Little Pro on 2019-08-07
ED10 is a very important reproductive toxicity dose descriptor. It is used to describe the potency of a potential reproductive toxicant. In this article, we will explain what ED10 is and show you how to calculate ED10.
The ED10 value is the lowest dose which induces reproductive toxic effects with an incidence or magnitude of 10% effect level above background data. It usually needs to be calculated from animal developmental and/or reproductive toxicity studies.
ED10 is primarily used to characterize the potency of a reproductive toxicant (high, medium or low). Each final potency group can be assigned with a generic concentration limit (GCL) or a specific concentration limit (SCL).
ECHA recommends setting the following GCLs and SCLs for the different categories of reproductive toxicant based on their potency.
Note: The ED10 is usually in the same range as the NOAEL and LOAEL. Sometimes, the LOAEL can be lower than ED10. If a substance would fall into a lower potency group based on the ED10 but into a higher potency group based on the LOAEL then the higher potency group should be assigned to that substance.
Let's assume that we have conducted a reliable prenatal developmental toxicity study for substance A and have obtained the following data.
|Type of Study - Effects||NOAEL in ppm (mg/kg bw/d)||LOAEL in ppm (mg/kg bw/d)|
OECD 414, Wistar rats (gavage)
Dose: 0, 20, 60, 180 mg/kg bw
180 mg/kg bw: Postimplantation loss: 35%, reduced fetus body weight by 10%.
60 mg/kg bw: Postimplantation loss: 12% (not statistically significant compared to control data, less than 5%)
20 mg/kg bw: Postimplantation loss: 11%
0 mg/kg bw: Postimplantation loss: 10%
Since control postimplantation loss is 10%, ED10 rate would be 20% (10% above control data). Interpolation between NOAEL (classification) (12% at 60 mg/kg) and LOAEL (classification) (35% at 180 mg/kg) can be done using the following equation.
This ED10 value of 102 mg/kg bw/d will place substance A into medium potency group.
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