NOAEL Studies
Active Ingredient
Alpha-Arbutin NOAEL Studies
INCI: ALPHA-ARBUTIN
CAS: 84380-01-8
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
SCCS Opinion 22 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS Opinion | NOAEL | =1550 | - | rat | oral | 28-day | repeated dose toxicity | p.37 |
| SCCS Opinion | NOAEL | =1000 | mg/kg bw/day | rat | oral | 28-day | repeated dose toxicity | p.37 |
| SCCS Opinion | NOAEL | =100 | mg/kg bw/day | - | dermal | - | NOAEL study | p.42 |
| SCCS Opinion | NOAEL | =20 | mg/kg bw/d | - | - | - | repeated dose toxicity | p.43 |
| SCCS Opinion | NOAEL | =15 | mg/kg bw/d | - | - | - | repeated dose toxicity | p.43 |
| SCCS Opinion | NOAEL | =2 | % | - | - | - | NOAEL study | p.38 |
| SCCS Opinion | NOAEL | =3.3 | - | guinea pig | oral | Sub-chronic | repeated dose toxicity | p.29 |
| SCCS Opinion | NOAEL | =9 | - | - | - | - | NOAEL study | p.38 |
| SCCS Opinion | NOAEL | =15 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.38 |
| SCCS Opinion | NOAEL | =15 | mg/kg bw | - | oral | - | carcinogenicity | p.41 |
| SCCS Opinion | NOAEL | =20 | mg/kg/day | rat | oral | 28d | NOAEL study | p.37 |
| SCCS Opinion | NOAEL | =20 | mg/kg bw/day | - | dermal | - | NOAEL study | p.40 |
| SCCS Opinion | NOAEL | =20 | mg/kg bw | - | oral | - | carcinogenicity | p.41 |
| SCCS Opinion | NOAEL | =20 | % | guinea pig | dermal | 14-day | irritation | p.43 |
| SCCS Opinion | NOAEL | =25 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.38 |
| SCCS Opinion | NOAEL | =29 | - | - | oral | 14 days | repeated dose toxicity | p.29 |
| SCCS Opinion | NOAEL | =56 | - | - | dermal | 14-day | repeated dose toxicity | p.40 |
| SCCS Opinion | NOAEL | =74 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.38 |
| SCCS Opinion | NOAEL | =75 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.38 |
| SCCS Opinion | NOAEL | =150 | mg/kg/day | rat | - | - | reproductive toxicity | p.38 |
| SCCS Opinion | NOAEL | >250 | mg/kg bw | rat | oral | 14-day | repeated dose toxicity | p.42 |
| SCCS Opinion | NOAEL | =344 | - | rat | - | - | NOAEL study | p.38 |
Regulatory source 28 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 100 | mg/kg bw/day | - | dermal | - | - | p.42 |
| Regulatory source | - | 2 | % | - | - | - | - | p.38 |
| Regulatory source | - | 9 | - | - | - | - | - | p.38 |
| Regulatory source | - | =15 | mg/kg/day | rat | - | - | - | p.38 |
| Regulatory source | - | =20 | mg/kg/day | rat | oral | 28d | - | p.37 |
| Regulatory source | - | 20 | mg/kg bw/day | - | dermal | - | - | p.40 |
| Regulatory source | - | =74 | mg/kg/day | rat | dermal | 28d | - | p.38 |
| Regulatory source | - | 344 | - | rat | - | - | - | p.38 |
| Regulatory source | carcinogenicity | 15 | mg/kg bw | - | oral | - | carcinogenicity | p.41 |
| Regulatory source | carcinogenicity | 20 | mg/kg bw | - | oral | - | carcinogenicity | p.41 |
| Regulatory source | carcinogenicity | 25 | mg/kg/day | - | - | - | carcinogenicity | p.38 |
| Regulatory source | developmental toxicity | =25 | mg/kg/day | rabbit | - | developmental | developmental toxicity | p.38 |
| Regulatory source | developmental toxicity | =75 | mg/kg/day | rabbit | - | developmental | developmental toxicity | p.38 |
| Regulatory source | irritation | 20 | % | guinea pig | dermal | 14-day | irritation | p.43 |
| Regulatory source | repeated dose toxicity | 1550 | - | rat | oral | 28-day | repeated dose toxicity | p.37 |
| Regulatory source | repeated dose toxicity | 1000 | mg/kg bw/day | rat | oral | 28-day | repeated dose toxicity | p.37 |
| Regulatory source | repeated dose toxicity | 20 | mg/kg bw/d | - | - | - | repeated dose toxicity | p.43 |
| Regulatory source | repeated dose toxicity | 15 | mg/kg bw/d | - | - | - | repeated dose toxicity | p.43 |
| Regulatory source | repeated dose toxicity | 3.3 | - | guinea pig | oral | Sub-chronic | repeated dose toxicity | p.29 |
| Regulatory source | repeated dose toxicity | 29 | - | - | oral | 14 days | repeated dose toxicity | p.29 |
| Regulatory source | repeated dose toxicity | 56 | - | - | dermal | 14-day | repeated dose toxicity | p.40 |
| Regulatory source | repeated dose toxicity | >250 | mg/kg bw | rat | oral | 14-day | repeated dose toxicity | p.42 |
| Regulatory source | repeated dose toxicity | >250 | mg/kg bw | guinea pig | oral | 14-day | repeated dose toxicity | p.42 |
| Regulatory source | reproductive toxicity | =15 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.38 |
| Regulatory source | reproductive toxicity | =25 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.38 |
| Regulatory source | reproductive toxicity | =74 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.38 |
| Regulatory source | reproductive toxicity | =75 | mg/kg/day | rat | oral | 28d | reproductive toxicity | p.38 |
| Regulatory source | reproductive toxicity | =150 | mg/kg/day | rat | - | - | reproductive toxicity | p.38 |
openFDA substances 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 72VUP07IT5 | UNII | - | - | - | chemical | - |