Registration Dossier
Registration Dossier
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EC number: 239-763-1 | CAS number: 15680-42-9
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The pigment is a poorly soluble complex of copper ions with an organic anion that is at least partly dissociated in stomach acid. Continuous high dose gavage treatment results in accumulation of copper in the liver of rats. As copper is naturally cleared from the liver upon cessation of dosing, this is not considered as bioaccumulation.
The findings in the acute inhalation study also indicate toxicity related to the release of copper ions.
The solid particles are in the range that qualifies as "nanomaterial" according to the EU definition. This has no specific impact on toxikokinetics as the substance is soluble in the low pH range.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
A preliminary qualitative experiment showed that Pigment Yellow 129 can release soluble copper ions in 1N HCl at 37°C after 15h. Therefore, a quantitative deterimnation of copper with included in the 14 -day dose range-finding study performed in each four male and female rats with 300 and 1000 mg/kg bw (BASF 2014). At the dose group of 300 mg/kg bw, the copper content was increased 2.4fold and 5.5fold in females and males, respectively. At the dose group of 1000 mg/kg bw, the copper content was increased 6.6fold and 25fold in females and males, respectively.
The organic anion is not expected to accumulate since it is negatively charged and may be subject to azo reduction and further metabolic degradation. Degradation products are expected to be so small that renal elimination should dominate.
During the OECD 422 study, liver histopathology findings were consistent with copper toxicity. No other adverse effects were noted. There were no adverse effects on offspring.
Copper accumulation in liver is reversible upon cessation of treatment and it occurred at very high doses. Therefore, the overall conclusion is that the substance is not bioaccumulating.
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