NOAEL Studies
Cosmetic Ingredient
N,N'-BIS(2-HYDROXYETHYL)-2-NITRO-P-PHENYLENEDIAMINE NOAEL Studies
CAS: 84041-77-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS DB 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS DB | LOAEL | 80 | mg/kg bw/day | rat | oral | 90 day | Subchronic | SCCS; Rossiello, E. and Andreini, I. (2005) B 034 – 13 week oral toxicity study in rats followed by a 4 week recovery period |
SCCNFP Opinion 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP Opinion | NOAEL | =5 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | p.6 |
| SCCNFP Opinion | NOAEL | =50 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | p.6 |
| SCCNFP Opinion | NOAEL | =100 | mg/kg bw/day | rat | dermal | - | dermal absorption | p.9 |
| SCCNFP Opinion | NOAEL | =1000 | mg/kg bw/day | rat | dermal | - | dermal absorption | p.9 |
SCCS Opinion 11 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS Opinion | NOAEL | =0.017 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | p.36 |
| SCCS Opinion | NOAEL | =0.029 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | p.36 |
| SCCS Opinion | NOAEL | =5 | mg/kg bw/day | rat | - | 4 weeks | NOAEL study | p.15 |
| SCCS Opinion | NOAEL | =50 | mg/kg bw/day | rat | - | 4 weeks | NOAEL study | p.15 |
| SCCS Opinion | NOAEL | =100 | mg/kg bw/day | rat | oral | Prenatal | developmental toxicity | p.32 |
| SCCS Opinion | NOAEL | =120 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | p.36 |
| SCCS Opinion | NOAEL | =240 | mg/kg/day | - | - | Chronic | genotoxicity | p.16 |
| SCCS Opinion | NOAEL | =240 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | p.36 |
| SCCS Opinion | NOAEL | =720 | mg/kg bw/day | mouse | - | 90 day | irritation | p.35 |
| SCCS Opinion | NOAEL | =1000 | mg/kg | rat | oral | Prenatal | developmental toxicity | p.32 |
| SCCS Opinion | NOAEL | =1200 | mg/kg/day | human | - | - | NOAEL study | p.27 |
Regulatory source 31 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | dermal absorption | 100 | mg/kg bw/day | rat | dermal | - | dermal absorption | p.9 |
| Regulatory source | dermal absorption | 1000 | mg/kg bw/day | rat | dermal | - | dermal absorption | p.9 |
| Regulatory source | repeated dose toxicity | 5 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | p.6 |
| Regulatory source | repeated dose toxicity | 5 | mg/kg bw/day | rabbit | oral | subchronic | repeated dose toxicity | p.18 |
| Regulatory source | repeated dose toxicity | 50 | mg/kg bw/day | - | dermal | Sub-chronic | repeated dose toxicity | p.6 |
| Regulatory source | repeated dose toxicity | 50 | mg/kg bw/day | rabbit | oral | subchronic | repeated dose toxicity | p.18 |
| Regulatory source | repeated dose toxicity | 100 | mg/kg bw/day | rabbit | oral | subchronic | repeated dose toxicity | p.18 |
| Regulatory source | repeated dose toxicity | 1000 | mg/kg bw/day | rabbit | oral | subchronic | repeated dose toxicity | p.18 |
| Regulatory source | - | 5 | mg/kg bw/day | rat | - | 4 weeks | - | p.15 |
| Regulatory source | - | 50 | mg/kg bw/day | rat | - | 4 weeks | - | p.15 |
| Regulatory source | - | 240 | mg/kg/day | - | - | - | - | p.15 |
| Regulatory source | - | 240 | mg/kg bw/d | - | - | - | - | p.15 |
| Regulatory source | - | 1200 | mg/kg/day | human | - | - | - | p.27 |
| Regulatory source | dermal absorption | =0.017 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | p.36 |
| Regulatory source | dermal absorption | =0.029 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | p.36 |
| Regulatory source | dermal absorption | =120 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | p.36 |
| Regulatory source | dermal absorption | =240 | mg/kg bw/d | rat | oral | 90-day | dermal absorption | p.36 |
| Regulatory source | dermal absorption | 1200 | mg/kg/day | rat | dermal | - | dermal absorption | p.33 |
| Regulatory source | developmental toxicity | 100 | mg/kg bw/day | rat | oral | Prenatal | developmental toxicity | p.32 |
| Regulatory source | developmental toxicity | 100 | mg/kg bw/day | rat | oral | Developmental | developmental toxicity | p.33 |
| Regulatory source | developmental toxicity | 1000 | mg/kg | rat | oral | Prenatal | developmental toxicity | p.32 |
| Regulatory source | developmental toxicity | 1000 | mg/kg | rat | - | Developmental | developmental toxicity | p.33 |
| Regulatory source | genotoxicity | 240 | mg/kg/day | - | - | Chronic | genotoxicity | p.16 |
| Regulatory source | genotoxicity | 240 | mg/kg bw/d | - | - | Chronic | genotoxicity | p.17 |
| Regulatory source | irritation | 240 | mg/kg/day | - | - | 90 day | irritation | p.28 |
| Regulatory source | irritation | 240 | mg/kg bw/day | - | - | 90 day | irritation | p.35 |
| Regulatory source | irritation | 240 | mg/kg bw/day | - | - | 90-day | irritation | p.37 |
| Regulatory source | irritation | 720 | mg/kg bw/day | mouse | - | 90 day | irritation | p.35 |
| Regulatory source | irritation | 720 | mg/kg bw/d | mouse | - | 90-day | irritation | p.37 |
| Regulatory source | irritation | 1200 | mg/kg/day | mouse | - | 90 day | irritation | p.28 |
| Regulatory source | irritation | 1200 | mg/kg bw/d | mouse | - | 90-day | irritation | p.37 |
openFDA substances 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 3X0E669O5S | UNII | - | - | - | chemical | - |