Registration Dossier
Registration Dossier
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EC number: 247-148-4 | CAS number: 25637-99-4
Neurotoxicity
Administrative data
Description of key information
The following information is available for neurotoxicity potential of the registered substance:
Mariussen, E. and Fonnum, F. (2003). The effect of brominated flame retardants on neurotransmitter uptake into rat brain synaptosomes and vesicles. Neurochemistry International (2003), Vol. 43, pp.533-542.
Reistad, T., Fonnum, F. and Mariussen, E. (2006). Neurotoxicity of the pentabrominated diphenyl ether mixture, DE-71, and hexabromocyclododecane (HBCD) in rat cerebellar granule cells in vitro. Arch. Toxicol. (2006), Vol. 80, pp.785-795.
It was not possible to score either neurotoxicity studies for reliability due to non-standard methodologies and lack of reporting of scientific principles. The studies were therefore both awarded reliability scores of 4 according to the criteria of Klimisch et al. (1997). It should be noted that the concentrations used in those assays are far above the water solubility of HBCDD and probably yhe solubility in the media. In vitro studies under those conditions are of questionable value and no conclusion can be drawn from those experiments.
Key value for chemical safety assessment
Additional information
Mariussen et al. (2003) conducted several experiments to evaluate the effect of brominated flame retardants, including the registered substance, on neurotransmitter uptake in rat brain synaptosomes and vesicles. Original test methodologies were used to model the effect of the registered substance on the rat brain, which makes comparing the investigations carried out by Mariussen et al. (2003) to other investigations difficult. Mariussen et al. (2003) reported that the registered substance inhibited the uptake of dopamine (IC50 4±1µm) and Glutamate (IC50 26±9µm) in rat synaptosomes and partly inhibited TPP+ uptake in rat synaptosomes under the conditions of the test. Mariussen et al. (2003) also reported that the registered substance induced the death of CGC in low micromolar concentrations.
Reistad et al. (2006) also examined the effect of the registered substance on vesicular uptake of dopamine in the rat brain, however, the methodology differed significantly from that employed by Mariussen et al. (2003). Reistad et al. (2006) concluded that the registered substance inhibited dopamine uptake in the rat brain and reported an IC50 value of 3±1µm.
Justification for classification or non-classification
No classification for neurotoxicity or adverse effect upon the central nervous system has been placed upon the registered substance. The available data do not indicate any specific target organ toxicity at relevant dose levels. In vitro data are not of a quality that they can be used in an assessment of the human health effects of the substance. They are also of limited use for considerations on a mode of action.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
