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EC number: 255-965-2 | CAS number: 42844-93-9
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Absorption: Based on the subacute (49-day) oral toxicity study absorption of toxicologically significant amounts of Pigment Orange 68 via the gastrointestinal tract has not to be assumed since neither obvious discoloration of inner organs nor any other effects on inner organs was observed throughout the body. There was only discoloration of digestive tract where direct exposure resulted from oral gavage.
Systemic availability seems to be negligible after exposure since no systemic signs of intoxication were seen after administration of 1000 mg Pigment Orange 68 per kg body weight in rats. Indications of a significant dermal absorptive potential were also not revealed by testing for primary irritation in rabbits. The notion of very limited dermal absorption is also corroborated by the very low solubility in water as well as octanol of 12.5 µg/L or less than 200 µg/L, respectively.
Distribution: Based on the results of the subacute oral toxicity study discolorations were observed in the digestive tract lumen only. Thus, it can be concluded, that Pigment Orange 68 is not absorbed through the gastrointestinal tract and not systemically available within the organism. Histopathological findings indicate no deposition of the pigment in any tissue.
There were no signs of bioaccumulation of the test material. This view is supported by the physical-chemical properties (very low solubility in water and octanol) and the molecular structure.
Excretion: Taking into account the physico-chemical properties and the molecular structure of the pigment and the considerations regarding absorption (above) it can be assumed that only traces of the applied dose will be available for excretion. The main route of excretion would most probably be the liver/bile. Nevertheless, the vast majority of the dose is expected to just pass through the digestive tract without being absorbed. This notion is confirmed by the discoloration of faeces only, observed in the subacute study.
Metabolism: Pigment Orange 68 proved to be inactive in the Ames-test with and without exogenous metabolic activation. It was not genotoxic in the HPRT and chromosomal aberration assay in vitro. This indicates that Pigment Orange 68 is not metabolically active. Metabolites, if any are formed, are not more toxic than the parent compound.
No effects were seen in the subacute study except for a discoloration of intestinal contents. No functional or structural impairments were detected. Therefore, Pigment Orange 68 is considered to just pass through the intestinal tract without significant metabolism.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
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