NOAEL Studies
Cosmetic Ingredient
Ammonium Silver Zinc Aluminum Silicate NOAEL Studies
INCI: AMMONIUM SILVER ZINC ALUMINUM SILICATE
CAS: 130328-20-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCS_vision_codex 80 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =0.04 | - | - | inhalation | - | NOAEL study | {"effect":"inhalation exposure estimate to account for the uncertainty regarding conservativeness of the proposed exposure estimates. Consequently, the SCCS will use an SED of 0.04 μg/kg bw/day for the calculation of the MoS. The Applicant also submitted data on a fraction of the systemic exposure from ingestion of the ethanol-based deodorant spray. The SCCS has examined these data and considers this contribution to the total SED as negligible. Zinc In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and not use the SED for zinc for the calculation of the MoS (see also 3.4.4.3).","page":18,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | dog | - | subchronic | repeated dose toxicity | {"citation":"Ref: Teunissen 2003","dose":"both sexes at the highest dose level; clinical chemistry analyses revealed increased cholesterol concentration and increased serum alkaline phosphatase activity.","effect":"both sexes at the highest dose level; clinical chemistry analyses revealed increased cholesterol concentration and increased serum alkaline phosphatase activity. At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d. Histopathological investigations showed effects on the kidney, including an increased severity of corticomedullary tubular basophilic and lymphoid infiltration, interstitial fibrosis and hyaline/cellular casts at 250 mg/kg bw/d. A NOAEL of 50 mg/kg bw/d was therefore determined for this study. Ref: Teunissen 2003. According to CAR-ECHA 2021, the overall subchronic NOAEL for the types of silver zinc zeolites used in representative formulations of 50 mg/kg bw/day is based on pigmentation, increased level of ALP, effects on haematological parameters and effects on behaviour/ activity observed in dogs administered 250 mg AgION Antimicrobial Types AK /kg bw/day. 3.4.4.3 Chronic (> 12 months) toxicity SZZ Combined chronic toxicity/carcinogenicity s","page":23,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_002"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | rat | - | subchronic | repeated dose toxicity | {"citation":"Ref: Teunissen 2003","dose":"At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d.","effect":"ine phosphatase activity. At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d. Histopathological investigations showed effects on the kidney, including an increased severity of corticomedullary tubular basophilic and lymphoid infiltration, interstitial fibrosis and hyaline/cellular casts at 250 mg/kg bw/d. A NOAEL of 50 mg/kg bw/d was therefore determined for this study. Ref: Teunissen 2003. According to CAR-ECHA 2021, the overall subchronic NOAEL for the types of silver zinc zeolites used in representative formulations of 50 mg/kg bw/day is based on pigmentation, increased level of ALP, effects on haematological parameters and effects on behaviour/ activity observed in dogs administered 250 mg AgION Antimicrobial Types AK /kg bw/day. 3.4.4.3 Chronic (> 12 months) toxicity SZZ Combined chronic toxicity/carcinogenicity study in mice and rats (Takizawa 1992). The test material Zeomic AJ 10N was an odourless crystalline powder with the Ag, Zn, and NH4 conte","page":23,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_003"} |
| SCCS_vision_codex | NOAEL | =5 | % | rat | oral | 24 months | NOAEL study | {"dose":"Effects on haematological parameters (decrease in HCT, Hb (12%), MCH and MCHC) were observed at 24 months in the two highest dose levels in females, but there were no effects in males.","effect":"at 24 months. Effects on haematological parameters (decrease in HCT, Hb (12%), MCH and MCHC) were observed at 24 months in the two highest dose levels in females, but there were no effects in males. There were no effects observed in any of the treated animals at 6 and 12 months or among animals in the lower dose groups at 24 months. The pathological examination revealed pigmentation of liver, kidneys, pancreas, stomach, lymph nodes and the choroid plexus in high-dose rats. According to CAR-ECHA 2021, the chronic NOAEL, derived from the above-mentioned oral dosing study in rats, based on pigmentation as a critical effect, is considered to be 9 mg AgION Type AJ/kg bw/day or 0.09 mg silver ion equivalents/kg bw). With correction for absorption from the stomach of 5%, this would imply a NOAEL for silver of 0.0045 mg (4.5 microgram)/kg bw/d Silver The Applicant summarised the toxicological reference values for silver as follows: All published reviews agree that the critical effect of silver exposure is argyria. Toxicological refere","page":24,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.0065 | mg/kg bw/d | human | oral | 70 years | NOAEL study | {"dose":"The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg bw/d), assuming a lifetime of 70 years and a bodyweight of 70 kg.","effect":"ll published reviews agree that the critical effect of silver exposure is argyria. Toxicological reference values for silver have been derived by the EPA, WHO and EFSA, as discussed below. The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg bw/d), assuming a lifetime of 70 years and a bodyweight of 70 kg. Using epidemiological and pharmacokinetic data, WHO (2003) derives a human NOAEL (lifetime oral intake) for silver of 10 g, corresponding to 0.39 mg/day or 0.0065 mg/kg bw/d. Assuming a gastrointestinal absorption of silver of 5%, this is equivalent to a systemic reference value of 0.000325 mg/kg bw/d (0.325 μg/kg bw/d), a value comparable to that derived by the US EPA. EFSA has evaluated silver-based preservatives for use in food-contact materials on the basis of human and animal data and has derived a group restriction limit of 0.05 mg/kg food, which corresponds to a worst-case exposure of 0","page":24,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_006"} |
| SCCS_vision_codex | NOAEL | =31.52 | mg/kg bw | human | oral | - | NOAEL study | {"dose":"603-404-0) ___________________________________________________________________________________________ ___________________________________________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d.","effect":"SCCS/1650/23 Final Opinion Opinion on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0) ___________________________________________________________________________________________ ___________________________________________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d. (From ECHA registration dossier – key study) Based on a study with zinc monoglycerolate the NOAEL is 31.52 mg/kg bw (»13.26 mg Zn2+/kg bw). Besides animal data, there are several human studies in which humans were supplemented with moderately high amounts of zinc (50 mg Zn/day) (as zinc gluconate). The EU Risk Assessment Report Zinc Oxide (2004) sets a NOAEL of 50 mg Zn2+ / day, which equals 0.83 mg Zn2+/kg bw/day. From SCCS on zinc in oral products (SCCS/1586/17): 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 (co","page":25,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.0045 | mg/kg bw/d | human | inhalation | 90-day | NOAEL study | {"citation":"Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this","dose":"Dose-related nonsuppurative inflammatory reactions were observed in animals of all dose groups.","effect":"on-fibrogenic dust with regard to human inhalation risk. Dose-related nonsuppurative inflammatory reactions were observed in animals of all dose groups. These reactions had diminished in severity but had not fully disappeared in the mid- and high-dose group. In the 1 mg/m³ dose group, these effects were not evident after the 90-day recovery period. The LOAEL for inhalation is 1 mg/m³. Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this at 0.0045 mg/kg bw/d. This will be used for the calculation of the MoS.","page":25,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_010"} |
| SCCS_vision_codex | NOAEL | =1109 | mg/kg bw | rat | oral | - | reproductive toxicity | {"dose":"_____ 26 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity SSZ A two-generation reproduction and fertility study of Zeomic (silver zinc zeolite) has been performed with oral gavage doses of 200, 700, 2000 mg/kg bw/day in Rats (Schroeder 2002) According to CAR-ECHA (2021), there is only substance-specific data available for...","effect":"_____ 26 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity SSZ A two-generation reproduction and fertility study of Zeomic (silver zinc zeolite) has been performed with oral gavage doses of 200, 700, 2000 mg/kg bw/day in Rats (Schroeder 2002) According to CAR-ECHA (2021), there is only substance-specific data available for this Silver Antimicrobial Type AK (Schroeder 2002). It was concluded that silver zinc zeolite does not affect fertility at doses up to 12500 ppm (984/1109 mg/kg bw): the NOAEL for reproduction is 1000 ppm (approximately 70 mg Type AK/mg kg bw). Silver (Taken from ECHA-CLH (2020) The data available on silver acetate and nanosilver indicate that the silver ion has the ability to cause adverse effects on sexual function and fertility possibly by a mechanism involving oxidative stress. According to the original report for the silver acetate study and the published studies with nanosilver, there were no marked general toxicity indicating that effects were “a non-specific consequence of the","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_011"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | rat | - | developmental | developmental toxicity | {"dose":"This same effect also appeared in F1 pups at the highest dose (6/14 males and 6/18 females), albeit in the presence of excessive maternal toxicity.","effect":"SCCS-rejected applicant NOAEL: city (mainly hydronephrosis and haematological alterations) and cannot be totally disregarded for classification. This same effect also appeared in F1 pups at the highest dose (6/14 males and 6/18 females), albeit in the presence of excessive maternal toxicity. The RAC considered these effects on the heart as relevant for classification of SZZ as toxic to development Cat 2. Silver (Taken from SCCS/1577/16) A high-quality developmental toxicity study performed in the rat with silver acetate (NTP, 2002) concludes a NOAEL for developmental toxicity of 100 mg/kg bw/d, the highest dose level tested. Indications of slight maternal toxicity were observed at this dose level; more severe maternal toxicity was observed at a dose level of 160 mg/kg bw/d in a screening study. Published data (Shavlovsky et al., 1995) indicate an effect of silver on development at maternally toxic dose levels and secondary to copper deficiency caused by the displacement of copper by silver from ceruloplasmin. Zinc (Taken from SCCS/1586/17) In animal studies","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_012"} |
| SCCS_vision_codex | NOAEL | =20 | - | - | oral | developmental | reproductive toxicity | {"dose":"While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element.","effect":"with healthy pregnant women, a daily oral zinc supplement of 20-90 mg has shown no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_013"} |
| SCCS_vision_codex | NOAEL | =2011 | - | - | oral | developmental | reproductive toxicity | {"dose":"While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element.","effect":"own no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_014"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | human | oral | - | reproductive toxicity | {"dose":"Zinc deficiency is associated with the impairment of fertility and foetal development; however, evidence from animal studies also indicates that high levels of exposure to zinc (≥200 mg/kg bw/d) may also cause adverse effects on fertility and foetal development.","effect":"ation with colloidal silver, there are no studies available on respiratory sensitisation (ECHA-CLH 2020). Zinc Zinc is an essential dietary element involved in many biochemical processes; and is critical for the maintenance of normal immune, sexual and neurosensory function such as cognition and vision. Adverse effects of zinc supplementation (as zinc sulphate) at a level of 150 mg/day are reported to be headache, nausea and gastric discomfort. The EU RAR for zinc concludes that 50 mg/day constitutes a human oral NOAEL for zinc. The EU RAR also concludes that there is no clear evidence for the mutagenicity or carcinogenicity of zinc. Zinc deficiency is associated with the impairment of fertility and foetal development; however, evidence from animal studies also indicates that high levels of exposure to zinc (≥200 mg/kg bw/d) may also cause adverse effects on fertility and foetal development. The EU RAR concludes that, as the reproductive effects seen in animal studies are seen only at high-dose levels associated with general tox","page":30,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_015"} |
| SCCS_vision_codex | NOAEL | =31 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"_______________ 31 against the criteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_016"} |
| SCCS_vision_codex | NOAEL | =2017 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"riteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED)","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_017"} |
| SCCS_vision_codex | NOAEL | =275 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_018"} |
| SCCS_vision_codex | NOAEL | =3.5 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"s not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_019"} |
| SCCS_vision_codex | NOAEL | =5 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_021"} |
| SCCS_vision_codex | NOAEL | =3.3 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_022"} |
| SCCS_vision_codex | NOAEL | =4.5 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_024"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | - | oral | developmental | reproductive toxicity | {"dose":"1000 mg/kg bw, silver zinc zeolite does not affect fertility.","effect":"Applicant, and based its safety assessment, in view of the apparently low inhalation toxicity from the zeolite itself, on the release of silver in the airways. Reproductive toxicity At gavage doses up to approx. 1000 mg/kg bw, silver zinc zeolite does not affect fertility. However developmental effects (pup mortality, decreased pup weight and cardiac effects) were noted and ascribed to the effects from silver. According to ECHA/BPC/275/21, silver zinc zeolite fulfils criteria for classification Repr 2; H361d. The NOAEL derived from the chronic oral toxicity study (which is used in the current assessment) is amply below the NOAEL for reproductive and developmental effects. Mutagenicity / genotoxicity The SCCS concurs with the ECHA Opinion (ECHA/BPC/275/2021) that the mutagenic potential of the substance has been adequately investigated in vitro and in vivo. While the in vitro test in mammalian cells indicated a mutagenic potential of silver zinc zeolite, there were no indications of genotoxicity in the in vivo studies conducted,","page":33,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_026"} |
| SCCS_vision_codex | NOAEL | =0.04 | - | - | inhalation | - | NOAEL study | {"effect":"inhalation exposure estimate to account for the uncertainty regarding conservativeness of the proposed exposure estimates. Consequently, the SCCS will use an SED of 0.04 μg/kg bw/day for the calculation of the MoS. The Applicant also submitted data on a fraction of the systemic exposure from ingestion of the ethanol-based deodorant spray. The SCCS has examined these data and considers this contribution to the total SED as negligible. Zinc In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and not use the SED for zinc for the calculation of the MoS (see also 3.4.4.3).","page":18,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | dog | - | subchronic | repeated dose toxicity | {"citation":"Ref: Teunissen 2003","dose":"both sexes at the highest dose level; clinical chemistry analyses revealed increased cholesterol concentration and increased serum alkaline phosphatase activity.","effect":"both sexes at the highest dose level; clinical chemistry analyses revealed increased cholesterol concentration and increased serum alkaline phosphatase activity. At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d. Histopathological investigations showed effects on the kidney, including an increased severity of corticomedullary tubular basophilic and lymphoid infiltration, interstitial fibrosis and hyaline/cellular casts at 250 mg/kg bw/d. A NOAEL of 50 mg/kg bw/d was therefore determined for this study. Ref: Teunissen 2003. According to CAR-ECHA 2021, the overall subchronic NOAEL for the types of silver zinc zeolites used in representative formulations of 50 mg/kg bw/day is based on pigmentation, increased level of ALP, effects on haematological parameters and effects on behaviour/ activity observed in dogs administered 250 mg AgION Antimicrobial Types AK /kg bw/day. 3.4.4.3 Chronic (> 12 months) toxicity SZZ Combined chronic toxicity/carcinogenicity s","page":23,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_002"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | rat | - | subchronic | repeated dose toxicity | {"citation":"Ref: Teunissen 2003","dose":"At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d.","effect":"ine phosphatase activity. At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d. Histopathological investigations showed effects on the kidney, including an increased severity of corticomedullary tubular basophilic and lymphoid infiltration, interstitial fibrosis and hyaline/cellular casts at 250 mg/kg bw/d. A NOAEL of 50 mg/kg bw/d was therefore determined for this study. Ref: Teunissen 2003. According to CAR-ECHA 2021, the overall subchronic NOAEL for the types of silver zinc zeolites used in representative formulations of 50 mg/kg bw/day is based on pigmentation, increased level of ALP, effects on haematological parameters and effects on behaviour/ activity observed in dogs administered 250 mg AgION Antimicrobial Types AK /kg bw/day. 3.4.4.3 Chronic (> 12 months) toxicity SZZ Combined chronic toxicity/carcinogenicity study in mice and rats (Takizawa 1992). The test material Zeomic AJ 10N was an odourless crystalline powder with the Ag, Zn, and NH4 conte","page":23,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_003"} |
| SCCS_vision_codex | NOAEL | =5 | % | rat | oral | 24 months | NOAEL study | {"dose":"Effects on haematological parameters (decrease in HCT, Hb (12%), MCH and MCHC) were observed at 24 months in the two highest dose levels in females, but there were no effects in males.","effect":"at 24 months. Effects on haematological parameters (decrease in HCT, Hb (12%), MCH and MCHC) were observed at 24 months in the two highest dose levels in females, but there were no effects in males. There were no effects observed in any of the treated animals at 6 and 12 months or among animals in the lower dose groups at 24 months. The pathological examination revealed pigmentation of liver, kidneys, pancreas, stomach, lymph nodes and the choroid plexus in high-dose rats. According to CAR-ECHA 2021, the chronic NOAEL, derived from the above-mentioned oral dosing study in rats, based on pigmentation as a critical effect, is considered to be 9 mg AgION Type AJ/kg bw/day or 0.09 mg silver ion equivalents/kg bw). With correction for absorption from the stomach of 5%, this would imply a NOAEL for silver of 0.0045 mg (4.5 microgram)/kg bw/d Silver The Applicant summarised the toxicological reference values for silver as follows: All published reviews agree that the critical effect of silver exposure is argyria. Toxicological refere","page":24,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.0065 | mg/kg bw/d | human | oral | 70 years | NOAEL study | {"dose":"The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg bw/d), assuming a lifetime of 70 years and a bodyweight of 70 kg.","effect":"ll published reviews agree that the critical effect of silver exposure is argyria. Toxicological reference values for silver have been derived by the EPA, WHO and EFSA, as discussed below. The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg bw/d), assuming a lifetime of 70 years and a bodyweight of 70 kg. Using epidemiological and pharmacokinetic data, WHO (2003) derives a human NOAEL (lifetime oral intake) for silver of 10 g, corresponding to 0.39 mg/day or 0.0065 mg/kg bw/d. Assuming a gastrointestinal absorption of silver of 5%, this is equivalent to a systemic reference value of 0.000325 mg/kg bw/d (0.325 μg/kg bw/d), a value comparable to that derived by the US EPA. EFSA has evaluated silver-based preservatives for use in food-contact materials on the basis of human and animal data and has derived a group restriction limit of 0.05 mg/kg food, which corresponds to a worst-case exposure of 0","page":24,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_006"} |
| SCCS_vision_codex | NOAEL | =31.52 | mg/kg bw | human | oral | - | NOAEL study | {"dose":"603-404-0) ___________________________________________________________________________________________ ___________________________________________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d.","effect":"SCCS/1650/23 Final Opinion Opinion on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0) ___________________________________________________________________________________________ ___________________________________________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d. (From ECHA registration dossier – key study) Based on a study with zinc monoglycerolate the NOAEL is 31.52 mg/kg bw (»13.26 mg Zn2+/kg bw). Besides animal data, there are several human studies in which humans were supplemented with moderately high amounts of zinc (50 mg Zn/day) (as zinc gluconate). The EU Risk Assessment Report Zinc Oxide (2004) sets a NOAEL of 50 mg Zn2+ / day, which equals 0.83 mg Zn2+/kg bw/day. From SCCS on zinc in oral products (SCCS/1586/17): 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 (co","page":25,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.0045 | mg/kg bw/d | human | inhalation | 90-day | NOAEL study | {"citation":"Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this","dose":"Dose-related nonsuppurative inflammatory reactions were observed in animals of all dose groups.","effect":"on-fibrogenic dust with regard to human inhalation risk. Dose-related nonsuppurative inflammatory reactions were observed in animals of all dose groups. These reactions had diminished in severity but had not fully disappeared in the mid- and high-dose group. In the 1 mg/m³ dose group, these effects were not evident after the 90-day recovery period. The LOAEL for inhalation is 1 mg/m³. Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this at 0.0045 mg/kg bw/d. This will be used for the calculation of the MoS.","page":25,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_010"} |
| SCCS_vision_codex | NOAEL | =1109 | mg/kg bw | rat | oral | - | reproductive toxicity | {"dose":"_____ 26 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity SSZ A two-generation reproduction and fertility study of Zeomic (silver zinc zeolite) has been performed with oral gavage doses of 200, 700, 2000 mg/kg bw/day in Rats (Schroeder 2002) According to CAR-ECHA (2021), there is only substance-specific data available for...","effect":"_____ 26 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity SSZ A two-generation reproduction and fertility study of Zeomic (silver zinc zeolite) has been performed with oral gavage doses of 200, 700, 2000 mg/kg bw/day in Rats (Schroeder 2002) According to CAR-ECHA (2021), there is only substance-specific data available for this Silver Antimicrobial Type AK (Schroeder 2002). It was concluded that silver zinc zeolite does not affect fertility at doses up to 12500 ppm (984/1109 mg/kg bw): the NOAEL for reproduction is 1000 ppm (approximately 70 mg Type AK/mg kg bw). Silver (Taken from ECHA-CLH (2020) The data available on silver acetate and nanosilver indicate that the silver ion has the ability to cause adverse effects on sexual function and fertility possibly by a mechanism involving oxidative stress. According to the original report for the silver acetate study and the published studies with nanosilver, there were no marked general toxicity indicating that effects were “a non-specific consequence of the","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_011"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | rat | - | developmental | developmental toxicity | {"dose":"This same effect also appeared in F1 pups at the highest dose (6/14 males and 6/18 females), albeit in the presence of excessive maternal toxicity.","effect":"SCCS-rejected applicant NOAEL: city (mainly hydronephrosis and haematological alterations) and cannot be totally disregarded for classification. This same effect also appeared in F1 pups at the highest dose (6/14 males and 6/18 females), albeit in the presence of excessive maternal toxicity. The RAC considered these effects on the heart as relevant for classification of SZZ as toxic to development Cat 2. Silver (Taken from SCCS/1577/16) A high-quality developmental toxicity study performed in the rat with silver acetate (NTP, 2002) concludes a NOAEL for developmental toxicity of 100 mg/kg bw/d, the highest dose level tested. Indications of slight maternal toxicity were observed at this dose level; more severe maternal toxicity was observed at a dose level of 160 mg/kg bw/d in a screening study. Published data (Shavlovsky et al., 1995) indicate an effect of silver on development at maternally toxic dose levels and secondary to copper deficiency caused by the displacement of copper by silver from ceruloplasmin. Zinc (Taken from SCCS/1586/17) In animal studies","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_012"} |
| SCCS_vision_codex | NOAEL | =20 | - | - | oral | developmental | reproductive toxicity | {"dose":"While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element.","effect":"with healthy pregnant women, a daily oral zinc supplement of 20-90 mg has shown no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_013"} |
| SCCS_vision_codex | NOAEL | =2011 | - | - | oral | developmental | reproductive toxicity | {"dose":"While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element.","effect":"own no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_014"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | human | oral | - | reproductive toxicity | {"dose":"Zinc deficiency is associated with the impairment of fertility and foetal development; however, evidence from animal studies also indicates that high levels of exposure to zinc (≥200 mg/kg bw/d) may also cause adverse effects on fertility and foetal development.","effect":"ation with colloidal silver, there are no studies available on respiratory sensitisation (ECHA-CLH 2020). Zinc Zinc is an essential dietary element involved in many biochemical processes; and is critical for the maintenance of normal immune, sexual and neurosensory function such as cognition and vision. Adverse effects of zinc supplementation (as zinc sulphate) at a level of 150 mg/day are reported to be headache, nausea and gastric discomfort. The EU RAR for zinc concludes that 50 mg/day constitutes a human oral NOAEL for zinc. The EU RAR also concludes that there is no clear evidence for the mutagenicity or carcinogenicity of zinc. Zinc deficiency is associated with the impairment of fertility and foetal development; however, evidence from animal studies also indicates that high levels of exposure to zinc (≥200 mg/kg bw/d) may also cause adverse effects on fertility and foetal development. The EU RAR concludes that, as the reproductive effects seen in animal studies are seen only at high-dose levels associated with general tox","page":30,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_015"} |
| SCCS_vision_codex | NOAEL | =31 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"_______________ 31 against the criteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_016"} |
| SCCS_vision_codex | NOAEL | =2017 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"riteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED)","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_017"} |
| SCCS_vision_codex | NOAEL | =275 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_018"} |
| SCCS_vision_codex | NOAEL | =3.5 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"s not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_019"} |
| SCCS_vision_codex | NOAEL | =5 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_021"} |
| SCCS_vision_codex | NOAEL | =3.3 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_022"} |
| SCCS_vision_codex | NOAEL | =4.5 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_024"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | - | oral | developmental | reproductive toxicity | {"dose":"1000 mg/kg bw, silver zinc zeolite does not affect fertility.","effect":"Applicant, and based its safety assessment, in view of the apparently low inhalation toxicity from the zeolite itself, on the release of silver in the airways. Reproductive toxicity At gavage doses up to approx. 1000 mg/kg bw, silver zinc zeolite does not affect fertility. However developmental effects (pup mortality, decreased pup weight and cardiac effects) were noted and ascribed to the effects from silver. According to ECHA/BPC/275/21, silver zinc zeolite fulfils criteria for classification Repr 2; H361d. The NOAEL derived from the chronic oral toxicity study (which is used in the current assessment) is amply below the NOAEL for reproductive and developmental effects. Mutagenicity / genotoxicity The SCCS concurs with the ECHA Opinion (ECHA/BPC/275/2021) that the mutagenic potential of the substance has been adequately investigated in vitro and in vivo. While the in vitro test in mammalian cells indicated a mutagenic potential of silver zinc zeolite, there were no indications of genotoxicity in the in vivo studies conducted,","page":33,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_026"} |
| SCCS_vision_codex | NOAEL | =0.04 | - | - | inhalation | - | NOAEL study | {"effect":"inhalation exposure estimate to account for the uncertainty regarding conservativeness of the proposed exposure estimates. Consequently, the SCCS will use an SED of 0.04 μg/kg bw/day for the calculation of the MoS. The Applicant also submitted data on a fraction of the systemic exposure from ingestion of the ethanol-based deodorant spray. The SCCS has examined these data and considers this contribution to the total SED as negligible. Zinc In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and not use the SED for zinc for the calculation of the MoS (see also 3.4.4.3).","page":18,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | dog | - | subchronic | repeated dose toxicity | {"citation":"Ref: Teunissen 2003","dose":"both sexes at the highest dose level; clinical chemistry analyses revealed increased cholesterol concentration and increased serum alkaline phosphatase activity.","effect":"both sexes at the highest dose level; clinical chemistry analyses revealed increased cholesterol concentration and increased serum alkaline phosphatase activity. At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d. Histopathological investigations showed effects on the kidney, including an increased severity of corticomedullary tubular basophilic and lymphoid infiltration, interstitial fibrosis and hyaline/cellular casts at 250 mg/kg bw/d. A NOAEL of 50 mg/kg bw/d was therefore determined for this study. Ref: Teunissen 2003. According to CAR-ECHA 2021, the overall subchronic NOAEL for the types of silver zinc zeolites used in representative formulations of 50 mg/kg bw/day is based on pigmentation, increased level of ALP, effects on haematological parameters and effects on behaviour/ activity observed in dogs administered 250 mg AgION Antimicrobial Types AK /kg bw/day. 3.4.4.3 Chronic (> 12 months) toxicity SZZ Combined chronic toxicity/carcinogenicity s","page":23,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_002"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | rat | - | subchronic | repeated dose toxicity | {"citation":"Ref: Teunissen 2003","dose":"At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d.","effect":"ine phosphatase activity. At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d. Histopathological investigations showed effects on the kidney, including an increased severity of corticomedullary tubular basophilic and lymphoid infiltration, interstitial fibrosis and hyaline/cellular casts at 250 mg/kg bw/d. A NOAEL of 50 mg/kg bw/d was therefore determined for this study. Ref: Teunissen 2003. According to CAR-ECHA 2021, the overall subchronic NOAEL for the types of silver zinc zeolites used in representative formulations of 50 mg/kg bw/day is based on pigmentation, increased level of ALP, effects on haematological parameters and effects on behaviour/ activity observed in dogs administered 250 mg AgION Antimicrobial Types AK /kg bw/day. 3.4.4.3 Chronic (> 12 months) toxicity SZZ Combined chronic toxicity/carcinogenicity study in mice and rats (Takizawa 1992). The test material Zeomic AJ 10N was an odourless crystalline powder with the Ag, Zn, and NH4 conte","page":23,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_003"} |
| SCCS_vision_codex | NOAEL | =5 | % | rat | oral | 24 months | NOAEL study | {"dose":"Effects on haematological parameters (decrease in HCT, Hb (12%), MCH and MCHC) were observed at 24 months in the two highest dose levels in females, but there were no effects in males.","effect":"at 24 months. Effects on haematological parameters (decrease in HCT, Hb (12%), MCH and MCHC) were observed at 24 months in the two highest dose levels in females, but there were no effects in males. There were no effects observed in any of the treated animals at 6 and 12 months or among animals in the lower dose groups at 24 months. The pathological examination revealed pigmentation of liver, kidneys, pancreas, stomach, lymph nodes and the choroid plexus in high-dose rats. According to CAR-ECHA 2021, the chronic NOAEL, derived from the above-mentioned oral dosing study in rats, based on pigmentation as a critical effect, is considered to be 9 mg AgION Type AJ/kg bw/day or 0.09 mg silver ion equivalents/kg bw). With correction for absorption from the stomach of 5%, this would imply a NOAEL for silver of 0.0045 mg (4.5 microgram)/kg bw/d Silver The Applicant summarised the toxicological reference values for silver as follows: All published reviews agree that the critical effect of silver exposure is argyria. Toxicological refere","page":24,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.0065 | mg/kg bw/d | human | oral | 70 years | NOAEL study | {"dose":"The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg bw/d), assuming a lifetime of 70 years and a bodyweight of 70 kg.","effect":"ll published reviews agree that the critical effect of silver exposure is argyria. Toxicological reference values for silver have been derived by the EPA, WHO and EFSA, as discussed below. The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg bw/d), assuming a lifetime of 70 years and a bodyweight of 70 kg. Using epidemiological and pharmacokinetic data, WHO (2003) derives a human NOAEL (lifetime oral intake) for silver of 10 g, corresponding to 0.39 mg/day or 0.0065 mg/kg bw/d. Assuming a gastrointestinal absorption of silver of 5%, this is equivalent to a systemic reference value of 0.000325 mg/kg bw/d (0.325 μg/kg bw/d), a value comparable to that derived by the US EPA. EFSA has evaluated silver-based preservatives for use in food-contact materials on the basis of human and animal data and has derived a group restriction limit of 0.05 mg/kg food, which corresponds to a worst-case exposure of 0","page":24,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_006"} |
| SCCS_vision_codex | NOAEL | =31.52 | mg/kg bw | human | oral | - | NOAEL study | {"dose":"603-404-0) ___________________________________________________________________________________________ ___________________________________________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d.","effect":"SCCS/1650/23 Final Opinion Opinion on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0) ___________________________________________________________________________________________ ___________________________________________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d. (From ECHA registration dossier – key study) Based on a study with zinc monoglycerolate the NOAEL is 31.52 mg/kg bw (»13.26 mg Zn2+/kg bw). Besides animal data, there are several human studies in which humans were supplemented with moderately high amounts of zinc (50 mg Zn/day) (as zinc gluconate). The EU Risk Assessment Report Zinc Oxide (2004) sets a NOAEL of 50 mg Zn2+ / day, which equals 0.83 mg Zn2+/kg bw/day. From SCCS on zinc in oral products (SCCS/1586/17): 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 (co","page":25,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.0045 | mg/kg bw/d | human | inhalation | 90-day | NOAEL study | {"citation":"Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this","dose":"Dose-related nonsuppurative inflammatory reactions were observed in animals of all dose groups.","effect":"on-fibrogenic dust with regard to human inhalation risk. Dose-related nonsuppurative inflammatory reactions were observed in animals of all dose groups. These reactions had diminished in severity but had not fully disappeared in the mid- and high-dose group. In the 1 mg/m³ dose group, these effects were not evident after the 90-day recovery period. The LOAEL for inhalation is 1 mg/m³. Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this at 0.0045 mg/kg bw/d. This will be used for the calculation of the MoS.","page":25,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_010"} |
| SCCS_vision_codex | NOAEL | =1109 | mg/kg bw | rat | oral | - | reproductive toxicity | {"dose":"_____ 26 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity SSZ A two-generation reproduction and fertility study of Zeomic (silver zinc zeolite) has been performed with oral gavage doses of 200, 700, 2000 mg/kg bw/day in Rats (Schroeder 2002) According to CAR-ECHA (2021), there is only substance-specific data available for...","effect":"_____ 26 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity SSZ A two-generation reproduction and fertility study of Zeomic (silver zinc zeolite) has been performed with oral gavage doses of 200, 700, 2000 mg/kg bw/day in Rats (Schroeder 2002) According to CAR-ECHA (2021), there is only substance-specific data available for this Silver Antimicrobial Type AK (Schroeder 2002). It was concluded that silver zinc zeolite does not affect fertility at doses up to 12500 ppm (984/1109 mg/kg bw): the NOAEL for reproduction is 1000 ppm (approximately 70 mg Type AK/mg kg bw). Silver (Taken from ECHA-CLH (2020) The data available on silver acetate and nanosilver indicate that the silver ion has the ability to cause adverse effects on sexual function and fertility possibly by a mechanism involving oxidative stress. According to the original report for the silver acetate study and the published studies with nanosilver, there were no marked general toxicity indicating that effects were “a non-specific consequence of the","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_011"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | rat | - | developmental | developmental toxicity | {"dose":"This same effect also appeared in F1 pups at the highest dose (6/14 males and 6/18 females), albeit in the presence of excessive maternal toxicity.","effect":"SCCS-rejected applicant NOAEL: city (mainly hydronephrosis and haematological alterations) and cannot be totally disregarded for classification. This same effect also appeared in F1 pups at the highest dose (6/14 males and 6/18 females), albeit in the presence of excessive maternal toxicity. The RAC considered these effects on the heart as relevant for classification of SZZ as toxic to development Cat 2. Silver (Taken from SCCS/1577/16) A high-quality developmental toxicity study performed in the rat with silver acetate (NTP, 2002) concludes a NOAEL for developmental toxicity of 100 mg/kg bw/d, the highest dose level tested. Indications of slight maternal toxicity were observed at this dose level; more severe maternal toxicity was observed at a dose level of 160 mg/kg bw/d in a screening study. Published data (Shavlovsky et al., 1995) indicate an effect of silver on development at maternally toxic dose levels and secondary to copper deficiency caused by the displacement of copper by silver from ceruloplasmin. Zinc (Taken from SCCS/1586/17) In animal studies","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_012"} |
| SCCS_vision_codex | NOAEL | =20 | - | - | oral | developmental | reproductive toxicity | {"dose":"While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element.","effect":"with healthy pregnant women, a daily oral zinc supplement of 20-90 mg has shown no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_013"} |
| SCCS_vision_codex | NOAEL | =2011 | - | - | oral | developmental | reproductive toxicity | {"dose":"While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element.","effect":"own no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_014"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | human | oral | - | reproductive toxicity | {"dose":"Zinc deficiency is associated with the impairment of fertility and foetal development; however, evidence from animal studies also indicates that high levels of exposure to zinc (≥200 mg/kg bw/d) may also cause adverse effects on fertility and foetal development.","effect":"ation with colloidal silver, there are no studies available on respiratory sensitisation (ECHA-CLH 2020). Zinc Zinc is an essential dietary element involved in many biochemical processes; and is critical for the maintenance of normal immune, sexual and neurosensory function such as cognition and vision. Adverse effects of zinc supplementation (as zinc sulphate) at a level of 150 mg/day are reported to be headache, nausea and gastric discomfort. The EU RAR for zinc concludes that 50 mg/day constitutes a human oral NOAEL for zinc. The EU RAR also concludes that there is no clear evidence for the mutagenicity or carcinogenicity of zinc. Zinc deficiency is associated with the impairment of fertility and foetal development; however, evidence from animal studies also indicates that high levels of exposure to zinc (≥200 mg/kg bw/d) may also cause adverse effects on fertility and foetal development. The EU RAR concludes that, as the reproductive effects seen in animal studies are seen only at high-dose levels associated with general tox","page":30,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_015"} |
| SCCS_vision_codex | NOAEL | =31 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"_______________ 31 against the criteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_016"} |
| SCCS_vision_codex | NOAEL | =2017 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"riteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED)","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_017"} |
| SCCS_vision_codex | NOAEL | =275 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_018"} |
| SCCS_vision_codex | NOAEL | =3.5 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"s not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_019"} |
| SCCS_vision_codex | NOAEL | =5 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_021"} |
| SCCS_vision_codex | NOAEL | =3.3 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_022"} |
| SCCS_vision_codex | NOAEL | =4.5 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_024"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | - | oral | developmental | reproductive toxicity | {"dose":"1000 mg/kg bw, silver zinc zeolite does not affect fertility.","effect":"Applicant, and based its safety assessment, in view of the apparently low inhalation toxicity from the zeolite itself, on the release of silver in the airways. Reproductive toxicity At gavage doses up to approx. 1000 mg/kg bw, silver zinc zeolite does not affect fertility. However developmental effects (pup mortality, decreased pup weight and cardiac effects) were noted and ascribed to the effects from silver. According to ECHA/BPC/275/21, silver zinc zeolite fulfils criteria for classification Repr 2; H361d. The NOAEL derived from the chronic oral toxicity study (which is used in the current assessment) is amply below the NOAEL for reproductive and developmental effects. Mutagenicity / genotoxicity The SCCS concurs with the ECHA Opinion (ECHA/BPC/275/2021) that the mutagenic potential of the substance has been adequately investigated in vitro and in vivo. While the in vitro test in mammalian cells indicated a mutagenic potential of silver zinc zeolite, there were no indications of genotoxicity in the in vivo studies conducted,","page":33,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_026"} |
| SCCS_vision_codex | NOAEL | =0.04 | - | - | inhalation | - | NOAEL study | {"effect":"inhalation exposure estimate to account for the uncertainty regarding conservativeness of the proposed exposure estimates. Consequently, the SCCS will use an SED of 0.04 μg/kg bw/day for the calculation of the MoS. The Applicant also submitted data on a fraction of the systemic exposure from ingestion of the ethanol-based deodorant spray. The SCCS has examined these data and considers this contribution to the total SED as negligible. Zinc In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and not use the SED for zinc for the calculation of the MoS (see also 3.4.4.3).","page":18,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_001"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw/d | dog | - | subchronic | repeated dose toxicity | {"citation":"Ref: Teunissen 2003","dose":"both sexes at the highest dose level; clinical chemistry analyses revealed increased cholesterol concentration and increased serum alkaline phosphatase activity.","effect":"both sexes at the highest dose level; clinical chemistry analyses revealed increased cholesterol concentration and increased serum alkaline phosphatase activity. At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d. Histopathological investigations showed effects on the kidney, including an increased severity of corticomedullary tubular basophilic and lymphoid infiltration, interstitial fibrosis and hyaline/cellular casts at 250 mg/kg bw/d. A NOAEL of 50 mg/kg bw/d was therefore determined for this study. Ref: Teunissen 2003. According to CAR-ECHA 2021, the overall subchronic NOAEL for the types of silver zinc zeolites used in representative formulations of 50 mg/kg bw/day is based on pigmentation, increased level of ALP, effects on haematological parameters and effects on behaviour/ activity observed in dogs administered 250 mg AgION Antimicrobial Types AK /kg bw/day. 3.4.4.3 Chronic (> 12 months) toxicity SZZ Combined chronic toxicity/carcinogenicity s","page":23,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_002"} |
| SCCS_vision_codex | NOAEL | =50 | mg/kg bw/day | rat | - | subchronic | repeated dose toxicity | {"citation":"Ref: Teunissen 2003","dose":"At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d.","effect":"ine phosphatase activity. At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d. Histopathological investigations showed effects on the kidney, including an increased severity of corticomedullary tubular basophilic and lymphoid infiltration, interstitial fibrosis and hyaline/cellular casts at 250 mg/kg bw/d. A NOAEL of 50 mg/kg bw/d was therefore determined for this study. Ref: Teunissen 2003. According to CAR-ECHA 2021, the overall subchronic NOAEL for the types of silver zinc zeolites used in representative formulations of 50 mg/kg bw/day is based on pigmentation, increased level of ALP, effects on haematological parameters and effects on behaviour/ activity observed in dogs administered 250 mg AgION Antimicrobial Types AK /kg bw/day. 3.4.4.3 Chronic (> 12 months) toxicity SZZ Combined chronic toxicity/carcinogenicity study in mice and rats (Takizawa 1992). The test material Zeomic AJ 10N was an odourless crystalline powder with the Ag, Zn, and NH4 conte","page":23,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_003"} |
| SCCS_vision_codex | NOAEL | =5 | % | rat | oral | 24 months | NOAEL study | {"dose":"Effects on haematological parameters (decrease in HCT, Hb (12%), MCH and MCHC) were observed at 24 months in the two highest dose levels in females, but there were no effects in males.","effect":"at 24 months. Effects on haematological parameters (decrease in HCT, Hb (12%), MCH and MCHC) were observed at 24 months in the two highest dose levels in females, but there were no effects in males. There were no effects observed in any of the treated animals at 6 and 12 months or among animals in the lower dose groups at 24 months. The pathological examination revealed pigmentation of liver, kidneys, pancreas, stomach, lymph nodes and the choroid plexus in high-dose rats. According to CAR-ECHA 2021, the chronic NOAEL, derived from the above-mentioned oral dosing study in rats, based on pigmentation as a critical effect, is considered to be 9 mg AgION Type AJ/kg bw/day or 0.09 mg silver ion equivalents/kg bw). With correction for absorption from the stomach of 5%, this would imply a NOAEL for silver of 0.0045 mg (4.5 microgram)/kg bw/d Silver The Applicant summarised the toxicological reference values for silver as follows: All published reviews agree that the critical effect of silver exposure is argyria. Toxicological refere","page":24,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_004"} |
| SCCS_vision_codex | NOAEL | =0.0065 | mg/kg bw/d | human | oral | 70 years | NOAEL study | {"dose":"The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg bw/d), assuming a lifetime of 70 years and a bodyweight of 70 kg.","effect":"ll published reviews agree that the critical effect of silver exposure is argyria. Toxicological reference values for silver have been derived by the EPA, WHO and EFSA, as discussed below. The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg bw/d), assuming a lifetime of 70 years and a bodyweight of 70 kg. Using epidemiological and pharmacokinetic data, WHO (2003) derives a human NOAEL (lifetime oral intake) for silver of 10 g, corresponding to 0.39 mg/day or 0.0065 mg/kg bw/d. Assuming a gastrointestinal absorption of silver of 5%, this is equivalent to a systemic reference value of 0.000325 mg/kg bw/d (0.325 μg/kg bw/d), a value comparable to that derived by the US EPA. EFSA has evaluated silver-based preservatives for use in food-contact materials on the basis of human and animal data and has derived a group restriction limit of 0.05 mg/kg food, which corresponds to a worst-case exposure of 0","page":24,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_006"} |
| SCCS_vision_codex | NOAEL | =31.52 | mg/kg bw | human | oral | - | NOAEL study | {"dose":"603-404-0) ___________________________________________________________________________________________ ___________________________________________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d.","effect":"SCCS/1650/23 Final Opinion Opinion on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0) ___________________________________________________________________________________________ ___________________________________________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d. (From ECHA registration dossier – key study) Based on a study with zinc monoglycerolate the NOAEL is 31.52 mg/kg bw (»13.26 mg Zn2+/kg bw). Besides animal data, there are several human studies in which humans were supplemented with moderately high amounts of zinc (50 mg Zn/day) (as zinc gluconate). The EU Risk Assessment Report Zinc Oxide (2004) sets a NOAEL of 50 mg Zn2+ / day, which equals 0.83 mg Zn2+/kg bw/day. From SCCS on zinc in oral products (SCCS/1586/17): 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 (co","page":25,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.0045 | mg/kg bw/d | human | inhalation | 90-day | NOAEL study | {"citation":"Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this","dose":"Dose-related nonsuppurative inflammatory reactions were observed in animals of all dose groups.","effect":"on-fibrogenic dust with regard to human inhalation risk. Dose-related nonsuppurative inflammatory reactions were observed in animals of all dose groups. These reactions had diminished in severity but had not fully disappeared in the mid- and high-dose group. In the 1 mg/m³ dose group, these effects were not evident after the 90-day recovery period. The LOAEL for inhalation is 1 mg/m³. Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this at 0.0045 mg/kg bw/d. This will be used for the calculation of the MoS.","page":25,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_010"} |
| SCCS_vision_codex | NOAEL | =1109 | mg/kg bw | rat | oral | - | reproductive toxicity | {"dose":"_____ 26 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity SSZ A two-generation reproduction and fertility study of Zeomic (silver zinc zeolite) has been performed with oral gavage doses of 200, 700, 2000 mg/kg bw/day in Rats (Schroeder 2002) According to CAR-ECHA (2021), there is only substance-specific data available for...","effect":"_____ 26 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity SSZ A two-generation reproduction and fertility study of Zeomic (silver zinc zeolite) has been performed with oral gavage doses of 200, 700, 2000 mg/kg bw/day in Rats (Schroeder 2002) According to CAR-ECHA (2021), there is only substance-specific data available for this Silver Antimicrobial Type AK (Schroeder 2002). It was concluded that silver zinc zeolite does not affect fertility at doses up to 12500 ppm (984/1109 mg/kg bw): the NOAEL for reproduction is 1000 ppm (approximately 70 mg Type AK/mg kg bw). Silver (Taken from ECHA-CLH (2020) The data available on silver acetate and nanosilver indicate that the silver ion has the ability to cause adverse effects on sexual function and fertility possibly by a mechanism involving oxidative stress. According to the original report for the silver acetate study and the published studies with nanosilver, there were no marked general toxicity indicating that effects were “a non-specific consequence of the","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_011"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/d | rat | - | developmental | developmental toxicity | {"dose":"This same effect also appeared in F1 pups at the highest dose (6/14 males and 6/18 females), albeit in the presence of excessive maternal toxicity.","effect":"SCCS-rejected applicant NOAEL: city (mainly hydronephrosis and haematological alterations) and cannot be totally disregarded for classification. This same effect also appeared in F1 pups at the highest dose (6/14 males and 6/18 females), albeit in the presence of excessive maternal toxicity. The RAC considered these effects on the heart as relevant for classification of SZZ as toxic to development Cat 2. Silver (Taken from SCCS/1577/16) A high-quality developmental toxicity study performed in the rat with silver acetate (NTP, 2002) concludes a NOAEL for developmental toxicity of 100 mg/kg bw/d, the highest dose level tested. Indications of slight maternal toxicity were observed at this dose level; more severe maternal toxicity was observed at a dose level of 160 mg/kg bw/d in a screening study. Published data (Shavlovsky et al., 1995) indicate an effect of silver on development at maternally toxic dose levels and secondary to copper deficiency caused by the displacement of copper by silver from ceruloplasmin. Zinc (Taken from SCCS/1586/17) In animal studies","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_012"} |
| SCCS_vision_codex | NOAEL | =20 | - | - | oral | developmental | reproductive toxicity | {"dose":"While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element.","effect":"with healthy pregnant women, a daily oral zinc supplement of 20-90 mg has shown no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_013"} |
| SCCS_vision_codex | NOAEL | =2011 | - | - | oral | developmental | reproductive toxicity | {"dose":"While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element.","effect":"own no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.","page":26,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_014"} |
| SCCS_vision_codex | NOAEL | =200 | mg/kg bw/d | human | oral | - | reproductive toxicity | {"dose":"Zinc deficiency is associated with the impairment of fertility and foetal development; however, evidence from animal studies also indicates that high levels of exposure to zinc (≥200 mg/kg bw/d) may also cause adverse effects on fertility and foetal development.","effect":"ation with colloidal silver, there are no studies available on respiratory sensitisation (ECHA-CLH 2020). Zinc Zinc is an essential dietary element involved in many biochemical processes; and is critical for the maintenance of normal immune, sexual and neurosensory function such as cognition and vision. Adverse effects of zinc supplementation (as zinc sulphate) at a level of 150 mg/day are reported to be headache, nausea and gastric discomfort. The EU RAR for zinc concludes that 50 mg/day constitutes a human oral NOAEL for zinc. The EU RAR also concludes that there is no clear evidence for the mutagenicity or carcinogenicity of zinc. Zinc deficiency is associated with the impairment of fertility and foetal development; however, evidence from animal studies also indicates that high levels of exposure to zinc (≥200 mg/kg bw/d) may also cause adverse effects on fertility and foetal development. The EU RAR concludes that, as the reproductive effects seen in animal studies are seen only at high-dose levels associated with general tox","page":30,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_015"} |
| SCCS_vision_codex | NOAEL | =31 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"_______________ 31 against the criteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_016"} |
| SCCS_vision_codex | NOAEL | =2017 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"riteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED)","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_017"} |
| SCCS_vision_codex | NOAEL | =275 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_018"} |
| SCCS_vision_codex | NOAEL | =3.5 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"s not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_019"} |
| SCCS_vision_codex | NOAEL | =5 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_021"} |
| SCCS_vision_codex | NOAEL | =3.3 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_022"} |
| SCCS_vision_codex | NOAEL | =4.5 | - | - | dermal | - | NOAEL study | {"dose":"Systemic exposure dose-SED (see 3.3.2):","effect":"level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_024"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw | - | oral | developmental | reproductive toxicity | {"dose":"1000 mg/kg bw, silver zinc zeolite does not affect fertility.","effect":"Applicant, and based its safety assessment, in view of the apparently low inhalation toxicity from the zeolite itself, on the release of silver in the airways. Reproductive toxicity At gavage doses up to approx. 1000 mg/kg bw, silver zinc zeolite does not affect fertility. However developmental effects (pup mortality, decreased pup weight and cardiac effects) were noted and ascribed to the effects from silver. According to ECHA/BPC/275/21, silver zinc zeolite fulfils criteria for classification Repr 2; H361d. The NOAEL derived from the chronic oral toxicity study (which is used in the current assessment) is amply below the NOAEL for reproductive and developmental effects. Mutagenicity / genotoxicity The SCCS concurs with the ECHA Opinion (ECHA/BPC/275/2021) that the mutagenic potential of the substance has been adequately investigated in vitro and in vivo. While the in vitro test in mammalian cells indicated a mutagenic potential of silver zinc zeolite, there were no indications of genotoxicity in the in vivo studies conducted,","page":33,"pdf":"sccs_o_270_final.pdf","row_type":"noael_study","study_id":"sccs_o_270_final_noael_026"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 27 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.04 | - | - | inhalation | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=unclear:inhalation exposure estimate to account for the uncertainty regarding conservativeness of the proposed exposure estimates. Consequently, the SCCS will use an SED of 0.04 μg/kg bw/day for the calculation of the MoS. The Applicant also submitted data on a fraction of the systemic exposure from ingestion of the ethanol-based deodorant spray. The SCCS has examined these data and considers this contribution to the total SED as negligible. Zinc In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and not use the SED for zinc for the calculation of the MoS (see also 3.4.4.3).; EFFECT=inhalation exposure estimate to account for the uncertainty regarding conservativeness of the proposed exposure estimates. Consequently, the SCCS will use an SED of 0.04 μg/kg bw/day for the calculation of the MoS. The Applicant also submitted data on a fraction of the systemic exposure from ingestion of the ethanol-based deodorant spray. The SCCS has examined these data and considers this contribution to the total SED as negligible. Zinc In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and not use the SED for zinc for the calculation of the MoS (see also 3.4.4.3).; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"","duration":"","effect":"inhalation exposure estimate to account for the uncertainty regarding conservativeness of the proposed exposure estimates. Consequently, the SCCS will use an SED of 0.04 μg/kg bw/day for the calculation of the MoS. The Applicant also submitted data on a fraction of the systemic exposure from ingestion of the ethanol-based deodorant spray. The SCCS has examined these data and considers this contribution to the total SED as negligible. Zinc In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and not use the SED for zinc for the calculation of the MoS (see also 3.4.4.3).","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"","noael_value":"unclear:inhalation exposure estimate to account for the uncertainty regarding conservativeness of the proposed exposure estimates. Consequently, the SCCS will use an SED of 0.04 μg/kg bw/day for the calculation of the MoS. The Applicant also submitted data on a fraction of the systemic exposure from ingestion of the ethanol-based deodorant spray. The SCCS has examined these data and considers this contribution to the total SED as negligible. Zinc In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and not use the SED for zinc for the calculation of the MoS (see also 3.4.4.3).","page":18,"route":"inhalation","species":"","study_id":"sccs_o_270_final_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 5 | % | rat | oral | 24 months | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=5; DOSE=Effects on haematological parameters (decrease in HCT, Hb (12%), MCH and MCHC) were observed at 24 months in the two highest dose levels in females, but there were no effects in males.; EFFECT=at 24 months. Effects on haematological parameters (decrease in HCT, Hb (12%), MCH and MCHC) were observed at 24 months in the two highest dose levels in females, but there were no effects in males. There were no effects observed in any of the treated animals at 6 and 12 months or among animals in the lower dose groups at 24 months. The pathological examination revealed pigmentation of liver, kidneys, pancreas, stomach, lymph nodes and the choroid plexus in high-dose rats. According to CAR-ECHA 2021, the chronic NOAEL, derived from the above-mentioned oral dosing study in rats, based on pigmentation as a critical effect, is considered to be 9 mg AgION Type AJ/kg bw/day or 0.09 mg silver ion equivalents/kg bw). With correction for absorption from the stomach of 5%, this would imply a NOAEL for silver of 0.0045 mg (4.5 microgram)/kg bw/d Silver The Applicant summarised the toxicological reference values for silver as follows: All published reviews agree that the critical effect of silver exposure is argyria. Toxicological refere; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"Effects on haematological parameters (decrease in HCT, Hb (12%), MCH and MCHC) were observed at 24 months in the two highest dose levels in females, but there were no effects in males.","duration":"24 months","effect":"at 24 months. Effects on haematological parameters (decrease in HCT, Hb (12%), MCH and MCHC) were observed at 24 months in the two highest dose levels in females, but there were no effects in males. There were no effects observed in any of the treated animals at 6 and 12 months or among animals in the lower dose groups at 24 months. The pathological examination revealed pigmentation of liver, kidneys, pancreas, stomach, lymph nodes and the choroid plexus in high-dose rats. According to CAR-ECHA 2021, the chronic NOAEL, derived from the above-mentioned oral dosing study in rats, based on pigmentation as a critical effect, is considered to be 9 mg AgION Type AJ/kg bw/day or 0.09 mg silver ion equivalents/kg bw). With correction for absorption from the stomach of 5%, this would imply a NOAEL for silver of 0.0045 mg (4.5 microgram)/kg bw/d Silver The Applicant summarised the toxicological reference values for silver as follows: All published reviews agree that the critical effect of silver exposure is argyria. Toxicological refere","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"%","noael_value":"5","page":24,"route":"oral","species":"rat","study_id":"sccs_o_270_final_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 5 | % | rat | oral | 24 months | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=5; DOSE=ths or among animals in the lower dose groups at 24 months.; EFFECT=ths or among animals in the lower dose groups at 24 months. The pathological examination revealed pigmentation of liver, kidneys, pancreas, stomach, lymph nodes and the choroid plexus in high-dose rats. According to CAR-ECHA 2021, the chronic NOAEL, derived from the above-mentioned oral dosing study in rats, based on pigmentation as a critical effect, is considered to be 9 mg AgION Type AJ/kg bw/day or 0.09 mg silver ion equivalents/kg bw). With correction for absorption from the stomach of 5%, this would imply a NOAEL for silver of 0.0045 mg (4.5 microgram)/kg bw/d Silver The Applicant summarised the toxicological reference values for silver as follows: All published reviews agree that the critical effect of silver exposure is argyria. Toxicological reference values for silver have been derived by the EPA, WHO and EFSA, as discussed below. The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"ths or among animals in the lower dose groups at 24 months.","duration":"24 months","effect":"ths or among animals in the lower dose groups at 24 months. The pathological examination revealed pigmentation of liver, kidneys, pancreas, stomach, lymph nodes and the choroid plexus in high-dose rats. According to CAR-ECHA 2021, the chronic NOAEL, derived from the above-mentioned oral dosing study in rats, based on pigmentation as a critical effect, is considered to be 9 mg AgION Type AJ/kg bw/day or 0.09 mg silver ion equivalents/kg bw). With correction for absorption from the stomach of 5%, this would imply a NOAEL for silver of 0.0045 mg (4.5 microgram)/kg bw/d Silver The Applicant summarised the toxicological reference values for silver as follows: All published reviews agree that the critical effect of silver exposure is argyria. Toxicological reference values for silver have been derived by the EPA, WHO and EFSA, as discussed below. The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"%","noael_value":"5","page":24,"route":"oral","species":"rat","study_id":"sccs_o_270_final_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.0065 | mg/kg bw/d | human | oral | 70 years | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=0.0065; DOSE=The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg bw/d), assuming a lifetime of 70 years and a bodyweight of 70 kg.; EFFECT=ll published reviews agree that the critical effect of silver exposure is argyria. Toxicological reference values for silver have been derived by the EPA, WHO and EFSA, as discussed below. The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg bw/d), assuming a lifetime of 70 years and a bodyweight of 70 kg. Using epidemiological and pharmacokinetic data, WHO (2003) derives a human NOAEL (lifetime oral intake) for silver of 10 g, corresponding to 0.39 mg/day or 0.0065 mg/kg bw/d. Assuming a gastrointestinal absorption of silver of 5%, this is equivalent to a systemic reference value of 0.000325 mg/kg bw/d (0.325 μg/kg bw/d), a value comparable to that derived by the US EPA. EFSA has evaluated silver-based preservatives for use in food-contact materials on the basis of human and animal data and has derived a group restriction limit of 0.05 mg/kg food, which corresponds to a worst-case exposure of 0; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg bw/d), assuming a lifetime of 70 years and a bodyweight of 70 kg.","duration":"70 years","effect":"ll published reviews agree that the critical effect of silver exposure is argyria. Toxicological reference values for silver have been derived by the EPA, WHO and EFSA, as discussed below. The US EPA uses a systemic lifetime (systemic) exposure of 1 g silver as a starting point; this is calculated to be equivalent to a systemic exposure level of 0.00056 mg/kg bw/d (0.56 μg/kg bw/d), assuming a lifetime of 70 years and a bodyweight of 70 kg. Using epidemiological and pharmacokinetic data, WHO (2003) derives a human NOAEL (lifetime oral intake) for silver of 10 g, corresponding to 0.39 mg/day or 0.0065 mg/kg bw/d. Assuming a gastrointestinal absorption of silver of 5%, this is equivalent to a systemic reference value of 0.000325 mg/kg bw/d (0.325 μg/kg bw/d), a value comparable to that derived by the US EPA. EFSA has evaluated silver-based preservatives for use in food-contact materials on the basis of human and animal data and has derived a group restriction limit of 0.05 mg/kg food, which corresponds to a worst-case exposure of 0","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.0065","page":24,"route":"oral","species":"human","study_id":"sccs_o_270_final_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 31.52 | mg/kg bw | human | oral | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=31.52; DOSE=603-404-0) ___________________________________________________________________________________________ ___________________________________________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d.; EFFECT=SCCS/1650/23 Final Opinion Opinion on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0) ___________________________________________________________________________________________ ___________________________________________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d. (From ECHA registration dossier – key study) Based on a study with zinc monoglycerolate the NOAEL is 31.52 mg/kg bw (»13.26 mg Zn2+/kg bw). Besides animal data, there are several human studies in which humans were supplemented with moderately high amounts of zinc (50 mg Zn/day) (as zinc gluconate). The EU Risk Assessment Report Zinc Oxide (2004) sets a NOAEL of 50 mg Zn2+ / day, which equals 0.83 mg Zn2+/kg bw/day. From SCCS on zinc in oral products (SCCS/1586/17): 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 (co; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"603-404-0) ___________________________________________________________________________________________ ___________________________________________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d.","duration":"","effect":"SCCS/1650/23 Final Opinion Opinion on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0) ___________________________________________________________________________________________ ___________________________________________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d. (From ECHA registration dossier – key study) Based on a study with zinc monoglycerolate the NOAEL is 31.52 mg/kg bw (»13.26 mg Zn2+/kg bw). Besides animal data, there are several human studies in which humans were supplemented with moderately high amounts of zinc (50 mg Zn/day) (as zinc gluconate). The EU Risk Assessment Report Zinc Oxide (2004) sets a NOAEL of 50 mg Zn2+ / day, which equals 0.83 mg Zn2+/kg bw/day. From SCCS on zinc in oral products (SCCS/1586/17): 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 (co","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw","noael_value":"31.52","page":25,"route":"oral","species":"human","study_id":"sccs_o_270_final_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 31.52 | mg/kg bw | human | oral | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=31.52; DOSE=______________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d.; EFFECT=______________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d. (From ECHA registration dossier – key study) Based on a study with zinc monoglycerolate the NOAEL is 31.52 mg/kg bw (»13.26 mg Zn2+/kg bw). Besides animal data, there are several human studies in which humans were supplemented with moderately high amounts of zinc (50 mg Zn/day) (as zinc gluconate). The EU Risk Assessment Report Zinc Oxide (2004) sets a NOAEL of 50 mg Zn2+ / day, which equals 0.83 mg Zn2+/kg bw/day. From SCCS on zinc in oral products (SCCS/1586/17): 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). An UL of 25 mg zinc/day also applies to pregnant and lactating women. The following ULs were extrapolated by SCF for children and young pe; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"______________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d.","duration":"","effect":"______________________________________________________________ 25 bodyweight of 60 kg, this is equivalent to a systemic exposure of approximately 0.42 mg/kg bw/d. (From ECHA registration dossier – key study) Based on a study with zinc monoglycerolate the NOAEL is 31.52 mg/kg bw (»13.26 mg Zn2+/kg bw). Besides animal data, there are several human studies in which humans were supplemented with moderately high amounts of zinc (50 mg Zn/day) (as zinc gluconate). The EU Risk Assessment Report Zinc Oxide (2004) sets a NOAEL of 50 mg Zn2+ / day, which equals 0.83 mg Zn2+/kg bw/day. From SCCS on zinc in oral products (SCCS/1586/17): 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). An UL of 25 mg zinc/day also applies to pregnant and lactating women. The following ULs were extrapolated by SCF for children and young pe","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw","noael_value":"31.52","page":25,"route":"oral","species":"human","study_id":"sccs_o_270_final_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 31.52 | mg/kg bw | human | oral | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=31.52; DOSE=d on a study with zinc monoglycerolate the NOAEL is 31.52 mg/kg bw (»13.26 mg Zn2+/kg bw).; EFFECT=SCCS-rejected applicant NOAEL: d on a study with zinc monoglycerolate the NOAEL is 31.52 mg/kg bw (»13.26 mg Zn2+/kg bw). Besides animal data, there are several human studies in which humans were supplemented with moderately high amounts of zinc (50 mg Zn/day) (as zinc gluconate). The EU Risk Assessment Report Zinc Oxide (2004) sets a NOAEL of 50 mg Zn2+ / day, which equals 0.83 mg Zn2+/kg bw/day. From SCCS on zinc in oral products (SCCS/1586/17): 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). An UL of 25 mg zinc/day also applies to pregnant and lactating women. The following ULs were extrapolated by SCF for children and young people: 1-3 yrs: 7 mg/day; 4-6 yrs: 10 mg/day; 7-10 yrs: 13 mg/day; 11-14 yrs: 18 mg/day, 15-17 yrs: 22 mg/day. Inhalation of zeolites According to ECHA-CLH (2020), silver is not considered a respiratory sensitiser; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"d on a study with zinc monoglycerolate the NOAEL is 31.52 mg/kg bw (»13.26 mg Zn2+/kg bw).","duration":"","effect":"SCCS-rejected applicant NOAEL: d on a study with zinc monoglycerolate the NOAEL is 31.52 mg/kg bw (»13.26 mg Zn2+/kg bw). Besides animal data, there are several human studies in which humans were supplemented with moderately high amounts of zinc (50 mg Zn/day) (as zinc gluconate). The EU Risk Assessment Report Zinc Oxide (2004) sets a NOAEL of 50 mg Zn2+ / day, which equals 0.83 mg Zn2+/kg bw/day. From SCCS on zinc in oral products (SCCS/1586/17): 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). An UL of 25 mg zinc/day also applies to pregnant and lactating women. The following ULs were extrapolated by SCF for children and young people: 1-3 yrs: 7 mg/day; 4-6 yrs: 10 mg/day; 7-10 yrs: 13 mg/day; 11-14 yrs: 18 mg/day, 15-17 yrs: 22 mg/day. Inhalation of zeolites According to ECHA-CLH (2020), silver is not considered a respiratory sensitiser","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw","noael_value":"31.52","page":25,"route":"oral","species":"human","study_id":"sccs_o_270_final_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 0.0045 | mg/kg bw/d | human | inhalation | 90-day | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=0.0045; DOSE=Dose-related nonsuppurative inflammatory reactions were observed in animals of all dose groups.; EFFECT=on-fibrogenic dust with regard to human inhalation risk. Dose-related nonsuppurative inflammatory reactions were observed in animals of all dose groups. These reactions had diminished in severity but had not fully disappeared in the mid- and high-dose group. In the 1 mg/m³ dose group, these effects were not evident after the 90-day recovery period. The LOAEL for inhalation is 1 mg/m³. Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this at 0.0045 mg/kg bw/d. This will be used for the calculation of the MoS.; CITATION=Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this; CITATION_NUMBERS=[2004,2021]; REFERENCE=Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this; DETAILS_JSON={"cas_number":"130328-20-0","citation":"Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this","dose":"Dose-related nonsuppurative inflammatory reactions were observed in animals of all dose groups.","duration":"90-day","effect":"on-fibrogenic dust with regard to human inhalation risk. Dose-related nonsuppurative inflammatory reactions were observed in animals of all dose groups. These reactions had diminished in severity but had not fully disappeared in the mid- and high-dose group. In the 1 mg/m³ dose group, these effects were not evident after the 90-day recovery period. The LOAEL for inhalation is 1 mg/m³. Ref: HERA 2004 SCCS overall comment on chronic toxicity In agreement with the conclusions in CAR-ECHA 2021 the SCCS will base the NOAEL on the effects observed from silver and set this at 0.0045 mg/kg bw/d. This will be used for the calculation of the MoS.","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.0045","page":25,"route":"inhalation","species":"human","study_id":"sccs_o_270_final_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 31 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=unclear:_______________ 31 against the criteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL; DOSE=Systemic exposure dose-SED (see 3.3.2):; EFFECT=_______________ 31 against the criteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"Systemic exposure dose-SED (see 3.3.2):","duration":"","effect":"_______________ 31 against the criteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"","noael_value":"unclear:_______________ 31 against the criteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL","page":31,"route":"dermal","species":"","study_id":"sccs_o_270_final_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 2017 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=unclear:riteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED); DOSE=Systemic exposure dose-SED (see 3.3.2):; EFFECT=riteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"Systemic exposure dose-SED (see 3.3.2):","duration":"","effect":"riteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED)","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"","noael_value":"unclear:riteria laid down in Regulation (EU) No 2017/2100. No further report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED)","page":31,"route":"dermal","species":"","study_id":"sccs_o_270_final_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 275 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=unclear:report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; DOSE=Systemic exposure dose-SED (see 3.3.2):; EFFECT=report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"Systemic exposure dose-SED (see 3.3.2):","duration":"","effect":"report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"","noael_value":"unclear:report was provided in this regard for this submission. Ref. ECHA/BPC/275/2021 SCCS comment The SCCS has not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"route":"dermal","species":"","study_id":"sccs_o_270_final_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 3.5 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=unclear:s not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; DOSE=Systemic exposure dose-SED (see 3.3.2):; EFFECT=s not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"Systemic exposure dose-SED (see 3.3.2):","duration":"","effect":"s not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"","noael_value":"unclear:s not been able to assess potential ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"route":"dermal","species":"","study_id":"sccs_o_270_final_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 3.5 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=unclear:al ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; DOSE=Systemic exposure dose-SED (see 3.3.2):; EFFECT=al ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"Systemic exposure dose-SED (see 3.3.2):","duration":"","effect":"al ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"","noael_value":"unclear:al ED effects of SZZ due to lack of relevant information. 3.5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"route":"dermal","species":"","study_id":"sccs_o_270_final_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 5 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=unclear:5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; DOSE=Systemic exposure dose-SED (see 3.3.2):; EFFECT=5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"Systemic exposure dose-SED (see 3.3.2):","duration":"","effect":"5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"","noael_value":"unclear:5 SAFETY EVALUATION (INCLUDING CALCULATION OF THE MOS, BASED ON EXPOSURE TO SILVER) Dermal exposure, aggregated for powder foundation and ethanol-based spray: Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"route":"dermal","species":"","study_id":"sccs_o_270_final_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 3.3 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=unclear:Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; DOSE=Systemic exposure dose-SED (see 3.3.2):; EFFECT=Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"Systemic exposure dose-SED (see 3.3.2):","duration":"","effect":"Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"","noael_value":"unclear:Systemic exposure dose-SED (see 3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"route":"dermal","species":"","study_id":"sccs_o_270_final_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 3.3 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=unclear:3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; DOSE=Systemic exposure dose-SED (see 3.3.2):; EFFECT=3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"Systemic exposure dose-SED (see 3.3.2):","duration":"","effect":"3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"","noael_value":"unclear:3.3.2): 0.00126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"route":"dermal","species":"","study_id":"sccs_o_270_final_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 4.5 | - | - | dermal | - | - | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=unclear:level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; DOSE=Systemic exposure dose-SED (see 3.3.2):; EFFECT=level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"Systemic exposure dose-SED (see 3.3.2):","duration":"","effect":"level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","endpoint":"","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"","noael_value":"unclear:level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 3570 Inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.04 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 112 Deterministic aggregated dermal and inhalation exposure: Systemic exposure dose-SED (see 3.3.2): 0.00126 + 0.04 = 0.04126 microgram/kg bw/d No observed adverse effect level-NOAEL: 4.5 microgram/kg bw/d (see 3.4.4.) Margin of Safety (NOAEL/SED) = 109","page":31,"route":"dermal","species":"","study_id":"sccs_o_270_final_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 100 | mg/kg bw/d | rat | - | developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=100; DOSE=This same effect also appeared in F1 pups at the highest dose (6/14 males and 6/18 females), albeit in the presence of excessive maternal toxicity.; EFFECT=SCCS-rejected applicant NOAEL: city (mainly hydronephrosis and haematological alterations) and cannot be totally disregarded for classification. This same effect also appeared in F1 pups at the highest dose (6/14 males and 6/18 females), albeit in the presence of excessive maternal toxicity. The RAC considered these effects on the heart as relevant for classification of SZZ as toxic to development Cat 2. Silver (Taken from SCCS/1577/16) A high-quality developmental toxicity study performed in the rat with silver acetate (NTP, 2002) concludes a NOAEL for developmental toxicity of 100 mg/kg bw/d, the highest dose level tested. Indications of slight maternal toxicity were observed at this dose level; more severe maternal toxicity was observed at a dose level of 160 mg/kg bw/d in a screening study. Published data (Shavlovsky et al., 1995) indicate an effect of silver on development at maternally toxic dose levels and secondary to copper deficiency caused by the displacement of copper by silver from ceruloplasmin. Zinc (Taken from SCCS/1586/17) In animal studies; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"This same effect also appeared in F1 pups at the highest dose (6/14 males and 6/18 females), albeit in the presence of excessive maternal toxicity.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: city (mainly hydronephrosis and haematological alterations) and cannot be totally disregarded for classification. This same effect also appeared in F1 pups at the highest dose (6/14 males and 6/18 females), albeit in the presence of excessive maternal toxicity. The RAC considered these effects on the heart as relevant for classification of SZZ as toxic to development Cat 2. Silver (Taken from SCCS/1577/16) A high-quality developmental toxicity study performed in the rat with silver acetate (NTP, 2002) concludes a NOAEL for developmental toxicity of 100 mg/kg bw/d, the highest dose level tested. Indications of slight maternal toxicity were observed at this dose level; more severe maternal toxicity was observed at a dose level of 160 mg/kg bw/d in a screening study. Published data (Shavlovsky et al., 1995) indicate an effect of silver on development at maternally toxic dose levels and secondary to copper deficiency caused by the displacement of copper by silver from ceruloplasmin. Zinc (Taken from SCCS/1586/17) In animal studies","endpoint":"developmental toxicity","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":26,"route":"","species":"rat","study_id":"sccs_o_270_final_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 250 | mg/kg bw/d | dog | - | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=250; DOSE=both sexes at the highest dose level; clinical chemistry analyses revealed increased cholesterol concentration and increased serum alkaline phosphatase activity.; EFFECT=both sexes at the highest dose level; clinical chemistry analyses revealed increased cholesterol concentration and increased serum alkaline phosphatase activity. At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d. Histopathological investigations showed effects on the kidney, including an increased severity of corticomedullary tubular basophilic and lymphoid infiltration, interstitial fibrosis and hyaline/cellular casts at 250 mg/kg bw/d. A NOAEL of 50 mg/kg bw/d was therefore determined for this study. Ref: Teunissen 2003. According to CAR-ECHA 2021, the overall subchronic NOAEL for the types of silver zinc zeolites used in representative formulations of 50 mg/kg bw/day is based on pigmentation, increased level of ALP, effects on haematological parameters and effects on behaviour/ activity observed in dogs administered 250 mg AgION Antimicrobial Types AK /kg bw/day. 3.4.4.3 Chronic (> 12 months) toxicity SZZ Combined chronic toxicity/carcinogenicity s; CITATION=Ref: Teunissen 2003; CITATION_NUMBERS=[2003]; REFERENCE=Ref: Teunissen 2003; DETAILS_JSON={"cas_number":"130328-20-0","citation":"Ref: Teunissen 2003","dose":"both sexes at the highest dose level; clinical chemistry analyses revealed increased cholesterol concentration and increased serum alkaline phosphatase activity.","duration":"subchronic","effect":"both sexes at the highest dose level; clinical chemistry analyses revealed increased cholesterol concentration and increased serum alkaline phosphatase activity. At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d. Histopathological investigations showed effects on the kidney, including an increased severity of corticomedullary tubular basophilic and lymphoid infiltration, interstitial fibrosis and hyaline/cellular casts at 250 mg/kg bw/d. A NOAEL of 50 mg/kg bw/d was therefore determined for this study. Ref: Teunissen 2003. According to CAR-ECHA 2021, the overall subchronic NOAEL for the types of silver zinc zeolites used in representative formulations of 50 mg/kg bw/day is based on pigmentation, increased level of ALP, effects on haematological parameters and effects on behaviour/ activity observed in dogs administered 250 mg AgION Antimicrobial Types AK /kg bw/day. 3.4.4.3 Chronic (> 12 months) toxicity SZZ Combined chronic toxicity/carcinogenicity s","endpoint":"repeated dose toxicity","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"250","page":23,"route":"","species":"dog","study_id":"sccs_o_270_final_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 50 | mg/kg bw/day | rat | - | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=50; DOSE=At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d.; EFFECT=ine phosphatase activity. At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d. Histopathological investigations showed effects on the kidney, including an increased severity of corticomedullary tubular basophilic and lymphoid infiltration, interstitial fibrosis and hyaline/cellular casts at 250 mg/kg bw/d. A NOAEL of 50 mg/kg bw/d was therefore determined for this study. Ref: Teunissen 2003. According to CAR-ECHA 2021, the overall subchronic NOAEL for the types of silver zinc zeolites used in representative formulations of 50 mg/kg bw/day is based on pigmentation, increased level of ALP, effects on haematological parameters and effects on behaviour/ activity observed in dogs administered 250 mg AgION Antimicrobial Types AK /kg bw/day. 3.4.4.3 Chronic (> 12 months) toxicity SZZ Combined chronic toxicity/carcinogenicity study in mice and rats (Takizawa 1992). The test material Zeomic AJ 10N was an odourless crystalline powder with the Ag, Zn, and NH4 conte; CITATION=Ref: Teunissen 2003; CITATION_NUMBERS=[2003]; REFERENCE=Ref: Teunissen 2003; DETAILS_JSON={"cas_number":"130328-20-0","citation":"Ref: Teunissen 2003","dose":"At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d.","duration":"subchronic","effect":"ine phosphatase activity. At necropsy, discoloration of the gastrointestinal tract and pancreas were observed at the high-dose level of 250 mg/kg bw/d. Histopathological investigations showed effects on the kidney, including an increased severity of corticomedullary tubular basophilic and lymphoid infiltration, interstitial fibrosis and hyaline/cellular casts at 250 mg/kg bw/d. A NOAEL of 50 mg/kg bw/d was therefore determined for this study. Ref: Teunissen 2003. According to CAR-ECHA 2021, the overall subchronic NOAEL for the types of silver zinc zeolites used in representative formulations of 50 mg/kg bw/day is based on pigmentation, increased level of ALP, effects on haematological parameters and effects on behaviour/ activity observed in dogs administered 250 mg AgION Antimicrobial Types AK /kg bw/day. 3.4.4.3 Chronic (> 12 months) toxicity SZZ Combined chronic toxicity/carcinogenicity study in mice and rats (Takizawa 1992). The test material Zeomic AJ 10N was an odourless crystalline powder with the Ag, Zn, and NH4 conte","endpoint":"repeated dose toxicity","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"50","page":23,"route":"","species":"rat","study_id":"sccs_o_270_final_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 0.0045 | mg/kg bw/d | rat | inhalation | chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=0.0045; DOSE=Repeated dose toxicity The NOAEL used in this evaluation (0.0045 mg/kg bw/d) is derived from a combined chronic (up to 24 months) toxicity/carcinogenicity study in mice and rats that were fed with a silver zinc zeolite containing 2.3% silver and is based on pigmentation as a critical effect from silver release.; EFFECT=study with SZZ shows no skin irritant properties. The positive result of a guideline eye irritation study is most likely due to the physical form of the test material and not to its chemical composition. Skin sensitisation Tests in guinea pigs indicate that silver zinc zeolite is unlikely to be a skin sensitiser. Although silver is proposed to have a classification as Skin Sens 1, the SCCS regards the risk of sensitisation from exposure to silver from silver zinc zeolite as negligible. Repeated dose toxicity The NOAEL used in this evaluation (0.0045 mg/kg bw/d) is derived from a combined chronic (up to 24 months) toxicity/carcinogenicity study in mice and rats that were fed with a silver zinc zeolite containing 2.3% silver and is based on pigmentation as a critical effect from silver release. Inhalation toxicity An industry-led risk assessment regarding zeolites type A from laundry detergent powder concluded for inhalation a LOAEL of 1 mg/m3. Inhalation studies with silver zinc zeolite are not available. Therefore, the SCCS mo; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"Repeated dose toxicity The NOAEL used in this evaluation (0.0045 mg/kg bw/d) is derived from a combined chronic (up to 24 months) toxicity/carcinogenicity study in mice and rats that were fed with a silver zinc zeolite containing 2.3% silver and is based on pigmentation as a critical effect from silver release.","duration":"chronic","effect":"study with SZZ shows no skin irritant properties. The positive result of a guideline eye irritation study is most likely due to the physical form of the test material and not to its chemical composition. Skin sensitisation Tests in guinea pigs indicate that silver zinc zeolite is unlikely to be a skin sensitiser. Although silver is proposed to have a classification as Skin Sens 1, the SCCS regards the risk of sensitisation from exposure to silver from silver zinc zeolite as negligible. Repeated dose toxicity The NOAEL used in this evaluation (0.0045 mg/kg bw/d) is derived from a combined chronic (up to 24 months) toxicity/carcinogenicity study in mice and rats that were fed with a silver zinc zeolite containing 2.3% silver and is based on pigmentation as a critical effect from silver release. Inhalation toxicity An industry-led risk assessment regarding zeolites type A from laundry detergent powder concluded for inhalation a LOAEL of 1 mg/m3. Inhalation studies with silver zinc zeolite are not available. Therefore, the SCCS mo","endpoint":"repeated dose toxicity","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"0.0045","page":33,"route":"inhalation","species":"rat","study_id":"sccs_o_270_final_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 1109 | mg/kg bw | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=1109; DOSE=_____ 26 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity SSZ A two-generation reproduction and fertility study of Zeomic (silver zinc zeolite) has been performed with oral gavage doses of 200, 700, 2000 mg/kg bw/day in Rats (Schroeder 2002) According to CAR-ECHA (2021), there is only substance-specific data available for...; EFFECT=_____ 26 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity SSZ A two-generation reproduction and fertility study of Zeomic (silver zinc zeolite) has been performed with oral gavage doses of 200, 700, 2000 mg/kg bw/day in Rats (Schroeder 2002) According to CAR-ECHA (2021), there is only substance-specific data available for this Silver Antimicrobial Type AK (Schroeder 2002). It was concluded that silver zinc zeolite does not affect fertility at doses up to 12500 ppm (984/1109 mg/kg bw): the NOAEL for reproduction is 1000 ppm (approximately 70 mg Type AK/mg kg bw). Silver (Taken from ECHA-CLH (2020) The data available on silver acetate and nanosilver indicate that the silver ion has the ability to cause adverse effects on sexual function and fertility possibly by a mechanism involving oxidative stress. According to the original report for the silver acetate study and the published studies with nanosilver, there were no marked general toxicity indicating that effects were “a non-specific consequence of the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"_____ 26 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity SSZ A two-generation reproduction and fertility study of Zeomic (silver zinc zeolite) has been performed with oral gavage doses of 200, 700, 2000 mg/kg bw/day in Rats (Schroeder 2002) According to CAR-ECHA (2021), there is only substance-specific data available for...","duration":"","effect":"_____ 26 3.4.5 Reproductive toxicity 3.4.5.1 Fertility and reproduction toxicity SSZ A two-generation reproduction and fertility study of Zeomic (silver zinc zeolite) has been performed with oral gavage doses of 200, 700, 2000 mg/kg bw/day in Rats (Schroeder 2002) According to CAR-ECHA (2021), there is only substance-specific data available for this Silver Antimicrobial Type AK (Schroeder 2002). It was concluded that silver zinc zeolite does not affect fertility at doses up to 12500 ppm (984/1109 mg/kg bw): the NOAEL for reproduction is 1000 ppm (approximately 70 mg Type AK/mg kg bw). Silver (Taken from ECHA-CLH (2020) The data available on silver acetate and nanosilver indicate that the silver ion has the ability to cause adverse effects on sexual function and fertility possibly by a mechanism involving oxidative stress. According to the original report for the silver acetate study and the published studies with nanosilver, there were no marked general toxicity indicating that effects were “a non-specific consequence of the","endpoint":"reproductive toxicity","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1109","page":26,"route":"oral","species":"rat","study_id":"sccs_o_270_final_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 20 | - | - | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=unclear:with healthy pregnant women, a daily oral zinc supplement of 20-90 mg has shown no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.; DOSE=While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element.; EFFECT=with healthy pregnant women, a daily oral zinc supplement of 20-90 mg has shown no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element.","duration":"developmental","effect":"with healthy pregnant women, a daily oral zinc supplement of 20-90 mg has shown no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.","endpoint":"reproductive toxicity","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"","noael_value":"unclear:with healthy pregnant women, a daily oral zinc supplement of 20-90 mg has shown no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.","page":26,"route":"oral","species":"","study_id":"sccs_o_270_final_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 2011 | - | - | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=unclear:own no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.; DOSE=While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element.; EFFECT=own no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element.","duration":"developmental","effect":"own no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.","endpoint":"reproductive toxicity","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"","noael_value":"unclear:own no indication of adverse effects. While there is some evidence for the developmental toxicity of ingestion of zinc chloride at high-dose levels (Johnson 2011), adverse effects will not occur at levels of exposure that are within the normal background levels of dietary exposure for this essential element. SCCS comment The SCCS agrees with ECHA/BPC/275/21 that silver zinc zeolite fulfils criteria for classification Repr. 2; H361d. The NOAEL derived from the chronic toxicity study (see 3.4.4.3) is far below the NOAEL for reproductive and developmental effects.","page":26,"route":"oral","species":"","study_id":"sccs_o_270_final_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 200 | mg/kg bw/d | human | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=200; DOSE=Zinc deficiency is associated with the impairment of fertility and foetal development; however, evidence from animal studies also indicates that high levels of exposure to zinc (≥200 mg/kg bw/d) may also cause adverse effects on fertility and foetal development.; EFFECT=ation with colloidal silver, there are no studies available on respiratory sensitisation (ECHA-CLH 2020). Zinc Zinc is an essential dietary element involved in many biochemical processes; and is critical for the maintenance of normal immune, sexual and neurosensory function such as cognition and vision. Adverse effects of zinc supplementation (as zinc sulphate) at a level of 150 mg/day are reported to be headache, nausea and gastric discomfort. The EU RAR for zinc concludes that 50 mg/day constitutes a human oral NOAEL for zinc. The EU RAR also concludes that there is no clear evidence for the mutagenicity or carcinogenicity of zinc. Zinc deficiency is associated with the impairment of fertility and foetal development; however, evidence from animal studies also indicates that high levels of exposure to zinc (≥200 mg/kg bw/d) may also cause adverse effects on fertility and foetal development. The EU RAR concludes that, as the reproductive effects seen in animal studies are seen only at high-dose levels associated with general tox; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"Zinc deficiency is associated with the impairment of fertility and foetal development; however, evidence from animal studies also indicates that high levels of exposure to zinc (≥200 mg/kg bw/d) may also cause adverse effects on fertility and foetal development.","duration":"","effect":"ation with colloidal silver, there are no studies available on respiratory sensitisation (ECHA-CLH 2020). Zinc Zinc is an essential dietary element involved in many biochemical processes; and is critical for the maintenance of normal immune, sexual and neurosensory function such as cognition and vision. Adverse effects of zinc supplementation (as zinc sulphate) at a level of 150 mg/day are reported to be headache, nausea and gastric discomfort. The EU RAR for zinc concludes that 50 mg/day constitutes a human oral NOAEL for zinc. The EU RAR also concludes that there is no clear evidence for the mutagenicity or carcinogenicity of zinc. Zinc deficiency is associated with the impairment of fertility and foetal development; however, evidence from animal studies also indicates that high levels of exposure to zinc (≥200 mg/kg bw/d) may also cause adverse effects on fertility and foetal development. The EU RAR concludes that, as the reproductive effects seen in animal studies are seen only at high-dose levels associated with general tox","endpoint":"reproductive toxicity","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":30,"route":"oral","species":"human","study_id":"sccs_o_270_final_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 1000 | mg/kg bw | - | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=1000; DOSE=1000 mg/kg bw, silver zinc zeolite does not affect fertility.; EFFECT=Applicant, and based its safety assessment, in view of the apparently low inhalation toxicity from the zeolite itself, on the release of silver in the airways. Reproductive toxicity At gavage doses up to approx. 1000 mg/kg bw, silver zinc zeolite does not affect fertility. However developmental effects (pup mortality, decreased pup weight and cardiac effects) were noted and ascribed to the effects from silver. According to ECHA/BPC/275/21, silver zinc zeolite fulfils criteria for classification Repr 2; H361d. The NOAEL derived from the chronic oral toxicity study (which is used in the current assessment) is amply below the NOAEL for reproductive and developmental effects. Mutagenicity / genotoxicity The SCCS concurs with the ECHA Opinion (ECHA/BPC/275/2021) that the mutagenic potential of the substance has been adequately investigated in vitro and in vivo. While the in vitro test in mammalian cells indicated a mutagenic potential of silver zinc zeolite, there were no indications of genotoxicity in the in vivo studies conducted,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"1000 mg/kg bw, silver zinc zeolite does not affect fertility.","duration":"developmental","effect":"Applicant, and based its safety assessment, in view of the apparently low inhalation toxicity from the zeolite itself, on the release of silver in the airways. Reproductive toxicity At gavage doses up to approx. 1000 mg/kg bw, silver zinc zeolite does not affect fertility. However developmental effects (pup mortality, decreased pup weight and cardiac effects) were noted and ascribed to the effects from silver. According to ECHA/BPC/275/21, silver zinc zeolite fulfils criteria for classification Repr 2; H361d. The NOAEL derived from the chronic oral toxicity study (which is used in the current assessment) is amply below the NOAEL for reproductive and developmental effects. Mutagenicity / genotoxicity The SCCS concurs with the ECHA Opinion (ECHA/BPC/275/2021) that the mutagenic potential of the substance has been adequately investigated in vitro and in vivo. While the in vitro test in mammalian cells indicated a mutagenic potential of silver zinc zeolite, there were no indications of genotoxicity in the in vivo studies conducted,","endpoint":"reproductive toxicity","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":33,"route":"oral","species":"","study_id":"sccs_o_270_final_noael_026"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 1000 | mg/kg bw | - | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_270_final; REPORT_TITLE=Final Opinion Scientific Committee on Consumer Safety SCCS OPINION on Silver Zinc Zeolite (CAS No. 130328-20- 0, EC No. 603-404-0); OPINION_NUMBER=SCCS/1650/23; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=final version of 21 December 2023; VALUE_TEXT=1000; DOSE=1000 mg/kg bw, silver zinc zeolite does not affect fertility.; EFFECT=tself, on the release of silver in the airways. Reproductive toxicity At gavage doses up to approx. 1000 mg/kg bw, silver zinc zeolite does not affect fertility. However developmental effects (pup mortality, decreased pup weight and cardiac effects) were noted and ascribed to the effects from silver. According to ECHA/BPC/275/21, silver zinc zeolite fulfils criteria for classification Repr 2; H361d. The NOAEL derived from the chronic oral toxicity study (which is used in the current assessment) is amply below the NOAEL for reproductive and developmental effects. Mutagenicity / genotoxicity The SCCS concurs with the ECHA Opinion (ECHA/BPC/275/2021) that the mutagenic potential of the substance has been adequately investigated in vitro and in vivo. While the in vitro test in mammalian cells indicated a mutagenic potential of silver zinc zeolite, there were no indications of genotoxicity in the in vivo studies conducted, thereby overruling the positive in vitro findings. Carcinogenicity According to previous SCCS Opinions, silver; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"130328-20-0","citation":"","dose":"1000 mg/kg bw, silver zinc zeolite does not affect fertility.","duration":"developmental","effect":"tself, on the release of silver in the airways. Reproductive toxicity At gavage doses up to approx. 1000 mg/kg bw, silver zinc zeolite does not affect fertility. However developmental effects (pup mortality, decreased pup weight and cardiac effects) were noted and ascribed to the effects from silver. According to ECHA/BPC/275/21, silver zinc zeolite fulfils criteria for classification Repr 2; H361d. The NOAEL derived from the chronic oral toxicity study (which is used in the current assessment) is amply below the NOAEL for reproductive and developmental effects. Mutagenicity / genotoxicity The SCCS concurs with the ECHA Opinion (ECHA/BPC/275/2021) that the mutagenic potential of the substance has been adequately investigated in vitro and in vivo. While the in vitro test in mammalian cells indicated a mutagenic potential of silver zinc zeolite, there were no indications of genotoxicity in the in vivo studies conducted, thereby overruling the positive in vitro findings. Carcinogenicity According to previous SCCS Opinions, silver","endpoint":"reproductive toxicity","ingredient":"Silver Zinc Zeolite","loael_value":"","noael_unit":"mg/kg bw","noael_value":"1000","page":33,"route":"oral","species":"","study_id":"sccs_o_270_final_noael_027"} |