Registration Dossier
Registration Dossier
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EC number: 926-571-4 | CAS number: 1187203-96-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
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:
In accordance with section 3 of REACH Annex XI, a study does not need to be conducted as, based on the Exposure Scenarios developed in the Chemical Safety Report, it is demonstrated and documented that throughout the life cycle Strictly Controlled Conditions as set out in Article 18(4)(a) to (f) of REACH do apply.
Effects on developmental toxicity
Description of key information
In accordance with section 3 of REACH Annex XI, a study does not need to be conducted as, based on the Exposure Scenarios developed in the Chemical Safety Report, it is demonstrated and documented that throughout the life cycle Strictly Controlled Conditions as set out in Article 18(4)(a) to (f) of REACH do apply.
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).
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.
Reproductive toxicity/Fertility: Neither phenol nor DPC showed effects in repeated dose or fertility studies that triggered classification for reproductive toxicity. BPA is ‘suspected of damaging fertility’ and classified accordingly with Repr. 2. According to Regulation 1272/2008 this triggers the same classification (Repr 2) for SPC resin because the generic concentration limit for this endpoint is 3% and thereby exceeded by the maximal BPA content in SPC resin (maximal 4% BPA). According to Directive 1999/45/EC the generic concentration limit for this endpoint is 5% and thereby not reached by the maximal BPA content in SPC resin. Thus, in accordance with Directive 1999/45/EC SPC resin is not classified for effects on fertility.
SPC Resin is classified with Repr 2 (H361f) according to Annex I of Regulation (EC) No 1272/2008. According to EU-Directive 1999/45/EC no classification is required.
Developmental toxicity: None of the monomers phenol, DPC and BPA showed effects in developmental toxicity studies that triggered classification for developmental toxicity. Therefore, for SPC resin no classification regarding developmental toxicity is required.
No classification for SPC resin with regard to developmental toxicity required.
Additional information
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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