NOAEL Studies Cosmetic Ingredient

Ammonium Persulfate NOAEL Studies

INCI: AMMONIUM PERSULFATE

CAS: 7727-54-0

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

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CIR Safety Assessment 32 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment NOAEL =5 mg/m3 rat oral - developmental toxicity {"citation":"10; 3; 5","dose":"6 males, 6 females/group) in accordance with OECD TG 421.3 The purpose of this study was to obtain initial in- formation on the possible effects of the test item on repro- duction and development when administered orally in the diet to Crl:CD (SD)IGS BR rats at dosages of 40, 100, and 250 mg/ kg bw/d compared to control animals (plain diet only).","effect":"Persulfate was 10.3 mg/m3, while the no-observed-effect level (NOEL) was 5.0 mg/m3. Developmental and Reproductive Toxicity Studies Ammonium Persulfate Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a screening test with rats (groups of 12; 6 males, 6 females/group) in accordance with OECD TG 421.3 The purpose of this study was to obtain initial in- formation on the possible effects of the test item on repro- duction and development when administered orally in the diet to Crl:CD (SD)IGS BR rats at dosages of 40, 100, and 250 mg/ kg bw/d compared to control animals (plain diet only). There were no treatment-related clinical signs of toxicity observed in F0 pare","page":8,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_006"}
CIR Safety Assessment NOAEL =5 mg/m3 rat oral - developmental toxicity {"citation":"10; 3; 5","dose":"6 males, 6 females/group) in accordance with OECD TG 421.3 The purpose of this study was to obtain initial in- formation on the possible effects of the test item on repro- duction and development when administered orally in the diet to Crl:CD (SD)IGS BR rats at dosages of 40, 100, and 250 mg/ kg bw/d compared to control animals (plain diet only).","effect":"Persulfate was 10.3 mg/m3, while the no-observed-effect level (NOEL) was 5.0 mg/m3. Developmental and Reproductive Toxicity Studies Ammonium Persulfate Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a screening test with rats (groups of 12; 6 males, 6 females/group) in accordance with OECD TG 421.3 The purpose of this study was to obtain initial in- formation on the possible effects of the test item on repro- duction and development when administered orally in the diet to Crl:CD (SD)IGS BR rats at dosages of 40, 100, and 250 mg/ kg bw/d compared to control animals (plain diet only). There were no treatment-related clinical signs of toxicity observed in F0 pare","page":8,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_006"}
CIR Safety Assessment NOAEL =5 mg/m3 rat oral - developmental toxicity {"citation":"10; 3; 5","dose":"6 males, 6 females/group) in accordance with OECD TG 421.3 The purpose of this study was to obtain initial in- formation on the possible effects of the test item on repro- duction and development when administered orally in the diet to Crl:CD (SD)IGS BR rats at dosages of 40, 100, and 250 mg/ kg bw/d compared to control animals (plain diet only).","effect":"Persulfate was 10.3 mg/m3, while the no-observed-effect level (NOEL) was 5.0 mg/m3. Developmental and Reproductive Toxicity Studies Ammonium Persulfate Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a screening test with rats (groups of 12; 6 males, 6 females/group) in accordance with OECD TG 421.3 The purpose of this study was to obtain initial in- formation on the possible effects of the test item on repro- duction and development when administered orally in the diet to Crl:CD (SD)IGS BR rats at dosages of 40, 100, and 250 mg/ kg bw/d compared to control animals (plain diet only). There were no treatment-related clinical signs of toxicity observed in F0 pare","page":8,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_006"}
CIR Safety Assessment NOAEL =5 mg/m3 rat oral - developmental toxicity {"citation":"10; 3; 5","dose":"6 males, 6 females/group) in accordance with OECD TG 421.3 The purpose of this study was to obtain initial in- formation on the possible effects of the test item on repro- duction and development when administered orally in the diet to Crl:CD (SD)IGS BR rats at dosages of 40, 100, and 250 mg/ kg bw/d compared to control animals (plain diet only).","effect":"Persulfate was 10.3 mg/m3, while the no-observed-effect level (NOEL) was 5.0 mg/m3. Developmental and Reproductive Toxicity Studies Ammonium Persulfate Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a screening test with rats (groups of 12; 6 males, 6 females/group) in accordance with OECD TG 421.3 The purpose of this study was to obtain initial in- formation on the possible effects of the test item on repro- duction and development when administered orally in the diet to Crl:CD (SD)IGS BR rats at dosages of 40, 100, and 250 mg/ kg bw/d compared to control animals (plain diet only). There were no treatment-related clinical signs of toxicity observed in F0 pare","page":8,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_006"}
CIR Safety Assessment NOAEL =10.3 mg/m3 rat oral 13 wk developmental toxicity {"citation":"13; 200; 91","dose":"Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk.","effect":"thological changes were equally distributed between test and control groups. Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk. LOAEL and NOAEL values of 200 and 91 mg/kg bw/d, respectively, were determined. The frequency of grossly observable lesions was comparable between test and control groups. In a 13-wk inhalation toxicity study (whole-body ex- posure) on Ammonium Persulfate (concentrations of 5, 10.3, and 25 mg/m3) involving male and female rats, the NOAEL was 10.3 mg/m3. The NOEL for the exposure of rats to a dust aerosol of Ammonium Persulfate was 5 mg/m3. Regarding human exposure, it has been predicted that, by using dust-free bleaching products and separate mixing areas, the total persulfate exposure in hairdresser salons can be lowered because the emission of particles <10 µm would be minimized. Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a test involving rats receiving daily doses up to 250 mg/kg bw/d. There were no treatment-related clinical signs of toxicity observed in F0...","page":14,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_008"}
CIR Safety Assessment NOAEL =10.3 mg/m3 rat oral 13 wk developmental toxicity {"citation":"13; 200; 91","dose":"Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk.","effect":"thological changes were equally distributed between test and control groups. Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk. LOAEL and NOAEL values of 200 and 91 mg/kg bw/d, respectively, were determined. The frequency of grossly observable lesions was comparable between test and control groups. In a 13-wk inhalation toxicity study (whole-body ex- posure) on Ammonium Persulfate (concentrations of 5, 10.3, and 25 mg/m3) involving male and female rats, the NOAEL was 10.3 mg/m3. The NOEL for the exposure of rats to a dust aerosol of Ammonium Persulfate was 5 mg/m3. Regarding human exposure, it has been predicted that, by using dust-free bleaching products and separate mixing areas, the total persulfate exposure in hairdresser salons can be lowered because the emission of particles <10 µm would be minimized. Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a test involving rats receiving daily doses up to 250 mg/kg bw/d. There were no treatment-related clinical signs of toxicity observed in F0...","page":14,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_008"}
CIR Safety Assessment NOAEL =10.3 mg/m3 rat oral 13 wk developmental toxicity {"citation":"13; 200; 91","dose":"Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk.","effect":"thological changes were equally distributed between test and control groups. Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk. LOAEL and NOAEL values of 200 and 91 mg/kg bw/d, respectively, were determined. The frequency of grossly observable lesions was comparable between test and control groups. In a 13-wk inhalation toxicity study (whole-body ex- posure) on Ammonium Persulfate (concentrations of 5, 10.3, and 25 mg/m3) involving male and female rats, the NOAEL was 10.3 mg/m3. The NOEL for the exposure of rats to a dust aerosol of Ammonium Persulfate was 5 mg/m3. Regarding human exposure, it has been predicted that, by using dust-free bleaching products and separate mixing areas, the total persulfate exposure in hairdresser salons can be lowered because the emission of particles <10 µm would be minimized. Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a test involving rats receiving daily doses up to 250 mg/kg bw/d. There were no treatment-related clinical signs of toxicity observed in F0...","page":14,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_008"}
CIR Safety Assessment NOAEL =10.3 mg/m3 rat oral 13 wk developmental toxicity {"citation":"13; 200; 91","dose":"Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk.","effect":"thological changes were equally distributed between test and control groups. Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk. LOAEL and NOAEL values of 200 and 91 mg/kg bw/d, respectively, were determined. The frequency of grossly observable lesions was comparable between test and control groups. In a 13-wk inhalation toxicity study (whole-body ex- posure) on Ammonium Persulfate (concentrations of 5, 10.3, and 25 mg/m3) involving male and female rats, the NOAEL was 10.3 mg/m3. The NOEL for the exposure of rats to a dust aerosol of Ammonium Persulfate was 5 mg/m3. Regarding human exposure, it has been predicted that, by using dust-free bleaching products and separate mixing areas, the total persulfate exposure in hairdresser salons can be lowered because the emission of particles <10 µm would be minimized. Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a test involving rats receiving daily doses up to 250 mg/kg bw/d. There were no treatment-related clinical signs of toxicity observed in F0...","page":14,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_008"}
CIR Safety Assessment NOAEL =25 mg/m3 rat inhalation 13 weeks inhalation toxicity {"citation":"25; 13; 6","dose":"By the end of the recovery period, body weights for the exposed animals were similar to the control group values.","effect":"most of the exposure period compared to the control group. By the end of the recovery period, body weights for the exposed animals were similar to the control group values. Lung weights were increased in the 25 mg/m3 group after 13 weeks of exposure, but were similar to controls at 6 week post-exposure. Irritation of the trachea and bronchi/ bronchiole was noted microscopically after 13 weeks of ex- posure to 25 mg/m3. These lesions were not observed at 6 week post-exposure. Based on the results of this study, the NOAEL for exposure of rats to a dust aerosol of Ammonium Johnson et al. 11S","page":7,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_005"}
CIR Safety Assessment NOAEL =25 mg/m3 rat inhalation 13 weeks inhalation toxicity {"citation":"25; 13; 6","dose":"By the end of the recovery period, body weights for the exposed animals were similar to the control group values.","effect":"most of the exposure period compared to the control group. By the end of the recovery period, body weights for the exposed animals were similar to the control group values. Lung weights were increased in the 25 mg/m3 group after 13 weeks of exposure, but were similar to controls at 6 week post-exposure. Irritation of the trachea and bronchi/ bronchiole was noted microscopically after 13 weeks of ex- posure to 25 mg/m3. These lesions were not observed at 6 week post-exposure. Based on the results of this study, the NOAEL for exposure of rats to a dust aerosol of Ammonium Johnson et al. 11S","page":7,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_005"}
CIR Safety Assessment NOAEL =25 mg/m3 rat inhalation 13 weeks inhalation toxicity {"citation":"25; 13; 6","dose":"By the end of the recovery period, body weights for the exposed animals were similar to the control group values.","effect":"most of the exposure period compared to the control group. By the end of the recovery period, body weights for the exposed animals were similar to the control group values. Lung weights were increased in the 25 mg/m3 group after 13 weeks of exposure, but were similar to controls at 6 week post-exposure. Irritation of the trachea and bronchi/ bronchiole was noted microscopically after 13 weeks of ex- posure to 25 mg/m3. These lesions were not observed at 6 week post-exposure. Based on the results of this study, the NOAEL for exposure of rats to a dust aerosol of Ammonium Johnson et al. 11S","page":7,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_005"}
CIR Safety Assessment NOAEL =25 mg/m3 rat inhalation 13 weeks inhalation toxicity {"citation":"25; 13; 6","dose":"By the end of the recovery period, body weights for the exposed animals were similar to the control group values.","effect":"most of the exposure period compared to the control group. By the end of the recovery period, body weights for the exposed animals were similar to the control group values. Lung weights were increased in the 25 mg/m3 group after 13 weeks of exposure, but were similar to controls at 6 week post-exposure. Irritation of the trachea and bronchi/ bronchiole was noted microscopically after 13 weeks of ex- posure to 25 mg/m3. These lesions were not observed at 6 week post-exposure. Based on the results of this study, the NOAEL for exposure of rats to a dust aerosol of Ammonium Johnson et al. 11S","page":7,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_005"}
CIR Safety Assessment NOAEL =41.1 mg/kg bw/d rat oral 28-d inhalation toxicity {"citation":"10; 28; 15","dose":"ate was tested for oral toxicity in groups of 10 male rats in a 28-d study.15 In this study, the test substance was administered to male weanling albino rats in the diet at concentrations of 0 ppm (control), 100 ppm (13.30 mg/kg bw/d), 300 ppm (41.05 mg/kg bw/d) and 600 ppm (82.08 mg/kg bw/d).","effect":"ate was tested for oral toxicity in groups of 10 male rats in a 28-d study.15 In this study, the test substance was administered to male weanling albino rats in the diet at concentrations of 0 ppm (control), 100 ppm (13.30 mg/kg bw/d), 300 ppm (41.05 mg/kg bw/d) and 600 ppm (82.08 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. Decreased relative adrenal weight was observed at the highest dose. The no- observed adverse effect level (NOAEL) was determined to be 41.1 mg/kg bw/d. Potassium persulfate. Potassium Persulfate was tested for toxicity in rats in a 28-d study in accordance with OECD TG 407.3 In this study, the test substance was administered (in diet) to groups of 10 male weanling albino rats at concentrations of 0 ppm (control), 100 ppm (12.62 mg/kg bw/d), 316 ppm (41.15 mg/kg bw/d) and 1000 ppm (131.50 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. The NOAEL was estimated to be 131.5 mg/kg bw/d. Inhalation A...","page":6,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_001"}
CIR Safety Assessment NOAEL =41.1 mg/kg bw/d rat oral 28-d inhalation toxicity {"citation":"10; 28; 15","dose":"ate was tested for oral toxicity in groups of 10 male rats in a 28-d study.15 In this study, the test substance was administered to male weanling albino rats in the diet at concentrations of 0 ppm (control), 100 ppm (13.30 mg/kg bw/d), 300 ppm (41.05 mg/kg bw/d) and 600 ppm (82.08 mg/kg bw/d).","effect":"ate was tested for oral toxicity in groups of 10 male rats in a 28-d study.15 In this study, the test substance was administered to male weanling albino rats in the diet at concentrations of 0 ppm (control), 100 ppm (13.30 mg/kg bw/d), 300 ppm (41.05 mg/kg bw/d) and 600 ppm (82.08 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. Decreased relative adrenal weight was observed at the highest dose. The no- observed adverse effect level (NOAEL) was determined to be 41.1 mg/kg bw/d. Potassium persulfate. Potassium Persulfate was tested for toxicity in rats in a 28-d study in accordance with OECD TG 407.3 In this study, the test substance was administered (in diet) to groups of 10 male weanling albino rats at concentrations of 0 ppm (control), 100 ppm (12.62 mg/kg bw/d), 316 ppm (41.15 mg/kg bw/d) and 1000 ppm (131.50 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. The NOAEL was estimated to be 131.5 mg/kg bw/d. Inhalation A...","page":6,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_001"}
CIR Safety Assessment NOAEL =41.1 mg/kg bw/d rat oral 28-d inhalation toxicity {"citation":"10; 28; 15","dose":"ate was tested for oral toxicity in groups of 10 male rats in a 28-d study.15 In this study, the test substance was administered to male weanling albino rats in the diet at concentrations of 0 ppm (control), 100 ppm (13.30 mg/kg bw/d), 300 ppm (41.05 mg/kg bw/d) and 600 ppm (82.08 mg/kg bw/d).","effect":"ate was tested for oral toxicity in groups of 10 male rats in a 28-d study.15 In this study, the test substance was administered to male weanling albino rats in the diet at concentrations of 0 ppm (control), 100 ppm (13.30 mg/kg bw/d), 300 ppm (41.05 mg/kg bw/d) and 600 ppm (82.08 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. Decreased relative adrenal weight was observed at the highest dose. The no- observed adverse effect level (NOAEL) was determined to be 41.1 mg/kg bw/d. Potassium persulfate. Potassium Persulfate was tested for toxicity in rats in a 28-d study in accordance with OECD TG 407.3 In this study, the test substance was administered (in diet) to groups of 10 male weanling albino rats at concentrations of 0 ppm (control), 100 ppm (12.62 mg/kg bw/d), 316 ppm (41.15 mg/kg bw/d) and 1000 ppm (131.50 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. The NOAEL was estimated to be 131.5 mg/kg bw/d. Inhalation A...","page":6,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_001"}
CIR Safety Assessment NOAEL =41.1 mg/kg bw/d rat oral 28-d inhalation toxicity {"citation":"10; 28; 15","dose":"ate was tested for oral toxicity in groups of 10 male rats in a 28-d study.15 In this study, the test substance was administered to male weanling albino rats in the diet at concentrations of 0 ppm (control), 100 ppm (13.30 mg/kg bw/d), 300 ppm (41.05 mg/kg bw/d) and 600 ppm (82.08 mg/kg bw/d).","effect":"ate was tested for oral toxicity in groups of 10 male rats in a 28-d study.15 In this study, the test substance was administered to male weanling albino rats in the diet at concentrations of 0 ppm (control), 100 ppm (13.30 mg/kg bw/d), 300 ppm (41.05 mg/kg bw/d) and 600 ppm (82.08 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. Decreased relative adrenal weight was observed at the highest dose. The no- observed adverse effect level (NOAEL) was determined to be 41.1 mg/kg bw/d. Potassium persulfate. Potassium Persulfate was tested for toxicity in rats in a 28-d study in accordance with OECD TG 407.3 In this study, the test substance was administered (in diet) to groups of 10 male weanling albino rats at concentrations of 0 ppm (control), 100 ppm (12.62 mg/kg bw/d), 316 ppm (41.15 mg/kg bw/d) and 1000 ppm (131.50 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. The NOAEL was estimated to be 131.5 mg/kg bw/d. Inhalation A...","page":6,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_001"}
CIR Safety Assessment NOAEL >80 mg/kg bw rat oral 13-wk repeated dose toxicity {"citation":"(5, 20, 80; 80; 13","dose":"All changes observed were about equally distributed among the controls and groups dosed with the test substance.","effect":"ion) in the liver (mild vacuolation also observed), kidneys, and lungs were observed in some of the animals of all groups. All changes observed were about equally distributed among the controls and groups dosed with the test substance. Because body weight changes, food consumption, and hematological, biochemical, and pathological examinations did not show any noticeable and significant differences between the administered (5, 20, 80 mg/kg bw) and control (vehicle only) group animals, the authors concluded that the NOAEL was >80 mg/kg bw. Sodium persulfate. Local damage to the mucous membrane in the gastrointestinal tract of rats, but no other systemic effects, was observed in a 13-wk (subchronic) feeding study of Sodium Persulfate (dose of 30 mg/kg/d). Lesions were not observed in another subchronic study of Sodium Persulfate (same dose).1 Sodium Persulfate was administered in the diet of rats (CR strain; groups of 40 (20 males, 20 females/group)) for 13 wk.3 Observations included body weight, food consumption, and blood and urine parameters. Ophthalmologic examinations and gross...","page":7,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_003"}
CIR Safety Assessment NOAEL >80 mg/kg bw rat oral 13-wk repeated dose toxicity {"citation":"(5, 20, 80; 80; 13","dose":"All changes observed were about equally distributed among the controls and groups dosed with the test substance.","effect":"ion) in the liver (mild vacuolation also observed), kidneys, and lungs were observed in some of the animals of all groups. All changes observed were about equally distributed among the controls and groups dosed with the test substance. Because body weight changes, food consumption, and hematological, biochemical, and pathological examinations did not show any noticeable and significant differences between the administered (5, 20, 80 mg/kg bw) and control (vehicle only) group animals, the authors concluded that the NOAEL was >80 mg/kg bw. Sodium persulfate. Local damage to the mucous membrane in the gastrointestinal tract of rats, but no other systemic effects, was observed in a 13-wk (subchronic) feeding study of Sodium Persulfate (dose of 30 mg/kg/d). Lesions were not observed in another subchronic study of Sodium Persulfate (same dose).1 Sodium Persulfate was administered in the diet of rats (CR strain; groups of 40 (20 males, 20 females/group)) for 13 wk.3 Observations included body weight, food consumption, and blood and urine parameters. Ophthalmologic examinations and gross...","page":7,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_003"}
CIR Safety Assessment NOAEL >80 mg/kg bw rat oral 13-wk repeated dose toxicity {"citation":"(5, 20, 80; 80; 13","dose":"All changes observed were about equally distributed among the controls and groups dosed with the test substance.","effect":"ion) in the liver (mild vacuolation also observed), kidneys, and lungs were observed in some of the animals of all groups. All changes observed were about equally distributed among the controls and groups dosed with the test substance. Because body weight changes, food consumption, and hematological, biochemical, and pathological examinations did not show any noticeable and significant differences between the administered (5, 20, 80 mg/kg bw) and control (vehicle only) group animals, the authors concluded that the NOAEL was >80 mg/kg bw. Sodium persulfate. Local damage to the mucous membrane in the gastrointestinal tract of rats, but no other systemic effects, was observed in a 13-wk (subchronic) feeding study of Sodium Persulfate (dose of 30 mg/kg/d). Lesions were not observed in another subchronic study of Sodium Persulfate (same dose).1 Sodium Persulfate was administered in the diet of rats (CR strain; groups of 40 (20 males, 20 females/group)) for 13 wk.3 Observations included body weight, food consumption, and blood and urine parameters. Ophthalmologic examinations and gross...","page":7,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_003"}
CIR Safety Assessment NOAEL >80 mg/kg bw rat oral 13-wk repeated dose toxicity {"citation":"(5, 20, 80; 80; 13","dose":"All changes observed were about equally distributed among the controls and groups dosed with the test substance.","effect":"ion) in the liver (mild vacuolation also observed), kidneys, and lungs were observed in some of the animals of all groups. All changes observed were about equally distributed among the controls and groups dosed with the test substance. Because body weight changes, food consumption, and hematological, biochemical, and pathological examinations did not show any noticeable and significant differences between the administered (5, 20, 80 mg/kg bw) and control (vehicle only) group animals, the authors concluded that the NOAEL was >80 mg/kg bw. Sodium persulfate. Local damage to the mucous membrane in the gastrointestinal tract of rats, but no other systemic effects, was observed in a 13-wk (subchronic) feeding study of Sodium Persulfate (dose of 30 mg/kg/d). Lesions were not observed in another subchronic study of Sodium Persulfate (same dose).1 Sodium Persulfate was administered in the diet of rats (CR strain; groups of 40 (20 males, 20 females/group)) for 13 wk.3 Observations included body weight, food consumption, and blood and urine parameters. Ophthalmologic examinations and gross...","page":7,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_003"}
CIR Safety Assessment NOAEL =131.5 mg/kg bw/d rat oral 28-d inhalation toxicity {"citation":"41; 1; 28","dose":"OAEL) was determined to be 41.1 mg/kg bw/d.","effect":"OAEL) was determined to be 41.1 mg/kg bw/d. Potassium persulfate. Potassium Persulfate was tested for toxicity in rats in a 28-d study in accordance with OECD TG 407.3 In this study, the test substance was administered (in diet) to groups of 10 male weanling albino rats at concentrations of 0 ppm (control), 100 ppm (12.62 mg/kg bw/d), 316 ppm (41.15 mg/kg bw/d) and 1000 ppm (131.50 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. The NOAEL was estimated to be 131.5 mg/kg bw/d. Inhalation Ammonium Persulfate. In a study involving rats, inhalation exposure to aerosolized Ammonium Persulfate at concentra- tions ranging from 4 mg/m3 to 20 mg/m3 for 7 d caused a significant increase in the wet weight of the right apical portion of the lung lobe.1 Protein and DNA concentrations were sig- nificantly increased in the lungs, and tracheal mucus glyco- protein secretion rates tended to be greater than that observed in the control animals. These changes were attributed to pulmo- nary edema and/or inflammation. N...","page":6,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_002"}
CIR Safety Assessment NOAEL =131.5 mg/kg bw/d rat oral 28-d inhalation toxicity {"citation":"41; 1; 28","dose":"OAEL) was determined to be 41.1 mg/kg bw/d.","effect":"OAEL) was determined to be 41.1 mg/kg bw/d. Potassium persulfate. Potassium Persulfate was tested for toxicity in rats in a 28-d study in accordance with OECD TG 407.3 In this study, the test substance was administered (in diet) to groups of 10 male weanling albino rats at concentrations of 0 ppm (control), 100 ppm (12.62 mg/kg bw/d), 316 ppm (41.15 mg/kg bw/d) and 1000 ppm (131.50 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. The NOAEL was estimated to be 131.5 mg/kg bw/d. Inhalation Ammonium Persulfate. In a study involving rats, inhalation exposure to aerosolized Ammonium Persulfate at concentra- tions ranging from 4 mg/m3 to 20 mg/m3 for 7 d caused a significant increase in the wet weight of the right apical portion of the lung lobe.1 Protein and DNA concentrations were sig- nificantly increased in the lungs, and tracheal mucus glyco- protein secretion rates tended to be greater than that observed in the control animals. These changes were attributed to pulmo- nary edema and/or inflammation. N...","page":6,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_002"}
CIR Safety Assessment NOAEL =131.5 mg/kg bw/d rat oral 28-d inhalation toxicity {"citation":"41; 1; 28","dose":"OAEL) was determined to be 41.1 mg/kg bw/d.","effect":"OAEL) was determined to be 41.1 mg/kg bw/d. Potassium persulfate. Potassium Persulfate was tested for toxicity in rats in a 28-d study in accordance with OECD TG 407.3 In this study, the test substance was administered (in diet) to groups of 10 male weanling albino rats at concentrations of 0 ppm (control), 100 ppm (12.62 mg/kg bw/d), 316 ppm (41.15 mg/kg bw/d) and 1000 ppm (131.50 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. The NOAEL was estimated to be 131.5 mg/kg bw/d. Inhalation Ammonium Persulfate. In a study involving rats, inhalation exposure to aerosolized Ammonium Persulfate at concentra- tions ranging from 4 mg/m3 to 20 mg/m3 for 7 d caused a significant increase in the wet weight of the right apical portion of the lung lobe.1 Protein and DNA concentrations were sig- nificantly increased in the lungs, and tracheal mucus glyco- protein secretion rates tended to be greater than that observed in the control animals. These changes were attributed to pulmo- nary edema and/or inflammation. N...","page":6,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_002"}
CIR Safety Assessment NOAEL =131.5 mg/kg bw/d rat oral 28-d inhalation toxicity {"citation":"41; 1; 28","dose":"OAEL) was determined to be 41.1 mg/kg bw/d.","effect":"OAEL) was determined to be 41.1 mg/kg bw/d. Potassium persulfate. Potassium Persulfate was tested for toxicity in rats in a 28-d study in accordance with OECD TG 407.3 In this study, the test substance was administered (in diet) to groups of 10 male weanling albino rats at concentrations of 0 ppm (control), 100 ppm (12.62 mg/kg bw/d), 316 ppm (41.15 mg/kg bw/d) and 1000 ppm (131.50 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. The NOAEL was estimated to be 131.5 mg/kg bw/d. Inhalation Ammonium Persulfate. In a study involving rats, inhalation exposure to aerosolized Ammonium Persulfate at concentra- tions ranging from 4 mg/m3 to 20 mg/m3 for 7 d caused a significant increase in the wet weight of the right apical portion of the lung lobe.1 Protein and DNA concentrations were sig- nificantly increased in the lungs, and tracheal mucus glyco- protein secretion rates tended to be greater than that observed in the control animals. These changes were attributed to pulmo- nary edema and/or inflammation. N...","page":6,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_002"}
CIR Safety Assessment NOAEL =200 mg/kg bw/d rat oral 13 week repeated dose toxicity {"citation":"13; 50; 300","dose":"3000 ppm of Sodium Persulfate for 13 week.","effect":"3000 ppm of Sodium Persulfate for 13 week. These changes were seen more frequently among females than males. The females received 50% more test material than the males on a dose per body weight basis. No statistically sig- nificant changes were seen among the controls or the groups that received 300 ppm in the diet for 13 week or 1000 ppm in the diet for 8 week, followed by 5000 ppm in the diet for the remainder of the study. No other microscopic changes were noted on comparison among these 3 groups. A LOAEL and a NOAEL of 200 and 91 mg/kg bw/d (3000 and 1000 ppm), respectively, were determined. Inhalation Ammonium persulfate. The subchronic inhalation toxicity of Ammonium Persulfate was characterized using Sprague- Dawley rats (20/sex/group) at respirable dust concentrations of 0, 5.0, 10.3, and 25 mg/m3.16 The average mass median aerodynamic diameters and geometric standard deviations of samples taken from the 5, 10.3, and 25 mg/m3 exposure levels were 2.5 ± 1.85, 2.7 ± 1.83, and 2.5 ± 1.80 μm, respectively. Whole-body exposures were conducted 6 h/d, 5 d/wk for 13 week. Gravimet...","page":7,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_004"}
CIR Safety Assessment NOAEL =200 mg/kg bw/d rat oral 13 week repeated dose toxicity {"citation":"13; 50; 300","dose":"3000 ppm of Sodium Persulfate for 13 week.","effect":"3000 ppm of Sodium Persulfate for 13 week. These changes were seen more frequently among females than males. The females received 50% more test material than the males on a dose per body weight basis. No statistically sig- nificant changes were seen among the controls or the groups that received 300 ppm in the diet for 13 week or 1000 ppm in the diet for 8 week, followed by 5000 ppm in the diet for the remainder of the study. No other microscopic changes were noted on comparison among these 3 groups. A LOAEL and a NOAEL of 200 and 91 mg/kg bw/d (3000 and 1000 ppm), respectively, were determined. Inhalation Ammonium persulfate. The subchronic inhalation toxicity of Ammonium Persulfate was characterized using Sprague- Dawley rats (20/sex/group) at respirable dust concentrations of 0, 5.0, 10.3, and 25 mg/m3.16 The average mass median aerodynamic diameters and geometric standard deviations of samples taken from the 5, 10.3, and 25 mg/m3 exposure levels were 2.5 ± 1.85, 2.7 ± 1.83, and 2.5 ± 1.80 μm, respectively. Whole-body exposures were conducted 6 h/d, 5 d/wk for 13 week. Gravimet...","page":7,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_004"}
CIR Safety Assessment NOAEL =200 mg/kg bw/d rat oral 13 week repeated dose toxicity {"citation":"13; 50; 300","dose":"3000 ppm of Sodium Persulfate for 13 week.","effect":"3000 ppm of Sodium Persulfate for 13 week. These changes were seen more frequently among females than males. The females received 50% more test material than the males on a dose per body weight basis. No statistically sig- nificant changes were seen among the controls or the groups that received 300 ppm in the diet for 13 week or 1000 ppm in the diet for 8 week, followed by 5000 ppm in the diet for the remainder of the study. No other microscopic changes were noted on comparison among these 3 groups. A LOAEL and a NOAEL of 200 and 91 mg/kg bw/d (3000 and 1000 ppm), respectively, were determined. Inhalation Ammonium persulfate. The subchronic inhalation toxicity of Ammonium Persulfate was characterized using Sprague- Dawley rats (20/sex/group) at respirable dust concentrations of 0, 5.0, 10.3, and 25 mg/m3.16 The average mass median aerodynamic diameters and geometric standard deviations of samples taken from the 5, 10.3, and 25 mg/m3 exposure levels were 2.5 ± 1.85, 2.7 ± 1.83, and 2.5 ± 1.80 μm, respectively. Whole-body exposures were conducted 6 h/d, 5 d/wk for 13 week. Gravimet...","page":7,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_004"}
CIR Safety Assessment NOAEL =200 mg/kg bw/d rat oral 13 week repeated dose toxicity {"citation":"13; 50; 300","dose":"3000 ppm of Sodium Persulfate for 13 week.","effect":"3000 ppm of Sodium Persulfate for 13 week. These changes were seen more frequently among females than males. The females received 50% more test material than the males on a dose per body weight basis. No statistically sig- nificant changes were seen among the controls or the groups that received 300 ppm in the diet for 13 week or 1000 ppm in the diet for 8 week, followed by 5000 ppm in the diet for the remainder of the study. No other microscopic changes were noted on comparison among these 3 groups. A LOAEL and a NOAEL of 200 and 91 mg/kg bw/d (3000 and 1000 ppm), respectively, were determined. Inhalation Ammonium persulfate. The subchronic inhalation toxicity of Ammonium Persulfate was characterized using Sprague- Dawley rats (20/sex/group) at respirable dust concentrations of 0, 5.0, 10.3, and 25 mg/m3.16 The average mass median aerodynamic diameters and geometric standard deviations of samples taken from the 5, 10.3, and 25 mg/m3 exposure levels were 2.5 ± 1.85, 2.7 ± 1.83, and 2.5 ± 1.80 μm, respectively. Whole-body exposures were conducted 6 h/d, 5 d/wk for 13 week. Gravimet...","page":7,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_004"}
CIR Safety Assessment NOAEL =250 mg/kg/d - - - reproductive toxicity {"citation":"4; 250; 1","dose":"Remarkable clinical signs in the F0 parents and F1 pups were not attributed to treatment with Ammonium Persulfate, as they occurred sporadically, were of short duration, and did not demonstrate a dose response.","effect":"ved in F0 parents of either sex or in F1 pups at any treatment level. Remarkable clinical signs in the F0 parents and F1 pups were not attributed to treatment with Ammonium Persulfate, as they occurred sporadically, were of short duration, and did not demonstrate a dose response. No significant changes were observed in male and female reproductive performance such as gonadal function, mating behavior, conception, pregnancy, parturition and in development of the F1 offspring from conception to day 4 postpartum. The NOAEL for male and female toxicity, the NOAEL for male and female fertility performance and the NOAEL for F1 viability and development were reported to be ≥250 mg/kg/d. Genotoxicity In Vitro Ammonium persulfate. Results for Ammonium Persulfate were negative in the Ames test.1 Sodium persulfate. The genotoxicity of Sodium Persulfate was evaluated in the Ames test using the following Salmonella typhimurium strains: TA98, TA100, TA1535, TA1537 and TA1538.3 Sodium Persulfate was tested at 5 dose levels ranging from 100 to 10 000 µg/plate. The assay was con- ducted in the pre...","page":8,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_007"}
CIR Safety Assessment NOAEL =250 mg/kg/d - - - reproductive toxicity {"citation":"4; 250; 1","dose":"Remarkable clinical signs in the F0 parents and F1 pups were not attributed to treatment with Ammonium Persulfate, as they occurred sporadically, were of short duration, and did not demonstrate a dose response.","effect":"ved in F0 parents of either sex or in F1 pups at any treatment level. Remarkable clinical signs in the F0 parents and F1 pups were not attributed to treatment with Ammonium Persulfate, as they occurred sporadically, were of short duration, and did not demonstrate a dose response. No significant changes were observed in male and female reproductive performance such as gonadal function, mating behavior, conception, pregnancy, parturition and in development of the F1 offspring from conception to day 4 postpartum. The NOAEL for male and female toxicity, the NOAEL for male and female fertility performance and the NOAEL for F1 viability and development were reported to be ≥250 mg/kg/d. Genotoxicity In Vitro Ammonium persulfate. Results for Ammonium Persulfate were negative in the Ames test.1 Sodium persulfate. The genotoxicity of Sodium Persulfate was evaluated in the Ames test using the following Salmonella typhimurium strains: TA98, TA100, TA1535, TA1537 and TA1538.3 Sodium Persulfate was tested at 5 dose levels ranging from 100 to 10 000 µg/plate. The assay was con- ducted in the pre...","page":8,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_007"}
CIR Safety Assessment NOAEL =250 mg/kg/d - - - reproductive toxicity {"citation":"4; 250; 1","dose":"Remarkable clinical signs in the F0 parents and F1 pups were not attributed to treatment with Ammonium Persulfate, as they occurred sporadically, were of short duration, and did not demonstrate a dose response.","effect":"ved in F0 parents of either sex or in F1 pups at any treatment level. Remarkable clinical signs in the F0 parents and F1 pups were not attributed to treatment with Ammonium Persulfate, as they occurred sporadically, were of short duration, and did not demonstrate a dose response. No significant changes were observed in male and female reproductive performance such as gonadal function, mating behavior, conception, pregnancy, parturition and in development of the F1 offspring from conception to day 4 postpartum. The NOAEL for male and female toxicity, the NOAEL for male and female fertility performance and the NOAEL for F1 viability and development were reported to be ≥250 mg/kg/d. Genotoxicity In Vitro Ammonium persulfate. Results for Ammonium Persulfate were negative in the Ames test.1 Sodium persulfate. The genotoxicity of Sodium Persulfate was evaluated in the Ames test using the following Salmonella typhimurium strains: TA98, TA100, TA1535, TA1537 and TA1538.3 Sodium Persulfate was tested at 5 dose levels ranging from 100 to 10 000 µg/plate. The assay was con- ducted in the pre...","page":8,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_007"}
CIR Safety Assessment NOAEL =250 mg/kg/d - - - reproductive toxicity {"citation":"4; 250; 1","dose":"Remarkable clinical signs in the F0 parents and F1 pups were not attributed to treatment with Ammonium Persulfate, as they occurred sporadically, were of short duration, and did not demonstrate a dose response.","effect":"ved in F0 parents of either sex or in F1 pups at any treatment level. Remarkable clinical signs in the F0 parents and F1 pups were not attributed to treatment with Ammonium Persulfate, as they occurred sporadically, were of short duration, and did not demonstrate a dose response. No significant changes were observed in male and female reproductive performance such as gonadal function, mating behavior, conception, pregnancy, parturition and in development of the F1 offspring from conception to day 4 postpartum. The NOAEL for male and female toxicity, the NOAEL for male and female fertility performance and the NOAEL for F1 viability and development were reported to be ≥250 mg/kg/d. Genotoxicity In Vitro Ammonium persulfate. Results for Ammonium Persulfate were negative in the Ames test.1 Sodium persulfate. The genotoxicity of Sodium Persulfate was evaluated in the Ames test using the following Salmonella typhimurium strains: TA98, TA100, TA1535, TA1537 and TA1538.3 Sodium Persulfate was tested at 5 dose levels ranging from 100 to 10 000 µg/plate. The assay was con- ducted in the pre...","page":8,"pdf":"PRS727.pdf","row_type":"noael_study","study_id":"PRS727_noael_007"}
NTP ICE acute inhalation 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE acute inhalation LC50 >=2.95 mg/L - Inhalation Duration=4 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=5161; Record_ID=acute_inhalation_883; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID9029691; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>=; Response=2.95; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14389/7/3/3/?documentUUID=e5bbb920-6e5b-4a9e-9673-debad95b11a2; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9029691
NTP ICE acute inhalation LC50 >5.1 mg/L - Inhalation Duration=4 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=5160; Record_ID=acute_inhalation_881; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID9029691; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=5.1; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14389/7/3/3/?documentUUID=8433bf2e-05e6-48e9-a7e3-ea2f0a010ebe; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9029691
NTP ICE acute inhalation LC50 >42.9 mg/L - Inhalation Duration=1 hr In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity sheet=Data; excel_row=5162; Record_ID=acute_inhalation_887; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID9029691; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=42.9; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/14389/7/3/3/?documentUUID=a036fe33-dd2b-4644-8edf-7b2cbe501657; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9029691
NTP ICE skin sensitization 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE skin sensitization EC3 2 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13202; Record_ID=skin_sensitization_invivo_3259; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID9029691; Assay=LLNA; Endpoint=EC3; Response=2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Cruz et al. 2009; 19207378; 10.1111/j.1600-0536.2008.01477.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9029691
NTP ICE skin sensitization EC3 2 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13202; Record_ID=skin_sensitization_invivo_3259; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID9029691; Assay=LLNA; Endpoint=EC3; Response=2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Cruz et al. 2009; 19207378; 10.1111/j.1600-0536.2008.01477.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9029691
NTP ICE skin sensitization EC3 2 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13202; Record_ID=skin_sensitization_invivo_3259; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID9029691; Assay=LLNA; Endpoint=EC3; Response=2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Cruz et al. 2009; 19207378; 10.1111/j.1600-0536.2008.01477.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9029691
NTP ICE skin sensitization EC3 2 % Mouse Dermal - In Vivo; LLNAdb2013; LLNA sheet=Data_invivo; excel_row=13202; Record_ID=skin_sensitization_invivo_3259; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID9029691; Assay=LLNA; Endpoint=EC3; Response=2; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Cruz et al. 2009; 19207378; 10.1111/j.1600-0536.2008.01477.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9029691
ToxValDB GESTIS DNEL 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB GESTIS DNEL DNEL local =0.824 mg/m3 Human inhalation - Toxicity Value STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15630999:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_dfb1ae134cd99ba6d71aedb72863906f
Regulatory source 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source developmental toxicity 5 mg/m3 rat oral - developmental toxicity SOURCE_SUBDIR=PRS727; REPORT_TITLE=Amended Safety Assessment of Persulfates as Used in Cosmetics Wilbur Johnson*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks***, Ronald C. Shank***, Thomas J. Slaga**; OPINION_NUMBER=PRS727; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=11 In 2008; VALUE_TEXT=5.0; DOSE=6 males, 6 females/group) in accordance with OECD TG 421.3 The purpose of this study was to obtain initial in- formation on the possible effects of the test item on repro- duction and development when administered orally in the diet to Crl:CD (SD)IGS BR rats at dosages of 40, 100, and 250 mg/ kg bw/d compared to control animals (plain diet only).; EFFECT=Persulfate was 10.3 mg/m3, while the no-observed-effect level (NOEL) was 5.0 mg/m3. Developmental and Reproductive Toxicity Studies Ammonium Persulfate Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a screening test with rats (groups of 12; 6 males, 6 females/group) in accordance with OECD TG 421.3 The purpose of this study was to obtain initial in- formation on the possible effects of the test item on repro- duction and development when administered orally in the diet to Crl:CD (SD)IGS BR rats at dosages of 40, 100, and 250 mg/ kg bw/d compared to control animals (plain diet only). There were no treatment-related clinical signs of toxicity observed in F0 pare; CITATION=10; 3; 5; CITATION_NUMBERS=[10,3,5]; REFERENCE=10; 3; 5; DETAILS_JSON={"cas_number":"7727-54-0","citation":"10; 3; 5","dose":"6 males, 6 females/group) in accordance with OECD TG 421.3 The purpose of this study was to obtain initial in- formation on the possible effects of the test item on repro- duction and development when administered orally in the diet to Crl:CD (SD)IGS BR rats at dosages of 40, 100, and 250 mg/ kg bw/d compared to control animals (plain diet only).","duration":"","effect":"Persulfate was 10.3 mg/m3, while the no-observed-effect level (NOEL) was 5.0 mg/m3. Developmental and Reproductive Toxicity Studies Ammonium Persulfate Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a screening test with rats (groups of 12; 6 males, 6 females/group) in accordance with OECD TG 421.3 The purpose of this study was to obtain initial in- formation on the possible effects of the test item on repro- duction and development when administered orally in the diet to Crl:CD (SD)IGS BR rats at dosages of 40, 100, and 250 mg/ kg bw/d compared to control animals (plain diet only). There were no treatment-related clinical signs of toxicity observed in F0 pare","endpoint":"developmental toxicity","ingredient":"Persulfates","loael_value":"","noael_unit":"mg/m3","noael_value":"5.0","page":8,"route":"oral","species":"rat","study_id":"PRS727_noael_006"}
Regulatory source developmental toxicity 5 mg/m3 rat oral 13 wk developmental toxicity SOURCE_SUBDIR=PRS727; REPORT_TITLE=Amended Safety Assessment of Persulfates as Used in Cosmetics Wilbur Johnson*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks***, Ronald C. Shank***, Thomas J. Slaga**; OPINION_NUMBER=PRS727; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=11 In 2008; VALUE_TEXT=5; DOSE=Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk.; LOAEL_VALUE=91 mg/kg bw/d; EFFECT=ually distributed between test and control groups. Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk. LOAEL and NOAEL values of 200 and 91 mg/kg bw/d, respectively, were determined. The frequency of grossly observable lesions was comparable between test and control groups. In a 13-wk inhalation toxicity study (whole-body ex- posure) on Ammonium Persulfate (concentrations of 5, 10.3, and 25 mg/m3) involving male and female rats, the NOAEL was 10.3 mg/m3. The NOEL for the exposure of rats to a dust aerosol of Ammonium Persulfate was 5 mg/m3. Regarding human exposure, it has been predicted that, by using dust-free bleaching products and separate mixing areas, the total persulfate exposure in hairdresser salons can be lowered because the emission of particles <10 µm would be minimized. Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a test involving rats receiving daily doses up to 250 mg/kg bw/d. There were no treatment-related clinical signs of toxicity observed in F0 parents of either sex or i...; CITATION=13; 200; 91; CITATION_NUMBERS=[13,200,91]; REFERENCE=13; 200; 91; DETAILS_JSON={"cas_number":"7727-54-0","citation":"13; 200; 91","dose":"Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk.","duration":"13 wk","effect":"ually distributed between test and control groups. Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk. LOAEL and NOAEL values of 200 and 91 mg/kg bw/d, respectively, were determined. The frequency of grossly observable lesions was comparable between test and control groups. In a 13-wk inhalation toxicity study (whole-body ex- posure) on Ammonium Persulfate (concentrations of 5, 10.3, and 25 mg/m3) involving male and female rats, the NOAEL was 10.3 mg/m3. The NOEL for the exposure of rats to a dust aerosol of Ammonium Persulfate was 5 mg/m3. Regarding human exposure, it has been predicted that, by using dust-free bleaching products and separate mixing areas, the total persulfate exposure in hairdresser salons can be lowered because the emission of particles <10 µm would be minimized. Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a test involving rats receiving daily doses up to 250 mg/kg bw/d. There were no treatment-related clinical signs of toxicity observed in F0 parents of either sex or i...","endpoint":"developmental toxicity","ingredient":"Persulfates","loael_value":"91 mg/kg bw/d","noael_unit":"mg/m3","noael_value":"5","page":14,"route":"oral","species":"rat","study_id":"PRS727_noael_009"}
Regulatory source developmental toxicity 10.3 mg/m3 rat oral 13 wk developmental toxicity SOURCE_SUBDIR=PRS727; REPORT_TITLE=Amended Safety Assessment of Persulfates as Used in Cosmetics Wilbur Johnson*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks***, Ronald C. Shank***, Thomas J. Slaga**; OPINION_NUMBER=PRS727; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=11 In 2008; VALUE_TEXT=10.3; DOSE=Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk.; LOAEL_VALUE=91 mg/kg bw/d; EFFECT=thological changes were equally distributed between test and control groups. Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk. LOAEL and NOAEL values of 200 and 91 mg/kg bw/d, respectively, were determined. The frequency of grossly observable lesions was comparable between test and control groups. In a 13-wk inhalation toxicity study (whole-body ex- posure) on Ammonium Persulfate (concentrations of 5, 10.3, and 25 mg/m3) involving male and female rats, the NOAEL was 10.3 mg/m3. The NOEL for the exposure of rats to a dust aerosol of Ammonium Persulfate was 5 mg/m3. Regarding human exposure, it has been predicted that, by using dust-free bleaching products and separate mixing areas, the total persulfate exposure in hairdresser salons can be lowered because the emission of particles <10 µm would be minimized. Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a test involving rats receiving daily doses up to 250 mg/kg bw/d. There were no treatment-related clinical signs of toxicity observed in F0...; CITATION=13; 200; 91; CITATION_NUMBERS=[13,200,91]; REFERENCE=13; 200; 91; DETAILS_JSON={"cas_number":"7727-54-0","citation":"13; 200; 91","dose":"Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk.","duration":"13 wk","effect":"thological changes were equally distributed between test and control groups. Sodium Persulfate was administered in the diet (up to 3000 or 5000 ppm Sodium Persulfate) of rats for 13 wk. LOAEL and NOAEL values of 200 and 91 mg/kg bw/d, respectively, were determined. The frequency of grossly observable lesions was comparable between test and control groups. In a 13-wk inhalation toxicity study (whole-body ex- posure) on Ammonium Persulfate (concentrations of 5, 10.3, and 25 mg/m3) involving male and female rats, the NOAEL was 10.3 mg/m3. The NOEL for the exposure of rats to a dust aerosol of Ammonium Persulfate was 5 mg/m3. Regarding human exposure, it has been predicted that, by using dust-free bleaching products and separate mixing areas, the total persulfate exposure in hairdresser salons can be lowered because the emission of particles <10 µm would be minimized. Ammonium Persulfate was tested for oral reproductive/ developmental toxicity in a test involving rats receiving daily doses up to 250 mg/kg bw/d. There were no treatment-related clinical signs of toxicity observed in F0...","endpoint":"developmental toxicity","ingredient":"Persulfates","loael_value":"91 mg/kg bw/d","noael_unit":"mg/m3","noael_value":"10.3","page":14,"route":"oral","species":"rat","study_id":"PRS727_noael_008"}
Regulatory source inhalation toxicity 25 mg/m3 rat inhalation 13 weeks inhalation toxicity SOURCE_SUBDIR=PRS727; REPORT_TITLE=Amended Safety Assessment of Persulfates as Used in Cosmetics Wilbur Johnson*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks***, Ronald C. Shank***, Thomas J. Slaga**; OPINION_NUMBER=PRS727; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=11 In 2008; VALUE_TEXT=25; DOSE=By the end of the recovery period, body weights for the exposed animals were similar to the control group values.; EFFECT=most of the exposure period compared to the control group. By the end of the recovery period, body weights for the exposed animals were similar to the control group values. Lung weights were increased in the 25 mg/m3 group after 13 weeks of exposure, but were similar to controls at 6 week post-exposure. Irritation of the trachea and bronchi/ bronchiole was noted microscopically after 13 weeks of ex- posure to 25 mg/m3. These lesions were not observed at 6 week post-exposure. Based on the results of this study, the NOAEL for exposure of rats to a dust aerosol of Ammonium Johnson et al. 11S; CITATION=25; 13; 6; CITATION_NUMBERS=[25,13,6]; REFERENCE=25; 13; 6; DETAILS_JSON={"cas_number":"7727-54-0","citation":"25; 13; 6","dose":"By the end of the recovery period, body weights for the exposed animals were similar to the control group values.","duration":"13 weeks","effect":"most of the exposure period compared to the control group. By the end of the recovery period, body weights for the exposed animals were similar to the control group values. Lung weights were increased in the 25 mg/m3 group after 13 weeks of exposure, but were similar to controls at 6 week post-exposure. Irritation of the trachea and bronchi/ bronchiole was noted microscopically after 13 weeks of ex- posure to 25 mg/m3. These lesions were not observed at 6 week post-exposure. Based on the results of this study, the NOAEL for exposure of rats to a dust aerosol of Ammonium Johnson et al. 11S","endpoint":"inhalation toxicity","ingredient":"Persulfates","loael_value":"","noael_unit":"mg/m3","noael_value":"25","page":7,"route":"inhalation","species":"rat","study_id":"PRS727_noael_005"}
Regulatory source inhalation toxicity 41.1 mg/kg bw/d rat oral 28-d inhalation toxicity SOURCE_SUBDIR=PRS727; REPORT_TITLE=Amended Safety Assessment of Persulfates as Used in Cosmetics Wilbur Johnson*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks***, Ronald C. Shank***, Thomas J. Slaga**; OPINION_NUMBER=PRS727; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=11 In 2008; VALUE_TEXT=41.1; DOSE=ate was tested for oral toxicity in groups of 10 male rats in a 28-d study.15 In this study, the test substance was administered to male weanling albino rats in the diet at concentrations of 0 ppm (control), 100 ppm (13.30 mg/kg bw/d), 300 ppm (41.05 mg/kg bw/d) and 600 ppm (82.08 mg/kg bw/d).; EFFECT=ate was tested for oral toxicity in groups of 10 male rats in a 28-d study.15 In this study, the test substance was administered to male weanling albino rats in the diet at concentrations of 0 ppm (control), 100 ppm (13.30 mg/kg bw/d), 300 ppm (41.05 mg/kg bw/d) and 600 ppm (82.08 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. Decreased relative adrenal weight was observed at the highest dose. The no- observed adverse effect level (NOAEL) was determined to be 41.1 mg/kg bw/d. Potassium persulfate. Potassium Persulfate was tested for toxicity in rats in a 28-d study in accordance with OECD TG 407.3 In this study, the test substance was administered (in diet) to groups of 10 male weanling albino rats at concentrations of 0 ppm (control), 100 ppm (12.62 mg/kg bw/d), 316 ppm (41.15 mg/kg bw/d) and 1000 ppm (131.50 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. The NOAEL was estimated to be 131.5 mg/kg bw/d. Inhalation A...; CITATION=10; 28; 15; CITATION_NUMBERS=[10,28,15]; REFERENCE=10; 28; 15; DETAILS_JSON={"cas_number":"7727-54-0","citation":"10; 28; 15","dose":"ate was tested for oral toxicity in groups of 10 male rats in a 28-d study.15 In this study, the test substance was administered to male weanling albino rats in the diet at concentrations of 0 ppm (control), 100 ppm (13.30 mg/kg bw/d), 300 ppm (41.05 mg/kg bw/d) and 600 ppm (82.08 mg/kg bw/d).","duration":"28-d","effect":"ate was tested for oral toxicity in groups of 10 male rats in a 28-d study.15 In this study, the test substance was administered to male weanling albino rats in the diet at concentrations of 0 ppm (control), 100 ppm (13.30 mg/kg bw/d), 300 ppm (41.05 mg/kg bw/d) and 600 ppm (82.08 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. Decreased relative adrenal weight was observed at the highest dose. The no- observed adverse effect level (NOAEL) was determined to be 41.1 mg/kg bw/d. Potassium persulfate. Potassium Persulfate was tested for toxicity in rats in a 28-d study in accordance with OECD TG 407.3 In this study, the test substance was administered (in diet) to groups of 10 male weanling albino rats at concentrations of 0 ppm (control), 100 ppm (12.62 mg/kg bw/d), 316 ppm (41.15 mg/kg bw/d) and 1000 ppm (131.50 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. The NOAEL was estimated to be 131.5 mg/kg bw/d. Inhalation A...","endpoint":"inhalation toxicity","ingredient":"Persulfates","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"41.1","page":6,"route":"oral","species":"rat","study_id":"PRS727_noael_001"}
Regulatory source inhalation toxicity 131.5 mg/kg bw/d rat oral 28-d inhalation toxicity SOURCE_SUBDIR=PRS727; REPORT_TITLE=Amended Safety Assessment of Persulfates as Used in Cosmetics Wilbur Johnson*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks***, Ronald C. Shank***, Thomas J. Slaga**; OPINION_NUMBER=PRS727; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=11 In 2008; VALUE_TEXT=131.5; DOSE=OAEL) was determined to be 41.1 mg/kg bw/d.; EFFECT=OAEL) was determined to be 41.1 mg/kg bw/d. Potassium persulfate. Potassium Persulfate was tested for toxicity in rats in a 28-d study in accordance with OECD TG 407.3 In this study, the test substance was administered (in diet) to groups of 10 male weanling albino rats at concentrations of 0 ppm (control), 100 ppm (12.62 mg/kg bw/d), 316 ppm (41.15 mg/kg bw/d) and 1000 ppm (131.50 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. The NOAEL was estimated to be 131.5 mg/kg bw/d. Inhalation Ammonium Persulfate. In a study involving rats, inhalation exposure to aerosolized Ammonium Persulfate at concentra- tions ranging from 4 mg/m3 to 20 mg/m3 for 7 d caused a significant increase in the wet weight of the right apical portion of the lung lobe.1 Protein and DNA concentrations were sig- nificantly increased in the lungs, and tracheal mucus glyco- protein secretion rates tended to be greater than that observed in the control animals. These changes were attributed to pulmo- nary edema and/or inflammation. N...; CITATION=41; 1; 28; CITATION_NUMBERS=[41,1,28]; REFERENCE=41; 1; 28; DETAILS_JSON={"cas_number":"7727-54-0","citation":"41; 1; 28","dose":"OAEL) was determined to be 41.1 mg/kg bw/d.","duration":"28-d","effect":"OAEL) was determined to be 41.1 mg/kg bw/d. Potassium persulfate. Potassium Persulfate was tested for toxicity in rats in a 28-d study in accordance with OECD TG 407.3 In this study, the test substance was administered (in diet) to groups of 10 male weanling albino rats at concentrations of 0 ppm (control), 100 ppm (12.62 mg/kg bw/d), 316 ppm (41.15 mg/kg bw/d) and 1000 ppm (131.50 mg/kg bw/d). All test animals showed normal body weight gain and survived the study period. No significant pathology was observed. The NOAEL was estimated to be 131.5 mg/kg bw/d. Inhalation Ammonium Persulfate. In a study involving rats, inhalation exposure to aerosolized Ammonium Persulfate at concentra- tions ranging from 4 mg/m3 to 20 mg/m3 for 7 d caused a significant increase in the wet weight of the right apical portion of the lung lobe.1 Protein and DNA concentrations were sig- nificantly increased in the lungs, and tracheal mucus glyco- protein secretion rates tended to be greater than that observed in the control animals. These changes were attributed to pulmo- nary edema and/or inflammation. N...","endpoint":"inhalation toxicity","ingredient":"Persulfates","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"131.5","page":6,"route":"oral","species":"rat","study_id":"PRS727_noael_002"}
Regulatory source repeated dose toxicity >80 mg/kg bw rat oral 13-wk repeated dose toxicity SOURCE_SUBDIR=PRS727; REPORT_TITLE=Amended Safety Assessment of Persulfates as Used in Cosmetics Wilbur Johnson*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks***, Ronald C. Shank***, Thomas J. Slaga**; OPINION_NUMBER=PRS727; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=11 In 2008; VALUE_TEXT=> 80; DOSE=All changes observed were about equally distributed among the controls and groups dosed with the test substance.; EFFECT=ion) in the liver (mild vacuolation also observed), kidneys, and lungs were observed in some of the animals of all groups. All changes observed were about equally distributed among the controls and groups dosed with the test substance. Because body weight changes, food consumption, and hematological, biochemical, and pathological examinations did not show any noticeable and significant differences between the administered (5, 20, 80 mg/kg bw) and control (vehicle only) group animals, the authors concluded that the NOAEL was >80 mg/kg bw. Sodium persulfate. Local damage to the mucous membrane in the gastrointestinal tract of rats, but no other systemic effects, was observed in a 13-wk (subchronic) feeding study of Sodium Persulfate (dose of 30 mg/kg/d). Lesions were not observed in another subchronic study of Sodium Persulfate (same dose).1 Sodium Persulfate was administered in the diet of rats (CR strain; groups of 40 (20 males, 20 females/group)) for 13 wk.3 Observations included body weight, food consumption, and blood and urine parameters. Ophthalmologic examinations and gross...; CITATION=(5, 20, 80; 80; 13; CITATION_NUMBERS=[5,20,80,13]; REFERENCE=(5, 20, 80; 80; 13; DETAILS_JSON={"cas_number":"7727-54-0","citation":"(5, 20, 80; 80; 13","dose":"All changes observed were about equally distributed among the controls and groups dosed with the test substance.","duration":"13-wk","effect":"ion) in the liver (mild vacuolation also observed), kidneys, and lungs were observed in some of the animals of all groups. All changes observed were about equally distributed among the controls and groups dosed with the test substance. Because body weight changes, food consumption, and hematological, biochemical, and pathological examinations did not show any noticeable and significant differences between the administered (5, 20, 80 mg/kg bw) and control (vehicle only) group animals, the authors concluded that the NOAEL was >80 mg/kg bw. Sodium persulfate. Local damage to the mucous membrane in the gastrointestinal tract of rats, but no other systemic effects, was observed in a 13-wk (subchronic) feeding study of Sodium Persulfate (dose of 30 mg/kg/d). Lesions were not observed in another subchronic study of Sodium Persulfate (same dose).1 Sodium Persulfate was administered in the diet of rats (CR strain; groups of 40 (20 males, 20 females/group)) for 13 wk.3 Observations included body weight, food consumption, and blood and urine parameters. Ophthalmologic examinations and gross...","endpoint":"repeated dose toxicity","ingredient":"Persulfates","loael_value":"","noael_unit":"mg/kg bw","noael_value":"> 80","page":7,"route":"oral","species":"rat","study_id":"PRS727_noael_003"}
Regulatory source repeated dose toxicity 200 mg/kg bw/d rat oral 13 week repeated dose toxicity SOURCE_SUBDIR=PRS727; REPORT_TITLE=Amended Safety Assessment of Persulfates as Used in Cosmetics Wilbur Johnson*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks***, Ronald C. Shank***, Thomas J. Slaga**; OPINION_NUMBER=PRS727; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=11 In 2008; VALUE_TEXT=200; 91; DOSE=3000 ppm of Sodium Persulfate for 13 week.; LOAEL_VALUE=91 mg/kg bw/d; EFFECT=3000 ppm of Sodium Persulfate for 13 week. These changes were seen more frequently among females than males. The females received 50% more test material than the males on a dose per body weight basis. No statistically sig- nificant changes were seen among the controls or the groups that received 300 ppm in the diet for 13 week or 1000 ppm in the diet for 8 week, followed by 5000 ppm in the diet for the remainder of the study. No other microscopic changes were noted on comparison among these 3 groups. A LOAEL and a NOAEL of 200 and 91 mg/kg bw/d (3000 and 1000 ppm), respectively, were determined. Inhalation Ammonium persulfate. The subchronic inhalation toxicity of Ammonium Persulfate was characterized using Sprague- Dawley rats (20/sex/group) at respirable dust concentrations of 0, 5.0, 10.3, and 25 mg/m3.16 The average mass median aerodynamic diameters and geometric standard deviations of samples taken from the 5, 10.3, and 25 mg/m3 exposure levels were 2.5 ± 1.85, 2.7 ± 1.83, and 2.5 ± 1.80 μm, respectively. Whole-body exposures were conducted 6 h/d, 5 d/wk for 13 week. Gravimet...; CITATION=13; 50; 300; CITATION_NUMBERS=[13,50,300]; REFERENCE=13; 50; 300; DETAILS_JSON={"cas_number":"7727-54-0","citation":"13; 50; 300","dose":"3000 ppm of Sodium Persulfate for 13 week.","duration":"13 week","effect":"3000 ppm of Sodium Persulfate for 13 week. These changes were seen more frequently among females than males. The females received 50% more test material than the males on a dose per body weight basis. No statistically sig- nificant changes were seen among the controls or the groups that received 300 ppm in the diet for 13 week or 1000 ppm in the diet for 8 week, followed by 5000 ppm in the diet for the remainder of the study. No other microscopic changes were noted on comparison among these 3 groups. A LOAEL and a NOAEL of 200 and 91 mg/kg bw/d (3000 and 1000 ppm), respectively, were determined. Inhalation Ammonium persulfate. The subchronic inhalation toxicity of Ammonium Persulfate was characterized using Sprague- Dawley rats (20/sex/group) at respirable dust concentrations of 0, 5.0, 10.3, and 25 mg/m3.16 The average mass median aerodynamic diameters and geometric standard deviations of samples taken from the 5, 10.3, and 25 mg/m3 exposure levels were 2.5 ± 1.85, 2.7 ± 1.83, and 2.5 ± 1.80 μm, respectively. Whole-body exposures were conducted 6 h/d, 5 d/wk for 13 week. Gravimet...","endpoint":"repeated dose toxicity","ingredient":"Persulfates","loael_value":"91 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"200; 91","page":7,"route":"oral","species":"rat","study_id":"PRS727_noael_004"}
Regulatory source reproductive toxicity >=250 mg/kg/d - - - reproductive toxicity SOURCE_SUBDIR=PRS727; REPORT_TITLE=Amended Safety Assessment of Persulfates as Used in Cosmetics Wilbur Johnson*, Wilma F. Bergfeld**, Donald V. Belsito**, Ronald A. Hill***, Curtis D. Klaassen**, Daniel C. Liebler***, James G. Marks***, Ronald C. Shank***, Thomas J. Slaga**; OPINION_NUMBER=PRS727; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=11 In 2008; VALUE_TEXT=≥ 250; DOSE=Remarkable clinical signs in the F0 parents and F1 pups were not attributed to treatment with Ammonium Persulfate, as they occurred sporadically, were of short duration, and did not demonstrate a dose response.; EFFECT=ved in F0 parents of either sex or in F1 pups at any treatment level. Remarkable clinical signs in the F0 parents and F1 pups were not attributed to treatment with Ammonium Persulfate, as they occurred sporadically, were of short duration, and did not demonstrate a dose response. No significant changes were observed in male and female reproductive performance such as gonadal function, mating behavior, conception, pregnancy, parturition and in development of the F1 offspring from conception to day 4 postpartum. The NOAEL for male and female toxicity, the NOAEL for male and female fertility performance and the NOAEL for F1 viability and development were reported to be ≥250 mg/kg/d. Genotoxicity In Vitro Ammonium persulfate. Results for Ammonium Persulfate were negative in the Ames test.1 Sodium persulfate. The genotoxicity of Sodium Persulfate was evaluated in the Ames test using the following Salmonella typhimurium strains: TA98, TA100, TA1535, TA1537 and TA1538.3 Sodium Persulfate was tested at 5 dose levels ranging from 100 to 10 000 µg/plate. The assay was con- ducted in the pre...; CITATION=4; 250; 1; CITATION_NUMBERS=[4,250,1]; REFERENCE=4; 250; 1; DETAILS_JSON={"cas_number":"7727-54-0","citation":"4; 250; 1","dose":"Remarkable clinical signs in the F0 parents and F1 pups were not attributed to treatment with Ammonium Persulfate, as they occurred sporadically, were of short duration, and did not demonstrate a dose response.","duration":"","effect":"ved in F0 parents of either sex or in F1 pups at any treatment level. Remarkable clinical signs in the F0 parents and F1 pups were not attributed to treatment with Ammonium Persulfate, as they occurred sporadically, were of short duration, and did not demonstrate a dose response. No significant changes were observed in male and female reproductive performance such as gonadal function, mating behavior, conception, pregnancy, parturition and in development of the F1 offspring from conception to day 4 postpartum. The NOAEL for male and female toxicity, the NOAEL for male and female fertility performance and the NOAEL for F1 viability and development were reported to be ≥250 mg/kg/d. Genotoxicity In Vitro Ammonium persulfate. Results for Ammonium Persulfate were negative in the Ames test.1 Sodium persulfate. The genotoxicity of Sodium Persulfate was evaluated in the Ames test using the following Salmonella typhimurium strains: TA98, TA100, TA1535, TA1537 and TA1538.3 Sodium Persulfate was tested at 5 dose levels ranging from 100 to 10 000 µg/plate. The assay was con- ducted in the pre...","endpoint":"reproductive toxicity","ingredient":"Persulfates","loael_value":"","noael_unit":"mg/kg/d","noael_value":"≥ 250","page":8,"route":"","species":"","study_id":"PRS727_noael_007"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 22QF6L357F UNII - - - chemical {"approval_status":null,"molecular_formula":"O8S2.2H4N","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"22QF6L357F"}
openFDA substances FDA UNII substance identifier 22QF6L357F UNII - - - chemical {"approval_status":null,"molecular_formula":"O8S2.2H4N","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"22QF6L357F"}
openFDA substances FDA UNII substance identifier 22QF6L357F UNII - - - chemical {"approval_status":null,"molecular_formula":"O8S2.2H4N","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"22QF6L357F"}
openFDA substances FDA UNII substance identifier 22QF6L357F UNII - - - chemical {"approval_status":null,"molecular_formula":"O8S2.2H4N","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"22QF6L357F"}