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Toxicological information


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Description of key information

No classification for SPC resin with regard to carcinogenicity required.

Key value for chemical safety assessment

Justification for classification or non-classification

Classification of SPC resin with regard to health hazards is based on the rules for classification of mixtures according to Regulation (EC) No. 1272/2008 and Directive 1999/45/EC. Generic or specific concentration limits for classification of the monomers, if available, are taken into account under worst-case assumptions. This includes that the maximal concentration of each of the monomeric components in SPC resin, i.e. 90% phenol, 50% DPC, and 4% BPA, is taken forward for classification of SPC resin. As a result human health classification of SPC resin follows the worst-case approach.

Carcinogenicity: None of the three monomeric components in SPC resin phenol, DPC and BPA showed effects in carcinogenicity studies that triggered classification for carcinogenicity. Therefore, for SPC resin no classification regarding carcinogenicity is required.

Additional information

SPC resin is a complex substance (UVCB) which can be regarded as a mixture of the monomers phenol, diphenyl carbonate (DPC), and 4,4’-isopropylidenediphenol (BPA) and their condensation products in which the monomers play the decisive role for human health. All three monomers are systemically available in laboratory animals after oral, dermal or inhalative exposure. They are toxicologically well investigated, show a comprehensive toxicological data base and have all been assessed in authority based peer review processes. Therefore, in line with Annex XI of Regulation (EC) No 1907/2006, read-across was chosen for the registration of SPC resin and no animal study has been performed with SPC resin itself. However, to substantiate the read-across hypothesis toxicologicalin vitrostudies with SPC resin have been performed; based on the results of these in vitro studies the read-across approach is supported (for details see attached document ‘Justification for Read-Across and Human Health Classification’ in section 13 of IUCLID data set).