NOAEL Studies Emulsifier

Polysorbate 20 NOAEL Studies

INCI: POLYSORBATE 20

CAS: 9005-64-5

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 75 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR_vision_codex DERMAL_ABSORPTION =3.43 % Hairless mouse dermal 5% Franz cells {"absorption_percent":"Enhancement ratio: 3.43±0.52 compared to control (saline buffer); 1.26±0.32 compared to vehicle (ethanol)","citation":"42","concentration_tested":"5%","page":6,"pdf":"FR696.pdf","row_type":"dermal_absorption_study"}
CIR_vision_codex DERMAL_ABSORPTION =3.43 % Hairless mouse dermal 5% Franz cells {"absorption_percent":"Enhancement ratio: 3.43±0.52 compared to control (saline buffer); 1.26±0.32 compared to vehicle (ethanol)","citation":"42","concentration_tested":"5%","page":6,"pdf":"FR696.pdf","row_type":"dermal_absorption_study"}
CIR_vision_codex DERMAL_ABSORPTION =3.43 % Hairless mouse dermal 5% Franz cells {"absorption_percent":"Enhancement ratio: 3.43±0.52 compared to control (saline buffer); 1.26±0.32 compared to vehicle (ethanol)","citation":"42","concentration_tested":"5%","page":6,"pdf":"FR696.pdf","row_type":"dermal_absorption_study"}
CIR_vision_codex NOAEL =250 mg/kg/d rat oral 14-day repeated dose toxicity {"citation":"5); 4; 22","dose":"Intravenous – Non-Human POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The...","effect":"Han) rats (n=5) for 4 h in a nose-only apparatus.22 No clinical signs of systemic toxicity were observed up to the end of the 14-day observation period. No abnormalities were observed at macroscopic post mortem examination of the rats. Intravenous – Non-Human POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_001"}
CIR_vision_codex NOAEL =10 mg/kg/d rat oral 1 month repeated dose toxicity {"citation":"20; 22; 4","dose":"POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for...","effect":"POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was 14285.71 mg/kg/d (10% in feed).24 Decreased hematologic values were observed but not specified. No characteristic morphologic anemia was observed. The test substance was administered in the feed at 5% or 10% polysorbate 20. No further details were provided. T...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_002"}
CIR_vision_codex NOAEL =0.2 % rat oral 1 month repeated dose toxicity {"citation":"420; 22; 4","dose":"420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respective...","effect":"420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was 14285.71 mg/kg/d (10% in feed).24 Decreased hematologic values were observed but not specified. No characteristic morphologic anemia was observed. The test substance was administered in the feed at 5% or 10% polysorbate 20. No further details were provided. There were no adverse effects or mortalities related to polysorbate 80 (0.005, 0.05,...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_003"}
CIR_vision_codex NOAEL =14285.71 mg/kg/d rat oral 1 month repeated dose toxicity {"citation":"11); 44; 20","dose":"various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice.","effect":"various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was 14285.71 mg/kg/d (10% in feed).24 Decreased hematologic values were observed but not specified. No characteristic morphologic anemia was observed. The test substance was administered in the feed at 5% or 10% polysorbate 20. No further details were provided. There were no adverse effects or mortalities related to polysorbate 80 (0.005, 0.05, or 0.15 g/kg/d) when administered by gavage to Sprague-Dawley rats (n=5) for 5 days.45 There were no clinical signs and no significant findings at necropsy. Serum glucose levels were...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_004"}
CIR_vision_codex NOAEL =7693 mg/kg/d rat oral 28 days developmental toxicity {"citation":"28; 5; 20","dose":"In additional studies, there were no adverse effects or mortalities reported when the same strain of mice (n=5/sex) were orally administered polysorbate 20, polysorbate 40, or polysorbate 60 (1600 mg/kg/d in saline) for 28 days, also after 28 days of a high-fat diet.","effect":"g/d in saline) for 28 days after 28 days of a high-fat diet. In additional studies, there were no adverse effects or mortalities reported when the same strain of mice (n=5/sex) were orally administered polysorbate 20, polysorbate 40, or polysorbate 60 (1600 mg/kg/d in saline) for 28 days, also after 28 days of a high-fat diet. It was not clear if the mice continued on the high-fat diet during treatment with the polysorbates.46 REPRODUCTIVE AND DEVELOPMENTAL TOXICITY POLYSORBATE 60 The teratogenic and reproductive NOAEL was reported to be 7693 mg/kg/d when polysorbate 60 (0, 0.1%, 1.0% or 10% in feed; 0, 99 mg/kg, 960 mg/kg, 7693 mg/kg) was administered to pregnant Wistar rats on gestations days 7-14.24 There were no effects by polysorbate 60 on the number, sex ratio, and body weights of live fetuses. There were no differences between the polysorbate 60-treated and control groups observed in the numbers of resorptions, dead fetuses and live fetuses per litter, the sex ratio of live fetuses, and the fetal body weight of both sexes. External, skeletal, and internal examinations of th...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_005"}
CIR_vision_codex NOAEL =5 mL/kg/d Dog Oral 90 days General toxicity {"citation":"44","dose":"5 mL/kg/d","effect":"As 1% of formulation; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_DOG_ORAL_1"}
CIR_vision_codex NOAEL =350 mg/kg Rat Oral Not reported General toxicity {"citation":"44","dose":"350 mg/kg","effect":"Well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_ORAL_1"}
CIR_vision_codex NOAEL =10 mL/kg/d Rat Oral 7 days General toxicity {"citation":"44","dose":"10 mL/kg/d","effect":"1%; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_ORAL_3"}
CIR_vision_codex NOAEL =100 mg/kg Rat Intravenous Not reported General toxicity {"citation":"44","dose":"100 mg/kg","effect":"Well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_IV_1"}
CIR_vision_codex NOAEL =10 µL/nostril/d Mouse Intranasal 3 days General toxicity {"citation":"44","dose":"10 µL/nostril/d","effect":"0.2%; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_MOUSE_INTRANASAL_1"}
CIR_vision_codex NOAEL =5 mL/kg Primate Oral Efficacy (distinct time not indicated.) General toxicity {"citation":"44","dose":"5 mL/kg","effect":"1%; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_PRIMATE_ORAL_1"}
CIR_vision_codex NOAEL >5000 mg/kg/d Crl:CD BR VAF/PlusTM outbred albino rat Gavage Gestation days 6-15 Reproductive and developmental toxicity {"citation":"23","dose":">5000 mg/kg/d","effect":"No adverse fetal effects","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_REPRO_1"}
CIR_vision_codex NOAEL =0.15 g/kg/d Sprague-Dawley rats Gavage 5 days General toxicity {"citation":"45","dose":"0.15 g/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_GAVAGE_RAT_1"}
CIR_vision_codex NOAEL =3700 mg/kg/d Sprague-Dawley rats Oral (gavage) 28 days General toxicity {"citation":"46","dose":"3700 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =6400 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"6400 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"1600 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS20_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"1600 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS40_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"1600 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS60_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =250 mg/kg/d rat oral 14-day repeated dose toxicity {"citation":"5); 4; 22","dose":"Intravenous – Non-Human POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The...","effect":"Han) rats (n=5) for 4 h in a nose-only apparatus.22 No clinical signs of systemic toxicity were observed up to the end of the 14-day observation period. No abnormalities were observed at macroscopic post mortem examination of the rats. Intravenous – Non-Human POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_001"}
CIR_vision_codex NOAEL =10 mg/kg/d rat oral 1 month repeated dose toxicity {"citation":"20; 22; 4","dose":"POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for...","effect":"POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was 14285.71 mg/kg/d (10% in feed).24 Decreased hematologic values were observed but not specified. No characteristic morphologic anemia was observed. The test substance was administered in the feed at 5% or 10% polysorbate 20. No further details were provided. T...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_002"}
CIR_vision_codex NOAEL =0.2 % rat oral 1 month repeated dose toxicity {"citation":"420; 22; 4","dose":"420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respective...","effect":"420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was 14285.71 mg/kg/d (10% in feed).24 Decreased hematologic values were observed but not specified. No characteristic morphologic anemia was observed. The test substance was administered in the feed at 5% or 10% polysorbate 20. No further details were provided. There were no adverse effects or mortalities related to polysorbate 80 (0.005, 0.05,...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_003"}
CIR_vision_codex NOAEL =14285.71 mg/kg/d rat oral 1 month repeated dose toxicity {"citation":"11); 44; 20","dose":"various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice.","effect":"various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was 14285.71 mg/kg/d (10% in feed).24 Decreased hematologic values were observed but not specified. No characteristic morphologic anemia was observed. The test substance was administered in the feed at 5% or 10% polysorbate 20. No further details were provided. There were no adverse effects or mortalities related to polysorbate 80 (0.005, 0.05, or 0.15 g/kg/d) when administered by gavage to Sprague-Dawley rats (n=5) for 5 days.45 There were no clinical signs and no significant findings at necropsy. Serum glucose levels were...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_004"}
CIR_vision_codex NOAEL =7693 mg/kg/d rat oral 28 days developmental toxicity {"citation":"28; 5; 20","dose":"In additional studies, there were no adverse effects or mortalities reported when the same strain of mice (n=5/sex) were orally administered polysorbate 20, polysorbate 40, or polysorbate 60 (1600 mg/kg/d in saline) for 28 days, also after 28 days of a high-fat diet.","effect":"g/d in saline) for 28 days after 28 days of a high-fat diet. In additional studies, there were no adverse effects or mortalities reported when the same strain of mice (n=5/sex) were orally administered polysorbate 20, polysorbate 40, or polysorbate 60 (1600 mg/kg/d in saline) for 28 days, also after 28 days of a high-fat diet. It was not clear if the mice continued on the high-fat diet during treatment with the polysorbates.46 REPRODUCTIVE AND DEVELOPMENTAL TOXICITY POLYSORBATE 60 The teratogenic and reproductive NOAEL was reported to be 7693 mg/kg/d when polysorbate 60 (0, 0.1%, 1.0% or 10% in feed; 0, 99 mg/kg, 960 mg/kg, 7693 mg/kg) was administered to pregnant Wistar rats on gestations days 7-14.24 There were no effects by polysorbate 60 on the number, sex ratio, and body weights of live fetuses. There were no differences between the polysorbate 60-treated and control groups observed in the numbers of resorptions, dead fetuses and live fetuses per litter, the sex ratio of live fetuses, and the fetal body weight of both sexes. External, skeletal, and internal examinations of th...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_005"}
CIR_vision_codex NOAEL =5 mL/kg/d Dog Oral 90 days General toxicity {"citation":"44","dose":"5 mL/kg/d","effect":"As 1% of formulation; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_DOG_ORAL_1"}
CIR_vision_codex NOAEL =350 mg/kg Rat Oral Not reported General toxicity {"citation":"44","dose":"350 mg/kg","effect":"Well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_ORAL_1"}
CIR_vision_codex NOAEL =10 mL/kg/d Rat Oral 7 days General toxicity {"citation":"44","dose":"10 mL/kg/d","effect":"1%; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_ORAL_3"}
CIR_vision_codex NOAEL =100 mg/kg Rat Intravenous Not reported General toxicity {"citation":"44","dose":"100 mg/kg","effect":"Well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_IV_1"}
CIR_vision_codex NOAEL =10 µL/nostril/d Mouse Intranasal 3 days General toxicity {"citation":"44","dose":"10 µL/nostril/d","effect":"0.2%; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_MOUSE_INTRANASAL_1"}
CIR_vision_codex NOAEL =5 mL/kg Primate Oral Efficacy (distinct time not indicated.) General toxicity {"citation":"44","dose":"5 mL/kg","effect":"1%; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_PRIMATE_ORAL_1"}
CIR_vision_codex NOAEL >5000 mg/kg/d Crl:CD BR VAF/PlusTM outbred albino rat Gavage Gestation days 6-15 Reproductive and developmental toxicity {"citation":"23","dose":">5000 mg/kg/d","effect":"No adverse fetal effects","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_REPRO_1"}
CIR_vision_codex NOAEL =0.15 g/kg/d Sprague-Dawley rats Gavage 5 days General toxicity {"citation":"45","dose":"0.15 g/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_GAVAGE_RAT_1"}
CIR_vision_codex NOAEL =3700 mg/kg/d Sprague-Dawley rats Oral (gavage) 28 days General toxicity {"citation":"46","dose":"3700 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =6400 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"6400 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"1600 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS20_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"1600 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS40_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"1600 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS60_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =250 mg/kg/d rat oral 14-day repeated dose toxicity {"citation":"5); 4; 22","dose":"Intravenous – Non-Human POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The...","effect":"Han) rats (n=5) for 4 h in a nose-only apparatus.22 No clinical signs of systemic toxicity were observed up to the end of the 14-day observation period. No abnormalities were observed at macroscopic post mortem examination of the rats. Intravenous – Non-Human POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_001"}
CIR_vision_codex NOAEL =10 mg/kg/d rat oral 1 month repeated dose toxicity {"citation":"20; 22; 4","dose":"POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for...","effect":"POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was 14285.71 mg/kg/d (10% in feed).24 Decreased hematologic values were observed but not specified. No characteristic morphologic anemia was observed. The test substance was administered in the feed at 5% or 10% polysorbate 20. No further details were provided. T...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_002"}
CIR_vision_codex NOAEL =0.2 % rat oral 1 month repeated dose toxicity {"citation":"420; 22; 4","dose":"420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respective...","effect":"420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was 14285.71 mg/kg/d (10% in feed).24 Decreased hematologic values were observed but not specified. No characteristic morphologic anemia was observed. The test substance was administered in the feed at 5% or 10% polysorbate 20. No further details were provided. There were no adverse effects or mortalities related to polysorbate 80 (0.005, 0.05,...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_003"}
CIR_vision_codex NOAEL =14285.71 mg/kg/d rat oral 1 month repeated dose toxicity {"citation":"11); 44; 20","dose":"various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice.","effect":"various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was 14285.71 mg/kg/d (10% in feed).24 Decreased hematologic values were observed but not specified. No characteristic morphologic anemia was observed. The test substance was administered in the feed at 5% or 10% polysorbate 20. No further details were provided. There were no adverse effects or mortalities related to polysorbate 80 (0.005, 0.05, or 0.15 g/kg/d) when administered by gavage to Sprague-Dawley rats (n=5) for 5 days.45 There were no clinical signs and no significant findings at necropsy. Serum glucose levels were...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_004"}
CIR_vision_codex NOAEL =7693 mg/kg/d rat oral 28 days developmental toxicity {"citation":"28; 5; 20","dose":"In additional studies, there were no adverse effects or mortalities reported when the same strain of mice (n=5/sex) were orally administered polysorbate 20, polysorbate 40, or polysorbate 60 (1600 mg/kg/d in saline) for 28 days, also after 28 days of a high-fat diet.","effect":"g/d in saline) for 28 days after 28 days of a high-fat diet. In additional studies, there were no adverse effects or mortalities reported when the same strain of mice (n=5/sex) were orally administered polysorbate 20, polysorbate 40, or polysorbate 60 (1600 mg/kg/d in saline) for 28 days, also after 28 days of a high-fat diet. It was not clear if the mice continued on the high-fat diet during treatment with the polysorbates.46 REPRODUCTIVE AND DEVELOPMENTAL TOXICITY POLYSORBATE 60 The teratogenic and reproductive NOAEL was reported to be 7693 mg/kg/d when polysorbate 60 (0, 0.1%, 1.0% or 10% in feed; 0, 99 mg/kg, 960 mg/kg, 7693 mg/kg) was administered to pregnant Wistar rats on gestations days 7-14.24 There were no effects by polysorbate 60 on the number, sex ratio, and body weights of live fetuses. There were no differences between the polysorbate 60-treated and control groups observed in the numbers of resorptions, dead fetuses and live fetuses per litter, the sex ratio of live fetuses, and the fetal body weight of both sexes. External, skeletal, and internal examinations of th...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_005"}
CIR_vision_codex NOAEL =5 mL/kg/d Dog Oral 90 days General toxicity {"citation":"44","dose":"5 mL/kg/d","effect":"As 1% of formulation; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_DOG_ORAL_1"}
CIR_vision_codex NOAEL =350 mg/kg Rat Oral Not reported General toxicity {"citation":"44","dose":"350 mg/kg","effect":"Well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_ORAL_1"}
CIR_vision_codex NOAEL =10 mL/kg/d Rat Oral 7 days General toxicity {"citation":"44","dose":"10 mL/kg/d","effect":"1%; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_ORAL_3"}
CIR_vision_codex NOAEL =100 mg/kg Rat Intravenous Not reported General toxicity {"citation":"44","dose":"100 mg/kg","effect":"Well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_IV_1"}
CIR_vision_codex NOAEL =10 µL/nostril/d Mouse Intranasal 3 days General toxicity {"citation":"44","dose":"10 µL/nostril/d","effect":"0.2%; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_MOUSE_INTRANASAL_1"}
CIR_vision_codex NOAEL =5 mL/kg Primate Oral Efficacy (distinct time not indicated.) General toxicity {"citation":"44","dose":"5 mL/kg","effect":"1%; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_PRIMATE_ORAL_1"}
CIR_vision_codex NOAEL >5000 mg/kg/d Crl:CD BR VAF/PlusTM outbred albino rat Gavage Gestation days 6-15 Reproductive and developmental toxicity {"citation":"23","dose":">5000 mg/kg/d","effect":"No adverse fetal effects","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_REPRO_1"}
CIR_vision_codex NOAEL =0.15 g/kg/d Sprague-Dawley rats Gavage 5 days General toxicity {"citation":"45","dose":"0.15 g/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_GAVAGE_RAT_1"}
CIR_vision_codex NOAEL =3700 mg/kg/d Sprague-Dawley rats Oral (gavage) 28 days General toxicity {"citation":"46","dose":"3700 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =6400 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"6400 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"1600 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS20_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"1600 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS40_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"1600 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS60_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =250 mg/kg/d rat oral 14-day repeated dose toxicity {"citation":"5); 4; 22","dose":"Intravenous – Non-Human POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The...","effect":"Han) rats (n=5) for 4 h in a nose-only apparatus.22 No clinical signs of systemic toxicity were observed up to the end of the 14-day observation period. No abnormalities were observed at macroscopic post mortem examination of the rats. Intravenous – Non-Human POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_001"}
CIR_vision_codex NOAEL =10 mg/kg/d rat oral 1 month repeated dose toxicity {"citation":"20; 22; 4","dose":"POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for...","effect":"POLYSORBATE 20 The intravenous LD50 for polysorbate 20 in mice was reported to be 1420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was 14285.71 mg/kg/d (10% in feed).24 Decreased hematologic values were observed but not specified. No characteristic morphologic anemia was observed. The test substance was administered in the feed at 5% or 10% polysorbate 20. No further details were provided. T...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_002"}
CIR_vision_codex NOAEL =0.2 % rat oral 1 month repeated dose toxicity {"citation":"420; 22; 4","dose":"420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respective...","effect":"420 mg/kg.22 Repeated Dose Toxicity In a survey of 4 laboratories of the historical use of vehicles for in vivo experiments, the highest no-observed- adverse-effect levels (NOAEL) for various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was 14285.71 mg/kg/d (10% in feed).24 Decreased hematologic values were observed but not specified. No characteristic morphologic anemia was observed. The test substance was administered in the feed at 5% or 10% polysorbate 20. No further details were provided. There were no adverse effects or mortalities related to polysorbate 80 (0.005, 0.05,...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_003"}
CIR_vision_codex NOAEL =14285.71 mg/kg/d rat oral 1 month repeated dose toxicity {"citation":"11); 44; 20","dose":"various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice.","effect":"various routes of administration were assembled (Table 11).44 The highest oral NOAELs for polysorbate 20 were 250 and 500 mg/kg/d for 1 month and 90 days in rats, respectively, and 10 mg/kg/d for 1 month in mice. For polysorbate 80, the highest oral NOAEL for 90 days in dogs was 5 mL/kg/d, and for 4 weeks in rats was 5 mL/kg/d. The NOAEL for intranasal administration of polysorbates 80 for 3 days to mice was 10 µL/nostril/d at 0.2%. Oral – Non-Human POLYSORBATE 20, 40, 60, and 80 In a 22-month feeding study, the NOAEL of polysorbate 20 in male C57BL/6 Jax mice was 14285.71 mg/kg/d (10% in feed).24 Decreased hematologic values were observed but not specified. No characteristic morphologic anemia was observed. The test substance was administered in the feed at 5% or 10% polysorbate 20. No further details were provided. There were no adverse effects or mortalities related to polysorbate 80 (0.005, 0.05, or 0.15 g/kg/d) when administered by gavage to Sprague-Dawley rats (n=5) for 5 days.45 There were no clinical signs and no significant findings at necropsy. Serum glucose levels were...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_004"}
CIR_vision_codex NOAEL =7693 mg/kg/d rat oral 28 days developmental toxicity {"citation":"28; 5; 20","dose":"In additional studies, there were no adverse effects or mortalities reported when the same strain of mice (n=5/sex) were orally administered polysorbate 20, polysorbate 40, or polysorbate 60 (1600 mg/kg/d in saline) for 28 days, also after 28 days of a high-fat diet.","effect":"g/d in saline) for 28 days after 28 days of a high-fat diet. In additional studies, there were no adverse effects or mortalities reported when the same strain of mice (n=5/sex) were orally administered polysorbate 20, polysorbate 40, or polysorbate 60 (1600 mg/kg/d in saline) for 28 days, also after 28 days of a high-fat diet. It was not clear if the mice continued on the high-fat diet during treatment with the polysorbates.46 REPRODUCTIVE AND DEVELOPMENTAL TOXICITY POLYSORBATE 60 The teratogenic and reproductive NOAEL was reported to be 7693 mg/kg/d when polysorbate 60 (0, 0.1%, 1.0% or 10% in feed; 0, 99 mg/kg, 960 mg/kg, 7693 mg/kg) was administered to pregnant Wistar rats on gestations days 7-14.24 There were no effects by polysorbate 60 on the number, sex ratio, and body weights of live fetuses. There were no differences between the polysorbate 60-treated and control groups observed in the numbers of resorptions, dead fetuses and live fetuses per litter, the sex ratio of live fetuses, and the fetal body weight of both sexes. External, skeletal, and internal examinations of th...","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"FR696_noael_005"}
CIR_vision_codex NOAEL =5 mL/kg/d Dog Oral 90 days General toxicity {"citation":"44","dose":"5 mL/kg/d","effect":"As 1% of formulation; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_DOG_ORAL_1"}
CIR_vision_codex NOAEL =350 mg/kg Rat Oral Not reported General toxicity {"citation":"44","dose":"350 mg/kg","effect":"Well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_ORAL_1"}
CIR_vision_codex NOAEL =10 mL/kg/d Rat Oral 7 days General toxicity {"citation":"44","dose":"10 mL/kg/d","effect":"1%; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_ORAL_3"}
CIR_vision_codex NOAEL =100 mg/kg Rat Intravenous Not reported General toxicity {"citation":"44","dose":"100 mg/kg","effect":"Well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_IV_1"}
CIR_vision_codex NOAEL =10 µL/nostril/d Mouse Intranasal 3 days General toxicity {"citation":"44","dose":"10 µL/nostril/d","effect":"0.2%; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_MOUSE_INTRANASAL_1"}
CIR_vision_codex NOAEL =5 mL/kg Primate Oral Efficacy (distinct time not indicated.) General toxicity {"citation":"44","dose":"5 mL/kg","effect":"1%; well tolerated","page":43,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_PRIMATE_ORAL_1"}
CIR_vision_codex NOAEL >5000 mg/kg/d Crl:CD BR VAF/PlusTM outbred albino rat Gavage Gestation days 6-15 Reproductive and developmental toxicity {"citation":"23","dose":">5000 mg/kg/d","effect":"No adverse fetal effects","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_REPRO_1"}
CIR_vision_codex NOAEL =0.15 g/kg/d Sprague-Dawley rats Gavage 5 days General toxicity {"citation":"45","dose":"0.15 g/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_GAVAGE_RAT_1"}
CIR_vision_codex NOAEL =3700 mg/kg/d Sprague-Dawley rats Oral (gavage) 28 days General toxicity {"citation":"46","dose":"3700 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_RAT_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =6400 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"6400 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS80_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"1600 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS20_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"1600 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS40_MOUSE_GAVAGE_HIGHFAT_1"}
CIR_vision_codex NOAEL =1600 mg/kg/d C57BL/6J mice Oral (gavage) 28 days General toxicity {"citation":"46","dose":"1600 mg/kg/d","effect":"No adverse effects or mortalities","page":7,"pdf":"FR696.pdf","row_type":"noael_study","study_id":"NOAEL_PS60_MOUSE_GAVAGE_HIGHFAT_1"}
COSMOS_DB 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 25000 mg/kg bw/day rat oral 147 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 3000 mg/kg bw/day hamster oral 273 day Chronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 6000 mg/kg bw/day hamster oral 68 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =2500 mg/kg bw/day Rat oral: unspecified 721 days chronic/long term toxicity EFSA ANS - 2015 - OutputID 2782 - mortality - systemic - Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives - doi:10.2903/j.efsa.2015.4152
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx NOAEL =2500 mg/kg bw/day Rat oral: unspecified 721 days chronic/long term toxicity EFSA ANS - 2015 - OutputID 2782 - mortality - systemic - Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives - doi:10.2903/j.efsa.2015.4152
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI (group) =25 mg/kg bw/day Consumers - - ADI (group) EFSA ANS - 2015 - OutputID 2782 - Consumers - Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives - doi:10.2903/j.efsa.2015.4152
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx ADI (group) =25 mg/kg bw/day Consumers - - ADI (group) EFSA ANS - 2015 - OutputID 2782 - Consumers - Scientific Opinion on the re-evaluation of polyoxyethylene sorbitan monolaurate (E 432), polyoxyethylene sorbitan monooleate (E 433), polyoxyethylene sorbitan monopalmitate (E 434), polyoxyethylene sorbitan monostearate (E 435) and polyoxyethylene sorbitan tristearate (E 436) as food additives - doi:10.2903/j.efsa.2015.4152
NTP_ICE_eye_irritation 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_eye_irritation Draize rabbit irritation score 4 unitless Rabbit Ocular - In Vivo; Draize Eye Irritation/Corrosion Test sheet=Data; excel_row=1074; Record_ID=eye_irritation_173; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID3031949; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=4; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3031949; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3031949
NTP_ICE_eye_irritation EPA Classification 3 unitless Rabbit Ocular - In Vivo; Draize Eye Irritation/Corrosion Test sheet=Data; excel_row=1076; Record_ID=eye_irritation_173; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID3031949; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=3; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3031949; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3031949
NTP_ICE_eye_irritation Intensity 0.03 %/sec - Ocular - In Vitro; Vitrigel sheet=Data; excel_row=1078; Record_ID=eye_irritation_1235; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID3031949; Assay=Vitrigel; Endpoint=Intensity; Response=0.03; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3031949; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3031949
NTP_ICE_eye_irritation Lag time >180 s - Ocular - In Vitro; Vitrigel sheet=Data; excel_row=1077; Record_ID=eye_irritation_1235; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID3031949; Assay=Vitrigel; Endpoint=Lag time; Response_Modifier=>; Response=180; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3031949; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3031949
NTP_ICE_eye_irritation Plateau level 0 % - Ocular - In Vitro; Vitrigel sheet=Data; excel_row=1079; Record_ID=eye_irritation_1235; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID3031949; Assay=Vitrigel; Endpoint=Plateau level; Response=0; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3031949; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3031949
openFDA substances 24 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 31JQ3WOL8T UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"31JQ3WOL8T"}
openFDA substances FDA UNII substance identifier 4Z93U4C2WN UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"4Z93U4C2WN"}
openFDA substances FDA UNII substance identifier 239B50Y732 UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"239B50Y732"}
openFDA substances FDA UNII substance identifier 7T1F30V5YH UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"7T1F30V5YH"}
openFDA substances FDA UNII substance identifier 59IO08SBZU UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"59IO08SBZU"}
openFDA substances FDA UNII substance identifier I42X3Q0FMF UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"I42X3Q0FMF"}
openFDA substances FDA UNII substance identifier 31JQ3WOL8T UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"31JQ3WOL8T"}
openFDA substances FDA UNII substance identifier 31JQ3WOL8T UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"31JQ3WOL8T"}
openFDA substances FDA UNII substance identifier 4Z93U4C2WN UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"4Z93U4C2WN"}
openFDA substances FDA UNII substance identifier 4Z93U4C2WN UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"4Z93U4C2WN"}
openFDA substances FDA UNII substance identifier 239B50Y732 UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"239B50Y732"}
openFDA substances FDA UNII substance identifier 239B50Y732 UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"239B50Y732"}
openFDA substances FDA UNII substance identifier 7T1F30V5YH UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"7T1F30V5YH"}
openFDA substances FDA UNII substance identifier 7T1F30V5YH UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"7T1F30V5YH"}
openFDA substances FDA UNII substance identifier 59IO08SBZU UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"59IO08SBZU"}
openFDA substances FDA UNII substance identifier 59IO08SBZU UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"59IO08SBZU"}
openFDA substances FDA UNII substance identifier 31JQ3WOL8T UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"31JQ3WOL8T"}
openFDA substances FDA UNII substance identifier 4Z93U4C2WN UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"4Z93U4C2WN"}
openFDA substances FDA UNII substance identifier 239B50Y732 UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"239B50Y732"}
openFDA substances FDA UNII substance identifier 7T1F30V5YH UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"7T1F30V5YH"}
openFDA substances FDA UNII substance identifier 59IO08SBZU UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"59IO08SBZU"}
openFDA substances FDA UNII substance identifier I42X3Q0FMF UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"I42X3Q0FMF"}
openFDA substances FDA UNII substance identifier I42X3Q0FMF UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"I42X3Q0FMF"}
openFDA substances FDA UNII substance identifier I42X3Q0FMF UNII - - - polymer {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"I42X3Q0FMF"}