NOAEL Studies
Active Ingredient
Kojic Acid NOAEL Studies
INCI: KOJIC ACID
CAS: 501-30-4
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR Safety Assessment 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR Safety Assessment | NOAEL | =0.5 | % | rat | oral | - | oral toxicity | 2; 0; 5, p.18 |
| CIR Safety Assessment | NOAEL | =1 | % | guinea pig | - | - | NOAEL study | 4; 1, p.26 |
| CIR Safety Assessment | NOAEL | =100 | mg/kg | rat | oral | Subchronic | repeated dose toxicity | 300; 100; 56, p.7 |
| CIR Safety Assessment | NOAEL | =125 | mg/kg | rat | dermal | Chronic | NOAEL study | 500; 2; 125, p.8 |
| CIR Safety Assessment | NOAEL | =150 | mg/kg | mouse | oral | 3 weeks | repeated dose toxicity | 3; 900; 18, p.11 |
COSMOS DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS DB | LOAEL | 5.84999990463 | mg/kg bw/day | rat | oral | 28 day | Short Term Toxicity | SCCP; Tamura T et al. Inhibition of Thyroid Iodine Uptake and Organification in Rats Treatedwith Kojic Acid. Toxicological Sciences47, 170-175 |
IARC Monographs 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| IARC Monographs | IARC carcinogenicity classification | 3 | IARC group | - | - | 2000 | IARC Monographs | - |
NTP ICE cancer 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE cancer | IARC group | 3 | unitless | - | - | - | WOE; IARC Carcinogenicity | sheet=Data; excel_row=3166; Record_ID=cancer_1714; Data_Type=WOE; Formulation_Name=Kojic acid; Mixture=Chemical; DTXSID=DTXSID2040236; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/97; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2040236 |
SCCS Opinion 32 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS Opinion | NOAEL | =0.003 | % | rat | oral | subchronic | repeated dose toxicity | p.70 |
| SCCS Opinion | NOAEL | =0.03 | % | rat | oral | 8 weeks | NOAEL study | p.50 |
| SCCS Opinion | NOAEL | =0.069 | mg/kg | rat | oral | 4-week | dermal absorption | p.69 |
| SCCS Opinion | NOAEL | =0.079 | mg/kg | rat | oral | 28 days | repeated dose toxicity | p.15 |
| SCCS Opinion | NOAEL | =0.104 | mg/kg | rat | oral | 28-days | dermal absorption | p.69 |
| SCCS Opinion | NOAEL | =0.12 | mg/kg | rat | oral | 28 days | repeated dose toxicity | p.15 |
| SCCS Opinion | NOAEL | =0.173 | mg/kg | rat | oral | 28-days | dermal absorption | p.69 |
| SCCS Opinion | NOAEL | =0.199 | mg/kg | rat | oral | 28 days | repeated dose toxicity | p.15 |
| SCCS Opinion | NOAEL | =0.5 | % | rat | oral | 28 days | NOAEL study | p.70 |
| SCCS Opinion | NOAEL | =2 | mg/kg bw/d | rat | oral | 28 days | repeated dose toxicity | p.15 |
| SCCS Opinion | NOAEL | =2 | % | rat | oral | 4 weeks | NOAEL study | p.68 |
| SCCS Opinion | NOAEL | =2 | - | - | - | - | NOAEL study | p.40 |
| SCCS Opinion | NOAEL | =2.38 | µg/cm | human | dermal | - | genotoxicity | (Ref. 11), p.14 |
| SCCS Opinion | NOAEL | =5.85 | mg/kg bw/day | rat | oral | 4 weeks | NOAEL study | p.21 |
| SCCS Opinion | NOAEL | =6 | mg/kg bw/day | rat | oral | 28 days | NOAEL study | p.22 |
| SCCS Opinion | NOAEL | =6 | mg/kg/day | rat | oral | 28-day | repeated dose toxicity | (Ref. 11), p.14 |
| SCCS Opinion | NOAEL | =8.39 | µg/cm | rat | oral | 28 days | repeated dose toxicity | p.15 |
| SCCS Opinion | NOAEL | =15 | mg/kg bw/day | rat | - | 4 weeks | NOAEL study | p.71 |
| SCCS Opinion | NOAEL | =15.5 | mg/kg bw | rat | oral | 2 weeks | NOAEL study | p.57 |
| SCCS Opinion | NOAEL | =15.5 | mg/kg bw/day | rat | - | subchronic | repeated dose toxicity | p.70 |
| SCCS Opinion | NOAEL | =23.8 | mg/kg bw/day | rat | oral | 4 weeks | NOAEL study | p.21 |
| SCCS Opinion | NOAEL | =30 | mg/kg bw/day | mouse | - | - | reproductive toxicity | p.61 |
| SCCS Opinion | NOAEL | =40 | - | - | - | - | NOAEL study | p.40 |
| SCCS Opinion | NOAEL | =62.5 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | Ref.: 32 Comment A NOAEL of 62, p.22 |
| SCCS Opinion | NOAEL | =68 | - | - | - | - | NOAEL study | p.68 |
| SCCS Opinion | NOAEL | =100 | mg/kg/day | rat | oral | 28 days | NOAEL study | p.20 |
| SCCS Opinion | NOAEL | =100 | mg/kg bw/day | rat | - | - | NOAEL study | p.62 |
| SCCS Opinion | NOAEL | =125 | mg/kg bw/day | rat | dermal | 28 day | NOAEL study | p.6 |
| SCCS Opinion | NOAEL | =150 | mg/kg bw/day | rat | - | 21 days | reproductive toxicity | p.59 |
| SCCS Opinion | NOAEL | =227 | mg/kg bw/day | rat | oral | 55-week | dermal absorption | (Ref. 5), p.11 |
| SCCS Opinion | NOAEL | =1637 | - | human | - | - | NOAEL study | p.40 |
| SCCS Opinion | NOAEL | =2600 | mg/kg bw | rat | oral | 28-day | repeated dose toxicity | p.41 |
Regulatory source 70 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 1 | % | guinea pig | - | - | - | p.26 |
| Regulatory source | - | 125 | mg/kg | rat | dermal | Chronic | - | p.8 |
| Regulatory source | oral toxicity | 0.5 | % | rat | oral | - | oral toxicity | p.18 |
| Regulatory source | repeated dose toxicity | 100 | mg/kg | rat | oral | Subchronic | repeated dose toxicity | p.7 |
| Regulatory source | repeated dose toxicity | 150 | mg/kg | mouse | oral | 3 weeks | repeated dose toxicity | p.11 |
| Regulatory source | - | 0.03 | % | rat | oral | 8 weeks | - | p.50 |
| Regulatory source | - | 0.03 | % | rat | - | 20 weeks | - | p.77 |
| Regulatory source | - | 0.5 | % | rat | oral | 28 days | - | p.70 |
| Regulatory source | - | 2 | % | rat | oral | 4 weeks | - | p.68 |
| Regulatory source | - | 2 | - | - | - | - | - | p.40 |
| Regulatory source | - | 5.85 | mg/kg bw/day | rat | oral | 4 weeks | - | p.21 |
| Regulatory source | - | 6 | mg/kg bw/day | rat | oral | 28 days | - | p.22 |
| Regulatory source | - | 6 | mg/kg bw | rat | oral | 28 day | - | p.73 |
| Regulatory source | - | 6 | mg/kg bw/day | rat | oral | 28 day | - | p.9 |
| Regulatory source | - | 6 | mg/kg bw/day | rat | oral | - | - | p.26 |
| Regulatory source | - | 6 | mg/kg bw/day | - | - | - | - | p.69 |
| Regulatory source | - | 6 | mg/kg bw/day | rat | oral | 4 weeks | - | p.69 |
| Regulatory source | - | 15 | mg/kg bw/day | rat | - | 4 weeks | - | p.71 |
| Regulatory source | - | 15.5 | mg/kg bw | rat | oral | 2 weeks | - | p.57 |
| Regulatory source | - | 23.8 | mg/kg bw/day | rat | oral | 4 weeks | - | p.21 |
| Regulatory source | - | 40 | - | - | - | - | - | p.40 |
| Regulatory source | - | 62.5 | mg/kg bw/day | rat | - | - | - | p.70 |
| Regulatory source | - | 62.5 | mg/kg bw/day | rat | oral | 28 days | - | p.70 |
| Regulatory source | - | 68 | - | - | - | - | - | p.68 |
| Regulatory source | - | 100 | mg/kg/day | rat | oral | 28 days | - | p.20 |
| Regulatory source | - | 100 | mg/kg bw/day | rat | - | - | - | p.62 |
| Regulatory source | - | 100 | mg/kg bw | rat | oral | - | - | p.73 |
| Regulatory source | - | 100 | mg/kg bw | rat | - | - | - | p.16 |
| Regulatory source | - | 100 | mg/kg/day | rat | oral | 28-day | - | p.25 |
| Regulatory source | - | 125 | mg/kg bw/day | rat | dermal | 28 day | - | p.6 |
| Regulatory source | - | 150 | mg/kg bw/day | mouse | - | 13-week | - | p.60 |
| Regulatory source | - | 150 | mg/kg bw/day | mouse | oral | - | - | p.29 |
| Regulatory source | - | 227 | mg/kg bw/day | rat | oral | 26 weeks | - | p.28 |
| Regulatory source | - | 1637 | - | human | - | - | - | p.40 |
| Regulatory source | dermal absorption | =0.069 | mg/kg | rat | oral | 4-week | dermal absorption | p.69 |
| Regulatory source | dermal absorption | =0.104 | mg/kg | rat | oral | 28-days | dermal absorption | p.69 |
| Regulatory source | dermal absorption | =0.173 | mg/kg | rat | oral | 28-days | dermal absorption | p.69 |
| Regulatory source | dermal absorption | 6 | mg/kg bw/day | rat | oral | 4-week | dermal absorption | p.69 |
| Regulatory source | dermal absorption | =6 | mg/kg | rat | oral | 4-week | dermal absorption | p.69 |
| Regulatory source | dermal absorption | =6 | mg/kg | rat | oral | 28-days | dermal absorption | p.69 |
| Regulatory source | dermal absorption | 6 | mg/kg bw/day | rat | dermal | 28-day | dermal absorption | p.10 |
| Regulatory source | dermal absorption | 6 | mg/kg bw/day | rat | oral | 28-day | dermal absorption | p.13 |
| Regulatory source | dermal absorption | 227 | mg/kg bw/day | rat | oral | 55-week | dermal absorption | p.11 |
| Regulatory source | developmental toxicity | 6 | mg/kg bw/day | rat | - | developmental | developmental toxicity | p.38 |
| Regulatory source | genotoxicity | 2.38 | µg/cm | human | dermal | - | genotoxicity | p.14 |
| Regulatory source | genotoxicity | 100 | mg/kg/day | rat | - | 4-week | genotoxicity | p.7 |
| Regulatory source | irritation | 100 | mg/kg bw/day | rat | dermal | 19 weeks | irritation | p.70 |
| Regulatory source | repeated dose toxicity | 0.003 | % | rat | oral | subchronic | repeated dose toxicity | p.70 |
| Regulatory source | repeated dose toxicity | =0.079 | mg/kg | rat | oral | 28 days | repeated dose toxicity | p.15 |
| Regulatory source | repeated dose toxicity | =0.12 | mg/kg | rat | oral | 28 days | repeated dose toxicity | p.15 |
| Regulatory source | repeated dose toxicity | =0.199 | mg/kg | rat | oral | 28 days | repeated dose toxicity | p.15 |
| Regulatory source | repeated dose toxicity | =2 | mg/kg bw/d | rat | oral | 28 days | repeated dose toxicity | p.15 |
| Regulatory source | repeated dose toxicity | =2 | mg/kg bw/d | rat | oral | subchronic | repeated dose toxicity | p.15 |
| Regulatory source | repeated dose toxicity | =2 | mg/kg bw/d | rat | oral | 6-month | repeated dose toxicity | p.15 |
| Regulatory source | repeated dose toxicity | 2 | mg/kg bw/day | rat | oral | 28-day | repeated dose toxicity | p.39 |
| Regulatory source | repeated dose toxicity | 6 | mg/kg/day | rat | oral | 28-day | repeated dose toxicity | p.14 |
| Regulatory source | repeated dose toxicity | =6 | mg/kg bw/d | rat | oral | 28 days | repeated dose toxicity | p.15 |
| Regulatory source | repeated dose toxicity | 6 | mg/kg bw/day | rat | oral | subchronic | repeated dose toxicity | p.29 |
| Regulatory source | repeated dose toxicity | 6 | mg/kg bw/day | rat | oral | 28-day | repeated dose toxicity | p.39 |
| Regulatory source | repeated dose toxicity | =8.39 | µg/cm | rat | oral | 28 days | repeated dose toxicity | p.15 |
| Regulatory source | repeated dose toxicity | 15.5 | mg/kg bw/day | rat | - | subchronic | repeated dose toxicity | p.70 |
| Regulatory source | repeated dose toxicity | 23.8 | mg/kg bw/day | rat | oral | subchronic | repeated dose toxicity | p.6 |
| Regulatory source | repeated dose toxicity | 62.5 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | p.22 |
| Regulatory source | repeated dose toxicity | 2600 | mg/kg bw | rat | oral | 28-day | repeated dose toxicity | p.41 |
| Regulatory source | reproductive toxicity | 30 | mg/kg bw/day | mouse | - | - | reproductive toxicity | p.61 |
| Regulatory source | reproductive toxicity | 30 | mg/kg bw/day | rat | - | 21 days | reproductive toxicity | p.31 |
| Regulatory source | reproductive toxicity | 100 | mg/kg bw/day | rat | - | 1 to day | reproductive toxicity | p.72 |
| Regulatory source | reproductive toxicity | 100 | mg/kg bw/day | rat | - | - | reproductive toxicity | p.32 |
| Regulatory source | reproductive toxicity | 100 | mg/kg bw/day | rat | oral | 28-day | reproductive toxicity | p.41 |
| Regulatory source | reproductive toxicity | 150 | mg/kg bw/day | rat | - | 21 days | reproductive toxicity | p.59 |
openFDA substances 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 6K23F1TT52 | UNII | - | - | - | chemical | - |