NOAEL Studies
Cosmetic Ingredient
CI 77947 (Zinc Oxide) NOAEL Studies
INCI: CI 77947
CAS: 1314-13-2
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 10 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | NOAEL | 606 | mg/kg bw/day | rat | oral | 10 day | Special Toxicology Study | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 600 | mg/kg bw/day | rat | oral | 21 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 500 | mg/kg bw/day | rat | oral | 28 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 400 | mg/kg bw/day | rat | oral | 56 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 172 | mg/kg bw/day | rat | oral | 252 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 99 | mg/kg bw/day | sheep | oral | 70 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 149 | mg/kg bw/day | cattle | oral | 4 day | Special Toxicology Study | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 45 | mg/kg bw/day | swine | oral | 14 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 100 | mg/kg bw/day | swine | oral | 14 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 164 | mg/kg bw/day | swine | oral | 28 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
NTP_ICE_acute_inhalation 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | LC50 | >5.7 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=4202; Record_ID=acute_inhalation_1839; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID7035016; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=5.7; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/16139/7/3/3/?documentUUID=f0900b38-089f-4db8-a4a5-d11deef9b233; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7035016 |
| NTP_ICE_acute_inhalation | LC50 | >1.79 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=4203; Record_ID=acute_inhalation_1832; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID7035016; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=1.79; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/16139/7/3/3/?documentUUID=d5093ff7-b3f3-4595-8fb5-707d8303b2e3; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID7035016 |
SCCNFP_vision_codex 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =3000 | ppm | rat | - | - | NOAEL study | {"dose":"e and cholesterol were reduced and alkaline phosphatase and urea nitrogen were increased in high dose animals.","effect":"e and cholesterol were reduced and alkaline phosphatase and urea nitrogen were increased in high dose animals. High dose females showed reduced ALAT and increased calcium levels, ASAT was increased in high dose males. Absolute and relative thyroid weights of males and kidney weights of females were increased at the highest dose. Gross pathology and histopathology showed changes in kidneys, thyroids, pancreas (degeneration/necrosis of acinar cells, clarification of nucleoli), gastrointestinal tract, and spleen. The NOEL for mice in this study was found at the mid dose at 3000 ppm (about 470 mg ZnSO4.7 H2O/kg bw (104 mg Zn2+/kg bw). Wistar rats : at the high dose level a moderate reduction in leucocyte counts, slightly decreased hematocrit and haemoglobin values (males only) and decreased total protein and cholesterol values were recorded. Absolute and relative liver weights and relative kidney weights were decreased in high dose males. Histopathology showed pancreatic damage (degeneration, necrosis of acinar cells, clarification","page":7,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =0.5 | mg/kg/day | human | oral | 6 weeks | NOAEL study | {"citation":"Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required","dose":"In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion.","effect":"2+/kg bw). Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required. In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion. In humans, the average daily intake is estimated at about 15 mg of Zn2+. The available evidence from human studies points to a NOEL of about 0.5 mg/kg/day and thus confirms the safe exposure level, which could be predicted from the animal data. A series of human experimental studies have been published which report adverse effects from oral administration of zinc salts : * 47 healthy volunteers ingested ZnSO4 tablets three times a day for 6 weeks, resulting in a total daily dose of 2 mg Zn2+/kg bw. Headaches, nausea, vomiting, loss of appetite and abdominal cramps were seen in 26 of the volunteers. Ref. : 15 * Oral doses of 160 mg ZnSO4/day (2","page":7,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =42.5 | mg/kg | rabbit | oral | developmental | developmental toxicity | {"citation":"Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0","dose":"Results No compound-related effects were observed at any dose level.","effect":"a lutea, implantations, viable foetuses and resorptions. All foetuses were weighed, sexed and examined for gross external defects. In addition, skeletal examinations (in two-thirds of the foetuses) and soft tissue examinations (in the remaining one-third of foetuses) were performed. Results No compound-related effects were observed at any dose level. In particular, there was no indication of any specific teratogenic activity of ZnSO4 under the conditions of this experiment. Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of ZnSO4 was 42.5 mg/kg (corresponding to about 17 mg/kg if expressed as zinc). Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0.6, 2.8, 13.0 and 60.0 mg/kg by gavage in water 6-amino-nicotinamide : 2.5 mg/kg by gavage Exposure period : ZnSO4: day 6-18 of gestation (p.c.) 6-amino-nicotinamide: single application at day 19 of gestat","page":13,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg | rat | oral | developmental | developmental toxicity | {"citation":"Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels","dose":"Zinc oxide ____________________________________________________________________________________________ 14 Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of Zinc Sulfate was at least 60.0 mg/kg (corresponding to about 24 mg/kg if expressed as zinc).","effect":"SCCNFP/0649/03, final Evaluation and opinion on : Zinc oxide ____________________________________________________________________________________________ 14 Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of Zinc Sulfate was at least 60.0 mg/kg (corresponding to about 24 mg/kg if expressed as zinc). Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels of 2000 (about 100 mg/kg/d) or 4000 ppm (about 200 mg/kg/day) in the diet. 7 equally sized control groups received the basal diet without test substance. 4 groups were fed the test die","page":14,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =40 | % | human | oral | developmental | developmental toxicity | {"citation":"Ref. : 29 2","dose":"Conclusion ZnO, 2000 ppm, administered from day 21 prior to mating until day 15 of gestation induced no adverse effects on foetal development.","effect":"e observed in foetal whole body samples. These analytical results support the interpretation that the observed developmental effects of exaggerated high zinc doses are mediated by depletion of certain essential minerals such as copper. Conclusion ZnO, 2000 ppm, administered from day 21 prior to mating until day 15 of gestation induced no adverse effects on foetal development. This dietary level corresponds to a daily dose of about 100 mg/kg expressed as ZnO, or about 80 mg/kg expressed as zinc which represents the NOEL in this study. Ref. : 29 2.7. Toxicokinetics (incl. Percutaneous Absorption) Method : In vivo, human Volunteers: : 6 healthy males Test substance : ZnO Site of application : Chest, upper and lower legs Exposure : Daily application of 40% ZnO in ointment for a of period 10 days","page":14,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =3000 | ppm | rat | - | - | NOAEL study | {"dose":"e and cholesterol were reduced and alkaline phosphatase and urea nitrogen were increased in high dose animals.","effect":"e and cholesterol were reduced and alkaline phosphatase and urea nitrogen were increased in high dose animals. High dose females showed reduced ALAT and increased calcium levels, ASAT was increased in high dose males. Absolute and relative thyroid weights of males and kidney weights of females were increased at the highest dose. Gross pathology and histopathology showed changes in kidneys, thyroids, pancreas (degeneration/necrosis of acinar cells, clarification of nucleoli), gastrointestinal tract, and spleen. The NOEL for mice in this study was found at the mid dose at 3000 ppm (about 470 mg ZnSO4.7 H2O/kg bw (104 mg Zn2+/kg bw). Wistar rats : at the high dose level a moderate reduction in leucocyte counts, slightly decreased hematocrit and haemoglobin values (males only) and decreased total protein and cholesterol values were recorded. Absolute and relative liver weights and relative kidney weights were decreased in high dose males. Histopathology showed pancreatic damage (degeneration, necrosis of acinar cells, clarification","page":7,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =0.5 | mg/kg/day | human | oral | 6 weeks | NOAEL study | {"citation":"Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required","dose":"In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion.","effect":"2+/kg bw). Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required. In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion. In humans, the average daily intake is estimated at about 15 mg of Zn2+. The available evidence from human studies points to a NOEL of about 0.5 mg/kg/day and thus confirms the safe exposure level, which could be predicted from the animal data. A series of human experimental studies have been published which report adverse effects from oral administration of zinc salts : * 47 healthy volunteers ingested ZnSO4 tablets three times a day for 6 weeks, resulting in a total daily dose of 2 mg Zn2+/kg bw. Headaches, nausea, vomiting, loss of appetite and abdominal cramps were seen in 26 of the volunteers. Ref. : 15 * Oral doses of 160 mg ZnSO4/day (2","page":7,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =42.5 | mg/kg | rabbit | oral | developmental | developmental toxicity | {"citation":"Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0","dose":"Results No compound-related effects were observed at any dose level.","effect":"a lutea, implantations, viable foetuses and resorptions. All foetuses were weighed, sexed and examined for gross external defects. In addition, skeletal examinations (in two-thirds of the foetuses) and soft tissue examinations (in the remaining one-third of foetuses) were performed. Results No compound-related effects were observed at any dose level. In particular, there was no indication of any specific teratogenic activity of ZnSO4 under the conditions of this experiment. Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of ZnSO4 was 42.5 mg/kg (corresponding to about 17 mg/kg if expressed as zinc). Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0.6, 2.8, 13.0 and 60.0 mg/kg by gavage in water 6-amino-nicotinamide : 2.5 mg/kg by gavage Exposure period : ZnSO4: day 6-18 of gestation (p.c.) 6-amino-nicotinamide: single application at day 19 of gestat","page":13,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg | rat | oral | developmental | developmental toxicity | {"citation":"Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels","dose":"Zinc oxide ____________________________________________________________________________________________ 14 Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of Zinc Sulfate was at least 60.0 mg/kg (corresponding to about 24 mg/kg if expressed as zinc).","effect":"SCCNFP/0649/03, final Evaluation and opinion on : Zinc oxide ____________________________________________________________________________________________ 14 Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of Zinc Sulfate was at least 60.0 mg/kg (corresponding to about 24 mg/kg if expressed as zinc). Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels of 2000 (about 100 mg/kg/d) or 4000 ppm (about 200 mg/kg/day) in the diet. 7 equally sized control groups received the basal diet without test substance. 4 groups were fed the test die","page":14,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =40 | % | human | oral | developmental | developmental toxicity | {"citation":"Ref. : 29 2","dose":"Conclusion ZnO, 2000 ppm, administered from day 21 prior to mating until day 15 of gestation induced no adverse effects on foetal development.","effect":"e observed in foetal whole body samples. These analytical results support the interpretation that the observed developmental effects of exaggerated high zinc doses are mediated by depletion of certain essential minerals such as copper. Conclusion ZnO, 2000 ppm, administered from day 21 prior to mating until day 15 of gestation induced no adverse effects on foetal development. This dietary level corresponds to a daily dose of about 100 mg/kg expressed as ZnO, or about 80 mg/kg expressed as zinc which represents the NOEL in this study. Ref. : 29 2.7. Toxicokinetics (incl. Percutaneous Absorption) Method : In vivo, human Volunteers: : 6 healthy males Test substance : ZnO Site of application : Chest, upper and lower legs Exposure : Daily application of 40% ZnO in ointment for a of period 10 days","page":14,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =3000 | ppm | rat | - | - | NOAEL study | {"dose":"e and cholesterol were reduced and alkaline phosphatase and urea nitrogen were increased in high dose animals.","effect":"e and cholesterol were reduced and alkaline phosphatase and urea nitrogen were increased in high dose animals. High dose females showed reduced ALAT and increased calcium levels, ASAT was increased in high dose males. Absolute and relative thyroid weights of males and kidney weights of females were increased at the highest dose. Gross pathology and histopathology showed changes in kidneys, thyroids, pancreas (degeneration/necrosis of acinar cells, clarification of nucleoli), gastrointestinal tract, and spleen. The NOEL for mice in this study was found at the mid dose at 3000 ppm (about 470 mg ZnSO4.7 H2O/kg bw (104 mg Zn2+/kg bw). Wistar rats : at the high dose level a moderate reduction in leucocyte counts, slightly decreased hematocrit and haemoglobin values (males only) and decreased total protein and cholesterol values were recorded. Absolute and relative liver weights and relative kidney weights were decreased in high dose males. Histopathology showed pancreatic damage (degeneration, necrosis of acinar cells, clarification","page":7,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =0.5 | mg/kg/day | human | oral | 6 weeks | NOAEL study | {"citation":"Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required","dose":"In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion.","effect":"2+/kg bw). Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required. In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion. In humans, the average daily intake is estimated at about 15 mg of Zn2+. The available evidence from human studies points to a NOEL of about 0.5 mg/kg/day and thus confirms the safe exposure level, which could be predicted from the animal data. A series of human experimental studies have been published which report adverse effects from oral administration of zinc salts : * 47 healthy volunteers ingested ZnSO4 tablets three times a day for 6 weeks, resulting in a total daily dose of 2 mg Zn2+/kg bw. Headaches, nausea, vomiting, loss of appetite and abdominal cramps were seen in 26 of the volunteers. Ref. : 15 * Oral doses of 160 mg ZnSO4/day (2","page":7,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =42.5 | mg/kg | rabbit | oral | developmental | developmental toxicity | {"citation":"Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0","dose":"Results No compound-related effects were observed at any dose level.","effect":"a lutea, implantations, viable foetuses and resorptions. All foetuses were weighed, sexed and examined for gross external defects. In addition, skeletal examinations (in two-thirds of the foetuses) and soft tissue examinations (in the remaining one-third of foetuses) were performed. Results No compound-related effects were observed at any dose level. In particular, there was no indication of any specific teratogenic activity of ZnSO4 under the conditions of this experiment. Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of ZnSO4 was 42.5 mg/kg (corresponding to about 17 mg/kg if expressed as zinc). Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0.6, 2.8, 13.0 and 60.0 mg/kg by gavage in water 6-amino-nicotinamide : 2.5 mg/kg by gavage Exposure period : ZnSO4: day 6-18 of gestation (p.c.) 6-amino-nicotinamide: single application at day 19 of gestat","page":13,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg | rat | oral | developmental | developmental toxicity | {"citation":"Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels","dose":"Zinc oxide ____________________________________________________________________________________________ 14 Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of Zinc Sulfate was at least 60.0 mg/kg (corresponding to about 24 mg/kg if expressed as zinc).","effect":"SCCNFP/0649/03, final Evaluation and opinion on : Zinc oxide ____________________________________________________________________________________________ 14 Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of Zinc Sulfate was at least 60.0 mg/kg (corresponding to about 24 mg/kg if expressed as zinc). Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels of 2000 (about 100 mg/kg/d) or 4000 ppm (about 200 mg/kg/day) in the diet. 7 equally sized control groups received the basal diet without test substance. 4 groups were fed the test die","page":14,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =40 | % | human | oral | developmental | developmental toxicity | {"citation":"Ref. : 29 2","dose":"Conclusion ZnO, 2000 ppm, administered from day 21 prior to mating until day 15 of gestation induced no adverse effects on foetal development.","effect":"e observed in foetal whole body samples. These analytical results support the interpretation that the observed developmental effects of exaggerated high zinc doses are mediated by depletion of certain essential minerals such as copper. Conclusion ZnO, 2000 ppm, administered from day 21 prior to mating until day 15 of gestation induced no adverse effects on foetal development. This dietary level corresponds to a daily dose of about 100 mg/kg expressed as ZnO, or about 80 mg/kg expressed as zinc which represents the NOEL in this study. Ref. : 29 2.7. Toxicokinetics (incl. Percutaneous Absorption) Method : In vivo, human Volunteers: : 6 healthy males Test substance : ZnO Site of application : Chest, upper and lower legs Exposure : Daily application of 40% ZnO in ointment for a of period 10 days","page":14,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =3000 | ppm | rat | - | - | NOAEL study | {"dose":"e and cholesterol were reduced and alkaline phosphatase and urea nitrogen were increased in high dose animals.","effect":"e and cholesterol were reduced and alkaline phosphatase and urea nitrogen were increased in high dose animals. High dose females showed reduced ALAT and increased calcium levels, ASAT was increased in high dose males. Absolute and relative thyroid weights of males and kidney weights of females were increased at the highest dose. Gross pathology and histopathology showed changes in kidneys, thyroids, pancreas (degeneration/necrosis of acinar cells, clarification of nucleoli), gastrointestinal tract, and spleen. The NOEL for mice in this study was found at the mid dose at 3000 ppm (about 470 mg ZnSO4.7 H2O/kg bw (104 mg Zn2+/kg bw). Wistar rats : at the high dose level a moderate reduction in leucocyte counts, slightly decreased hematocrit and haemoglobin values (males only) and decreased total protein and cholesterol values were recorded. Absolute and relative liver weights and relative kidney weights were decreased in high dose males. Histopathology showed pancreatic damage (degeneration, necrosis of acinar cells, clarification","page":7,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =0.5 | mg/kg/day | human | oral | 6 weeks | NOAEL study | {"citation":"Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required","dose":"In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion.","effect":"2+/kg bw). Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required. In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion. In humans, the average daily intake is estimated at about 15 mg of Zn2+. The available evidence from human studies points to a NOEL of about 0.5 mg/kg/day and thus confirms the safe exposure level, which could be predicted from the animal data. A series of human experimental studies have been published which report adverse effects from oral administration of zinc salts : * 47 healthy volunteers ingested ZnSO4 tablets three times a day for 6 weeks, resulting in a total daily dose of 2 mg Zn2+/kg bw. Headaches, nausea, vomiting, loss of appetite and abdominal cramps were seen in 26 of the volunteers. Ref. : 15 * Oral doses of 160 mg ZnSO4/day (2","page":7,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_003"} |
| SCCNFP_vision_codex | NOAEL | =42.5 | mg/kg | rabbit | oral | developmental | developmental toxicity | {"citation":"Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0","dose":"Results No compound-related effects were observed at any dose level.","effect":"a lutea, implantations, viable foetuses and resorptions. All foetuses were weighed, sexed and examined for gross external defects. In addition, skeletal examinations (in two-thirds of the foetuses) and soft tissue examinations (in the remaining one-third of foetuses) were performed. Results No compound-related effects were observed at any dose level. In particular, there was no indication of any specific teratogenic activity of ZnSO4 under the conditions of this experiment. Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of ZnSO4 was 42.5 mg/kg (corresponding to about 17 mg/kg if expressed as zinc). Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0.6, 2.8, 13.0 and 60.0 mg/kg by gavage in water 6-amino-nicotinamide : 2.5 mg/kg by gavage Exposure period : ZnSO4: day 6-18 of gestation (p.c.) 6-amino-nicotinamide: single application at day 19 of gestat","page":13,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_004"} |
| SCCNFP_vision_codex | NOAEL | =60 | mg/kg | rat | oral | developmental | developmental toxicity | {"citation":"Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels","dose":"Zinc oxide ____________________________________________________________________________________________ 14 Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of Zinc Sulfate was at least 60.0 mg/kg (corresponding to about 24 mg/kg if expressed as zinc).","effect":"SCCNFP/0649/03, final Evaluation and opinion on : Zinc oxide ____________________________________________________________________________________________ 14 Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of Zinc Sulfate was at least 60.0 mg/kg (corresponding to about 24 mg/kg if expressed as zinc). Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels of 2000 (about 100 mg/kg/d) or 4000 ppm (about 200 mg/kg/day) in the diet. 7 equally sized control groups received the basal diet without test substance. 4 groups were fed the test die","page":14,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_005"} |
| SCCNFP_vision_codex | NOAEL | =40 | % | human | oral | developmental | developmental toxicity | {"citation":"Ref. : 29 2","dose":"Conclusion ZnO, 2000 ppm, administered from day 21 prior to mating until day 15 of gestation induced no adverse effects on foetal development.","effect":"e observed in foetal whole body samples. These analytical results support the interpretation that the observed developmental effects of exaggerated high zinc doses are mediated by depletion of certain essential minerals such as copper. Conclusion ZnO, 2000 ppm, administered from day 21 prior to mating until day 15 of gestation induced no adverse effects on foetal development. This dietary level corresponds to a daily dose of about 100 mg/kg expressed as ZnO, or about 80 mg/kg expressed as zinc which represents the NOEL in this study. Ref. : 29 2.7. Toxicokinetics (incl. Percutaneous Absorption) Method : In vivo, human Volunteers: : 6 healthy males Test substance : ZnO Site of application : Chest, upper and lower legs Exposure : Daily application of 40% ZnO in ointment for a of period 10 days","page":14,"pdf":"out222_en.pdf","row_type":"noael_study","study_id":"out222_en_noael_006"} |
SCCS_vision_codex 60 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =1000 | mg/kg | mouse | oral | - | NOAEL study | {"citation":"Reference: AR16)","dose":"hip, many effects were noted at the highest dose administered that should be considered dose related even when they only occur at the highest dose.","effect":"hip, many effects were noted at the highest dose administered that should be considered dose related even when they only occur at the highest dose. The pathological findings indicate a dose response relationship with the highest dose inducing the most severe alterations. The lowest dose investigated (1,000 mg/kg) also induced pathological effects in the animals. Most effects showed some minor differences between the 20 and 120 nm sized ZnO. Target organs for toxicity were liver, heart, spleen, pancreas and bone. A no observed adverse effect level (NOAEL) was not dentified because alterations were also observed at the lowest dose investigated (1,000 mg/kg). No deaths were observed in a similar study using a single oral dose of 5 mg/kg in mice (Reference: AR16). ZnO nanoparticles were approximately 50 nm in size (TEM evaluation), which were compared to ZnO microparticles showing at least one diameter >100 nm (TEM evaluation). DLS evaluation showed an average hydrodynamic diameter of 1,226 ± 120 nm for the ZnO microparticles, and an average hydrodynamic diame","page":29,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_001"} |
| SCCS_vision_codex | NOAEL | =1 | mg/kg bw | rat | intravenous | - | repeated dose toxicity | {"citation":"(References: 85, 94, 119)","dose":"In view of the indications for liver damage, a repeated dose toxicity study would have provided better information on potential toxicity.","effect":"toxic reactions were not observed. In view of the indications for liver damage, a repeated dose toxicity study would have provided better information on potential toxicity. In conclusion, after intravenous administration obtaining an internal dose of 5 mg/kg bw alterations in clinical pathology were observed that were indicative of liver damage. The liver damage appeared to be transient as similar alterations were not observed at four weeks after the single administration. Based on this study, the SCCS considers a NOAEL of 1 mg/kg bw for acute toxicity of ZnO in rats after intravenous administration. Additional studies submitted Additional information was included in the dossier on ZnO commercially obtained from Sigma-Aldrich and not related to the ZnO presented in the dossier. (References: 85, 94, 119)","page":86,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_003"} |
| SCCS_vision_codex | NOAEL | =2 | % | human | oral | 18 days | repeated dose toxicity | {"dose":"An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.","effect":"nc or zinc compounds is therefore chosen to be 2%. Based on the physical appearance, for dust exposure to zinc or zinc compounds a 10-fold lower default value of 0.2% is chosen in the risk assessment. For sunscreen containing 10% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical","page":89,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_004"} |
| SCCS_vision_codex | NOAEL | =20 | % | human | oral | 18 days | repeated dose toxicity | {"dose":"An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.","effect":"the risk assessment. For sunscreen containing 10% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consum","page":89,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_005"} |
| SCCS_vision_codex | NOAEL | =1 | - | human | - | - | NOAEL study | {"dose":"t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population.","effect":"t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from the SCCS Notes of Guidance for the risk assessment of zinc oxide nanoparticles in sun screens as follows:","page":89,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.0225 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0","dose":"36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...","effect":"inc oxide (nano form) ___________________________________________________________________________________________ 90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.166 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0","dose":"36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...","effect":"________________________________________________________________________________ 90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_012"} |
| SCCS_vision_codex | NOAEL | =0.9 | mg/kg/d | human | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"CS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4.","effect":"CS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day =","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_017"} |
| SCCS_vision_codex | NOAEL | =0.225 | mg/kg bw/day | human | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III).","effect":"clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time fram","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_018"} |
| SCCS_vision_codex | NOAEL | =0.83 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"nly at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III).","effect":"nly at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time frames, e.","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_019"} |
| SCCS_vision_codex | NOAEL | =50 | - | mouse | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"However, no differences weren observed between ZnO administered as nanoscale or microscale particles.","effect":"ure In one exploratory study in mice, systemic availability of Zn was indicated after a single oral exposure. However, no differences weren observed between ZnO administered as nanoscale or microscale particles. It is likely that absorbed Zn in the GI-tract was in the dissolved ionic form. In view of the data provided, oral exposure of nano-ZnO via applications of nano-ZnO as a cosmetic ingredient in sunscreens should be considered to be of a similar risk to micron-sized ZnO as previously evaluated in the RAR. The NOAEL for oral intake of ZnO is 50 mg /bw day (Reference 44, sub III). The oral exposure to ZnO nanoparticles as cosmetic ingredient in sunscreens is limited to accidental ingestion of small fractions of lip products and sun protection products and can be considered to be low. Inhalation exposure Upon inhalation of ZnO nanoparticles, serious local effects in the lung were observed. Even if this may be due to the solubilized Zn ions, the effects are a direct result of the exposure to the ZnO nanoparticles. Therefore, th","page":96,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_023"} |
| SCCS_vision_codex | NOAEL | =90 | - | - | inhalation | 90 days | NOAEL study | {"dose":"Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study.","effect":"upporting the rapid elimination. In the study four animals were found dead or killed moribund, the cause of death being in two animals a purulent and necrotizing inflammation of the urogenital organs, in one animal due to a pronounced malignant lymphoma, and in one animal due to unknown cause. These observations were not treatment related. Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study. A NOAEL of 1.5 g/m³ can be identified for the test item Z-COTE® HP1. Under the conditions of this test no persistent toxicity was found and all lesions were found to be recovered within the 28 day post exposure period. SCCS comments The file received for the study report was not signed by the study director and/or scientists involved. The report was supposedly to be published by the end of 2012, however, it was not found on Cefic website (June 2013). Size distributions of both nano- and micron-sized ZnO particles used","page":12,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_001"} |
| SCCS_vision_codex | NOAEL | =1518 | - | - | - | - | NOAEL study | {"dose":"Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein).","effect":"SCCS/1518/13 Revision of the addendum to the opinion on zinc oxide (nano form) ___________________________________________________________________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for","page":13,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_002"} |
| SCCS_vision_codex | NOAEL | =96 | % | - | - | - | NOAEL study | {"dose":"Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein).","effect":"______________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for use on the skin as UV filter in sunscreen formulations: 1. ZnO nanoparticles of purity ≥96%, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or","page":13,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_003"} |
| SCCS_vision_codex | NOAEL | =4 | - | - | inhalation | 90 days | NOAEL study | {"effect":". Other cosmetic ingredients can be used as coatings as long as they are demonstrated to the SCCS to be safe and do not affect the particle properties related to behaviour and/or effects, compared to the nanomaterials covered in the current opinion. 4. ZnO nanoparticles that have a comparable solubility to that reported in the dossier, i.e. below 50 mg/L (approximately the maximum solubility of the ZnO nanomaterials for which data are provided in the dossier). The submitted 90 days inhalation study resulted in a NOAEL of 0.3 mg/m3. However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects. 5. MINORITY OPINION / 6. REFERENCES /","page":13,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_004"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg | mouse | oral | - | NOAEL study | {"citation":"Reference: AR16)","dose":"hip, many effects were noted at the highest dose administered that should be considered dose related even when they only occur at the highest dose.","effect":"hip, many effects were noted at the highest dose administered that should be considered dose related even when they only occur at the highest dose. The pathological findings indicate a dose response relationship with the highest dose inducing the most severe alterations. The lowest dose investigated (1,000 mg/kg) also induced pathological effects in the animals. Most effects showed some minor differences between the 20 and 120 nm sized ZnO. Target organs for toxicity were liver, heart, spleen, pancreas and bone. A no observed adverse effect level (NOAEL) was not dentified because alterations were also observed at the lowest dose investigated (1,000 mg/kg). No deaths were observed in a similar study using a single oral dose of 5 mg/kg in mice (Reference: AR16). ZnO nanoparticles were approximately 50 nm in size (TEM evaluation), which were compared to ZnO microparticles showing at least one diameter >100 nm (TEM evaluation). DLS evaluation showed an average hydrodynamic diameter of 1,226 ± 120 nm for the ZnO microparticles, and an average hydrodynamic diame","page":29,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_001"} |
| SCCS_vision_codex | NOAEL | =1 | mg/kg bw | rat | intravenous | - | repeated dose toxicity | {"citation":"(References: 85, 94, 119)","dose":"In view of the indications for liver damage, a repeated dose toxicity study would have provided better information on potential toxicity.","effect":"toxic reactions were not observed. In view of the indications for liver damage, a repeated dose toxicity study would have provided better information on potential toxicity. In conclusion, after intravenous administration obtaining an internal dose of 5 mg/kg bw alterations in clinical pathology were observed that were indicative of liver damage. The liver damage appeared to be transient as similar alterations were not observed at four weeks after the single administration. Based on this study, the SCCS considers a NOAEL of 1 mg/kg bw for acute toxicity of ZnO in rats after intravenous administration. Additional studies submitted Additional information was included in the dossier on ZnO commercially obtained from Sigma-Aldrich and not related to the ZnO presented in the dossier. (References: 85, 94, 119)","page":86,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_003"} |
| SCCS_vision_codex | NOAEL | =2 | % | human | oral | 18 days | repeated dose toxicity | {"dose":"An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.","effect":"nc or zinc compounds is therefore chosen to be 2%. Based on the physical appearance, for dust exposure to zinc or zinc compounds a 10-fold lower default value of 0.2% is chosen in the risk assessment. For sunscreen containing 10% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical","page":89,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_004"} |
| SCCS_vision_codex | NOAEL | =20 | % | human | oral | 18 days | repeated dose toxicity | {"dose":"An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.","effect":"the risk assessment. For sunscreen containing 10% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consum","page":89,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_005"} |
| SCCS_vision_codex | NOAEL | =1 | - | human | - | - | NOAEL study | {"dose":"t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population.","effect":"t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from the SCCS Notes of Guidance for the risk assessment of zinc oxide nanoparticles in sun screens as follows:","page":89,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.0225 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0","dose":"36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...","effect":"inc oxide (nano form) ___________________________________________________________________________________________ 90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.166 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0","dose":"36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...","effect":"________________________________________________________________________________ 90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_012"} |
| SCCS_vision_codex | NOAEL | =0.9 | mg/kg/d | human | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"CS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4.","effect":"CS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day =","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_017"} |
| SCCS_vision_codex | NOAEL | =0.225 | mg/kg bw/day | human | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III).","effect":"clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time fram","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_018"} |
| SCCS_vision_codex | NOAEL | =0.83 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"nly at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III).","effect":"nly at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time frames, e.","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_019"} |
| SCCS_vision_codex | NOAEL | =50 | - | mouse | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"However, no differences weren observed between ZnO administered as nanoscale or microscale particles.","effect":"ure In one exploratory study in mice, systemic availability of Zn was indicated after a single oral exposure. However, no differences weren observed between ZnO administered as nanoscale or microscale particles. It is likely that absorbed Zn in the GI-tract was in the dissolved ionic form. In view of the data provided, oral exposure of nano-ZnO via applications of nano-ZnO as a cosmetic ingredient in sunscreens should be considered to be of a similar risk to micron-sized ZnO as previously evaluated in the RAR. The NOAEL for oral intake of ZnO is 50 mg /bw day (Reference 44, sub III). The oral exposure to ZnO nanoparticles as cosmetic ingredient in sunscreens is limited to accidental ingestion of small fractions of lip products and sun protection products and can be considered to be low. Inhalation exposure Upon inhalation of ZnO nanoparticles, serious local effects in the lung were observed. Even if this may be due to the solubilized Zn ions, the effects are a direct result of the exposure to the ZnO nanoparticles. Therefore, th","page":96,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_023"} |
| SCCS_vision_codex | NOAEL | =90 | - | - | inhalation | 90 days | NOAEL study | {"dose":"Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study.","effect":"upporting the rapid elimination. In the study four animals were found dead or killed moribund, the cause of death being in two animals a purulent and necrotizing inflammation of the urogenital organs, in one animal due to a pronounced malignant lymphoma, and in one animal due to unknown cause. These observations were not treatment related. Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study. A NOAEL of 1.5 g/m³ can be identified for the test item Z-COTE® HP1. Under the conditions of this test no persistent toxicity was found and all lesions were found to be recovered within the 28 day post exposure period. SCCS comments The file received for the study report was not signed by the study director and/or scientists involved. The report was supposedly to be published by the end of 2012, however, it was not found on Cefic website (June 2013). Size distributions of both nano- and micron-sized ZnO particles used","page":12,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_001"} |
| SCCS_vision_codex | NOAEL | =1518 | - | - | - | - | NOAEL study | {"dose":"Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein).","effect":"SCCS/1518/13 Revision of the addendum to the opinion on zinc oxide (nano form) ___________________________________________________________________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for","page":13,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_002"} |
| SCCS_vision_codex | NOAEL | =96 | % | - | - | - | NOAEL study | {"dose":"Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein).","effect":"______________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for use on the skin as UV filter in sunscreen formulations: 1. ZnO nanoparticles of purity ≥96%, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or","page":13,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_003"} |
| SCCS_vision_codex | NOAEL | =4 | - | - | inhalation | 90 days | NOAEL study | {"effect":". Other cosmetic ingredients can be used as coatings as long as they are demonstrated to the SCCS to be safe and do not affect the particle properties related to behaviour and/or effects, compared to the nanomaterials covered in the current opinion. 4. ZnO nanoparticles that have a comparable solubility to that reported in the dossier, i.e. below 50 mg/L (approximately the maximum solubility of the ZnO nanomaterials for which data are provided in the dossier). The submitted 90 days inhalation study resulted in a NOAEL of 0.3 mg/m3. However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects. 5. MINORITY OPINION / 6. REFERENCES /","page":13,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_004"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg | mouse | oral | - | NOAEL study | {"citation":"Reference: AR16)","dose":"hip, many effects were noted at the highest dose administered that should be considered dose related even when they only occur at the highest dose.","effect":"hip, many effects were noted at the highest dose administered that should be considered dose related even when they only occur at the highest dose. The pathological findings indicate a dose response relationship with the highest dose inducing the most severe alterations. The lowest dose investigated (1,000 mg/kg) also induced pathological effects in the animals. Most effects showed some minor differences between the 20 and 120 nm sized ZnO. Target organs for toxicity were liver, heart, spleen, pancreas and bone. A no observed adverse effect level (NOAEL) was not dentified because alterations were also observed at the lowest dose investigated (1,000 mg/kg). No deaths were observed in a similar study using a single oral dose of 5 mg/kg in mice (Reference: AR16). ZnO nanoparticles were approximately 50 nm in size (TEM evaluation), which were compared to ZnO microparticles showing at least one diameter >100 nm (TEM evaluation). DLS evaluation showed an average hydrodynamic diameter of 1,226 ± 120 nm for the ZnO microparticles, and an average hydrodynamic diame","page":29,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_001"} |
| SCCS_vision_codex | NOAEL | =1 | mg/kg bw | rat | intravenous | - | repeated dose toxicity | {"citation":"(References: 85, 94, 119)","dose":"In view of the indications for liver damage, a repeated dose toxicity study would have provided better information on potential toxicity.","effect":"toxic reactions were not observed. In view of the indications for liver damage, a repeated dose toxicity study would have provided better information on potential toxicity. In conclusion, after intravenous administration obtaining an internal dose of 5 mg/kg bw alterations in clinical pathology were observed that were indicative of liver damage. The liver damage appeared to be transient as similar alterations were not observed at four weeks after the single administration. Based on this study, the SCCS considers a NOAEL of 1 mg/kg bw for acute toxicity of ZnO in rats after intravenous administration. Additional studies submitted Additional information was included in the dossier on ZnO commercially obtained from Sigma-Aldrich and not related to the ZnO presented in the dossier. (References: 85, 94, 119)","page":86,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_003"} |
| SCCS_vision_codex | NOAEL | =2 | % | human | oral | 18 days | repeated dose toxicity | {"dose":"An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.","effect":"nc or zinc compounds is therefore chosen to be 2%. Based on the physical appearance, for dust exposure to zinc or zinc compounds a 10-fold lower default value of 0.2% is chosen in the risk assessment. For sunscreen containing 10% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical","page":89,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_004"} |
| SCCS_vision_codex | NOAEL | =20 | % | human | oral | 18 days | repeated dose toxicity | {"dose":"An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.","effect":"the risk assessment. For sunscreen containing 10% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consum","page":89,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_005"} |
| SCCS_vision_codex | NOAEL | =1 | - | human | - | - | NOAEL study | {"dose":"t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population.","effect":"t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from the SCCS Notes of Guidance for the risk assessment of zinc oxide nanoparticles in sun screens as follows:","page":89,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.0225 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0","dose":"36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...","effect":"inc oxide (nano form) ___________________________________________________________________________________________ 90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.166 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0","dose":"36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...","effect":"________________________________________________________________________________ 90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_012"} |
| SCCS_vision_codex | NOAEL | =0.9 | mg/kg/d | human | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"CS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4.","effect":"CS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day =","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_017"} |
| SCCS_vision_codex | NOAEL | =0.225 | mg/kg bw/day | human | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III).","effect":"clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time fram","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_018"} |
| SCCS_vision_codex | NOAEL | =0.83 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"nly at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III).","effect":"nly at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time frames, e.","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_019"} |
| SCCS_vision_codex | NOAEL | =50 | - | mouse | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"However, no differences weren observed between ZnO administered as nanoscale or microscale particles.","effect":"ure In one exploratory study in mice, systemic availability of Zn was indicated after a single oral exposure. However, no differences weren observed between ZnO administered as nanoscale or microscale particles. It is likely that absorbed Zn in the GI-tract was in the dissolved ionic form. In view of the data provided, oral exposure of nano-ZnO via applications of nano-ZnO as a cosmetic ingredient in sunscreens should be considered to be of a similar risk to micron-sized ZnO as previously evaluated in the RAR. The NOAEL for oral intake of ZnO is 50 mg /bw day (Reference 44, sub III). The oral exposure to ZnO nanoparticles as cosmetic ingredient in sunscreens is limited to accidental ingestion of small fractions of lip products and sun protection products and can be considered to be low. Inhalation exposure Upon inhalation of ZnO nanoparticles, serious local effects in the lung were observed. Even if this may be due to the solubilized Zn ions, the effects are a direct result of the exposure to the ZnO nanoparticles. Therefore, th","page":96,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_023"} |
| SCCS_vision_codex | NOAEL | =90 | - | - | inhalation | 90 days | NOAEL study | {"dose":"Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study.","effect":"upporting the rapid elimination. In the study four animals were found dead or killed moribund, the cause of death being in two animals a purulent and necrotizing inflammation of the urogenital organs, in one animal due to a pronounced malignant lymphoma, and in one animal due to unknown cause. These observations were not treatment related. Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study. A NOAEL of 1.5 g/m³ can be identified for the test item Z-COTE® HP1. Under the conditions of this test no persistent toxicity was found and all lesions were found to be recovered within the 28 day post exposure period. SCCS comments The file received for the study report was not signed by the study director and/or scientists involved. The report was supposedly to be published by the end of 2012, however, it was not found on Cefic website (June 2013). Size distributions of both nano- and micron-sized ZnO particles used","page":12,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_001"} |
| SCCS_vision_codex | NOAEL | =1518 | - | - | - | - | NOAEL study | {"dose":"Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein).","effect":"SCCS/1518/13 Revision of the addendum to the opinion on zinc oxide (nano form) ___________________________________________________________________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for","page":13,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_002"} |
| SCCS_vision_codex | NOAEL | =96 | % | - | - | - | NOAEL study | {"dose":"Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein).","effect":"______________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for use on the skin as UV filter in sunscreen formulations: 1. ZnO nanoparticles of purity ≥96%, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or","page":13,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_003"} |
| SCCS_vision_codex | NOAEL | =4 | - | - | inhalation | 90 days | NOAEL study | {"effect":". Other cosmetic ingredients can be used as coatings as long as they are demonstrated to the SCCS to be safe and do not affect the particle properties related to behaviour and/or effects, compared to the nanomaterials covered in the current opinion. 4. ZnO nanoparticles that have a comparable solubility to that reported in the dossier, i.e. below 50 mg/L (approximately the maximum solubility of the ZnO nanomaterials for which data are provided in the dossier). The submitted 90 days inhalation study resulted in a NOAEL of 0.3 mg/m3. However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects. 5. MINORITY OPINION / 6. REFERENCES /","page":13,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_004"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg | mouse | oral | - | NOAEL study | {"citation":"Reference: AR16)","dose":"hip, many effects were noted at the highest dose administered that should be considered dose related even when they only occur at the highest dose.","effect":"hip, many effects were noted at the highest dose administered that should be considered dose related even when they only occur at the highest dose. The pathological findings indicate a dose response relationship with the highest dose inducing the most severe alterations. The lowest dose investigated (1,000 mg/kg) also induced pathological effects in the animals. Most effects showed some minor differences between the 20 and 120 nm sized ZnO. Target organs for toxicity were liver, heart, spleen, pancreas and bone. A no observed adverse effect level (NOAEL) was not dentified because alterations were also observed at the lowest dose investigated (1,000 mg/kg). No deaths were observed in a similar study using a single oral dose of 5 mg/kg in mice (Reference: AR16). ZnO nanoparticles were approximately 50 nm in size (TEM evaluation), which were compared to ZnO microparticles showing at least one diameter >100 nm (TEM evaluation). DLS evaluation showed an average hydrodynamic diameter of 1,226 ± 120 nm for the ZnO microparticles, and an average hydrodynamic diame","page":29,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_001"} |
| SCCS_vision_codex | NOAEL | =1 | mg/kg bw | rat | intravenous | - | repeated dose toxicity | {"citation":"(References: 85, 94, 119)","dose":"In view of the indications for liver damage, a repeated dose toxicity study would have provided better information on potential toxicity.","effect":"toxic reactions were not observed. In view of the indications for liver damage, a repeated dose toxicity study would have provided better information on potential toxicity. In conclusion, after intravenous administration obtaining an internal dose of 5 mg/kg bw alterations in clinical pathology were observed that were indicative of liver damage. The liver damage appeared to be transient as similar alterations were not observed at four weeks after the single administration. Based on this study, the SCCS considers a NOAEL of 1 mg/kg bw for acute toxicity of ZnO in rats after intravenous administration. Additional studies submitted Additional information was included in the dossier on ZnO commercially obtained from Sigma-Aldrich and not related to the ZnO presented in the dossier. (References: 85, 94, 119)","page":86,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_003"} |
| SCCS_vision_codex | NOAEL | =2 | % | human | oral | 18 days | repeated dose toxicity | {"dose":"An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.","effect":"nc or zinc compounds is therefore chosen to be 2%. Based on the physical appearance, for dust exposure to zinc or zinc compounds a 10-fold lower default value of 0.2% is chosen in the risk assessment. For sunscreen containing 10% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical","page":89,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_004"} |
| SCCS_vision_codex | NOAEL | =20 | % | human | oral | 18 days | repeated dose toxicity | {"dose":"An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.","effect":"the risk assessment. For sunscreen containing 10% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consum","page":89,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_005"} |
| SCCS_vision_codex | NOAEL | =1 | - | human | - | - | NOAEL study | {"dose":"t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population.","effect":"t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from the SCCS Notes of Guidance for the risk assessment of zinc oxide nanoparticles in sun screens as follows:","page":89,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_010"} |
| SCCS_vision_codex | NOAEL | =0.0225 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0","dose":"36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...","effect":"inc oxide (nano form) ___________________________________________________________________________________________ 90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_011"} |
| SCCS_vision_codex | NOAEL | =0.166 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0","dose":"36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...","effect":"________________________________________________________________________________ 90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_012"} |
| SCCS_vision_codex | NOAEL | =0.9 | mg/kg/d | human | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"CS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4.","effect":"CS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day =","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_017"} |
| SCCS_vision_codex | NOAEL | =0.225 | mg/kg bw/day | human | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III).","effect":"clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time fram","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_018"} |
| SCCS_vision_codex | NOAEL | =0.83 | mg/kg bw/d | human | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"nly at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III).","effect":"nly at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time frames, e.","page":90,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_019"} |
| SCCS_vision_codex | NOAEL | =50 | - | mouse | oral | - | NOAEL study | {"citation":"(Reference 44, sub III)","dose":"However, no differences weren observed between ZnO administered as nanoscale or microscale particles.","effect":"ure In one exploratory study in mice, systemic availability of Zn was indicated after a single oral exposure. However, no differences weren observed between ZnO administered as nanoscale or microscale particles. It is likely that absorbed Zn in the GI-tract was in the dissolved ionic form. In view of the data provided, oral exposure of nano-ZnO via applications of nano-ZnO as a cosmetic ingredient in sunscreens should be considered to be of a similar risk to micron-sized ZnO as previously evaluated in the RAR. The NOAEL for oral intake of ZnO is 50 mg /bw day (Reference 44, sub III). The oral exposure to ZnO nanoparticles as cosmetic ingredient in sunscreens is limited to accidental ingestion of small fractions of lip products and sun protection products and can be considered to be low. Inhalation exposure Upon inhalation of ZnO nanoparticles, serious local effects in the lung were observed. Even if this may be due to the solubilized Zn ions, the effects are a direct result of the exposure to the ZnO nanoparticles. Therefore, th","page":96,"pdf":"sccs_o_103.pdf","row_type":"noael_study","study_id":"sccs_o_103_noael_023"} |
| SCCS_vision_codex | NOAEL | =90 | - | - | inhalation | 90 days | NOAEL study | {"dose":"Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study.","effect":"upporting the rapid elimination. In the study four animals were found dead or killed moribund, the cause of death being in two animals a purulent and necrotizing inflammation of the urogenital organs, in one animal due to a pronounced malignant lymphoma, and in one animal due to unknown cause. These observations were not treatment related. Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study. A NOAEL of 1.5 g/m³ can be identified for the test item Z-COTE® HP1. Under the conditions of this test no persistent toxicity was found and all lesions were found to be recovered within the 28 day post exposure period. SCCS comments The file received for the study report was not signed by the study director and/or scientists involved. The report was supposedly to be published by the end of 2012, however, it was not found on Cefic website (June 2013). Size distributions of both nano- and micron-sized ZnO particles used","page":12,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_001"} |
| SCCS_vision_codex | NOAEL | =1518 | - | - | - | - | NOAEL study | {"dose":"Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein).","effect":"SCCS/1518/13 Revision of the addendum to the opinion on zinc oxide (nano form) ___________________________________________________________________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for","page":13,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_002"} |
| SCCS_vision_codex | NOAEL | =96 | % | - | - | - | NOAEL study | {"dose":"Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein).","effect":"______________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for use on the skin as UV filter in sunscreen formulations: 1. ZnO nanoparticles of purity ≥96%, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or","page":13,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_003"} |
| SCCS_vision_codex | NOAEL | =4 | - | - | inhalation | 90 days | NOAEL study | {"effect":". Other cosmetic ingredients can be used as coatings as long as they are demonstrated to the SCCS to be safe and do not affect the particle properties related to behaviour and/or effects, compared to the nanomaterials covered in the current opinion. 4. ZnO nanoparticles that have a comparable solubility to that reported in the dossier, i.e. below 50 mg/L (approximately the maximum solubility of the ZnO nanomaterials for which data are provided in the dossier). The submitted 90 days inhalation study resulted in a NOAEL of 0.3 mg/m3. However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects. 5. MINORITY OPINION / 6. REFERENCES /","page":13,"pdf":"sccs_o_137.pdf","row_type":"noael_study","study_id":"sccs_o_137_noael_004"} |
ToxValDB_DOE_Wildlife_Benchmarks 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_DOE_Wildlife_Benchmarks | LOAEL | =320 | mg/kg bw/day | Rat | oral | - | repeat dose other | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65bd1d53e4b063812d68c240; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://rais.ornl.gov/documents/tm86r3.pdf; STUDY_GROUP=DOE Wildlife Benchmarks_dup_-_15511732_15511733:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_3ebf403078a5e913b57b05bc20466670 |
| ToxValDB_DOE_Wildlife_Benchmarks | NOAEL | =160 | mg/kg bw/day | Rat | oral | - | repeat dose other | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65bd1d53e4b063812d68c240; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://rais.ornl.gov/documents/tm86r3.pdf; STUDY_GROUP=DOE Wildlife Benchmarks_dup_-_15511732_15511733:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_5842136dc14ffb68cb0f57e51d356058 |
ToxValDB_ECHA_IUCLID 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LEL | =2.5 | mg/m3 | Rat | inhalation | - | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61b61e4b096bca876de2f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10228/7/3/3?documentUUID=819bf807-93be-4ebf-8cda-44ec703048cc; YEAR=1969; ORIGINAL_YEAR=1969; STUDY_GROUP=ECHA IUCLID:15795745:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ab3ff196fb47d292a28ee1e5d0bcd425 |
| ToxValDB_ECHA_IUCLID | LEL | =7.8 | mg/m3 | Guinea Pig | inhalation | - | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059759e4b063812d6fa6de; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10329/7/3/3?documentUUID=9335e422-4b04-439e-b32c-4a913c2da116; YEAR=2013; ORIGINAL_YEAR=2013; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Inhalation_15795975_15796897:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_084b71e7b0617cdc7e06127d20f0ba17 |
| ToxValDB_ECHA_IUCLID | LEL | =5 | mg/m3 | Rabbit | inhalation | - | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059759e4b063812d6fa6de; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/11214/7/3/3?documentUUID=fcaa6bea-650a-413b-94a6-3d002945fc60; YEAR=1982; ORIGINAL_YEAR=1982; STUDY_GROUP=ECHA IUCLID:15796094:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4cd11eedad53117f0d834ca188afbb0c |
| ToxValDB_ECHA_IUCLID | LEL | ~4.6 | mg/m3 | Guinea Pig | inhalation | short-term; 6 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61fd3e4b096bca877eff6; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24855/7/6/3?documentUUID=07ed0690-2bf9-419e-8ccc-30c37dab3fe1; YEAR=1977; ORIGINAL_YEAR=1977; STUDY_GROUP=ECHA IUCLID:15827097:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_592f1e6aa088d65cd7c4a8a8d2298d72 |
| ToxValDB_ECHA_IUCLID | LEL | ~731 | ppm | Sheep | oral | short-term; 14 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb96e4b0a7c65d226a94; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24962/7/6/2?documentUUID=dfc1dee8-bb78-4fd3-b706-372ddde549af; YEAR=1996; ORIGINAL_YEAR=1996; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15830373_15832877_15836688_15840371_15842751_15843448_15845544:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_1af5230e229d1c877d2660e0a369d87a |
| ToxValDB_ECHA_IUCLID | LOAEL | =125 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadc7e4b0a7c65d1c5fc5; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10329/7/6/2?documentUUID=9335e422-4b04-439e-b32c-4a913c2da116; YEAR=2013; ORIGINAL_YEAR=2013; TOXICOLOGICAL_EFFECT=histopathology: nonneoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15847227_15847468_15848640_15848676_15848947_15848951_15850702_15850703_15850704_15850705_15850706_15850707_15850708_15850709_15850710_15850711_15850712_15850713:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_00676d649c76c64849dab92425be8636 |
| ToxValDB_ECHA_IUCLID | NOAEC | =7.5 | mg/m3 | Rat | inhalation | - | developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d215e4b0a7c65d2316a1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/1803/7/9/3?documentUUID=93089a17-9c2c-4eaf-8903-70c9beb87b12; YEAR=2018; ORIGINAL_YEAR=2018; TOXICOLOGICAL_EFFECT=fetus: changes in sex ratio|fetus: fetal/pup body weight changes|fetus: changes in litter size and weights|fetus: external malformations|fetus: skeletal malformations|fetus: visceral malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15820793_15821376_15821531_15821592_15821667:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_128fb7ffc5b43921d687956bec6ca77a |
| ToxValDB_ECHA_IUCLID | NOAEC | =1.96 | mg/m3 | Rat | inhalation | short-term; 10 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61fa0e4b096bca877e312; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/13376/7/6/3?documentUUID=1bb64f22-9e4c-4f54-991f-a093ab5588fc; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID:15826939:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_b860d08df8e8c7b27c1804413734155f |
| ToxValDB_ECHA_IUCLID | NOAEL | =200 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac6ee4b0a7c65d1bf122; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14696/7/9/3?documentUUID=e1d3e977-4ed0-49fc-861b-0d67daaf4fde; YEAR=1995; ORIGINAL_YEAR=1995; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15820650_15820651_15820673_15820985_15820993_15821730_15824230_15824231_15824232_15824233_15824234_15824235:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_70077948745acaa946b78013c60e2d4a |
| ToxValDB_ECHA_IUCLID | NOAEL | =400 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eabe9e4b0a7c65d1bc68a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/13376/7/9/3?documentUUID=1bb64f22-9e4c-4f54-991f-a093ab5588fc; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15820650_15820651_15820673_15820985_15820993_15821730_15824230_15824231_15824232_15824233_15824234_15824235:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_000740ca595654ca7a18084b25335caa |
| ToxValDB_ECHA_IUCLID | NOAEL | ~240 | mg/kg bw/day | Sheep | oral | short-term; 28 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cc1ae4b0a7c65d228eec; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/11214/7/6/2?documentUUID=fcaa6bea-650a-413b-94a6-3d002945fc60; YEAR=1982; ORIGINAL_YEAR=1982; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15831592_15833010_15836300_15838074_15839691_15841330_15845352:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_336b101d3d234b9fe42a8f72b142f3c3 |
| ToxValDB_ECHA_IUCLID | NOAEL | =31.25 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cbd8e4b0a7c65d227c5d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/25400/7/6/2?documentUUID=a83e3d7f-2fc0-4f85-bebd-551b8cb28c3f; YEAR=2020; ORIGINAL_YEAR=2020; TOXICOLOGICAL_EFFECT=haematology|histopathology: non-neoplastic|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=hematology|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15847227_15847468_15848640_15848676_15848947_15848951_15850702_15850703_15850704_15850705_15850706_15850707_15850708_15850709_15850710_15850711_15850712_15850713:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_88dff0c829a2181d0ba79bfeaabe8612 |
ToxValDB_ECOTOX 15 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =0.4 | % | Rat | oral | short-term; 20 days | reproduction developmental | LONG_REF=J. Nutr.95:287-294 Schlicker,S.A., and D.H. Cox Maternal Dietary Zinc, and Development and Zinc, Iron, and Copper Content of the Rat Fetus 1968; TITLE=Maternal Dietary Zinc, and Development and Zinc, Iron, and Copper Content of the Rat Fetus; AUTHOR=Schlicker,S.A., and D.H. Cox; DOI=10.1093/jn/95.2.287; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=68036; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1968; ORIGINAL_YEAR=1968; TOXICOLOGICAL_EFFECT=Accumulation: Residue|Biochemistry: Copper (Cu) content|Growth: Weight|Morphology: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15594320_15597202:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=7e8a1f7aef69ecae9e6ec42af42e1af0 |
| ToxValDB_ECOTOX | LOEL | =31.2 | mg/kg bw/day | Rat | oral | chronic; 120 days | chronic | LONG_REF=Int. J. Vitam. Nutr. Res.56:329-337 Shankar,S., P.R. Sundaresan, and S. Mohla Effect of Chronic Administration of Excess Dietary Vitamin A and Zinc on Lipid Metabolism in Rats 1986; TITLE=Effect of Chronic Administration of Excess Dietary Vitamin A and Zinc on Lipid Metabolism in Rats; AUTHOR=Shankar,S., P.R. Sundaresan, and S. Mohla; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=79334; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1986; ORIGINAL_YEAR=1986; TOXICOLOGICAL_EFFECT=Accumulation: Residue|Biochemistry: Cholesterol|Biochemistry: Total lipids|Biochemistry: Vitamin A; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15595646_15596056:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=6bfe6812185848bb5fd44df8c4e3238f |
| ToxValDB_ECOTOX | LOEL | =1000 | ppm | Rat | oral | short-term; 10 days | short-term | LONG_REF=J. Nutr. Biochem.15(4): 206-209 Szabo,J., M. Hegedus, G. Bruckner, E. Kosa, E. Andrasofszky, and E. Berta Large Doses of Zinc Oxide Increases the Activity of Hydrolases in Rats 2004; TITLE=Large Doses of Zinc Oxide Increases the Activity of Hydrolases in Rats; AUTHOR=Szabo,J., M. Hegedus, G. Bruckner, E. Kosa, E. Andrasofszky, and E. Berta; DOI=10.1016/j.jnutbio.2003.09.005; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=100797; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2004; ORIGINAL_YEAR=2004; TOXICOLOGICAL_EFFECT=Enzyme(s): Amylase|Enzyme(s): Lipase|Enzyme(s): Protease|Enzyme(s): Trypsin; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|enzyme activity; STUDY_GROUP=ECOTOX:15595835:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=3bf0813b6a9b87a9152c2545dfb01d7d |
| ToxValDB_ECOTOX | LOEL | =1200 | ppm | Rat | oral | short-term; 21 days | short-term | LONG_REF=Proc. Soc. Exp. Biol. Med.152:192-194 Ansari,M.S., W.J. Miller, M.W. Neathery, J.W. Lassiter, R.P. Gentry, and R.L. Kincaid Zinc Metabolism and Homeostasis in Rats Fed a Wide Range of High Dietary Zinc Levels 1976; TITLE=Zinc Metabolism and Homeostasis in Rats Fed a Wide Range of High Dietary Zinc Levels; AUTHOR=Ansari,M.S., W.J. Miller, M.W. Neathery, J.W. Lassiter, R.P. Gentry, and R.L. Kincaid; DOI=10.3181/00379727-152-39358; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=68021; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1976; ORIGINAL_YEAR=1976; TOXICOLOGICAL_EFFECT=Accumulation: Residue; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15596631_15601911_15603183_15603184_15610362_15610363:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=f348fe139df36d6e82744086bb1c8a09 |
| ToxValDB_ECOTOX | LOEL | =6010 | ppm | Mouse | oral | short-term; 10 days | short-term | LONG_REF=Am. J. Vet. Res.56(3): 334-339 Zhang,P., G.E. Duhamel, J.V. Mysore, M.P. Carlson, and N.R. Schneider Prophylactic Effect of Dietary Zinc in a Laboratory Mouse Model of Swine Dysentery 1995; TITLE=Prophylactic Effect of Dietary Zinc in a Laboratory Mouse Model of Swine Dysentery; AUTHOR=Zhang,P., G.E. Duhamel, J.V. Mysore, M.P. Carlson, and N.R. Schneider; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=86644; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1995; ORIGINAL_YEAR=1995; TOXICOLOGICAL_EFFECT=Accumulation: Residue; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15597911:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=3d7064d679e5547a417477d10b588e85 |
| ToxValDB_ECOTOX | LOEL | =2400 | ppm | Rat | oral | short-term; 21 days | short-term | LONG_REF=Proc. Soc. Exp. Biol. Med.152:192-194 Ansari,M.S., W.J. Miller, M.W. Neathery, J.W. Lassiter, R.P. Gentry, and R.L. Kincaid Zinc Metabolism and Homeostasis in Rats Fed a Wide Range of High Dietary Zinc Levels 1976; TITLE=Zinc Metabolism and Homeostasis in Rats Fed a Wide Range of High Dietary Zinc Levels; AUTHOR=Ansari,M.S., W.J. Miller, M.W. Neathery, J.W. Lassiter, R.P. Gentry, and R.L. Kincaid; DOI=10.3181/00379727-152-39358; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=68021; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1976; ORIGINAL_YEAR=1976; TOXICOLOGICAL_EFFECT=Accumulation: Residue; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15596631_15601911_15603183_15603184_15610362_15610363:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=0bdf651349b67c89989a3353b736f777 |
| ToxValDB_ECOTOX | LOEL | =4.8 | mg/kg bw/day | Rat | oral | subchronic; 42 days | subchronic | LONG_REF=- | Nutr. Res.20(3): 413-425 Subramanian,P., S. Sivabalan, V.P. Menon, and K. Vasudevan Influence of Chronic Zinc Supplementation on Biochemical Variables and Circadian Rhythms in Wistar Rats 2000; TITLE=Influence of Chronic Zinc Supplementation on Biochemical Variables and Circadian Rhythms in Wistar Rats; AUTHOR=Subramanian,P., S. Sivabalan, V.P. Menon, and K. Vasudevan; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=68812; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=Biochemistry: Iron content|Biochemistry: Thiobarbituric acid reactive substances|Enzyme(s): Ceruloplasmin activity; TOXICOLOGICAL_EFFECT_CATEGORY=clinical chemistry|enzyme activity|other; STUDY_GROUP=ECOTOX:15613045:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; Source overall passed QC, and this record was expert reviewed and revised from ECOTOX source; QC_STATUS=pass; SOURCE_HASH=2b51eee8eaf3867c51cf8a88986f58f1 |
| ToxValDB_ECOTOX | NOEL | =200 | ppm | Rat | oral | short-term; 21 days | short-term | LONG_REF=Toxicol. Appl. Pharmacol.84:12-24 Agarwal,D.K., S. Eustis, J.C. Lamb IV, C.W. Jameson, and W.M. Kluwe Influence of Dietary Zinc on Di(2-ethylhexyl)Phthalate-Induced Testicular Atrophy and Zinc Depletion in Adult Rats 1986; TITLE=Influence of Dietary Zinc on Di(2-ethylhexyl)Phthalate-Induced Testicular Atrophy and Zinc Depletion in Adult Rats; AUTHOR=Agarwal,D.K., S. Eustis, J.C. Lamb IV, C.W. Jameson, and W.M. Kluwe; DOI=10.1016/0041-008x(86)90412-6; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=67779; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1986; ORIGINAL_YEAR=1986; TOXICOLOGICAL_EFFECT=Accumulation: Residue|Biochemistry: Cholesterol|Biochemistry: Sulfhydryl|Biochemistry: Triglycerides|Enzyme(s): Lactate dehydrogenase|Growth: Weight|Histology: Atrophy|Morphology: Organ weight in relationship to body weight|Morphology: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|nonneoplastic histopathology|organ weight|other; STUDY_GROUP=ECOTOX:15594126:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=6adb079de583dee0dd1b140c8a0a1359 |
| ToxValDB_ECOTOX | NOEL | =160 | mg/kg bw/day | Rat | multiple | short-term; 7 days | short-term | LONG_REF=Br. J. Nutr.57(1): 35-44 Coppen,D.E., and N.T. Davies Studies on the Effects of Dietary Zinc Dose on 65Zn Absorption In Vivo and on the Effects of Zn Status on 65Zn Absorption and Body Loss in Young Rats 1987; TITLE=Studies on the Effects of Dietary Zinc Dose on 65Zn Absorption In Vivo and on the Effects of Zn Status on 65Zn Absorption and Body Loss in Young Rats; AUTHOR=Coppen,D.E., and N.T. Davies; DOI=10.1079/bjn19870007; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=68815; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1987; ORIGINAL_YEAR=1987; TOXICOLOGICAL_EFFECT=Growth: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX:15594936:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=eef87ceb15d5156136369a42c6f74a52 |
| ToxValDB_ECOTOX | NOEL | =0.5 | % | Rat | oral | short-term; 23 days | reproduction developmental | LONG_REF=J. Nutr.98:303-311 Ketcheson,M.R., G.P. Barron, and D.H. Cox Relationship of Maternal Dietary Zinc During Gestation and Lactation to Development and Zinc, Iron and Copper Content of the Postnatal Rat 1969; TITLE=Relationship of Maternal Dietary Zinc During Gestation and Lactation to Development and Zinc, Iron and Copper Content of the Postnatal Rat; AUTHOR=Ketcheson,M.R., G.P. Barron, and D.H. Cox; DOI=10.1093/jn/98.3.303; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=78356; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1969; ORIGINAL_YEAR=1969; TOXICOLOGICAL_EFFECT=Biochemistry: Copper (Cu) content|Biochemistry: Iron content|Feeding behavior: Food consumption|Morphology: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption|other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15595307_15595308_15595309_15599517:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=596aacdcd28c9a2288e4a05b7b0cb9f4 |
| ToxValDB_ECOTOX | NOEL | =0.2 | % | Rat | oral | short-term; 23 days | reproduction developmental | LONG_REF=J. Nutr.98:303-311 Ketcheson,M.R., G.P. Barron, and D.H. Cox Relationship of Maternal Dietary Zinc During Gestation and Lactation to Development and Zinc, Iron and Copper Content of the Postnatal Rat 1969; TITLE=Relationship of Maternal Dietary Zinc During Gestation and Lactation to Development and Zinc, Iron and Copper Content of the Postnatal Rat; AUTHOR=Ketcheson,M.R., G.P. Barron, and D.H. Cox; DOI=10.1093/jn/98.3.303; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=78356; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1969; ORIGINAL_YEAR=1969; TOXICOLOGICAL_EFFECT=Biochemistry: Copper (Cu) content|Biochemistry: Iron content|Growth: Weight|Morphology: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15595307_15595308_15595309_15599517:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=820fd639219c01a602809f6447952547 |
| ToxValDB_ECOTOX | NOEL | =97.46 | ppm | Rat | oral | short-term; 17 days | developmental | LONG_REF=Toxicology126:9-21 Bui,L.M., M.W. Taubeneck, J.F. Commisso, J.Y. Uriu-Hare, W.D. Faber, and C.L. Keen Altered Zinc Metabolism Contributes to the Developmental Toxicity of 2-Ethylhexanoic Acid, 2-Ethylhexanol and Valproic Acid 1998; TITLE=Altered Zinc Metabolism Contributes to the Developmental Toxicity of 2-Ethylhexanoic Acid, 2-Ethylhexanol and Valproic Acid; AUTHOR=Bui,L.M., M.W. Taubeneck, J.F. Commisso, J.Y. Uriu-Hare, W.D. Faber, and C.L. Keen; DOI=10.1016/s0300-483x(97)00171-6; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=67778; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=Accumulation: Residue|Biochemistry: Metallothionein|Development: Abnormal|Development: Slowed, Retarded, Delayed or Non-development|Development: Weight|Growth: Weight gain|Histology: Hernia|Injury: Hydrocephaly|Morphology: Length|Reproduction: Resorbed embryos; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|development|gross pathology|other|reproduction; STUDY_GROUP=ECOTOX:15597812:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=8ccaedbbc98616953ee2fae6f0e079aa |
| ToxValDB_ECOTOX | NOEL | =8400 | ppm | Rat | oral | short-term; 21 days | short-term | LONG_REF=Proc. Soc. Exp. Biol. Med.152:192-194 Ansari,M.S., W.J. Miller, M.W. Neathery, J.W. Lassiter, R.P. Gentry, and R.L. Kincaid Zinc Metabolism and Homeostasis in Rats Fed a Wide Range of High Dietary Zinc Levels 1976; TITLE=Zinc Metabolism and Homeostasis in Rats Fed a Wide Range of High Dietary Zinc Levels; AUTHOR=Ansari,M.S., W.J. Miller, M.W. Neathery, J.W. Lassiter, R.P. Gentry, and R.L. Kincaid; DOI=10.3181/00379727-152-39358; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=68021; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1976; ORIGINAL_YEAR=1976; TOXICOLOGICAL_EFFECT=Accumulation: Residue|Feeding behavior: Food consumption|Growth: Weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15596631_15601911_15603183_15603184_15610362_15610363:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=1a641f8969fcb6476372432011151f6f |
| ToxValDB_ECOTOX | NOEL | =20 | % w/v | Mouse | dermal | short-term; 5 days | short-term | LONG_REF=Food Chem. Toxicol.29(1): 57-64 Lansdown,A.B.G. Interspecies Variations in Response to Topical Application of Selected Zinc Compounds 1991; TITLE=Interspecies Variations in Response to Topical Application of Selected Zinc Compounds; AUTHOR=Lansdown,A.B.G.; DOI=10.1016/0278-6915(91)90063-d; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=85721; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=Genetics: Mitotic index (# mitoses/total cells); TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15609914:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=1eaae6dcf15a303ca8c96864ec24098b |
| ToxValDB_ECOTOX | NOEL | =7200 | ppm | Rat | oral | short-term; 21 days | short-term | LONG_REF=Proc. Soc. Exp. Biol. Med.152:192-194 Ansari,M.S., W.J. Miller, M.W. Neathery, J.W. Lassiter, R.P. Gentry, and R.L. Kincaid Zinc Metabolism and Homeostasis in Rats Fed a Wide Range of High Dietary Zinc Levels 1976; TITLE=Zinc Metabolism and Homeostasis in Rats Fed a Wide Range of High Dietary Zinc Levels; AUTHOR=Ansari,M.S., W.J. Miller, M.W. Neathery, J.W. Lassiter, R.P. Gentry, and R.L. Kincaid; DOI=10.3181/00379727-152-39358; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=68021; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1976; ORIGINAL_YEAR=1976; TOXICOLOGICAL_EFFECT=Accumulation: Residue; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX_dup_EPA ORD_15596631_15601911_15603183_15603184_15610362_15610363:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=c5f39ca3364f03cd73d7afff30a2f997 |
ToxValDB_GESTIS_DNEL 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL local | =0.5 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL_dup_-_15635797_15635798:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0afe08211dcb59355f05b2290e8737f9 |
| ToxValDB_GESTIS_DNEL | DNEL systemic | =5 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL_dup_-_15635797_15635798:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_828b69a487421f7fe32e65e2f03a0056 |
ToxValDB_NIOSH_IDLH 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_NIOSH_IDLH | LEL | =320 | mg/m3 | Human | inhalation | acute; 3 hours | occupational | LONG_REF=Hammond JW [1944]. Metal fume fever in the crushed stone industry. J Ind Hyg Toxicol 26(4):117-119.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c9b384e4b02565fc7d7211; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.cdc.gov/niosh/idlh/; SUBSOURCE_URL=https://www.cdc.gov/niosh/idlh/1314132.html; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=nausea on the job, and chills, shortness of breath, and severe chest pains 2 to 12 hours later; STUDY_GROUP=NIOSH IDLH:15953833:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_ceb47f03f2e0fa564077f3be3b8daa9a |
| ToxValDB_NIOSH_IDLH | LEL | =600 | mg/m3 | Human | inhalation | acute; 12 minutes | clinical | LONG_REF=Sturgis CC, Thompson PD [1927]. Metal fume fever: I. Clinical observations on the effect of the experimental inhalation of zinc oxide by two apparently normal persons. J Ind Hyg 9(3):88-97.; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/68c9b384e4b02565fc7d7211; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.cdc.gov/niosh/idlh/; SUBSOURCE_URL=https://www.cdc.gov/niosh/idlh/1314132.html; YEAR=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=headaches, chills, and fever with cough and a decrease in vital capacity which persisted for 15 hours after exposure; STUDY_GROUP=NIOSH IDLH:15953834:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_1e81bfe7ebdea3f6cc59db87bd89c690 |
UnifiedCodex:SCCNFP:beta.noael_studies 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 3000 | ppm | rat | - | - | - | SOURCE_SUBDIR=out222_en; REPORT_TITLE=OPINION CONCERNING ZINC OXIDE COLIPA n° S 76; OPINION_NUMBER=SCCNFP/0649/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=3000; DOSE=e and cholesterol were reduced and alkaline phosphatase and urea nitrogen were increased in high dose animals.; EFFECT=e and cholesterol were reduced and alkaline phosphatase and urea nitrogen were increased in high dose animals. High dose females showed reduced ALAT and increased calcium levels, ASAT was increased in high dose males. Absolute and relative thyroid weights of males and kidney weights of females were increased at the highest dose. Gross pathology and histopathology showed changes in kidneys, thyroids, pancreas (degeneration/necrosis of acinar cells, clarification of nucleoli), gastrointestinal tract, and spleen. The NOEL for mice in this study was found at the mid dose at 3000 ppm (about 470 mg ZnSO4.7 H2O/kg bw (104 mg Zn2+/kg bw). Wistar rats : at the high dose level a moderate reduction in leucocyte counts, slightly decreased hematocrit and haemoglobin values (males only) and decreased total protein and cholesterol values were recorded. Absolute and relative liver weights and relative kidney weights were decreased in high dose males. Histopathology showed pancreatic damage (degeneration, necrosis of acinar cells, clarification; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1314-13-2","citation":"","dose":"e and cholesterol were reduced and alkaline phosphatase and urea nitrogen were increased in high dose animals.","duration":"","effect":"e and cholesterol were reduced and alkaline phosphatase and urea nitrogen were increased in high dose animals. High dose females showed reduced ALAT and increased calcium levels, ASAT was increased in high dose males. Absolute and relative thyroid weights of males and kidney weights of females were increased at the highest dose. Gross pathology and histopathology showed changes in kidneys, thyroids, pancreas (degeneration/necrosis of acinar cells, clarification of nucleoli), gastrointestinal tract, and spleen. The NOEL for mice in this study was found at the mid dose at 3000 ppm (about 470 mg ZnSO4.7 H2O/kg bw (104 mg Zn2+/kg bw). Wistar rats : at the high dose level a moderate reduction in leucocyte counts, slightly decreased hematocrit and haemoglobin values (males only) and decreased total protein and cholesterol values were recorded. Absolute and relative liver weights and relative kidney weights were decreased in high dose males. Histopathology showed pancreatic damage (degeneration, necrosis of acinar cells, clarification","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"ppm","noael_value":"3000","page":7,"route":"","species":"rat","study_id":"out222_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 3000 | ppm | rat | oral | - | - | SOURCE_SUBDIR=out222_en; REPORT_TITLE=OPINION CONCERNING ZINC OXIDE COLIPA n° S 76; OPINION_NUMBER=SCCNFP/0649/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=3000; DOSE=Wistar rats : at the high dose level a moderate reduction in leucocyte counts, slightly decreased hematocrit and haemoglobin values (males only) and decreased total protein and cholesterol values were recorded.; EFFECT=ZnSO4.7 H2O/kg bw (104 mg Zn2+/kg bw). Wistar rats : at the high dose level a moderate reduction in leucocyte counts, slightly decreased hematocrit and haemoglobin values (males only) and decreased total protein and cholesterol values were recorded. Absolute and relative liver weights and relative kidney weights were decreased in high dose males. Histopathology showed pancreatic damage (degeneration, necrosis of acinar cells, clarification of centroacinar cells and interstitial fibrosis) in high dose animals. The NOEL for rats was found at the mid dose at 3000 ppm (about 240 mg ZnSO4.7 H2O/kg bw for males and females, respectively (53.5 mg Zn2+/kg bw). Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required. In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion.; CITATION=Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required; CITATION_NUMBERS=[14]; REFERENCE=Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required; DETAILS_JSON={"cas_number":"1314-13-2","citation":"Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required","dose":"Wistar rats : at the high dose level a moderate reduction in leucocyte counts, slightly decreased hematocrit and haemoglobin values (males only) and decreased total protein and cholesterol values were recorded.","duration":"","effect":"ZnSO4.7 H2O/kg bw (104 mg Zn2+/kg bw). Wistar rats : at the high dose level a moderate reduction in leucocyte counts, slightly decreased hematocrit and haemoglobin values (males only) and decreased total protein and cholesterol values were recorded. Absolute and relative liver weights and relative kidney weights were decreased in high dose males. Histopathology showed pancreatic damage (degeneration, necrosis of acinar cells, clarification of centroacinar cells and interstitial fibrosis) in high dose animals. The NOEL for rats was found at the mid dose at 3000 ppm (about 240 mg ZnSO4.7 H2O/kg bw for males and females, respectively (53.5 mg Zn2+/kg bw). Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required. In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion.","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"ppm","noael_value":"3000","page":7,"route":"oral","species":"rat","study_id":"out222_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 0.5 | mg/kg/day | human | oral | 6 weeks | - | SOURCE_SUBDIR=out222_en; REPORT_TITLE=OPINION CONCERNING ZINC OXIDE COLIPA n° S 76; OPINION_NUMBER=SCCNFP/0649/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=0.5; DOSE=In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion.; EFFECT=2+/kg bw). Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required. In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion. In humans, the average daily intake is estimated at about 15 mg of Zn2+. The available evidence from human studies points to a NOEL of about 0.5 mg/kg/day and thus confirms the safe exposure level, which could be predicted from the animal data. A series of human experimental studies have been published which report adverse effects from oral administration of zinc salts : * 47 healthy volunteers ingested ZnSO4 tablets three times a day for 6 weeks, resulting in a total daily dose of 2 mg Zn2+/kg bw. Headaches, nausea, vomiting, loss of appetite and abdominal cramps were seen in 26 of the volunteers. Ref. : 15 * Oral doses of 160 mg ZnSO4/day (2; CITATION=Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required; CITATION_NUMBERS=[14]; REFERENCE=Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required; DETAILS_JSON={"cas_number":"1314-13-2","citation":"Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required","dose":"In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion.","duration":"6 weeks","effect":"2+/kg bw). Ref. : 14 Human studies Since zinc is an essential trace element for all mammalian species, its presence in the diet of humans and animals as well as in drinking water is required. In this regard, the mammalian organism is used to handle varying quantities of externally administered zinc, such that Zn2+ homeostasis is regulated via control mechanisms of absorption and excretion. In humans, the average daily intake is estimated at about 15 mg of Zn2+. The available evidence from human studies points to a NOEL of about 0.5 mg/kg/day and thus confirms the safe exposure level, which could be predicted from the animal data. A series of human experimental studies have been published which report adverse effects from oral administration of zinc salts : * 47 healthy volunteers ingested ZnSO4 tablets three times a day for 6 weeks, resulting in a total daily dose of 2 mg Zn2+/kg bw. Headaches, nausea, vomiting, loss of appetite and abdominal cramps were seen in 26 of the volunteers. Ref. : 15 * Oral doses of 160 mg ZnSO4/day (2","endpoint":"","ingredient":"codes","loael_value":"","noael_unit":"mg/kg/day","noael_value":"0.5","page":7,"route":"oral","species":"human","study_id":"out222_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 42.5 | mg/kg | rabbit | oral | developmental | developmental toxicity | SOURCE_SUBDIR=out222_en; REPORT_TITLE=OPINION CONCERNING ZINC OXIDE COLIPA n° S 76; OPINION_NUMBER=SCCNFP/0649/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=42.5; DOSE=Results No compound-related effects were observed at any dose level.; EFFECT=a lutea, implantations, viable foetuses and resorptions. All foetuses were weighed, sexed and examined for gross external defects. In addition, skeletal examinations (in two-thirds of the foetuses) and soft tissue examinations (in the remaining one-third of foetuses) were performed. Results No compound-related effects were observed at any dose level. In particular, there was no indication of any specific teratogenic activity of ZnSO4 under the conditions of this experiment. Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of ZnSO4 was 42.5 mg/kg (corresponding to about 17 mg/kg if expressed as zinc). Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0.6, 2.8, 13.0 and 60.0 mg/kg by gavage in water 6-amino-nicotinamide : 2.5 mg/kg by gavage Exposure period : ZnSO4: day 6-18 of gestation (p.c.) 6-amino-nicotinamide: single application at day 19 of gestat; CITATION=Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0; CITATION_NUMBERS=[27,14,19,4,6]; REFERENCE=Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0; DETAILS_JSON={"cas_number":"1314-13-2","citation":"Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0","dose":"Results No compound-related effects were observed at any dose level.","duration":"developmental","effect":"a lutea, implantations, viable foetuses and resorptions. All foetuses were weighed, sexed and examined for gross external defects. In addition, skeletal examinations (in two-thirds of the foetuses) and soft tissue examinations (in the remaining one-third of foetuses) were performed. Results No compound-related effects were observed at any dose level. In particular, there was no indication of any specific teratogenic activity of ZnSO4 under the conditions of this experiment. Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of ZnSO4 was 42.5 mg/kg (corresponding to about 17 mg/kg if expressed as zinc). Ref. : 27 Species : Female Dutch rabbits Number of animals : 14-19 animals per group Test substance : ZnSO4 (unspecified) 6-amino-nicotinamide (positive control) Doses : ZnSO4 : 0, 0.6, 2.8, 13.0 and 60.0 mg/kg by gavage in water 6-amino-nicotinamide : 2.5 mg/kg by gavage Exposure period : ZnSO4: day 6-18 of gestation (p.c.) 6-amino-nicotinamide: single application at day 19 of gestat","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"42.5","page":13,"route":"oral","species":"rabbit","study_id":"out222_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 60 | mg/kg | rat | oral | developmental | developmental toxicity | SOURCE_SUBDIR=out222_en; REPORT_TITLE=OPINION CONCERNING ZINC OXIDE COLIPA n° S 76; OPINION_NUMBER=SCCNFP/0649/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=60.0; DOSE=Zinc oxide ____________________________________________________________________________________________ 14 Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of Zinc Sulfate was at least 60.0 mg/kg (corresponding to about 24 mg/kg if expressed as zinc).; EFFECT=SCCNFP/0649/03, final Evaluation and opinion on : Zinc oxide ____________________________________________________________________________________________ 14 Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of Zinc Sulfate was at least 60.0 mg/kg (corresponding to about 24 mg/kg if expressed as zinc). Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels of 2000 (about 100 mg/kg/d) or 4000 ppm (about 200 mg/kg/day) in the diet. 7 equally sized control groups received the basal diet without test substance. 4 groups were fed the test die; CITATION=Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels; CITATION_NUMBERS=[28,10,7]; REFERENCE=Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels; DETAILS_JSON={"cas_number":"1314-13-2","citation":"Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels","dose":"Zinc oxide ____________________________________________________________________________________________ 14 Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of Zinc Sulfate was at least 60.0 mg/kg (corresponding to about 24 mg/kg if expressed as zinc).","duration":"developmental","effect":"SCCNFP/0649/03, final Evaluation and opinion on : Zinc oxide ____________________________________________________________________________________________ 14 Conclusion The No Observed Effect Level (NOEL) with regard to maternal and developmental toxicity of Zinc Sulfate was at least 60.0 mg/kg (corresponding to about 24 mg/kg if expressed as zinc). Ref. : 28 Species : Female Sprague Dawley: CFE rats Number of animals : 10 animals per group Test substance : ZnO Doses and exposure period 7 groups received the test substance at levels of 2000 (about 100 mg/kg/d) or 4000 ppm (about 200 mg/kg/day) in the diet. 7 equally sized control groups received the basal diet without test substance. 4 groups were fed the test die","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg","noael_value":"60.0","page":14,"route":"oral","species":"rat","study_id":"out222_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 40 | % | human | oral | developmental | developmental toxicity | SOURCE_SUBDIR=out222_en; REPORT_TITLE=OPINION CONCERNING ZINC OXIDE COLIPA n° S 76; OPINION_NUMBER=SCCNFP/0649/03; COMMITTEE=SCCNFP; REPORT_DATE=25 June 2003; VALUE_TEXT=40; DOSE=Conclusion ZnO, 2000 ppm, administered from day 21 prior to mating until day 15 of gestation induced no adverse effects on foetal development.; EFFECT=e observed in foetal whole body samples. These analytical results support the interpretation that the observed developmental effects of exaggerated high zinc doses are mediated by depletion of certain essential minerals such as copper. Conclusion ZnO, 2000 ppm, administered from day 21 prior to mating until day 15 of gestation induced no adverse effects on foetal development. This dietary level corresponds to a daily dose of about 100 mg/kg expressed as ZnO, or about 80 mg/kg expressed as zinc which represents the NOEL in this study. Ref. : 29 2.7. Toxicokinetics (incl. Percutaneous Absorption) Method : In vivo, human Volunteers: : 6 healthy males Test substance : ZnO Site of application : Chest, upper and lower legs Exposure : Daily application of 40% ZnO in ointment for a of period 10 days; CITATION=Ref. : 29 2; CITATION_NUMBERS=[29,2]; REFERENCE=Ref. : 29 2; DETAILS_JSON={"cas_number":"1314-13-2","citation":"Ref. : 29 2","dose":"Conclusion ZnO, 2000 ppm, administered from day 21 prior to mating until day 15 of gestation induced no adverse effects on foetal development.","duration":"developmental","effect":"e observed in foetal whole body samples. These analytical results support the interpretation that the observed developmental effects of exaggerated high zinc doses are mediated by depletion of certain essential minerals such as copper. Conclusion ZnO, 2000 ppm, administered from day 21 prior to mating until day 15 of gestation induced no adverse effects on foetal development. This dietary level corresponds to a daily dose of about 100 mg/kg expressed as ZnO, or about 80 mg/kg expressed as zinc which represents the NOEL in this study. Ref. : 29 2.7. Toxicokinetics (incl. Percutaneous Absorption) Method : In vivo, human Volunteers: : 6 healthy males Test substance : ZnO Site of application : Chest, upper and lower legs Exposure : Daily application of 40% ZnO in ointment for a of period 10 days","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"%","noael_value":"40","page":14,"route":"oral","species":"human","study_id":"out222_en_noael_006"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 27 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1000 | mg/kg | mouse | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=1,000; DOSE=hip, many effects were noted at the highest dose administered that should be considered dose related even when they only occur at the highest dose.; EFFECT=hip, many effects were noted at the highest dose administered that should be considered dose related even when they only occur at the highest dose. The pathological findings indicate a dose response relationship with the highest dose inducing the most severe alterations. The lowest dose investigated (1,000 mg/kg) also induced pathological effects in the animals. Most effects showed some minor differences between the 20 and 120 nm sized ZnO. Target organs for toxicity were liver, heart, spleen, pancreas and bone. A no observed adverse effect level (NOAEL) was not dentified because alterations were also observed at the lowest dose investigated (1,000 mg/kg). No deaths were observed in a similar study using a single oral dose of 5 mg/kg in mice (Reference: AR16). ZnO nanoparticles were approximately 50 nm in size (TEM evaluation), which were compared to ZnO microparticles showing at least one diameter >100 nm (TEM evaluation). DLS evaluation showed an average hydrodynamic diameter of 1,226 ± 120 nm for the ZnO microparticles, and an average hydrodynamic diame; CITATION=Reference: AR16); CITATION_NUMBERS=[16]; REFERENCE=Reference: AR16); DETAILS_JSON={"cas_number":"1314-13-2","citation":"Reference: AR16)","dose":"hip, many effects were noted at the highest dose administered that should be considered dose related even when they only occur at the highest dose.","duration":"","effect":"hip, many effects were noted at the highest dose administered that should be considered dose related even when they only occur at the highest dose. The pathological findings indicate a dose response relationship with the highest dose inducing the most severe alterations. The lowest dose investigated (1,000 mg/kg) also induced pathological effects in the animals. Most effects showed some minor differences between the 20 and 120 nm sized ZnO. Target organs for toxicity were liver, heart, spleen, pancreas and bone. A no observed adverse effect level (NOAEL) was not dentified because alterations were also observed at the lowest dose investigated (1,000 mg/kg). No deaths were observed in a similar study using a single oral dose of 5 mg/kg in mice (Reference: AR16). ZnO nanoparticles were approximately 50 nm in size (TEM evaluation), which were compared to ZnO microparticles showing at least one diameter >100 nm (TEM evaluation). DLS evaluation showed an average hydrodynamic diameter of 1,226 ± 120 nm for the ZnO microparticles, and an average hydrodynamic diame","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg","noael_value":"1,000","page":29,"route":"oral","species":"mouse","study_id":"sccs_o_103_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1000 | mg/kg | mouse | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=1,000; DOSE=e highest dose administered that should be considered dose related even when they only occur at the highest dose.; EFFECT=e highest dose administered that should be considered dose related even when they only occur at the highest dose. The pathological findings indicate a dose response relationship with the highest dose inducing the most severe alterations. The lowest dose investigated (1,000 mg/kg) also induced pathological effects in the animals. Most effects showed some minor differences between the 20 and 120 nm sized ZnO. Target organs for toxicity were liver, heart, spleen, pancreas and bone. A no observed adverse effect level (NOAEL) was not dentified because alterations were also observed at the lowest dose investigated (1,000 mg/kg). No deaths were observed in a similar study using a single oral dose of 5 mg/kg in mice (Reference: AR16). ZnO nanoparticles were approximately 50 nm in size (TEM evaluation), which were compared to ZnO microparticles showing at least one diameter >100 nm (TEM evaluation). DLS evaluation showed an average hydrodynamic diameter of 1,226 ± 120 nm for the ZnO microparticles, and an average hydrodynamic diameter of; CITATION=Reference: AR16); CITATION_NUMBERS=[16]; REFERENCE=Reference: AR16); DETAILS_JSON={"cas_number":"1314-13-2","citation":"Reference: AR16)","dose":"e highest dose administered that should be considered dose related even when they only occur at the highest dose.","duration":"","effect":"e highest dose administered that should be considered dose related even when they only occur at the highest dose. The pathological findings indicate a dose response relationship with the highest dose inducing the most severe alterations. The lowest dose investigated (1,000 mg/kg) also induced pathological effects in the animals. Most effects showed some minor differences between the 20 and 120 nm sized ZnO. Target organs for toxicity were liver, heart, spleen, pancreas and bone. A no observed adverse effect level (NOAEL) was not dentified because alterations were also observed at the lowest dose investigated (1,000 mg/kg). No deaths were observed in a similar study using a single oral dose of 5 mg/kg in mice (Reference: AR16). ZnO nanoparticles were approximately 50 nm in size (TEM evaluation), which were compared to ZnO microparticles showing at least one diameter >100 nm (TEM evaluation). DLS evaluation showed an average hydrodynamic diameter of 1,226 ± 120 nm for the ZnO microparticles, and an average hydrodynamic diameter of","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg","noael_value":"1,000","page":29,"route":"oral","species":"mouse","study_id":"sccs_o_103_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 20 | % | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=20; DOSE=Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population.; EFFECT=mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from the SCCS Notes of Guidance for the risk assessment of zinc oxide nanoparticles in sun screens as follows:; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1314-13-2","citation":"","dose":"Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population.","duration":"","effect":"mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from the SCCS Notes of Guidance for the risk assessment of zinc oxide nanoparticles in sun screens as follows:","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"%","noael_value":"20","page":89,"route":"oral","species":"human","study_id":"sccs_o_103_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1 | - | human | - | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=unclear:t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from the SCCS Notes of Guidance for the risk assessment of zinc oxide nanoparticles in sun screens as follows:; DOSE=t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population.; EFFECT=t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from the SCCS Notes of Guidance for the risk assessment of zinc oxide nanoparticles in sun screens as follows:; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1314-13-2","citation":"","dose":"t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population.","duration":"","effect":"t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from the SCCS Notes of Guidance for the risk assessment of zinc oxide nanoparticles in sun screens as follows:","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"","noael_value":"unclear:t this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from the SCCS Notes of Guidance for the risk assessment of zinc oxide nanoparticles in sun screens as follows:","page":89,"route":"","species":"human","study_id":"sccs_o_103_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.0225 | mg/kg bw/d | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=0.0225; DOSE=36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...; EFFECT=inc oxide (nano form) ___________________________________________________________________________________________ 90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on; CITATION=Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0; CITATION_NUMBERS=[36,18,25,100]; REFERENCE=Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0; DETAILS_JSON={"cas_number":"1314-13-2","citation":"Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0","dose":"36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...","duration":"","effect":"inc oxide (nano form) ___________________________________________________________________________________________ 90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.0225","page":90,"route":"oral","species":"human","study_id":"sccs_o_103_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.166 | mg/kg bw/d | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=0.166; DOSE=36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...; EFFECT=________________________________________________________________________________ 90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women; CITATION=Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0; CITATION_NUMBERS=[36,18,25,100]; REFERENCE=Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0; DETAILS_JSON={"cas_number":"1314-13-2","citation":"Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0","dose":"36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...","duration":"","effect":"________________________________________________________________________________ 90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.166","page":90,"route":"oral","species":"human","study_id":"sccs_o_103_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.166 | mg/kg bw/d | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=0.166; DOSE=36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...; EFFECT=90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in wom; CITATION=Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0; CITATION_NUMBERS=[36,18,25,100]; REFERENCE=Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0; DETAILS_JSON={"cas_number":"1314-13-2","citation":"Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0","dose":"36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...","duration":"","effect":"90 Calculation of the margin of safety for ZnO (nano) (See section 3.1.16 for the range of nano-ZnO covered by this opinion) Amount of sunscreen applied* 18,000 mg Maximum concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in wom","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.166","page":90,"route":"oral","species":"human","study_id":"sccs_o_103_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =0.166 | mg /kg bw | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT== 0.166; DOSE=36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...; EFFECT=concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels f; CITATION=Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0; CITATION_NUMBERS=[36,18,25,100]; REFERENCE=Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0; DETAILS_JSON={"cas_number":"1314-13-2","citation":"Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0","dose":"36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance f...","duration":"","effect":"concentration of ZnO 25% Absorption through the skin 0.03% (Reference: 36) Amount absorbed/day (18,000 × 25%/100 × 0.03%/100) 1.35 mg Typical body weight of human 60 kg Systemic exposure dose (1.35 mg/60 kg) 0.0225 mg/kg bw/d No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels f","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg /kg bw","noael_value":"= 0.166","page":90,"route":"oral","species":"human","study_id":"sccs_o_103_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =0.166 | mg /kg bw | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT== 0.166; DOSE=No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw pe...; EFFECT=No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS; CITATION=(Reference 44, sub III); CITATION_NUMBERS=[44]; REFERENCE=(Reference 44, sub III); DETAILS_JSON={"cas_number":"1314-13-2","citation":"(Reference 44, sub III)","dose":"No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw pe...","duration":"","effect":"No Observed Adverse Effect Level NOAEL (oral, human, sensitive subpopulation)** 0.166 mg/kg bw/d Margin of Safety NOAEL/SED = 7.4 * Standard amount as indicated in the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg /kg bw","noael_value":"= 0.166","page":90,"route":"oral","species":"human","study_id":"sccs_o_103_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =0.166 | mg /kg bw | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT== 0.166; DOSE=dance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4.; EFFECT=dance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/; CITATION=(Reference 44, sub III); CITATION_NUMBERS=[44]; REFERENCE=(Reference 44, sub III); DETAILS_JSON={"cas_number":"1314-13-2","citation":"(Reference 44, sub III)","dose":"dance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4.","duration":"","effect":"dance for the testing of cosmetic ingredients and their safety evaluation SCCS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg /kg bw","noael_value":"= 0.166","page":90,"route":"oral","species":"human","study_id":"sccs_o_103_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.9 | mg/kg/d | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=0.9; DOSE=CS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4.; EFFECT=CS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day =; CITATION=(Reference 44, sub III); CITATION_NUMBERS=[44]; REFERENCE=(Reference 44, sub III); DETAILS_JSON={"cas_number":"1314-13-2","citation":"(Reference 44, sub III)","dose":"CS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4.","duration":"","effect":"CS/1416/11 ** The internal NOAEL for ZnO is 10 mg Zn2+/day = 10/60= 0.166 mg /kg bw per day (Reference 44, sub III) The calculation of the exposure via sun protection products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 7.4. Given that the NOAEL is derived from a study on women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day =","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg/d","noael_value":"0.9","page":90,"route":"oral","species":"human","study_id":"sccs_o_103_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.225 | mg/kg bw/day | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=0.225; DOSE=clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III).; EFFECT=clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time fram; CITATION=(Reference 44, sub III); CITATION_NUMBERS=[44]; REFERENCE=(Reference 44, sub III); DETAILS_JSON={"cas_number":"1314-13-2","citation":"(Reference 44, sub III)","dose":"clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III).","duration":"","effect":"clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time fram","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"0.225","page":90,"route":"oral","species":"human","study_id":"sccs_o_103_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.83 | mg/kg bw/d | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=0.83; DOSE=nly at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III).; EFFECT=nly at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time frames, e.; CITATION=(Reference 44, sub III); CITATION_NUMBERS=[44]; REFERENCE=(Reference 44, sub III); DETAILS_JSON={"cas_number":"1314-13-2","citation":"(Reference 44, sub III)","dose":"nly at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III).","duration":"","effect":"nly at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time frames, e.","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.83","page":90,"route":"oral","species":"human","study_id":"sccs_o_103_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.83 | mg/kg bw/d | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=0.83; DOSE=Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d.; EFFECT=is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time frames, e.g. during outdoor holidays. Therefore 0.9 mg/kg bw/d is; CITATION=(Reference 44, sub III); CITATION_NUMBERS=[44]; REFERENCE=(Reference 44, sub III); DETAILS_JSON={"cas_number":"1314-13-2","citation":"(Reference 44, sub III)","dose":"Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d.","duration":"","effect":"is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time frames, e.g. during outdoor holidays. Therefore 0.9 mg/kg bw/d is","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.83","page":90,"route":"oral","species":"human","study_id":"sccs_o_103_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =0.83 | mg /kg bw | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT== 0.83; DOSE=Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d.; EFFECT=nt when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time frames, e.g. during outdoor holidays. Therefore 0.9 mg/kg bw/d is considered a conservati; CITATION=(Reference 44, sub III); CITATION_NUMBERS=[44]; REFERENCE=(Reference 44, sub III); DETAILS_JSON={"cas_number":"1314-13-2","citation":"(Reference 44, sub III)","dose":"Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d.","duration":"","effect":"nt when comparing the human NOAEL with the exposure levels for workers/consumers/general population (Reference 44, sub III). Calculation of the Margin of Safety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time frames, e.g. during outdoor holidays. Therefore 0.9 mg/kg bw/d is considered a conservati","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg /kg bw","noael_value":"= 0.83","page":90,"route":"oral","species":"human","study_id":"sccs_o_103_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =0.83 | mg /kg bw | human | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT== 0.83; DOSE=afety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d.; EFFECT=afety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time frames, e.g. during outdoor holidays. Therefore 0.9 mg/kg bw/d is considered a conservative value. The calculation of the exposure via lip products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 3.7 (with a minimal MOS of 1 requi; CITATION=(Reference 44, sub III); CITATION_NUMBERS=[44]; REFERENCE=(Reference 44, sub III); DETAILS_JSON={"cas_number":"1314-13-2","citation":"(Reference 44, sub III)","dose":"afety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d.","duration":"","effect":"afety for Lip products According to the SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation (SCCS/1416/11) the daily exposure to lipstick/lipproducts is 0.9 mg/kg/d. Exposure dose (0.9 x 25%) 0.225 mg/kg bw/day. No Observed Adverse Effect Level NOAEL (oral, human)* 0.83 mg/kg bw/d Margin of Safety NOAEL/ED** = 3.7 * The NOAEL for ZnO is 50 mg Zn2+/day = 50/60= 0.83 mg /kg bw per day (Reference 44, sub III) ** Since route to route extrapolation is not needed, the (external) NOAEL is compared to the (external) exposure dose It is expected that the exposure to lipstick/lip products that contain high SPF factors (eg ZnO nanomaterial) is less than the exposure to ‘regular’ lipstick/lip products. Typically, these products are used only in specific time frames, e.g. during outdoor holidays. Therefore 0.9 mg/kg bw/d is considered a conservative value. The calculation of the exposure via lip products to ZnO nanoparticles assuming Zn2+ uptake results in a MoS of 3.7 (with a minimal MOS of 1 requi","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg /kg bw","noael_value":"= 0.83","page":90,"route":"oral","species":"human","study_id":"sccs_o_103_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 50 | - | mouse | oral | - | - | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=unclear:ure In one exploratory study in mice, systemic availability of Zn was indicated after a single oral exposure. However, no differences weren observed between ZnO administered as nanoscale or microscale particles. It is likely that absorbed Zn in the GI-tract was in the dissolved ionic form. In view of the data provided, oral exposure of nano-ZnO via applications of nano-ZnO as a cosmetic ingredient in sunscreens should be considered to be of a similar risk to micron-sized ZnO as previously evaluated in the RAR. The NOAEL for oral intake of ZnO is 50 mg /bw day (Reference 44, sub III). The oral exposure to ZnO nanoparticles as cosmetic ingredient in sunscreens is limited to accidental ingestion of small fractions of lip products and sun protection products and can be considered to be low. Inhalation exposure Upon inhalation of ZnO nanoparticles, serious local effects in the lung were observed. Even if this may be due to the solubilized Zn ions, the effects are a direct result of the exposure to the ZnO nanoparticles. Therefore, th; DOSE=However, no differences weren observed between ZnO administered as nanoscale or microscale particles.; EFFECT=ure In one exploratory study in mice, systemic availability of Zn was indicated after a single oral exposure. However, no differences weren observed between ZnO administered as nanoscale or microscale particles. It is likely that absorbed Zn in the GI-tract was in the dissolved ionic form. In view of the data provided, oral exposure of nano-ZnO via applications of nano-ZnO as a cosmetic ingredient in sunscreens should be considered to be of a similar risk to micron-sized ZnO as previously evaluated in the RAR. The NOAEL for oral intake of ZnO is 50 mg /bw day (Reference 44, sub III). The oral exposure to ZnO nanoparticles as cosmetic ingredient in sunscreens is limited to accidental ingestion of small fractions of lip products and sun protection products and can be considered to be low. Inhalation exposure Upon inhalation of ZnO nanoparticles, serious local effects in the lung were observed. Even if this may be due to the solubilized Zn ions, the effects are a direct result of the exposure to the ZnO nanoparticles. Therefore, th; CITATION=(Reference 44, sub III); CITATION_NUMBERS=[44]; REFERENCE=(Reference 44, sub III); DETAILS_JSON={"cas_number":"1314-13-2","citation":"(Reference 44, sub III)","dose":"However, no differences weren observed between ZnO administered as nanoscale or microscale particles.","duration":"","effect":"ure In one exploratory study in mice, systemic availability of Zn was indicated after a single oral exposure. However, no differences weren observed between ZnO administered as nanoscale or microscale particles. It is likely that absorbed Zn in the GI-tract was in the dissolved ionic form. In view of the data provided, oral exposure of nano-ZnO via applications of nano-ZnO as a cosmetic ingredient in sunscreens should be considered to be of a similar risk to micron-sized ZnO as previously evaluated in the RAR. The NOAEL for oral intake of ZnO is 50 mg /bw day (Reference 44, sub III). The oral exposure to ZnO nanoparticles as cosmetic ingredient in sunscreens is limited to accidental ingestion of small fractions of lip products and sun protection products and can be considered to be low. Inhalation exposure Upon inhalation of ZnO nanoparticles, serious local effects in the lung were observed. Even if this may be due to the solubilized Zn ions, the effects are a direct result of the exposure to the ZnO nanoparticles. Therefore, th","endpoint":"","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"","noael_value":"unclear:ure In one exploratory study in mice, systemic availability of Zn was indicated after a single oral exposure. However, no differences weren observed between ZnO administered as nanoscale or microscale particles. It is likely that absorbed Zn in the GI-tract was in the dissolved ionic form. In view of the data provided, oral exposure of nano-ZnO via applications of nano-ZnO as a cosmetic ingredient in sunscreens should be considered to be of a similar risk to micron-sized ZnO as previously evaluated in the RAR. The NOAEL for oral intake of ZnO is 50 mg /bw day (Reference 44, sub III). The oral exposure to ZnO nanoparticles as cosmetic ingredient in sunscreens is limited to accidental ingestion of small fractions of lip products and sun protection products and can be considered to be low. Inhalation exposure Upon inhalation of ZnO nanoparticles, serious local effects in the lung were observed. Even if this may be due to the solubilized Zn ions, the effects are a direct result of the exposure to the ZnO nanoparticles. Therefore, th","page":96,"route":"oral","species":"mouse","study_id":"sccs_o_103_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 90 | - | - | inhalation | 90 days | - | SOURCE_SUBDIR=sccs_o_137; REPORT_TITLE=ADDENDUM to the OPINION SCCS/1489/12 on Zinc oxide (nano form) COLIPA S76; OPINION_NUMBER=SCCS/1518/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 April 2014; VALUE_TEXT=unclear:upporting the rapid elimination. In the study four animals were found dead or killed moribund, the cause of death being in two animals a purulent and necrotizing inflammation of the urogenital organs, in one animal due to a pronounced malignant lymphoma, and in one animal due to unknown cause. These observations were not treatment related. Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study. A NOAEL of 1.5 g/m³ can be identified for the test item Z-COTE® HP1. Under the conditions of this test no persistent toxicity was found and all lesions were found to be recovered within the 28 day post exposure period. SCCS comments The file received for the study report was not signed by the study director and/or scientists involved. The report was supposedly to be published by the end of 2012, however, it was not found on Cefic website (June 2013). Size distributions of both nano- and micron-sized ZnO particles used; DOSE=Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study.; EFFECT=upporting the rapid elimination. In the study four animals were found dead or killed moribund, the cause of death being in two animals a purulent and necrotizing inflammation of the urogenital organs, in one animal due to a pronounced malignant lymphoma, and in one animal due to unknown cause. These observations were not treatment related. Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study. A NOAEL of 1.5 g/m³ can be identified for the test item Z-COTE® HP1. Under the conditions of this test no persistent toxicity was found and all lesions were found to be recovered within the 28 day post exposure period. SCCS comments The file received for the study report was not signed by the study director and/or scientists involved. The report was supposedly to be published by the end of 2012, however, it was not found on Cefic website (June 2013). Size distributions of both nano- and micron-sized ZnO particles used; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1314-13-2","citation":"","dose":"Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study.","duration":"90 days","effect":"upporting the rapid elimination. In the study four animals were found dead or killed moribund, the cause of death being in two animals a purulent and necrotizing inflammation of the urogenital organs, in one animal due to a pronounced malignant lymphoma, and in one animal due to unknown cause. These observations were not treatment related. Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study. A NOAEL of 1.5 g/m³ can be identified for the test item Z-COTE® HP1. Under the conditions of this test no persistent toxicity was found and all lesions were found to be recovered within the 28 day post exposure period. SCCS comments The file received for the study report was not signed by the study director and/or scientists involved. The report was supposedly to be published by the end of 2012, however, it was not found on Cefic website (June 2013). Size distributions of both nano- and micron-sized ZnO particles used","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"unclear:upporting the rapid elimination. In the study four animals were found dead or killed moribund, the cause of death being in two animals a purulent and necrotizing inflammation of the urogenital organs, in one animal due to a pronounced malignant lymphoma, and in one animal due to unknown cause. These observations were not treatment related. Conclusions The study authors concluded that transient local effects on the respiratory tract were only observed in the highest dose group for this 90 days inhalation study. A NOAEL of 1.5 g/m³ can be identified for the test item Z-COTE® HP1. Under the conditions of this test no persistent toxicity was found and all lesions were found to be recovered within the 28 day post exposure period. SCCS comments The file received for the study report was not signed by the study director and/or scientists involved. The report was supposedly to be published by the end of 2012, however, it was not found on Cefic website (June 2013). Size distributions of both nano- and micron-sized ZnO particles used","page":12,"route":"inhalation","species":"","study_id":"sccs_o_137_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1518 | - | - | - | - | - | SOURCE_SUBDIR=sccs_o_137; REPORT_TITLE=ADDENDUM to the OPINION SCCS/1489/12 on Zinc oxide (nano form) COLIPA S76; OPINION_NUMBER=SCCS/1518/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 April 2014; VALUE_TEXT=unclear:SCCS/1518/13 Revision of the addendum to the opinion on zinc oxide (nano form) ___________________________________________________________________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for; DOSE=Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein).; EFFECT=SCCS/1518/13 Revision of the addendum to the opinion on zinc oxide (nano form) ___________________________________________________________________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1314-13-2","citation":"","dose":"Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein).","duration":"","effect":"SCCS/1518/13 Revision of the addendum to the opinion on zinc oxide (nano form) ___________________________________________________________________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1518/13 Revision of the addendum to the opinion on zinc oxide (nano form) ___________________________________________________________________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for","page":13,"route":"","species":"","study_id":"sccs_o_137_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 96 | % | - | - | - | - | SOURCE_SUBDIR=sccs_o_137; REPORT_TITLE=ADDENDUM to the OPINION SCCS/1489/12 on Zinc oxide (nano form) COLIPA S76; OPINION_NUMBER=SCCS/1518/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 April 2014; VALUE_TEXT=96; DOSE=Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein).; EFFECT=______________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for use on the skin as UV filter in sunscreen formulations: 1. ZnO nanoparticles of purity ≥96%, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1314-13-2","citation":"","dose":"Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein).","duration":"","effect":"______________________________________ 13 animals were used. Some explanation might have given insight to how and why this was done. Statistical difference in total protein in BALF between high dose group Z-COTE® HP1 with controls not mentioned (high dose group 112.2 ± 8.7 vs control 79.6 ± 9.2 total protein). The NOAEL derived by the study authors is based on both observations in BAL and lung histopathology occurring at the high dose group and not in mid dose group of 1.5 mg/m3. However, the SCCS concludes on a NOAEL of 0.3 mg/ m3 in view of the ongoing activation of lung macrophages and lung draining lymph nodes. 4. CONCLUSION The SCCS concludes that ZnO nanomaterials with the following characteristics can be considered similar to the ZnO nanomaterials as evaluated in opinion SCCS/1489/12 and thus pose no or limited risk for use on the skin as UV filter in sunscreen formulations: 1. ZnO nanoparticles of purity ≥96%, with wurtzite crystalline structure and physical appearance as clusters that are rod-like, star-like and/or","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"96","page":13,"route":"","species":"","study_id":"sccs_o_137_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 4 | - | - | inhalation | 90 days | - | SOURCE_SUBDIR=sccs_o_137; REPORT_TITLE=ADDENDUM to the OPINION SCCS/1489/12 on Zinc oxide (nano form) COLIPA S76; OPINION_NUMBER=SCCS/1518/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=22 April 2014; VALUE_TEXT=unclear:. Other cosmetic ingredients can be used as coatings as long as they are demonstrated to the SCCS to be safe and do not affect the particle properties related to behaviour and/or effects, compared to the nanomaterials covered in the current opinion. 4. ZnO nanoparticles that have a comparable solubility to that reported in the dossier, i.e. below 50 mg/L (approximately the maximum solubility of the ZnO nanomaterials for which data are provided in the dossier). The submitted 90 days inhalation study resulted in a NOAEL of 0.3 mg/m3. However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects. 5. MINORITY OPINION / 6. REFERENCES /; EFFECT=. Other cosmetic ingredients can be used as coatings as long as they are demonstrated to the SCCS to be safe and do not affect the particle properties related to behaviour and/or effects, compared to the nanomaterials covered in the current opinion. 4. ZnO nanoparticles that have a comparable solubility to that reported in the dossier, i.e. below 50 mg/L (approximately the maximum solubility of the ZnO nanomaterials for which data are provided in the dossier). The submitted 90 days inhalation study resulted in a NOAEL of 0.3 mg/m3. However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects. 5. MINORITY OPINION / 6. REFERENCES /; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1314-13-2","citation":"","dose":"","duration":"90 days","effect":". Other cosmetic ingredients can be used as coatings as long as they are demonstrated to the SCCS to be safe and do not affect the particle properties related to behaviour and/or effects, compared to the nanomaterials covered in the current opinion. 4. ZnO nanoparticles that have a comparable solubility to that reported in the dossier, i.e. below 50 mg/L (approximately the maximum solubility of the ZnO nanomaterials for which data are provided in the dossier). The submitted 90 days inhalation study resulted in a NOAEL of 0.3 mg/m3. However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects. 5. MINORITY OPINION / 6. REFERENCES /","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"unclear:. Other cosmetic ingredients can be used as coatings as long as they are demonstrated to the SCCS to be safe and do not affect the particle properties related to behaviour and/or effects, compared to the nanomaterials covered in the current opinion. 4. ZnO nanoparticles that have a comparable solubility to that reported in the dossier, i.e. below 50 mg/L (approximately the maximum solubility of the ZnO nanomaterials for which data are provided in the dossier). The submitted 90 days inhalation study resulted in a NOAEL of 0.3 mg/m3. However these new data do not address the concerns relating to the lung exposure and the potential manifestation of harmful effects. 5. MINORITY OPINION / 6. REFERENCES /","page":13,"route":"inhalation","species":"","study_id":"sccs_o_137_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 1 | mg/kg bw | rat | intravenous | - | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=1; DOSE=In view of the indications for liver damage, a repeated dose toxicity study would have provided better information on potential toxicity.; EFFECT=toxic reactions were not observed. In view of the indications for liver damage, a repeated dose toxicity study would have provided better information on potential toxicity. In conclusion, after intravenous administration obtaining an internal dose of 5 mg/kg bw alterations in clinical pathology were observed that were indicative of liver damage. The liver damage appeared to be transient as similar alterations were not observed at four weeks after the single administration. Based on this study, the SCCS considers a NOAEL of 1 mg/kg bw for acute toxicity of ZnO in rats after intravenous administration. Additional studies submitted Additional information was included in the dossier on ZnO commercially obtained from Sigma-Aldrich and not related to the ZnO presented in the dossier. (References: 85, 94, 119); CITATION=(References: 85, 94, 119); CITATION_NUMBERS=[85,94,119]; REFERENCE=(References: 85, 94, 119); DETAILS_JSON={"cas_number":"1314-13-2","citation":"(References: 85, 94, 119)","dose":"In view of the indications for liver damage, a repeated dose toxicity study would have provided better information on potential toxicity.","duration":"","effect":"toxic reactions were not observed. In view of the indications for liver damage, a repeated dose toxicity study would have provided better information on potential toxicity. In conclusion, after intravenous administration obtaining an internal dose of 5 mg/kg bw alterations in clinical pathology were observed that were indicative of liver damage. The liver damage appeared to be transient as similar alterations were not observed at four weeks after the single administration. Based on this study, the SCCS considers a NOAEL of 1 mg/kg bw for acute toxicity of ZnO in rats after intravenous administration. Additional studies submitted Additional information was included in the dossier on ZnO commercially obtained from Sigma-Aldrich and not related to the ZnO presented in the dossier. (References: 85, 94, 119)","endpoint":"repeated dose toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1","page":86,"route":"intravenous","species":"rat","study_id":"sccs_o_103_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 2 | % | human | oral | 18 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=2; DOSE=An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.; EFFECT=nc or zinc compounds is therefore chosen to be 2%. Based on the physical appearance, for dust exposure to zinc or zinc compounds a 10-fold lower default value of 0.2% is chosen in the risk assessment. For sunscreen containing 10% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1314-13-2","citation":"","dose":"An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.","duration":"18 days","effect":"nc or zinc compounds is therefore chosen to be 2%. Based on the physical appearance, for dust exposure to zinc or zinc compounds a 10-fold lower default value of 0.2% is chosen in the risk assessment. For sunscreen containing 10% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical","endpoint":"repeated dose toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"%","noael_value":"2","page":89,"route":"oral","species":"human","study_id":"sccs_o_103_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 20 | % | human | oral | 18 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=20; DOSE=An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.; EFFECT=the risk assessment. For sunscreen containing 10% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consum; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1314-13-2","citation":"","dose":"An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.","duration":"18 days","effect":"the risk assessment. For sunscreen containing 10% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consum","endpoint":"repeated dose toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"%","noael_value":"20","page":89,"route":"oral","species":"human","study_id":"sccs_o_103_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 20 | % | human | oral | 18 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=20; DOSE=An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.; EFFECT=0% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1314-13-2","citation":"","dose":"An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.","duration":"18 days","effect":"0% zinc oxide the following exposure assessment was performed: By an application of 9 g sunscreen/event, 3 events/day during 18 days/year the exposure will be 1,332 mg sunscreen/day, being 107 mg Zn2+/day. Assuming a dermal absorption of 2% the uptake is estimated to be 2.14 mg Zn2+/ day. An NOAEL of 50 mg Zn2+/day was derived from a 10-week oral study with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this in","endpoint":"repeated dose toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"%","noael_value":"20","page":89,"route":"oral","species":"human","study_id":"sccs_o_103_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 20 | % | human | oral | - | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=20; DOSE=y with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.; EFFECT=y with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from th; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1314-13-2","citation":"","dose":"y with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity.","duration":"","effect":"y with human volunteers and was used as a starting point for the risk characterization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from th","endpoint":"repeated dose toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"%","noael_value":"20","page":89,"route":"oral","species":"human","study_id":"sccs_o_103_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 20 | % | human | oral | - | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_103; REPORT_TITLE=OPINION ON Zinc oxide (nano form) COLIPA S 76; OPINION_NUMBER=SCCS/1489/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 December 2012; VALUE_TEXT=20; DOSE=terization for repeated dose toxicity.; EFFECT=terization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from the SCCS Notes of Guidance for the risk assessment of zinc oxide nanoparticles; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"1314-13-2","citation":"","dose":"terization for repeated dose toxicity.","duration":"","effect":"terization for repeated dose toxicity. This NOAEL of 50 mg Zn2+/day results in an internal NOAEL of 10 mg Zn2+/day by correction for oral absorption (20%; worst case, because of the homeostasis the relative absorption will be smaller by excess of Zn2+-intake). Given that this study was with women (the most sensitive population in zinc supplementation studies), and that in women clinical signs begin to appear only at a dose three times this NOAEL, a minimal MOS of 1 is considered sufficient when comparing the human NOAEL with the exposure levels for workers/consumers/general population. The MOS between this internal NOAEL and the internal exposure as a result of exposure to sunscreen formulations is 5, which is a factor of 5 larger than the minimal MOS. The SCCS agrees with the NOAEL indicated in the RAR statement. Therefore, this information is used together with the data from the absorption study provided in the dossier and exposure assumptions from the SCCS Notes of Guidance for the risk assessment of zinc oxide nanoparticles","endpoint":"repeated dose toxicity","ingredient":"codes.................................... 9","loael_value":"","noael_unit":"%","noael_value":"20","page":89,"route":"oral","species":"human","study_id":"sccs_o_103_noael_008"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | SOI2LOH54Z | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"O.Zn","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SOI2LOH54Z"} |
| openFDA substances | FDA UNII substance identifier | SOI2LOH54Z | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"O.Zn","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SOI2LOH54Z"} |
| openFDA substances | FDA UNII substance identifier | SOI2LOH54Z | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"O.Zn","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SOI2LOH54Z"} |
| openFDA substances | FDA UNII substance identifier | SOI2LOH54Z | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"O.Zn","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"SOI2LOH54Z"} |