NOAEL Studies Cosmetic Ingredient

ZINC ACETATE NOAEL Studies

CAS: 557-34-6

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

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SCCS Opinion 48 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
SCCS Opinion NOAEL =0.1 % - oral - NOAEL study {"effect":"-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 16 Table 3 – Aggregate exposures in comparison to ULs and NOAEL. Age Intake from Toothpaste at 1.0 % Zn Intake from Mouthwash at 0.1 % Zn Aggregate Intake from Oral Care Weighted Median Dietary Intake based on food consumption data SCF Tolerable Upper Intake Levels IOM Tolerable Upper Intake Levels Aggregate Exposure Oral Care + Weighted Dietary Average NOAEL by Yadrik et al. (1989) [years] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] 1 2.00 0 2.00 5.01 7 7 7.01 10 2 2.00 0 2.00 5.01 7 7 7.01 10 3 2.00 0 2.00 7.40 7 7 9.40 10 4 2.00 0 2.00 7.40 10 12 9.40 16 5 2.00 0 2.00 7.40 10 12 9.40 16 6 2.00 2.16 4.16 7.40 10 12 11.56 16 7 1.38 2.16 3.54 7.40 13 12 10.94 24 8 1.38 2.16 3.54 7.40 13 12 10.94 24 9 1.38 2.16 3.54 7.40 13 23 10.94 24 10 1.38 2.16 3.54 8.74 13 23 12.28 24 11 1.38 2.16 3.54 8.74 18 23 12.28 37 12 1.38 2.16 3.54 8.74 1","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_005"}
SCCS Opinion NOAEL =0.1 % - oral - NOAEL study {"effect":"-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 16 Table 3 – Aggregate exposures in comparison to ULs and NOAEL. Age Intake from Toothpaste at 1.0 % Zn Intake from Mouthwash at 0.1 % Zn Aggregate Intake from Oral Care Weighted Median Dietary Intake based on food consumption data SCF Tolerable Upper Intake Levels IOM Tolerable Upper Intake Levels Aggregate Exposure Oral Care + Weighted Dietary Average NOAEL by Yadrik et al. (1989) [years] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] 1 2.00 0 2.00 5.01 7 7 7.01 10 2 2.00 0 2.00 5.01 7 7 7.01 10 3 2.00 0 2.00 7.40 7 7 9.40 10 4 2.00 0 2.00 7.40 10 12 9.40 16 5 2.00 0 2.00 7.40 10 12 9.40 16 6 2.00 2.16 4.16 7.40 10 12 11.56 16 7 1.38 2.16 3.54 7.40 13 12 10.94 24 8 1.38 2.16 3.54 7.40 13 12 10.94 24 9 1.38 2.16 3.54 7.40 13 23 10.94 24 10 1.38 2.16 3.54 8.74 13 23 12.28 24 11 1.38 2.16 3.54 8.74 18 23 12.28 37 12 1.38 2.16 3.54 8.74 1","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_005"}
SCCS Opinion NOAEL =0.1 % - oral - NOAEL study {"effect":"-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 16 Table 3 – Aggregate exposures in comparison to ULs and NOAEL. Age Intake from Toothpaste at 1.0 % Zn Intake from Mouthwash at 0.1 % Zn Aggregate Intake from Oral Care Weighted Median Dietary Intake based on food consumption data SCF Tolerable Upper Intake Levels IOM Tolerable Upper Intake Levels Aggregate Exposure Oral Care + Weighted Dietary Average NOAEL by Yadrik et al. (1989) [years] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] 1 2.00 0 2.00 5.01 7 7 7.01 10 2 2.00 0 2.00 5.01 7 7 7.01 10 3 2.00 0 2.00 7.40 7 7 9.40 10 4 2.00 0 2.00 7.40 10 12 9.40 16 5 2.00 0 2.00 7.40 10 12 9.40 16 6 2.00 2.16 4.16 7.40 10 12 11.56 16 7 1.38 2.16 3.54 7.40 13 12 10.94 24 8 1.38 2.16 3.54 7.40 13 12 10.94 24 9 1.38 2.16 3.54 7.40 13 23 10.94 24 10 1.38 2.16 3.54 8.74 13 23 12.28 24 11 1.38 2.16 3.54 8.74 18 23 12.28 37 12 1.38 2.16 3.54 8.74 1","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_005"}
SCCS Opinion NOAEL =0.1 % - oral - NOAEL study {"effect":"-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 16 Table 3 – Aggregate exposures in comparison to ULs and NOAEL. Age Intake from Toothpaste at 1.0 % Zn Intake from Mouthwash at 0.1 % Zn Aggregate Intake from Oral Care Weighted Median Dietary Intake based on food consumption data SCF Tolerable Upper Intake Levels IOM Tolerable Upper Intake Levels Aggregate Exposure Oral Care + Weighted Dietary Average NOAEL by Yadrik et al. (1989) [years] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] 1 2.00 0 2.00 5.01 7 7 7.01 10 2 2.00 0 2.00 5.01 7 7 7.01 10 3 2.00 0 2.00 7.40 7 7 9.40 10 4 2.00 0 2.00 7.40 10 12 9.40 16 5 2.00 0 2.00 7.40 10 12 9.40 16 6 2.00 2.16 4.16 7.40 10 12 11.56 16 7 1.38 2.16 3.54 7.40 13 12 10.94 24 8 1.38 2.16 3.54 7.40 13 12 10.94 24 9 1.38 2.16 3.54 7.40 13 23 10.94 24 10 1.38 2.16 3.54 8.74 13 23 12.28 24 11 1.38 2.16 3.54 8.74 18 23 12.28 37 12 1.38 2.16 3.54 8.74 1","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_005"}
SCCS Opinion NOAEL =0.43 - - oral - NOAEL study {"effect":"ased concentrations of plasma copper and decreased activity of copper-containing enzymes (superoxide dismutase and caeruloplasmin), altered lipoprotein metabolism and impaired immune function. Many of the reported biochemical and physiological changes are comparable to those observed during copper deficiency, and the reduction in superoxide dismutase activity might mark the range where effects on copper balance begin. Based on an oral zinc intake level where no effects on parameters of the copper balance occur, a NOAEL of 0.43 mg zinc/kg body weight and day (corresponding to 25.8 mg/day for an adult with a body weight of 60 kg) after oral intake was defined by Hartwig et al. (2014). From the data available, the experts of the SCF (2003) drew the conclusion that no adverse effects are to be expected at zinc doses below 50 mg/day. This NOAEL was based on the absence of any adverse effects on a wide range of relevant indicators of copper status (such as erythrocyte copper-zinc superoxide dismutase activity, lipoprotein metabolism,","page":9,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_001"}
SCCS Opinion NOAEL =0.43 - - oral - NOAEL study {"effect":"ased concentrations of plasma copper and decreased activity of copper-containing enzymes (superoxide dismutase and caeruloplasmin), altered lipoprotein metabolism and impaired immune function. Many of the reported biochemical and physiological changes are comparable to those observed during copper deficiency, and the reduction in superoxide dismutase activity might mark the range where effects on copper balance begin. Based on an oral zinc intake level where no effects on parameters of the copper balance occur, a NOAEL of 0.43 mg zinc/kg body weight and day (corresponding to 25.8 mg/day for an adult with a body weight of 60 kg) after oral intake was defined by Hartwig et al. (2014). From the data available, the experts of the SCF (2003) drew the conclusion that no adverse effects are to be expected at zinc doses below 50 mg/day. This NOAEL was based on the absence of any adverse effects on a wide range of relevant indicators of copper status (such as erythrocyte copper-zinc superoxide dismutase activity, lipoprotein metabolism,","page":9,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_001"}
SCCS Opinion NOAEL =0.43 - - oral - NOAEL study {"effect":"ased concentrations of plasma copper and decreased activity of copper-containing enzymes (superoxide dismutase and caeruloplasmin), altered lipoprotein metabolism and impaired immune function. Many of the reported biochemical and physiological changes are comparable to those observed during copper deficiency, and the reduction in superoxide dismutase activity might mark the range where effects on copper balance begin. Based on an oral zinc intake level where no effects on parameters of the copper balance occur, a NOAEL of 0.43 mg zinc/kg body weight and day (corresponding to 25.8 mg/day for an adult with a body weight of 60 kg) after oral intake was defined by Hartwig et al. (2014). From the data available, the experts of the SCF (2003) drew the conclusion that no adverse effects are to be expected at zinc doses below 50 mg/day. This NOAEL was based on the absence of any adverse effects on a wide range of relevant indicators of copper status (such as erythrocyte copper-zinc superoxide dismutase activity, lipoprotein metabolism,","page":9,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_001"}
SCCS Opinion NOAEL =0.43 - - oral - NOAEL study {"effect":"ased concentrations of plasma copper and decreased activity of copper-containing enzymes (superoxide dismutase and caeruloplasmin), altered lipoprotein metabolism and impaired immune function. Many of the reported biochemical and physiological changes are comparable to those observed during copper deficiency, and the reduction in superoxide dismutase activity might mark the range where effects on copper balance begin. Based on an oral zinc intake level where no effects on parameters of the copper balance occur, a NOAEL of 0.43 mg zinc/kg body weight and day (corresponding to 25.8 mg/day for an adult with a body weight of 60 kg) after oral intake was defined by Hartwig et al. (2014). From the data available, the experts of the SCF (2003) drew the conclusion that no adverse effects are to be expected at zinc doses below 50 mg/day. This NOAEL was based on the absence of any adverse effects on a wide range of relevant indicators of copper status (such as erythrocyte copper-zinc superoxide dismutase activity, lipoprotein metabolism,","page":9,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_001"}
SCCS Opinion NOAEL =1 % - oral - NOAEL study {"effect":"SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 16 Table 3 – Aggregate exposures in comparison to ULs and NOAEL. Age Intake from Toothpaste at 1.0 % Zn Intake from Mouthwash at 0.1 % Zn Aggregate Intake from Oral Care Weighted Median Dietary Intake based on food consumption data SCF Tolerable Upper Intake Levels IOM Tolerable Upper Intake Levels Aggregate Exposure Oral Care + Weighted Dietary Average NOAEL by Yadrik et al. (1989) [years] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] 1 2.00 0 2.00 5.01 7 7 7.01 10 2 2.00 0 2.00 5.01 7 7 7.01 10 3 2.00 0 2.00 7.40 7 7 9.40 10 4 2.00 0 2.00","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_004"}
SCCS Opinion NOAEL =1 % - oral - NOAEL study {"effect":"SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 16 Table 3 – Aggregate exposures in comparison to ULs and NOAEL. Age Intake from Toothpaste at 1.0 % Zn Intake from Mouthwash at 0.1 % Zn Aggregate Intake from Oral Care Weighted Median Dietary Intake based on food consumption data SCF Tolerable Upper Intake Levels IOM Tolerable Upper Intake Levels Aggregate Exposure Oral Care + Weighted Dietary Average NOAEL by Yadrik et al. (1989) [years] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] 1 2.00 0 2.00 5.01 7 7 7.01 10 2 2.00 0 2.00 5.01 7 7 7.01 10 3 2.00 0 2.00 7.40 7 7 9.40 10 4 2.00 0 2.00","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_004"}
SCCS Opinion NOAEL =1 % - oral - NOAEL study {"effect":"SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 16 Table 3 – Aggregate exposures in comparison to ULs and NOAEL. Age Intake from Toothpaste at 1.0 % Zn Intake from Mouthwash at 0.1 % Zn Aggregate Intake from Oral Care Weighted Median Dietary Intake based on food consumption data SCF Tolerable Upper Intake Levels IOM Tolerable Upper Intake Levels Aggregate Exposure Oral Care + Weighted Dietary Average NOAEL by Yadrik et al. (1989) [years] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] 1 2.00 0 2.00 5.01 7 7 7.01 10 2 2.00 0 2.00 5.01 7 7 7.01 10 3 2.00 0 2.00 7.40 7 7 9.40 10 4 2.00 0 2.00","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_004"}
SCCS Opinion NOAEL =1 % - oral - NOAEL study {"effect":"SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 16 Table 3 – Aggregate exposures in comparison to ULs and NOAEL. Age Intake from Toothpaste at 1.0 % Zn Intake from Mouthwash at 0.1 % Zn Aggregate Intake from Oral Care Weighted Median Dietary Intake based on food consumption data SCF Tolerable Upper Intake Levels IOM Tolerable Upper Intake Levels Aggregate Exposure Oral Care + Weighted Dietary Average NOAEL by Yadrik et al. (1989) [years] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] 1 2.00 0 2.00 5.01 7 7 7.01 10 2 2.00 0 2.00 5.01 7 7 7.01 10 3 2.00 0 2.00 7.40 7 7 9.40 10 4 2.00 0 2.00","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_004"}
SCCS Opinion NOAEL =6 - - oral 6 year NOAEL study {"effect":"hed UL for 6 year-olds is the value for age 4, while it should instead be closer to the UL for age 7. In addition, dietary intakes were also grouped - by even larger age differentials. Thus, the dietary intake for age 3 is dominated by data from older children (up to age 9). Consequently, dietary intake data for 3 year-olds must be considered exceedingly conservative as well. In conclusion, Table 3 might provide the incorrect impression that zinc exposure randomly peaks above known safe levels (but still below the NOAEL) for ages 3 and 6. It is important to emphasize that these levels do not pose a health hazard, that the body maintains the homeostasis of this essential element at these exposure levels, and that the arbitrarily set ULs and dietary intake age groups artificially create false concerns. Zinc does not spontaneously exert toxicity with the 3rd and 6th birthday.","page":15,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_003"}
SCCS Opinion NOAEL =6 - - oral 6 year NOAEL study {"effect":"hed UL for 6 year-olds is the value for age 4, while it should instead be closer to the UL for age 7. In addition, dietary intakes were also grouped - by even larger age differentials. Thus, the dietary intake for age 3 is dominated by data from older children (up to age 9). Consequently, dietary intake data for 3 year-olds must be considered exceedingly conservative as well. In conclusion, Table 3 might provide the incorrect impression that zinc exposure randomly peaks above known safe levels (but still below the NOAEL) for ages 3 and 6. It is important to emphasize that these levels do not pose a health hazard, that the body maintains the homeostasis of this essential element at these exposure levels, and that the arbitrarily set ULs and dietary intake age groups artificially create false concerns. Zinc does not spontaneously exert toxicity with the 3rd and 6th birthday.","page":15,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_003"}
SCCS Opinion NOAEL =6 - - oral 6 year NOAEL study {"effect":"hed UL for 6 year-olds is the value for age 4, while it should instead be closer to the UL for age 7. In addition, dietary intakes were also grouped - by even larger age differentials. Thus, the dietary intake for age 3 is dominated by data from older children (up to age 9). Consequently, dietary intake data for 3 year-olds must be considered exceedingly conservative as well. In conclusion, Table 3 might provide the incorrect impression that zinc exposure randomly peaks above known safe levels (but still below the NOAEL) for ages 3 and 6. It is important to emphasize that these levels do not pose a health hazard, that the body maintains the homeostasis of this essential element at these exposure levels, and that the arbitrarily set ULs and dietary intake age groups artificially create false concerns. Zinc does not spontaneously exert toxicity with the 3rd and 6th birthday.","page":15,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_003"}
SCCS Opinion NOAEL =6 - - oral 6 year NOAEL study {"effect":"hed UL for 6 year-olds is the value for age 4, while it should instead be closer to the UL for age 7. In addition, dietary intakes were also grouped - by even larger age differentials. Thus, the dietary intake for age 3 is dominated by data from older children (up to age 9). Consequently, dietary intake data for 3 year-olds must be considered exceedingly conservative as well. In conclusion, Table 3 might provide the incorrect impression that zinc exposure randomly peaks above known safe levels (but still below the NOAEL) for ages 3 and 6. It is important to emphasize that these levels do not pose a health hazard, that the body maintains the homeostasis of this essential element at these exposure levels, and that the arbitrarily set ULs and dietary intake age groups artificially create false concerns. Zinc does not spontaneously exert toxicity with the 3rd and 6th birthday.","page":15,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_003"}
SCCS Opinion NOAEL =10 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 1 | 2.00 | 0 | 2.00 | 5.01 | 7 | 7 | 7.01 | 10","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_009"}
SCCS Opinion NOAEL =10 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 1 | 2.00 | 0 | 2.00 | 5.01 | 7 | 7 | 7.01 | 10","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_009"}
SCCS Opinion NOAEL =10 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 1 | 2.00 | 0 | 2.00 | 5.01 | 7 | 7 | 7.01 | 10","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_009"}
SCCS Opinion NOAEL =10 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 1 | 2.00 | 0 | 2.00 | 5.01 | 7 | 7 | 7.01 | 10","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_009"}
SCCS Opinion NOAEL =16 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 4 | 2.00 | 0 | 2.00 | 7.40 | 10 | 12 | 9.40 | 16","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_012"}
SCCS Opinion NOAEL =16 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 4 | 2.00 | 0 | 2.00 | 7.40 | 10 | 12 | 9.40 | 16","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_012"}
SCCS Opinion NOAEL =16 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 4 | 2.00 | 0 | 2.00 | 7.40 | 10 | 12 | 9.40 | 16","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_012"}
SCCS Opinion NOAEL =16 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 4 | 2.00 | 0 | 2.00 | 7.40 | 10 | 12 | 9.40 | 16","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_012"}
SCCS Opinion NOAEL =17 - - oral - NOAEL study {"effect":"salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Upper Intake Levels (UL) =25*((BW/60)^0.75) The SCCS calculated the aggregate exposure to zinc from cosmetics and diet according to the largest median reported by EFSA. Table 4 and Figure 1 below summarise the total aggregated oral exposure for zinc from a","page":17,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_007"}
SCCS Opinion NOAEL =17 - - oral - NOAEL study {"effect":"salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Upper Intake Levels (UL) =25*((BW/60)^0.75) The SCCS calculated the aggregate exposure to zinc from cosmetics and diet according to the largest median reported by EFSA. Table 4 and Figure 1 below summarise the total aggregated oral exposure for zinc from a","page":17,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_007"}
SCCS Opinion NOAEL =17 - - oral - NOAEL study {"effect":"salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Upper Intake Levels (UL) =25*((BW/60)^0.75) The SCCS calculated the aggregate exposure to zinc from cosmetics and diet according to the largest median reported by EFSA. Table 4 and Figure 1 below summarise the total aggregated oral exposure for zinc from a","page":17,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_007"}
SCCS Opinion NOAEL =17 - - oral - NOAEL study {"effect":"salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Upper Intake Levels (UL) =25*((BW/60)^0.75) The SCCS calculated the aggregate exposure to zinc from cosmetics and diet according to the largest median reported by EFSA. Table 4 and Figure 1 below summarise the total aggregated oral exposure for zinc from a","page":17,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_007"}
SCCS Opinion NOAEL =24 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 7 | 1.38 | 2.16 | 3.54 | 7.40 | 13 | 12 | 10.94 | 24","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_015"}
SCCS Opinion NOAEL =24 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 7 | 1.38 | 2.16 | 3.54 | 7.40 | 13 | 12 | 10.94 | 24","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_015"}
SCCS Opinion NOAEL =24 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 7 | 1.38 | 2.16 | 3.54 | 7.40 | 13 | 12 | 10.94 | 24","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_015"}
SCCS Opinion NOAEL =24 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 7 | 1.38 | 2.16 | 3.54 | 7.40 | 13 | 12 | 10.94 | 24","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_015"}
SCCS Opinion NOAEL =37 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 11 | 1.38 | 2.16 | 3.54 | 8.74 | 18 | 23 | 12.28 | 37","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_019"}
SCCS Opinion NOAEL =37 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 11 | 1.38 | 2.16 | 3.54 | 8.74 | 18 | 23 | 12.28 | 37","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_019"}
SCCS Opinion NOAEL =37 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 11 | 1.38 | 2.16 | 3.54 | 8.74 | 18 | 23 | 12.28 | 37","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_019"}
SCCS Opinion NOAEL =37 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 11 | 1.38 | 2.16 | 3.54 | 8.74 | 18 | 23 | 12.28 | 37","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_019"}
SCCS Opinion NOAEL =50 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 15 | 1.38 | 2.16 | 3.54 | 8.74 | 22 | 34 | 12.28 | 50","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_023"}
SCCS Opinion NOAEL =50 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 15 | 1.38 | 2.16 | 3.54 | 8.74 | 22 | 34 | 12.28 | 50","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_023"}
SCCS Opinion NOAEL =50 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 15 | 1.38 | 2.16 | 3.54 | 8.74 | 22 | 34 | 12.28 | 50","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_023"}
SCCS Opinion NOAEL =50 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 15 | 1.38 | 2.16 | 3.54 | 8.74 | 22 | 34 | 12.28 | 50","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_023"}
SCCS Opinion NOAEL =53 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: adult | 1.38 | 2.16 | 3.54 | 9.76 | 25 | 40 | 12.28 | 53","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_026"}
SCCS Opinion NOAEL =53 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: adult | 1.38 | 2.16 | 3.54 | 9.76 | 25 | 40 | 12.28 | 53","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_026"}
SCCS Opinion NOAEL =53 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: adult | 1.38 | 2.16 | 3.54 | 9.76 | 25 | 40 | 12.28 | 53","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_026"}
SCCS Opinion NOAEL =53 - - - - NOAEL study {"effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: adult | 1.38 | 2.16 | 3.54 | 9.76 | 25 | 40 | 12.28 | 53","page":16,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_026"}
SCCS Opinion NOAEL =1657 - - oral - NOAEL study {"effect":"SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Up","page":17,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_006"}
SCCS Opinion NOAEL =1657 - - oral - NOAEL study {"effect":"SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Up","page":17,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_006"}
SCCS Opinion NOAEL =1657 - - oral - NOAEL study {"effect":"SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Up","page":17,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_006"}
SCCS Opinion NOAEL =1657 - - oral - NOAEL study {"effect":"SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Up","page":17,"pdf":"sccs_o_279.pdf","row_type":"noael_study","study_id":"sccs_o_279_noael_006"}
ECHA 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ECHA LOAEL =136 mg/kg bw/day Mouse oral - subchronic QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaa35e4b0a7c65d1b4d83; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17716/7/10/2?documentUUID=a81c8668-011c-4386-863a-f63c77d30a06; YEAR=1993; ORIGINAL_YEAR=1993; STUDY_GROUP=ECHA IUCLID:15825519: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_d85152cf70b2779125ea1c3d49520ead
ECHA NOAEL >=8 mg/kg bw/day Rat injection - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c905e4b0a7c65d21b381; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17716/7/9/2?documentUUID=a81c8668-011c-4386-863a-f63c77d30a06; YEAR=1993; ORIGINAL_YEAR=1993; STUDY_GROUP=ECHA IUCLID:15857517:M:P0-; 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_fc6d72bf89ba796dbea210c8281bdbf4
ECHA NOAEL =50 mg/kg bw/day Rat oral - reproduction developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab0de4b0a7c65d1b8a3e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17716/7/9/2?documentUUID=a81c8668-011c-4386-863a-f63c77d30a06; YEAR=1993; ORIGINAL_YEAR=1993; STUDY_GROUP=ECHA IUCLID:15855869:F:P0-; 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_976cd0c72a6399d682574160a0131416
ECHA NOAEL >=372 mg/kg bw/day Mouse oral - developmental QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eab0de4b0a7c65d1b8a3a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/17716/7/9/2?documentUUID=a81c8668-011c-4386-863a-f63c77d30a06; YEAR=1993; ORIGINAL_YEAR=1993; STUDY_GROUP=ECHA IUCLID:15862060:M/F:F1-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_a28eb206cbb024e68b24a742dd382e94
ToxValDB ECOTOX 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB ECOTOX LOEL =0.1 mg/mL Mouse oral short-term; 2 weeks short-term LONG_REF=- | J. Infect.50(5): 417-424 Tran,C.D., M.A.F. Campbell, Y. Kolev, S. Chamberlain, H.Q. Huynh, and R.N. Butler Short-Term Zinc Supplementation Attenuates Helicobacter felis-Induced Gastritis in the Mouse 2005; TITLE=Short-Term Zinc Supplementation Attenuates Helicobacter felis-Induced Gastritis in the Mouse; AUTHOR=Tran,C.D., M.A.F. Campbell, Y. Kolev, S. Chamberlain, H.Q. Huynh, and R.N. Butler; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=100807; 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=2005; ORIGINAL_YEAR=2005; TOXICOLOGICAL_EFFECT=Histology: Histological changes in stomach; STUDY_GROUP=ECOTOX:15613158:F:--; 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=d87abb08ff3732f563637ab33b4809a5
ToxValDB ECOTOX LOEL =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: Concurrent 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:15608793:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=9717510e56a08a01fa115b740ffbd785
ToxValDB ECOTOX LOEL =5000 mg/kg bw/day Rat oral short-term; 30 days short-term LONG_REF=- | Toxicol. Lett.29(1): 1-4 Rana,S.V.S., R. Prakash, A. Kumar, and C.B. Sharma A Study of Glycogen in the Liver of Metal-fed Rats 1985; TITLE=A Study of Glycogen in the Liver of Metal-fed Rats; AUTHOR=Rana,S.V.S., R. Prakash, A. Kumar, and C.B. Sharma; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=73682; 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=1985; ORIGINAL_YEAR=1985; TOXICOLOGICAL_EFFECT=Biochemistry: Glycogen, increase; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15613368: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=ad76450946ad7ac0835d32d27dc9efa5
ToxValDB ECOTOX NOEL =444 ppm Rat oral short-term; 11 days short-term LONG_REF=Toxicol. Appl. Pharmacol.48:229-235 Khera,K.S., and B.G. Shah Failure of Zinc Acetate to Reduce Ethylenethiourea-Induced Fetal Anomalies in Rats 1979; TITLE=Failure of Zinc Acetate to Reduce Ethylenethiourea-Induced Fetal Anomalies in Rats; AUTHOR=Khera,K.S., and B.G. Shah; DOI=10.1016/0041-008x(79)90028-0; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=67806; 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=1979; ORIGINAL_YEAR=1979; TOXICOLOGICAL_EFFECT=Growth: Weight|Reproduction: Early resorbed embryos|Reproduction: Late resorbed embryos|Reproduction: Pregnant, Paris or Gravid|Reproduction: Viability; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|reproduction; STUDY_GROUP=ECOTOX:15596308:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=18b729ac19fb9b27c61109665f7a5326
ToxValDB GESTIS DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB GESTIS DNEL DNEL systemic =4.71 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:15635761:-:--; 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_c4b9a5b2d4c4688b33573219c56e9598
Regulatory source 26 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source - 0.1 % - oral - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=0.1; EFFECT=-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 16 Table 3 – Aggregate exposures in comparison to ULs and NOAEL. Age Intake from Toothpaste at 1.0 % Zn Intake from Mouthwash at 0.1 % Zn Aggregate Intake from Oral Care Weighted Median Dietary Intake based on food consumption data SCF Tolerable Upper Intake Levels IOM Tolerable Upper Intake Levels Aggregate Exposure Oral Care + Weighted Dietary Average NOAEL by Yadrik et al. (1989) [years] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] 1 2.00 0 2.00 5.01 7 7 7.01 10 2 2.00 0 2.00 5.01 7 7 7.01 10 3 2.00 0 2.00 7.40 7 7 9.40 10 4 2.00 0 2.00 7.40 10 12 9.40 16 5 2.00 0 2.00 7.40 10 12 9.40 16 6 2.00 2.16 4.16 7.40 10 12 11.56 16 7 1.38 2.16 3.54 7.40 13 12 10.94 24 8 1.38 2.16 3.54 7.40 13 12 10.94 24 9 1.38 2.16 3.54 7.40 13 23 10.94 24 10 1.38 2.16 3.54 8.74 13 23 12.28 24 11 1.38 2.16 3.54 8.74 18 23 12.28 37 12 1.38 2.16 3.54 8.74 1; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 16 Table 3 – Aggregate exposures in comparison to ULs and NOAEL. Age Intake from Toothpaste at 1.0 % Zn Intake from Mouthwash at 0.1 % Zn Aggregate Intake from Oral Care Weighted Median Dietary Intake based on food consumption data SCF Tolerable Upper Intake Levels IOM Tolerable Upper Intake Levels Aggregate Exposure Oral Care + Weighted Dietary Average NOAEL by Yadrik et al. (1989) [years] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] 1 2.00 0 2.00 5.01 7 7 7.01 10 2 2.00 0 2.00 5.01 7 7 7.01 10 3 2.00 0 2.00 7.40 7 7 9.40 10 4 2.00 0 2.00 7.40 10 12 9.40 16 5 2.00 0 2.00 7.40 10 12 9.40 16 6 2.00 2.16 4.16 7.40 10 12 11.56 16 7 1.38 2.16 3.54 7.40 13 12 10.94 24 8 1.38 2.16 3.54 7.40 13 12 10.94 24 9 1.38 2.16 3.54 7.40 13 23 10.94 24 10 1.38 2.16 3.54 8.74 13 23 12.28 24 11 1.38 2.16 3.54 8.74 18 23 12.28 37 12 1.38 2.16 3.54 8.74 1","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"0.1","page":16,"route":"oral","species":"","study_id":"sccs_o_279_noael_005"}
Regulatory source - 0.43 - - oral - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=unclear:ased concentrations of plasma copper and decreased activity of copper-containing enzymes (superoxide dismutase and caeruloplasmin), altered lipoprotein metabolism and impaired immune function. Many of the reported biochemical and physiological changes are comparable to those observed during copper deficiency, and the reduction in superoxide dismutase activity might mark the range where effects on copper balance begin. Based on an oral zinc intake level where no effects on parameters of the copper balance occur, a NOAEL of 0.43 mg zinc/kg body weight and day (corresponding to 25.8 mg/day for an adult with a body weight of 60 kg) after oral intake was defined by Hartwig et al. (2014). From the data available, the experts of the SCF (2003) drew the conclusion that no adverse effects are to be expected at zinc doses below 50 mg/day. This NOAEL was based on the absence of any adverse effects on a wide range of relevant indicators of copper status (such as erythrocyte copper-zinc superoxide dismutase activity, lipoprotein metabolism,; EFFECT=ased concentrations of plasma copper and decreased activity of copper-containing enzymes (superoxide dismutase and caeruloplasmin), altered lipoprotein metabolism and impaired immune function. Many of the reported biochemical and physiological changes are comparable to those observed during copper deficiency, and the reduction in superoxide dismutase activity might mark the range where effects on copper balance begin. Based on an oral zinc intake level where no effects on parameters of the copper balance occur, a NOAEL of 0.43 mg zinc/kg body weight and day (corresponding to 25.8 mg/day for an adult with a body weight of 60 kg) after oral intake was defined by Hartwig et al. (2014). From the data available, the experts of the SCF (2003) drew the conclusion that no adverse effects are to be expected at zinc doses below 50 mg/day. This NOAEL was based on the absence of any adverse effects on a wide range of relevant indicators of copper status (such as erythrocyte copper-zinc superoxide dismutase activity, lipoprotein metabolism,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"ased concentrations of plasma copper and decreased activity of copper-containing enzymes (superoxide dismutase and caeruloplasmin), altered lipoprotein metabolism and impaired immune function. Many of the reported biochemical and physiological changes are comparable to those observed during copper deficiency, and the reduction in superoxide dismutase activity might mark the range where effects on copper balance begin. Based on an oral zinc intake level where no effects on parameters of the copper balance occur, a NOAEL of 0.43 mg zinc/kg body weight and day (corresponding to 25.8 mg/day for an adult with a body weight of 60 kg) after oral intake was defined by Hartwig et al. (2014). From the data available, the experts of the SCF (2003) drew the conclusion that no adverse effects are to be expected at zinc doses below 50 mg/day. This NOAEL was based on the absence of any adverse effects on a wide range of relevant indicators of copper status (such as erythrocyte copper-zinc superoxide dismutase activity, lipoprotein metabolism,","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:ased concentrations of plasma copper and decreased activity of copper-containing enzymes (superoxide dismutase and caeruloplasmin), altered lipoprotein metabolism and impaired immune function. Many of the reported biochemical and physiological changes are comparable to those observed during copper deficiency, and the reduction in superoxide dismutase activity might mark the range where effects on copper balance begin. Based on an oral zinc intake level where no effects on parameters of the copper balance occur, a NOAEL of 0.43 mg zinc/kg body weight and day (corresponding to 25.8 mg/day for an adult with a body weight of 60 kg) after oral intake was defined by Hartwig et al. (2014). From the data available, the experts of the SCF (2003) drew the conclusion that no adverse effects are to be expected at zinc doses below 50 mg/day. This NOAEL was based on the absence of any adverse effects on a wide range of relevant indicators of copper status (such as erythrocyte copper-zinc superoxide dismutase activity, lipoprotein metabolism,","page":9,"route":"oral","species":"","study_id":"sccs_o_279_noael_001"}
Regulatory source - 0.43 - - oral - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=unclear:in superoxide dismutase activity might mark the range where effects on copper balance begin. Based on an oral zinc intake level where no effects on parameters of the copper balance occur, a NOAEL of 0.43 mg zinc/kg body weight and day (corresponding to 25.8 mg/day for an adult with a body weight of 60 kg) after oral intake was defined by Hartwig et al. (2014). From the data available, the experts of the SCF (2003) drew the conclusion that no adverse effects are to be expected at zinc doses below 50 mg/day. This NOAEL was based on the absence of any adverse effects on a wide range of relevant indicators of copper status (such as erythrocyte copper-zinc superoxide dismutase activity, lipoprotein metabolism, and haemoglobin and blood profiles). It is also inferred that, taking into account an uncertainty factor of 2 due to the sometimes small number of test persons in the short-term studies, an upper limit (UL) of 25 mg/day of zinc for adults should not be exceeded. Available studies indicate no increased susceptibility to zinc s; EFFECT=in superoxide dismutase activity might mark the range where effects on copper balance begin. Based on an oral zinc intake level where no effects on parameters of the copper balance occur, a NOAEL of 0.43 mg zinc/kg body weight and day (corresponding to 25.8 mg/day for an adult with a body weight of 60 kg) after oral intake was defined by Hartwig et al. (2014). From the data available, the experts of the SCF (2003) drew the conclusion that no adverse effects are to be expected at zinc doses below 50 mg/day. This NOAEL was based on the absence of any adverse effects on a wide range of relevant indicators of copper status (such as erythrocyte copper-zinc superoxide dismutase activity, lipoprotein metabolism, and haemoglobin and blood profiles). It is also inferred that, taking into account an uncertainty factor of 2 due to the sometimes small number of test persons in the short-term studies, an upper limit (UL) of 25 mg/day of zinc for adults should not be exceeded. Available studies indicate no increased susceptibility to zinc s; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"in superoxide dismutase activity might mark the range where effects on copper balance begin. Based on an oral zinc intake level where no effects on parameters of the copper balance occur, a NOAEL of 0.43 mg zinc/kg body weight and day (corresponding to 25.8 mg/day for an adult with a body weight of 60 kg) after oral intake was defined by Hartwig et al. (2014). From the data available, the experts of the SCF (2003) drew the conclusion that no adverse effects are to be expected at zinc doses below 50 mg/day. This NOAEL was based on the absence of any adverse effects on a wide range of relevant indicators of copper status (such as erythrocyte copper-zinc superoxide dismutase activity, lipoprotein metabolism, and haemoglobin and blood profiles). It is also inferred that, taking into account an uncertainty factor of 2 due to the sometimes small number of test persons in the short-term studies, an upper limit (UL) of 25 mg/day of zinc for adults should not be exceeded. Available studies indicate no increased susceptibility to zinc s","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:in superoxide dismutase activity might mark the range where effects on copper balance begin. Based on an oral zinc intake level where no effects on parameters of the copper balance occur, a NOAEL of 0.43 mg zinc/kg body weight and day (corresponding to 25.8 mg/day for an adult with a body weight of 60 kg) after oral intake was defined by Hartwig et al. (2014). From the data available, the experts of the SCF (2003) drew the conclusion that no adverse effects are to be expected at zinc doses below 50 mg/day. This NOAEL was based on the absence of any adverse effects on a wide range of relevant indicators of copper status (such as erythrocyte copper-zinc superoxide dismutase activity, lipoprotein metabolism, and haemoglobin and blood profiles). It is also inferred that, taking into account an uncertainty factor of 2 due to the sometimes small number of test persons in the short-term studies, an upper limit (UL) of 25 mg/day of zinc for adults should not be exceeded. Available studies indicate no increased susceptibility to zinc s","page":9,"route":"oral","species":"","study_id":"sccs_o_279_noael_002"}
Regulatory source - 1 % - oral - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=1.0; EFFECT=SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 16 Table 3 – Aggregate exposures in comparison to ULs and NOAEL. Age Intake from Toothpaste at 1.0 % Zn Intake from Mouthwash at 0.1 % Zn Aggregate Intake from Oral Care Weighted Median Dietary Intake based on food consumption data SCF Tolerable Upper Intake Levels IOM Tolerable Upper Intake Levels Aggregate Exposure Oral Care + Weighted Dietary Average NOAEL by Yadrik et al. (1989) [years] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] 1 2.00 0 2.00 5.01 7 7 7.01 10 2 2.00 0 2.00 5.01 7 7 7.01 10 3 2.00 0 2.00 7.40 7 7 9.40 10 4 2.00 0 2.00; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 16 Table 3 – Aggregate exposures in comparison to ULs and NOAEL. Age Intake from Toothpaste at 1.0 % Zn Intake from Mouthwash at 0.1 % Zn Aggregate Intake from Oral Care Weighted Median Dietary Intake based on food consumption data SCF Tolerable Upper Intake Levels IOM Tolerable Upper Intake Levels Aggregate Exposure Oral Care + Weighted Dietary Average NOAEL by Yadrik et al. (1989) [years] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] [mg Zn/d] 1 2.00 0 2.00 5.01 7 7 7.01 10 2 2.00 0 2.00 5.01 7 7 7.01 10 3 2.00 0 2.00 7.40 7 7 9.40 10 4 2.00 0 2.00","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"1.0","page":16,"route":"oral","species":"","study_id":"sccs_o_279_noael_004"}
Regulatory source - 1 % - oral - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=1.0; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: Age | Intake from Toothpaste at 1.0 % Zn | Intake from Mouthwash at 0.1 % Zn | Aggregate Intake from Oral Care | Weighted Median Dietary Intake based on food consumption data | SCF Tolerable Upper Intake Levels | IOM Tolerable Upper Intake Levels | Aggregate Exposure Oral Care + Weighted Dietary Average | NOAEL by Yadrik et al. (1989); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: Age | Intake from Toothpaste at 1.0 % Zn | Intake from Mouthwash at 0.1 % Zn | Aggregate Intake from Oral Care | Weighted Median Dietary Intake based on food consumption data | SCF Tolerable Upper Intake Levels | IOM Tolerable Upper Intake Levels | Aggregate Exposure Oral Care + Weighted Dietary Average | NOAEL by Yadrik et al. (1989)","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"%","noael_value":"1.0","page":16,"route":"oral","species":"","study_id":"sccs_o_279_noael_008"}
Regulatory source - 6 - - oral 6 year - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=unclear:hed UL for 6 year-olds is the value for age 4, while it should instead be closer to the UL for age 7. In addition, dietary intakes were also grouped - by even larger age differentials. Thus, the dietary intake for age 3 is dominated by data from older children (up to age 9). Consequently, dietary intake data for 3 year-olds must be considered exceedingly conservative as well. In conclusion, Table 3 might provide the incorrect impression that zinc exposure randomly peaks above known safe levels (but still below the NOAEL) for ages 3 and 6. It is important to emphasize that these levels do not pose a health hazard, that the body maintains the homeostasis of this essential element at these exposure levels, and that the arbitrarily set ULs and dietary intake age groups artificially create false concerns. Zinc does not spontaneously exert toxicity with the 3rd and 6th birthday.; EFFECT=hed UL for 6 year-olds is the value for age 4, while it should instead be closer to the UL for age 7. In addition, dietary intakes were also grouped - by even larger age differentials. Thus, the dietary intake for age 3 is dominated by data from older children (up to age 9). Consequently, dietary intake data for 3 year-olds must be considered exceedingly conservative as well. In conclusion, Table 3 might provide the incorrect impression that zinc exposure randomly peaks above known safe levels (but still below the NOAEL) for ages 3 and 6. It is important to emphasize that these levels do not pose a health hazard, that the body maintains the homeostasis of this essential element at these exposure levels, and that the arbitrarily set ULs and dietary intake age groups artificially create false concerns. Zinc does not spontaneously exert toxicity with the 3rd and 6th birthday.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"6 year","effect":"hed UL for 6 year-olds is the value for age 4, while it should instead be closer to the UL for age 7. In addition, dietary intakes were also grouped - by even larger age differentials. Thus, the dietary intake for age 3 is dominated by data from older children (up to age 9). Consequently, dietary intake data for 3 year-olds must be considered exceedingly conservative as well. In conclusion, Table 3 might provide the incorrect impression that zinc exposure randomly peaks above known safe levels (but still below the NOAEL) for ages 3 and 6. It is important to emphasize that these levels do not pose a health hazard, that the body maintains the homeostasis of this essential element at these exposure levels, and that the arbitrarily set ULs and dietary intake age groups artificially create false concerns. Zinc does not spontaneously exert toxicity with the 3rd and 6th birthday.","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:hed UL for 6 year-olds is the value for age 4, while it should instead be closer to the UL for age 7. In addition, dietary intakes were also grouped - by even larger age differentials. Thus, the dietary intake for age 3 is dominated by data from older children (up to age 9). Consequently, dietary intake data for 3 year-olds must be considered exceedingly conservative as well. In conclusion, Table 3 might provide the incorrect impression that zinc exposure randomly peaks above known safe levels (but still below the NOAEL) for ages 3 and 6. It is important to emphasize that these levels do not pose a health hazard, that the body maintains the homeostasis of this essential element at these exposure levels, and that the arbitrarily set ULs and dietary intake age groups artificially create false concerns. Zinc does not spontaneously exert toxicity with the 3rd and 6th birthday.","page":15,"route":"oral","species":"","study_id":"sccs_o_279_noael_003"}
Regulatory source - 10 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=10; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 1 | 2.00 | 0 | 2.00 | 5.01 | 7 | 7 | 7.01 | 10; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 1 | 2.00 | 0 | 2.00 | 5.01 | 7 | 7 | 7.01 | 10","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"10","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_009"}
Regulatory source - 10 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=10; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 2 | 2.00 | 0 | 2.00 | 5.01 | 7 | 7 | 7.01 | 10; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 2 | 2.00 | 0 | 2.00 | 5.01 | 7 | 7 | 7.01 | 10","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"10","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_010"}
Regulatory source - 10 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=10; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 3 | 2.00 | 0 | 2.00 | 7.40 | 7 | 7 | 9.40 | 10; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 3 | 2.00 | 0 | 2.00 | 7.40 | 7 | 7 | 9.40 | 10","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"10","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_011"}
Regulatory source - 16 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=16; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 4 | 2.00 | 0 | 2.00 | 7.40 | 10 | 12 | 9.40 | 16; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 4 | 2.00 | 0 | 2.00 | 7.40 | 10 | 12 | 9.40 | 16","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"16","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_012"}
Regulatory source - 16 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=16; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 5 | 2.00 | 0 | 2.00 | 7.40 | 10 | 12 | 9.40 | 16; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 5 | 2.00 | 0 | 2.00 | 7.40 | 10 | 12 | 9.40 | 16","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"16","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_013"}
Regulatory source - 16 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=16; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 6 | 2.00 | 2.16 | 4.16 | 7.40 | 10 | 12 | 11.56 | 16; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 6 | 2.00 | 2.16 | 4.16 | 7.40 | 10 | 12 | 11.56 | 16","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"16","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_014"}
Regulatory source - 17 - - oral - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=unclear:salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Upper Intake Levels (UL) =25*((BW/60)^0.75) The SCCS calculated the aggregate exposure to zinc from cosmetics and diet according to the largest median reported by EFSA. Table 4 and Figure 1 below summarise the total aggregated oral exposure for zinc from a; EFFECT=salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Upper Intake Levels (UL) =25*((BW/60)^0.75) The SCCS calculated the aggregate exposure to zinc from cosmetics and diet according to the largest median reported by EFSA. Table 4 and Figure 1 below summarise the total aggregated oral exposure for zinc from a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Upper Intake Levels (UL) =25*((BW/60)^0.75) The SCCS calculated the aggregate exposure to zinc from cosmetics and diet according to the largest median reported by EFSA. Table 4 and Figure 1 below summarise the total aggregated oral exposure for zinc from a","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Upper Intake Levels (UL) =25*((BW/60)^0.75) The SCCS calculated the aggregate exposure to zinc from cosmetics and diet according to the largest median reported by EFSA. Table 4 and Figure 1 below summarise the total aggregated oral exposure for zinc from a","page":17,"route":"oral","species":"","study_id":"sccs_o_279_noael_007"}
Regulatory source - 24 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=24; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 7 | 1.38 | 2.16 | 3.54 | 7.40 | 13 | 12 | 10.94 | 24; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 7 | 1.38 | 2.16 | 3.54 | 7.40 | 13 | 12 | 10.94 | 24","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"24","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_015"}
Regulatory source - 24 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=24; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 8 | 1.38 | 2.16 | 3.54 | 7.40 | 13 | 12 | 10.94 | 24; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 8 | 1.38 | 2.16 | 3.54 | 7.40 | 13 | 12 | 10.94 | 24","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"24","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_016"}
Regulatory source - 24 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=24; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 9 | 1.38 | 2.16 | 3.54 | 7.40 | 13 | 23 | 10.94 | 24; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 9 | 1.38 | 2.16 | 3.54 | 7.40 | 13 | 23 | 10.94 | 24","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"24","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_017"}
Regulatory source - 24 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=24; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 10 | 1.38 | 2.16 | 3.54 | 8.74 | 13 | 23 | 12.28 | 24; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 10 | 1.38 | 2.16 | 3.54 | 8.74 | 13 | 23 | 12.28 | 24","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"24","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_018"}
Regulatory source - 37 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=37; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 11 | 1.38 | 2.16 | 3.54 | 8.74 | 18 | 23 | 12.28 | 37; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 11 | 1.38 | 2.16 | 3.54 | 8.74 | 18 | 23 | 12.28 | 37","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"37","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_019"}
Regulatory source - 37 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=37; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 12 | 1.38 | 2.16 | 3.54 | 8.74 | 18 | 23 | 12.28 | 37; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 12 | 1.38 | 2.16 | 3.54 | 8.74 | 18 | 23 | 12.28 | 37","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"37","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_020"}
Regulatory source - 37 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=37; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 13 | 1.38 | 2.16 | 3.54 | 8.74 | 18 | 23 | 12.28 | 37; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 13 | 1.38 | 2.16 | 3.54 | 8.74 | 18 | 23 | 12.28 | 37","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"37","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_021"}
Regulatory source - 37 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=37; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 14 | 1.38 | 2.16 | 3.54 | 8.74 | 18 | 34 | 12.28 | 37; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 14 | 1.38 | 2.16 | 3.54 | 8.74 | 18 | 34 | 12.28 | 37","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"37","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_022"}
Regulatory source - 50 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=50; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 15 | 1.38 | 2.16 | 3.54 | 8.74 | 22 | 34 | 12.28 | 50; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 15 | 1.38 | 2.16 | 3.54 | 8.74 | 22 | 34 | 12.28 | 50","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"50","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_023"}
Regulatory source - 50 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=50; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 16 | 1.38 | 2.16 | 3.54 | 8.74 | 22 | 34 | 12.28 | 50; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 16 | 1.38 | 2.16 | 3.54 | 8.74 | 22 | 34 | 12.28 | 50","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"50","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_024"}
Regulatory source - 50 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=50; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 17 | 1.38 | 2.16 | 3.54 | 8.74 | 22 | 34 | 12.28 | 50; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: 17 | 1.38 | 2.16 | 3.54 | 8.74 | 22 | 34 | 12.28 | 50","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"50","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_025"}
Regulatory source - 53 - - - - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=53; EFFECT=Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: adult | 1.38 | 2.16 | 3.54 | 9.76 | 25 | 40 | 12.28 | 53; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"Table 3 – Aggregate exposures in comparison to ULs and NOAEL.: adult | 1.38 | 2.16 | 3.54 | 9.76 | 25 | 40 | 12.28 | 53","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"53","page":16,"route":"","species":"","study_id":"sccs_o_279_noael_026"}
Regulatory source - 1657 - - oral - - SOURCE_SUBDIR=sccs_o_279; REPORT_TITLE=OPINION ON water-soluble zinc salts used in oral hygiene products; OPINION_NUMBER=SCCS/1657/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 26 October 2023; VALUE_TEXT=unclear:SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Up; EFFECT=SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Up; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"557-34-6","citation":"","dose":"","duration":"","effect":"SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Up","endpoint":"","ingredient":"s, toys, textiles, clothing,","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1657/23 Final version Opinion on water-soluble zinc salts used in oral hygiene products - Submission II ___________________________________________________________________________________________ 17 The following equation was used: BW= 3.68+4.47*year-0.093*year^2+0.00061*year^3 The SCCS disagrees with using the NOAEL as proposed by the Applicant and considers the international Tolerable Upper Intake Levels (UL) (published by the European Commission Scientific Committee on Food (EU SCF 2003) as the reference level for the safety evaluation. The UL were based on a NOAEL of 50mg/day for adults and extrapolated to children by allometric scaling, with an uncertainty factor of 2 (due to the small number of subjects) by the EU SCF 2003. The following equation was then used by the SCCS to calculate UL in a linear fashion: Tolerable Up","page":17,"route":"oral","species":"","study_id":"sccs_o_279_noael_006"}
openFDA substances 8 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier FM5526K07A UNII - - - chemical {"approval_status":null,"molecular_formula":"2C2H3O2.Zn.2H2O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"FM5526K07A"}
openFDA substances FDA UNII substance identifier FM5526K07A UNII - - - chemical {"approval_status":null,"molecular_formula":"2C2H3O2.Zn.2H2O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"FM5526K07A"}
openFDA substances FDA UNII substance identifier FM5526K07A UNII - - - chemical {"approval_status":null,"molecular_formula":"2C2H3O2.Zn.2H2O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"FM5526K07A"}
openFDA substances FDA UNII substance identifier FM5526K07A UNII - - - chemical {"approval_status":null,"molecular_formula":"2C2H3O2.Zn.2H2O","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"FM5526K07A"}
openFDA substances FDA UNII substance identifier H2ZEY72PME UNII - - - chemical {"approval_status":null,"molecular_formula":"2C2H3O2.Zn","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"H2ZEY72PME"}
openFDA substances FDA UNII substance identifier H2ZEY72PME UNII - - - chemical {"approval_status":null,"molecular_formula":"2C2H3O2.Zn","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"H2ZEY72PME"}
openFDA substances FDA UNII substance identifier H2ZEY72PME UNII - - - chemical {"approval_status":null,"molecular_formula":"2C2H3O2.Zn","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"H2ZEY72PME"}
openFDA substances FDA UNII substance identifier H2ZEY72PME UNII - - - chemical {"approval_status":null,"molecular_formula":"2C2H3O2.Zn","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"H2ZEY72PME"}