NOAEL Studies
Cosmetic Ingredient
Butylene/Ethylene/Styrene Copolymer NOAEL Studies
INCI: BUTYLENE/ETHYLENE/STYRENE COPOLYMER
CAS: 68648-89-5
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR_vision_codex 24 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR_vision_codex | NOAEL | =0.05 | mg/m3 | rat | inhalation | 24 months | inhalation toxicity | {"citation":"0; 05; 2","dose":"/m3 (at this concentration, threshold for clearing inhaled test material from the lungs was exceeded) caused adverse pulmonary effects (marked inflammation and benign alveolar/bronchiolar adenoma) that are not relevant to subthreshold exposure concentrations.","effect":"/m3 (at this concentration, threshold for clearing inhaled test material from the lungs was exceeded) caused adverse pulmonary effects (marked inflammation and benign alveolar/bronchiolar adenoma) that are not relevant to subthreshold exposure concentrations. Inflammation decreased during the recovery period. The authors stated that these results support the inhalation safety of the polyacrylate material under both occupational and consumer exposure conditions. The 0.05 and 0.2 mg/m3 concentrations were considered no-adverse-effect levels. Three groups of 120 F344 rats (60 males, 60 females/group) were exposed for 24 months to respirable polyacrylate particles (MMAD ≈ 2 to 3 microns) at concentrations of 0.05, 0.2, and 0.8 mg/m3, respectively.38","page":8,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_001"} |
| CIR_vision_codex | NOAEL | =10.8 | mg polymer solids/m3 | rat | oral | 2-week | repeated dose toxicity | {"citation":"2; 29,30; 10","dose":"There were no signs of clinical toxicity at any administered dose.","effect":"odule formation in all exposure groups. The authors noted that characterization of the nodules was not possible, and it was determined that conclusions regarding the lung nodule incidence and its significance (if any) in this study could not be made. Styrene/Acrylates Copolymer ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer were evaluated in a 2-week aerosol (nose only) exposure study involving rats.29,30 The test protocol was not stated. There were no signs of clinical toxicity at any administered dose. The no-observed-effect-concentration (NOEC) was 10.8 mg polymer solids/m3, based on slight irritant effects in the lungs at a concentration of 100 mg/m3. In a 13-week aerosol (nose only) study on ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer involving rats, the no-observable adverse-effect level (NOAEL) for changes in the lung (and related lymph nodes) was 8.3 mg/m3.29,30 Oral Styrene The Environmental Protection Agency (EPA) has established a reference dose for chronic oral exposure (RfD) to styrene of 1 mg/kg/day, based on effects on red blood cells and the liver of dog...","page":9,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_002"} |
| CIR_vision_codex | NOAEL | =8.3 | mg/m3 | rat | oral | 2-week | repeated dose toxicity | {"citation":"2; 29,30; 10","dose":"There were no signs of clinical toxicity at any administered dose.","effect":"lates Copolymer ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer were evaluated in a 2-week aerosol (nose only) exposure study involving rats.29,30 The test protocol was not stated. There were no signs of clinical toxicity at any administered dose. The no-observed-effect-concentration (NOEC) was 10.8 mg polymer solids/m3, based on slight irritant effects in the lungs at a concentration of 100 mg/m3. In a 13-week aerosol (nose only) study on ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer involving rats, the no-observable adverse-effect level (NOAEL) for changes in the lung (and related lymph nodes) was 8.3 mg/m3.29,30 Oral Styrene The Environmental Protection Agency (EPA) has established a reference dose for chronic oral exposure (RfD) to styrene of 1 mg/kg/day, based on effects on red blood cells and the liver of dogs.39 The RfD is based on the assumption that thresholds exist for certain toxic effects, such as cellular necrosis. In general, the RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the human population (including...","page":9,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_003"} |
| CIR_vision_codex | NOAEL | =200 | mg/kg-day | dog | - | - | NOAEL study | {"citation":"200; 400; (4","dose":"erved for dogs administered styrene at 200 mg/kg-day.","effect":"erved for dogs administered styrene at 200 mg/kg-day. In the higher dose groups, increased numbers of Heinz bodies in the RBCs, decreased packed cell volume, and sporadic decreases in hemoglobin and RBC counts were observed. Additionally, increased iron deposits and elevated numbers of Heinz bodies were found in the livers. Marked individual variations in blood cell parameters were noted for animals at the same dose. Other parameters examined were body weight, organ weights, urinalyses, and clinical chemistry. The NOAEL in this study was 200 mg/kg-day and the LOAEL was 400 mg/kg-day. Ocular Irritation Non-Human Ethylene/Propylene/Styrene Copolymer and Butylene/Ethylene/Styrene Copolymer (mixture) A mixture containing ethylene/propylene/styrene copolymer (4 to 15%) and butylene/ethylene/styrene copolymer (0.1 to 2%) was evaluated in an ocular irritation study involving albino rabbits (number of animals not stated).41 Details relating to the test protocol were not included. The mixture was not a primary ocular irritant in this study. It was noted that, under EPA Guideline No. 81-4,...","page":9,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_004"} |
| CIR_vision_codex | NOAEL | =80 | ppm | - | oral | - | oral toxicity | {"citation":"10; 20; 40","dose":"There were no significant differences in mean absolute and relative uterus weights between the control group and the 10 ppm, 20 ppm, 40 ppm, or 80 ppm group.","effect":"hts of the treatment groups were used for qualitative and quantitative assessment of possible uterotrophic activity. There were no significant differences in mean absolute and relative uterus weights between the control group and the 10 ppm, 20 ppm, 40 ppm, or 80 ppm group. However, significant and dose -related increases in mean absolute and relative uterus weights were observed in the 160 ppm group and in groups fed 5 ppb, 10 ppb, and 20 ppb DES, respectively. The results of this study indicated that the highest no-effect-level for estrogenic activity was 80 ppm polystyrene in the diet, which corresponded to a daily intake of 13.3 mg polystyrene/kg body weight. It was noted that 100 ppm polystyrene induced the same level of estrogenic activity as 5 ppb DES. It was concluded that the potentcy (estrogenic activity) of low molecular weight polystyrene (F2L5250) was a factor of 20,000 less than that of DES. SUMMARY The safety of 35 styrene and vinyl-type styrene copolymers as used in cosmetics is evaluated in this safety assessment. These ingredients function mostly as viscosity inc...","page":15,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_005"} |
| CIR_vision_codex | NOAEL | =250 | ppm | Rats | Inhalation | Multigeneration study | Developmental and reproductive effects | {"citation":"53","dose":"250 ppm","effect":"No treatment-related effects on maternal food consumption or weight gain","page":13,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"Rats_Styrene_Inhalation_Multigeneration"} |
| CIR_vision_codex | NOAEL | =0.05 | mg/m3 | rat | inhalation | 24 months | inhalation toxicity | {"citation":"0; 05; 2","dose":"/m3 (at this concentration, threshold for clearing inhaled test material from the lungs was exceeded) caused adverse pulmonary effects (marked inflammation and benign alveolar/bronchiolar adenoma) that are not relevant to subthreshold exposure concentrations.","effect":"/m3 (at this concentration, threshold for clearing inhaled test material from the lungs was exceeded) caused adverse pulmonary effects (marked inflammation and benign alveolar/bronchiolar adenoma) that are not relevant to subthreshold exposure concentrations. Inflammation decreased during the recovery period. The authors stated that these results support the inhalation safety of the polyacrylate material under both occupational and consumer exposure conditions. The 0.05 and 0.2 mg/m3 concentrations were considered no-adverse-effect levels. Three groups of 120 F344 rats (60 males, 60 females/group) were exposed for 24 months to respirable polyacrylate particles (MMAD ≈ 2 to 3 microns) at concentrations of 0.05, 0.2, and 0.8 mg/m3, respectively.38","page":8,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_001"} |
| CIR_vision_codex | NOAEL | =10.8 | mg polymer solids/m3 | rat | oral | 2-week | repeated dose toxicity | {"citation":"2; 29,30; 10","dose":"There were no signs of clinical toxicity at any administered dose.","effect":"odule formation in all exposure groups. The authors noted that characterization of the nodules was not possible, and it was determined that conclusions regarding the lung nodule incidence and its significance (if any) in this study could not be made. Styrene/Acrylates Copolymer ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer were evaluated in a 2-week aerosol (nose only) exposure study involving rats.29,30 The test protocol was not stated. There were no signs of clinical toxicity at any administered dose. The no-observed-effect-concentration (NOEC) was 10.8 mg polymer solids/m3, based on slight irritant effects in the lungs at a concentration of 100 mg/m3. In a 13-week aerosol (nose only) study on ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer involving rats, the no-observable adverse-effect level (NOAEL) for changes in the lung (and related lymph nodes) was 8.3 mg/m3.29,30 Oral Styrene The Environmental Protection Agency (EPA) has established a reference dose for chronic oral exposure (RfD) to styrene of 1 mg/kg/day, based on effects on red blood cells and the liver of dog...","page":9,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_002"} |
| CIR_vision_codex | NOAEL | =8.3 | mg/m3 | rat | oral | 2-week | repeated dose toxicity | {"citation":"2; 29,30; 10","dose":"There were no signs of clinical toxicity at any administered dose.","effect":"lates Copolymer ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer were evaluated in a 2-week aerosol (nose only) exposure study involving rats.29,30 The test protocol was not stated. There were no signs of clinical toxicity at any administered dose. The no-observed-effect-concentration (NOEC) was 10.8 mg polymer solids/m3, based on slight irritant effects in the lungs at a concentration of 100 mg/m3. In a 13-week aerosol (nose only) study on ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer involving rats, the no-observable adverse-effect level (NOAEL) for changes in the lung (and related lymph nodes) was 8.3 mg/m3.29,30 Oral Styrene The Environmental Protection Agency (EPA) has established a reference dose for chronic oral exposure (RfD) to styrene of 1 mg/kg/day, based on effects on red blood cells and the liver of dogs.39 The RfD is based on the assumption that thresholds exist for certain toxic effects, such as cellular necrosis. In general, the RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the human population (including...","page":9,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_003"} |
| CIR_vision_codex | NOAEL | =200 | mg/kg-day | dog | - | - | NOAEL study | {"citation":"200; 400; (4","dose":"erved for dogs administered styrene at 200 mg/kg-day.","effect":"erved for dogs administered styrene at 200 mg/kg-day. In the higher dose groups, increased numbers of Heinz bodies in the RBCs, decreased packed cell volume, and sporadic decreases in hemoglobin and RBC counts were observed. Additionally, increased iron deposits and elevated numbers of Heinz bodies were found in the livers. Marked individual variations in blood cell parameters were noted for animals at the same dose. Other parameters examined were body weight, organ weights, urinalyses, and clinical chemistry. The NOAEL in this study was 200 mg/kg-day and the LOAEL was 400 mg/kg-day. Ocular Irritation Non-Human Ethylene/Propylene/Styrene Copolymer and Butylene/Ethylene/Styrene Copolymer (mixture) A mixture containing ethylene/propylene/styrene copolymer (4 to 15%) and butylene/ethylene/styrene copolymer (0.1 to 2%) was evaluated in an ocular irritation study involving albino rabbits (number of animals not stated).41 Details relating to the test protocol were not included. The mixture was not a primary ocular irritant in this study. It was noted that, under EPA Guideline No. 81-4,...","page":9,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_004"} |
| CIR_vision_codex | NOAEL | =80 | ppm | - | oral | - | oral toxicity | {"citation":"10; 20; 40","dose":"There were no significant differences in mean absolute and relative uterus weights between the control group and the 10 ppm, 20 ppm, 40 ppm, or 80 ppm group.","effect":"hts of the treatment groups were used for qualitative and quantitative assessment of possible uterotrophic activity. There were no significant differences in mean absolute and relative uterus weights between the control group and the 10 ppm, 20 ppm, 40 ppm, or 80 ppm group. However, significant and dose -related increases in mean absolute and relative uterus weights were observed in the 160 ppm group and in groups fed 5 ppb, 10 ppb, and 20 ppb DES, respectively. The results of this study indicated that the highest no-effect-level for estrogenic activity was 80 ppm polystyrene in the diet, which corresponded to a daily intake of 13.3 mg polystyrene/kg body weight. It was noted that 100 ppm polystyrene induced the same level of estrogenic activity as 5 ppb DES. It was concluded that the potentcy (estrogenic activity) of low molecular weight polystyrene (F2L5250) was a factor of 20,000 less than that of DES. SUMMARY The safety of 35 styrene and vinyl-type styrene copolymers as used in cosmetics is evaluated in this safety assessment. These ingredients function mostly as viscosity inc...","page":15,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_005"} |
| CIR_vision_codex | NOAEL | =250 | ppm | Rats | Inhalation | Multigeneration study | Developmental and reproductive effects | {"citation":"53","dose":"250 ppm","effect":"No treatment-related effects on maternal food consumption or weight gain","page":13,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"Rats_Styrene_Inhalation_Multigeneration"} |
| CIR_vision_codex | NOAEL | =0.05 | mg/m3 | rat | inhalation | 24 months | inhalation toxicity | {"citation":"0; 05; 2","dose":"/m3 (at this concentration, threshold for clearing inhaled test material from the lungs was exceeded) caused adverse pulmonary effects (marked inflammation and benign alveolar/bronchiolar adenoma) that are not relevant to subthreshold exposure concentrations.","effect":"/m3 (at this concentration, threshold for clearing inhaled test material from the lungs was exceeded) caused adverse pulmonary effects (marked inflammation and benign alveolar/bronchiolar adenoma) that are not relevant to subthreshold exposure concentrations. Inflammation decreased during the recovery period. The authors stated that these results support the inhalation safety of the polyacrylate material under both occupational and consumer exposure conditions. The 0.05 and 0.2 mg/m3 concentrations were considered no-adverse-effect levels. Three groups of 120 F344 rats (60 males, 60 females/group) were exposed for 24 months to respirable polyacrylate particles (MMAD ≈ 2 to 3 microns) at concentrations of 0.05, 0.2, and 0.8 mg/m3, respectively.38","page":8,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_001"} |
| CIR_vision_codex | NOAEL | =10.8 | mg polymer solids/m3 | rat | oral | 2-week | repeated dose toxicity | {"citation":"2; 29,30; 10","dose":"There were no signs of clinical toxicity at any administered dose.","effect":"odule formation in all exposure groups. The authors noted that characterization of the nodules was not possible, and it was determined that conclusions regarding the lung nodule incidence and its significance (if any) in this study could not be made. Styrene/Acrylates Copolymer ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer were evaluated in a 2-week aerosol (nose only) exposure study involving rats.29,30 The test protocol was not stated. There were no signs of clinical toxicity at any administered dose. The no-observed-effect-concentration (NOEC) was 10.8 mg polymer solids/m3, based on slight irritant effects in the lungs at a concentration of 100 mg/m3. In a 13-week aerosol (nose only) study on ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer involving rats, the no-observable adverse-effect level (NOAEL) for changes in the lung (and related lymph nodes) was 8.3 mg/m3.29,30 Oral Styrene The Environmental Protection Agency (EPA) has established a reference dose for chronic oral exposure (RfD) to styrene of 1 mg/kg/day, based on effects on red blood cells and the liver of dog...","page":9,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_002"} |
| CIR_vision_codex | NOAEL | =8.3 | mg/m3 | rat | oral | 2-week | repeated dose toxicity | {"citation":"2; 29,30; 10","dose":"There were no signs of clinical toxicity at any administered dose.","effect":"lates Copolymer ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer were evaluated in a 2-week aerosol (nose only) exposure study involving rats.29,30 The test protocol was not stated. There were no signs of clinical toxicity at any administered dose. The no-observed-effect-concentration (NOEC) was 10.8 mg polymer solids/m3, based on slight irritant effects in the lungs at a concentration of 100 mg/m3. In a 13-week aerosol (nose only) study on ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer involving rats, the no-observable adverse-effect level (NOAEL) for changes in the lung (and related lymph nodes) was 8.3 mg/m3.29,30 Oral Styrene The Environmental Protection Agency (EPA) has established a reference dose for chronic oral exposure (RfD) to styrene of 1 mg/kg/day, based on effects on red blood cells and the liver of dogs.39 The RfD is based on the assumption that thresholds exist for certain toxic effects, such as cellular necrosis. In general, the RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the human population (including...","page":9,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_003"} |
| CIR_vision_codex | NOAEL | =200 | mg/kg-day | dog | - | - | NOAEL study | {"citation":"200; 400; (4","dose":"erved for dogs administered styrene at 200 mg/kg-day.","effect":"erved for dogs administered styrene at 200 mg/kg-day. In the higher dose groups, increased numbers of Heinz bodies in the RBCs, decreased packed cell volume, and sporadic decreases in hemoglobin and RBC counts were observed. Additionally, increased iron deposits and elevated numbers of Heinz bodies were found in the livers. Marked individual variations in blood cell parameters were noted for animals at the same dose. Other parameters examined were body weight, organ weights, urinalyses, and clinical chemistry. The NOAEL in this study was 200 mg/kg-day and the LOAEL was 400 mg/kg-day. Ocular Irritation Non-Human Ethylene/Propylene/Styrene Copolymer and Butylene/Ethylene/Styrene Copolymer (mixture) A mixture containing ethylene/propylene/styrene copolymer (4 to 15%) and butylene/ethylene/styrene copolymer (0.1 to 2%) was evaluated in an ocular irritation study involving albino rabbits (number of animals not stated).41 Details relating to the test protocol were not included. The mixture was not a primary ocular irritant in this study. It was noted that, under EPA Guideline No. 81-4,...","page":9,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_004"} |
| CIR_vision_codex | NOAEL | =80 | ppm | - | oral | - | oral toxicity | {"citation":"10; 20; 40","dose":"There were no significant differences in mean absolute and relative uterus weights between the control group and the 10 ppm, 20 ppm, 40 ppm, or 80 ppm group.","effect":"hts of the treatment groups were used for qualitative and quantitative assessment of possible uterotrophic activity. There were no significant differences in mean absolute and relative uterus weights between the control group and the 10 ppm, 20 ppm, 40 ppm, or 80 ppm group. However, significant and dose -related increases in mean absolute and relative uterus weights were observed in the 160 ppm group and in groups fed 5 ppb, 10 ppb, and 20 ppb DES, respectively. The results of this study indicated that the highest no-effect-level for estrogenic activity was 80 ppm polystyrene in the diet, which corresponded to a daily intake of 13.3 mg polystyrene/kg body weight. It was noted that 100 ppm polystyrene induced the same level of estrogenic activity as 5 ppb DES. It was concluded that the potentcy (estrogenic activity) of low molecular weight polystyrene (F2L5250) was a factor of 20,000 less than that of DES. SUMMARY The safety of 35 styrene and vinyl-type styrene copolymers as used in cosmetics is evaluated in this safety assessment. These ingredients function mostly as viscosity inc...","page":15,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_005"} |
| CIR_vision_codex | NOAEL | =250 | ppm | Rats | Inhalation | Multigeneration study | Developmental and reproductive effects | {"citation":"53","dose":"250 ppm","effect":"No treatment-related effects on maternal food consumption or weight gain","page":13,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"Rats_Styrene_Inhalation_Multigeneration"} |
| CIR_vision_codex | NOAEL | =0.05 | mg/m3 | rat | inhalation | 24 months | inhalation toxicity | {"citation":"0; 05; 2","dose":"/m3 (at this concentration, threshold for clearing inhaled test material from the lungs was exceeded) caused adverse pulmonary effects (marked inflammation and benign alveolar/bronchiolar adenoma) that are not relevant to subthreshold exposure concentrations.","effect":"/m3 (at this concentration, threshold for clearing inhaled test material from the lungs was exceeded) caused adverse pulmonary effects (marked inflammation and benign alveolar/bronchiolar adenoma) that are not relevant to subthreshold exposure concentrations. Inflammation decreased during the recovery period. The authors stated that these results support the inhalation safety of the polyacrylate material under both occupational and consumer exposure conditions. The 0.05 and 0.2 mg/m3 concentrations were considered no-adverse-effect levels. Three groups of 120 F344 rats (60 males, 60 females/group) were exposed for 24 months to respirable polyacrylate particles (MMAD ≈ 2 to 3 microns) at concentrations of 0.05, 0.2, and 0.8 mg/m3, respectively.38","page":8,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_001"} |
| CIR_vision_codex | NOAEL | =10.8 | mg polymer solids/m3 | rat | oral | 2-week | repeated dose toxicity | {"citation":"2; 29,30; 10","dose":"There were no signs of clinical toxicity at any administered dose.","effect":"odule formation in all exposure groups. The authors noted that characterization of the nodules was not possible, and it was determined that conclusions regarding the lung nodule incidence and its significance (if any) in this study could not be made. Styrene/Acrylates Copolymer ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer were evaluated in a 2-week aerosol (nose only) exposure study involving rats.29,30 The test protocol was not stated. There were no signs of clinical toxicity at any administered dose. The no-observed-effect-concentration (NOEC) was 10.8 mg polymer solids/m3, based on slight irritant effects in the lungs at a concentration of 100 mg/m3. In a 13-week aerosol (nose only) study on ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer involving rats, the no-observable adverse-effect level (NOAEL) for changes in the lung (and related lymph nodes) was 8.3 mg/m3.29,30 Oral Styrene The Environmental Protection Agency (EPA) has established a reference dose for chronic oral exposure (RfD) to styrene of 1 mg/kg/day, based on effects on red blood cells and the liver of dog...","page":9,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_002"} |
| CIR_vision_codex | NOAEL | =8.3 | mg/m3 | rat | oral | 2-week | repeated dose toxicity | {"citation":"2; 29,30; 10","dose":"There were no signs of clinical toxicity at any administered dose.","effect":"lates Copolymer ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer were evaluated in a 2-week aerosol (nose only) exposure study involving rats.29,30 The test protocol was not stated. There were no signs of clinical toxicity at any administered dose. The no-observed-effect-concentration (NOEC) was 10.8 mg polymer solids/m3, based on slight irritant effects in the lungs at a concentration of 100 mg/m3. In a 13-week aerosol (nose only) study on ACUDYNETM Shine Polymer and ACUDYNETM Bold Polymer involving rats, the no-observable adverse-effect level (NOAEL) for changes in the lung (and related lymph nodes) was 8.3 mg/m3.29,30 Oral Styrene The Environmental Protection Agency (EPA) has established a reference dose for chronic oral exposure (RfD) to styrene of 1 mg/kg/day, based on effects on red blood cells and the liver of dogs.39 The RfD is based on the assumption that thresholds exist for certain toxic effects, such as cellular necrosis. In general, the RfD is an estimate (with uncertainty spanning perhaps an order of magnitude) of a daily exposure to the human population (including...","page":9,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_003"} |
| CIR_vision_codex | NOAEL | =200 | mg/kg-day | dog | - | - | NOAEL study | {"citation":"200; 400; (4","dose":"erved for dogs administered styrene at 200 mg/kg-day.","effect":"erved for dogs administered styrene at 200 mg/kg-day. In the higher dose groups, increased numbers of Heinz bodies in the RBCs, decreased packed cell volume, and sporadic decreases in hemoglobin and RBC counts were observed. Additionally, increased iron deposits and elevated numbers of Heinz bodies were found in the livers. Marked individual variations in blood cell parameters were noted for animals at the same dose. Other parameters examined were body weight, organ weights, urinalyses, and clinical chemistry. The NOAEL in this study was 200 mg/kg-day and the LOAEL was 400 mg/kg-day. Ocular Irritation Non-Human Ethylene/Propylene/Styrene Copolymer and Butylene/Ethylene/Styrene Copolymer (mixture) A mixture containing ethylene/propylene/styrene copolymer (4 to 15%) and butylene/ethylene/styrene copolymer (0.1 to 2%) was evaluated in an ocular irritation study involving albino rabbits (number of animals not stated).41 Details relating to the test protocol were not included. The mixture was not a primary ocular irritant in this study. It was noted that, under EPA Guideline No. 81-4,...","page":9,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_004"} |
| CIR_vision_codex | NOAEL | =80 | ppm | - | oral | - | oral toxicity | {"citation":"10; 20; 40","dose":"There were no significant differences in mean absolute and relative uterus weights between the control group and the 10 ppm, 20 ppm, 40 ppm, or 80 ppm group.","effect":"hts of the treatment groups were used for qualitative and quantitative assessment of possible uterotrophic activity. There were no significant differences in mean absolute and relative uterus weights between the control group and the 10 ppm, 20 ppm, 40 ppm, or 80 ppm group. However, significant and dose -related increases in mean absolute and relative uterus weights were observed in the 160 ppm group and in groups fed 5 ppb, 10 ppb, and 20 ppb DES, respectively. The results of this study indicated that the highest no-effect-level for estrogenic activity was 80 ppm polystyrene in the diet, which corresponded to a daily intake of 13.3 mg polystyrene/kg body weight. It was noted that 100 ppm polystyrene induced the same level of estrogenic activity as 5 ppb DES. It was concluded that the potentcy (estrogenic activity) of low molecular weight polystyrene (F2L5250) was a factor of 20,000 less than that of DES. SUMMARY The safety of 35 styrene and vinyl-type styrene copolymers as used in cosmetics is evaluated in this safety assessment. These ingredients function mostly as viscosity inc...","page":15,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"FR673_noael_005"} |
| CIR_vision_codex | NOAEL | =250 | ppm | Rats | Inhalation | Multigeneration study | Developmental and reproductive effects | {"citation":"53","dose":"250 ppm","effect":"No treatment-related effects on maternal food consumption or weight gain","page":13,"pdf":"FR673.pdf","row_type":"noael_study","study_id":"Rats_Styrene_Inhalation_Multigeneration"} |
openFDA substances 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | H58HX2GWJ5 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"H58HX2GWJ5"} |
| openFDA substances | FDA UNII substance identifier | H58HX2GWJ5 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"H58HX2GWJ5"} |
| openFDA substances | FDA UNII substance identifier | H58HX2GWJ5 | UNII | - | - | - | polymer | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"polymer","unii_code":"H58HX2GWJ5"} |