Registration Dossier
Registration Dossier
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EC number: 296-120-8 | CAS number: 92257-31-3
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 30
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 40
Additional information
Due to the complex composition of this substance 6 representative constituents (A-G) were used to assess the potential ADME properties using
ADMET predictor (v7.2, Simulations Plus Inc, Lancaster, CA, USA),andGastroPlus (v9.0, Simulations Plus Inc, Lancaster, CA, USA).
The model used an exposure of 1 mg/kg (oral, dermal, inhalation) or 5 mg/kg (dermal) in a 30-year old human (70 kg), and predicted the fractional absorption (Fa%), bioavailability (F%), and maximum plasma concentration (Cmax) values for oral, dermal, and inhalation exposures to components A-G.
Overall, the predicted Cmaxvalues from oral or inhalation exposure for each component are higher than from dermal exposure; at the dermal exposure level of 1mg/kg or 5 mg/kg, the predicted Cmaxvalues for each component are much lower than the corresponding Cmaxvalues at 1 mg/kg oral exposure level, indicating that much higher than 5 mg/kg dermal exposure level of each component will be needed to produce the corresponding oral Cmaxlevel. Similar human protein binding (approx 99%) and Vd values (between 0.7 and 1.15 l/Kg) are predicted for all components.
Taking the predicted bioavailability for each of the representative structures along with the amount of each structure likely to be present in the registered substance it was possible to estimate the approximate amount of the overal substance that would be bioavailable via each route. These figures are reported above.
Based on the metabolism prediction by ADMET predictor, all components can be metabolized to hydroxylated metabolites (by human CYP 1A2 and CYP 3A4). Also according to the metabolism information of some Azo dyes, all components can be metabolized to the individual aromatic amine metabolites (by Azo reduction in human intestine ad to a limited extent on the skin).The formed metabolites can also be further metabolized to water soluble metabolites (such as glucuronides and sulfates), which will be mainly excreted into urine and feces.
On the basis of low volume of distribution, and predicted metabolism and excretion of all components, it can be predicted that this substance is not likely to bioaccumulate in humans.
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