NOAEL Studies Cosmetic Ingredient

Cyamopsis Tetragonoloba Gum NOAEL Studies

INCI: CYAMOPSIS TETRAGONOLOBA GUM

CAS: 9000-30-0

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 12 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
CIR Safety Assessment NOAEL =0 ppm rat oral 6 weeks developmental toxicity {"citation":"50; 000; (5","dose":"Based on the results from this study and the preceding study, the NOAEL was considered to be >50 000 ppm (5%) in the diet.92 Cassia gum.","effect":"d not reveal any abnormalities that were related to gum administration. There was no evidence of test substance- related abnormalities after external, visceral, and skeletal examinations of fetuses were performed. Additionally, there were no differences in the sex ratios of fetuses or statistically significant differences in fetal body weights. It was concluded that C spinosa gum did not induce maternal toxicity, embry- otoxicity, or teratogenicity. Based on the results from this study and the preceding study, the NOAEL was considered to be >50 000 ppm (5%) in the diet.92 Cassia gum. In a 2-generation reproductive toxicity study (OECD Test Guideline 416), semirefined cassia gum was administered to groups of 25 female Ico: OFA.SD Sprague- Dawley rats (6 weeks old) at dietary concentrations of 0, 5000, 20 000, or 50 000 mg/kg.93 An additional group was fed a diet containing purified semirefined cassia gum (which resulted from an additional isopropano extraction step) at a dose of 50 000 mg/kg. Parental animals were dosed for approx- imately 10 weeks prior to mating and during mating...","page":21,"pdf":"PRS600.pdf","row_type":"noael_study","study_id":"PRS600_noael_002"}
CIR Safety Assessment NOAEL =0 ppm rat oral 6 weeks developmental toxicity {"citation":"50; 000; (5","dose":"Based on the results from this study and the preceding study, the NOAEL was considered to be >50 000 ppm (5%) in the diet.92 Cassia gum.","effect":"d not reveal any abnormalities that were related to gum administration. There was no evidence of test substance- related abnormalities after external, visceral, and skeletal examinations of fetuses were performed. Additionally, there were no differences in the sex ratios of fetuses or statistically significant differences in fetal body weights. It was concluded that C spinosa gum did not induce maternal toxicity, embry- otoxicity, or teratogenicity. Based on the results from this study and the preceding study, the NOAEL was considered to be >50 000 ppm (5%) in the diet.92 Cassia gum. In a 2-generation reproductive toxicity study (OECD Test Guideline 416), semirefined cassia gum was administered to groups of 25 female Ico: OFA.SD Sprague- Dawley rats (6 weeks old) at dietary concentrations of 0, 5000, 20 000, or 50 000 mg/kg.93 An additional group was fed a diet containing purified semirefined cassia gum (which resulted from an additional isopropano extraction step) at a dose of 50 000 mg/kg. Parental animals were dosed for approx- imately 10 weeks prior to mating and during mating...","page":21,"pdf":"PRS600.pdf","row_type":"noael_study","study_id":"PRS600_noael_002"}
CIR Safety Assessment NOAEL =0 ppm rat oral 6 weeks developmental toxicity {"citation":"50; 000; (5","dose":"Based on the results from this study and the preceding study, the NOAEL was considered to be >50 000 ppm (5%) in the diet.92 Cassia gum.","effect":"d not reveal any abnormalities that were related to gum administration. There was no evidence of test substance- related abnormalities after external, visceral, and skeletal examinations of fetuses were performed. Additionally, there were no differences in the sex ratios of fetuses or statistically significant differences in fetal body weights. It was concluded that C spinosa gum did not induce maternal toxicity, embry- otoxicity, or teratogenicity. Based on the results from this study and the preceding study, the NOAEL was considered to be >50 000 ppm (5%) in the diet.92 Cassia gum. In a 2-generation reproductive toxicity study (OECD Test Guideline 416), semirefined cassia gum was administered to groups of 25 female Ico: OFA.SD Sprague- Dawley rats (6 weeks old) at dietary concentrations of 0, 5000, 20 000, or 50 000 mg/kg.93 An additional group was fed a diet containing purified semirefined cassia gum (which resulted from an additional isopropano extraction step) at a dose of 50 000 mg/kg. Parental animals were dosed for approx- imately 10 weeks prior to mating and during mating...","page":21,"pdf":"PRS600.pdf","row_type":"noael_study","study_id":"PRS600_noael_002"}
CIR Safety Assessment NOAEL =0 ppm rat oral 6 weeks developmental toxicity {"citation":"50; 000; (5","dose":"Based on the results from this study and the preceding study, the NOAEL was considered to be >50 000 ppm (5%) in the diet.92 Cassia gum.","effect":"d not reveal any abnormalities that were related to gum administration. There was no evidence of test substance- related abnormalities after external, visceral, and skeletal examinations of fetuses were performed. Additionally, there were no differences in the sex ratios of fetuses or statistically significant differences in fetal body weights. It was concluded that C spinosa gum did not induce maternal toxicity, embry- otoxicity, or teratogenicity. Based on the results from this study and the preceding study, the NOAEL was considered to be >50 000 ppm (5%) in the diet.92 Cassia gum. In a 2-generation reproductive toxicity study (OECD Test Guideline 416), semirefined cassia gum was administered to groups of 25 female Ico: OFA.SD Sprague- Dawley rats (6 weeks old) at dietary concentrations of 0, 5000, 20 000, or 50 000 mg/kg.93 An additional group was fed a diet containing purified semirefined cassia gum (which resulted from an additional isopropano extraction step) at a dose of 50 000 mg/kg. Parental animals were dosed for approx- imately 10 weeks prior to mating and during mating...","page":21,"pdf":"PRS600.pdf","row_type":"noael_study","study_id":"PRS600_noael_002"}
CIR Safety Assessment NOAEL =1 g/kg/d rat oral 90 days repeated dose toxicity {"citation":"54; 2; 4","dose":"An no-observable-adverse-effect-level (NOAEL) of 1000 mg/kg body weight was reported for cassia gum in rats.","effect":"ys.54 There were no treatment-related effects on the following: mortality, body weight gain, food consumption, food utilization, hemato- logical parameters, or various biochemical parameters (eg, albumin, cholesterol, and aspartate aminotransferase). Gross examination results were negative, and there were no treatment-related histopathologic changes or effects on weight in the following organs: liver, kidney, spleen, ovaries, and testes. There were also no histopathologic changes in the sto- mach or intestines. An no-observable-adverse-effect-level (NOAEL) of 1000 mg/kg body weight was reported for cassia gum in rats. Semirefined cassia gum (in dog food) was administered to 2 groups of 4 male and 4 female Beagle dogs at dietary doses of 1 and 3.5 g/kg/d, respectively, for 90 days.68 The control group received dog food without cassia gum; however, cassia gum was replaced by a substance with similar technological char- acteristics. A dose-related increase in water consumption was the only treatment-related effect noted but was not considered toxicologically significant. Hematologica...","page":17,"pdf":"PRS600.pdf","row_type":"noael_study","study_id":"PRS600_noael_001"}
CIR Safety Assessment NOAEL =1 g/kg/d rat oral 90 days repeated dose toxicity {"citation":"54; 2; 4","dose":"An no-observable-adverse-effect-level (NOAEL) of 1000 mg/kg body weight was reported for cassia gum in rats.","effect":"ys.54 There were no treatment-related effects on the following: mortality, body weight gain, food consumption, food utilization, hemato- logical parameters, or various biochemical parameters (eg, albumin, cholesterol, and aspartate aminotransferase). Gross examination results were negative, and there were no treatment-related histopathologic changes or effects on weight in the following organs: liver, kidney, spleen, ovaries, and testes. There were also no histopathologic changes in the sto- mach or intestines. An no-observable-adverse-effect-level (NOAEL) of 1000 mg/kg body weight was reported for cassia gum in rats. Semirefined cassia gum (in dog food) was administered to 2 groups of 4 male and 4 female Beagle dogs at dietary doses of 1 and 3.5 g/kg/d, respectively, for 90 days.68 The control group received dog food without cassia gum; however, cassia gum was replaced by a substance with similar technological char- acteristics. A dose-related increase in water consumption was the only treatment-related effect noted but was not considered toxicologically significant. Hematologica...","page":17,"pdf":"PRS600.pdf","row_type":"noael_study","study_id":"PRS600_noael_001"}
CIR Safety Assessment NOAEL =1 g/kg/d rat oral 90 days repeated dose toxicity {"citation":"54; 2; 4","dose":"An no-observable-adverse-effect-level (NOAEL) of 1000 mg/kg body weight was reported for cassia gum in rats.","effect":"ys.54 There were no treatment-related effects on the following: mortality, body weight gain, food consumption, food utilization, hemato- logical parameters, or various biochemical parameters (eg, albumin, cholesterol, and aspartate aminotransferase). Gross examination results were negative, and there were no treatment-related histopathologic changes or effects on weight in the following organs: liver, kidney, spleen, ovaries, and testes. There were also no histopathologic changes in the sto- mach or intestines. An no-observable-adverse-effect-level (NOAEL) of 1000 mg/kg body weight was reported for cassia gum in rats. Semirefined cassia gum (in dog food) was administered to 2 groups of 4 male and 4 female Beagle dogs at dietary doses of 1 and 3.5 g/kg/d, respectively, for 90 days.68 The control group received dog food without cassia gum; however, cassia gum was replaced by a substance with similar technological char- acteristics. A dose-related increase in water consumption was the only treatment-related effect noted but was not considered toxicologically significant. Hematologica...","page":17,"pdf":"PRS600.pdf","row_type":"noael_study","study_id":"PRS600_noael_001"}
CIR Safety Assessment NOAEL =1 g/kg/d rat oral 90 days repeated dose toxicity {"citation":"54; 2; 4","dose":"An no-observable-adverse-effect-level (NOAEL) of 1000 mg/kg body weight was reported for cassia gum in rats.","effect":"ys.54 There were no treatment-related effects on the following: mortality, body weight gain, food consumption, food utilization, hemato- logical parameters, or various biochemical parameters (eg, albumin, cholesterol, and aspartate aminotransferase). Gross examination results were negative, and there were no treatment-related histopathologic changes or effects on weight in the following organs: liver, kidney, spleen, ovaries, and testes. There were also no histopathologic changes in the sto- mach or intestines. An no-observable-adverse-effect-level (NOAEL) of 1000 mg/kg body weight was reported for cassia gum in rats. Semirefined cassia gum (in dog food) was administered to 2 groups of 4 male and 4 female Beagle dogs at dietary doses of 1 and 3.5 g/kg/d, respectively, for 90 days.68 The control group received dog food without cassia gum; however, cassia gum was replaced by a substance with similar technological char- acteristics. A dose-related increase in water consumption was the only treatment-related effect noted but was not considered toxicologically significant. Hematologica...","page":17,"pdf":"PRS600.pdf","row_type":"noael_study","study_id":"PRS600_noael_001"}
CIR Safety Assessment NOAEL =1000 mg/kg body weight rat oral - developmental toxicity {"citation":"50; 000; 12","dose":"These effects were observed at the highest dose level (both groups), and therefore, 50 000 mg/kg feed (equal to 5280 mg/kg body weight per day) was considered the no- observed-effect level NOEL.","effect":"These effects were observed at the highest dose level (both groups), and therefore, 50 000 mg/kg feed (equal to 5280 mg/kg body weight per day) was considered the no- observed-effect level NOEL. Groups of 12 pregnant female SD rats received oral doses of cassia gum (by gavage) at doses of 0, 250, 500, or 1000 mg/kg body weight per day on days 7 through 16 of gestation.54 There were no treatment-related effects on maternal body weight, the number of resorptions or dead embryos, or the weight and length of fetuses. Also, abnormalities were not observed at skeletal or visceral examination of the fetuses. Therefore, no adverse effects were observed in dams or offspring at doses up to and including 1000 mg/kg body weight per day. The developmental toxicity of semirefined cassia gum (in distilled water) was evaluated using grou","page":22,"pdf":"PRS600.pdf","row_type":"noael_study","study_id":"PRS600_noael_003"}
CIR Safety Assessment NOAEL =1000 mg/kg body weight rat oral - developmental toxicity {"citation":"50; 000; 12","dose":"These effects were observed at the highest dose level (both groups), and therefore, 50 000 mg/kg feed (equal to 5280 mg/kg body weight per day) was considered the no- observed-effect level NOEL.","effect":"These effects were observed at the highest dose level (both groups), and therefore, 50 000 mg/kg feed (equal to 5280 mg/kg body weight per day) was considered the no- observed-effect level NOEL. Groups of 12 pregnant female SD rats received oral doses of cassia gum (by gavage) at doses of 0, 250, 500, or 1000 mg/kg body weight per day on days 7 through 16 of gestation.54 There were no treatment-related effects on maternal body weight, the number of resorptions or dead embryos, or the weight and length of fetuses. Also, abnormalities were not observed at skeletal or visceral examination of the fetuses. Therefore, no adverse effects were observed in dams or offspring at doses up to and including 1000 mg/kg body weight per day. The developmental toxicity of semirefined cassia gum (in distilled water) was evaluated using grou","page":22,"pdf":"PRS600.pdf","row_type":"noael_study","study_id":"PRS600_noael_003"}
CIR Safety Assessment NOAEL =1000 mg/kg body weight rat oral - developmental toxicity {"citation":"50; 000; 12","dose":"These effects were observed at the highest dose level (both groups), and therefore, 50 000 mg/kg feed (equal to 5280 mg/kg body weight per day) was considered the no- observed-effect level NOEL.","effect":"These effects were observed at the highest dose level (both groups), and therefore, 50 000 mg/kg feed (equal to 5280 mg/kg body weight per day) was considered the no- observed-effect level NOEL. Groups of 12 pregnant female SD rats received oral doses of cassia gum (by gavage) at doses of 0, 250, 500, or 1000 mg/kg body weight per day on days 7 through 16 of gestation.54 There were no treatment-related effects on maternal body weight, the number of resorptions or dead embryos, or the weight and length of fetuses. Also, abnormalities were not observed at skeletal or visceral examination of the fetuses. Therefore, no adverse effects were observed in dams or offspring at doses up to and including 1000 mg/kg body weight per day. The developmental toxicity of semirefined cassia gum (in distilled water) was evaluated using grou","page":22,"pdf":"PRS600.pdf","row_type":"noael_study","study_id":"PRS600_noael_003"}
CIR Safety Assessment NOAEL =1000 mg/kg body weight rat oral - developmental toxicity {"citation":"50; 000; 12","dose":"These effects were observed at the highest dose level (both groups), and therefore, 50 000 mg/kg feed (equal to 5280 mg/kg body weight per day) was considered the no- observed-effect level NOEL.","effect":"These effects were observed at the highest dose level (both groups), and therefore, 50 000 mg/kg feed (equal to 5280 mg/kg body weight per day) was considered the no- observed-effect level NOEL. Groups of 12 pregnant female SD rats received oral doses of cassia gum (by gavage) at doses of 0, 250, 500, or 1000 mg/kg body weight per day on days 7 through 16 of gestation.54 There were no treatment-related effects on maternal body weight, the number of resorptions or dead embryos, or the weight and length of fetuses. Also, abnormalities were not observed at skeletal or visceral examination of the fetuses. Therefore, no adverse effects were observed in dams or offspring at doses up to and including 1000 mg/kg body weight per day. The developmental toxicity of semirefined cassia gum (in distilled water) was evaluated using grou","page":22,"pdf":"PRS600.pdf","row_type":"noael_study","study_id":"PRS600_noael_003"}
COSMOS DB 15 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS DB NOAEL 200 mg/kg bw/day monkey oral 180 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 500 mg/kg bw/day rat oral 180 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 600 mg/kg bw/day hamster oral 5 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 700 mg/kg bw/day rabbit oral 13 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 800 mg/kg bw/day mouse oral 10 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 900 mg/kg bw/day rat oral 10 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 2500 mg/kg bw/day rat oral 28 day Special Toxicology Study US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 4000 mg/kg bw/day swine oral 8 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 5000 mg/kg bw/day rat oral 21 day Short Term Toxicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 5770 mg/kg bw/day rat oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 6000 mg/kg bw/day rat oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 7500 mg/kg bw/day mouse oral 721 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 10000 mg/kg bw/day rat oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 11757 mg/kg bw/day rat oral 111 day Developmental US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS DB NOAEL 15000 mg/kg bw/day mouse oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
EFSA 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
EFSA NOAEL =2500 mg/kg bw/day Rat - - chronic/long term toxicity EFSA FEEDAP - 2022 - OutputID 4123 - Safety and efficacy of a feed additive consisting of guar gum for all animal species (A.I.P.G. Association for International Promotion of Gums) - doi:10.2903/j.efsa.2022.7253
EFSA NOAEL =2500 mg/kg bw/day Rat - - chronic/long term toxicity EFSA FEEDAP - 2022 - OutputID 4123 - Safety and efficacy of a feed additive consisting of guar gum for all animal species (A.I.P.G. Association for International Promotion of Gums) - doi:10.2903/j.efsa.2022.7253
NTP ICE acute oral 2 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE acute oral LD50 =6770 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_11318; row=5457; data_type=In Vivo; mixture=Chemical; chemical_name=Guar gum; preferred_name=alpha-D-Galactopyrano-beta-D-mannopyranan; dtxsid=DTXSID3020675; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3020675; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID3020675; source_file=acute_oral.xlsx
NTP ICE acute oral LD50 =9400 mg/kg bw Rat oral acute Rat Acute Oral Toxicity record_id=acute_oral_11320; row=5456; data_type=In Vivo; mixture=Chemical; chemical_name=Guar gum; preferred_name=alpha-D-Galactopyrano-beta-D-mannopyranan; dtxsid=DTXSID3020675; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3020675; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID3020675; source_file=acute_oral.xlsx
NTP ICE cancer 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
NTP ICE cancer Top dose 50000 ppm Mouse Dosed feed - In Vivo; NTP Carcinogenicity sheet=Data; excel_row=3447; Record_ID=cancer_4726; Data_Type=In Vivo; Formulation_Name=Guar gum; Mixture=Chemical; DTXSID=DTXSID3020675; Assay=NTP Carcinogenicity; Endpoint=Top dose; Response=50000; Response_Unit=ppm; Species=Mouse; Strain=B6C3F1; Sex=Male; Route=Dosed feed; Reference=TR-229; URL=https://ntp.niehs.nih.gov/publications/reports/tr/200s/tr229/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID3020675; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID3020675
Regulatory source 3 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
Regulatory source developmental toxicity 0 ppm rat oral 6 weeks developmental toxicity SOURCE_SUBDIR=PRS600; REPORT_TITLE=Safety Assessment of Galactomannans as Used in Cosmetics Wilbur Johnson Jr1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel C. Liebler3, James G. Marks Jr3, Ronald C. Shank3,; OPINION_NUMBER=PRS600; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Toxicology 2015; VALUE_TEXT=000; DOSE=Based on the results from this study and the preceding study, the NOAEL was considered to be >50 000 ppm (5%) in the diet.92 Cassia gum.; EFFECT=d not reveal any abnormalities that were related to gum administration. There was no evidence of test substance- related abnormalities after external, visceral, and skeletal examinations of fetuses were performed. Additionally, there were no differences in the sex ratios of fetuses or statistically significant differences in fetal body weights. It was concluded that C spinosa gum did not induce maternal toxicity, embry- otoxicity, or teratogenicity. Based on the results from this study and the preceding study, the NOAEL was considered to be >50 000 ppm (5%) in the diet.92 Cassia gum. In a 2-generation reproductive toxicity study (OECD Test Guideline 416), semirefined cassia gum was administered to groups of 25 female Ico: OFA.SD Sprague- Dawley rats (6 weeks old) at dietary concentrations of 0, 5000, 20 000, or 50 000 mg/kg.93 An additional group was fed a diet containing purified semirefined cassia gum (which resulted from an additional isopropano extraction step) at a dose of 50 000 mg/kg. Parental animals were dosed for approx- imately 10 weeks prior to mating and during mating...; CITATION=50; 000; (5; CITATION_NUMBERS=[50,5]; REFERENCE=50; 000; (5; DETAILS_JSON={"cas_number":"9000-30-0","citation":"50; 000; (5","dose":"Based on the results from this study and the preceding study, the NOAEL was considered to be >50 000 ppm (5%) in the diet.92 Cassia gum.","duration":"6 weeks","effect":"d not reveal any abnormalities that were related to gum administration. There was no evidence of test substance- related abnormalities after external, visceral, and skeletal examinations of fetuses were performed. Additionally, there were no differences in the sex ratios of fetuses or statistically significant differences in fetal body weights. It was concluded that C spinosa gum did not induce maternal toxicity, embry- otoxicity, or teratogenicity. Based on the results from this study and the preceding study, the NOAEL was considered to be >50 000 ppm (5%) in the diet.92 Cassia gum. In a 2-generation reproductive toxicity study (OECD Test Guideline 416), semirefined cassia gum was administered to groups of 25 female Ico: OFA.SD Sprague- Dawley rats (6 weeks old) at dietary concentrations of 0, 5000, 20 000, or 50 000 mg/kg.93 An additional group was fed a diet containing purified semirefined cassia gum (which resulted from an additional isopropano extraction step) at a dose of 50 000 mg/kg. Parental animals were dosed for approx- imately 10 weeks prior to mating and during mating...","endpoint":"developmental toxicity","ingredient":"Galactomannans","loael_value":"","noael_unit":"ppm","noael_value":"000","page":21,"route":"oral","species":"rat","study_id":"PRS600_noael_002"}
Regulatory source developmental toxicity 1000 mg/kg body weight rat oral - developmental toxicity SOURCE_SUBDIR=PRS600; REPORT_TITLE=Safety Assessment of Galactomannans as Used in Cosmetics Wilbur Johnson Jr1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel C. Liebler3, James G. Marks Jr3, Ronald C. Shank3,; OPINION_NUMBER=PRS600; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Toxicology 2015; VALUE_TEXT=1000; DOSE=These effects were observed at the highest dose level (both groups), and therefore, 50 000 mg/kg feed (equal to 5280 mg/kg body weight per day) was considered the no- observed-effect level NOEL.; EFFECT=These effects were observed at the highest dose level (both groups), and therefore, 50 000 mg/kg feed (equal to 5280 mg/kg body weight per day) was considered the no- observed-effect level NOEL. Groups of 12 pregnant female SD rats received oral doses of cassia gum (by gavage) at doses of 0, 250, 500, or 1000 mg/kg body weight per day on days 7 through 16 of gestation.54 There were no treatment-related effects on maternal body weight, the number of resorptions or dead embryos, or the weight and length of fetuses. Also, abnormalities were not observed at skeletal or visceral examination of the fetuses. Therefore, no adverse effects were observed in dams or offspring at doses up to and including 1000 mg/kg body weight per day. The developmental toxicity of semirefined cassia gum (in distilled water) was evaluated using grou; CITATION=50; 000; 12; CITATION_NUMBERS=[50,12]; REFERENCE=50; 000; 12; DETAILS_JSON={"cas_number":"9000-30-0","citation":"50; 000; 12","dose":"These effects were observed at the highest dose level (both groups), and therefore, 50 000 mg/kg feed (equal to 5280 mg/kg body weight per day) was considered the no- observed-effect level NOEL.","duration":"","effect":"These effects were observed at the highest dose level (both groups), and therefore, 50 000 mg/kg feed (equal to 5280 mg/kg body weight per day) was considered the no- observed-effect level NOEL. Groups of 12 pregnant female SD rats received oral doses of cassia gum (by gavage) at doses of 0, 250, 500, or 1000 mg/kg body weight per day on days 7 through 16 of gestation.54 There were no treatment-related effects on maternal body weight, the number of resorptions or dead embryos, or the weight and length of fetuses. Also, abnormalities were not observed at skeletal or visceral examination of the fetuses. Therefore, no adverse effects were observed in dams or offspring at doses up to and including 1000 mg/kg body weight per day. The developmental toxicity of semirefined cassia gum (in distilled water) was evaluated using grou","endpoint":"developmental toxicity","ingredient":"Galactomannans","loael_value":"","noael_unit":"mg/kg body weight","noael_value":"1000","page":22,"route":"oral","species":"rat","study_id":"PRS600_noael_003"}
Regulatory source repeated dose toxicity 1 g/kg/d rat oral 90 days repeated dose toxicity SOURCE_SUBDIR=PRS600; REPORT_TITLE=Safety Assessment of Galactomannans as Used in Cosmetics Wilbur Johnson Jr1, Bart Heldreth2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel C. Liebler3, James G. Marks Jr3, Ronald C. Shank3,; OPINION_NUMBER=PRS600; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=Toxicology 2015; VALUE_TEXT=1; 3.5; DOSE=An no-observable-adverse-effect-level (NOAEL) of 1000 mg/kg body weight was reported for cassia gum in rats.; EFFECT=ys.54 There were no treatment-related effects on the following: mortality, body weight gain, food consumption, food utilization, hemato- logical parameters, or various biochemical parameters (eg, albumin, cholesterol, and aspartate aminotransferase). Gross examination results were negative, and there were no treatment-related histopathologic changes or effects on weight in the following organs: liver, kidney, spleen, ovaries, and testes. There were also no histopathologic changes in the sto- mach or intestines. An no-observable-adverse-effect-level (NOAEL) of 1000 mg/kg body weight was reported for cassia gum in rats. Semirefined cassia gum (in dog food) was administered to 2 groups of 4 male and 4 female Beagle dogs at dietary doses of 1 and 3.5 g/kg/d, respectively, for 90 days.68 The control group received dog food without cassia gum; however, cassia gum was replaced by a substance with similar technological char- acteristics. A dose-related increase in water consumption was the only treatment-related effect noted but was not considered toxicologically significant. Hematologica...; CITATION=54; 2; 4; CITATION_NUMBERS=[54,2,4]; REFERENCE=54; 2; 4; DETAILS_JSON={"cas_number":"9000-30-0","citation":"54; 2; 4","dose":"An no-observable-adverse-effect-level (NOAEL) of 1000 mg/kg body weight was reported for cassia gum in rats.","duration":"90 days","effect":"ys.54 There were no treatment-related effects on the following: mortality, body weight gain, food consumption, food utilization, hemato- logical parameters, or various biochemical parameters (eg, albumin, cholesterol, and aspartate aminotransferase). Gross examination results were negative, and there were no treatment-related histopathologic changes or effects on weight in the following organs: liver, kidney, spleen, ovaries, and testes. There were also no histopathologic changes in the sto- mach or intestines. An no-observable-adverse-effect-level (NOAEL) of 1000 mg/kg body weight was reported for cassia gum in rats. Semirefined cassia gum (in dog food) was administered to 2 groups of 4 male and 4 female Beagle dogs at dietary doses of 1 and 3.5 g/kg/d, respectively, for 90 days.68 The control group received dog food without cassia gum; however, cassia gum was replaced by a substance with similar technological char- acteristics. A dose-related increase in water consumption was the only treatment-related effect noted but was not considered toxicologically significant. Hematologica...","endpoint":"repeated dose toxicity","ingredient":"Galactomannans","loael_value":"","noael_unit":"g/kg/d","noael_value":"1; 3.5","page":17,"route":"oral","species":"rat","study_id":"PRS600_noael_001"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier E89I1637KE UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"E89I1637KE"}
openFDA substances FDA UNII substance identifier E89I1637KE UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"E89I1637KE"}
openFDA substances FDA UNII substance identifier E89I1637KE UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"E89I1637KE"}
openFDA substances FDA UNII substance identifier E89I1637KE UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"E89I1637KE"}