NOAEL Studies Cosmetic Ingredient

CI 77713 NOAEL Studies

CAS: 546-93-0

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_vision_codex 36 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR_vision_codex NOAEL =1.25 % rat oral 62-d developmental toxicity {"citation":"331; 0; 5","dose":"g/kg body weight/d; the equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d.","effect":"g/kg body weight/d; the equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Female Swiss mice were bred after feeding with a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate. Calcium Carbonate (2%) in the diet caused hypertrophy of the heart and decreased thymus weight in weanling mice. In a reproductive toxicity study, rats were fed oral doses of Cal- cium Carbonate (nano form) up to 1000 mg/kg body weight/d for 48 consecutive days. The maximum dose administered was the NOEL in this study. In a 62-d developmental toxicity study, rats were fed Calcium Carbonate at concentrations up to 1.25% in the diet, and the NOAEL for teratogenicity was determined to be >1.25% in the diet. There was no evidence of embryotoxicity or teratogenicity in the offspring of rats dosed orally with sodium bicarbonate (up to 340 mg/kg body weight) on gestation days 6 through 15. In another study on sodium bicarbonate, there were no test substance-related abnormalities in the offspring of rats that received sodium bicarbonate at concentrations of 0.5% and 2% (in...","page":23,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_009"}
CIR_vision_codex NOAEL =1.25 % rat oral 62-d developmental toxicity {"citation":"331; 0; 5","dose":"g/kg body weight/d; the equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d.","effect":"g/kg body weight/d; the equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Female Swiss mice were bred after feeding with a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate. Calcium Carbonate (2%) in the diet caused hypertrophy of the heart and decreased thymus weight in weanling mice. In a reproductive toxicity study, rats were fed oral doses of Cal- cium Carbonate (nano form) up to 1000 mg/kg body weight/d for 48 consecutive days. The maximum dose administered was the NOEL in this study. In a 62-d developmental toxicity study, rats were fed Calcium Carbonate at concentrations up to 1.25% in the diet, and the NOAEL for teratogenicity was determined to be >1.25% in the diet. There was no evidence of embryotoxicity or teratogenicity in the offspring of rats dosed orally with sodium bicarbonate (up to 340 mg/kg body weight) on gestation days 6 through 15. In another study on sodium bicarbonate, there were no test substance-related abnormalities in the offspring of rats that received sodium bicarbonate at concentrations of 0.5% and 2% (in...","page":23,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_009"}
CIR_vision_codex NOAEL =1.25 % rat oral 62-d developmental toxicity {"citation":"331; 0; 5","dose":"g/kg body weight/d; the equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d.","effect":"g/kg body weight/d; the equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Female Swiss mice were bred after feeding with a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate. Calcium Carbonate (2%) in the diet caused hypertrophy of the heart and decreased thymus weight in weanling mice. In a reproductive toxicity study, rats were fed oral doses of Cal- cium Carbonate (nano form) up to 1000 mg/kg body weight/d for 48 consecutive days. The maximum dose administered was the NOEL in this study. In a 62-d developmental toxicity study, rats were fed Calcium Carbonate at concentrations up to 1.25% in the diet, and the NOAEL for teratogenicity was determined to be >1.25% in the diet. There was no evidence of embryotoxicity or teratogenicity in the offspring of rats dosed orally with sodium bicarbonate (up to 340 mg/kg body weight) on gestation days 6 through 15. In another study on sodium bicarbonate, there were no test substance-related abnormalities in the offspring of rats that received sodium bicarbonate at concentrations of 0.5% and 2% (in...","page":23,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_009"}
CIR_vision_codex NOAEL =1.25 % rat oral 62-d developmental toxicity {"citation":"331; 0; 5","dose":"g/kg body weight/d; the equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d.","effect":"g/kg body weight/d; the equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Female Swiss mice were bred after feeding with a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate. Calcium Carbonate (2%) in the diet caused hypertrophy of the heart and decreased thymus weight in weanling mice. In a reproductive toxicity study, rats were fed oral doses of Cal- cium Carbonate (nano form) up to 1000 mg/kg body weight/d for 48 consecutive days. The maximum dose administered was the NOEL in this study. In a 62-d developmental toxicity study, rats were fed Calcium Carbonate at concentrations up to 1.25% in the diet, and the NOAEL for teratogenicity was determined to be >1.25% in the diet. There was no evidence of embryotoxicity or teratogenicity in the offspring of rats dosed orally with sodium bicarbonate (up to 340 mg/kg body weight) on gestation days 6 through 15. In another study on sodium bicarbonate, there were no test substance-related abnormalities in the offspring of rats that received sodium bicarbonate at concentrations of 0.5% and 2% (in...","page":23,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_009"}
CIR_vision_codex NOAEL =290 mg/kg body weight/d - - - NOAEL study {"citation":"290; 41; 1)","dose":"The no- observed-effect-level (NOEL) for maternal toxicity was 290 mg/kg body weight/d (i.e., the highest dose tested).","effect":"tion sites, live and dead fetuses, and body weights of live pups. The urogenital tract of each dam was examined in detail for anatomical normality. All of the fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetuses in each litter were subjected to detailed visceral ex- aminations, and the remaining two-thirds were examined for skeletal defects. There were no effects on mortality, body weight gain, or the urogenital tracts of dams. The no- observed-effect-level (NOEL) for maternal toxicity was 290 mg/kg body weight/d (i.e., the highest dose tested). There were no effects on any of the following: numbers of corpora 92S International Journal of Toxicology 41(Supplement 1)","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_007"}
CIR_vision_codex NOAEL =290 mg/kg body weight/d - - - NOAEL study {"citation":"290; 41; 1)","dose":"The no- observed-effect-level (NOEL) for maternal toxicity was 290 mg/kg body weight/d (i.e., the highest dose tested).","effect":"tion sites, live and dead fetuses, and body weights of live pups. The urogenital tract of each dam was examined in detail for anatomical normality. All of the fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetuses in each litter were subjected to detailed visceral ex- aminations, and the remaining two-thirds were examined for skeletal defects. There were no effects on mortality, body weight gain, or the urogenital tracts of dams. The no- observed-effect-level (NOEL) for maternal toxicity was 290 mg/kg body weight/d (i.e., the highest dose tested). There were no effects on any of the following: numbers of corpora 92S International Journal of Toxicology 41(Supplement 1)","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_007"}
CIR_vision_codex NOAEL =290 mg/kg body weight/d - - - NOAEL study {"citation":"290; 41; 1)","dose":"The no- observed-effect-level (NOEL) for maternal toxicity was 290 mg/kg body weight/d (i.e., the highest dose tested).","effect":"tion sites, live and dead fetuses, and body weights of live pups. The urogenital tract of each dam was examined in detail for anatomical normality. All of the fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetuses in each litter were subjected to detailed visceral ex- aminations, and the remaining two-thirds were examined for skeletal defects. There were no effects on mortality, body weight gain, or the urogenital tracts of dams. The no- observed-effect-level (NOEL) for maternal toxicity was 290 mg/kg body weight/d (i.e., the highest dose tested). There were no effects on any of the following: numbers of corpora 92S International Journal of Toxicology 41(Supplement 1)","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_007"}
CIR_vision_codex NOAEL =290 mg/kg body weight/d - - - NOAEL study {"citation":"290; 41; 1)","dose":"The no- observed-effect-level (NOEL) for maternal toxicity was 290 mg/kg body weight/d (i.e., the highest dose tested).","effect":"tion sites, live and dead fetuses, and body weights of live pups. The urogenital tract of each dam was examined in detail for anatomical normality. All of the fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetuses in each litter were subjected to detailed visceral ex- aminations, and the remaining two-thirds were examined for skeletal defects. There were no effects on mortality, body weight gain, or the urogenital tracts of dams. The no- observed-effect-level (NOEL) for maternal toxicity was 290 mg/kg body weight/d (i.e., the highest dose tested). There were no effects on any of the following: numbers of corpora 92S International Journal of Toxicology 41(Supplement 1)","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_007"}
CIR_vision_codex NOAEL >331 mg/kg body weight/d rat oral - oral toxicity {"citation":"800; 4; 6","dose":"bserved in one fetus of the 800 mg/kg/d dose group.","effect":"bserved in one fetus of the 800 mg/kg/d dose group. There were no intergroup differences in bone abnormality, effects on lumbocostale, extra ribs, sacrococcygea, metacarpal bone, or its ossification. Visceral malformations were ob- served in 4 to 6 fetuses from each dose group, but without intergroup differences. It was concluded that magnesium chloride hexahydrate was not teratogenic in rats dosed by gavage. The NOAEL was estimated to be >800 mg/kg body weight/d for pregnant rats and their fetuses. The equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Calcium Carbonate Female Swiss mice were bred after being fed (number of animals/feeding duration not stated) a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate.24 First and second litters were studied. Calcium Carbonate (1% and 2% in diet) yielded an intake of approximately 3000 mg/kg body weight. When compared to the control diet, feeding with the supplemented diet significantly decreased the number and total weight of the weanling mice, and increased the proportion of deaths. Cal- ciu...","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_005"}
CIR_vision_codex NOAEL >331 mg/kg body weight/d rat oral - oral toxicity {"citation":"800; 4; 6","dose":"bserved in one fetus of the 800 mg/kg/d dose group.","effect":"bserved in one fetus of the 800 mg/kg/d dose group. There were no intergroup differences in bone abnormality, effects on lumbocostale, extra ribs, sacrococcygea, metacarpal bone, or its ossification. Visceral malformations were ob- served in 4 to 6 fetuses from each dose group, but without intergroup differences. It was concluded that magnesium chloride hexahydrate was not teratogenic in rats dosed by gavage. The NOAEL was estimated to be >800 mg/kg body weight/d for pregnant rats and their fetuses. The equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Calcium Carbonate Female Swiss mice were bred after being fed (number of animals/feeding duration not stated) a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate.24 First and second litters were studied. Calcium Carbonate (1% and 2% in diet) yielded an intake of approximately 3000 mg/kg body weight. When compared to the control diet, feeding with the supplemented diet significantly decreased the number and total weight of the weanling mice, and increased the proportion of deaths. Cal- ciu...","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_005"}
CIR_vision_codex NOAEL >331 mg/kg body weight/d rat oral - oral toxicity {"citation":"800; 4; 6","dose":"bserved in one fetus of the 800 mg/kg/d dose group.","effect":"bserved in one fetus of the 800 mg/kg/d dose group. There were no intergroup differences in bone abnormality, effects on lumbocostale, extra ribs, sacrococcygea, metacarpal bone, or its ossification. Visceral malformations were ob- served in 4 to 6 fetuses from each dose group, but without intergroup differences. It was concluded that magnesium chloride hexahydrate was not teratogenic in rats dosed by gavage. The NOAEL was estimated to be >800 mg/kg body weight/d for pregnant rats and their fetuses. The equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Calcium Carbonate Female Swiss mice were bred after being fed (number of animals/feeding duration not stated) a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate.24 First and second litters were studied. Calcium Carbonate (1% and 2% in diet) yielded an intake of approximately 3000 mg/kg body weight. When compared to the control diet, feeding with the supplemented diet significantly decreased the number and total weight of the weanling mice, and increased the proportion of deaths. Cal- ciu...","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_005"}
CIR_vision_codex NOAEL >331 mg/kg body weight/d rat oral - oral toxicity {"citation":"800; 4; 6","dose":"bserved in one fetus of the 800 mg/kg/d dose group.","effect":"bserved in one fetus of the 800 mg/kg/d dose group. There were no intergroup differences in bone abnormality, effects on lumbocostale, extra ribs, sacrococcygea, metacarpal bone, or its ossification. Visceral malformations were ob- served in 4 to 6 fetuses from each dose group, but without intergroup differences. It was concluded that magnesium chloride hexahydrate was not teratogenic in rats dosed by gavage. The NOAEL was estimated to be >800 mg/kg body weight/d for pregnant rats and their fetuses. The equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Calcium Carbonate Female Swiss mice were bred after being fed (number of animals/feeding duration not stated) a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate.24 First and second litters were studied. Calcium Carbonate (1% and 2% in diet) yielded an intake of approximately 3000 mg/kg body weight. When compared to the control diet, feeding with the supplemented diet significantly decreased the number and total weight of the weanling mice, and increased the proportion of deaths. Cal- ciu...","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_005"}
CIR_vision_codex NOAEL =414 mg/kg body weight/d rat oral 29 d developmental toxicity {"citation":"3; 28; 29","dose":"so administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d.","effect":"so administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d. There were no treatment-related mortalities or major toxicological findings. There were no remarkable clinical signs or effects on hematology or clinical chemistry. The same was true for necropsy and histopathological findings relating to non-reproductive organs. It was concluded that the NOAEL for magnesium chloride hexahydrate was 1000 mg/kg body weight/d. Furthermore, it was determined that the equivalent NOAEL for Magnesium Carbonate was 414 mg/kg body weight/d. Results relating to toxic effects of magnesium chloride hexahydrate on reproductive organs are included in the section on Developmental and Reproductive Toxicity. Calcium Carbonate Five rats were fed [45Ca]labeled Calcium Carbonate (0.3 g/kg body weight) in feed for 3 d.24 The strain of rats tested was not identified. All of the animals remained healthy. The oral toxicity of Calcium Carbonate (nano form) was evaluated in a 14-d study using groups of 6 (3 male, 3 female) Wistar rats.26 The 4 groups consisted of th...","page":10,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_002"}
CIR_vision_codex NOAEL =414 mg/kg body weight/d rat oral 29 d developmental toxicity {"citation":"3; 28; 29","dose":"so administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d.","effect":"so administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d. There were no treatment-related mortalities or major toxicological findings. There were no remarkable clinical signs or effects on hematology or clinical chemistry. The same was true for necropsy and histopathological findings relating to non-reproductive organs. It was concluded that the NOAEL for magnesium chloride hexahydrate was 1000 mg/kg body weight/d. Furthermore, it was determined that the equivalent NOAEL for Magnesium Carbonate was 414 mg/kg body weight/d. Results relating to toxic effects of magnesium chloride hexahydrate on reproductive organs are included in the section on Developmental and Reproductive Toxicity. Calcium Carbonate Five rats were fed [45Ca]labeled Calcium Carbonate (0.3 g/kg body weight) in feed for 3 d.24 The strain of rats tested was not identified. All of the animals remained healthy. The oral toxicity of Calcium Carbonate (nano form) was evaluated in a 14-d study using groups of 6 (3 male, 3 female) Wistar rats.26 The 4 groups consisted of th...","page":10,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_002"}
CIR_vision_codex NOAEL =414 mg/kg body weight/d rat oral 29 d developmental toxicity {"citation":"3; 28; 29","dose":"so administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d.","effect":"so administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d. There were no treatment-related mortalities or major toxicological findings. There were no remarkable clinical signs or effects on hematology or clinical chemistry. The same was true for necropsy and histopathological findings relating to non-reproductive organs. It was concluded that the NOAEL for magnesium chloride hexahydrate was 1000 mg/kg body weight/d. Furthermore, it was determined that the equivalent NOAEL for Magnesium Carbonate was 414 mg/kg body weight/d. Results relating to toxic effects of magnesium chloride hexahydrate on reproductive organs are included in the section on Developmental and Reproductive Toxicity. Calcium Carbonate Five rats were fed [45Ca]labeled Calcium Carbonate (0.3 g/kg body weight) in feed for 3 d.24 The strain of rats tested was not identified. All of the animals remained healthy. The oral toxicity of Calcium Carbonate (nano form) was evaluated in a 14-d study using groups of 6 (3 male, 3 female) Wistar rats.26 The 4 groups consisted of th...","page":10,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_002"}
CIR_vision_codex NOAEL =414 mg/kg body weight/d rat oral 29 d developmental toxicity {"citation":"3; 28; 29","dose":"so administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d.","effect":"so administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d. There were no treatment-related mortalities or major toxicological findings. There were no remarkable clinical signs or effects on hematology or clinical chemistry. The same was true for necropsy and histopathological findings relating to non-reproductive organs. It was concluded that the NOAEL for magnesium chloride hexahydrate was 1000 mg/kg body weight/d. Furthermore, it was determined that the equivalent NOAEL for Magnesium Carbonate was 414 mg/kg body weight/d. Results relating to toxic effects of magnesium chloride hexahydrate on reproductive organs are included in the section on Developmental and Reproductive Toxicity. Calcium Carbonate Five rats were fed [45Ca]labeled Calcium Carbonate (0.3 g/kg body weight) in feed for 3 d.24 The strain of rats tested was not identified. All of the animals remained healthy. The oral toxicity of Calcium Carbonate (nano form) was evaluated in a 14-d study using groups of 6 (3 male, 3 female) Wistar rats.26 The 4 groups consisted of th...","page":10,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_002"}
CIR_vision_codex NOAEL <684 mg/kg body weight/d rat inhalation - inhalation toxicity {"citation":"3; 684; 30","dose":"The NOEL for ammonium chloride was <684 mg/kg body weight/d.","effect":"copic examinations of the bladder were performed. There were no significant differences in food consumption among the 3 groups. The difference also was not significant when animals fed ammonium chloride were compared to the negative control group. Body weight was significantly decreased in the positive control group. Gross and microscopic examination results were negative for animals fed ammonium chloride and for the negative control group. Hyperplasia of the bladder was observed in the positive control group. The NOEL for ammonium chloride was <684 mg/kg body weight/d. Inhalation Potassium Carbonate. The potential for short-term toxicity and neurotoxicity of a Potassium Carbonate-based scrubbing so- lution (containing 30.8% (w/v) Potassium Carbonate) used in petroleum refineries was evaluated in Sprague-Dawley Crl: CD BR rats.35 Inhalation exposures were to aerosols of a “used” scrubbing solution in a whole-body exposure chamber, 6 h/d for 21 consecutive days at target concentrations of 0 (filtered air—control), 0.1, 0.2, or 0.4 mg/l (30 animals/sex/ group). Five rats per sex per...","page":11,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_003"}
CIR_vision_codex NOAEL <684 mg/kg body weight/d rat inhalation - inhalation toxicity {"citation":"3; 684; 30","dose":"The NOEL for ammonium chloride was <684 mg/kg body weight/d.","effect":"copic examinations of the bladder were performed. There were no significant differences in food consumption among the 3 groups. The difference also was not significant when animals fed ammonium chloride were compared to the negative control group. Body weight was significantly decreased in the positive control group. Gross and microscopic examination results were negative for animals fed ammonium chloride and for the negative control group. Hyperplasia of the bladder was observed in the positive control group. The NOEL for ammonium chloride was <684 mg/kg body weight/d. Inhalation Potassium Carbonate. The potential for short-term toxicity and neurotoxicity of a Potassium Carbonate-based scrubbing so- lution (containing 30.8% (w/v) Potassium Carbonate) used in petroleum refineries was evaluated in Sprague-Dawley Crl: CD BR rats.35 Inhalation exposures were to aerosols of a “used” scrubbing solution in a whole-body exposure chamber, 6 h/d for 21 consecutive days at target concentrations of 0 (filtered air—control), 0.1, 0.2, or 0.4 mg/l (30 animals/sex/ group). Five rats per sex per...","page":11,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_003"}
CIR_vision_codex NOAEL <684 mg/kg body weight/d rat inhalation - inhalation toxicity {"citation":"3; 684; 30","dose":"The NOEL for ammonium chloride was <684 mg/kg body weight/d.","effect":"copic examinations of the bladder were performed. There were no significant differences in food consumption among the 3 groups. The difference also was not significant when animals fed ammonium chloride were compared to the negative control group. Body weight was significantly decreased in the positive control group. Gross and microscopic examination results were negative for animals fed ammonium chloride and for the negative control group. Hyperplasia of the bladder was observed in the positive control group. The NOEL for ammonium chloride was <684 mg/kg body weight/d. Inhalation Potassium Carbonate. The potential for short-term toxicity and neurotoxicity of a Potassium Carbonate-based scrubbing so- lution (containing 30.8% (w/v) Potassium Carbonate) used in petroleum refineries was evaluated in Sprague-Dawley Crl: CD BR rats.35 Inhalation exposures were to aerosols of a “used” scrubbing solution in a whole-body exposure chamber, 6 h/d for 21 consecutive days at target concentrations of 0 (filtered air—control), 0.1, 0.2, or 0.4 mg/l (30 animals/sex/ group). Five rats per sex per...","page":11,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_003"}
CIR_vision_codex NOAEL <684 mg/kg body weight/d rat inhalation - inhalation toxicity {"citation":"3; 684; 30","dose":"The NOEL for ammonium chloride was <684 mg/kg body weight/d.","effect":"copic examinations of the bladder were performed. There were no significant differences in food consumption among the 3 groups. The difference also was not significant when animals fed ammonium chloride were compared to the negative control group. Body weight was significantly decreased in the positive control group. Gross and microscopic examination results were negative for animals fed ammonium chloride and for the negative control group. Hyperplasia of the bladder was observed in the positive control group. The NOEL for ammonium chloride was <684 mg/kg body weight/d. Inhalation Potassium Carbonate. The potential for short-term toxicity and neurotoxicity of a Potassium Carbonate-based scrubbing so- lution (containing 30.8% (w/v) Potassium Carbonate) used in petroleum refineries was evaluated in Sprague-Dawley Crl: CD BR rats.35 Inhalation exposures were to aerosols of a “used” scrubbing solution in a whole-body exposure chamber, 6 h/d for 21 consecutive days at target concentrations of 0 (filtered air—control), 0.1, 0.2, or 0.4 mg/l (30 animals/sex/ group). Five rats per sex per...","page":11,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_003"}
CIR_vision_codex NOAEL >800 mg/kg body weight/d rat oral - oral toxicity {"citation":"800; 4; 6","dose":"mation was observed in the dose groups, but without any intergroup differences.","effect":"mation was observed in the dose groups, but without any intergroup differences. Bone malformation was observed in one fetus of the 800 mg/kg/d dose group. There were no intergroup differences in bone abnormality, effects on lumbocostale, extra ribs, sacrococcygea, metacarpal bone, or its ossification. Visceral malformations were ob- served in 4 to 6 fetuses from each dose group, but without intergroup differences. It was concluded that magnesium chloride hexahydrate was not teratogenic in rats dosed by gavage. The NOAEL was estimated to be >800 mg/kg body weight/d for pregnant rats and their fetuses. The equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Calcium Carbonate Female Swiss mice were bred after being fed (number of animals/feeding duration not stated) a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate.24 First and second litters were studied. Calcium Carbonate (1% and 2% in diet) yielded an intake of approximately 3000 mg/kg body weight. When compared to the control diet, feeding with the supplemented diet significantly decre...","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_004"}
CIR_vision_codex NOAEL >800 mg/kg body weight/d rat oral - oral toxicity {"citation":"800; 4; 6","dose":"mation was observed in the dose groups, but without any intergroup differences.","effect":"mation was observed in the dose groups, but without any intergroup differences. Bone malformation was observed in one fetus of the 800 mg/kg/d dose group. There were no intergroup differences in bone abnormality, effects on lumbocostale, extra ribs, sacrococcygea, metacarpal bone, or its ossification. Visceral malformations were ob- served in 4 to 6 fetuses from each dose group, but without intergroup differences. It was concluded that magnesium chloride hexahydrate was not teratogenic in rats dosed by gavage. The NOAEL was estimated to be >800 mg/kg body weight/d for pregnant rats and their fetuses. The equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Calcium Carbonate Female Swiss mice were bred after being fed (number of animals/feeding duration not stated) a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate.24 First and second litters were studied. Calcium Carbonate (1% and 2% in diet) yielded an intake of approximately 3000 mg/kg body weight. When compared to the control diet, feeding with the supplemented diet significantly decre...","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_004"}
CIR_vision_codex NOAEL >800 mg/kg body weight/d rat oral - oral toxicity {"citation":"800; 4; 6","dose":"mation was observed in the dose groups, but without any intergroup differences.","effect":"mation was observed in the dose groups, but without any intergroup differences. Bone malformation was observed in one fetus of the 800 mg/kg/d dose group. There were no intergroup differences in bone abnormality, effects on lumbocostale, extra ribs, sacrococcygea, metacarpal bone, or its ossification. Visceral malformations were ob- served in 4 to 6 fetuses from each dose group, but without intergroup differences. It was concluded that magnesium chloride hexahydrate was not teratogenic in rats dosed by gavage. The NOAEL was estimated to be >800 mg/kg body weight/d for pregnant rats and their fetuses. The equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Calcium Carbonate Female Swiss mice were bred after being fed (number of animals/feeding duration not stated) a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate.24 First and second litters were studied. Calcium Carbonate (1% and 2% in diet) yielded an intake of approximately 3000 mg/kg body weight. When compared to the control diet, feeding with the supplemented diet significantly decre...","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_004"}
CIR_vision_codex NOAEL >800 mg/kg body weight/d rat oral - oral toxicity {"citation":"800; 4; 6","dose":"mation was observed in the dose groups, but without any intergroup differences.","effect":"mation was observed in the dose groups, but without any intergroup differences. Bone malformation was observed in one fetus of the 800 mg/kg/d dose group. There were no intergroup differences in bone abnormality, effects on lumbocostale, extra ribs, sacrococcygea, metacarpal bone, or its ossification. Visceral malformations were ob- served in 4 to 6 fetuses from each dose group, but without intergroup differences. It was concluded that magnesium chloride hexahydrate was not teratogenic in rats dosed by gavage. The NOAEL was estimated to be >800 mg/kg body weight/d for pregnant rats and their fetuses. The equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Calcium Carbonate Female Swiss mice were bred after being fed (number of animals/feeding duration not stated) a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate.24 First and second litters were studied. Calcium Carbonate (1% and 2% in diet) yielded an intake of approximately 3000 mg/kg body weight. When compared to the control diet, feeding with the supplemented diet significantly decre...","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_004"}
CIR_vision_codex NOAEL =1000 mg/kg body weight/d rat oral 14 d developmental toxicity {"citation":"14; 3; 28","dose":"The test substance was also administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d.","effect":"istered orally (by gavage) to males and females daily during 14 d pre-mating and 14 d of mating. The test substance was also administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d. There were no treatment-related mortalities or major toxicological findings. There were no remarkable clinical signs or effects on hematology or clinical chemistry. The same was true for necropsy and histopathological findings relating to non-reproductive organs. It was concluded that the NOAEL for magnesium chloride hexahydrate was 1000 mg/kg body weight/d. Furthermore, it was determined that the equivalent NOAEL for Magnesium Carbonate was 414 mg/kg body weight/d. Results relating to toxic effects of magnesium chloride hexahydrate on reproductive organs are included in the section on Developmental and Reproductive Toxicity. Calcium Carbonate Five rats were fed [45Ca]labeled Calcium Carbonate (0.3 g/kg body weight) in feed for 3 d.24 The strain of rats tested was not identified. All of the animals remained healthy. The oral toxicity of Calcium Carbonate...","page":10,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_001"}
CIR_vision_codex NOAEL =1000 mg/kg body weight/d rat oral 14 d developmental toxicity {"citation":"14; 3; 28","dose":"The test substance was also administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d.","effect":"istered orally (by gavage) to males and females daily during 14 d pre-mating and 14 d of mating. The test substance was also administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d. There were no treatment-related mortalities or major toxicological findings. There were no remarkable clinical signs or effects on hematology or clinical chemistry. The same was true for necropsy and histopathological findings relating to non-reproductive organs. It was concluded that the NOAEL for magnesium chloride hexahydrate was 1000 mg/kg body weight/d. Furthermore, it was determined that the equivalent NOAEL for Magnesium Carbonate was 414 mg/kg body weight/d. Results relating to toxic effects of magnesium chloride hexahydrate on reproductive organs are included in the section on Developmental and Reproductive Toxicity. Calcium Carbonate Five rats were fed [45Ca]labeled Calcium Carbonate (0.3 g/kg body weight) in feed for 3 d.24 The strain of rats tested was not identified. All of the animals remained healthy. The oral toxicity of Calcium Carbonate...","page":10,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_001"}
CIR_vision_codex NOAEL =1000 mg/kg body weight/d rat oral 14 d developmental toxicity {"citation":"14; 3; 28","dose":"The test substance was also administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d.","effect":"istered orally (by gavage) to males and females daily during 14 d pre-mating and 14 d of mating. The test substance was also administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d. There were no treatment-related mortalities or major toxicological findings. There were no remarkable clinical signs or effects on hematology or clinical chemistry. The same was true for necropsy and histopathological findings relating to non-reproductive organs. It was concluded that the NOAEL for magnesium chloride hexahydrate was 1000 mg/kg body weight/d. Furthermore, it was determined that the equivalent NOAEL for Magnesium Carbonate was 414 mg/kg body weight/d. Results relating to toxic effects of magnesium chloride hexahydrate on reproductive organs are included in the section on Developmental and Reproductive Toxicity. Calcium Carbonate Five rats were fed [45Ca]labeled Calcium Carbonate (0.3 g/kg body weight) in feed for 3 d.24 The strain of rats tested was not identified. All of the animals remained healthy. The oral toxicity of Calcium Carbonate...","page":10,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_001"}
CIR_vision_codex NOAEL =1000 mg/kg body weight/d rat oral 14 d developmental toxicity {"citation":"14; 3; 28","dose":"The test substance was also administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d.","effect":"istered orally (by gavage) to males and females daily during 14 d pre-mating and 14 d of mating. The test substance was also administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d. There were no treatment-related mortalities or major toxicological findings. There were no remarkable clinical signs or effects on hematology or clinical chemistry. The same was true for necropsy and histopathological findings relating to non-reproductive organs. It was concluded that the NOAEL for magnesium chloride hexahydrate was 1000 mg/kg body weight/d. Furthermore, it was determined that the equivalent NOAEL for Magnesium Carbonate was 414 mg/kg body weight/d. Results relating to toxic effects of magnesium chloride hexahydrate on reproductive organs are included in the section on Developmental and Reproductive Toxicity. Calcium Carbonate Five rats were fed [45Ca]labeled Calcium Carbonate (0.3 g/kg body weight) in feed for 3 d.24 The strain of rats tested was not identified. All of the animals remained healthy. The oral toxicity of Calcium Carbonate...","page":10,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_001"}
CIR_vision_codex NOAEL =1963 mg/kg body weight mouse oral - developmental toxicity {"citation":"1; 25; 22","dose":"There were no dose-related changes in the average number of implantations, resorptions and viable fe- tuses, or fetal length or weight.","effect":"There was no evidence of test substance-related maternal toxicity or embryotoxic/ teratogenic effects. There were no dose-related changes in the average number of implantations, resorptions and viable fe- tuses, or fetal length or weight. When compared to the control group, there were no statistically significant increases in the litter incidence regarding specific external, visceral, or skeletal variations of the fetuses. The NOAEC for teratogenicity was >1.25% Calcium Carbonate in the diet and corresponded to a NOAEL between 1963 and 2188 mg/kg body weight per day. Potassium Carbonate The teratogenicity of Potassium Carbonate was evaluated using groups of 22 to 25 CD-1 mice, according to a protocol similar to OECD Test Guideline 414.28,38 The test substance was administered, by gavage, at doses of 0, 2.9, 13.5, 62.5, or 290 mg/kg body weight/d, on gestation days 6 through 15. On day 17, Caesarean section was performed on all of the dams, and the following information was recorded: sex, numbers of corpora lutea, implantation sites, resorption sites, live and dead fetuses, and bod...","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_006"}
CIR_vision_codex NOAEL =1963 mg/kg body weight mouse oral - developmental toxicity {"citation":"1; 25; 22","dose":"There were no dose-related changes in the average number of implantations, resorptions and viable fe- tuses, or fetal length or weight.","effect":"There was no evidence of test substance-related maternal toxicity or embryotoxic/ teratogenic effects. There were no dose-related changes in the average number of implantations, resorptions and viable fe- tuses, or fetal length or weight. When compared to the control group, there were no statistically significant increases in the litter incidence regarding specific external, visceral, or skeletal variations of the fetuses. The NOAEC for teratogenicity was >1.25% Calcium Carbonate in the diet and corresponded to a NOAEL between 1963 and 2188 mg/kg body weight per day. Potassium Carbonate The teratogenicity of Potassium Carbonate was evaluated using groups of 22 to 25 CD-1 mice, according to a protocol similar to OECD Test Guideline 414.28,38 The test substance was administered, by gavage, at doses of 0, 2.9, 13.5, 62.5, or 290 mg/kg body weight/d, on gestation days 6 through 15. On day 17, Caesarean section was performed on all of the dams, and the following information was recorded: sex, numbers of corpora lutea, implantation sites, resorption sites, live and dead fetuses, and bod...","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_006"}
CIR_vision_codex NOAEL =1963 mg/kg body weight mouse oral - developmental toxicity {"citation":"1; 25; 22","dose":"There were no dose-related changes in the average number of implantations, resorptions and viable fe- tuses, or fetal length or weight.","effect":"There was no evidence of test substance-related maternal toxicity or embryotoxic/ teratogenic effects. There were no dose-related changes in the average number of implantations, resorptions and viable fe- tuses, or fetal length or weight. When compared to the control group, there were no statistically significant increases in the litter incidence regarding specific external, visceral, or skeletal variations of the fetuses. The NOAEC for teratogenicity was >1.25% Calcium Carbonate in the diet and corresponded to a NOAEL between 1963 and 2188 mg/kg body weight per day. Potassium Carbonate The teratogenicity of Potassium Carbonate was evaluated using groups of 22 to 25 CD-1 mice, according to a protocol similar to OECD Test Guideline 414.28,38 The test substance was administered, by gavage, at doses of 0, 2.9, 13.5, 62.5, or 290 mg/kg body weight/d, on gestation days 6 through 15. On day 17, Caesarean section was performed on all of the dams, and the following information was recorded: sex, numbers of corpora lutea, implantation sites, resorption sites, live and dead fetuses, and bod...","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_006"}
CIR_vision_codex NOAEL =1963 mg/kg body weight mouse oral - developmental toxicity {"citation":"1; 25; 22","dose":"There were no dose-related changes in the average number of implantations, resorptions and viable fe- tuses, or fetal length or weight.","effect":"There was no evidence of test substance-related maternal toxicity or embryotoxic/ teratogenic effects. There were no dose-related changes in the average number of implantations, resorptions and viable fe- tuses, or fetal length or weight. When compared to the control group, there were no statistically significant increases in the litter incidence regarding specific external, visceral, or skeletal variations of the fetuses. The NOAEC for teratogenicity was >1.25% Calcium Carbonate in the diet and corresponded to a NOAEL between 1963 and 2188 mg/kg body weight per day. Potassium Carbonate The teratogenicity of Potassium Carbonate was evaluated using groups of 22 to 25 CD-1 mice, according to a protocol similar to OECD Test Guideline 414.28,38 The test substance was administered, by gavage, at doses of 0, 2.9, 13.5, 62.5, or 290 mg/kg body weight/d, on gestation days 6 through 15. On day 17, Caesarean section was performed on all of the dams, and the following information was recorded: sex, numbers of corpora lutea, implantation sites, resorption sites, live and dead fetuses, and bod...","page":13,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_006"}
CIR_vision_codex NOAEL =4128 mg/kg body weight/d rat oral 14 d repeated dose toxicity {"citation":"14; 3; 28","dose":"A NOAEL of 1000 mg/kg body weight/day was reported in a study in which male and female rats received oral doses of magnesium chloride hexahydrate for 14 d pre-mating and 14 d of mating.","effect":"orted for Ammonium Bicarbonate and Ammonium Carbonate, respectively, in studies involving albino rats. A NOAEL of 1000 mg/kg body weight/day was reported in a study in which male and female rats received oral doses of magnesium chloride hexahydrate for 14 d pre-mating and 14 d of mating. The same results were reported for female rats dosed orally during gestation and up to PND 3 and for male rats dosed orally for 28 to 29 d. Based on the results of the preceding 2 experiments, it was determined that the equivalent NOAEL for Magnesium Carbonate was 4128 mg/kg body weight/d. Rats fed Calcium Carbonate at 300 mg/kg for 3 d had no indication of toxicity, and the same was true for Calcium Carbonate (nano form) at oral doses up to 1000 mg/ kg body weight/day for 14 d. There were no test substance- related changes in rats fed doses up to 4228.5 mg/kg body weight/d ammonium chloride for 28 d. In repeated dose oral toxicity studies (4-wk, 13-wk, 18-mo, and 30-mo studies) of Potassium Bicarbonate (2% or 4% in diet), most of the histopathological changes observed were considered equally dist...","page":22,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_008"}
CIR_vision_codex NOAEL =4128 mg/kg body weight/d rat oral 14 d repeated dose toxicity {"citation":"14; 3; 28","dose":"A NOAEL of 1000 mg/kg body weight/day was reported in a study in which male and female rats received oral doses of magnesium chloride hexahydrate for 14 d pre-mating and 14 d of mating.","effect":"orted for Ammonium Bicarbonate and Ammonium Carbonate, respectively, in studies involving albino rats. A NOAEL of 1000 mg/kg body weight/day was reported in a study in which male and female rats received oral doses of magnesium chloride hexahydrate for 14 d pre-mating and 14 d of mating. The same results were reported for female rats dosed orally during gestation and up to PND 3 and for male rats dosed orally for 28 to 29 d. Based on the results of the preceding 2 experiments, it was determined that the equivalent NOAEL for Magnesium Carbonate was 4128 mg/kg body weight/d. Rats fed Calcium Carbonate at 300 mg/kg for 3 d had no indication of toxicity, and the same was true for Calcium Carbonate (nano form) at oral doses up to 1000 mg/ kg body weight/day for 14 d. There were no test substance- related changes in rats fed doses up to 4228.5 mg/kg body weight/d ammonium chloride for 28 d. In repeated dose oral toxicity studies (4-wk, 13-wk, 18-mo, and 30-mo studies) of Potassium Bicarbonate (2% or 4% in diet), most of the histopathological changes observed were considered equally dist...","page":22,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_008"}
CIR_vision_codex NOAEL =4128 mg/kg body weight/d rat oral 14 d repeated dose toxicity {"citation":"14; 3; 28","dose":"A NOAEL of 1000 mg/kg body weight/day was reported in a study in which male and female rats received oral doses of magnesium chloride hexahydrate for 14 d pre-mating and 14 d of mating.","effect":"orted for Ammonium Bicarbonate and Ammonium Carbonate, respectively, in studies involving albino rats. A NOAEL of 1000 mg/kg body weight/day was reported in a study in which male and female rats received oral doses of magnesium chloride hexahydrate for 14 d pre-mating and 14 d of mating. The same results were reported for female rats dosed orally during gestation and up to PND 3 and for male rats dosed orally for 28 to 29 d. Based on the results of the preceding 2 experiments, it was determined that the equivalent NOAEL for Magnesium Carbonate was 4128 mg/kg body weight/d. Rats fed Calcium Carbonate at 300 mg/kg for 3 d had no indication of toxicity, and the same was true for Calcium Carbonate (nano form) at oral doses up to 1000 mg/ kg body weight/day for 14 d. There were no test substance- related changes in rats fed doses up to 4228.5 mg/kg body weight/d ammonium chloride for 28 d. In repeated dose oral toxicity studies (4-wk, 13-wk, 18-mo, and 30-mo studies) of Potassium Bicarbonate (2% or 4% in diet), most of the histopathological changes observed were considered equally dist...","page":22,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_008"}
CIR_vision_codex NOAEL =4128 mg/kg body weight/d rat oral 14 d repeated dose toxicity {"citation":"14; 3; 28","dose":"A NOAEL of 1000 mg/kg body weight/day was reported in a study in which male and female rats received oral doses of magnesium chloride hexahydrate for 14 d pre-mating and 14 d of mating.","effect":"orted for Ammonium Bicarbonate and Ammonium Carbonate, respectively, in studies involving albino rats. A NOAEL of 1000 mg/kg body weight/day was reported in a study in which male and female rats received oral doses of magnesium chloride hexahydrate for 14 d pre-mating and 14 d of mating. The same results were reported for female rats dosed orally during gestation and up to PND 3 and for male rats dosed orally for 28 to 29 d. Based on the results of the preceding 2 experiments, it was determined that the equivalent NOAEL for Magnesium Carbonate was 4128 mg/kg body weight/d. Rats fed Calcium Carbonate at 300 mg/kg for 3 d had no indication of toxicity, and the same was true for Calcium Carbonate (nano form) at oral doses up to 1000 mg/ kg body weight/day for 14 d. There were no test substance- related changes in rats fed doses up to 4228.5 mg/kg body weight/d ammonium chloride for 28 d. In repeated dose oral toxicity studies (4-wk, 13-wk, 18-mo, and 30-mo studies) of Potassium Bicarbonate (2% or 4% in diet), most of the histopathological changes observed were considered equally dist...","page":22,"pdf":"PRS722.pdf","row_type":"noael_study","study_id":"PRS722_noael_008"}
NTP_ICE_acute_oral 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP_ICE_acute_oral LD50 >2000 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_7536; row=7947; data_type=In Vivo; mixture=Chemical; chemical_name=Magnesium carbonate (1:1); preferred_name=Magnesium carbonate (1:1); dtxsid=DTXSID4049660; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID4049660; source_file=acute_oral.xlsx
UnifiedCodex:CIR:beta.noael_studies 10 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:CIR:beta.noael_studies - 290 mg/kg body weight/d - - - - SOURCE_SUBDIR=PRS722; REPORT_TITLE=Safety Assessment of Carbonate Salts 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†, Paul W. Snyder; OPINION_NUMBER=PRS722; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=290; DOSE=The no- observed-effect-level (NOEL) for maternal toxicity was 290 mg/kg body weight/d (i.e., the highest dose tested).; EFFECT=tion sites, live and dead fetuses, and body weights of live pups. The urogenital tract of each dam was examined in detail for anatomical normality. All of the fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetuses in each litter were subjected to detailed visceral ex- aminations, and the remaining two-thirds were examined for skeletal defects. There were no effects on mortality, body weight gain, or the urogenital tracts of dams. The no- observed-effect-level (NOEL) for maternal toxicity was 290 mg/kg body weight/d (i.e., the highest dose tested). There were no effects on any of the following: numbers of corpora 92S International Journal of Toxicology 41(Supplement 1); CITATION=290; 41; 1); CITATION_NUMBERS=[290,41,1]; REFERENCE=290; 41; 1); DETAILS_JSON={"cas_number":"546-93-0","citation":"290; 41; 1)","dose":"The no- observed-effect-level (NOEL) for maternal toxicity was 290 mg/kg body weight/d (i.e., the highest dose tested).","duration":"","effect":"tion sites, live and dead fetuses, and body weights of live pups. The urogenital tract of each dam was examined in detail for anatomical normality. All of the fetuses were examined grossly for the presence of external congenital abnormalities. One-third of the fetuses in each litter were subjected to detailed visceral ex- aminations, and the remaining two-thirds were examined for skeletal defects. There were no effects on mortality, body weight gain, or the urogenital tracts of dams. The no- observed-effect-level (NOEL) for maternal toxicity was 290 mg/kg body weight/d (i.e., the highest dose tested). There were no effects on any of the following: numbers of corpora 92S International Journal of Toxicology 41(Supplement 1)","endpoint":"","ingredient":"Carbonate Salts","loael_value":"","noael_unit":"mg/kg body weight/d","noael_value":"290","page":13,"route":"","species":"","study_id":"PRS722_noael_007"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 1.25 % rat oral 62-d developmental toxicity SOURCE_SUBDIR=PRS722; REPORT_TITLE=Safety Assessment of Carbonate Salts 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†, Paul W. Snyder; OPINION_NUMBER=PRS722; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=1.25; DOSE=g/kg body weight/d; the equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d.; EFFECT=g/kg body weight/d; the equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Female Swiss mice were bred after feeding with a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate. Calcium Carbonate (2%) in the diet caused hypertrophy of the heart and decreased thymus weight in weanling mice. In a reproductive toxicity study, rats were fed oral doses of Cal- cium Carbonate (nano form) up to 1000 mg/kg body weight/d for 48 consecutive days. The maximum dose administered was the NOEL in this study. In a 62-d developmental toxicity study, rats were fed Calcium Carbonate at concentrations up to 1.25% in the diet, and the NOAEL for teratogenicity was determined to be >1.25% in the diet. There was no evidence of embryotoxicity or teratogenicity in the offspring of rats dosed orally with sodium bicarbonate (up to 340 mg/kg body weight) on gestation days 6 through 15. In another study on sodium bicarbonate, there were no test substance-related abnormalities in the offspring of rats that received sodium bicarbonate at concentrations of 0.5% and 2% (in...; CITATION=331; 0; 5; CITATION_NUMBERS=[331,5]; REFERENCE=331; 0; 5; DETAILS_JSON={"cas_number":"546-93-0","citation":"331; 0; 5","dose":"g/kg body weight/d; the equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d.","duration":"62-d","effect":"g/kg body weight/d; the equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Female Swiss mice were bred after feeding with a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate. Calcium Carbonate (2%) in the diet caused hypertrophy of the heart and decreased thymus weight in weanling mice. In a reproductive toxicity study, rats were fed oral doses of Cal- cium Carbonate (nano form) up to 1000 mg/kg body weight/d for 48 consecutive days. The maximum dose administered was the NOEL in this study. In a 62-d developmental toxicity study, rats were fed Calcium Carbonate at concentrations up to 1.25% in the diet, and the NOAEL for teratogenicity was determined to be >1.25% in the diet. There was no evidence of embryotoxicity or teratogenicity in the offspring of rats dosed orally with sodium bicarbonate (up to 340 mg/kg body weight) on gestation days 6 through 15. In another study on sodium bicarbonate, there were no test substance-related abnormalities in the offspring of rats that received sodium bicarbonate at concentrations of 0.5% and 2% (in...","endpoint":"developmental toxicity","ingredient":"Carbonate Salts","loael_value":"","noael_unit":"%","noael_value":"1.25","page":23,"route":"oral","species":"rat","study_id":"PRS722_noael_009"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity >1.25 % rat oral 62-d developmental toxicity SOURCE_SUBDIR=PRS722; REPORT_TITLE=Safety Assessment of Carbonate Salts 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†, Paul W. Snyder; OPINION_NUMBER=PRS722; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=> 1.25; DOSE=In a reproductive toxicity study, rats were fed oral doses of Cal- cium Carbonate (nano form) up to 1000 mg/kg body weight/d for 48 consecutive days.; EFFECT=er feeding with a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate. Calcium Carbonate (2%) in the diet caused hypertrophy of the heart and decreased thymus weight in weanling mice. In a reproductive toxicity study, rats were fed oral doses of Cal- cium Carbonate (nano form) up to 1000 mg/kg body weight/d for 48 consecutive days. The maximum dose administered was the NOEL in this study. In a 62-d developmental toxicity study, rats were fed Calcium Carbonate at concentrations up to 1.25% in the diet, and the NOAEL for teratogenicity was determined to be >1.25% in the diet. There was no evidence of embryotoxicity or teratogenicity in the offspring of rats dosed orally with sodium bicarbonate (up to 340 mg/kg body weight) on gestation days 6 through 15. In another study on sodium bicarbonate, there were no test substance-related abnormalities in the offspring of rats that received sodium bicarbonate at concentrations of 0.5% and 2% (in drinking water) on gestation days 15 through 20. The number of abnormalities observed in soft or skeletal tissues in groups of mice that receiv...; CITATION=0; 5; 1; CITATION_NUMBERS=[5,1]; REFERENCE=0; 5; 1; DETAILS_JSON={"cas_number":"546-93-0","citation":"0; 5; 1","dose":"In a reproductive toxicity study, rats were fed oral doses of Cal- cium Carbonate (nano form) up to 1000 mg/kg body weight/d for 48 consecutive days.","duration":"62-d","effect":"er feeding with a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate. Calcium Carbonate (2%) in the diet caused hypertrophy of the heart and decreased thymus weight in weanling mice. In a reproductive toxicity study, rats were fed oral doses of Cal- cium Carbonate (nano form) up to 1000 mg/kg body weight/d for 48 consecutive days. The maximum dose administered was the NOEL in this study. In a 62-d developmental toxicity study, rats were fed Calcium Carbonate at concentrations up to 1.25% in the diet, and the NOAEL for teratogenicity was determined to be >1.25% in the diet. There was no evidence of embryotoxicity or teratogenicity in the offspring of rats dosed orally with sodium bicarbonate (up to 340 mg/kg body weight) on gestation days 6 through 15. In another study on sodium bicarbonate, there were no test substance-related abnormalities in the offspring of rats that received sodium bicarbonate at concentrations of 0.5% and 2% (in drinking water) on gestation days 15 through 20. The number of abnormalities observed in soft or skeletal tissues in groups of mice that receiv...","endpoint":"developmental toxicity","ingredient":"Carbonate Salts","loael_value":"","noael_unit":"%","noael_value":"> 1.25","page":23,"route":"oral","species":"rat","study_id":"PRS722_noael_010"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 414 mg/kg body weight/d rat oral 29 d developmental toxicity SOURCE_SUBDIR=PRS722; REPORT_TITLE=Safety Assessment of Carbonate Salts 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†, Paul W. Snyder; OPINION_NUMBER=PRS722; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=414; DOSE=so administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d.; EFFECT=so administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d. There were no treatment-related mortalities or major toxicological findings. There were no remarkable clinical signs or effects on hematology or clinical chemistry. The same was true for necropsy and histopathological findings relating to non-reproductive organs. It was concluded that the NOAEL for magnesium chloride hexahydrate was 1000 mg/kg body weight/d. Furthermore, it was determined that the equivalent NOAEL for Magnesium Carbonate was 414 mg/kg body weight/d. Results relating to toxic effects of magnesium chloride hexahydrate on reproductive organs are included in the section on Developmental and Reproductive Toxicity. Calcium Carbonate Five rats were fed [45Ca]labeled Calcium Carbonate (0.3 g/kg body weight) in feed for 3 d.24 The strain of rats tested was not identified. All of the animals remained healthy. The oral toxicity of Calcium Carbonate (nano form) was evaluated in a 14-d study using groups of 6 (3 male, 3 female) Wistar rats.26 The 4 groups consisted of th...; CITATION=3; 28; 29; CITATION_NUMBERS=[3,28,29]; REFERENCE=3; 28; 29; DETAILS_JSON={"cas_number":"546-93-0","citation":"3; 28; 29","dose":"so administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d.","duration":"29 d","effect":"so administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d. There were no treatment-related mortalities or major toxicological findings. There were no remarkable clinical signs or effects on hematology or clinical chemistry. The same was true for necropsy and histopathological findings relating to non-reproductive organs. It was concluded that the NOAEL for magnesium chloride hexahydrate was 1000 mg/kg body weight/d. Furthermore, it was determined that the equivalent NOAEL for Magnesium Carbonate was 414 mg/kg body weight/d. Results relating to toxic effects of magnesium chloride hexahydrate on reproductive organs are included in the section on Developmental and Reproductive Toxicity. Calcium Carbonate Five rats were fed [45Ca]labeled Calcium Carbonate (0.3 g/kg body weight) in feed for 3 d.24 The strain of rats tested was not identified. All of the animals remained healthy. The oral toxicity of Calcium Carbonate (nano form) was evaluated in a 14-d study using groups of 6 (3 male, 3 female) Wistar rats.26 The 4 groups consisted of th...","endpoint":"developmental toxicity","ingredient":"Carbonate Salts","loael_value":"","noael_unit":"mg/kg body weight/d","noael_value":"414","page":10,"route":"oral","species":"rat","study_id":"PRS722_noael_002"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 1000 mg/kg body weight/d rat oral 14 d developmental toxicity SOURCE_SUBDIR=PRS722; REPORT_TITLE=Safety Assessment of Carbonate Salts 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†, Paul W. Snyder; OPINION_NUMBER=PRS722; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=1000; DOSE=The test substance was also administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d.; EFFECT=istered orally (by gavage) to males and females daily during 14 d pre-mating and 14 d of mating. The test substance was also administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d. There were no treatment-related mortalities or major toxicological findings. There were no remarkable clinical signs or effects on hematology or clinical chemistry. The same was true for necropsy and histopathological findings relating to non-reproductive organs. It was concluded that the NOAEL for magnesium chloride hexahydrate was 1000 mg/kg body weight/d. Furthermore, it was determined that the equivalent NOAEL for Magnesium Carbonate was 414 mg/kg body weight/d. Results relating to toxic effects of magnesium chloride hexahydrate on reproductive organs are included in the section on Developmental and Reproductive Toxicity. Calcium Carbonate Five rats were fed [45Ca]labeled Calcium Carbonate (0.3 g/kg body weight) in feed for 3 d.24 The strain of rats tested was not identified. All of the animals remained healthy. The oral toxicity of Calcium Carbonate...; CITATION=14; 3; 28; CITATION_NUMBERS=[14,3,28]; REFERENCE=14; 3; 28; DETAILS_JSON={"cas_number":"546-93-0","citation":"14; 3; 28","dose":"The test substance was also administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d.","duration":"14 d","effect":"istered orally (by gavage) to males and females daily during 14 d pre-mating and 14 d of mating. The test substance was also administered to females during ges- tation and up to postnatal day (PND) 3, and to males for 28 to 29 d. There were no treatment-related mortalities or major toxicological findings. There were no remarkable clinical signs or effects on hematology or clinical chemistry. The same was true for necropsy and histopathological findings relating to non-reproductive organs. It was concluded that the NOAEL for magnesium chloride hexahydrate was 1000 mg/kg body weight/d. Furthermore, it was determined that the equivalent NOAEL for Magnesium Carbonate was 414 mg/kg body weight/d. Results relating to toxic effects of magnesium chloride hexahydrate on reproductive organs are included in the section on Developmental and Reproductive Toxicity. Calcium Carbonate Five rats were fed [45Ca]labeled Calcium Carbonate (0.3 g/kg body weight) in feed for 3 d.24 The strain of rats tested was not identified. All of the animals remained healthy. The oral toxicity of Calcium Carbonate...","endpoint":"developmental toxicity","ingredient":"Carbonate Salts","loael_value":"","noael_unit":"mg/kg body weight/d","noael_value":"1000","page":10,"route":"oral","species":"rat","study_id":"PRS722_noael_001"}
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 1963 mg/kg body weight mouse oral - developmental toxicity SOURCE_SUBDIR=PRS722; REPORT_TITLE=Safety Assessment of Carbonate Salts 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†, Paul W. Snyder; OPINION_NUMBER=PRS722; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=between 1963 and 2188; DOSE=There were no dose-related changes in the average number of implantations, resorptions and viable fe- tuses, or fetal length or weight.; EFFECT=There was no evidence of test substance-related maternal toxicity or embryotoxic/ teratogenic effects. There were no dose-related changes in the average number of implantations, resorptions and viable fe- tuses, or fetal length or weight. When compared to the control group, there were no statistically significant increases in the litter incidence regarding specific external, visceral, or skeletal variations of the fetuses. The NOAEC for teratogenicity was >1.25% Calcium Carbonate in the diet and corresponded to a NOAEL between 1963 and 2188 mg/kg body weight per day. Potassium Carbonate The teratogenicity of Potassium Carbonate was evaluated using groups of 22 to 25 CD-1 mice, according to a protocol similar to OECD Test Guideline 414.28,38 The test substance was administered, by gavage, at doses of 0, 2.9, 13.5, 62.5, or 290 mg/kg body weight/d, on gestation days 6 through 15. On day 17, Caesarean section was performed on all of the dams, and the following information was recorded: sex, numbers of corpora lutea, implantation sites, resorption sites, live and dead fetuses, and bod...; CITATION=1; 25; 22; CITATION_NUMBERS=[1,25,22]; REFERENCE=1; 25; 22; DETAILS_JSON={"cas_number":"546-93-0","citation":"1; 25; 22","dose":"There were no dose-related changes in the average number of implantations, resorptions and viable fe- tuses, or fetal length or weight.","duration":"","effect":"There was no evidence of test substance-related maternal toxicity or embryotoxic/ teratogenic effects. There were no dose-related changes in the average number of implantations, resorptions and viable fe- tuses, or fetal length or weight. When compared to the control group, there were no statistically significant increases in the litter incidence regarding specific external, visceral, or skeletal variations of the fetuses. The NOAEC for teratogenicity was >1.25% Calcium Carbonate in the diet and corresponded to a NOAEL between 1963 and 2188 mg/kg body weight per day. Potassium Carbonate The teratogenicity of Potassium Carbonate was evaluated using groups of 22 to 25 CD-1 mice, according to a protocol similar to OECD Test Guideline 414.28,38 The test substance was administered, by gavage, at doses of 0, 2.9, 13.5, 62.5, or 290 mg/kg body weight/d, on gestation days 6 through 15. On day 17, Caesarean section was performed on all of the dams, and the following information was recorded: sex, numbers of corpora lutea, implantation sites, resorption sites, live and dead fetuses, and bod...","endpoint":"developmental toxicity","ingredient":"Carbonate Salts","loael_value":"","noael_unit":"mg/kg body weight","noael_value":"between 1963 and 2188","page":13,"route":"oral","species":"mouse","study_id":"PRS722_noael_006"}
UnifiedCodex:CIR:beta.noael_studies inhalation toxicity <684 mg/kg body weight/d rat inhalation - inhalation toxicity SOURCE_SUBDIR=PRS722; REPORT_TITLE=Safety Assessment of Carbonate Salts 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†, Paul W. Snyder; OPINION_NUMBER=PRS722; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=< 684; DOSE=The NOEL for ammonium chloride was <684 mg/kg body weight/d.; EFFECT=copic examinations of the bladder were performed. There were no significant differences in food consumption among the 3 groups. The difference also was not significant when animals fed ammonium chloride were compared to the negative control group. Body weight was significantly decreased in the positive control group. Gross and microscopic examination results were negative for animals fed ammonium chloride and for the negative control group. Hyperplasia of the bladder was observed in the positive control group. The NOEL for ammonium chloride was <684 mg/kg body weight/d. Inhalation Potassium Carbonate. The potential for short-term toxicity and neurotoxicity of a Potassium Carbonate-based scrubbing so- lution (containing 30.8% (w/v) Potassium Carbonate) used in petroleum refineries was evaluated in Sprague-Dawley Crl: CD BR rats.35 Inhalation exposures were to aerosols of a “used” scrubbing solution in a whole-body exposure chamber, 6 h/d for 21 consecutive days at target concentrations of 0 (filtered air—control), 0.1, 0.2, or 0.4 mg/l (30 animals/sex/ group). Five rats per sex per...; CITATION=3; 684; 30; CITATION_NUMBERS=[3,684,30]; REFERENCE=3; 684; 30; DETAILS_JSON={"cas_number":"546-93-0","citation":"3; 684; 30","dose":"The NOEL for ammonium chloride was <684 mg/kg body weight/d.","duration":"","effect":"copic examinations of the bladder were performed. There were no significant differences in food consumption among the 3 groups. The difference also was not significant when animals fed ammonium chloride were compared to the negative control group. Body weight was significantly decreased in the positive control group. Gross and microscopic examination results were negative for animals fed ammonium chloride and for the negative control group. Hyperplasia of the bladder was observed in the positive control group. The NOEL for ammonium chloride was <684 mg/kg body weight/d. Inhalation Potassium Carbonate. The potential for short-term toxicity and neurotoxicity of a Potassium Carbonate-based scrubbing so- lution (containing 30.8% (w/v) Potassium Carbonate) used in petroleum refineries was evaluated in Sprague-Dawley Crl: CD BR rats.35 Inhalation exposures were to aerosols of a “used” scrubbing solution in a whole-body exposure chamber, 6 h/d for 21 consecutive days at target concentrations of 0 (filtered air—control), 0.1, 0.2, or 0.4 mg/l (30 animals/sex/ group). Five rats per sex per...","endpoint":"inhalation toxicity","ingredient":"Carbonate Salts","loael_value":"","noael_unit":"mg/kg body weight/d","noael_value":"< 684","page":11,"route":"inhalation","species":"rat","study_id":"PRS722_noael_003"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity >331 mg/kg body weight/d rat oral - oral toxicity SOURCE_SUBDIR=PRS722; REPORT_TITLE=Safety Assessment of Carbonate Salts 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†, Paul W. Snyder; OPINION_NUMBER=PRS722; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=> 331; DOSE=bserved in one fetus of the 800 mg/kg/d dose group.; EFFECT=bserved in one fetus of the 800 mg/kg/d dose group. There were no intergroup differences in bone abnormality, effects on lumbocostale, extra ribs, sacrococcygea, metacarpal bone, or its ossification. Visceral malformations were ob- served in 4 to 6 fetuses from each dose group, but without intergroup differences. It was concluded that magnesium chloride hexahydrate was not teratogenic in rats dosed by gavage. The NOAEL was estimated to be >800 mg/kg body weight/d for pregnant rats and their fetuses. The equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Calcium Carbonate Female Swiss mice were bred after being fed (number of animals/feeding duration not stated) a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate.24 First and second litters were studied. Calcium Carbonate (1% and 2% in diet) yielded an intake of approximately 3000 mg/kg body weight. When compared to the control diet, feeding with the supplemented diet significantly decreased the number and total weight of the weanling mice, and increased the proportion of deaths. Cal- ciu...; CITATION=800; 4; 6; CITATION_NUMBERS=[800,4,6]; REFERENCE=800; 4; 6; DETAILS_JSON={"cas_number":"546-93-0","citation":"800; 4; 6","dose":"bserved in one fetus of the 800 mg/kg/d dose group.","duration":"","effect":"bserved in one fetus of the 800 mg/kg/d dose group. There were no intergroup differences in bone abnormality, effects on lumbocostale, extra ribs, sacrococcygea, metacarpal bone, or its ossification. Visceral malformations were ob- served in 4 to 6 fetuses from each dose group, but without intergroup differences. It was concluded that magnesium chloride hexahydrate was not teratogenic in rats dosed by gavage. The NOAEL was estimated to be >800 mg/kg body weight/d for pregnant rats and their fetuses. The equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Calcium Carbonate Female Swiss mice were bred after being fed (number of animals/feeding duration not stated) a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate.24 First and second litters were studied. Calcium Carbonate (1% and 2% in diet) yielded an intake of approximately 3000 mg/kg body weight. When compared to the control diet, feeding with the supplemented diet significantly decreased the number and total weight of the weanling mice, and increased the proportion of deaths. Cal- ciu...","endpoint":"oral toxicity","ingredient":"Carbonate Salts","loael_value":"","noael_unit":"mg/kg body weight/d","noael_value":"> 331","page":13,"route":"oral","species":"rat","study_id":"PRS722_noael_005"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity >800 mg/kg body weight/d rat oral - oral toxicity SOURCE_SUBDIR=PRS722; REPORT_TITLE=Safety Assessment of Carbonate Salts 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†, Paul W. Snyder; OPINION_NUMBER=PRS722; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=> 800; DOSE=mation was observed in the dose groups, but without any intergroup differences.; EFFECT=mation was observed in the dose groups, but without any intergroup differences. Bone malformation was observed in one fetus of the 800 mg/kg/d dose group. There were no intergroup differences in bone abnormality, effects on lumbocostale, extra ribs, sacrococcygea, metacarpal bone, or its ossification. Visceral malformations were ob- served in 4 to 6 fetuses from each dose group, but without intergroup differences. It was concluded that magnesium chloride hexahydrate was not teratogenic in rats dosed by gavage. The NOAEL was estimated to be >800 mg/kg body weight/d for pregnant rats and their fetuses. The equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Calcium Carbonate Female Swiss mice were bred after being fed (number of animals/feeding duration not stated) a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate.24 First and second litters were studied. Calcium Carbonate (1% and 2% in diet) yielded an intake of approximately 3000 mg/kg body weight. When compared to the control diet, feeding with the supplemented diet significantly decre...; CITATION=800; 4; 6; CITATION_NUMBERS=[800,4,6]; REFERENCE=800; 4; 6; DETAILS_JSON={"cas_number":"546-93-0","citation":"800; 4; 6","dose":"mation was observed in the dose groups, but without any intergroup differences.","duration":"","effect":"mation was observed in the dose groups, but without any intergroup differences. Bone malformation was observed in one fetus of the 800 mg/kg/d dose group. There were no intergroup differences in bone abnormality, effects on lumbocostale, extra ribs, sacrococcygea, metacarpal bone, or its ossification. Visceral malformations were ob- served in 4 to 6 fetuses from each dose group, but without intergroup differences. It was concluded that magnesium chloride hexahydrate was not teratogenic in rats dosed by gavage. The NOAEL was estimated to be >800 mg/kg body weight/d for pregnant rats and their fetuses. The equivalent NOAEL for Magnesium Carbonate was determined to be >331 mg/kg body weight/d. Calcium Carbonate Female Swiss mice were bred after being fed (number of animals/feeding duration not stated) a diet supplemented with 0.5%, 1%, or 2% Calcium Carbonate.24 First and second litters were studied. Calcium Carbonate (1% and 2% in diet) yielded an intake of approximately 3000 mg/kg body weight. When compared to the control diet, feeding with the supplemented diet significantly decre...","endpoint":"oral toxicity","ingredient":"Carbonate Salts","loael_value":"","noael_unit":"mg/kg body weight/d","noael_value":"> 800","page":13,"route":"oral","species":"rat","study_id":"PRS722_noael_004"}
UnifiedCodex:CIR:beta.noael_studies repeated dose toxicity 4128 mg/kg body weight/d rat oral 14 d repeated dose toxicity SOURCE_SUBDIR=PRS722; REPORT_TITLE=Safety Assessment of Carbonate Salts 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†, Paul W. Snyder; OPINION_NUMBER=PRS722; COMMITTEE=Expert Panel for Cosmetic Ingredient Safety; REPORT_DATE=Toxicology 2022; VALUE_TEXT=4128; DOSE=A NOAEL of 1000 mg/kg body weight/day was reported in a study in which male and female rats received oral doses of magnesium chloride hexahydrate for 14 d pre-mating and 14 d of mating.; EFFECT=orted for Ammonium Bicarbonate and Ammonium Carbonate, respectively, in studies involving albino rats. A NOAEL of 1000 mg/kg body weight/day was reported in a study in which male and female rats received oral doses of magnesium chloride hexahydrate for 14 d pre-mating and 14 d of mating. The same results were reported for female rats dosed orally during gestation and up to PND 3 and for male rats dosed orally for 28 to 29 d. Based on the results of the preceding 2 experiments, it was determined that the equivalent NOAEL for Magnesium Carbonate was 4128 mg/kg body weight/d. Rats fed Calcium Carbonate at 300 mg/kg for 3 d had no indication of toxicity, and the same was true for Calcium Carbonate (nano form) at oral doses up to 1000 mg/ kg body weight/day for 14 d. There were no test substance- related changes in rats fed doses up to 4228.5 mg/kg body weight/d ammonium chloride for 28 d. In repeated dose oral toxicity studies (4-wk, 13-wk, 18-mo, and 30-mo studies) of Potassium Bicarbonate (2% or 4% in diet), most of the histopathological changes observed were considered equally dist...; CITATION=14; 3; 28; CITATION_NUMBERS=[14,3,28]; REFERENCE=14; 3; 28; DETAILS_JSON={"cas_number":"546-93-0","citation":"14; 3; 28","dose":"A NOAEL of 1000 mg/kg body weight/day was reported in a study in which male and female rats received oral doses of magnesium chloride hexahydrate for 14 d pre-mating and 14 d of mating.","duration":"14 d","effect":"orted for Ammonium Bicarbonate and Ammonium Carbonate, respectively, in studies involving albino rats. A NOAEL of 1000 mg/kg body weight/day was reported in a study in which male and female rats received oral doses of magnesium chloride hexahydrate for 14 d pre-mating and 14 d of mating. The same results were reported for female rats dosed orally during gestation and up to PND 3 and for male rats dosed orally for 28 to 29 d. Based on the results of the preceding 2 experiments, it was determined that the equivalent NOAEL for Magnesium Carbonate was 4128 mg/kg body weight/d. Rats fed Calcium Carbonate at 300 mg/kg for 3 d had no indication of toxicity, and the same was true for Calcium Carbonate (nano form) at oral doses up to 1000 mg/ kg body weight/day for 14 d. There were no test substance- related changes in rats fed doses up to 4228.5 mg/kg body weight/d ammonium chloride for 28 d. In repeated dose oral toxicity studies (4-wk, 13-wk, 18-mo, and 30-mo studies) of Potassium Bicarbonate (2% or 4% in diet), most of the histopathological changes observed were considered equally dist...","endpoint":"repeated dose toxicity","ingredient":"Carbonate Salts","loael_value":"","noael_unit":"mg/kg body weight/d","noael_value":"4128","page":22,"route":"oral","species":"rat","study_id":"PRS722_noael_008"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier 0IHC698356 UNII - - - chemical {"approval_status":null,"molecular_formula":"CO3.Mg","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0IHC698356"}
openFDA substances FDA UNII substance identifier 0IHC698356 UNII - - - chemical {"approval_status":null,"molecular_formula":"CO3.Mg","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0IHC698356"}
openFDA substances FDA UNII substance identifier 0IHC698356 UNII - - - chemical {"approval_status":null,"molecular_formula":"CO3.Mg","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0IHC698356"}
openFDA substances FDA UNII substance identifier 0IHC698356 UNII - - - chemical {"approval_status":null,"molecular_formula":"CO3.Mg","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"0IHC698356"}