Registration Dossier
Registration Dossier
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EC number: 926-571-4 | CAS number: 1187203-96-8
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- 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).
Migrated from Short description of key information:
SPC Resin is classified with as skin sensitizer (Skin Sens 1) via its BPA content.
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 Sensitization: Neither phenol nor DPC induced skin sensitization in animal models. BPA, however, is classified as ‘skin sensitizer’ (Skin Sens 1), although new information from in vivo animal studies does not confirm this assumption. Since the maximal concentration of BPA in SPC resin exceeds the generic concentration limit of 1% (maximal 4%) Skin Sens 1 is triggered for SPC resin.
SPC Resin is classified with Skin Sens 1 (H317) according to Annex I of Regulation (EC) No 1272/2008 and R 43 according to EU-Directive 1999/45/EEC.
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.
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