PEG Glyceryl Cocoates. The current reported concentration of use in leave-on products is slightly higher, that is, 11.3% PEG-7 Glyceryl Cocoate in tonics, dressings, and other hair grooming aids. PEG-8 Caprylic/Capric Glycerides can be a dermal penetra- tion enhancer. In rats, PEG-6 Caprylic/Capric Glycerides had an oral LD50 of > 5 g/kg, PEG-8 Caprylic/Capric Glycerides had an oral LD50 of 22 g/kg, and PEG-7 Glyceryl Cocoate has an oral LD50 of > 19.9 mg/g. In a 4-week study in rats, the NOAEL for a blend of 40% PEG-8 Caprylic/Capric Glycer- ides, 40% apricot kernel oil PEG-6 esters, and 20% ethoxydi- glycol was 5 mL/kg/d. Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence. In a 4-week dietary study in rats, the NOEL of a formulation containing 0.8% PEG-7 Glyceryl Cocoate was 2.5%; at higher concentrations, soft feces, a distended cecum, and enlarged mesenteric lymph nod...","page":28,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_005"} |
| CIR Safety Assessment | NOAEL | =2000 | mg/ kg/d | rat | oral | - | developmental toxicity | {"citation":"2; 5; 0","dose":"Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals.","effect":"ciated with dos- ing. Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level. No other details were provided. Genotoxicity PEG-6 Caprylic/Capric Glycerides, PEG-7 Glyceryl Cocoate, and PEG-10 Olive Glycerides were not mutagenic, with or without metabolic activation. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA102 were exposed to concentrations of 50-5,000 mg/plate PEG-6 Caprylic/Capric Glycerides in one study,42 and S...","page":22,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_003"} |
| CIR Safety Assessment | NOAEL | =2000 | mg/ kg/d | rat | oral | - | developmental toxicity | {"citation":"2; 5; 0","dose":"Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals.","effect":"ciated with dos- ing. Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level. No other details were provided. Genotoxicity PEG-6 Caprylic/Capric Glycerides, PEG-7 Glyceryl Cocoate, and PEG-10 Olive Glycerides were not mutagenic, with or without metabolic activation. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA102 were exposed to concentrations of 50-5,000 mg/plate PEG-6 Caprylic/Capric Glycerides in one study,42 and S...","page":22,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_003"} |
| CIR Safety Assessment | NOAEL | =2000 | mg/ kg/d | rat | oral | - | developmental toxicity | {"citation":"2; 5; 0","dose":"Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals.","effect":"ciated with dos- ing. Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level. No other details were provided. Genotoxicity PEG-6 Caprylic/Capric Glycerides, PEG-7 Glyceryl Cocoate, and PEG-10 Olive Glycerides were not mutagenic, with or without metabolic activation. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA102 were exposed to concentrations of 50-5,000 mg/plate PEG-6 Caprylic/Capric Glycerides in one study,42 and S...","page":22,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_003"} |
| CIR Safety Assessment | NOAEL | =2000 | mg/ kg/d | rat | oral | - | developmental toxicity | {"citation":"2; 5; 0","dose":"Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals.","effect":"ciated with dos- ing. Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level. No other details were provided. Genotoxicity PEG-6 Caprylic/Capric Glycerides, PEG-7 Glyceryl Cocoate, and PEG-10 Olive Glycerides were not mutagenic, with or without metabolic activation. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA102 were exposed to concentrations of 50-5,000 mg/plate PEG-6 Caprylic/Capric Glycerides in one study,42 and S...","page":22,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_003"} |
| CIR Safety Assessment | NOAEL | =3000 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"2; 5; 0","dose":"erved at necropsy in the mid- and high-dose animals.","effect":"erved at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level. No other details were provided. Genotoxicity PEG-6 Caprylic/Capric Glycerides, PEG-7 Glyceryl Cocoate, and PEG-10 Olive Glycerides were not mutagenic, with or without metabolic activation. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA102 were exposed to concentrations of 50-5,000 mg/plate PEG-6 Caprylic/Capric Glycerides in one study,42 and Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 were exposed to 0.04% PEG-6...","page":22,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_004"} |
| CIR Safety Assessment | NOAEL | =3000 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"2; 5; 0","dose":"erved at necropsy in the mid- and high-dose animals.","effect":"erved at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level. No other details were provided. Genotoxicity PEG-6 Caprylic/Capric Glycerides, PEG-7 Glyceryl Cocoate, and PEG-10 Olive Glycerides were not mutagenic, with or without metabolic activation. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA102 were exposed to concentrations of 50-5,000 mg/plate PEG-6 Caprylic/Capric Glycerides in one study,42 and Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 were exposed to 0.04% PEG-6...","page":22,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_004"} |
| CIR Safety Assessment | NOAEL | =3000 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"2; 5; 0","dose":"erved at necropsy in the mid- and high-dose animals.","effect":"erved at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level. No other details were provided. Genotoxicity PEG-6 Caprylic/Capric Glycerides, PEG-7 Glyceryl Cocoate, and PEG-10 Olive Glycerides were not mutagenic, with or without metabolic activation. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA102 were exposed to concentrations of 50-5,000 mg/plate PEG-6 Caprylic/Capric Glycerides in one study,42 and Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 were exposed to 0.04% PEG-6...","page":22,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_004"} |
| CIR Safety Assessment | NOAEL | =3000 | mg/kg/d | rat | oral | - | developmental toxicity | {"citation":"2; 5; 0","dose":"erved at necropsy in the mid- and high-dose animals.","effect":"erved at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level. No other details were provided. Genotoxicity PEG-6 Caprylic/Capric Glycerides, PEG-7 Glyceryl Cocoate, and PEG-10 Olive Glycerides were not mutagenic, with or without metabolic activation. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA102 were exposed to concentrations of 50-5,000 mg/plate PEG-6 Caprylic/Capric Glycerides in one study,42 and Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 were exposed to 0.04% PEG-6...","page":22,"pdf":"PRS681.pdf","row_type":"noael_study","study_id":"PRS681_noael_004"} |
Regulatory source 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | developmental toxicity | 0.8 | % | rat | oral | 4-week | developmental toxicity | SOURCE_SUBDIR=PRS681; REPORT_TITLE=Safety Assessment of PEGylated Alkyl Glycerides 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; OPINION_NUMBER=PRS681; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Suite 1200; VALUE_TEXT=0.8; DOSE=Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence.; EFFECT=of 22 g/kg, and PEG-7 Glyceryl Cocoate has an oral LD50 of > 19.9 mg/g. In a 4-week study in rats, the NOAEL for a blend of 40% PEG-8 Caprylic/Capric Glycer- ides, 40% apricot kernel oil PEG-6 esters, and 20% ethoxydi- glycol was 5 mL/kg/d. Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence. In a 4-week dietary study in rats, the NOEL of a formulation containing 0.8% PEG-7 Glyceryl Cocoate was 2.5%; at higher concentrations, soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed, and a decrease in spleen weights was reported. No adverse effects were observed in dogs that were dosed orally for 13 weeks with 1.0 g/kg/d PEG-8 Caprylic/Capric Glycerides. PEG-8 Caprylic/Capric Glycerides, up to 3,000 mg/kg in purified water, did not produce embryotoxicity, fetotoxicity, or teratogenicity. The maternal embryo/fetal NOAELs were 2,000 and 3,000 mg/kg/d, respectively. The PEG-6 Ca...; CITATION=22; 7; 19; CITATION_NUMBERS=[22,7,19]; REFERENCE=22; 7; 19; DETAILS_JSON={"cas_number":"124046-50-0","citation":"22; 7; 19","dose":"Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence.","duration":"4-week","effect":"of 22 g/kg, and PEG-7 Glyceryl Cocoate has an oral LD50 of > 19.9 mg/g. In a 4-week study in rats, the NOAEL for a blend of 40% PEG-8 Caprylic/Capric Glycer- ides, 40% apricot kernel oil PEG-6 esters, and 20% ethoxydi- glycol was 5 mL/kg/d. Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence. In a 4-week dietary study in rats, the NOEL of a formulation containing 0.8% PEG-7 Glyceryl Cocoate was 2.5%; at higher concentrations, soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed, and a decrease in spleen weights was reported. No adverse effects were observed in dogs that were dosed orally for 13 weeks with 1.0 g/kg/d PEG-8 Caprylic/Capric Glycerides. PEG-8 Caprylic/Capric Glycerides, up to 3,000 mg/kg in purified water, did not produce embryotoxicity, fetotoxicity, or teratogenicity. The maternal embryo/fetal NOAELs were 2,000 and 3,000 mg/kg/d, respectively. The PEG-6 Ca...","endpoint":"developmental toxicity","ingredient":"PEGylated Alkyl Glycerides","loael_value":"","noael_unit":"%","noael_value":"0.8","page":28,"route":"oral","species":"rat","study_id":"PRS681_noael_006"} |
| Regulatory source | developmental toxicity | 1.1 | g/kg/d | rat | - | - | developmental toxicity | SOURCE_SUBDIR=PRS681; REPORT_TITLE=Safety Assessment of PEGylated Alkyl Glycerides 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; OPINION_NUMBER=PRS681; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Suite 1200; VALUE_TEXT=1.1; DOSE=s are not genotoxic (up to *5,700 mg/kg/d in a rat dominant lethal assay) or carcinogenic (up to 0.25 mL/ wk in a rat subcutaneous injection study).; EFFECT=s are not genotoxic (up to *5,700 mg/kg/d in a rat dominant lethal assay) or carcinogenic (up to 0.25 mL/ wk in a rat subcutaneous injection study). PEGs are not reproductive or developmental toxicants at doses up to 6.78 g/kg in mice. Use of antimicrobial creams with a PEG vehicle was associated with renal toxicity when applied to burned skin, but studies of extensively tape stripped skin demonstrated that the levels of PEGs that could penetrate in a worst case analysis are >100 times less than the renal toxicity no observable effect level of 1.1 g/kg/d, providing a margin of safety. 4 Plant-Derived Fatty Acid Oils includes: almond oil; apricot kernel oil; avocado oil; babassu oil; Theobroma cacao (cocoa) seed butter; coconut oil; evening primrose oil; moringa oleifera seed oil; moringa pterygosperma seed oil; olive oil; palm oil; palm kernel oil; safflower oil; Butyrospermum parkii (shea) butter; soybean oil; Carthamus tinctorius (safflower) seed oil; sunflower seed oil; Camellia japonica seed oil Safe for use in cosmetics in the present practices of use and concentration Oils a...; CITATION=5,700; 0; 25; CITATION_NUMBERS=[5,700,25]; REFERENCE=5,700; 0; 25; DETAILS_JSON={"cas_number":"124046-50-0","citation":"5,700; 0; 25","dose":"s are not genotoxic (up to *5,700 mg/kg/d in a rat dominant lethal assay) or carcinogenic (up to 0.25 mL/ wk in a rat subcutaneous injection study).","duration":"","effect":"s are not genotoxic (up to *5,700 mg/kg/d in a rat dominant lethal assay) or carcinogenic (up to 0.25 mL/ wk in a rat subcutaneous injection study). PEGs are not reproductive or developmental toxicants at doses up to 6.78 g/kg in mice. Use of antimicrobial creams with a PEG vehicle was associated with renal toxicity when applied to burned skin, but studies of extensively tape stripped skin demonstrated that the levels of PEGs that could penetrate in a worst case analysis are >100 times less than the renal toxicity no observable effect level of 1.1 g/kg/d, providing a margin of safety. 4 Plant-Derived Fatty Acid Oils includes: almond oil; apricot kernel oil; avocado oil; babassu oil; Theobroma cacao (cocoa) seed butter; coconut oil; evening primrose oil; moringa oleifera seed oil; moringa pterygosperma seed oil; olive oil; palm oil; palm kernel oil; safflower oil; Butyrospermum parkii (shea) butter; soybean oil; Carthamus tinctorius (safflower) seed oil; sunflower seed oil; Camellia japonica seed oil Safe for use in cosmetics in the present practices of use and concentration Oils a...","endpoint":"developmental toxicity","ingredient":"PEGylated Alkyl Glycerides","loael_value":"","noael_unit":"g/kg/d","noael_value":"1.1","page":9,"route":"","species":"rat","study_id":"PRS681_noael_001"} |
| Regulatory source | developmental toxicity | 2.5 | % | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS681; REPORT_TITLE=Safety Assessment of PEGylated Alkyl Glycerides 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; OPINION_NUMBER=PRS681; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Suite 1200; VALUE_TEXT=2.5; DOSE=Select tissues of animals in the control and high-dose group were examined microscopically.; EFFECT=All animals survived until study termination. For all groups, select tissues were weighed at necropsy. Select tissues of animals in the control and high-dose group were examined microscopically. Spleen weights were significantly decreased in high-dose ani- mals; although there were no associated microscopic changes, the researchers stated the change could be associated with dos- ing. Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level....; CITATION=2; 5; 0; CITATION_NUMBERS=[2,5]; REFERENCE=2; 5; 0; DETAILS_JSON={"cas_number":"124046-50-0","citation":"2; 5; 0","dose":"Select tissues of animals in the control and high-dose group were examined microscopically.","duration":"","effect":"All animals survived until study termination. For all groups, select tissues were weighed at necropsy. Select tissues of animals in the control and high-dose group were examined microscopically. Spleen weights were significantly decreased in high-dose ani- mals; although there were no associated microscopic changes, the researchers stated the change could be associated with dos- ing. Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level....","endpoint":"developmental toxicity","ingredient":"PEGylated Alkyl Glycerides","loael_value":"","noael_unit":"%","noael_value":"2.5","page":22,"route":"oral","species":"rat","study_id":"PRS681_noael_002"} |
| Regulatory source | developmental toxicity | 2000 | mg/ kg/d | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS681; REPORT_TITLE=Safety Assessment of PEGylated Alkyl Glycerides 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; OPINION_NUMBER=PRS681; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Suite 1200; VALUE_TEXT=2,000; DOSE=Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals.; EFFECT=ciated with dos- ing. Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level. No other details were provided. Genotoxicity PEG-6 Caprylic/Capric Glycerides, PEG-7 Glyceryl Cocoate, and PEG-10 Olive Glycerides were not mutagenic, with or without metabolic activation. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA102 were exposed to concentrations of 50-5,000 mg/plate PEG-6 Caprylic/Capric Glycerides in one study,42 and S...; CITATION=2; 5; 0; CITATION_NUMBERS=[2,5]; REFERENCE=2; 5; 0; DETAILS_JSON={"cas_number":"124046-50-0","citation":"2; 5; 0","dose":"Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals.","duration":"","effect":"ciated with dos- ing. Soft feces, a distended cecum, and enlarged mesenteric lymph nodes were observed at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level. No other details were provided. Genotoxicity PEG-6 Caprylic/Capric Glycerides, PEG-7 Glyceryl Cocoate, and PEG-10 Olive Glycerides were not mutagenic, with or without metabolic activation. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA102 were exposed to concentrations of 50-5,000 mg/plate PEG-6 Caprylic/Capric Glycerides in one study,42 and S...","endpoint":"developmental toxicity","ingredient":"PEGylated Alkyl Glycerides","loael_value":"","noael_unit":"mg/ kg/d","noael_value":"2,000","page":22,"route":"oral","species":"rat","study_id":"PRS681_noael_003"} |
| Regulatory source | developmental toxicity | 3000 | mg/kg/d | rat | oral | - | developmental toxicity | SOURCE_SUBDIR=PRS681; REPORT_TITLE=Safety Assessment of PEGylated Alkyl Glycerides 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; OPINION_NUMBER=PRS681; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Suite 1200; VALUE_TEXT=3,000; DOSE=erved at necropsy in the mid- and high-dose animals.; EFFECT=erved at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level. No other details were provided. Genotoxicity PEG-6 Caprylic/Capric Glycerides, PEG-7 Glyceryl Cocoate, and PEG-10 Olive Glycerides were not mutagenic, with or without metabolic activation. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA102 were exposed to concentrations of 50-5,000 mg/plate PEG-6 Caprylic/Capric Glycerides in one study,42 and Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 were exposed to 0.04% PEG-6...; CITATION=2; 5; 0; CITATION_NUMBERS=[2,5]; REFERENCE=2; 5; 0; DETAILS_JSON={"cas_number":"124046-50-0","citation":"2; 5; 0","dose":"erved at necropsy in the mid- and high-dose animals.","duration":"","effect":"erved at necropsy in the mid- and high-dose animals. The no-observable effect level (NOEL) was 2.5% of the formulation containing 0.8% PEG-7 Glyceryl Cocoate. Reproductive and Developmental Toxicity A segment II developmental toxicity test was performed in rats with PEG-8 Caprylic/Capric Glycerides.46 The animals were dosed with 0, 1,000, 2,000, or 3,000 mg/kg/d by gavage on days 6 through 17 of gestation. The maternal NOAEL was 2,000 mg/ kg/d; effects on body weigh were reported at 3,000 mg/kg/d. The embryo/fetal NOAEL was 3,000 mg/kg/d. No signs of embryotoxicity, fetotoxicity, or teratogenicity were noted at any dose level. No other details were provided. Genotoxicity PEG-6 Caprylic/Capric Glycerides, PEG-7 Glyceryl Cocoate, and PEG-10 Olive Glycerides were not mutagenic, with or without metabolic activation. Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA102 were exposed to concentrations of 50-5,000 mg/plate PEG-6 Caprylic/Capric Glycerides in one study,42 and Salmonella typhimurium strains TA98, TA100, TA1535, TA1537, and TA1538 were exposed to 0.04% PEG-6...","endpoint":"developmental toxicity","ingredient":"PEGylated Alkyl Glycerides","loael_value":"","noael_unit":"mg/kg/d","noael_value":"3,000","page":22,"route":"oral","species":"rat","study_id":"PRS681_noael_004"} |
| Regulatory source | oral toxicity | 40 | % | rat | oral | 4-week | oral toxicity | SOURCE_SUBDIR=PRS681; REPORT_TITLE=Safety Assessment of PEGylated Alkyl Glycerides 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; OPINION_NUMBER=PRS681; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Suite 1200; VALUE_TEXT=40; DOSE=The current reported concentration of use in leave-on products is slightly higher, that is, 11.3% PEG-7 Glyceryl Cocoate in tonics, dressings, and other hair grooming aids.; EFFECT=ve-on products containing PEG Glyceryl Cocoates. The current reported concentration of use in leave-on products is slightly higher, that is, 11.3% PEG-7 Glyceryl Cocoate in tonics, dressings, and other hair grooming aids. PEG-8 Caprylic/Capric Glycerides can be a dermal penetra- tion enhancer. In rats, PEG-6 Caprylic/Capric Glycerides had an oral LD50 of > 5 g/kg, PEG-8 Caprylic/Capric Glycerides had an oral LD50 of 22 g/kg, and PEG-7 Glyceryl Cocoate has an oral LD50 of > 19.9 mg/g. In a 4-week study in rats, the NOAEL for a blend of 40% PEG-8 Caprylic/Capric Glycer- ides, 40% apricot kernel oil PEG-6 esters, and 20% ethoxydi- glycol was 5 mL/kg/d. Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence. In a 4-week dietary study in rats, the NOEL of a formulation containing 0.8% PEG-7 Glyceryl Cocoate was 2.5%; at higher concentrations, soft feces, a distended cecum, and enlarged mesenteric lymph nod...; CITATION=11; 3; 7; CITATION_NUMBERS=[11,3,7]; REFERENCE=11; 3; 7; DETAILS_JSON={"cas_number":"124046-50-0","citation":"11; 3; 7","dose":"The current reported concentration of use in leave-on products is slightly higher, that is, 11.3% PEG-7 Glyceryl Cocoate in tonics, dressings, and other hair grooming aids.","duration":"4-week","effect":"ve-on products containing PEG Glyceryl Cocoates. The current reported concentration of use in leave-on products is slightly higher, that is, 11.3% PEG-7 Glyceryl Cocoate in tonics, dressings, and other hair grooming aids. PEG-8 Caprylic/Capric Glycerides can be a dermal penetra- tion enhancer. In rats, PEG-6 Caprylic/Capric Glycerides had an oral LD50 of > 5 g/kg, PEG-8 Caprylic/Capric Glycerides had an oral LD50 of 22 g/kg, and PEG-7 Glyceryl Cocoate has an oral LD50 of > 19.9 mg/g. In a 4-week study in rats, the NOAEL for a blend of 40% PEG-8 Caprylic/Capric Glycer- ides, 40% apricot kernel oil PEG-6 esters, and 20% ethoxydi- glycol was 5 mL/kg/d. Test-article related effects were reported in the kidneys, livers, and gastrointestinal systems of animals dosed with 20 mL/g/d; effects were also observed in animals given 10 mL/kg/d, but they did not occur at the same rate of incidence. In a 4-week dietary study in rats, the NOEL of a formulation containing 0.8% PEG-7 Glyceryl Cocoate was 2.5%; at higher concentrations, soft feces, a distended cecum, and enlarged mesenteric lymph nod...","endpoint":"oral toxicity","ingredient":"PEGylated Alkyl Glycerides","loael_value":"","noael_unit":"%","noael_value":"40","page":28,"route":"oral","species":"rat","study_id":"PRS681_noael_005"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 4Y0E651N0F | UNII | - | - | - | structurallyDiverse | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"4Y0E651N0F"} |
| openFDA substances | FDA UNII substance identifier | 4Y0E651N0F | UNII | - | - | - | structurallyDiverse | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"4Y0E651N0F"} |
| openFDA substances | FDA UNII substance identifier | 4Y0E651N0F | UNII | - | - | - | structurallyDiverse | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"4Y0E651N0F"} |
| openFDA substances | FDA UNII substance identifier | 4Y0E651N0F | UNII | - | - | - | structurallyDiverse | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"4Y0E651N0F"} |