Registration Dossier
Registration Dossier
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EC number: 305-897-5 | CAS number: 95193-83-2
Neurotoxicity
Administrative data
Description of key information
The substance is not neurotoxic.
Key value for chemical safety assessment
Additional information
The effects of the substance (1-50 μM) have been tested on neurite outgrowths of a differentiated mouse NB2a neuroblastoma cell line in vitro. The differentiation of neurons in culture is a physiological process that is a general indicator of cellular well-being. Neurotoxicity was measured as an inhibition in neurite length. Over a 24-hour period, the substnace in combination with aspartame synergistically reduced neurite outgrowth length in the presence of appreciable cell death; although the substance alone was a relatively weak inhibitor of neurite outgrowth. The maximum tested concentrations were theoretically achievable in blood of children consuming typical substance and aspartame-containing foods and beverages. However, the concentration that may reach the nervous system should be much lower due to the presence of the blood-brain-barrier. EFSA Panel (EFSA, 2009) considered that the experimental model had a number of limitations. The Panel stated that no conclusion could be reached on the possible neurotoxicity risks of the substance based on these results.
EFSA. (2009). Scientific Opinion on the re-evaluation of Quinoline Yellow (E 104) as a food additive.
Justification for classification or non-classification
Not classified for neurotoxicity according to the CLP Regulation (EC) No. 1272/2008.
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