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Diss Factsheets

Administrative data

Key value for chemical safety assessment

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).

Short description of key information:

SPC Resin was negative in the Ames Test and induced chromosomal aberrations in mammalian cells. SPC resin is classified in analogy to its main component phenol with Muta 2.

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.

Genetic Toxicity: BPA showed no significant mutagenic potential in vivo and is consequently not classified for genetic toxicity. Although DPC showed positive results in the chromosomal aberration testin vitro, it was negativein vivoand therefore not classified for mutagenicity. Phenol is ‘suspected of causing genetic defects’ (Muta 2), however, the available results fromin vivotest systems suggest a possible threshold mechanism for the induction of micronuclei via prolonged hypothermia.In vitrophenol was shown to induce gene- and chromosomal mutations in mammalian cells. SPC resin itself has been testedin vitrofor its mutagenic potential. In bacteria SPC resin did not show mutagenic effects, however, a Chromosomal Aberration assay led to enhanced frequencies of chromosomal mutations in mammalian cells. SPC resin is therefore classified in analogy to phenol with Muta 2.

SPC Resin is classified with Muta 2 (H341) according to Annex I of Regulation (EC) No 1272/2008 and Muta Cat 3, R 68 according to EU-Directive 1999/45/EEC.