Registration Dossier

Administrative data

Link to relevant study record(s)

Description of key information

There are no toxicokinetic studies available.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Nickel, 5,5'-azobis-2,4,6(1H,3H,5H)-pyrimidinetrione complexes (Gelbpigment E4GN) is insoluble in water (the water solubility of the test item in demineralized water was 0.08 mg/L at 20 °C and pH 6.2.) and has a log Pow of -2.63 (estimated value with EPIWIN using the formula of the nickel free substance. The model KOWWIN included in the Estimation Program Interface (EPI) Suite v4.11 revealed a value of - 2.63 of the substance).

Gelbpigment E4GN has a low acute toxicity (LD50 oral >5000 mg/kg bw ; LC50 inhalation > 5222 mg/m³). The substance is not irritating to the skin and eyes and has no sensitising potential. Gelbpigment E4GN was negative in all in-vitro gene mutation assays with and without metabolic activation. No toxification via metabolic activation of parent compounds are therefore expected. The NOAEL in a repeated dose study was 1000 mg/kg bw.