Registration Dossier

Administrative data

Description of key information

SPC resin is classified as ‘causes severe skin burns and eye damage' (Skin Corrosion 1B) via its main component phenol. 

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 toxicological in vitro studies 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).

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.

Skin, Eye, and Respiratory tract irritation: DPC is not irritating to skin or eyes. Phenol ‘causes severe skin burns and eye damage’ (Skin Corrosion 1B) and BPA is classified as ‘causing serious eye damage’ (Eye Damage 1). Since classification for corrosivity also covers serious eye damage only Skin Corrosion 1B/R34 is taken over for SPC resin. In vitro studies with SPC resin showed that the multi-component substance induces irritating effects in reconstructed human skin tissue cultures. This result supports the read-across approach for SPC resin via the monomeric components. BPA is classified with STOT SE 3 (may cause respiratory irritation). However, the concentration limit of ≥ 20% BPA which would trigger classification for this endpoint is not reached in SPC resin. Additionally, this organ specific classification only refers to non lethal effects but SPC resin is already classified as ‘toxic if inhaled’ via its phenol content. Therefore SPC is not classified with STOT SE 3.

SPC Resin is classified with Skin Corrosion 1B (H314) according to Annex I of Regulation (EC) No 1272/2008 and R 34 according to EU-Directive 1999/45. No classification for respiratory irritation is required.