s, toys, textiles, clothing,, Zinc Acetate; Zinc Chloride; Zinc Gluconate; Zinc Citrate; Zinc Sulphate, water-soluble zinc salts used in oral hygiene

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

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"}

sccs_o_279.pdf

{"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_o_279.pdf

{"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_o_279.pdf

{"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_o_279.pdf

{"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_o_279.pdf

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sccs_o_279.pdf

{"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_o_279.pdf

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sccs_o_279.pdf

{"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_o_279.pdf