NOAEL Studies
Cosmetic Ingredient
Maltitol NOAEL Studies
INCI: MALTITOL
CAS: 585-88-6
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR Safety Assessment 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR Safety Assessment | NOAEL | =69.09 | % | rat | - | - | NOAEL study | {"citation":"3; 20; 4","dose":"Some differences were observed in hematological parameters; however, except for a decrease in leukocytes in the mid-dose females, none of these findings were present at all observation points.","effect":"in blood chemistry or urinalysis. Some differences were observed in hematological parameters; however, except for a decrease in leukocytes in the mid-dose females, none of these findings were present at all observation points. Gross or histopathological changes were not observed. There was an increase in cecum diameter in males of the high-dose group, which the authors concluded to be due to higher values in 3 out of 20 rats; the opposite was observed for females of the low- and high-dose groups. In this study the no adverse effect level (NOEL) was the highest dose tested - 4.5 g commercial product/kg bw/day (Herrman 1993). Ocular and/or Mucosal Irritation Shiseido Research Center (2008a) studied the eye irritation of Maltitol (69.09%) in 3 rabbits. The test material was instilled into one eye of each animal without irrigation. The other eye remained untreated and served as the control. The eye reactions were evaluated according to the Draize scoring method. The eye","page":8,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"FR465_noael_001"} |
| CIR Safety Assessment | NOAEL | =2.5 | g/kg/day | New Zealand White rabbits (pregnant females) | gavage | day 6 through day 18 of pregnancy | reproductive/developmental toxicity | {"citation":"1","dose":"1.25, 2.5, or 5 g/kg/day","effect":"At 5 g/kg/day there was an increase in the number of early resorptions and increased post-implantation losses. No effects were observed in any treated group on maternal body weight increase, number of viable and dead fetuses, or on fetal body weights. No malformed fetuses were found at any of the doses administered.","page":6,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"Bussi_1985_repro"} |
| CIR Safety Assessment | NOAEL | =69.09 | % | rat | - | - | NOAEL study | {"citation":"3; 20; 4","dose":"Some differences were observed in hematological parameters; however, except for a decrease in leukocytes in the mid-dose females, none of these findings were present at all observation points.","effect":"in blood chemistry or urinalysis. Some differences were observed in hematological parameters; however, except for a decrease in leukocytes in the mid-dose females, none of these findings were present at all observation points. Gross or histopathological changes were not observed. There was an increase in cecum diameter in males of the high-dose group, which the authors concluded to be due to higher values in 3 out of 20 rats; the opposite was observed for females of the low- and high-dose groups. In this study the no adverse effect level (NOEL) was the highest dose tested - 4.5 g commercial product/kg bw/day (Herrman 1993). Ocular and/or Mucosal Irritation Shiseido Research Center (2008a) studied the eye irritation of Maltitol (69.09%) in 3 rabbits. The test material was instilled into one eye of each animal without irrigation. The other eye remained untreated and served as the control. The eye reactions were evaluated according to the Draize scoring method. The eye","page":8,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"FR465_noael_001"} |
| CIR Safety Assessment | NOAEL | =2.5 | g/kg/day | New Zealand White rabbits (pregnant females) | gavage | day 6 through day 18 of pregnancy | reproductive/developmental toxicity | {"citation":"1","dose":"1.25, 2.5, or 5 g/kg/day","effect":"At 5 g/kg/day there was an increase in the number of early resorptions and increased post-implantation losses. No effects were observed in any treated group on maternal body weight increase, number of viable and dead fetuses, or on fetal body weights. No malformed fetuses were found at any of the doses administered.","page":6,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"Bussi_1985_repro"} |
| CIR Safety Assessment | NOAEL | =69.09 | % | rat | - | - | NOAEL study | {"citation":"3; 20; 4","dose":"Some differences were observed in hematological parameters; however, except for a decrease in leukocytes in the mid-dose females, none of these findings were present at all observation points.","effect":"in blood chemistry or urinalysis. Some differences were observed in hematological parameters; however, except for a decrease in leukocytes in the mid-dose females, none of these findings were present at all observation points. Gross or histopathological changes were not observed. There was an increase in cecum diameter in males of the high-dose group, which the authors concluded to be due to higher values in 3 out of 20 rats; the opposite was observed for females of the low- and high-dose groups. In this study the no adverse effect level (NOEL) was the highest dose tested - 4.5 g commercial product/kg bw/day (Herrman 1993). Ocular and/or Mucosal Irritation Shiseido Research Center (2008a) studied the eye irritation of Maltitol (69.09%) in 3 rabbits. The test material was instilled into one eye of each animal without irrigation. The other eye remained untreated and served as the control. The eye reactions were evaluated according to the Draize scoring method. The eye","page":8,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"FR465_noael_001"} |
| CIR Safety Assessment | NOAEL | =2.5 | g/kg/day | New Zealand White rabbits (pregnant females) | gavage | day 6 through day 18 of pregnancy | reproductive/developmental toxicity | {"citation":"1","dose":"1.25, 2.5, or 5 g/kg/day","effect":"At 5 g/kg/day there was an increase in the number of early resorptions and increased post-implantation losses. No effects were observed in any treated group on maternal body weight increase, number of viable and dead fetuses, or on fetal body weights. No malformed fetuses were found at any of the doses administered.","page":6,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"Bussi_1985_repro"} |
| CIR Safety Assessment | NOAEL | =69.09 | % | rat | - | - | NOAEL study | {"citation":"3; 20; 4","dose":"Some differences were observed in hematological parameters; however, except for a decrease in leukocytes in the mid-dose females, none of these findings were present at all observation points.","effect":"in blood chemistry or urinalysis. Some differences were observed in hematological parameters; however, except for a decrease in leukocytes in the mid-dose females, none of these findings were present at all observation points. Gross or histopathological changes were not observed. There was an increase in cecum diameter in males of the high-dose group, which the authors concluded to be due to higher values in 3 out of 20 rats; the opposite was observed for females of the low- and high-dose groups. In this study the no adverse effect level (NOEL) was the highest dose tested - 4.5 g commercial product/kg bw/day (Herrman 1993). Ocular and/or Mucosal Irritation Shiseido Research Center (2008a) studied the eye irritation of Maltitol (69.09%) in 3 rabbits. The test material was instilled into one eye of each animal without irrigation. The other eye remained untreated and served as the control. The eye reactions were evaluated according to the Draize scoring method. The eye","page":8,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"FR465_noael_001"} |
| CIR Safety Assessment | NOAEL | =2.5 | g/kg/day | New Zealand White rabbits (pregnant females) | gavage | day 6 through day 18 of pregnancy | reproductive/developmental toxicity | {"citation":"1","dose":"1.25, 2.5, or 5 g/kg/day","effect":"At 5 g/kg/day there was an increase in the number of early resorptions and increased post-implantation losses. No effects were observed in any treated group on maternal body weight increase, number of viable and dead fetuses, or on fetal body weights. No malformed fetuses were found at any of the doses administered.","page":6,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"Bussi_1985_repro"} |
| CIR Safety Assessment | NOAEL | =4.5 | g/kg bw/day | Crl:CD(SD)BR rats | oral (diet) | 52 weeks (chronic toxicity) / 106 weeks (carcinogenicity) | chronic toxicity/carcinogenicity | {"citation":"1","dose":"0, 0.5, 1.5, or 4.5 g/kg bw/day","effect":"no adverse effect level (NOEL) was the highest dose tested - 4.5 g commercial product/kg bw/day","page":5,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"Herrman_1993_chronic"} |
| CIR Safety Assessment | NOAEL | =4.5 | g/kg bw/day | Crl:CD(SD)BR rats | oral (diet) | 52 weeks (chronic toxicity) / 106 weeks (carcinogenicity) | chronic toxicity/carcinogenicity | {"citation":"1","dose":"0, 0.5, 1.5, or 4.5 g/kg bw/day","effect":"no adverse effect level (NOEL) was the highest dose tested - 4.5 g commercial product/kg bw/day","page":5,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"Herrman_1993_chronic"} |
| CIR Safety Assessment | NOAEL | =4.5 | g/kg bw/day | Crl:CD(SD)BR rats | oral (diet) | 52 weeks (chronic toxicity) / 106 weeks (carcinogenicity) | chronic toxicity/carcinogenicity | {"citation":"1","dose":"0, 0.5, 1.5, or 4.5 g/kg bw/day","effect":"no adverse effect level (NOEL) was the highest dose tested - 4.5 g commercial product/kg bw/day","page":5,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"Herrman_1993_chronic"} |
| CIR Safety Assessment | NOAEL | =4.5 | g/kg bw/day | Crl:CD(SD)BR rats | oral (diet) | 52 weeks (chronic toxicity) / 106 weeks (carcinogenicity) | chronic toxicity/carcinogenicity | {"citation":"1","dose":"0, 0.5, 1.5, or 4.5 g/kg bw/day","effect":"no adverse effect level (NOEL) was the highest dose tested - 4.5 g commercial product/kg bw/day","page":5,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"Herrman_1993_chronic"} |
| CIR Safety Assessment | NOAEL | =18 | g/kg (rats); 43 g/kg (dogs) | rats and dogs | oral (diet) | 90 days | subchronic toxicity | {"citation":"1","dose":"up to 18 g/kg (rats) and 43 g/kg (dogs) of body weight per day","effect":"no treatment-related toxicity was seen in any rats or dogs","page":5,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"WHO_1999_subchronic"} |
| CIR Safety Assessment | NOAEL | =18 | g/kg (rats); 43 g/kg (dogs) | rats and dogs | oral (diet) | 90 days | subchronic toxicity | {"citation":"1","dose":"up to 18 g/kg (rats) and 43 g/kg (dogs) of body weight per day","effect":"no treatment-related toxicity was seen in any rats or dogs","page":5,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"WHO_1999_subchronic"} |
| CIR Safety Assessment | NOAEL | =18 | g/kg (rats); 43 g/kg (dogs) | rats and dogs | oral (diet) | 90 days | subchronic toxicity | {"citation":"1","dose":"up to 18 g/kg (rats) and 43 g/kg (dogs) of body weight per day","effect":"no treatment-related toxicity was seen in any rats or dogs","page":5,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"WHO_1999_subchronic"} |
| CIR Safety Assessment | NOAEL | =18 | g/kg (rats); 43 g/kg (dogs) | rats and dogs | oral (diet) | 90 days | subchronic toxicity | {"citation":"1","dose":"up to 18 g/kg (rats) and 43 g/kg (dogs) of body weight per day","effect":"no treatment-related toxicity was seen in any rats or dogs","page":5,"pdf":"FR465.pdf","row_type":"noael_study","study_id":"WHO_1999_subchronic"} |
EFSA 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA | NOAEL | =7600 | mg/kg bw/day | Rat | oral: feed | 91 days | subchronic | EFSA ANS - 2009 - OutputID 401 - no adverse effect observed at single/highest dose - Scientific Opinion on the use of Polyglycitol Syrup as a food additive - doi:10.2903/j.efsa.2009.1413 |
| EFSA | NOAEL | =7600 | mg/kg bw/day | Rat | oral: feed | 91 days | subchronic | EFSA ANS - 2009 - OutputID 401 - no adverse effect observed at single/highest dose - Scientific Opinion on the use of Polyglycitol Syrup as a food additive - doi:10.2903/j.efsa.2009.1413 |
| EFSA | NOAEL | =15400 | mg/kg bw/day | Rat | oral: feed | 91 days | subchronic | EFSA ANS - 2009 - OutputID 401 - no adverse effect observed at single/highest dose - Scientific Opinion on the use of Polyglycitol Syrup as a food additive - doi:10.2903/j.efsa.2009.1413 |
| EFSA | NOAEL | =15400 | mg/kg bw/day | Rat | oral: feed | 91 days | subchronic | EFSA ANS - 2009 - OutputID 401 - no adverse effect observed at single/highest dose - Scientific Opinion on the use of Polyglycitol Syrup as a food additive - doi:10.2903/j.efsa.2009.1413 |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | D65DG142WK | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C12H24O11","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"D65DG142WK"} |
| openFDA substances | FDA UNII substance identifier | D65DG142WK | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C12H24O11","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"D65DG142WK"} |
| openFDA substances | FDA UNII substance identifier | D65DG142WK | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C12H24O11","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"D65DG142WK"} |
| openFDA substances | FDA UNII substance identifier | D65DG142WK | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C12H24O11","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"D65DG142WK"} |