NOAEL Studies Cosmetic Ingredient

Dehydroxanthan Gum NOAEL Studies

INCI: DEHYDROXANTHAN GUM

CAS: 11138-66-2

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 =0.25 g/kg dog oral 12 weeks oral toxicity {"citation":"5; 2; 61","dose":"ficant differences in growth rate, survival, hematology and clinical chemistry parameters, or organ weight were observed between treated and control animals; although not statistically significant (stat. sig.), there was an increase in uterine polyps in the high-dose groups compared to controls, 5 in the high-dose animals vs 2 in controls 61 Xanthan gum B...","effect":"ficant differences in growth rate, survival, hematology and clinical chemistry parameters, or organ weight were observed between treated and control animals; although not statistically significant (stat. sig.), there was an increase in uterine polyps in the high-dose groups compared to controls, 5 in the high-dose animals vs 2 in controls 61 Xanthan gum Beagle dogs, 3 M/3 F 12 weeks In diet 0, 0.25, or 0.5 g/kg BW/d Growth of high-dose males was slightly less than controls; the no- observable adverse effect level (NOAEL) was 0.25 g/kg BW/d 38 Xanthan gum Beagle dogs, 2 M/2 F 12 weeks In diet 0, 1, or 2 g/kg BW/d; positive controls were given 20 g/kg BW/d powdered cellulose Immediate and persistent diarrhea in the 2 g/kg group; body wt loss was observed in treated and control animals, with the wt loss greatest in the 2 g/kg group; red blood cell counts, hemoglobin, and serum cholesterol levels were decreased in high-dose animals; adrenal glands were slightly enlarged in the 2 g/kg group; no treatment-related microscopic lesion were observed at necropsy 111 Xanthan gum Beagle dogs,...","page":27,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_001"}
CIR_vision_codex NOAEL =5 % rat oral 28 days oral toxicity {"citation":"2; 28; 0, 1, 2","effect":"sac. Rhesus monkey, 2 M/2 F 28 days Not provided 0, 1, 2, or 3 g/kg, by gavage No signs of toxicity 39 Dextran Albino rats, 6 M 62 days In diet 15% Wt gain was normal 104 Beta-glucan (as curdlan) CD-1 mice, 10 M/10 F 8 weeks In diet 0%, 1%, 5%, 10%, 20%, or 30%; equivalent to 0, 1.4, 7.1, 14, 29, and 43 g/kg B, respectively One female of the 30% group died; body wt gains of male mice of the 30% group were decreased compared to controls; no gross abnormalities; differences in stools and cecal wts were reported; the NOEL was 5% based on an increase in full cecal wts and large stools at higher doses 42 (continued) 31S","page":27,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_002"}
CIR_vision_codex NOAEL =2000 mg/kg BW rat oral 3 months reproductive toxicity {"citation":"12; 3; 0, 500, 1,000","dose":"lucidum) CD (SD) IGS rats, 12 M,12 F 3 months Sterile water; by gavage 0, 500, 1,000, or 2,000 mg/kg BW (10 mL/kg dosing volume) No test article-related adverse effects on mortality, toxicity; ophthalmoscopy, body wts or body wt gains, clinical chemistry, hematology, or urinalysis; statistically significant decreases in testes wt in males of the low-dose...","effect":"lucidum) CD (SD) IGS rats, 12 M,12 F 3 months Sterile water; by gavage 0, 500, 1,000, or 2,000 mg/kg BW (10 mL/kg dosing volume) No test article-related adverse effects on mortality, toxicity; ophthalmoscopy, body wts or body wt gains, clinical chemistry, hematology, or urinalysis; statistically significant decreases in testes wt in males of the low-dose group and heart wts in females of the high-dose group were not considered test-article related; there were no treatment-related gross or microscopic lesions, the NOAEL was 2,000 mg/kg BW 42 Beta-glucan (as curdlan) CD rats; 60 M/60 F 2 years In diet 0%, 1%, 5%, or 15% No changes in mortality, behavior, appearance, or ophthalmic parameters; wt gain was decreased by *10%, which was not stat. sig., in the 15% group; feed consumption was also reduced; no microscopic lesions were found, the NOEL was 5% based on decreased feed consumption, body wt gain, and increased cecal wts 42 Beta-glucan (as curdlan) CD rats; 60 M/60 F, of the F1a generation of a reproductive toxicology study 124-127 weeks (20% survival) In diet 0%, 1%, 5%, or 15% N...","page":28,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_003"}
CIR_vision_codex NOAEL =1 % - oral - oral toxicity {"citation":"15; 5; 65","effect":"ers; body wts of the 15% group were stat. sig. decreased, and body wts were stat. sig. decreased in 5% males until wk 65; feed consumption was decreased in the 15% group; no changes in hematology or urinary parameters, but some stat. sig. changes were reported in blood chemistry; stat. sig increase in gross and microscopic incidences of uterine polyps in the 15% groups—the incidences were 0/450, 3/50, 4/51, and 7/50 for the 0%, 1%, 5%, and 15% groups, indicating that the polyps were possible treatment related; the NOEL was 1% based on increased cecal wts, decreased body wts and feed consumption, and the incidence of polyps 42 (continued) 32S","page":28,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_004"}
CIR_vision_codex NOAEL =100 mg/kg BW/d rat oral 28 days oral toxicity {"citation":"0, 2, 33; 3; 100","dose":"ays Water 0, 2, 33.3, or 100 mg/kg BW / d, volume 0.5 mL/100 g BW, by gavage No mortality; no stat. sig. differences in wt gains, feed consumption, or gross or microscopic lesions; a dose-dependent and stat. sig. increase in clotting time in males, isolated stat. sig. changes in some clinical chemistry parameters, and slight but stat. sig. incr. in absolu...","effect":"ays Water 0, 2, 33.3, or 100 mg/kg BW / d, volume 0.5 mL/100 g BW, by gavage No mortality; no stat. sig. differences in wt gains, feed consumption, or gross or microscopic lesions; a dose-dependent and stat. sig. increase in clotting time in males, isolated stat. sig. changes in some clinical chemistry parameters, and slight but stat. sig. incr. in absolute liver, kidney, heart, spleen, adrenal, and testicle wts in males and absolute kidney and thymus wts in females were not considered toxicologically significant; NOAEL was 100 mg/kg BW/d 106 Beta-glucan (high-purity extract barley beta-glucan) SPF Wistar rats, 5 M/5 F 28 days In diet 0%, 1%, 5%, or 10%, supplemented with \u000210% potato starch No mortality; no sig. effects on body wts, feed consumption, or functional observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts,...","page":29,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_005"}
CIR_vision_codex NOAEL =20 mg/kg rat oral 52 weeks oral toxicity {"citation":"113; 20; 52","dose":"l observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts, feed consumption, or hematology,...","effect":"l observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts, feed consumption, or hematology, clinical chemistry, or urinalysis parameters; with the exception of cecal enlargement with variable hyperplasia, not gross or microscopic lesions were noted; the NOEL was 100 mg/kg/d 114 Pullulan 8 Wistar rats, males (test and cellulose control groups) 4 or 9 weeks In diet 0%, 5%, 10%, 20%, or 40%; equivalent to 0, 2,500, 5,000, 10,000, or 20,000 mg/kg, respectively; cellulose controls: 20% or 40% cellulose Body wt gains were decreased by day 10 in rats of the 20% and 40% groups when compared to untreated controls; wt gains of animals of the 5% and 10% pullulan group were lower than untreated controls after 7 weeks, but this difference was not stat. sig.; similar decreases were observed in the animals fed cellulose; diarrhea was...","page":29,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_006"}
CIR_vision_codex NOAEL =10 % rat oral 62 weeks oral toxicity {"citation":"5; 10; 44","dose":"l wts were observed in males of the 5% and males and females of the 10% group; no microscopic changes were observed 44 Pullulan Sprague-Dawley rats, 15 M/15 F 62 weeks (was to be 24 months; study was terminated because of poor survival due to pneumonia) In diet 0%, 1%, 5%, and 10% No treatment-related effects on body wts, feed consumption, or organ wts (e...","effect":"l wts were observed in males of the 5% and males and females of the 10% group; no microscopic changes were observed 44 Pullulan Sprague-Dawley rats, 15 M/15 F 62 weeks (was to be 24 months; study was terminated because of poor survival due to pneumonia) In diet 0%, 1%, 5%, and 10% No treatment-related effects on body wts, feed consumption, or organ wts (except for cecal wts); changes in hematology or clinical chemistry parameters and microscopic lesions that were observed were not considered treatment related; the NOAEL was 10% in the diet (equivalent to 4,450 mg/kg BW /d) 115 (continued) 33S","page":29,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_007"}
CIR_vision_codex NOAEL =15 % rat oral 100 days reproductive toxicity {"citation":"20; 40; 15","effect":"y treated dams. A no observable effect level (NOEL) was not established. The researchers also examined whether there would be decreased weight gain by the pups if dosing was discontinued during lactation. The protocol was similar to that just described, except that all groups consisted of 20 male and 40 female CD rats, and there was no crossover at lactation. Weight gain by all pups during lactations was similar, although the researchers did state that the pups could have consumed par- ental diet from day 10þ. The NOEL for parental toxicity and embryotoxicity was 15% beta-glucan. A 3-generation reproductive study was performed in which groups of 20 male and 40 female CD rats were fed a diet containing 0%, 1%, 5%, or 15% beta-glucan (as curdlan) for 100 days.42 The F0 parents were mated twice, and the number of parents was halved after weaning of the first litter. The F1 parents were mated 3 times and the F2 parents were mated twice. The F1b and F2b litters were used to produce the next generation. After the third mating of the F1 parents, half of the F1 dams were killed on day 13...","page":31,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_008"}
CIR_vision_codex NOAEL =5 g/kg rabbit - - developmental toxicity {"citation":"2; 28; 1, 1","dose":"Eleven resorptions were observed in the high- dose group, as compared to 4 in the control group, 6 in the 1 g/kg group, and 5 in the 2 g/kg group.","effect":"es, and the controls received 2 empty capsules. The rabbits were killed on day 28 of gestation. None of the controls died, but 1, 1, and 3 dams of the 1, 2, and 5 g/kg BW/day groups, respectively, died during the study. Eleven resorptions were observed in the high- dose group, as compared to 4 in the control group, 6 in the 1 g/kg group, and 5 in the 2 g/kg group. The researchers stated, how- ever, that the number of dams with resorptions was similar in all groups and that no teratogenic effects were observed. The NOEL for both maternal and embryotoxicity was 5 g/kg BW/d. Genotoxicity Genotoxicity studies are summarized in Table 10. The in vitro genotoxicity of gellan gum (\u000220 mg/mL), sodium dextran sul- fate (\u000225 mg/plate), beta-glucan (\u00025,000 mg/plate or mg/mL), sodium carboxymethyl beta-glucan (\u000250,000 mg/plate or mg/mL), and pullulan (\u000212 mg/mL) was evaluated using Ames test, chromosomal aberration assays, and/or DNA repair tests, with and without metabolic activation. The results were nega- tive in these tests. The only nonnegative result was a weak positive outcome with 20 m...","page":32,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_009"}
CIR_vision_codex NOAEL =0.25 g/kg dog oral 12 weeks oral toxicity {"citation":"5; 2; 61","dose":"ficant differences in growth rate, survival, hematology and clinical chemistry parameters, or organ weight were observed between treated and control animals; although not statistically significant (stat. sig.), there was an increase in uterine polyps in the high-dose groups compared to controls, 5 in the high-dose animals vs 2 in controls 61 Xanthan gum B...","effect":"ficant differences in growth rate, survival, hematology and clinical chemistry parameters, or organ weight were observed between treated and control animals; although not statistically significant (stat. sig.), there was an increase in uterine polyps in the high-dose groups compared to controls, 5 in the high-dose animals vs 2 in controls 61 Xanthan gum Beagle dogs, 3 M/3 F 12 weeks In diet 0, 0.25, or 0.5 g/kg BW/d Growth of high-dose males was slightly less than controls; the no- observable adverse effect level (NOAEL) was 0.25 g/kg BW/d 38 Xanthan gum Beagle dogs, 2 M/2 F 12 weeks In diet 0, 1, or 2 g/kg BW/d; positive controls were given 20 g/kg BW/d powdered cellulose Immediate and persistent diarrhea in the 2 g/kg group; body wt loss was observed in treated and control animals, with the wt loss greatest in the 2 g/kg group; red blood cell counts, hemoglobin, and serum cholesterol levels were decreased in high-dose animals; adrenal glands were slightly enlarged in the 2 g/kg group; no treatment-related microscopic lesion were observed at necropsy 111 Xanthan gum Beagle dogs,...","page":27,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_001"}
CIR_vision_codex NOAEL =5 % rat oral 28 days oral toxicity {"citation":"2; 28; 0, 1, 2","effect":"sac. Rhesus monkey, 2 M/2 F 28 days Not provided 0, 1, 2, or 3 g/kg, by gavage No signs of toxicity 39 Dextran Albino rats, 6 M 62 days In diet 15% Wt gain was normal 104 Beta-glucan (as curdlan) CD-1 mice, 10 M/10 F 8 weeks In diet 0%, 1%, 5%, 10%, 20%, or 30%; equivalent to 0, 1.4, 7.1, 14, 29, and 43 g/kg B, respectively One female of the 30% group died; body wt gains of male mice of the 30% group were decreased compared to controls; no gross abnormalities; differences in stools and cecal wts were reported; the NOEL was 5% based on an increase in full cecal wts and large stools at higher doses 42 (continued) 31S","page":27,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_002"}
CIR_vision_codex NOAEL =2000 mg/kg BW rat oral 3 months reproductive toxicity {"citation":"12; 3; 0, 500, 1,000","dose":"lucidum) CD (SD) IGS rats, 12 M,12 F 3 months Sterile water; by gavage 0, 500, 1,000, or 2,000 mg/kg BW (10 mL/kg dosing volume) No test article-related adverse effects on mortality, toxicity; ophthalmoscopy, body wts or body wt gains, clinical chemistry, hematology, or urinalysis; statistically significant decreases in testes wt in males of the low-dose...","effect":"lucidum) CD (SD) IGS rats, 12 M,12 F 3 months Sterile water; by gavage 0, 500, 1,000, or 2,000 mg/kg BW (10 mL/kg dosing volume) No test article-related adverse effects on mortality, toxicity; ophthalmoscopy, body wts or body wt gains, clinical chemistry, hematology, or urinalysis; statistically significant decreases in testes wt in males of the low-dose group and heart wts in females of the high-dose group were not considered test-article related; there were no treatment-related gross or microscopic lesions, the NOAEL was 2,000 mg/kg BW 42 Beta-glucan (as curdlan) CD rats; 60 M/60 F 2 years In diet 0%, 1%, 5%, or 15% No changes in mortality, behavior, appearance, or ophthalmic parameters; wt gain was decreased by *10%, which was not stat. sig., in the 15% group; feed consumption was also reduced; no microscopic lesions were found, the NOEL was 5% based on decreased feed consumption, body wt gain, and increased cecal wts 42 Beta-glucan (as curdlan) CD rats; 60 M/60 F, of the F1a generation of a reproductive toxicology study 124-127 weeks (20% survival) In diet 0%, 1%, 5%, or 15% N...","page":28,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_003"}
CIR_vision_codex NOAEL =1 % - oral - oral toxicity {"citation":"15; 5; 65","effect":"ers; body wts of the 15% group were stat. sig. decreased, and body wts were stat. sig. decreased in 5% males until wk 65; feed consumption was decreased in the 15% group; no changes in hematology or urinary parameters, but some stat. sig. changes were reported in blood chemistry; stat. sig increase in gross and microscopic incidences of uterine polyps in the 15% groups—the incidences were 0/450, 3/50, 4/51, and 7/50 for the 0%, 1%, 5%, and 15% groups, indicating that the polyps were possible treatment related; the NOEL was 1% based on increased cecal wts, decreased body wts and feed consumption, and the incidence of polyps 42 (continued) 32S","page":28,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_004"}
CIR_vision_codex NOAEL =100 mg/kg BW/d rat oral 28 days oral toxicity {"citation":"0, 2, 33; 3; 100","dose":"ays Water 0, 2, 33.3, or 100 mg/kg BW / d, volume 0.5 mL/100 g BW, by gavage No mortality; no stat. sig. differences in wt gains, feed consumption, or gross or microscopic lesions; a dose-dependent and stat. sig. increase in clotting time in males, isolated stat. sig. changes in some clinical chemistry parameters, and slight but stat. sig. incr. in absolu...","effect":"ays Water 0, 2, 33.3, or 100 mg/kg BW / d, volume 0.5 mL/100 g BW, by gavage No mortality; no stat. sig. differences in wt gains, feed consumption, or gross or microscopic lesions; a dose-dependent and stat. sig. increase in clotting time in males, isolated stat. sig. changes in some clinical chemistry parameters, and slight but stat. sig. incr. in absolute liver, kidney, heart, spleen, adrenal, and testicle wts in males and absolute kidney and thymus wts in females were not considered toxicologically significant; NOAEL was 100 mg/kg BW/d 106 Beta-glucan (high-purity extract barley beta-glucan) SPF Wistar rats, 5 M/5 F 28 days In diet 0%, 1%, 5%, or 10%, supplemented with \u000210% potato starch No mortality; no sig. effects on body wts, feed consumption, or functional observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts,...","page":29,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_005"}
CIR_vision_codex NOAEL =20 mg/kg rat oral 52 weeks oral toxicity {"citation":"113; 20; 52","dose":"l observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts, feed consumption, or hematology,...","effect":"l observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts, feed consumption, or hematology, clinical chemistry, or urinalysis parameters; with the exception of cecal enlargement with variable hyperplasia, not gross or microscopic lesions were noted; the NOEL was 100 mg/kg/d 114 Pullulan 8 Wistar rats, males (test and cellulose control groups) 4 or 9 weeks In diet 0%, 5%, 10%, 20%, or 40%; equivalent to 0, 2,500, 5,000, 10,000, or 20,000 mg/kg, respectively; cellulose controls: 20% or 40% cellulose Body wt gains were decreased by day 10 in rats of the 20% and 40% groups when compared to untreated controls; wt gains of animals of the 5% and 10% pullulan group were lower than untreated controls after 7 weeks, but this difference was not stat. sig.; similar decreases were observed in the animals fed cellulose; diarrhea was...","page":29,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_006"}
CIR_vision_codex NOAEL =10 % rat oral 62 weeks oral toxicity {"citation":"5; 10; 44","dose":"l wts were observed in males of the 5% and males and females of the 10% group; no microscopic changes were observed 44 Pullulan Sprague-Dawley rats, 15 M/15 F 62 weeks (was to be 24 months; study was terminated because of poor survival due to pneumonia) In diet 0%, 1%, 5%, and 10% No treatment-related effects on body wts, feed consumption, or organ wts (e...","effect":"l wts were observed in males of the 5% and males and females of the 10% group; no microscopic changes were observed 44 Pullulan Sprague-Dawley rats, 15 M/15 F 62 weeks (was to be 24 months; study was terminated because of poor survival due to pneumonia) In diet 0%, 1%, 5%, and 10% No treatment-related effects on body wts, feed consumption, or organ wts (except for cecal wts); changes in hematology or clinical chemistry parameters and microscopic lesions that were observed were not considered treatment related; the NOAEL was 10% in the diet (equivalent to 4,450 mg/kg BW /d) 115 (continued) 33S","page":29,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_007"}
CIR_vision_codex NOAEL =15 % rat oral 100 days reproductive toxicity {"citation":"20; 40; 15","effect":"y treated dams. A no observable effect level (NOEL) was not established. The researchers also examined whether there would be decreased weight gain by the pups if dosing was discontinued during lactation. The protocol was similar to that just described, except that all groups consisted of 20 male and 40 female CD rats, and there was no crossover at lactation. Weight gain by all pups during lactations was similar, although the researchers did state that the pups could have consumed par- ental diet from day 10þ. The NOEL for parental toxicity and embryotoxicity was 15% beta-glucan. A 3-generation reproductive study was performed in which groups of 20 male and 40 female CD rats were fed a diet containing 0%, 1%, 5%, or 15% beta-glucan (as curdlan) for 100 days.42 The F0 parents were mated twice, and the number of parents was halved after weaning of the first litter. The F1 parents were mated 3 times and the F2 parents were mated twice. The F1b and F2b litters were used to produce the next generation. After the third mating of the F1 parents, half of the F1 dams were killed on day 13...","page":31,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_008"}
CIR_vision_codex NOAEL =5 g/kg rabbit - - developmental toxicity {"citation":"2; 28; 1, 1","dose":"Eleven resorptions were observed in the high- dose group, as compared to 4 in the control group, 6 in the 1 g/kg group, and 5 in the 2 g/kg group.","effect":"es, and the controls received 2 empty capsules. The rabbits were killed on day 28 of gestation. None of the controls died, but 1, 1, and 3 dams of the 1, 2, and 5 g/kg BW/day groups, respectively, died during the study. Eleven resorptions were observed in the high- dose group, as compared to 4 in the control group, 6 in the 1 g/kg group, and 5 in the 2 g/kg group. The researchers stated, how- ever, that the number of dams with resorptions was similar in all groups and that no teratogenic effects were observed. The NOEL for both maternal and embryotoxicity was 5 g/kg BW/d. Genotoxicity Genotoxicity studies are summarized in Table 10. The in vitro genotoxicity of gellan gum (\u000220 mg/mL), sodium dextran sul- fate (\u000225 mg/plate), beta-glucan (\u00025,000 mg/plate or mg/mL), sodium carboxymethyl beta-glucan (\u000250,000 mg/plate or mg/mL), and pullulan (\u000212 mg/mL) was evaluated using Ames test, chromosomal aberration assays, and/or DNA repair tests, with and without metabolic activation. The results were nega- tive in these tests. The only nonnegative result was a weak positive outcome with 20 m...","page":32,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_009"}
CIR_vision_codex NOAEL =0.25 g/kg dog oral 12 weeks oral toxicity {"citation":"5; 2; 61","dose":"ficant differences in growth rate, survival, hematology and clinical chemistry parameters, or organ weight were observed between treated and control animals; although not statistically significant (stat. sig.), there was an increase in uterine polyps in the high-dose groups compared to controls, 5 in the high-dose animals vs 2 in controls 61 Xanthan gum B...","effect":"ficant differences in growth rate, survival, hematology and clinical chemistry parameters, or organ weight were observed between treated and control animals; although not statistically significant (stat. sig.), there was an increase in uterine polyps in the high-dose groups compared to controls, 5 in the high-dose animals vs 2 in controls 61 Xanthan gum Beagle dogs, 3 M/3 F 12 weeks In diet 0, 0.25, or 0.5 g/kg BW/d Growth of high-dose males was slightly less than controls; the no- observable adverse effect level (NOAEL) was 0.25 g/kg BW/d 38 Xanthan gum Beagle dogs, 2 M/2 F 12 weeks In diet 0, 1, or 2 g/kg BW/d; positive controls were given 20 g/kg BW/d powdered cellulose Immediate and persistent diarrhea in the 2 g/kg group; body wt loss was observed in treated and control animals, with the wt loss greatest in the 2 g/kg group; red blood cell counts, hemoglobin, and serum cholesterol levels were decreased in high-dose animals; adrenal glands were slightly enlarged in the 2 g/kg group; no treatment-related microscopic lesion were observed at necropsy 111 Xanthan gum Beagle dogs,...","page":27,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_001"}
CIR_vision_codex NOAEL =5 % rat oral 28 days oral toxicity {"citation":"2; 28; 0, 1, 2","effect":"sac. Rhesus monkey, 2 M/2 F 28 days Not provided 0, 1, 2, or 3 g/kg, by gavage No signs of toxicity 39 Dextran Albino rats, 6 M 62 days In diet 15% Wt gain was normal 104 Beta-glucan (as curdlan) CD-1 mice, 10 M/10 F 8 weeks In diet 0%, 1%, 5%, 10%, 20%, or 30%; equivalent to 0, 1.4, 7.1, 14, 29, and 43 g/kg B, respectively One female of the 30% group died; body wt gains of male mice of the 30% group were decreased compared to controls; no gross abnormalities; differences in stools and cecal wts were reported; the NOEL was 5% based on an increase in full cecal wts and large stools at higher doses 42 (continued) 31S","page":27,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_002"}
CIR_vision_codex NOAEL =2000 mg/kg BW rat oral 3 months reproductive toxicity {"citation":"12; 3; 0, 500, 1,000","dose":"lucidum) CD (SD) IGS rats, 12 M,12 F 3 months Sterile water; by gavage 0, 500, 1,000, or 2,000 mg/kg BW (10 mL/kg dosing volume) No test article-related adverse effects on mortality, toxicity; ophthalmoscopy, body wts or body wt gains, clinical chemistry, hematology, or urinalysis; statistically significant decreases in testes wt in males of the low-dose...","effect":"lucidum) CD (SD) IGS rats, 12 M,12 F 3 months Sterile water; by gavage 0, 500, 1,000, or 2,000 mg/kg BW (10 mL/kg dosing volume) No test article-related adverse effects on mortality, toxicity; ophthalmoscopy, body wts or body wt gains, clinical chemistry, hematology, or urinalysis; statistically significant decreases in testes wt in males of the low-dose group and heart wts in females of the high-dose group were not considered test-article related; there were no treatment-related gross or microscopic lesions, the NOAEL was 2,000 mg/kg BW 42 Beta-glucan (as curdlan) CD rats; 60 M/60 F 2 years In diet 0%, 1%, 5%, or 15% No changes in mortality, behavior, appearance, or ophthalmic parameters; wt gain was decreased by *10%, which was not stat. sig., in the 15% group; feed consumption was also reduced; no microscopic lesions were found, the NOEL was 5% based on decreased feed consumption, body wt gain, and increased cecal wts 42 Beta-glucan (as curdlan) CD rats; 60 M/60 F, of the F1a generation of a reproductive toxicology study 124-127 weeks (20% survival) In diet 0%, 1%, 5%, or 15% N...","page":28,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_003"}
CIR_vision_codex NOAEL =1 % - oral - oral toxicity {"citation":"15; 5; 65","effect":"ers; body wts of the 15% group were stat. sig. decreased, and body wts were stat. sig. decreased in 5% males until wk 65; feed consumption was decreased in the 15% group; no changes in hematology or urinary parameters, but some stat. sig. changes were reported in blood chemistry; stat. sig increase in gross and microscopic incidences of uterine polyps in the 15% groups—the incidences were 0/450, 3/50, 4/51, and 7/50 for the 0%, 1%, 5%, and 15% groups, indicating that the polyps were possible treatment related; the NOEL was 1% based on increased cecal wts, decreased body wts and feed consumption, and the incidence of polyps 42 (continued) 32S","page":28,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_004"}
CIR_vision_codex NOAEL =100 mg/kg BW/d rat oral 28 days oral toxicity {"citation":"0, 2, 33; 3; 100","dose":"ays Water 0, 2, 33.3, or 100 mg/kg BW / d, volume 0.5 mL/100 g BW, by gavage No mortality; no stat. sig. differences in wt gains, feed consumption, or gross or microscopic lesions; a dose-dependent and stat. sig. increase in clotting time in males, isolated stat. sig. changes in some clinical chemistry parameters, and slight but stat. sig. incr. in absolu...","effect":"ays Water 0, 2, 33.3, or 100 mg/kg BW / d, volume 0.5 mL/100 g BW, by gavage No mortality; no stat. sig. differences in wt gains, feed consumption, or gross or microscopic lesions; a dose-dependent and stat. sig. increase in clotting time in males, isolated stat. sig. changes in some clinical chemistry parameters, and slight but stat. sig. incr. in absolute liver, kidney, heart, spleen, adrenal, and testicle wts in males and absolute kidney and thymus wts in females were not considered toxicologically significant; NOAEL was 100 mg/kg BW/d 106 Beta-glucan (high-purity extract barley beta-glucan) SPF Wistar rats, 5 M/5 F 28 days In diet 0%, 1%, 5%, or 10%, supplemented with \u000210% potato starch No mortality; no sig. effects on body wts, feed consumption, or functional observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts,...","page":29,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_005"}
CIR_vision_codex NOAEL =20 mg/kg rat oral 52 weeks oral toxicity {"citation":"113; 20; 52","dose":"l observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts, feed consumption, or hematology,...","effect":"l observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts, feed consumption, or hematology, clinical chemistry, or urinalysis parameters; with the exception of cecal enlargement with variable hyperplasia, not gross or microscopic lesions were noted; the NOEL was 100 mg/kg/d 114 Pullulan 8 Wistar rats, males (test and cellulose control groups) 4 or 9 weeks In diet 0%, 5%, 10%, 20%, or 40%; equivalent to 0, 2,500, 5,000, 10,000, or 20,000 mg/kg, respectively; cellulose controls: 20% or 40% cellulose Body wt gains were decreased by day 10 in rats of the 20% and 40% groups when compared to untreated controls; wt gains of animals of the 5% and 10% pullulan group were lower than untreated controls after 7 weeks, but this difference was not stat. sig.; similar decreases were observed in the animals fed cellulose; diarrhea was...","page":29,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_006"}
CIR_vision_codex NOAEL =10 % rat oral 62 weeks oral toxicity {"citation":"5; 10; 44","dose":"l wts were observed in males of the 5% and males and females of the 10% group; no microscopic changes were observed 44 Pullulan Sprague-Dawley rats, 15 M/15 F 62 weeks (was to be 24 months; study was terminated because of poor survival due to pneumonia) In diet 0%, 1%, 5%, and 10% No treatment-related effects on body wts, feed consumption, or organ wts (e...","effect":"l wts were observed in males of the 5% and males and females of the 10% group; no microscopic changes were observed 44 Pullulan Sprague-Dawley rats, 15 M/15 F 62 weeks (was to be 24 months; study was terminated because of poor survival due to pneumonia) In diet 0%, 1%, 5%, and 10% No treatment-related effects on body wts, feed consumption, or organ wts (except for cecal wts); changes in hematology or clinical chemistry parameters and microscopic lesions that were observed were not considered treatment related; the NOAEL was 10% in the diet (equivalent to 4,450 mg/kg BW /d) 115 (continued) 33S","page":29,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_007"}
CIR_vision_codex NOAEL =15 % rat oral 100 days reproductive toxicity {"citation":"20; 40; 15","effect":"y treated dams. A no observable effect level (NOEL) was not established. The researchers also examined whether there would be decreased weight gain by the pups if dosing was discontinued during lactation. The protocol was similar to that just described, except that all groups consisted of 20 male and 40 female CD rats, and there was no crossover at lactation. Weight gain by all pups during lactations was similar, although the researchers did state that the pups could have consumed par- ental diet from day 10þ. The NOEL for parental toxicity and embryotoxicity was 15% beta-glucan. A 3-generation reproductive study was performed in which groups of 20 male and 40 female CD rats were fed a diet containing 0%, 1%, 5%, or 15% beta-glucan (as curdlan) for 100 days.42 The F0 parents were mated twice, and the number of parents was halved after weaning of the first litter. The F1 parents were mated 3 times and the F2 parents were mated twice. The F1b and F2b litters were used to produce the next generation. After the third mating of the F1 parents, half of the F1 dams were killed on day 13...","page":31,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_008"}
CIR_vision_codex NOAEL =5 g/kg rabbit - - developmental toxicity {"citation":"2; 28; 1, 1","dose":"Eleven resorptions were observed in the high- dose group, as compared to 4 in the control group, 6 in the 1 g/kg group, and 5 in the 2 g/kg group.","effect":"es, and the controls received 2 empty capsules. The rabbits were killed on day 28 of gestation. None of the controls died, but 1, 1, and 3 dams of the 1, 2, and 5 g/kg BW/day groups, respectively, died during the study. Eleven resorptions were observed in the high- dose group, as compared to 4 in the control group, 6 in the 1 g/kg group, and 5 in the 2 g/kg group. The researchers stated, how- ever, that the number of dams with resorptions was similar in all groups and that no teratogenic effects were observed. The NOEL for both maternal and embryotoxicity was 5 g/kg BW/d. Genotoxicity Genotoxicity studies are summarized in Table 10. The in vitro genotoxicity of gellan gum (\u000220 mg/mL), sodium dextran sul- fate (\u000225 mg/plate), beta-glucan (\u00025,000 mg/plate or mg/mL), sodium carboxymethyl beta-glucan (\u000250,000 mg/plate or mg/mL), and pullulan (\u000212 mg/mL) was evaluated using Ames test, chromosomal aberration assays, and/or DNA repair tests, with and without metabolic activation. The results were nega- tive in these tests. The only nonnegative result was a weak positive outcome with 20 m...","page":32,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_009"}
CIR_vision_codex NOAEL =0.25 g/kg dog oral 12 weeks oral toxicity {"citation":"5; 2; 61","dose":"ficant differences in growth rate, survival, hematology and clinical chemistry parameters, or organ weight were observed between treated and control animals; although not statistically significant (stat. sig.), there was an increase in uterine polyps in the high-dose groups compared to controls, 5 in the high-dose animals vs 2 in controls 61 Xanthan gum B...","effect":"ficant differences in growth rate, survival, hematology and clinical chemistry parameters, or organ weight were observed between treated and control animals; although not statistically significant (stat. sig.), there was an increase in uterine polyps in the high-dose groups compared to controls, 5 in the high-dose animals vs 2 in controls 61 Xanthan gum Beagle dogs, 3 M/3 F 12 weeks In diet 0, 0.25, or 0.5 g/kg BW/d Growth of high-dose males was slightly less than controls; the no- observable adverse effect level (NOAEL) was 0.25 g/kg BW/d 38 Xanthan gum Beagle dogs, 2 M/2 F 12 weeks In diet 0, 1, or 2 g/kg BW/d; positive controls were given 20 g/kg BW/d powdered cellulose Immediate and persistent diarrhea in the 2 g/kg group; body wt loss was observed in treated and control animals, with the wt loss greatest in the 2 g/kg group; red blood cell counts, hemoglobin, and serum cholesterol levels were decreased in high-dose animals; adrenal glands were slightly enlarged in the 2 g/kg group; no treatment-related microscopic lesion were observed at necropsy 111 Xanthan gum Beagle dogs,...","page":27,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_001"}
CIR_vision_codex NOAEL =5 % rat oral 28 days oral toxicity {"citation":"2; 28; 0, 1, 2","effect":"sac. Rhesus monkey, 2 M/2 F 28 days Not provided 0, 1, 2, or 3 g/kg, by gavage No signs of toxicity 39 Dextran Albino rats, 6 M 62 days In diet 15% Wt gain was normal 104 Beta-glucan (as curdlan) CD-1 mice, 10 M/10 F 8 weeks In diet 0%, 1%, 5%, 10%, 20%, or 30%; equivalent to 0, 1.4, 7.1, 14, 29, and 43 g/kg B, respectively One female of the 30% group died; body wt gains of male mice of the 30% group were decreased compared to controls; no gross abnormalities; differences in stools and cecal wts were reported; the NOEL was 5% based on an increase in full cecal wts and large stools at higher doses 42 (continued) 31S","page":27,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_002"}
CIR_vision_codex NOAEL =2000 mg/kg BW rat oral 3 months reproductive toxicity {"citation":"12; 3; 0, 500, 1,000","dose":"lucidum) CD (SD) IGS rats, 12 M,12 F 3 months Sterile water; by gavage 0, 500, 1,000, or 2,000 mg/kg BW (10 mL/kg dosing volume) No test article-related adverse effects on mortality, toxicity; ophthalmoscopy, body wts or body wt gains, clinical chemistry, hematology, or urinalysis; statistically significant decreases in testes wt in males of the low-dose...","effect":"lucidum) CD (SD) IGS rats, 12 M,12 F 3 months Sterile water; by gavage 0, 500, 1,000, or 2,000 mg/kg BW (10 mL/kg dosing volume) No test article-related adverse effects on mortality, toxicity; ophthalmoscopy, body wts or body wt gains, clinical chemistry, hematology, or urinalysis; statistically significant decreases in testes wt in males of the low-dose group and heart wts in females of the high-dose group were not considered test-article related; there were no treatment-related gross or microscopic lesions, the NOAEL was 2,000 mg/kg BW 42 Beta-glucan (as curdlan) CD rats; 60 M/60 F 2 years In diet 0%, 1%, 5%, or 15% No changes in mortality, behavior, appearance, or ophthalmic parameters; wt gain was decreased by *10%, which was not stat. sig., in the 15% group; feed consumption was also reduced; no microscopic lesions were found, the NOEL was 5% based on decreased feed consumption, body wt gain, and increased cecal wts 42 Beta-glucan (as curdlan) CD rats; 60 M/60 F, of the F1a generation of a reproductive toxicology study 124-127 weeks (20% survival) In diet 0%, 1%, 5%, or 15% N...","page":28,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_003"}
CIR_vision_codex NOAEL =1 % - oral - oral toxicity {"citation":"15; 5; 65","effect":"ers; body wts of the 15% group were stat. sig. decreased, and body wts were stat. sig. decreased in 5% males until wk 65; feed consumption was decreased in the 15% group; no changes in hematology or urinary parameters, but some stat. sig. changes were reported in blood chemistry; stat. sig increase in gross and microscopic incidences of uterine polyps in the 15% groups—the incidences were 0/450, 3/50, 4/51, and 7/50 for the 0%, 1%, 5%, and 15% groups, indicating that the polyps were possible treatment related; the NOEL was 1% based on increased cecal wts, decreased body wts and feed consumption, and the incidence of polyps 42 (continued) 32S","page":28,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_004"}
CIR_vision_codex NOAEL =100 mg/kg BW/d rat oral 28 days oral toxicity {"citation":"0, 2, 33; 3; 100","dose":"ays Water 0, 2, 33.3, or 100 mg/kg BW / d, volume 0.5 mL/100 g BW, by gavage No mortality; no stat. sig. differences in wt gains, feed consumption, or gross or microscopic lesions; a dose-dependent and stat. sig. increase in clotting time in males, isolated stat. sig. changes in some clinical chemistry parameters, and slight but stat. sig. incr. in absolu...","effect":"ays Water 0, 2, 33.3, or 100 mg/kg BW / d, volume 0.5 mL/100 g BW, by gavage No mortality; no stat. sig. differences in wt gains, feed consumption, or gross or microscopic lesions; a dose-dependent and stat. sig. increase in clotting time in males, isolated stat. sig. changes in some clinical chemistry parameters, and slight but stat. sig. incr. in absolute liver, kidney, heart, spleen, adrenal, and testicle wts in males and absolute kidney and thymus wts in females were not considered toxicologically significant; NOAEL was 100 mg/kg BW/d 106 Beta-glucan (high-purity extract barley beta-glucan) SPF Wistar rats, 5 M/5 F 28 days In diet 0%, 1%, 5%, or 10%, supplemented with \u000210% potato starch No mortality; no sig. effects on body wts, feed consumption, or functional observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts,...","page":29,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_005"}
CIR_vision_codex NOAEL =20 mg/kg rat oral 52 weeks oral toxicity {"citation":"113; 20; 52","dose":"l observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts, feed consumption, or hematology,...","effect":"l observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts, feed consumption, or hematology, clinical chemistry, or urinalysis parameters; with the exception of cecal enlargement with variable hyperplasia, not gross or microscopic lesions were noted; the NOEL was 100 mg/kg/d 114 Pullulan 8 Wistar rats, males (test and cellulose control groups) 4 or 9 weeks In diet 0%, 5%, 10%, 20%, or 40%; equivalent to 0, 2,500, 5,000, 10,000, or 20,000 mg/kg, respectively; cellulose controls: 20% or 40% cellulose Body wt gains were decreased by day 10 in rats of the 20% and 40% groups when compared to untreated controls; wt gains of animals of the 5% and 10% pullulan group were lower than untreated controls after 7 weeks, but this difference was not stat. sig.; similar decreases were observed in the animals fed cellulose; diarrhea was...","page":29,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_006"}
CIR_vision_codex NOAEL =10 % rat oral 62 weeks oral toxicity {"citation":"5; 10; 44","dose":"l wts were observed in males of the 5% and males and females of the 10% group; no microscopic changes were observed 44 Pullulan Sprague-Dawley rats, 15 M/15 F 62 weeks (was to be 24 months; study was terminated because of poor survival due to pneumonia) In diet 0%, 1%, 5%, and 10% No treatment-related effects on body wts, feed consumption, or organ wts (e...","effect":"l wts were observed in males of the 5% and males and females of the 10% group; no microscopic changes were observed 44 Pullulan Sprague-Dawley rats, 15 M/15 F 62 weeks (was to be 24 months; study was terminated because of poor survival due to pneumonia) In diet 0%, 1%, 5%, and 10% No treatment-related effects on body wts, feed consumption, or organ wts (except for cecal wts); changes in hematology or clinical chemistry parameters and microscopic lesions that were observed were not considered treatment related; the NOAEL was 10% in the diet (equivalent to 4,450 mg/kg BW /d) 115 (continued) 33S","page":29,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_007"}
CIR_vision_codex NOAEL =15 % rat oral 100 days reproductive toxicity {"citation":"20; 40; 15","effect":"y treated dams. A no observable effect level (NOEL) was not established. The researchers also examined whether there would be decreased weight gain by the pups if dosing was discontinued during lactation. The protocol was similar to that just described, except that all groups consisted of 20 male and 40 female CD rats, and there was no crossover at lactation. Weight gain by all pups during lactations was similar, although the researchers did state that the pups could have consumed par- ental diet from day 10þ. The NOEL for parental toxicity and embryotoxicity was 15% beta-glucan. A 3-generation reproductive study was performed in which groups of 20 male and 40 female CD rats were fed a diet containing 0%, 1%, 5%, or 15% beta-glucan (as curdlan) for 100 days.42 The F0 parents were mated twice, and the number of parents was halved after weaning of the first litter. The F1 parents were mated 3 times and the F2 parents were mated twice. The F1b and F2b litters were used to produce the next generation. After the third mating of the F1 parents, half of the F1 dams were killed on day 13...","page":31,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_008"}
CIR_vision_codex NOAEL =5 g/kg rabbit - - developmental toxicity {"citation":"2; 28; 1, 1","dose":"Eleven resorptions were observed in the high- dose group, as compared to 4 in the control group, 6 in the 1 g/kg group, and 5 in the 2 g/kg group.","effect":"es, and the controls received 2 empty capsules. The rabbits were killed on day 28 of gestation. None of the controls died, but 1, 1, and 3 dams of the 1, 2, and 5 g/kg BW/day groups, respectively, died during the study. Eleven resorptions were observed in the high- dose group, as compared to 4 in the control group, 6 in the 1 g/kg group, and 5 in the 2 g/kg group. The researchers stated, how- ever, that the number of dams with resorptions was similar in all groups and that no teratogenic effects were observed. The NOEL for both maternal and embryotoxicity was 5 g/kg BW/d. Genotoxicity Genotoxicity studies are summarized in Table 10. The in vitro genotoxicity of gellan gum (\u000220 mg/mL), sodium dextran sul- fate (\u000225 mg/plate), beta-glucan (\u00025,000 mg/plate or mg/mL), sodium carboxymethyl beta-glucan (\u000250,000 mg/plate or mg/mL), and pullulan (\u000212 mg/mL) was evaluated using Ames test, chromosomal aberration assays, and/or DNA repair tests, with and without metabolic activation. The results were nega- tive in these tests. The only nonnegative result was a weak positive outcome with 20 m...","page":32,"pdf":"PRS611.pdf","row_type":"noael_study","study_id":"PRS611_noael_009"}
COSMOS_DB 5 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
COSMOS_DB NOAEL 1000 mg/kg bw/day rat oral 730 day Carcinogenicity US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 500 mg/kg bw/day rat oral NA Multigeneration Reproductive US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 2000 mg/kg bw/day dog oral 84 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 3250 mg/kg bw/day rat oral 99 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB NOAEL 7500 mg/kg bw/day rat oral 91 day Subchronic US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
ToxValDB_EFSA 1 endpoint
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
ToxValDB_EFSA LEL =214 mg/kg bw/day Human oral short-term; 10 days clinical LONG_REF=EFSA ANS (2017). Re-evaluation of xanthan gum (E 415) as a food additive. doi:10.2903/j.efsa.2017.4909.; TITLE=Re-evaluation of xanthan gum (E 415) as a food additive; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2017.4909; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15625123:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_13fc3e92ef0a4e6f40b94add6d8e0e1b
UnifiedCodex:CIR:beta.noael_studies 9 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
UnifiedCodex:CIR:beta.noael_studies developmental toxicity 5 g/kg rabbit - - developmental toxicity SOURCE_SUBDIR=PRS611; REPORT_TITLE=Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics Monice M. Fiume1, 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=PRS611; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=2 In 2009; VALUE_TEXT=5; DOSE=Eleven resorptions were observed in the high- dose group, as compared to 4 in the control group, 6 in the 1 g/kg group, and 5 in the 2 g/kg group.; EFFECT=es, and the controls received 2 empty capsules. The rabbits were killed on day 28 of gestation. None of the controls died, but 1, 1, and 3 dams of the 1, 2, and 5 g/kg BW/day groups, respectively, died during the study. Eleven resorptions were observed in the high- dose group, as compared to 4 in the control group, 6 in the 1 g/kg group, and 5 in the 2 g/kg group. The researchers stated, how- ever, that the number of dams with resorptions was similar in all groups and that no teratogenic effects were observed. The NOEL for both maternal and embryotoxicity was 5 g/kg BW/d. Genotoxicity Genotoxicity studies are summarized in Table 10. The in vitro genotoxicity of gellan gum (20 mg/mL), sodium dextran sul- fate (25 mg/plate), beta-glucan (5,000 mg/plate or mg/mL), sodium carboxymethyl beta-glucan (50,000 mg/plate or mg/mL), and pullulan (12 mg/mL) was evaluated using Ames test, chromosomal aberration assays, and/or DNA repair tests, with and without metabolic activation. The results were nega- tive in these tests. The only nonnegative result was a weak positive outcome with 20 m...; CITATION=2; 28; 1, 1; CITATION_NUMBERS=[2,28,1]; REFERENCE=2; 28; 1, 1; DETAILS_JSON={"cas_number":"11138-66-2","citation":"2; 28; 1, 1","dose":"Eleven resorptions were observed in the high- dose group, as compared to 4 in the control group, 6 in the 1 g/kg group, and 5 in the 2 g/kg group.","duration":"","effect":"es, and the controls received 2 empty capsules. The rabbits were killed on day 28 of gestation. None of the controls died, but 1, 1, and 3 dams of the 1, 2, and 5 g/kg BW/day groups, respectively, died during the study. Eleven resorptions were observed in the high- dose group, as compared to 4 in the control group, 6 in the 1 g/kg group, and 5 in the 2 g/kg group. The researchers stated, how- ever, that the number of dams with resorptions was similar in all groups and that no teratogenic effects were observed. The NOEL for both maternal and embryotoxicity was 5 g/kg BW/d. Genotoxicity Genotoxicity studies are summarized in Table 10. The in vitro genotoxicity of gellan gum (\u000220 mg/mL), sodium dextran sul- fate (\u000225 mg/plate), beta-glucan (\u00025,000 mg/plate or mg/mL), sodium carboxymethyl beta-glucan (\u000250,000 mg/plate or mg/mL), and pullulan (\u000212 mg/mL) was evaluated using Ames test, chromosomal aberration assays, and/or DNA repair tests, with and without metabolic activation. The results were nega- tive in these tests. The only nonnegative result was a weak positive outcome with 20 m...","endpoint":"developmental toxicity","ingredient":"Microbial Polysaccharide Gums","loael_value":"","noael_unit":"g/kg","noael_value":"5","page":32,"route":"","species":"rabbit","study_id":"PRS611_noael_009"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity 0.25 g/kg dog oral 12 weeks oral toxicity SOURCE_SUBDIR=PRS611; REPORT_TITLE=Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics Monice M. Fiume1, 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=PRS611; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=2 In 2009; VALUE_TEXT=0.25; DOSE=ficant differences in growth rate, survival, hematology and clinical chemistry parameters, or organ weight were observed between treated and control animals; although not statistically significant (stat. sig.), there was an increase in uterine polyps in the high-dose groups compared to controls, 5 in the high-dose animals vs 2 in controls 61 Xanthan gum B...; EFFECT=ficant differences in growth rate, survival, hematology and clinical chemistry parameters, or organ weight were observed between treated and control animals; although not statistically significant (stat. sig.), there was an increase in uterine polyps in the high-dose groups compared to controls, 5 in the high-dose animals vs 2 in controls 61 Xanthan gum Beagle dogs, 3 M/3 F 12 weeks In diet 0, 0.25, or 0.5 g/kg BW/d Growth of high-dose males was slightly less than controls; the no- observable adverse effect level (NOAEL) was 0.25 g/kg BW/d 38 Xanthan gum Beagle dogs, 2 M/2 F 12 weeks In diet 0, 1, or 2 g/kg BW/d; positive controls were given 20 g/kg BW/d powdered cellulose Immediate and persistent diarrhea in the 2 g/kg group; body wt loss was observed in treated and control animals, with the wt loss greatest in the 2 g/kg group; red blood cell counts, hemoglobin, and serum cholesterol levels were decreased in high-dose animals; adrenal glands were slightly enlarged in the 2 g/kg group; no treatment-related microscopic lesion were observed at necropsy 111 Xanthan gum Beagle dogs,...; CITATION=5; 2; 61; CITATION_NUMBERS=[5,2,61]; REFERENCE=5; 2; 61; DETAILS_JSON={"cas_number":"11138-66-2","citation":"5; 2; 61","dose":"ficant differences in growth rate, survival, hematology and clinical chemistry parameters, or organ weight were observed between treated and control animals; although not statistically significant (stat. sig.), there was an increase in uterine polyps in the high-dose groups compared to controls, 5 in the high-dose animals vs 2 in controls 61 Xanthan gum B...","duration":"12 weeks","effect":"ficant differences in growth rate, survival, hematology and clinical chemistry parameters, or organ weight were observed between treated and control animals; although not statistically significant (stat. sig.), there was an increase in uterine polyps in the high-dose groups compared to controls, 5 in the high-dose animals vs 2 in controls 61 Xanthan gum Beagle dogs, 3 M/3 F 12 weeks In diet 0, 0.25, or 0.5 g/kg BW/d Growth of high-dose males was slightly less than controls; the no- observable adverse effect level (NOAEL) was 0.25 g/kg BW/d 38 Xanthan gum Beagle dogs, 2 M/2 F 12 weeks In diet 0, 1, or 2 g/kg BW/d; positive controls were given 20 g/kg BW/d powdered cellulose Immediate and persistent diarrhea in the 2 g/kg group; body wt loss was observed in treated and control animals, with the wt loss greatest in the 2 g/kg group; red blood cell counts, hemoglobin, and serum cholesterol levels were decreased in high-dose animals; adrenal glands were slightly enlarged in the 2 g/kg group; no treatment-related microscopic lesion were observed at necropsy 111 Xanthan gum Beagle dogs,...","endpoint":"oral toxicity","ingredient":"Microbial Polysaccharide Gums","loael_value":"","noael_unit":"g/kg","noael_value":"0.25","page":27,"route":"oral","species":"dog","study_id":"PRS611_noael_001"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity 5 % rat oral 28 days oral toxicity SOURCE_SUBDIR=PRS611; REPORT_TITLE=Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics Monice M. Fiume1, 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=PRS611; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=2 In 2009; VALUE_TEXT=5; EFFECT=sac. Rhesus monkey, 2 M/2 F 28 days Not provided 0, 1, 2, or 3 g/kg, by gavage No signs of toxicity 39 Dextran Albino rats, 6 M 62 days In diet 15% Wt gain was normal 104 Beta-glucan (as curdlan) CD-1 mice, 10 M/10 F 8 weeks In diet 0%, 1%, 5%, 10%, 20%, or 30%; equivalent to 0, 1.4, 7.1, 14, 29, and 43 g/kg B, respectively One female of the 30% group died; body wt gains of male mice of the 30% group were decreased compared to controls; no gross abnormalities; differences in stools and cecal wts were reported; the NOEL was 5% based on an increase in full cecal wts and large stools at higher doses 42 (continued) 31S; CITATION=2; 28; 0, 1, 2; CITATION_NUMBERS=[2,28,1]; REFERENCE=2; 28; 0, 1, 2; DETAILS_JSON={"cas_number":"11138-66-2","citation":"2; 28; 0, 1, 2","dose":"","duration":"28 days","effect":"sac. Rhesus monkey, 2 M/2 F 28 days Not provided 0, 1, 2, or 3 g/kg, by gavage No signs of toxicity 39 Dextran Albino rats, 6 M 62 days In diet 15% Wt gain was normal 104 Beta-glucan (as curdlan) CD-1 mice, 10 M/10 F 8 weeks In diet 0%, 1%, 5%, 10%, 20%, or 30%; equivalent to 0, 1.4, 7.1, 14, 29, and 43 g/kg B, respectively One female of the 30% group died; body wt gains of male mice of the 30% group were decreased compared to controls; no gross abnormalities; differences in stools and cecal wts were reported; the NOEL was 5% based on an increase in full cecal wts and large stools at higher doses 42 (continued) 31S","endpoint":"oral toxicity","ingredient":"Microbial Polysaccharide Gums","loael_value":"","noael_unit":"%","noael_value":"5","page":27,"route":"oral","species":"rat","study_id":"PRS611_noael_002"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity 1 % - oral - oral toxicity SOURCE_SUBDIR=PRS611; REPORT_TITLE=Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics Monice M. Fiume1, 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=PRS611; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=2 In 2009; VALUE_TEXT=1; EFFECT=ers; body wts of the 15% group were stat. sig. decreased, and body wts were stat. sig. decreased in 5% males until wk 65; feed consumption was decreased in the 15% group; no changes in hematology or urinary parameters, but some stat. sig. changes were reported in blood chemistry; stat. sig increase in gross and microscopic incidences of uterine polyps in the 15% groups—the incidences were 0/450, 3/50, 4/51, and 7/50 for the 0%, 1%, 5%, and 15% groups, indicating that the polyps were possible treatment related; the NOEL was 1% based on increased cecal wts, decreased body wts and feed consumption, and the incidence of polyps 42 (continued) 32S; CITATION=15; 5; 65; CITATION_NUMBERS=[15,5,65]; REFERENCE=15; 5; 65; DETAILS_JSON={"cas_number":"11138-66-2","citation":"15; 5; 65","dose":"","duration":"","effect":"ers; body wts of the 15% group were stat. sig. decreased, and body wts were stat. sig. decreased in 5% males until wk 65; feed consumption was decreased in the 15% group; no changes in hematology or urinary parameters, but some stat. sig. changes were reported in blood chemistry; stat. sig increase in gross and microscopic incidences of uterine polyps in the 15% groups—the incidences were 0/450, 3/50, 4/51, and 7/50 for the 0%, 1%, 5%, and 15% groups, indicating that the polyps were possible treatment related; the NOEL was 1% based on increased cecal wts, decreased body wts and feed consumption, and the incidence of polyps 42 (continued) 32S","endpoint":"oral toxicity","ingredient":"Microbial Polysaccharide Gums","loael_value":"","noael_unit":"%","noael_value":"1","page":28,"route":"oral","species":"","study_id":"PRS611_noael_004"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity 100 mg/kg BW/d rat oral 28 days oral toxicity SOURCE_SUBDIR=PRS611; REPORT_TITLE=Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics Monice M. Fiume1, 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=PRS611; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=2 In 2009; VALUE_TEXT=100; DOSE=ays Water 0, 2, 33.3, or 100 mg/kg BW / d, volume 0.5 mL/100 g BW, by gavage No mortality; no stat. sig. differences in wt gains, feed consumption, or gross or microscopic lesions; a dose-dependent and stat. sig. increase in clotting time in males, isolated stat. sig. changes in some clinical chemistry parameters, and slight but stat. sig. incr. in absolu...; EFFECT=ays Water 0, 2, 33.3, or 100 mg/kg BW / d, volume 0.5 mL/100 g BW, by gavage No mortality; no stat. sig. differences in wt gains, feed consumption, or gross or microscopic lesions; a dose-dependent and stat. sig. increase in clotting time in males, isolated stat. sig. changes in some clinical chemistry parameters, and slight but stat. sig. incr. in absolute liver, kidney, heart, spleen, adrenal, and testicle wts in males and absolute kidney and thymus wts in females were not considered toxicologically significant; NOAEL was 100 mg/kg BW/d 106 Beta-glucan (high-purity extract barley beta-glucan) SPF Wistar rats, 5 M/5 F 28 days In diet 0%, 1%, 5%, or 10%, supplemented with 10% potato starch No mortality; no sig. effects on body wts, feed consumption, or functional observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts,...; CITATION=0, 2, 33; 3; 100; CITATION_NUMBERS=[2,33,3,100]; REFERENCE=0, 2, 33; 3; 100; DETAILS_JSON={"cas_number":"11138-66-2","citation":"0, 2, 33; 3; 100","dose":"ays Water 0, 2, 33.3, or 100 mg/kg BW / d, volume 0.5 mL/100 g BW, by gavage No mortality; no stat. sig. differences in wt gains, feed consumption, or gross or microscopic lesions; a dose-dependent and stat. sig. increase in clotting time in males, isolated stat. sig. changes in some clinical chemistry parameters, and slight but stat. sig. incr. in absolu...","duration":"28 days","effect":"ays Water 0, 2, 33.3, or 100 mg/kg BW / d, volume 0.5 mL/100 g BW, by gavage No mortality; no stat. sig. differences in wt gains, feed consumption, or gross or microscopic lesions; a dose-dependent and stat. sig. increase in clotting time in males, isolated stat. sig. changes in some clinical chemistry parameters, and slight but stat. sig. incr. in absolute liver, kidney, heart, spleen, adrenal, and testicle wts in males and absolute kidney and thymus wts in females were not considered toxicologically significant; NOAEL was 100 mg/kg BW/d 106 Beta-glucan (high-purity extract barley beta-glucan) SPF Wistar rats, 5 M/5 F 28 days In diet 0%, 1%, 5%, or 10%, supplemented with \u000210% potato starch No mortality; no sig. effects on body wts, feed consumption, or functional observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts,...","endpoint":"oral toxicity","ingredient":"Microbial Polysaccharide Gums","loael_value":"","noael_unit":"mg/kg BW/d","noael_value":"100","page":29,"route":"oral","species":"rat","study_id":"PRS611_noael_005"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity 20 mg/kg rat oral 52 weeks oral toxicity SOURCE_SUBDIR=PRS611; REPORT_TITLE=Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics Monice M. Fiume1, 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=PRS611; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=2 In 2009; VALUE_TEXT=20; 000; DOSE=l observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts, feed consumption, or hematology,...; EFFECT=l observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts, feed consumption, or hematology, clinical chemistry, or urinalysis parameters; with the exception of cecal enlargement with variable hyperplasia, not gross or microscopic lesions were noted; the NOEL was 100 mg/kg/d 114 Pullulan 8 Wistar rats, males (test and cellulose control groups) 4 or 9 weeks In diet 0%, 5%, 10%, 20%, or 40%; equivalent to 0, 2,500, 5,000, 10,000, or 20,000 mg/kg, respectively; cellulose controls: 20% or 40% cellulose Body wt gains were decreased by day 10 in rats of the 20% and 40% groups when compared to untreated controls; wt gains of animals of the 5% and 10% pullulan group were lower than untreated controls after 7 weeks, but this difference was not stat. sig.; similar decreases were observed in the animals fed cellulose; diarrhea was...; CITATION=113; 20; 52; CITATION_NUMBERS=[113,20,52]; REFERENCE=113; 20; 52; DETAILS_JSON={"cas_number":"11138-66-2","citation":"113; 20; 52","dose":"l observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts, feed consumption, or hematology,...","duration":"52 weeks","effect":"l observational battery results; no treatment-related change in hematology or urinalysis values; empty caecum wt was increased 113 Beta-glucan (extracted from Candida albicans) Sprague-Dawley rats, 20 M/20 F 52 weeks Sterile saline (using a rubber catheter) 0, 50, 100, or 200 mg/kg/d No sig. effects on mortality, body wts, feed consumption, or hematology, clinical chemistry, or urinalysis parameters; with the exception of cecal enlargement with variable hyperplasia, not gross or microscopic lesions were noted; the NOEL was 100 mg/kg/d 114 Pullulan 8 Wistar rats, males (test and cellulose control groups) 4 or 9 weeks In diet 0%, 5%, 10%, 20%, or 40%; equivalent to 0, 2,500, 5,000, 10,000, or 20,000 mg/kg, respectively; cellulose controls: 20% or 40% cellulose Body wt gains were decreased by day 10 in rats of the 20% and 40% groups when compared to untreated controls; wt gains of animals of the 5% and 10% pullulan group were lower than untreated controls after 7 weeks, but this difference was not stat. sig.; similar decreases were observed in the animals fed cellulose; diarrhea was...","endpoint":"oral toxicity","ingredient":"Microbial Polysaccharide Gums","loael_value":"","noael_unit":"mg/kg","noael_value":"20; 000","page":29,"route":"oral","species":"rat","study_id":"PRS611_noael_006"}
UnifiedCodex:CIR:beta.noael_studies oral toxicity 10 % rat oral 62 weeks oral toxicity SOURCE_SUBDIR=PRS611; REPORT_TITLE=Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics Monice M. Fiume1, 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=PRS611; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=2 In 2009; VALUE_TEXT=10; DOSE=l wts were observed in males of the 5% and males and females of the 10% group; no microscopic changes were observed 44 Pullulan Sprague-Dawley rats, 15 M/15 F 62 weeks (was to be 24 months; study was terminated because of poor survival due to pneumonia) In diet 0%, 1%, 5%, and 10% No treatment-related effects on body wts, feed consumption, or organ wts (e...; EFFECT=l wts were observed in males of the 5% and males and females of the 10% group; no microscopic changes were observed 44 Pullulan Sprague-Dawley rats, 15 M/15 F 62 weeks (was to be 24 months; study was terminated because of poor survival due to pneumonia) In diet 0%, 1%, 5%, and 10% No treatment-related effects on body wts, feed consumption, or organ wts (except for cecal wts); changes in hematology or clinical chemistry parameters and microscopic lesions that were observed were not considered treatment related; the NOAEL was 10% in the diet (equivalent to 4,450 mg/kg BW /d) 115 (continued) 33S; CITATION=5; 10; 44; CITATION_NUMBERS=[5,10,44]; REFERENCE=5; 10; 44; DETAILS_JSON={"cas_number":"11138-66-2","citation":"5; 10; 44","dose":"l wts were observed in males of the 5% and males and females of the 10% group; no microscopic changes were observed 44 Pullulan Sprague-Dawley rats, 15 M/15 F 62 weeks (was to be 24 months; study was terminated because of poor survival due to pneumonia) In diet 0%, 1%, 5%, and 10% No treatment-related effects on body wts, feed consumption, or organ wts (e...","duration":"62 weeks","effect":"l wts were observed in males of the 5% and males and females of the 10% group; no microscopic changes were observed 44 Pullulan Sprague-Dawley rats, 15 M/15 F 62 weeks (was to be 24 months; study was terminated because of poor survival due to pneumonia) In diet 0%, 1%, 5%, and 10% No treatment-related effects on body wts, feed consumption, or organ wts (except for cecal wts); changes in hematology or clinical chemistry parameters and microscopic lesions that were observed were not considered treatment related; the NOAEL was 10% in the diet (equivalent to 4,450 mg/kg BW /d) 115 (continued) 33S","endpoint":"oral toxicity","ingredient":"Microbial Polysaccharide Gums","loael_value":"","noael_unit":"%","noael_value":"10","page":29,"route":"oral","species":"rat","study_id":"PRS611_noael_007"}
UnifiedCodex:CIR:beta.noael_studies reproductive toxicity 2000 mg/kg BW rat oral 3 months reproductive toxicity SOURCE_SUBDIR=PRS611; REPORT_TITLE=Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics Monice M. Fiume1, 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=PRS611; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=2 In 2009; VALUE_TEXT=2,000; DOSE=lucidum) CD (SD) IGS rats, 12 M,12 F 3 months Sterile water; by gavage 0, 500, 1,000, or 2,000 mg/kg BW (10 mL/kg dosing volume) No test article-related adverse effects on mortality, toxicity; ophthalmoscopy, body wts or body wt gains, clinical chemistry, hematology, or urinalysis; statistically significant decreases in testes wt in males of the low-dose...; EFFECT=lucidum) CD (SD) IGS rats, 12 M,12 F 3 months Sterile water; by gavage 0, 500, 1,000, or 2,000 mg/kg BW (10 mL/kg dosing volume) No test article-related adverse effects on mortality, toxicity; ophthalmoscopy, body wts or body wt gains, clinical chemistry, hematology, or urinalysis; statistically significant decreases in testes wt in males of the low-dose group and heart wts in females of the high-dose group were not considered test-article related; there were no treatment-related gross or microscopic lesions, the NOAEL was 2,000 mg/kg BW 42 Beta-glucan (as curdlan) CD rats; 60 M/60 F 2 years In diet 0%, 1%, 5%, or 15% No changes in mortality, behavior, appearance, or ophthalmic parameters; wt gain was decreased by *10%, which was not stat. sig., in the 15% group; feed consumption was also reduced; no microscopic lesions were found, the NOEL was 5% based on decreased feed consumption, body wt gain, and increased cecal wts 42 Beta-glucan (as curdlan) CD rats; 60 M/60 F, of the F1a generation of a reproductive toxicology study 124-127 weeks (20% survival) In diet 0%, 1%, 5%, or 15% N...; CITATION=12; 3; 0, 500, 1,000; CITATION_NUMBERS=[12,3,500,1]; REFERENCE=12; 3; 0, 500, 1,000; DETAILS_JSON={"cas_number":"11138-66-2","citation":"12; 3; 0, 500, 1,000","dose":"lucidum) CD (SD) IGS rats, 12 M,12 F 3 months Sterile water; by gavage 0, 500, 1,000, or 2,000 mg/kg BW (10 mL/kg dosing volume) No test article-related adverse effects on mortality, toxicity; ophthalmoscopy, body wts or body wt gains, clinical chemistry, hematology, or urinalysis; statistically significant decreases in testes wt in males of the low-dose...","duration":"3 months","effect":"lucidum) CD (SD) IGS rats, 12 M,12 F 3 months Sterile water; by gavage 0, 500, 1,000, or 2,000 mg/kg BW (10 mL/kg dosing volume) No test article-related adverse effects on mortality, toxicity; ophthalmoscopy, body wts or body wt gains, clinical chemistry, hematology, or urinalysis; statistically significant decreases in testes wt in males of the low-dose group and heart wts in females of the high-dose group were not considered test-article related; there were no treatment-related gross or microscopic lesions, the NOAEL was 2,000 mg/kg BW 42 Beta-glucan (as curdlan) CD rats; 60 M/60 F 2 years In diet 0%, 1%, 5%, or 15% No changes in mortality, behavior, appearance, or ophthalmic parameters; wt gain was decreased by *10%, which was not stat. sig., in the 15% group; feed consumption was also reduced; no microscopic lesions were found, the NOEL was 5% based on decreased feed consumption, body wt gain, and increased cecal wts 42 Beta-glucan (as curdlan) CD rats; 60 M/60 F, of the F1a generation of a reproductive toxicology study 124-127 weeks (20% survival) In diet 0%, 1%, 5%, or 15% N...","endpoint":"reproductive toxicity","ingredient":"Microbial Polysaccharide Gums","loael_value":"","noael_unit":"mg/kg BW","noael_value":"2,000","page":28,"route":"oral","species":"rat","study_id":"PRS611_noael_003"}
UnifiedCodex:CIR:beta.noael_studies reproductive toxicity 15 % rat oral 100 days reproductive toxicity SOURCE_SUBDIR=PRS611; REPORT_TITLE=Safety Assessment of Microbial Polysaccharide Gums as Used in Cosmetics Monice M. Fiume1, 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=PRS611; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=2 In 2009; VALUE_TEXT=15; EFFECT=y treated dams. A no observable effect level (NOEL) was not established. The researchers also examined whether there would be decreased weight gain by the pups if dosing was discontinued during lactation. The protocol was similar to that just described, except that all groups consisted of 20 male and 40 female CD rats, and there was no crossover at lactation. Weight gain by all pups during lactations was similar, although the researchers did state that the pups could have consumed par- ental diet from day 10þ. The NOEL for parental toxicity and embryotoxicity was 15% beta-glucan. A 3-generation reproductive study was performed in which groups of 20 male and 40 female CD rats were fed a diet containing 0%, 1%, 5%, or 15% beta-glucan (as curdlan) for 100 days.42 The F0 parents were mated twice, and the number of parents was halved after weaning of the first litter. The F1 parents were mated 3 times and the F2 parents were mated twice. The F1b and F2b litters were used to produce the next generation. After the third mating of the F1 parents, half of the F1 dams were killed on day 13...; CITATION=20; 40; 15; CITATION_NUMBERS=[20,40,15]; REFERENCE=20; 40; 15; DETAILS_JSON={"cas_number":"11138-66-2","citation":"20; 40; 15","dose":"","duration":"100 days","effect":"y treated dams. A no observable effect level (NOEL) was not established. The researchers also examined whether there would be decreased weight gain by the pups if dosing was discontinued during lactation. The protocol was similar to that just described, except that all groups consisted of 20 male and 40 female CD rats, and there was no crossover at lactation. Weight gain by all pups during lactations was similar, although the researchers did state that the pups could have consumed par- ental diet from day 10þ. The NOEL for parental toxicity and embryotoxicity was 15% beta-glucan. A 3-generation reproductive study was performed in which groups of 20 male and 40 female CD rats were fed a diet containing 0%, 1%, 5%, or 15% beta-glucan (as curdlan) for 100 days.42 The F0 parents were mated twice, and the number of parents was halved after weaning of the first litter. The F1 parents were mated 3 times and the F2 parents were mated twice. The F1b and F2b litters were used to produce the next generation. After the third mating of the F1 parents, half of the F1 dams were killed on day 13...","endpoint":"reproductive toxicity","ingredient":"Microbial Polysaccharide Gums","loael_value":"","noael_unit":"%","noael_value":"15","page":31,"route":"oral","species":"rat","study_id":"PRS611_noael_008"}
openFDA substances 4 endpoints
Source Endpoint Type Value Unit Species Route Duration Study Type Reference
openFDA substances FDA UNII substance identifier TTV12P4NEE UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"TTV12P4NEE"}
openFDA substances FDA UNII substance identifier TTV12P4NEE UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"TTV12P4NEE"}
openFDA substances FDA UNII substance identifier TTV12P4NEE UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"TTV12P4NEE"}
openFDA substances FDA UNII substance identifier TTV12P4NEE UNII - - - structurallyDiverse {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"TTV12P4NEE"}