NOAEL Studies
Active Ingredient
Beta-Arbutin NOAEL Studies
INCI: BETA-ARBUTIN
CAS: 497-76-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCS Opinion 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | p.17 |
| SCCS Opinion | NOAEL | =618 | mg/kg bw/day | - | oral | 28 day | NOAEL study | p.18 |
| SCCS Opinion | NOAEL | =400 | mg/kg bw/day | rat | - | 28 day | repeated dose toxicity | p.21 |
| SCCS Opinion | NOAEL | =0.522 | µg/cm | rat | oral | 28d | reproductive toxicity | p.30 |
| SCCS Opinion | NOAEL | =20 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.30 |
| SCCS Opinion | NOAEL | =74 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.30 |
| SCCS Opinion | NOAEL | =25 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.30 |
| SCCS Opinion | NOAEL | =75 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.30 |
| SCCS Opinion | NOAEL | =15 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.30 |
| SCCS Opinion | NOAEL | =100 | mg/kg bw/day | rat | dermal | - | reproductive toxicity | p.33 |
| SCCS Opinion | NOAEL | =150 | mg/kg/day | rat | - | - | reproductive toxicity | p.30 |
| SCCS Opinion | NOAEL | =1550 | - | - | - | - | reproductive toxicity | p.29 |
| SCCS Opinion | NOAEL | =1000 | mg/ kg bw | rat | oral | 28-day | dermal absorption | (ref. 8), p.36 |
| SCCS Opinion | NOAEL | =333 | mg/kg bw/d | rat | oral | 28-day | dermal absorption | (ref. 15), p.37 |
| SCCS Opinion | NOAEL | =100 | mg/kg bw | rat | oral | 28-day | dermal absorption | (ref. 15), p.37 |
| SCCS Opinion | NOAEL | =0.0005 | mg/kg bw/d | - | dermal | - | dermal absorption | (ref. 9), p.37 |
| SCCS Opinion | NOAEL | =20 | mg/kg bw/d | - | dermal | - | dermal absorption | (ref. 9), p.37 |
| SCCS Opinion | NOAEL | =0.00076 | mg/kg bw/d | - | dermal | - | dermal absorption | (ref. 9), p.37 |
| SCCS Opinion | NOAEL | =1 | % | - | - | - | NOAEL study | p.38 |
| SCCS Opinion | NOAEL | =37 | - | - | - | - | NOAEL study | p.37 |
Regulatory source 32 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 618 | mg/kg bw/day | - | oral | 28 day | - | p.18 |
| Regulatory source | - | =20 | mg/kg/day | rat | oral | 28d | - | p.30 |
| Regulatory source | - | =74 | mg/kg/day | rat | dermal | 28d | - | p.30 |
| Regulatory source | - | =15 | mg/kg/day | rat | - | - | - | p.30 |
| Regulatory source | - | 1 | % | - | - | - | - | p.38 |
| Regulatory source | - | 20 | mg/kg bw/d | - | - | - | - | p.37 |
| Regulatory source | - | 37 | - | - | - | - | - | p.37 |
| Regulatory source | dermal absorption | 1000 | mg/ kg bw | rat | oral | 28-day | dermal absorption | p.36 |
| Regulatory source | dermal absorption | =333 | mg/kg bw/d | rat | oral | 28-day | dermal absorption | p.37 |
| Regulatory source | dermal absorption | 100 | mg/kg bw | rat | oral | 28-day | dermal absorption | p.37 |
| Regulatory source | dermal absorption | 0.0005 | mg/kg bw/d | - | dermal | - | dermal absorption | p.37 |
| Regulatory source | dermal absorption | 20 | mg/kg bw/d | - | dermal | - | dermal absorption | p.37 |
| Regulatory source | dermal absorption | 0.00076 | mg/kg bw/d | - | dermal | - | dermal absorption | p.37 |
| Regulatory source | developmental toxicity | =25 | mg/kg/day | rabbit | - | developmental | developmental toxicity | p.30 |
| Regulatory source | developmental toxicity | =75 | mg/kg/day | rabbit | - | developmental | developmental toxicity | p.30 |
| Regulatory source | repeated dose toxicity | 1000 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | p.17 |
| Regulatory source | repeated dose toxicity | 400 | mg/kg bw/day | rat | - | 28 day | repeated dose toxicity | p.21 |
| Regulatory source | repeated dose toxicity | 1000 | mg/kg bw/day | rat | oral | 28 day | repeated dose toxicity | p.32 |
| Regulatory source | repeated dose toxicity | 1000 | mg/kg bw/day | rat | dermal | Sub-chronic | repeated dose toxicity | p.23 |
| Regulatory source | repeated dose toxicity | 618 | mg/kg bw/day | rat | oral | 28-day | repeated dose toxicity | p.24 |
| Regulatory source | repeated dose toxicity | 1000 | mg/kg bw/day | rat | oral | 28-day | repeated dose toxicity | p.24 |
| Regulatory source | repeated dose toxicity | 400 | mg/kg bw/day | rat | - | 28-day | repeated dose toxicity | p.27 |
| Regulatory source | reproductive toxicity | 0.522 | µg/cm | rat | oral | 28d | reproductive toxicity | p.30 |
| Regulatory source | reproductive toxicity | =20 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.30 |
| Regulatory source | reproductive toxicity | =74 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.30 |
| Regulatory source | reproductive toxicity | =25 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.30 |
| Regulatory source | reproductive toxicity | =75 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.30 |
| Regulatory source | reproductive toxicity | =15 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.30 |
| Regulatory source | reproductive toxicity | 100 | mg/kg bw/day | rat | dermal | - | reproductive toxicity | p.33 |
| Regulatory source | reproductive toxicity | =150 | mg/kg/day | rat | - | - | reproductive toxicity | p.30 |
| Regulatory source | reproductive toxicity | 1550 | - | - | - | - | reproductive toxicity | p.29 |
| Regulatory source | reproductive toxicity | 100 | mg/kg bw/day | rat | - | 12 months | reproductive toxicity | p.41 |
openFDA substances 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | C5INA23HXF | UNII | - | - | - | chemical | - |